Past Studies
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
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
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
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
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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Past Studies
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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Past Studies
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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Past Studies
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
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
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
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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Past Studies
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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Past Studies
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
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
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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Past Studies
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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Past Studies
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
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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Past Studies
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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Past Studies
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
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
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
Primary Objective:
To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients...
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Past Studies
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
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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Past Studies
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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Past Studies
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
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
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
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
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
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
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
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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Past Studies
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
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
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
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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Past Studies
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
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
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
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
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
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
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
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
Primary Objective
To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with...
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Past Studies
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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Past Studies
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
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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Past Studies
3.1 Primary Objective:
To compare the effectiveness of two approaches for the management of Barrett s esophagus (BE) and low-grade dysplasia (LGD), endoscopic surveillance and endoscopic eradication therapy (EET), using an accepted clinical endpoint of neoplastic progression [high-grade dysplasia...
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Past Studies
RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of...
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Past Studies
To evaluate the diagnostic accuracy of a plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRCT) software device (ElucidVivoTM) as compared to invasive fractional flow reserve (FFR) in patients who underwent clinically indicated CCTA and invasive FFR.
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Past Studies
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
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
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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Past Studies
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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Past Studies
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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Past Studies
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
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
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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Past Studies
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
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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Past Studies
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
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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Past Studies
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
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
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
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
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
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
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
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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Past Studies
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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Past Studies
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
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
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
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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Past Studies
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
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
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-L1positive tumors
Secondary Objectives
Among patients with measurable residual disease in the primary...
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Past Studies
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
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
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
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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Past Studies
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
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
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
The
purpose of this database is to have a comprehensive look at cardiac arrest care and
outcomes.
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Past Studies
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
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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Past Studies
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
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
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
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
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
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
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
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
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
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
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
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
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
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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Past Studies
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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Past Studies
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
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
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
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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Past Studies
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
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
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus
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Past Studies
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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Past Studies
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
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
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
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
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
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
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
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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Past Studies
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
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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Past Studies
To assess the diagnosis, treatment and outcomes of those patients with gastrointestinal stromal tumors
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Past Studies
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
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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Past Studies
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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Past Studies
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
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
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
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
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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Past Studies
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
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
Co-primary Objectives
To determine the progression free survival (PFS) for paclitaxel with and without nivolumab in subjects with taxane naïve 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
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
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
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
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
The hypothesis of this study is that the Taking Root program has been effective at improving the participants health outcome measures of BMI, body fat and aerobic capacity. Objectives
To assess change in body fat, BMI, and aerobic capacity after participating in the taking root program
To...
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Past Studies
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
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
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
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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Past Studies
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
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
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
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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Past Studies
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
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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Past Studies
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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Past Studies
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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Past Studies
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
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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Past Studies
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
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
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
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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Past Studies
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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Past Studies
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
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
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
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
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Past Studies
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
* 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
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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Past Studies
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
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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Past Studies
To elucidate long-term outcomes of patients with mild and rapidly improving stroke and examine the association with tPA treatment.
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Past Studies
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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Past Studies
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
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
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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Past Studies
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
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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Past Studies
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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Past Studies
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
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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Past Studies
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
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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Past Studies
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
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
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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Past Studies
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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Past Studies
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
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
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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Past Studies
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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Past Studies
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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Past Studies
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
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
For patients presenting with confirmed or suspected viral URI to same-day or walk-in appointment; does delayed antibiotic prescription with patient education compared with education and instructions to return/call back for prescription reduce antibiotic fill rates and reduce healthcare burden...
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Past Studies
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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Past Studies
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
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
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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Past Studies
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
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
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
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
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
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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Past Studies
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
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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Past Studies
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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Past Studies
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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Past Studies
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
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
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
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
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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Past Studies
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
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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Past Studies
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
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
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
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
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
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
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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Past Studies
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
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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Past Studies
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
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
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
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
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
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
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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Past Studies
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
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
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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Past Studies
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
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
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
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
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
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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Past Studies
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
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
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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Past Studies
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
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
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
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
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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Past Studies
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
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
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
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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Past Studies
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
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
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
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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Past Studies
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
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
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
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
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
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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Past Studies
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
The purpose of this study is to explore the ESD feasibility and efficacy in duodenal tumors treatment.
