301 matching studies

Sponsor Condition of Interest
Gene Transfer Clinical Study in Crigler-Najjar Syndrome
Audentes Therapeutics Crigler-Najjar Syndrome
This is a Phase 1/2, multinational, open-label, ascending-dose, delayed-treatment concurrent control clinical study to evaluate the safety and preliminary efficacy of AT342 in subjects with Crigler-Najjar aged ≥1 year. Subjects will receive a single dose of AT342 and will be... expand

This is a Phase 1/2, multinational, open-label, ascending-dose, delayed-treatment concurrent control clinical study to evaluate the safety and preliminary efficacy of AT342 in subjects with Crigler-Najjar aged ≥1 year. Subjects will receive a single dose of AT342 and will be followed for safety and efficacy for 5 years.

Type: Interventional

Start Date: Sep 2017

open study

ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC
Calithera Biosciences, Inc Clear Cell Renal Cell Carcinoma
Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC expand

Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC

Type: Interventional

Start Date: Jul 2017

open study

New Onset Type 1 Diabetes: Role of Exenatide
Albert Einstein College of Medicine, Inc. Type 1 Diabetes
There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This... expand

There are many recent advances in insulin treatment of type 1 diabetes, however after a meal sugars are always a concern. There is a drug Exenatide (Byetta) which is FDA approved to treat people with type 2 diabetes which helps correct their glucoses (sugars) after meals. This study is going to test whether this drug can improve the after meal sugars in people with new onset type 1 diabetes. To test this you will be given a dose of exenatide (1.25 mcg) and long acting insulin or inulin alone before the boost. There is also a placebo group (healthy subjects) who do not get any medication before the boost. Insulin levels and other hormones that affect blood glucose as well as your sugar will be measured by a series of blood tests. The role exenatide as compared to insulin alone will be examined to prevent low blood sugars which might occur because of food staying longer in the stomach than usual or due to the suppression of a hormone called glucagon which increases blood sugar. If you qualify you will be given exenatide (Byetta 1.25 mcg) along with insulin or insulin alone. You and the researchers will not know which dose you are taking at any single visit. A total of 20 people in which some will be children aged 12- 18 years will participate, being diagnosed within 3 months of having been found to have type 1 diabetes.

Type: Interventional

Start Date: Dec 2010

open study

Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
Montefiore Medical Center Surgery
Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing in the post-operative period. There is wide variation in the prescribing practices for post-operative... expand

Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing in the post-operative period. There is wide variation in the prescribing practices for post-operative pain control and there is no standard of care for pain control after minor laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to show that on average half of the opioids prescribed are unused by the patient. The aim of the study is to evaluate two opioid prescription regimens.

Type: Interventional

Start Date: Aug 2018

open study

Pembrolizumab in Combination With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation...
University of Michigan Cancer Center Non-small Cell Lung Cancer
Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of carboplatin and pemetrexed in EGFR (epidermal growth factor receptor) mutation and ALK (anaplastic lymphoma kinase) positive NSCLC patients who have disease progression following prior TKIs... expand

Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of carboplatin and pemetrexed in EGFR (epidermal growth factor receptor) mutation and ALK (anaplastic lymphoma kinase) positive NSCLC patients who have disease progression following prior TKIs (tyrosine kinase inhibitors).

Type: Interventional

Start Date: Oct 2017

open study

Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide...
BeiGene USA, Inc. Locally Advanced or Metastatic Solid Tumors
This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and temozolomide (TMZ) in subjects with locally advanced or metastatic solid tumors. expand

This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and temozolomide (TMZ) in subjects with locally advanced or metastatic solid tumors.

