Clinical Trials

Find a Parkview Health Clinical Trial

322 results found

Current Studies

(A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement (COMPLETE TAVR)

Primary Objective: To determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the...

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Past Studies

28431754HFA3002 Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure (CHIEF - HF)

The primary objective is: * to determine the superiority of the effectiveness of canagliflozin 100 mg daily versus placebo in participants with symptomatic HF in improving the overall KCCQ TSS. The first key secondary objective is: * to determine the superiority of the effectiveness of...

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Past Studies

A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

Primary Objective of the Master Protocol (S1400) The overarching goal for this protocol is to establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub-study ...

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Past Studies

A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study

Primary Objectives The primary objectives of this study are to assess the safety and efficacy of the Durata or Optisure lead and Ellipse VR ICD in an MRI environment.

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A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest

To demonstrate the safety and clinical effectiveness of the Jewel P-WCD

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Past Studies

A Clinical Evaluation of the Medtronic Endeavor� Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries with a Reference Vessel Diameter of 2.25 mm to 4.2 mm. The Medtronic RESOLUTE US Clinical Trial

To assess the safety and efficacy of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.

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A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia

Primary Outcome Measures Incidence of adverse events following administration of BBP-671 (Time Frame= 43 day) BBP-671 concentration dependent change in change from baseline in QTcF (Time Frame= 43 days) Pharmacokinetic Assessments: Cmax (Time Frame= 43 days) Time to maximum concentration...

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Past Studies

A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)

Primary Objective: The primary objective is to evaluate the effectiveness of adding Epanova to statin therapy (with or without ezetimibe) for lowering MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergent/elective coronary revascularization, or hospitalization for...

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Current Studies

A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)

Primary Objective of the Master Protocol (LungMAP) The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol. Secondary Objectives a....

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Current Studies

A Multicenter Phase II Trial of Paclitaxel With and Without Nivolumab in Taxane Naive, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects With Angiosarcoma

Co-primary Objectives To determine the progression free survival (PFS) for paclitaxel with and without nivolumab in subjects with taxane na�ve angiosarcoma. To determine the overall response rate (ORR) of nivolumab in combination with cabozantinib in patients with taxane pre-treated...

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Past Studies

A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke

The primary objective of the study is to assess the clinical effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of functional independence and activities of daily living. The secondary objective of the study is to explore dose and exposure response and the...

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Current Studies

A Multi-center, Double-Blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) plus Pembrolizumab (MK-3475) Versus Placebo plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (6482-022)

Primary To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab Hypothesis (1): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to...

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Past Studies

A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients with Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage

Primary Outcome Measures 1.Resolution of Acute Cholecystitis [ Time Frame: Up to 15 weeks ] Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5�F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc,...

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Past Studies

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects with Head and Neck Cancer (HNC) Receiving Concurrent Radiation and Chemotherapy (RT/CT)

Primary Outcome Measures 1.Proportion of subjects with a diagnosis of severe oral mucositis during the course of receiving up to 50 Gray (Gy) cumulative radiation dose administration with concurrent chemotherapy [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 2.Overall mean Area Under the Curve...

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Current Studies

A Novel Retraction Device for Endoscopic Submucosal Dissection (ESD): A Multicenter Retrospective Study

Specific Study Aims: Study Aim 1: The primary aim of this study was to determine the technical success of ESD using the retraction device by determining completeness of the resection (�en-bloc vs incomplete). Study Aim 2: We aim to determine the safety of the device with regards to perforation and...

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Past Studies

A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases

Primary Objective: To determine the recommended SBRT dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting Secondary Objective: To estimate rates of greater...

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Past Studies

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Monotherapy in Subjects with Advanced Solid Tumors and Lymphomas and in combination with Exemestane or Fulvestrant in Subjects with Estrogen Receptor Positive Breast Cancer

Charactierize the safety and tolerability of GS-5829 as a monotherapy in subjects with advanced solid tumors and lymphomas Determine the maximum tolerated dose (MTD) or recommended dose for phase 2 (RDP2) of GS-5829 as a monotherapy in subjects with advanced solid tumors and lymphomas characterize...

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Past Studies

A Phase 1b/2 Dose-Escalation and Expansion Trial of NC-6300 (Nanoparticle Epirubicin) in Patients With Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft Tissue Sarcoma

Primary Objectives: The primary objectives of this study are: -Part 1: In the dose-escalation part of the study, to determine the MTD and RPII dose of NC-6300 -Part 2: In the expansion part of the study, to evaluate the activity of NC-6300 at the RPII dose compared to historical controls in...

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A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Investigational Agents for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)

Primary Outcome Measures: : Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days in Cycle 1 (Cycle 1 = 21 days) ] DLTs = ≥1 of the following treatment-related toxicities: Grade (G)4 nonhematologic toxicity; G4 hematologic toxicity lasting >7 days...

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A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

Primary Outcome Measures : Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment [ Time Frame: Up to end of treatment (average 3 years) ] ORR, is defined as the rate of the overall best response, complete response (CR) or...

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A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZNc3 in Subjects with Malignant Tumors Harboring DNA Repair and Cell Cycle Gene Alterations

Primary Objective: To investigate the antitumor activity of ZN-c3 based on the objective response rate (ORR) Secondary Objectives: To further investigate the antitumor activity of ZN-c3 based on duration of response (DOR) and progression-free survival (PFS) To investigate overall survival...

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A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)

Primary Outcome Measures: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 5 years ] ORR is defined as the percentage of participants with Complete...

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Past Studies

A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination with Platinum Doublet Chemotherapy and Radiotherapy for Participants with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)

Primary Objectives Objective: Within each platinum doublet chemotherapy cohort, evaluate the percentage of participants who develop Grade 3 or higher pneumonitis Objective: Within each platinum doublet chemotherapy cohort, estimate the ORR as assessed by BICR according to RECIST 1.1 Secondary...

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Past Studies

A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

Primary Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in Group A. Secondary Objectives: To assess the duration of response (DOR) in Group A. To assess progression-free...

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Past Studies

A Phase 2, Multicenter, Randomized, Single-Blind, Active-Control Study to Evaluate the Efficacy and Safety of Nivolumab Administered in Combination with IPI-549 Compared to Nivolumab Monotherapy in the Treatment of Patients with Immune Therapy-Na�ve, Advanced Urothelial Carcinoma

Primary Objective: To compare the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with baseline mMDSC levels greater than or equal to 22.3 percent following combination treatment with nivolumab plus IPI-549 with that of nivolumab...

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Past Studies

A Phase 2, Open-Label Multicenter Study to Evaluate the Safety and Clinical Activity of Durvalumab in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) or with Lenalidomide Plus R-CHOP (R2 CHOP) in Subjects with Previously Untreated, High Risk Diffuse Large B Cell Lymphoma

Primary Objective The primary objective of the study is to explore he clinical activity of Durvalumab (MEDI4736) in combination with R-CHOP (non-ABC) or R2-CHOP (ABC) followed by Durvalumab consolidation therapy in previously untreated subjects diagnosed with high-risk DLBCL. Secondary...

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Past Studies

A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined With Nivolumab Versus Nivolumab Alone in Subjects With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

Primary Objective: To evaluate and compare the efficacy of andecaliximab in combination with nivolumab versus nivolumab alone in subjects with recurrent gastric or GEJ adenocarcinoma Secondary Objectives: To characterize and compare safety and tolerability of andecaliximab in combination...

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Past Studies

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

Primary Objective: The primary objective of this study is to evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with fibroblast growth factor receptor (FGFR) 2 translocation who have failed at least 1 previous treatment. Secondary...

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Current Studies

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection (PUNCH)

Primary Objective: To evaluate the safety and tolerability of RBX2660 in subjects with recurrent CDI. Secondary Objectives: 1. To evaluate the efficacy of RBX2660 in preventing recurrent episodes of CDI through 8 weeks after treatment. 2. To evaluate the sustained clinical response rate of...

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Past Studies

A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients With Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Primary Objectives To compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone. Secondary Objectives To evaluate for...

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Current Studies

A Phase 3 Randomized Study of Cystectomy plus Perioperative Pembrolizumab versus Cystectomy Alone in Cisplatin-ineligible Participants with Muscleinvasive Bladder Cancer (KEYNOTE-905)

- Objective: To compare pathologic complete response (pCR) rates obtained in Arm A (preoperative pembrolizumab and RC+PLND) and Arm B (RC+PLND), based on central pathologic review, evaluated in participants whose tumors express PD-L1 CPS ≥10 and all participants, irrespective of CPS score. -...

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Past Studies

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Primary Objective To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by overall survival (OS) Secondary Objectives To compare the efficacy of GS-5745 versus placebo in combination with mFOLFOX6 as measured by progression-free survival (PFS) To compare the...

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Current Studies

A Phase 3 Study of Pembrolizumab (MK-7339) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib Compared with Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

Primary: To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review. To compare...

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A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Investigator s choice in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Primary To evaluate progression-free survival (PFS) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with Investigator s choice of chemotherapy (liposomal doxorubicin, paclitaxel, topotecan, or...

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Past Studies

A Phase 3 Trial of Peri-operative Pembrolizumab + Neoadjuvant Chemotherapy vs. Placebo + Neoadjuvant Chemotherapy for Cis-Eligible MIBC

Primary: To compare pathologic complete response (pCR) rates obtained in Arm A (preoperative pembrolizumab plus neoadjuvant chemotherapy plus Radical Cystectomy (RC) plus Pelvis Lymph Node Dissection [PLND]) and Arm B (preoperative placebo plus neoadjuvant chemotherapy plus RC plus PLND), based on...

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Current Studies

A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma

Primary: Progression-free survival (PFS) To determine the efficacy by progression free survival (using investigator assessment of scans according to RECIST v1.1) of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with...

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Past Studies

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemibatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement

Primary: Evaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants with cholangiocarcinoma with FGFR2 rearrangement. Secondary: Evaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of...

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Past Studies

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Versus Pembrolizumab Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer Expressing High Levels of PD-L1

Primary Objectives To compare PFS of the combination of pembrolizumab plus epacadostat versus pembrolizumab plus placebo. Hypothesis (H1): The combination of pembrolizumab plus epacadostat has superior PFS compared to pembrolizumab plus placebo. To compare OS of the combination of pembrolizumab...

