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Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length...
Montefiore Medical Center
Cesarean Section
To determine whether women randomized to an enhanced recovery program will have improved
postoperative outcomes including improved breastfeeding initiation and continuation,
reduction in hospital length of stay without compromising patient satisfaction in comparison
to standard... expand
To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions. Type: Interventional Start Date: Sep 2017 |
A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
Janssen Research & Development, LLC
Diabetes Mellitus, Type 1
The primary purpose of this study is to determine if golimumab can preserve beta-cell
function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).
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The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D). Type: Interventional Start Date: Aug 2016 |
A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative...
Fox Chase Cancer Center
Carcinoma Breast Stage IV
The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy
(carboplatin and gemcitabine) is safe and effective in treating patients with metastatic
triple negative breast cancer.
Pembrolizumab is a drug which may help the immune system to target... expand
The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer. Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells. Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and metastatic non-small cell lung cancer. However, it has not been approved as a treatment for breast cancer. Type: Interventional Start Date: May 2016 |
Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Flamel Ireland Limited
Excessive Daytime Sleepiness
Cataplexy
Narcolepsy
The purpose of this study is to determine whether FT218 is safe and effective for the
treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
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The purpose of this study is to determine whether FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy. Type: Interventional Start Date: Nov 2016 |
The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed...
Dana-Farber Cancer Institute
Flat Epithelia Atypia
Intraductal Papilloma Without Atypia
This research study is studying a surgical intervention to rule out the presence of cancer in
participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal
papilloma without atypia (IPWA) by core needle biopsy.
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This research study is studying a surgical intervention to rule out the presence of cancer in participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA) by core needle biopsy. Type: Interventional Start Date: Sep 2015 |
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Southwest Oncology Group
Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or
exemestane, may fight breast cancer by lowering the amount of estrogen the body makes.
Everolimus may stop... expand
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer. Type: Interventional Start Date: Apr 2013 |
Evaluation of the Duration of Therapy for Thrombosis in Children
Johns Hopkins All Children's Hospital
Venous Thrombosis
The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to
evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3
months) anticoagulation in children with first-episode acute venous thrombosis. The first
stage... expand
The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3 months) anticoagulation in children with first-episode acute venous thrombosis. The first stage of the trial has consisted of a pilot/feasibility component, which then continues as the definitively-powered trial. Type: Interventional Start Date: Mar 2008 |
A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With...
Millennium Pharmaceuticals, Inc.
Advanced Solid Neoplasm
The purpose of this study is to characterize the effects of 25 and 50 milligram per square
meter (mg/m^2) pevonedistat on the Fridericia corrected QT interval (QTcF) of the
electrocardiogram (ECG).
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The purpose of this study is to characterize the effects of 25 and 50 milligram per square meter (mg/m^2) pevonedistat on the Fridericia corrected QT interval (QTcF) of the electrocardiogram (ECG). Type: Interventional Start Date: Nov 2017 |
Study of Immune Checkpoint Inhibition With Radiation Therapy in Unresectable, Non-metastatic Pancreatic...
New York University School of Medicine
Pancreatic Cancer
This is an open-label, three-cohort, phase Ib study to determine the safety, recommended
phase 2 dose (RP2D), and efficacy of Stereotactic Body Radiation Therapy (SBRT) in
combination with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of
MEDI4736 and... expand
This is an open-label, three-cohort, phase Ib study to determine the safety, recommended phase 2 dose (RP2D), and efficacy of Stereotactic Body Radiation Therapy (SBRT) in combination with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of MEDI4736 and tremelimumab for patients with unresectable locally advanced adenocarcinoma of pancreas. Type: Interventional Start Date: Aug 2016 |
The Influence of Breakfast on Hormone Responses and Cognitive Performance
Albert Einstein College of Medicine, Inc.