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Past Studies
Primary Outcome Measures :
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10 [ Time Frame: Up to approximately 33 months ]
PFS is defined as the...
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Past Studies
1) Complete closure rate: proportion of cases in which complete tissue approximation is achieved with the use of the DAT clip (no substantial gaps are visible in the closure line)
2) Achievement of intended targeted therapy: defined as cases in which utilization of the DAT clip accomplished the...
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Past Studies
Primary Objective/Aim/Goal/Hypothesis
Aim. The primary aim is to evaluate the efficacy of the SAP gel in the prevention of stricture formation following endoscopic resection in high-risk patients
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Past Studies
Primary Aim
Retrospective analysis of clinical outcomes of POEM for the treatment of symptomatic esophageal dysmotility in patients on chronic opioids.
Secondary Aim
Factors associated with clinical response to POEM in patients on chronic opioids.
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Past Studies
To analyze the safety, efficacy and outcomes of endoscopic submucosal dissection (ESD) for previously attempted colorectal lesions in North American population.
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Past Studies
To investigate the safety and efficacy of STER and EFTR for treatment of SELs in the upper GI tract.
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Past Studies
Complete Remission (CR) [ Time Frame: Up To 36 Months ]
CR is defined as achieving a complete remission at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
Overall survival (OS) [ Time Frame: Up To 5 Years ]
OS is...
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Past Studies
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
To collect and analyze data on long-term outcomes of patients who have undergone endoscopic submucosal dissection (ESD) for a gastrointestinal cancer to help guide surveillance.
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Coming Soon
Primary Outcome Measures :
Time from randomization until treatment failure [ Time Frame: Randomization to until end of study (up to 39 months after randomization of last participant) ]
Time from randomization until treatment failure is defined as the time from randomization date until the first of...
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Coming Soon
Primary objective(s)
To demonstrate that either dose of ianalumab induces durable hemoglobin (Hb) response compared to placebo, in patients with wAIHA who failed at least one previous line of treatment
Secondary objective(s)
Key secondary objective: to demonstrate that either dose of ianalumab...
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Coming Soon
Primary Objective:
The primary objective of this study is to evaluate the efficacy of Vigil / bevacizumab (or
bevacizumab biosimilar) versus Vigil placebo / bevacizumab (or bevacizumab biosimilar), as
measured by progression free survival in individuals with Stage IIIb-IV, BRCA-wt HRP...
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Coming Soon
Efficacy
-To evaluate the efficacy of two dosing regimens of RRx-001 as comparted to placebo in terms of the attenuation of severe oral mucositis (SOM, WHO Grade greater than or equal to 3) in patients receiver CRT for the treatment of cancers of the oral cavity or oropharynx through IMRT
-To...
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Coming Soon
Primary
Evaluate anti-tumor efficacy of VB10.16 + placebo and VB10.16 + Atezolizumab
Secondary
Further evaluate anti-tumor efficacy and response durability of VB10.16 + placebo and VB10.16 + atezolizumab
Evaluate clinical efficacy of VB10.16 + placebo and VB10.16 + atezolizumab
Characterize safety...
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Coming Soon
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
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Coming Soon
The primary endpoint of this post market registry study is to provide real-world evidence on the Composite Safety Success rate to enable meaningful comparison to other similar procedures. The Composite Safety Success rate is defined as the absence of Reoperation, Revision, Failure of Fixation,...
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Coming Soon
Primary
To demonstrate the superiority of camizestrant + capivasertib relative to physician s choice of ET by assessment of PFS in the overall study population and/or
a subpopulation of patients with breast cancers harboring PIK3CA/AKT1/PTEN-alteration(s)1 and/or
a subpopulation of patients with...
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Coming Soon
Primary Objective (Part 1)
To evaluate the incidence of treatment-emergent laboratory TLS per Howard criteria (2 or more lab abnormalities [hyperkalemia (potassium greater than 6.0 mmol/L), hyperphosphatemia (phosphorus greater than 4.5 mg/dL), hypocalcemia (corrected calcium lest than 7.0 mg/dL or...