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Past Studies

A phase 3, randomized, double-blind trial of pembrolizumab (MK 3475) with or without lenvatinib in participants with treatment-na�ve, metastatic non-small cell lung cancer (NSCLC) who have a tumor proportion score (TPS) greater than or equal to 1%

Primary Objectives: To compare PFS per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) based on blinded independent central review (BICR) of the combinations of pembrolizumab + lenvatinib versus pembrolizumab + matching placebo. To compare OS of the combinations of pembrolizumab +...

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Past Studies

A Phase 3, Randomized, Double-blind, Multicenter Study of TSR-042 plus Carboplatin-Paclitaxel versus Placebo plus Carboplatin-Paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer

To compare the progression-free survival (PFS) of treatment with dostarlimab plus carboplatin-paclitaxel to treatment with placebo plus carboplatin-paclitaxel, as assessed by the Investigator per RECIST v.1.1, in the following: [ Time Frame: Up to 5 years ] * All subjects with recurrent or...

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Comb

Primary Outcome Measures : Complete Remission (CR) [ Time Frame: Up to 7 months ] CR is defined as the proportion of participants who achieve CR within 6 cycles of treatment as determined by the investigator while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or...

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Past Studies

A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia

Primary Objective: * To evaluate the safety and tolerability of acalabrutinib monotherapy in subjects with treatment-naive or relapsed/refractory chronic lymphocytic leukemia. Secondary Objective: * To evaluate the investigator-assessed overall response rate, duration of response,...

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Past Studies

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors

Primary: To determine the maximum tolerated dose (MTD) of GS-5745 Monotherapy in subjects with advanced solid tumors. To characterize the safety and tolerability of GS-5745 as Monotherapy and in combination with various chemotherapy regimens in subjects with select tumor types. Secondary: To...

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Past Studies

A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers

Phase I Primary: In Phase I, the primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles, in previously treated patients with advanced epithelial cancer. Phase I Secondary: The secondary objectives are to obtain initial...

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Past Studies

A Phase I/II Study of Ruxolitinib With Front-Line Neoadjuvant and Post-Surgical Therapy in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Primary Objective Phase I Determine whether treatment with ruxolitinib in combination with conventional neoadjuvant and post-surgical chemotherapy is safe and tolerable in the primary therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Phase II Demonstrate whether...

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Past Studies

A Phase I/II Study to Assess the Safety and Efficacy of MK-3475 in Combination with Trametinib and Dabrafenib in Subjects with Advanced Melanoma

Part 3: To evaluate the efficacy with respect to progression-free survival (PFS) of MK-3475 administered intravenously in combination with oral dabrafenib and trametinib in subjects with advanced (unresectable or metastatic) melanoma with BRAF V600 E or K mutations, compared with placebo...

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Past Studies

A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer

Primary To determine the acute toxicity (90 days from protocol treatment start) from chemoradiotherapy including paclitaxel � trastuzumab and irradiation in non-cystectomy patients with or without her2/neu overexpression. Secondary To determine the ability of patients with bladder cancer who are...

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Past Studies

A Phase Ib Clinical Study of BBI608 in Combination with Standard Chemotherapies in Adult Patients with Metastatic Pancreatic Adenocarcinoma

Primary: To determine the safety, tolerability and the RP2D of BBI608 when administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin in adult patients with metastatic pancreatic ductal adenocarcinoma. Secondary: To determine the...

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Past Studies

A Phase Ib/II Clinical Study of BBI503 in Combination with Selected Anti-Cancer Therapeutics in Adult Patients with Advanced Cancer

Primary Objectives: To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of BBI503 when administered in combination with selected anti-cancer therapeutics in adult patients with advanced cancer. Secondary Objectives: To assess the preliminary anti-tumor activity of BBI503 when...

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Past Studies

A Phase Ib/II Clinical Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer

Primary Objectives The primary objective of Phase Ib of this study is: To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of BBI608 when administered in combination with FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, regorafenib or...

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Past Studies

A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer

Primary Objective To demonstrate an absolute improvement in Neoadjuvant Rectal Cancer (NAR) score for the experimental regimen as compared to concurrently randomized control patients. Secondary Objectives To compare overall survival (OS) To compare disease-free survival (DFS) To compare the rate...

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Past Studies

A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging

Primary To evaluate the rate of freedom from radical cystectomy at 3 years. Secondary To evaluate the rate of freedom from radical cystectomy at 5 years. To evaluate the rate of freedom from the development of distant disease progression at 3 and 5 years. Rate of freedom from progression of...

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Past Studies

A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pemblrolizumab) versus Standard of Care for Patients Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-Map Non-Matched Sub-Study)

Primary Objective To compare overall survival between patients previously treated with platinum-based chemotherapy and immunotherapy for Stage IV or recurrent non-small cell lung cancer randomized to ramucirumab and MK-3475 (pembrolizumab) versus standard of care (SoC). Secondary Objectives a. To...

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Past Studies

A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND #15380) Vaccine Given With Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

Primary Objective: To determine whether there is an overall survival advantage of HSPPC-96 administered with bevacizumab, given concomitantly or at the point of progression, in comparison with bevacizumab alone in patients with surgically resectable recurrent GBM. Secondary Objectives: To evaluate...

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Past Studies

A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and Nab-paclitaxel for Locally Advanced Pancreatic Cancer

Primary Objectives To determine if intensified radiochemotherapy following gemcitabine and nab-Paclitaxel in patients with unresectable pancreatic cancer will show a signal for improved 2-year OS from 10% to 22.5% as compared to chemotherapy with gemcitabine and nab-Paclitaxel alone. To determine...

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Past Studies

A PHASE II STUDY OF ABBV-399 (Process II) IN PATIENTS WITH C-MET POSITIVE STAGE IV OR RECURRENT SQUAMOUS CELL LUNG CANCER (LUNG-MAP SUB-STUDY)

Primary Objective The primary objective is to evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with ABBV-399 (Process II) in all patients with c-Met-positive lung squamous cell carcinoma. (SCCA) Secondary Objectives To evaluate investigator-assessed...

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Current Studies

A Phase II Study of AMG 510 in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)

Primary Objective To evaluate the response rate (confirmed, complete or partial) of AMG 510 in participants with KRASG12C mutated Stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). The response rates will be evaluated separately with cohorts defined as: i. Cohort 1 (co-mutation...

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Past Studies

A Phase II Study of LOXO-292 in Patients With RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

Primary Objective To evaluate the objective response rate (ORR) (confirmed complete or partial response) by blinded independent centralized review (BICR) associated with LOXO-292 in patients with previously-treated Stage IV or recurrent RET fusion-positive non-small cell lung cancer...

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Past Studies

A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients With Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-Map Non-Match Sub-Study)

Primary Objective To evaluate the objective response rate (confirmed and unconfirmed, complete and partial) by RECIST 1.1 among patients treated with MEDI4736 (Durvalumab) plus tremelimumab. Secondary and Exploratory Objectives To estimate the duration of response (DoR) among patients who achieve...

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A Phase II Study of Ribociclib And Endocrine Treatment of Physician?s Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer...

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Past Studies

A Phase II Study of Rucaparib in Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

Primary Objective a. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) associated with rucaparib in patients with genomic LOH high and/or deleterious BRCA1/2 mutations within: i. Cohort 1: Patients with squamous cell histology or mixed histology with a...

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Past Studies

A Phase II Study of Talazoparib Plus Avelumab in Patients With Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)

Primary Objectives To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib plus avelumab in patients with Stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated...

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Current Studies

A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent Endometrioid/Clear Cell Carcinoma of the Ovary or Peritoneum, and Recurrent Low Grade Endometrioid Endometrial Adenocarcinoma

OBJECTIVES Primary Objective To assess the clinical activity (overall response rate) of tazemetostat in patients with recurrent or persistent endometrioid or clear cell ovarian carcinoma, and patients with recurrent or persistent endometrioid endometrial adenocarcinoma. Secondary Objectives To...

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Past Studies

A Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients With Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without Surgery

Primary Objective To assess the accuracy of post-neoadjuvant systemic therapy (NST) image-directed tumor bed biopsy for pathologic complete response (pCR), defined as resolution of both invasive disease and DCIS (von Minckwitz 2012), in cases of clinical and radiologic complete response with...

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Past Studies

A Phase II Trial Evaluating Cisplatin (NSC #119875) and Gemcitabine (NSC #613327) Concurrent With Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva

Primary Objectives To determine the efficacy of cisplatin, gemcitabine, and Intensity-Modulated Radiation Therapy (IMRT) in achieving a complete pathologic response when used for the primary treatment of locally-advanced squamous cell carcinoma of the vulva. Secondary Objectives To determine the...

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Past Studies

A Phase II, Double-Blinded, Placebo Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-androgen Therapy With Apalutamide in Recurrent Prostate Cancer

Primary Objective To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone. A bPFS event is defined as a rise in PSA greater than...

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Current Studies

A Phase II/III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPCA

Primary Objectives Phase II To assess the efficacy of concurrent definitive therapy followed by nivolumab compared with concurrent definitive therapy followed by observation in terms of progression-free survival (PFS). Phase III To assess the efficacy of concurrent definitive therapy followed by...

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Past Studies

A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation

Primary Objective: Test whether the experimental combination of ABT-888 (Veliparib) combined with TMZ, compared to the control of placebo combined with TMZ, significantly extends overall survival in newly diagnosed GBM patients with tumor MGMT promoter Hypermethylation. Secondary Objectives: Test...

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Past Studies

A Phase II/III Trial of Neoadjuvant FOLFOX With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision (PROSPECT)

Primary Objective: Phase II component: To assure that neoadjuvant FOLFOX followed by selective use of 5FUCMT group (Group 1) maintains the current high rate of pelvic R0 resection and is consistent with non-inferiority for time to local recurrence (TLR). Phase III component: To compare neoadjuvant...

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Past Studies

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

PRIMARY OBJECTIVES: I. To determine the value of trastuzumab given during radiation therapy (RT) compared to RT alone in preventing subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma in situ (IIBCR-SCR-DCIS) in women...

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Past Studies

A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

Primary: To compare overall survival (OS) of patients with pre-treated, advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma treated with BBI608 plus weekly paclitaxel versus placebo plus weekly paclitaxel. OS is defined as the time from randomization until death from any...