Insulin Resistance
The purpose of this study is to see what effect skipping breakfast versus consuming breakfast
has on cognitive performance and the hormones responsible for glucose homeostasis in lean and
obese adolescent males. The subjects will be tested on their ability to maintain attention... expand
The purpose of this study is to see what effect skipping breakfast versus consuming breakfast has on cognitive performance and the hormones responsible for glucose homeostasis in lean and obese adolescent males. The subjects will be tested on their ability to maintain attention when given several tasks called continuous temporal expectancy tasks (CTET) and electrophysiological signals using electroencephalogram (EEG) will be monitored. These two study groups will be randomized to one of two orders: (A,B) or (B,A) where A = breakfast intervention and B = no breakfast. There will be a washout period of 7 days in between study visits. Type: Interventional Start Date: Jun 2016 |
Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor...
University of North Carolina, Chapel Hill
Pediatric Crohn's Disease
The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF
therapy is more effective than treatment with anti-TNF therapy alone in inducing and
maintaining steroid-free remission for children with Crohn's Disease.
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The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease. Type: Interventional Start Date: Oct 2016 |
VEST Venous Graft External Support Pivotal Study
Vascular Graft Solutions Ltd.
Coronary Artery Disease
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients
with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with
arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one... expand
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set. Type: Interventional Start Date: Jan 2018 |
The Effect of AposTherapy on Knee Pain
Montefiore Medical Center
Knee Osteoarthritis
Knee Pain
AposTherapy is a home based exercise program utilizing footwear that causes exercise with
normal activity that may significantly improve function in patients with knee osteoarthritis
since patients with knee osteoarthritis have altered mechanics of motion contributing or due... expand
AposTherapy is a home based exercise program utilizing footwear that causes exercise with normal activity that may significantly improve function in patients with knee osteoarthritis since patients with knee osteoarthritis have altered mechanics of motion contributing or due to the presence of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of ApostTherapy in patients with significant knee OA, the investigators propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in an at-risk urban inner city population. Type: Interventional Start Date: Nov 2016 |
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors,...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Bladder Carcinoma
Breast Carcinoma
Cervical Carcinoma
Colon Carcinoma
This phase II MATCH trial studies how well treatment that is directed by genetic testing
works in patients with solid tumors or lymphomas that have progressed following at least one
line of standard treatment or for which no agreed upon treatment approach exists. Genetic
tests... expand
This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma. Type: Interventional Start Date: Aug 2015 |
Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
Baxalta now part of Shire
Primary Immunodeficiency Diseases (PID)
The purpose of the proposed study is to acquire additional data (including the assessment of
anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed
treatment regimens and treatment administration in routine clinical practice.
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The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and treatment administration in routine clinical practice. Type: Observational Start Date: Nov 2015 |
Cerebrotendinous Xanthomatosis (CTX) Prevalence Study
Retrophin, Inc.
Cerebrotendinous Xanthomatosis (CTX)
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous
Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral
cataracts. Patients who are potentially eligible for study participation will be identified
through... expand
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial. Type: Observational Start Date: Sep 2015 |
PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Kaiser Permanente
Opioid-use Disorder
Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for
treating OUDs—buprenorphine and injectable naltrexone—can be prescribed in primary care (PC).
However, despite the current opioid epidemic and expert recommendations that OUDs should be... expand
Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for treating OUDs—buprenorphine and injectable naltrexone—can be prescribed in primary care (PC). However, despite the current opioid epidemic and expert recommendations that OUDs should be treated in PC, most PC clinics do not offer treatment for OUDs. This reflects a lack of consensus among health system leaders and clinicians that OUDs should be treated in PC. The PRimary care Opioid Use Disorders treatment (PROUD) Trial is a pragmatic cluster-randomized, quality improvement trial that evaluates implementation of a team-based approach to PC supported by a full time nurse (the "PROUD intervention"). This type of team-based PC is often referred to as "collaborative care" for management of OUDs in PC, and this type of trial is often referred to as a Hybrid Type III implementation trial. The trial is being conducted in 6 diverse health systems spanning 5 states (New York, Florida, Michigan, Texas, and Washington), with 2 PC clinics in each system randomized. One clinic is randomly selected to implement the PROUD intervention and the other continues usual PC (UPC). The overall objective of the PROUD trial is to provide information to guide health system leaders who are faced with the decision of whether or not to treat OUDs in PC, by evaluating the benefits of implementing the PROUD intervention that integrates high quality OUD treatment (i.e. buprenorphine or injectable naltrexone) into the normal flow of PC. The primary objective of the PROUD trial is to evaluate whether the PROUD intervention increases OUD treatment with buprenorphine or injectable naltrexone, documented in the electronic health records (EHRs) of PC patients, over a 2 year follow-up, as compared to UPC. The primary hypothesis is that there will be a significant increase in the number of patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2 years after clinics are randomized to the PROUD intervention compared to PC clinics randomized to UPC. This implementation objective reflects whether the PROUD intervention increases initiation of and/or retention in OUD treatment, documented in EHRs within medical settings. The main secondary objective is to test the hypothesis that PC patients with OUDs documented in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention clinics, compared to those who receive care in UPC clinics, will have fewer days of acute care utilization (including urgent care, emergency department [ED] and hospital care) in the 2 years after randomization. This effectiveness objective assesses whether implementation of the MA Model improves patient outcomes. Type: Interventional Start Date: Feb 2018 |
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Stage III-IVB Head and Neck...