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Coming Soon
The endpoint for patient participation will be local recurrence
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Current Studies
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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Current Studies
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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Current Studies
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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Current Studies
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
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
- 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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Current Studies
Primary Objectives
To compare the complete response rate at 6 cycles after randomization as defined by centrally read PET/CT (integral biomarker) of 2 targeted therapeutic regimens (obinutuzumab + TGR-1202 or obinutuzumab + lenalidomide) with obinutuzumab + CHOP in patients with early relapsing or...
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Current Studies
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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Current Studies
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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Current Studies
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
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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Current Studies
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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Current Studies
Primary
The primary objective of this Phase 2 study is to evaluate the safety of Epcoritamab monotherapy without mandatory hospitalization for the first full dose of Epcoritamab in subjects with R/R DLBCL or R/R FL Grade 1-3a who have received at least 2 prior lines of systemic anti-lymphoma...
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Current Studies
Primary Objective
Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with SABR plus placebo vs. SABR plus relugolix.
Secondary...
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Current Studies
Aim of study: to examine outcomes and complications of rectal ESDs performed within 2 cm of the dentate line
Primary endpoints: to determine the rate of R0 resection of rectal ESDs performed within 2 cm of the dentate line
Secondary endpoints: to determine complication rates of rectal ESDs...
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Current Studies
Our objective with this study is to take a retrospective look at patients with achalasia in the state of Indiana who have undergone either surgical therapy via laparoscopic or open Heller myotomy, or endoscopic therapy with the Per-oral endoscopic myotomy (POEM) procedure. We plan to compare the...
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Current Studies
To offer NODE-301, NODE-302 and NODE-303 subjects continued access to Etripamil
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Current Studies
Primary Objective
ctDNA-ve Cohort (Arms 1 + 2):
Phase II: To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from...
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Current Studies
Primary objective
To evaluate and compare the cCR rates in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed by neoadjuvant mFOLFOX6.
Secondary objective(s)
To evaluate and compare organ-preservation-time...
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Current Studies
Primary Objective:
To evaluate the impact of Envisia on:
* Treatment decision: Increase in proportion of patients prescribed anti-fibrotics in those with an Envisia UIP+ result versus their pre-Envisia plan.
Secondary Objectives:
To evaluate the impact of Envisia on:
* Diagnosis: Increase in...
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Current Studies
The primary objective is to evaluate whether invasive procedures in the group classified as low-risk by the Percepta Nasal Swab test and that are benign are reduced in the test group who received a Percepta Nasal Swab result as compared to the control group who were managed without a Percepta Nasal...
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Current Studies
Primary Objective:
* To evaluate the efficacy of MK-0616 compared with placebo on increasing the time to the first event of death from coronary heart disease, MI, ischemic stroke, acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or...
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Current Studies
Analyze the outcomes of endoscopic esophageal stent placement in those with esophageal cancer
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Current Studies
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong PFS compared with 6 cycles of standard R-CHOP followed by 2 cycles of rituximab (R-CHOP) in subjects with newly...
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Current Studies
Primary: Incidence and proportion of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study ]
Selected AEs include xerostomia, xerophtalmia, myelosupression, renal...
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Current Studies
Primary Objective:
To compare MK-2870 to Treatment of Physician s Choice (TPC) with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR)
To compare MK-2870 to TPC with respect to overall survival (OS)
Secondary Objectives:
To compare...
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Current Studies
Primary: Determine the safety of a single administration of HMI-103
To evaluate the efficacy of HMI-103on reduction of plasma Pheconcentration at each dose level
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Current Studies
Primary Outcome Measures :
Time from randomization to treatment failure (TTF) [ Time Frame: Randomization to end of study (up to 39 months after randomization of last patient) ]
Time from randomization until platelet count below 30 G/L, need for a rescue treatment or start of a second-line therapy...
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Current Studies
The purpose of the NeuroBell EEG Monitor Clinical Feasibility Study is to evaluate the
suitability of the NeuroBell EEG Monitor for use in acquiring neonatal electroencephalogram (EEG)
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Current Studies
Primary Outcome Measures :
Part 1: To determine the navtemadlin Phase 3 dose [ Time Frame: 12 months ]
Safety review committee (SRC) will determine the navtemadlin Phase 3 dose for Part 2 based on safety data from Part 1
Part 2: To compare progression-free (PFS) survival by independent review...
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Current Studies
Primary Outcome Measures:
The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal myocardial infarction in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene.
Secondoary Outcome...
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