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Past Studies

A Phase III Comparison Of Prophylactic Cranial Irradiation (PCI) Versus Observation In Patients With Locally Advanced Non-Small Cell Lung Cancer

Primary Objective: Determine whether prophylactic cranial irradiation (PCI) improves survival after effective locoregional/systemic therapy for patients with locally advanced non-small cell lung cancer (LA-NSCLC). Secondary Objectives: Determine the neuropsychologic impact of PCI Determine the...

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Past Studies

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

Primary To demonstrate an overall survival (OS) advantage for the addition of short-term (6 months) ADT to dose-escalated RT for patients with intermediate-risk prostate cancer. The events for OS will be defined as death due to any cause. Secondary (12/10/10) Determine whether the addition of ADT...

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Past Studies

A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer

Primary To assess the relative efficacy of the combination of androgen suppression (AS) + radiotherapy (RT) followed by androgen suppression vs. AS + RT followed by docetaxel and prednisone chemotherapy + androgen suppression in a population of patients with clinically localized prostate cancer...

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Past Studies

A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Primary Objective: Assess the efficacy of either single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer. Secondary...

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Past Studies

A Phase III Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).

PRIMARY OBJECTIVE OF THE STUDY: To compare overall survival (OS) of patients with metastatic (Stage IV) pretreated CRC treated with BBI-608 plus biweekly FOLFIRI with or without bevacizumab versus biweekly FOLFIRI with or without bevacizumab. SECONDARY OBJECTIVES: To compare OS in patients...

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Past Studies

A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Primary Objective: To compare overall survival (OS) of patients with metastatic pancreatic adenocarcinoma (PDAC) treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine (Arm 1) versus weekly nab-paclitaxel with gemcitabine (Arm 2). Secondary Objectives: To compare OS in patients treated...

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Past Studies

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer

Primary Objective Test whether the addition of cetuximab to radiation therapy will improve overall survival (OS) in postoperative patients with intermediate risk following surgery Secondary Objectives (6/4/10) Assess the impact of the addition of cetuximab to postoperative radiation therapy on...

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Past Studies

A PHASE III TRIAL COMPARING WHOLE PELVIC IRRADIATION FOLLOWED BY A CONEDOWN BOOST TO BOOST IRRADIATION ONLY AND COMPARING NEOADJUVANT TO ADJUVANT TOTAL ANDROGEN SUPPRESSION (TAS)

OBJECTIVES To test the hypothesis that TAS and whole pelvic irradiation followed by a conedown boost to the prostate improves the progression-free survival (an "early endpoint") by at least 10% at 5 years compared to TAS and prostate only irradiation. To test the hypothesis that induction...

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Past Studies

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Primary To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiation improves overall survival compared to paclitaxel, cisplatin, and radiation alone in patients with esophageal cancer who are treated without surgery. Secondary To evaluate if the addition of cetuximab to...

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Past Studies

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

Primary Objective: To determine if trastuzumab increases disease-free survival when combined with trimodality treatment (radiation plus chemotherapy followed by surgery) for patients with HER2-overexpressing esophageal adenocarcinoma Secondary Objectives: To evaluate if the addition of trastuzumab...

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Past Studies

A Phase III Trial of Pelvic Radiation Therapy Versus Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma

To determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to pelvic radiation therapy. To compare survival between the two treatment groups. To compare patterns...

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Past Studies

A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

Primary To determine whether the addition of NC-STAD to PBRT improves freedom from progression (FFP) [maintenance of a PSA less than the nadir+2 ng/mL, absence of clinical failure and absence of death from any cause] for 5 years, over that of PBRT alone in men treated with salvage RT after radical...

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Past Studies

A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary-Syndrome (ACS): The dal-GenE trial

The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality ( cardiovascular death resuscitated cardiac arrest, non-fatal myocardial infarction (MI) and non-fatal stroke) in subjects with a documented recent ACS and the AA...

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Past Studies

A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED STUDY OF ATEZOLIZUMAB VERSUS PLACEBO IN COMBINATION WITH PACLITAXEL, CARBOPLATIN, AND BEVACIZUMAB FOR PATIENTS WITH NEWLY DIAGNOSED STAGE III/IV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER

Primary Objective To evaluate the efficacy of atezolizumab versus placebo in combination with paclitaxel plus carboplatin plus bevacizumab among all patients and in those patients with PD-L1positive tumors Secondary Objectives Among patients with measurable residual disease in the primary...

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Past Studies

A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) AS MONOTHERAPY AND IN COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA

2.1.1 Primary Efficacy Objective The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab plus platinum-based chemotherapy compared with placebo plus platinum-based chemotherapy on the basis of the following endpoints:  Co-primary endpoints of...

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Past Studies

A Phase III, Open-label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

Primary Efficacy Objective: To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of PFS by independent review Primary Endpoint: PFS, defined as the time from randomization to the first occurrence of disease progression, as...

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Current Studies

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age greater than/= 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Primary Objective: To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin, vinblastine, dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine,...

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Past Studies

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/- Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

Primary Objective: To evaluate event-free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using RECIST 1.1 assessed by blinded independent central review (BICR). To evaluate the overall survival (OS). Secondary Objective: To evaluate the rate of major pathological...

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Past Studies

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

Primary Outcome Measures: 1.Progression-Free Survival (PFS) assessed by BICR according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC [ Time Frame: up to 5 years ] Secondary: 1.Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage...

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Past Studies

A PHASE IIIb, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALTEPLASE IN PATIENTS WITH MILD STROKE: RAPIDLY IMPROVING SYMPTOMS AND MINOR NEUROLOGICAL DEFICITS (PRISMS)

The primary objective of this study is to determine the efficacy of IV alteplase for treatment of AIS in patients with mild stroke (also known as minor neurologic deficit and rapidly improving stroke symptoms ), defined as an NIHSS score View Details

Past Studies

A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma

Primary Objectives (5/12/16) Ph II-R: To determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head,...

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Past Studies

A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

Primary Objectives Phase II-R To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the...

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Past Studies

A Phase l/ll Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 Antibody (Varlilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

Primary Objective *Phase I: To assess the safety and tolerability of varlilumab (0.1 to 10 mg/kg i.v. every 2 weeks) in combination with nivolumab (3 mg/kg i.v. every 2 weeks), and to identify dose limiting toxicities (DLT's) and the recommended Phase II dose of Varlilumab for use in combination...

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Past Studies

A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients with Persistent Local Esophageal Cancer

The primary objective is to study the effects of the truFreeze Spray Cryotherapy System in a population of subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy. Primary Endpoints: Change from...

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Past Studies

A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischaemic Stroke or TIA [SOCRATES ?Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES]

The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets]...

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Past Studies

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Primary Objective The primary objective is to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS) Safety Objective To assess the safety and tolerability of adjuvant treatment with olaparib Secondary Objectives 1. To assess the effect of adjuvant...

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Past Studies

A Randomized Phase 3 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer

Primary Objectives To compare OS of the combinations of epacadostat + pembrolizumab AND epacadostat + pembrolizumab + chemotherapy versus placebo + pembrolizumab + chemotherapy. Hypothesis (H1): The combination of epacadostat + pembrolizumab + chemotherapy has superior OS compared to placebo +...

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Past Studies

A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC 737754)/Placebo, for the Treatment of Anaplastic Thyroid Cancer

Primary Objective for Run-In Components To evaluate the safety of IMRT, paclitaxel, and pazopanib suspension Primary Objective for Phase II Component To evaluate and compare overall survival at 1 year from study registration Secondary Objectives for Phase II Component To evaluate local-regional...

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Past Studies

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)

Primary Objective To assess whether patients with unresectable local-regionally advanced NSCLC treated with targeted agents based on molecular characteristics have a longer progression-free survival than those treated with standard care therapy alone Secondary Objectives To evaluate response...

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Past Studies

A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

Primary Objectives: To assess 2-year overall survival in each treatment arm (mFOLFIRINOX and gemcitabine/nab-paclitaxel) in patients with resectable pancreatic cancer. If the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall...

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Current Studies

A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination With BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients With Molecular Evidence of Disease

Primary Objective To compare the rate of molecular response 4.5 (MR4.5) after 12 months of combination therapy with ruxolitinib plus a TKI (dasatinib or nilotinib) versus a TKI alone, based on local PCR testing to measure BCR-ABL transcripts in chronic phase CML patients with molecular evidence of...

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Past Studies

A Randomized Phase II Trial for Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer

Primary Objective To select the arm(s) achieving a 2-year progression-free survival rate of greater than or equal to 85% without unacceptable swallowing toxicity at 1 year Secondary Objectives (5/24/16) To determine patterns of failure (locoregional relapse versus distant) and survival (overall...

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Past Studies

A Randomized Phase II Trial of Nivolumab, Cabozantinib Plus Nivolumab, and Cabozantinib Plus Nivolumab Plus Ipilimumab in Patients With Previously Treated Non-Squamous NSCLC

PRIMARY OBJECTIVES: I. To demonstrate whether combination therapy of nivolumab and cabozantinib s-malate (cabozantinib), or of nivolumab and cabozantinib, and ipilimumab as compared to nivolumab alone, extends progression-free survival (PFS) for this patient population with non-squamous non-small...

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Past Studies

A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Primary Objective: To determine if the addition of metformin to the standard regimen of carboplatin and paclitaxel prolongs progression-free survival (PFS) in women with advanced or recurrent endometrial cancer (Phase II). To determine if the addition of metformin to the standard regimen of...

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Past Studies

A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

Phase II Study Primary Objective: To assess the efficacy and identify (in)active arm(s) of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by PFS in the setting of recurrent platinum-resistant...

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Past Studies

A Randomized Phase II/III Trial of "Novel Therapeutics" Versus Azacitidine in Newly Diagnosed Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older LEAP: Less-Intense AML Platform Trial

Primary Objectives a. Phase II Component: To select, based on overall survival, any or all of the ?Novel Therapeutic? regimens for further testing against azacitidine in patients age 60 and older with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome with excessive blasts-2...

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Past Studies

A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients With Advanced, EGFR Mutation Positive Non-small Cell Lung Cancer (NSCLC)

Primary Objective a. Phase II: To evaluate if there is sufficient evidence to continue to the Phase III component by comparing progression-free survival (PFS) between patients randomized to afatinib in combination with cetuximab versus afatinib alone in the first-line treatment of patients with...

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Past Studies

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

Primary aim and endpoint Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who...

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Past Studies

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

Primary objective To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients. Secondary objectives 1.To compare the effect of aspirin versus placebo in early stage node-positive HER2...