Type: Interventional

Start Date: Jul 2017

open study

Anti-ESO (Cancer/Test Antigen) mTCR-transduced Autologous Peripheral Blood Lymphocytes and Combination...
Albert Einstein College of Medicine, Inc. HLA-A2 Positive Cells Present Metastatic Malignant Neoplasm Metastatic Malignant Neoplasm in the Brain
This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer... expand

This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer that has spread to other places in the body (metastatic) and expresses the gene NY-ESO-1. Donor white blood cells that are treated in the laboratory with anti-cluster of differentiation (CD)3 may help treat metastatic cancer. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, 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 more than one drug (combination chemotherapy) may kill more cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to kill metastatic cancer cells. Giving anti-ESO (cancer/test antigen) mTCR-transduced autologous peripheral blood lymphocytes together with combination chemotherapy and aldesleukin may kill more cancer cells.

Type: Interventional

Start Date: Aug 2016

open study

Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
Avelas Biosciences, Inc. Primary Invasive Malignant Neoplasm of Female Breast Carcinoma Breast Breast Cancer Female Carcinoma, Ductal, Breast Stage II Breast Cancer
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery. expand

Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.

Type: Interventional

Start Date: Jul 2017

open study

Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
Alliance for Clinical Trials in Oncology Stage II Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage I Prostate Cancer
This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.... expand

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

Type: Interventional

Start Date: Jul 2017

open study

Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity
Ipsen Lower Limb Spasticity
The purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after abobotulinumtoxinA injection (including following repeated injection cycles where they occur) alongside... expand

The purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after abobotulinumtoxinA injection (including following repeated injection cycles where they occur) alongside spasticity management used in real life settings over a period of 18 months (and a maximum of six injection cycles).

Type: Observational

Start Date: Feb 2017

open study

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer...
Alliance for Clinical Trials in Oncology Node Positive HER2 Negative Breast Cancer
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces... expand

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

Type: Interventional

Start Date: Dec 2016

open study

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

open study

Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating...
Children's Oncology Group Cellular Ependymoma Childhood Anaplastic Ependymoma Childhood Infratentorial Ependymoma Childhood Supratentorial Ependymoma Clear Cell Ependymoma
This partially randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such... expand

This partially randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Type: Interventional

Start Date: Mar 2010

open study

Matched Targeted Therapy For High-Risk Leukemias
Dana-Farber Cancer Institute Recurrent, Refractory, or High Risk Leukemias Matched Targeted Therapy
This research study is seeking to gain new knowledge about Recurrent, Refractory, or High Risk Leukemias in children and young adults. This study is evaluating the use of specialized testing called leukemia profiling. Once the profiling is performed, the results are evaluated... expand

This research study is seeking to gain new knowledge about Recurrent, Refractory, or High Risk Leukemias in children and young adults. This study is evaluating the use of specialized testing called leukemia profiling. Once the profiling is performed, the results are evaluated by an expert panel of physicians, scientists and pharmacists. This may result in a recommendation for a specific cancer therapy or a clinical trial called matched targeted therapy (MTT). The results of the leukemia profiling and, if applicable, the MTT recommendation will be communicated to the participant's primary oncologist.

Type: Interventional

Start Date: Feb 2016

open study

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

open study

Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
Montefiore Medical Center Nephrolithiasis
There are two options for postoperative pain management: opioid and non-opioid analgesia. Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous nephrolithotomy by randomly administering opioid and non-opioid analgesia. expand

There are two options for postoperative pain management: opioid and non-opioid analgesia. Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous nephrolithotomy by randomly administering opioid and non-opioid analgesia.

Type: Interventional

Start Date: Jul 2018

open study

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS
Alliance Foundation Trials, LLC. DCIS Ductal Carcinoma in Situ
This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ... expand

This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.

Type: Interventional

Start Date: Feb 2017

open study

Randomized Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid...
Cantex Pharmaceuticals Acute Myeloid Leukemia
The purpose of this study is to determine whether CX-01 when given together with standard induction and consolidation therapy for acute myeloid leukemia (AML) will increase the effectiveness of the induction/consolidation therapy. Two different doses of CX-01 will be studied... expand

The purpose of this study is to determine whether CX-01 when given together with standard induction and consolidation therapy for acute myeloid leukemia (AML) will increase the effectiveness of the induction/consolidation therapy. Two different doses of CX-01 will be studied and safety and tolerability will be assessed.