National Cancer Institute (NCI)
Head and Neck Squamous Cell Carcinoma
Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
This randomized phase II/III trial studies how well radiation therapy works with durvalumab
or cetuximab in treating patients with stage III-IVB head and neck cancer who cannot take
cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
Monoclonal... expand
This randomized phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with stage III-IVB head and neck cancer who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as durvalumab and cetuximab, may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer. Type: Interventional Start Date: Dec 2017 |
BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)
Bayer
Leukemia, Myeloid, Acute
To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1
(mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics,
pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced
acute... expand
To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML) Type: Interventional Start Date: Jun 2017 |
The Effect of Footwear Generated Biomechanical Manipulation on Symptoms of Stress Urinary Incontinence
Montefiore Medical Center
Pelvic Floor Disorders
Stress Urinary Incontinence
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of
pelvic muscles. While there have been no published studies to our knowledge investigating the
effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that
create... expand
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population. Type: Interventional Start Date: Nov 2017 |
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated...
National Cancer Institute (NCI)
AIDS-Related Hodgkin Lymphoma
Ann Arbor Stage II Hodgkin Lymphoma
Ann Arbor Stage IIA Hodgkin Lymphoma
Ann Arbor Stage IIB Hodgkin Lymphoma
Ann Arbor Stage III Hodgkin Lymphoma
This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin
when given together with combination chemotherapy and to see how well they work in treating
patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma.... expand
This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells. Type: Interventional Start Date: Mar 2013 |
Topiramate for Cryptogenic Sensory Peripheral Neuropathy
University of Utah
Cryptogenic Sensory Peripheral Neuropathy
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate
as a potential disease altering therapy for cryptogenic sensory peripheral neuropathy (CSPN).
Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do... expand
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate as a potential disease altering therapy for cryptogenic sensory peripheral neuropathy (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do not have an alternative cause for neuropathy will be potentially eligible. The co primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase will last 24 months. Type: Interventional Start Date: Feb 2018 |
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
St. Jude Medical
Heart Failure
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study
of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
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This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use. Type: Interventional Start Date: Nov 2016 |
Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Metastatic Breast Cancer
Montefiore Medical Center
Breast Cancer
Breast Adenocarcinoma
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Recurrent Breast Carcinoma
Stage IV Breast Cancer
The purpose of this study is to determine the safety and tolerability of rebastinib when
combined with antitubulin therapy with paclitaxel or eribulin in patients with advanced
breast cancer.
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The purpose of this study is to determine the safety and tolerability of rebastinib when combined with antitubulin therapy with paclitaxel or eribulin in patients with advanced breast cancer. Type: Interventional Start Date: Jul 2016 |
Cytochrome C Oxidase Activity in Newly Diagnosed Glioblastoma Multiforme (GBM)
University of Alabama at Birmingham
Primary Glioblastoma Multiforme
This is a multi-institutional, consortium-based, non-interventional prospective blinded
endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in
tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened
OS... expand
This is a multi-institutional, consortium-based, non-interventional prospective blinded endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened OS (primary outcome) and PFS (secondary outcome) times. Type: Observational Start Date: Nov 2016 |