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Past Studies

A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer

Primary aim To determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast irradiation (WBI) in the local management of early stage breast...

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Past Studies

A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)

Primary Objectives To determine if IMRT reduces acute gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation as measured with EPIC. Secondary Objectives To determine if grade 2+ gastrointestinal toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional...

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Past Studies

A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)

Primary Objective The primary objective for the trial is to compare the progression free survival (PFS) of the time limited administration of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of...

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Current Studies

A Randomized Phase III Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Primary Objective: To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) for patients with stage IB greater than or equal to 4cm, II and IIIA, ALK-positive NSCLC following surgical resection. Secondary Objectives: To evaluate and compare disease-free...

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Past Studies

A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases

Primary Objective: Determine whether the addition of HA-WBRT increases time to neurocognitive failure at months 2, 4, 6 and 12 as measured by neurocognitive decline on a battery of tests: the Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition,...

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Past Studies

A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination With Intravenous Triapine in Women With Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Primary Objective To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase progression-free survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix and vaginal cancer. Secondary Objectives To...

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Current Studies

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Primary Objective To examine if letrozole monotherapy/maintenance is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction. Secondary...

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Past Studies

A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Depo-Provera (Medroxyprogesterone Acetate) (NSC #26386) Compared to Depo-Provera Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Primary Endometrioid Adenocarcinoma of the Uterine Corpus

Primary Objective To determine whether the addition of the histone deacetylase inhibitor, entinostat, in combination with medroxyprogesterone acetate in the pre-operative setting results in up-regulation of activated progesterone receptors (PR) compared to medroxyprogesterone acetate...

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Past Studies

A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

Primary Objectives To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina. Secondary Objectives To capture...

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Past Studies

A Randomized, Controlled, Double-Arm, Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined With Paclitaxel vs. Paclitaxel Combined With Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

Primary Outcome Measures: 1. Overal Survival [Time Frame: From date of study entry until the date of death from any cause (up to 5 years)] 2. Progression Free Survival (PFS) by RECIST 1.1 [Time Frame: From date of study entry until the death from any cause, or up to 5 years after last study...

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Coming Soon

A Randomized, Controlled, Multicenter, Open-Label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome (VICTORION-INCEPTION)

Primary Outcome Measures: 1. Percentage change in low-density lipoprotein cholesterol (LDL-C). [Time Frame: Baseline and Day 330]. Inclisiran compared to usual care in reducing LDL-C [percentage change] at day 330 (Year 1). 2. Percentage achieving change in low-density lipoprotein cholesterol...

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Past Studies

A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

Objectives: Primary objective- The primary objective of the study is to compare the effect of long-term treatment with ticagrelor vs. clopidogrel on the event rate of the composite of cardiovascular (CV) death, myocardial infarction (MI), and ischaemic stroke (defined as any stroke not...

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Past Studies

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Everolimus (CBE) vs. Placebo With Everolimus (PboE) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)

Primary Objectives To compare the progression free survival (PFS) of patients treated with CB-839 + everolimus (CBE) versus placebo + everolimus (PboE) for advanced or metastatic clear cell RCC (ccRCC) previously treated with:  At least 2 lines of therapy, including at least one vascular...

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Past Studies

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency

The primary objectiv of this study is to determine the efficacy and safety of iron terapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction.

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Past Studies

A Randomized, Double-blind, Placebo-controlled, Clinical Trial of LY3127804 in Patients Who Are Hospitalized With Pneumonia and Presumed or Confirmed COVID-19

PRIMARY OUTCOME MEASURES Number of Ventilator Free Days [ Time Frame: Day 1 to Day 28 ] Number of days on which a participant breathes without assistance SECONDARY OUTCOME MEASURES: Number of Participants Reporting Each Severity Rating on the National Institute of Allergy and Infectious Diseases...

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Past Studies

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CERC-002 in Adults with COVID-19 Pneumonia and Acute Lung Injury

Primary Objective: * To evaluate the effect of CERC-002 compared with placebo in addition to standard of care on prevention of ARDS in adults with COVID-19 pneumonia and acute lung injury. Secondary Objectives: * To evaluate the safety and tolerability of CERC-002 compared with placebo in...

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Past Studies

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection

Primary; To evaluate the effect of baricitinib 4-mg once daily (QD) compared to placebo on disease progression in patients with COVID-19 infection. Key Secondary: To evaluate the effect of baricitinib 4-mg QD compared to placebo on clinical outcomes in patients with COVID-19 infection

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Current Studies

A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18 / ENGOT-cx11)

Primary: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Time Frame: Up to approximately 38 months] Overall Survival (OS) [Time Frame: Up to approximately 46 months] Secondary: Progression-Free Survival (PFS) Per Response Evaluation...

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Past Studies

A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer

Primary Objectives Safety Lead-in: Estimate the probability of a dose limiting toxicity (DLT) following cycle 1 of experimental regimens (PLD and atezolizumab and PLD/bevacizumab and atezolizumab). Phase II Study: Estimate and compare the hazard of first progression or death (PFS) of each...

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Past Studies

A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer

Primary Objectives Safety Lead-in: Estimate the probability of a dose limiting toxicity (DLT) following cycle 1 of experimental regimens (PLD and atezolizumab and PLD/bevacizumab and atezolizumab). Phase II Study: Estimate and compare the hazard of first progression or death (PFS) of each...

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Past Studies

A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With greater than 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy (MK3475-242)

Primary Objective To compare invasive disease-free survival (IDFS) of patients with triple-negative breast cancer (TNBC) who have either >1 cm residual invasive breast cancer and/or positive lymph nodes (>ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 (pembrolizumab)...

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Past Studies

A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy

Primary Objective Determine whether the addition of memantine to WBRT preserves cognitive function, specifically memory as measured by the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R delayed recall), over that of placebo and WBRT in patients with brain metastases at 24 weeks...

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Past Studies

A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

Primary Objective: Phase 2b: To determine whether the addition of ABT-414 to concomitant radiotherapy and TMZ plus adjuvant TMZ prolongs Progression Free Survival (PFS) among subjects with newly diagnosed GBM harboring EGFR amplification. Phase 3: To determine whether the addition of ABT-414 to...

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Past Studies

A Retrospective Review of the Forticore� Intervertebral Body Fusion Device in Patients with Degenerative Disc Disease

The primary objective of this retrospective data collection is to demonstrate that the Forticore intervertebral body fusion device promotes bony fusion and limits subsidence of the cervical and lumbar spine in patients with degenerative disc disease.

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Past Studies

A Study of ARRY-382 in Combination With Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients With Advanced Solid Tumors

Phase 1b/Part A Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives: To describe the preliminary antitumor activity of the combination based...

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Past Studies

A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (FIERCE-22)

Phase 1b Primary Objective: To evaluate the initial safety and to identify the recommended Phase 2 dose (RP2D) of B-701 and pembrolizumab Phase 2 Primary Objectives: 1. To evaluate the safety and tolerability of B-701 plus pembrolizumab in subjects with UCC. 2. To evaluate efficacy of B-701 in...

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Past Studies

A Trial Evaluating Escalating Doses and the Safety of Intracystic Injection of NanoPac� in Subjects With Mucinous Cystic Pancreatic Neoplasms

Primary Outcome Measures 1.Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to 6 (six) months after NanoPac� injection ] Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. Secondary...

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Current Studies

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Primary Objectives: To centrally test resected NSCLC for genetic mutations to facilitate accrual to randomized adjuvant studies. To obtain clinically annotated tumor tissue and patient-matched non-malignant DNA from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to...

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Past Studies

Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

Co-Primary Endpoints: To evaluate whether adjuvant therapy with nivolumab will result in improved overall survival (OS) and/or disease-free survival (DFS) over standard observation in patients with Stage IB greater than or equal to 4cm, II and IIIA, NSCLC following surgical resection and standard...

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Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure (ALLEVIATE-HF)

Primary Outcome Measures: *Safety of patient management pathway - Proportion of medication interventions with associated medication intervention related serious adverse events (Time Frame: Up to 3 years) *The proportion of medication interventions with one or more associated medication...

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Past Studies

Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study

Primary objectives: 1. To determine whether fulvestrant administered for 24 weeks as neoadjuvant endocrine treatment increases the proportion of endocrine sensitive tumors* relative to patients treated with anastrozole. 2. To determine whether fulvestrant in combination with anastrozole,...

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Past Studies

An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer

Primary: To evaluate the effect of treatment with rovalpituzumab tesirine on cardiac ventricular repolarization (QT/QTc) in subjects with small cell lung cancer (SCLC) Secondary: To evaluate the effect of treatment with rovalpituzumab tesirine on other electrocardiogram (ECG) parameters,...

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Past Studies

An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures

Primary efficacy objective: to evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as myocardial infarction (MI), ischemic stroke, cardiovascular (CV) death, acute limb ischemia (ALI), and...

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Past Studies

An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis

Primary Objective: To evaluate preliminary efficacy of itacitinib on SVR from baseline at Week 24 in the 2 following cohorts of MF subjects: Cohort A: in combination in subjects with ruxolitinib low dose (less than 20mg daily). Cohort B: as monotherapy in subjects who progressed (per revised ELN...

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Current Studies

An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination with Lenvatinib, versus Pembrolizumab and Lenvatinib, as First-line Treatment in Participants with Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Primary Objectives - Objective: To compare the HIF triplet to the doublet with respect to PFS per RECIST 1.1 as assessed by BICR. - Hypothesis (H1): The HIF triplet is superior to the doublet with respect to PFS per RECIST 1.1 by BICR in advanced ccRCC patients with IMDC intermediate/poor risk. -...

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Past Studies

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

Primary Objective Demonstrate that prophylactic neoadjuvant androgen deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) in patients with unfavorable intermediate risk or favorable high risk prostate cancer compared to NADT...

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Past Studies

Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage

The specific aims of this study are to: Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom...

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Past Studies

Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary revascularization, or hospitalization for unstable angina...

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Current Studies

BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

Primary Objectives 1. Examine the impact of SIGNATERATM on adjuvant treatment decisions 2. Determine the rate of patient s diagnosed with CRC recurrence while asymptomatic using SIGNATERA Secondary Objectives 1. Molecular residual disease clearance 2. Percent of patients undergoing surgery for...

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Past Studies

BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - V

OBJECTIVES To assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.