Type: Interventional

Start Date: Aug 2016

open study

A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Balance Therapeutics Idiopathic Hypersomnia
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia. expand

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.

Type: Interventional

Start Date: May 2018

open study

Determination of Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When...
Oragenics, Inc. Oral Mucositis
The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time... expand

The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion. The effect of AG013 on patient-reported symptoms and analgesic use during the active treatment phase, and on the cumulative radiation dose administered before the onset of OM will also be evaluated, as will biomarkers and, in a subset of subjects, the PK (pharmacokinetic) profile of AG013.

Type: Interventional

Start Date: Jul 2017

open study

Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally Advanced Rectal...
National Cancer Institute (NCI) Rectal Adenocarcinoma Stage II Rectal Cancer AJCC v7 Stage III Rectal Cancer AJCC v7
This randomized phase II trial studies how well veliparib or pembrolizumab work with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may... expand

This randomized phase II trial studies how well veliparib or pembrolizumab work with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib or pembrolizumab with combination chemotherapy and radiation therapy may kill more tumor cells, make the tumor smaller, and reduce the amount of normal tissue that needs to be removed.

Type: Interventional

Start Date: Oct 2016

open study

A Study To Confirm Efficacy and Safety of Terlipressin in HRS Type 1
Mallinckrodt Hepatorenal Syndrome
This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1. expand

This study is to confirm the efficacy and safety of intravenous terlipressin versus placebo in the treatment of adult subjects with hepatorenal syndrome (HRS) Type 1.

Type: Interventional

Start Date: Jul 2016

open study

S1417CD Financial Impact Assessment Tool in Patients With Metastatic Colorectal Cancer
Southwest Oncology Group Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer
This clinical trial studies the use of the financial impact assessment tool in patients with colorectal cancer that has spread from the primary site to other places in the body. Gathering information about patients with colorectal cancer over time may help doctors better understand... expand

This clinical trial studies the use of the financial impact assessment tool in patients with colorectal cancer that has spread from the primary site to other places in the body. Gathering information about patients with colorectal cancer over time may help doctors better understand the financial impact of cancer and help patients avoid financial problems during treatment.

Type: Observational

Start Date: Apr 2016

open study

Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL...
miRagen Therapeutics, Inc. Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides (MF) Chronic Lymphocytic Leukemia (CLL) Diffuse Large B-Cell Lymphoma (DLBCL) Adult T-Cell Leukemia/Lymphoma (ATLL)
Objectives of this clinical trial are to evaluate the safety, tolerability, pharmacokinetics and potential efficacy of the investigational drug, MRG-106, in patients diagnosed with certain lymphomas and leukemias, including cutaneous T-cell lymphoma (CTCL) [mycosis fungoides... expand

Objectives of this clinical trial are to evaluate the safety, tolerability, pharmacokinetics and potential efficacy of the investigational drug, MRG-106, in patients diagnosed with certain lymphomas and leukemias, including cutaneous T-cell lymphoma (CTCL) [mycosis fungoides (MF) subtype], chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), and adult T-cell leukemia/lymphoma (ATLL). MRG-106 is an inhibitor of a molecule called miR-155 that is found at high levels in these types of cancers and may be important in promoting the growth and survival of the cancer cells. Participants in the clinical trial will receive weekly doses of MRG-106 administered by injection under the skin or into a vein, or by injection directly into cancerous lesions in the skin (for CTCL only). Blood samples will be collected to measure how MRG-106 is processed by the body, and other measurements will be performed to study how normal and cancerous cells of the immune system respond when exposed to MRG-106.

Type: Interventional

Start Date: Feb 2016

open study

Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
Conatus Pharmaceuticals Inc. Decompensated Cirrhosis
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and MELD score progression... expand

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and MELD score progression are events) in subjects with decompensated NASH cirrhosis.

Type: Interventional

Start Date: Jun 2017

open study