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Past Studies

Cabazitaxel With Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial

Primary Objective To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can improve PFS compared to abiraterone acetate alone. Secondary Objectives To assess whether the addition of 6 cycles...

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Past Studies

CardioMEMS HF System Post Approval Study

The objective of this sub-study is to confirm the post-market safety and effectiveness of the CardioMEMS? HF System to premarket.

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Past Studies

CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL (CREST-2) PROTOCOL

There are two equally important primary hypotheses, which will be tested in two independent parallel, randomized clinical trials. One trial will test the primary hypothesis that intensive medical management differs from the combination of CEA and intensive medical management in preventing the...

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Past Studies

Carotid Revascularization Endarterectomy vs Stenting Trial (CREST)

The primary goal of CREST is to assess if the efficacy of CAS differs from that of CEA over a multi-year time horizon. Data from CREST will be used to both provide an assessment of the differential efficacy of CEA and CAS and support a submission to the FDA for an indication for CAS for the subject...

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Past Studies

CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry

The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.

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Changes in Type of Latent Patient Safety Threats Identified during Simulations

This study will test the hypothesis that repeated simulations in the same patient care areas will result in a reduction in the number and type of latent patient safety threats.

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Current Studies

Clinical efficacy and safety of a novel over-the-scope Gastroduodenal Full Thickness Resection Device (gFTRD) for the treatment of upper gastrointestinal tract lesions: A Multicenter Experience

The main endpoint is the technical success rate of EFTR of UGIT lesions using gFTRD including A. Technical success B. Histological margin Secondary end points include: A. Adverse events B. Procedure time C. Residual or recurrence of lesion on repeat endoscopy

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Clinical Performance of Elecsys� Troponin T hs Gen 6 in Subjects with Symptoms of Acute Coronary Syndrome (PERFORM-TSIX)

To determine the clinical performance of Elecsys� Troponin T hs Gen 6 against clinical diagnosis at various time points after ED presentation (T0, T1, T2, T3, T6) using the previously determined universal or combined sex-specific cut-off of a 99th percentile URL

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Current Studies

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

The purpose of this study is to assess correlations between expression of blood serum biomarkers and cognitive impairment (CI) in patients with colorectal cancer throughout and following chemotherapy treatment. Our primary goal is to establish a panel of biomarkers that predict CI that can be...

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Current Studies

Colorectal Endoscopic Mucosal Resection: A Chart Review Study of Outcomes

This study will determine recurrence and complication rates for those that have undergone endoscopic mucosal resection of colorectal polyps at Parkview Regional Medical Center.

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Past Studies

Comparison of 2 techniques using EUS guided Liver biopsies via 19g CORE biopsy needle to Obtain Optimal Core Liver Biopsies in Benign Disease

Objective a. To determine if there is a significant difference in pathological yield as determined by fragmentation, length and number of portal tracts of the biopsy sample between a modified wet suction, and a slow pull techniques in obtaining CORE of histologic tissue from nonmalignant liver...

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Past Studies

Comparison Study in Pancreatic Fiducial Placement

Primary Objectives: 1. Determine the difference in cost between utilization of using 19 gauge EUS FNA BNX needles to 22 gauge EUS FNA BNX needles for fiducial placement. 2. Determine the difference in the amount of time required to place pancreatic fiducials for pancreatic cancer between 19...

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Current Studies

Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions (CLIMB)

Primary Outcome Measures: Accuracy of PCL diagnosis [Time Frame: 48 months] Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types,...

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Past Studies

COVID-19 Plasma Single-Patient Expanded Access Request

To treat the patient's COVID-19 diagnosis

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Current Studies

Cryotherapy Ablation Therapy for the Treatment of Esophageal Cancer: A Retrospective Review

Primary: to assess the efficacy of cryoablation therapy in the treatment of esophageal adenocarcinoma as adjuvant, neoadjuvant or palliative therapy. Secondary: to assess the safety of cryoablation therapy in the treatment of esophageal cancer

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Current Studies

CT vs. Endoscopic Ultrasonography in Tumor Discovery and Diagnosis: A Chart Review Study

To identify the incidence of and variables associate with those patients found to have pancreatic tumors upon Endoscopic Ultrasound that were unidentifiable on CT/MRI imaging.

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Current Studies

Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure - Thrombolysis in Myocardial Infarction 68 ( DAPA ACT HF-TIMI 68)

PRIMARY OBJECTIVE To assess the effect of in-hospital initiation of dapagliflozin, as compared with placebo, on the clinical outcomes of cardiovascular death or worsening heart failure in patients who have been stabilized during hospitalization for acute heart failure. To evaluate the safety and...

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Current Studies

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

Primary Objective a To evaluate the RECIST v1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. b To evaluate the overall response rate (ORR, per criteria in Section 10.8) in patients with gestational...

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Current Studies

DecisionDx-Melanoma Impact on Sentinel Lymph Node Biopsy Decisions and Clinical Outcomes (DECIDE)

Primary Aim 1. Determine the association of GEP test result with SLNB surgical decisions in patients with SLNB-eligible T1-T2 melanoma Primary Aim 2: Track and evaluate 5-year clinical outcomes for patients in each GEP subclass, including those who did and did not undergo SLNB and those with T3-T4...

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Past Studies

Decisions About Cancer Screening in Alzheimer's Disease (DECAD)

Primary Aim: To examine the effect of a mammography screening decision aid intervention for older women with AD on markers of decision quality among caregivers. Secondary Aim: To examine the effect of a mammography screening decision aid intervention for caregivers on the utilization of mammograms...

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Current Studies

Development and Validation of a Gene Expression Assay to Predict the Risk of Recurrence Disease in Cutaneous Squamous Cell Carcinoma

Primary Endpoint: To identify a gene expression and/or mutational profile that can separate primary cSCC tumors that have a high risk of recurrence compared to primary cSCC tumors that have a low risk of recurrence using RT-PCR and RNA sequencing (RNASeq). Secondary Endpoint: To validate the...

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EF-36/Keynote B36: A Pilot, Single Arm, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Intrathoracic Non-small Cell Lung Cancer

Primary Outcome Measures : Objective Response Rate (ORR) [ Time Frame: 24 months ] ORR will be measured from the date of enrollment to date of progression (in months) based on RECIST 1.1 criteria. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50...

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Effect of Delay in Thrombectomy Reperfusion on Patient Outcome After Acute Ischemic Stroke

This study is aimed at investigating variables in combination recanalization therapies for acute, large vessel ischemic stroke that are associated with better clinical outcomes (measured by NIH stoke scale and modified Rankin Scale). Identification of these variable could potentially improve...

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Past Studies

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer

Primary Outcome Measures: Local-regional recurrence (LRR) [Time Frame: Up to 5 years] Secondary Outcome Measures: Re-operation rate [Time Frame: Up to 5 years] Conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis [Time Frame: Within the first 6 months] Time to...

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Past Studies

Electronic Patient Notification of Remote Implantable Cardioverter-Defibrillator (ICD) Monitoring Data: Impact of Patient Engagement on Outcomes in the Merlin.Net System

Primary Objectives: To evaluate the impact of sharing remote monitoring ICD data with patients through their ePHR on patient engagement. To evaluate the impact of sharing remote monitoring ICD data with patients through their ePHR on provider--patient communication. To determine the impact of...

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Current Studies

Endoscopic Mucosal Resection for Management (EMR) of Early Stage Esophageal Adenocarcinoma (EA)

The purpose of our retrospective and prospective study is to gather data about a group of patients that were treated with EMR for early stage EA to asses for overall survival, disease-free survival, complications of the procedure, quality of life after the interventions as well as compare patient...

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Current Studies

Endoscopic Mucosal Resection vs. Colon Resection: A Retrospective Efficacy and Cost Comparison Analysis in a Tertiary Community Referral Setting

Objectives 1. To compare efficacy of EMR to Laparoscopic Colon Resection (hemicolectomy) in the treatment of benign, flat colon polyps 2. To compare safety of EMR to Laparoscopic Colon Resection (hemicolectomy) in the treatment of benign, flat colon polyps 3. To compare cost...

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Current Studies

Endoscopic Repair of Esophageal Perforation: A Chart Review Study

It is the aim of this study to analyze the outcomes of esophageal perforation with esophageal fully covered metal stents or endoscopic suturing.

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Current Studies

Endoscopic Stenting in Esophageal Cancer: A Chart Review Study

It is the aim of this study to analyze the outcomes of endoscopic esophageal stent placement in those with esophageal cancer

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Current Studies

Endoscopic Submucosal Dissection for Resection of T1b N0 Esophageal Cancer: A Retrospective Multicenter Trial

Central Hypothesis: Endoscopic submucosal dissection with and without adjuvant therapy (XRT, chemotherapy based on final precise pathology) allows for adequate management of T1b N0 EAC and SCC. Specific Aim #1: To assess the long-term outcomes (local and metastatic recurrence) of ESD +/- adjuvant...

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Enfortumab Vedotin and Pembrolizumab, With or Without Chemotherapy, vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)

Primary: Duration of Progression-free Survival (PFS) per RECIST v1.1 by Blinded Independent Central Review (BICR) Duration of Overall Survival (OS) Secondary: Duration of PFS per RECIST v1.1 by Investigator Assessment Overall Response Rate (ORR) per RECIST v1.1 by BICR ORR per RECIST v1.1 by...

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Past Studies

Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Expanded access for patients with cancer with RET activation who are ineligible for an ongoing LOXO-292 clinical trial or have other considerations that prevent access to LOXO-292 through an existing clinical trial.

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Past Studies

Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

Primary Objective: Provide access to COVID-19 convalescent plasma Secondary Objectives: Safety

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Past Studies

Gastrointestinal Stromal Tumors: A Chart Review Study

To assess the diagnosis, treatment and outcomes of those patients with gastrointestinal stromal tumors

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Past Studies

GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)

Main Objective The main objectives are: To investigate the patient characteristics influencing the choice of antithrombotic treatment for the prevention of stroke in non-valvular AF patients To collect real world data on important outcome events of antithrombotic treatments for the prevention of...

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Current Studies

HPS 4/TIMI 65 ORION 4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease.

The HPS-4/TIMI 65/ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. Consistent with relevant guideline recommendations for people with vascular disease, it is intended that participants be on intensive background LDL-lowering therapy, at screening. The...

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Past Studies

Impact of Early FDG-PET- Directed Intervention on Preoperative Therapy for Locally Advanced Gastric Cancer: A Random Assignment Phase II Study

Primary Objective: To assess and compare the overall survival (OS) of patients with locally advanced gastric cancer classified as FDG-PET non-responders after one cycle of pre-operative chemotherapy randomly assigned to receive either salvage chemotherapy before and after surgery or immediate...

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Current Studies

Incidence and Risk Factors for the Recurrence of Ampullary Polyps after Endoscopic Papillectomy: A Multicenter, Retrospective Study

Central Hypothesis: Histological and endoscopic features of the papilla impact recurrence. Recurrence is higher in patients with Familial adenomatous polyposis than with sporadic adenomas of the papilla. Specific Aim #1: Rate of recurrence of ampullary adenomas in patients with and without...

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Past Studies

Individual Patient [TPD] Emergency Use Expanded Access to NanoPac� for the Treatment of a Pancreatic Cancer Lesion with Liver Metastases

Treatment of a pancreatic cancer lesion via direct intratumoral (ITU) injection via intraperitoneal (IP) instillate for metastatic lesions in the liver.

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Current Studies

Integrated Cancer Repository for Cancer Research (iCaRe2)- Subproject: Pancreatic Cancer Collaborative Registry

OBJECTIVES: Develop Integrated Biomedical Computing Tools (IBCT) for the better understanding and treatment of pancreatic cancer by using the power of computer and informatics sciences. Continue development of the Pancreatic Cancer Collaborative Registry (PCCR) infrastructure to act as a...

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Current Studies

Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO

Primary Objective To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over observation for patients with completely resected stage IB (4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative...

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Current Studies

Intermediate-Size Patient Population Expanded Access of NanoPac� for the Treatment of Localized Esophageal Cancer

To provide access to NanoPac to patients with localized esophageal cancer who have failed prior therapy, are not surgical candidates, or are refusing surgery at this time.

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Past Studies

Intermediate-Size Patient Population Expanded Access of NanoPac� for the Treatment of Pancreatic Cancer

The objective of this expanded access is to provide NanoPac to patients with pancreatic adenocarcinoma who received NanoPac under clinical trial NANOPAC-2016-05 and have completed their participation in the formal clinical trial.

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Past Studies

Investigation of the Two Level Simplify� Cervical Artificial Disc

The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Simplify Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of two contiguous discs from C3 to C7 following discectomy at two contiguous levels for...

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Past Studies

KCP-330-024: A RANDOMIZED, DOUBLE-BLIND, PHASE 3 TRIAL OF MAINTENANCE WITH SELINEXOR/ PLACEBO AFTER COMBINATION CHEMOTHERAPY FOR PATIENTS WITH ADVANCED OR RECURRENT ENDOMETRIAL CANCER

Primary Outcome Measures : Progression Free Survival (PFS) [ Time Frame: Time from randomization until disease progression (PD) or death, whichever occurs first (approximately 12 months after the last participant enrolled) ] Compare progression free survival of the two treatment arms as assessed...

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Current Studies

Laparoscopic-Endoscopic Approach to Submucosal Mass Removal: A Chart Review Study

To assess the diagnosis, treatment and outcomes of patients with a gastrointestinal submucosal mass treated by combined laparoscopic-endoscopic removal

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Past Studies

Late Sodium Current Blockade in High-Risk ICD Patients (RAID)

Primary aim of the study is: To determine whether ranolazine administration will decrease the likelihood of a composite arrhythmia endpoint consisting of ventricular tachycardia or ventricular fibrillation (VT/VF) requiring antitachycardia pacing (ATP), ICD shocks, or death; In addition to the...

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Past Studies

LEOPARD Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD

The objective of this pos-market study is to evaluate Endologix AFX enodvascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S. clinical centers will be involvd in the study to include a broad range of experience. Imaging data...

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Current Studies

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Primary Objective Phase II: To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. Phase III: To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/-...

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Past Studies

Longitudinal Surveillance Study of the 4-SITE Lead/Header System

Study Objective: The objective of the LSS of 4-SITE Study is to prospectively determine the chronic complication-free rate of the 4-SITE Lead/Header System in order to verify its long-term functional integrity.

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Past Studies

Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

Primary Objectives: Phase II: To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic...

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Current Studies

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry

Primary: Create a large scale, population-based registry of full genome expression data matched with clinical data to investigate new gene associations with prognostic and/or predictive value Utilize registry data to graduate identified expression signatures into subset trials and recommend...

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Marani

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Past Studies

MEDI4736-MM-005 (FUSION MM-005): A Phase 2, Multicenter, Single-Arm, Study to Determine the Efficacy for the Combination of Durvalumab (DURVA) Plus Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) That Have Progressed While on Current Treatment Regimen Containing Daratumumab.

Primary: To determine the efficacy of DARA plus durvalumab (DURVA) in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment. Secondary: Determine the safety of DARA plus DURVA in subjects with RRMM who have progressed on DARA while on a...

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Past Studies

Mild and Rapidly Improving Stroke Study

To elucidate long-term outcomes of patients with mild and rapidly improving stroke and examine the association with tPA treatment.

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Current Studies

MK3475 Protocol B96: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96)

To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator Hypothesis (H1): pembrolizumab plus paclitaxel with or without bevacizumab is...

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Current Studies

MK6482-011 An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line or Third-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti- PD-1/L1 Therapy

Primary Objective: -To compare MK- 6482+lenvatinib to cabozantinib with respect to PFS per Response Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). -Hypothesis (H1): MK-6482+lenvatinib is superior to cabozantinib with respect to PFS per RECIST 1.1 by...

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Current Studies

Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population

Primary An Excision of the targeted lesion in a single specimen Secondary Rate of R0 resection Time Frame 3-4 hours when all vertical and horizontal margins are negative Rate of R1 resection Time Frame 3-4 hours complete resection with no grossly visible lesion defined by...

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Past Studies

Multi-Centre, Open-Label, Safety Study of Etripamil Nasal Spray in Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The NODE-302 Trial (Extension of NODE-301)

The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e. without medical supervision)

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Current Studies

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. The NODE-301 Trial.

The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg is superior to placebo at terminating episodes of PSVT in an outpatient setting. Primary Outcome Measures: 1. The time to conversion of an episode of PSVT to sinus rhythm (SR) after study drug...

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Past Studies

Multiple Cardiac Sensors for the Management of Heart Failure (MANAGE-HF)

MANAGE HF has two objectives and will fulfill the requirements of the post-approval study: 1. To evaluate and optimize HeartLogic Heart Failure Diagnostics (called HeartLogic from here on) clinical integration and the alert management process (Phase I) 2. To evaluate HeartLogic in regards to...

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Current Studies

Neuroform� Microdelivery Stent System

The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2 mm and ≤ 4.5 mm that are not amenable to treatment with surgical clipping. Wide neck...

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Past Studies

Optisure Lead Post Approval Study

The following objectives will be evaluated in the post approval study: 1. To determine the Optisure lead related complication free rate at 5 years 2. To document all Optisure lead related adverse events Additionally, the following objectives will be evaluated in a subset of patients in the...

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Current Studies

ORACLE Registry Dr. Biswas Biodesix Nodify XL2

Primary Outcome Measures : Statistically significant change in the proportion of benign lung nodules managed by BDX-XL2 experiencing invasive procedures. [ Time Frame: Up to 2 years ]

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Past Studies

Pancreatic Cancer Treatments and Outcomes: A Chart Review Study

This study will determine pancreatic cancer diagnosis rates and methods, stage at diagnosis as well as resectability at diagnosis. Treatment and outcome data will also be collected to analyze results.

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Current Studies

Parkview Health Falls Registry

Primary: * To identify risk factors in patient history among patients evaluated at the Fall Prevention Clinic. Secondary: * To compare the characteristics of adult patients who experience falls v/s those who do not. * To review findings on examination (general and neurological) and testing...

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Patient Specific Talus Spacer

A treatment option for avascular necrosis of the ankle joint.

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Past Studies

Penn Alliance for Therapeutic Hypothermia (PATH) Registry

The purpose of this database is to have a comprehensive look at cardiac arrest care and outcomes.

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Past Studies

Perfusion CT to Predict Progression-Free Survival and Response Rate in Bevacizumab Treatment of Platinum-Resistant Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Carcinoma

PRIMARY OBJECTIVES: I. To evaluate whether those patients with an increase in perfusion computed tomography (CT) tumor blood flow (BF) from T0 to T1 demonstrate poorer progression-free survival (PFS) compared to those patients with a decrease in BF from T0 to T1, among platinum-resistant,...

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Current Studies

Phase 2 Trial Evaluating the Safety and Tolerability of Intratumoral Injections of NanoPac� With Standard of Care Therapy in Subjects With Lung Cancer

The primary objective of this study is to evaluate the safety and tolerability of NanoPac injected into lung cancer lesions by EBUS-TBNI on multiple (up to three) occasions, each injection procedure administered 4 weeks apart. Safety and tolerability will be assessed for 24 weeks following first...

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Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety, and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy 2 Trial)

The objective of this study is to evaluate the safety, and efficacy of DM199 in treating patients presenting with Acute Ischemic Stroke (AIS) - evaluating rates of both Recovery and Recurrent AIS for whom thrombolysis and/or catheter-based procedure, mechanical thrombectomy (MT), are not medically...

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Past Studies

Phase I/II Trial of Concurrent RAD001 (Everolimus) With Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma

Phase I Primary Objective To define the maximum tolerated dose of RAD001 (up to established dose of 10mg/day) when combined with concurrent radiation and temozolomide in newly diagnosed GBM. Secondary Objective To characterize the safety profile of RAD001 in combination with radiation and...

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Past Studies

PHASE II DOUBLE BLIND DOSE FINDING TRIAL OF BUPROPION VERSUS PLACEBO FOR SEXUAL DESIRE IN WOMEN WITH BREAST OR GYNECOLOGIC CANCER

Primary Objective Measure the ability of two dose levels of bupropion, 150 or 300 mg of extended release, to improve sexual desire more than a placebo at 9 weeks (8 weeks on the target dose) as measured by the desire subscale of the FSFI. 1.2 Secondary Objectives 1.2.1 Evaluate the side effects of...

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Past Studies

Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of NRG Oncology and KROG

Primary Objective: To determine if there is a signal for an increase in complete response (CR) rate in the measurable brain metastases at 12 weeks post RT (whole brain or SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. Secondary...

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Past Studies

Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

Primary Phase II Component Determine the feasibility of successfully delivering image-guided radiosurgery/SBRT for spine metastases in a cooperative group setting Phase III Component Determine whether image-guided radiosurgery/SBRT (single dose of 16 or 18 Gy) improves pain control (as measured by...

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Past Studies

Phase IIa Trial Evaluating the Safety of Intratumoral Injection of NanoPac� in Subjects with Locally Advanced Pancreatic Adenocarcinoma

Primary: 1.Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to 3 (three) months after NanoPac� injection ] Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. Secondary: 1.Pharmacokinetics:...

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Past Studies

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide

Primary Objective: To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice-daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice-daily over 3...

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Past Studies

Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

Primary To determine whether the addition of bevacizumab to temozolomide and radiation improves efficacy as measured by progression-free and/or overall survival. Secondary To determine whether the tumor molecular profile conferring a mesenchymal/angiogenic phenotype is associated with a selective...

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Past Studies

Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

Primary Objectives To determine whether SBRT can be shown to be superior to hypofractionated IMRT in terms of GU and GI toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel HRQOL as measured by EPIC-26 at 24 months post...

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Past Studies

Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Primary Goal: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide (RT + TMZ → TMZ) (ARM B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by adjuvant PCV...

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Past Studies

Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) Versus Observation

Primary Objective To demonstrate an absolute improvement in Neoadjuvant Rectal Cancer (NAR) score for the experimental regimen as compared to concurrently randomized control patients. Secondary Objectives To compare overall survival (OS) To compare disease-free survival (DFS) To compare the rate...

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Past Studies

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Primary: To determine if adjuvant systemic chemotherapy following chemoradiation therapy will improve disease-free survival compared to chemoradiation therapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after a radical...

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Past Studies

Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas

Primary Objectives To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients requiring treatment for low-grade gliomas. To determine whether the addition of temozolomide to fractionated radiotherapy improves the median...

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Past Studies

Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma

Primary Objective: To determine if dose-intensifying (increasing the dose-density ) the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by overall survival. Secondary Objectives: To determine if dose-intensifying the adjuvant temozolomide...

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Past Studies

Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) With a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT With a GNRH Agonist and TAK-700 For Men With High Risk Prostate Cancer

Primary Objective: To evaluate the difference in overall survival in men with clinically localized prostate cancer with unfavorable prognostic features between a) standard treatment (ADT + radiotherapy) and b) standard treatment with the addition of 24 months of TAK-700. Secondary Objectives: To...

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Past Studies

Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

1. Overall Survival To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 2. Neurocognitive Progression To determine in patients with one to four brain...

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Past Studies

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Primary Objective: To determine whether substitution of cisplatin with Cetuximab will result in comparable 5-year overall survival Secondary Objectives: To monitor and compare progression-free survival for safety ; To compare patterns of failure (locoregional vs. distant); To compare acute...

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Past Studies

Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Objectives In the defined good-risk group, assess the role of whole breast radiation plus/minus tamoxifen compared to wide excision to negative margins alone plus/minus tamoxifen, in decreasing or delaying the appearance of local failure, both invasive and in situ, and preventing the need for...

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Past Studies

Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

Primary Objectives To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma. To assess whether adjuvant temozolomide chemotherapy improves survival as compared...

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Current Studies

Phase II-III Trial of Adjuvant Radiotherapy Following Radical Prostatectomy With or Without Adjuvant Docetaxel

PRIMARY OBJECTIVES: I. To assess the benefit of docetaxel as measured by improvement in freedom from progression (phase II) and subsequently metastasis free survival (phase III) when given in combination with radiation and androgen deprivation in treatment of high risk prostate cancer post-radical...

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Past Studies

Post-Market, Long-Term Follow Up of Mobi-C� Cervical Disc for One and Two Level Treatment of Cervical Disc Disease

Primary outcome measures: ? NDI Score ? Subsequent surgery rates ? Device-related complications Mean NDI scores, rates of subsequent surgery and incidence of device-related complications will be compared to those at 7 years post-surgery. Secondary outcome measures: The following parameters will...

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Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation

Determine if early treatment with dronedarone is superior to usual care for the prevention of cardiovascular hospitalization or death from any cause in patients with first-detected atrial fibrillation.

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Past Studies

Pre-operative Assessment and Post-operative Outcomes of Elderly Women With Gynecologic Cancers

Primary Objective: To determine whether the preoperative GA-GYN score will be associated with major post-operative complications in elderly patients undergoing open primary cytoreduction surgery. Secondary Objectives: To explore associations between individual variables of the preoperative...

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Prognostic Gene Expression Profiling and Adjuvant Therapy in Stage IIB-C and IIIA-B Cutaneous Melanoma (PERSONALize)

Primary Objective To evaluate outcomes (RFS, DMFS, MSS, and OS) of Class 1 and Class 2, stage IIB-IIIB cutaneous melanoma patients who are not treated with contemporary adjuvant therapies. Secondary Objective To evaluate outcomes (RFS, DMFS, MSS, and OS) and interaction effect (relative benefit) of...

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Past Studies

Prospective Development and Validation of a Gene Expression Assay to Predict the Risk of Recurrence Disease in Cutaneous Squamous Cell Carcinoma

Primary endpoint: To prospectively validate a gene expression and/or mutation profile to predict the risk of recurrence associated with primary cSCC tumors Secondary endpoints: To further develop a gene expression profile assay through use of gene expression data, including that from subgroups...

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Past Studies

Prosper: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled, Efficacy And Safety Study Of Enzalutamide in Patients With Non-metastatic Castration-resistant Prostate Cancer

Primary Objective: The primary objective is to determine the efficacy of enzalutamide compared with placebo as assessed by MFS. Secondary Objectives: To evaluate the benefit of enzalutamide compared with placebo as measured by the following: Overall survival; Time to pain progression; Time to...

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Past Studies

Protego DF4 Post Approval Registry

Primary Endpoint 2: Protego DF4 Lead Safety Individual 5-Year Adverse Event-Free Rates Each of the individual types of adverse events contributing to primary endpoint 1 will be evaluated separately in the following superiority hypothesis. Ho: The individual adverse event rate (AEIndividual) for...

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Past Studies

Protocol for Flexible Endoscopic Incisional Therapy of Zenker s Diverticulum

Primary Outcome Measures: a. Technical success in performing endoscopic myotomy b. Clinical success Improvement in symptoms and objectively assessed by improvement in radiographic imaging c. Adverse Events as defined by published ASGE criteria (22). Secondary Outcome Measures: a. Procedure...

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Past Studies

Protocol Title: Understanding the Time and Resources Associated with SPRAVATO� Administration and Monitoring Among Patients with Treatment-Resistant Depression (TRD) in the United States (US): A Non-interventional Time and Motion Study (

Primary Objectives To characterize and quantify steps for using SPRAVATO among adult patients with treatment resistant depression (TRD) in the United States (US) To assess time and resources associated with each component of the administration and monitoring of SPRAVATO To assess whether time...

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Current Studies

PulseRider� Aneurysm Neck Reconstruction Device (ANRD)

PulseRider� is indicated for use with neurovascular embolic coils in patients greater than or equal to 18 years of age for the treatment of unruptured wide-necked intracranial aneurysms with neck widths greater than 4 mm or dome to neck ratio < 2 originating on or near a vessel bifurcation of the...

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Past Studies

Quadripolar CRT-D On Currently Approved Lead SystemS

The goal of this study is to evaluate the left ventricular (LV) pacing vectors available in Boston Scientific s (BSC) FDA-approved quadripolar (X4) CRT-Ds compared to the LV pacing vectors available in St. Jude Medical s (STJ) CRT-Ds using a quadripolar LV lead.

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Past Studies

Quadripolar Pacing Post Approval Study

The purpose of this post approval study is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy.

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Current Studies

Quality of life assessment in patients receiving cryotherapy in addition to chemotherapy for palliation of unresectable esophageal or gastroesophageal cancer

Primary Objective: To determine the effect of cryoablation combined with chemotherapy on the quality of life (QOL) of patients with non-resectable esophageal or gastroesophageal cancer. Secondary Objective: To determine the effect of cryotherapy on dysphagia scores To describe the safety profile...

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Past Studies

QuickFlex Micro Left Ventricular Lead Post Approval Study

Complication free survival rate at 5 years for complications related to the left ventricular lead [ Time Frame: 5 years ] LV lead electrical performance [ Time Frame: 5 years period ]

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Past Studies

Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Patients With Metastatic or Unresectable Sarcoma

Primary objective To evaluate the confirmed response rate of single agent nivolumab and dual agent nivolumab plus ipilimumab in patients with locally advanced/unresectable or metastatic soft tissue sarcoma. Secondary objectives To evaluate adverse event rates (NCI CTCAE v4.0) within each treatment...

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Current Studies

Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women with Early Stage Breast Cancer (PBI 3.0)

Primary Objective Non-inferiority of partial breast irradation (PBI) and concurrent compared to sequential chemotherapy with respect to acute grade 3-4 radiation toxicity Secondary Objectives Evaluate and compare any first tumor recurrence (local plus distant) between arms of the study. Evaluate...

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Past Studies

RANDOMIZED PHASE II TRIAL OF CONCURRENT BEVACIZUMAB AND RE-IRRADIATION VERSUS BEVACIZUMAB ALONE AS TREATMENT FOR RECURRENT GLIOBLASTOMA

Primary Objective To establish an improvement in overall survival in recurrent GBM patients receiving bevacizumab and re-irradiation compared with patients receiving bevacizumab alone. Secondary Objectives To estimate and compare the rate of objective response in patients with measurable...

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Past Studies

Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC

Primary Objective To determine whether MET added to chemoradiotherapy can improve progression-free survival (PFS) in patients with locally advanced NSCLC Secondary Objectives Determine the effects of MET on overall survival (OS), time to local-regional progression (LRP), and time to distant...

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Past Studies

Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

Primary: To determine if dose-escalated and -intensified photon IMRT or proton beam therapy (using a dose-per-fraction escalation with simultaneous integrated boost) with concomitant and adjuvant temozolomide improves overall survival, as compared to standard-dose photon irradiation with...

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Past Studies

Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer

Primary Objective: To evaluate the ability of post-cystectomy adjuvant radiotherapy to safely reduce pelvic tumor recurrence, defined as pelvic recurrence-free survival in Section 16.3.2. Secondary Objectives: Evaluate increase in disease-free survival Evaluate toxicity of adjuvant pelvic...

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Current Studies

Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

Primary Objective: Randomized Phase II Component (Non-Inferiority): Determine whether the 12-month intracranial relapse rate following HA-PCI is non-inferior compared to the rate following PCI for patients with SCLC. Phase III Component (Efficacy): Determine whether HA-PCI reduces the likelihood of...

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Past Studies

Randomized Phase II/III Trial of Radiotherapy With Concurrent Durvalumab vs. Radiotherapy With Concurrent Cetuximab in Patients With Stage III-IVB Head and Neck Cancer With a Contraindication to Cisplatin

Primary Objective Lead-In: To determine the safety of radiotherapy (RT) with concurrent and adjuvant anti-PD-L1 therapy [MEDI4736 (durvalumab)] is safe in patients with locoregionally advanced head and neck cancer (HNC) who have a contraindication to cisplatin. Phase II: To test the hypothesis...

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Past Studies

Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered With Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

Randomized Phase II Component Primary Objective To select the better experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin Phase III Component Primary Objective To determine whether the selected experimental arm will improve overall survival (OS)...

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Past Studies

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Primary Objectives: To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in Stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical...

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Past Studies

Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular Carcinoma

Primary Objective: To determine if SBRT improves overall survival in HCC patients treated with Sorafenib Secondary Objectives: To determine the difference in time to progression (TTP) and progression-free survival (PFS) in HCC patients treated with Sorafenib compared to SBRT followed by...

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Past Studies

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer

To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (iDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥30kg/m2) women diagnosed with HER-2 negative, stage II and III...

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Past Studies

Randomized Phase III Trial of Bortezomib, LENalidomide, and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients With Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)

Primary Objective To compare the overall survival between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression. Secondary...

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Past Studies

Randomized Study of Erlotinib vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Primary Objective: To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over observation for patients with completely resected stage IB (greater than or equal to 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard...

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Past Studies

Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses

1. To compare the number of median passes needed to obtain satisfactory diagnostic yield of EUS-FNA of pancreatic masses performed using needle 1 versus needle 2, which are both standard, accepted, and practiced methods of care

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Past Studies

Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS)

The objective of this study is to demonstrate that the efficacy of DE (110 mg b.i.d. or 150 mg b.i.d., with dosing according to age and renal function), is superior to ASA (100 mg once daily) for the prevention of stroke recurrence in patients with stroke of undetermined source. The trial will also...

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Past Studies

Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivolumab Clinical Trial Evaluation 812)

Primary Objective: To compare progression free survival of nivolumab + BV vs BV based on BICR assessments Primary Endpoint: Progression Free Survival (PFS): defined as time from date of randomization to death, or disease progression. Secondary Objectives: To compare the complete response rate...

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Past Studies

Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo in Patients With Newly Diagnosed Glioblastoma

Primary To determine if the addition of cediranib to chemoradiation treatment enhances treatment efficacy as measured by the 6-month progression-free survival rate Secondary To determine if the addition of cediranib to chemoradiation treatment enhances treatment efficacy as measured by overall...

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Past Studies

Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes

Primary objective To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung...

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Past Studies

REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification. A Large-scale, Randomized Placebo-controlled Trial of the Clinical Effects of Anacetrapib Among People With Established Vascular Disease

Primary assessment will involve an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib versus placebo on major coronary events (defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during...

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Past Studies

ROMAN: Reduction in Oral Mucositis with Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer

Primary Objective: To assess the effect of GC4419 administered intravenously (IV) on the incidence and severity of severe oral mucositis (SOM) in subjects receiving post-operative or definitive therapy with single-agent cisplatin plus Intensity-Modulated Radiation Therapy (IMRT) for locally...

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Past Studies

Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker (LEADLESS II)

The primary objectives of this study are to assess the safety and effectiveness of the Nanostim device from implant through 6-months in a subject population indicated for a VVI(R) pacemaker.

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Past Studies

Safety Evaluations of Nivolumab (Anti-PD-1) Added To Chemotherapy (CRT) Platforms In Patients With Intermediate And High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma

Primary Objectives for Lead In Component To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with weekly cisplatin (40 mg/m2/week x 7) for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) (Arm 1); To evaluate the...

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Past Studies

Safety for Healthcare Workers and Patients: Acomparison of Ceiling Lifts and Prevalon(tm) AirTAP(tm) for In-bed Repositioning and Lateral Transfers

The primary aims of this study are to measure task completion times, perceived exertion for nurses, turning effectiveness during in-bed repositioning, nursing ease -of-use; and to compare difference between using ceiling lifts and the Prevalon(tm)AirTAP(tm) system (will be referred to as...

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Current Studies

Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia (NODE-303)

Primary: 1. The primary objective is to evaluate the safety of self-administered etripamil nasal spray (NS) outside of the clinical setting. Secondary Objectives: 1. To evaluate the efficacy of self-administered etripamil NS outside of the clinical setting, and 2. To evaluate the impact of...

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Past Studies

Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

Primary Objective Phase I Portion To determine the maximal tolerated dose (MTD) of SBRT for centrally-located NSCLC and the efficacy of that dose in patients who are not operative candidates Phase II Portion (8/20/10) To estimate the primary tumor control rate at the MTD of SBRT Secondary...

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Past Studies

SEASONS: A ProSpEctive Study Assessing the PhysicAl, PsychoSOcial, Spiritual, and Financial Needs of Breast and ProState Cancer Patients

OBJECTIVES Primary objectives: 1. Identify the physical, psychosocial, financial, and spiritual needs of breast cancer survivors in Northeast Indiana who are being treated at the Parkview Cancer Center in the acute phase, the extended phase, and the permanent phase of survivorship 2. Identify the...

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Past Studies

Sentus QP-Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs)

Pre Market: Confirm the safety and effectiveness of the BIOTRONIK Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 6 months post-implant. The evaluation of effectiveness will be based on LV pacing capture...

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SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

Primary Outcome Measures : Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1 [ Time Frame: From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to...

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Past Studies

S-ICD� System Post Approval Study

Primary Objective The primary purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.

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Current Studies

SILVIA

Primary Endpoints: Radiographic Proportion of subjects with S2AI screw loosening or other adverse findings on 2-year CT scans (see protocol for details) Clinical Proportion of subjects who develop new onset SIJ pain Change in SIJ pain in subjects with SIJ pain preoperatively (see protocol...

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Past Studies

Single-Patient Expanded Access of Onapristone ER in Gynecologic Cancers

Primary Objective: 1) To evaluate the efficacy, in terms of response rate (CR or PR) of onapristone ER, as determined by RECIST 1.1 response within 36 weeks of treatment, in patients with PR+ recurrent or advanced granulosa cell tumor, low grade serous ovarian cancer, or endometrioid endometrial...

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Past Studies

SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients

Study Endpoints/Objectives The endpoints of the study are: * Complication free survival rate at 5 years for complications related to the RV lead or SJ4 connector * Electrical performance (capture threshold) of St. Jude Medical's SJ4 system The study will also characterize the complication rates...

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Past Studies

Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment With Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy

Primary objective To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more promising than zoledronic acid alone in increasing the time before progression to multiple myeloma. Secondary objectives To assess changes in minimal residual disease [MRD] by flow cytometry from...

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Past Studies

St. Jude Medical Product Longevity and Performance (SCORE Registry)

The primary objective of the registry is to evaluate acute and long-term performance of SJM market-released CRM products by analyzing product survival probabilities. The secondary objective of the registry is to evaluate acute and long-term electrical and mechanical performance of these products.

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Past Studies

Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study

Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approval labeling.

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Current Studies

Surveillance AFter Extremity Tumor surgerY (SAFETY) International Randomized Controlled Trial

Feasibility Research Objectives For the purposes of the pilot phase, the primary objective will be to determine whether it is feasible to conduct a large multi-center RCT that will evaluate the impact of surveillance strategies on patient survival following extremity STS surgery. To do so, we will...

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Past Studies

Tenecteplase in Stroke Patients Between 4 and 24 Hours (TIMELESS)

* To compare the efficacy of tenecteplase with placebo. * To evaluate the efficacy of tenecteplase compared with placebo. * To evaluate the safety of tenecteplase compared with placebo.

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Past Studies

The Effect of Weight-Bearing Symmetry Feedback During Squatting Following Anterior Cruciate Ligament (ACL) Reconstruction

The purpose of this study is explore the effectiveness of weight-bearing symmetry feedback training following ACL reconstruction. Our hypothesis is that athletes will demonstrate improvements in weight-bearing symmetry during bodyweight squatting (i.e. squatting without resistance) during/following...

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The Impact of Simulation on Confidence Levels over Time

The hypothesis of this study is that serial emergent patient care simulations will affect participants self-confidence from pre to post simulation and over time.

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The role of circulating tumor DNA in the detection and surveillance of patients with early stage esophageal adenocarcinoma treated with endoscopic mucosal resection.

3. RATIONALE/ OBJECTIVES: The purpose of this study is to evaluate the role of circulating tumor DNAs in patients with stage Tis/T1/T2 esophageal adenocarcinoma treated with endoscopic resections in predicting risk of recurrence. 3.1 PRIMARY OBJECTIVE: a. To observe the frequency of detection of...

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Past Studies

This is a Phase 1b/2, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of B-701 plus docetaxel versus placebo plus docetaxel in the treatment of locally advanced or metastatic urothelial cell carcinoma in subjects who have relapsed after, or are refractory to standard therapy.

Lead-In Phase Primary Objectives To determine an acceptable maximum tolerated dose (MTD) of B-701 plus docetaxel in subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. To evaluate the safety and efficacy...

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Past Studies

Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)

Primary Outcome Measures: ICU and hospital mortality of COVID-19 patients [ Time Frame: 7 days ] Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients Secondary Outcome Measures: 30 days mortality [ Time Frame: 30 days ] Secondary outcome will be to...

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Past Studies

VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Overall Survival [ Time Frame: Every 6-8 weeks until end of treatment and every 3 months during long term follow up [up to 24 months ] Overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/standard of care

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Past Studies

WATCH - TAVR study (WATCHMAN FOR PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT)

To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR) Primary Outcome Measures: Compostie of all-cause mortality,...

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Past Studies

Weighted Blanket Study

The goal of this study is to assess the effectiveness of a weighted blanket on the outpatient infusion center patient's state of anxiety while receiving chemotherapy infusions.

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ZORION

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