516 matching studies

Sponsor Condition of Interest
Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)
ACADIA Pharmaceuticals Inc. Rett Syndrome
To investigate the efficacy of treatment with oral trofinetide versus placebo in females with Rett syndrome expand

To investigate the efficacy of treatment with oral trofinetide versus placebo in females with Rett syndrome

Type: Interventional

Start Date: Nov 2019

open study

Open-Label Placebos to Treat Fatigue in Multiple Sclerosis
University of Alabama at Birmingham Multiple Sclerosis Fatigue
Fatigue is one of the most prevalent and disabling symptoms of multiple sclerosis. Current treatments, including pharmacological, physical therapy, sleep regulation and psychological interventions are of marginal benefit. Pharmacological treatments have inconsistent evidence.... expand

Fatigue is one of the most prevalent and disabling symptoms of multiple sclerosis. Current treatments, including pharmacological, physical therapy, sleep regulation and psychological interventions are of marginal benefit. Pharmacological treatments have inconsistent evidence. Recent studies show that non-deceptive open-label placebos (OLP) have moderate-to-large effects on symptoms, including fatigue, in adults with a variety of medical conditions. Hence, this is a pilot and feasibility study to obtain data on the feasibility and effects of OLP for multiple sclerosis related fatigue and its impact to provide the basis for a competitive NIH application. This pilot study will be the first study to evaluate whether OLP, that garners full consent and engages patients in their wellness, may offer a safe, effective treatment for multiple sclerosis related fatigue.

Type: Interventional

Start Date: Feb 2020

open study

In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence
University of Alabama at Birmingham Smoking Reduction or Abstinence
This is a study to determine the efficacy of a smoking cessation intervention (nicotine replacement therapy (NRT) and counseling) done in a systematized manner with participants recruited from the UAB Substance Abuse Program. The definition of In Vivo experience is: use of... expand

This is a study to determine the efficacy of a smoking cessation intervention (nicotine replacement therapy (NRT) and counseling) done in a systematized manner with participants recruited from the UAB Substance Abuse Program. The definition of In Vivo experience is: use of the NRT medication during the session using specialized counseling focused around their experience of using NRT, including how the use of NRT may help them quit smoking, side effects, and smoking cessation expectancies. In this study those in the In Vivo group will put the patch on during Session 1 and given nicotine gum in Session 2 and will discuss the experience of wearing the patch or chewing the gum while they are in session. The control group will not put on the patch or chew gum during the sessions but will be given standard counseling regarding quitting smoking.

Type: Interventional

Start Date: Jan 2017

open study

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly...
National Cancer Institute (NCI) Endometrial Endometrioid Adenocarcinoma Stage I Uterine Corpus Cancer AJCC v8 Stage IA Uterine Corpus Cancer AJCC v8 Stage IB Uterine Corpus Cancer AJCC v8 Stage II Uterine Corpus Cancer AJCC v8
This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with... expand

This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

Type: Interventional

Start Date: Feb 2020

open study

Long-Term Study That Measures the Safety and Efficacy of BMS-986165 in Participants With Psoriasis.
Bristol-Myers Squibb Psoriasis
The main purpose of this study is to characterize the long-term safety and efficacy of the drug BMS-986165 in patients who have been previously enrolled in an applicable Phase 3 psoriasis study. expand

The main purpose of this study is to characterize the long-term safety and efficacy of the drug BMS-986165 in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

Type: Interventional

Start Date: Jan 2020

open study

A Safety Study of SGN-TGT (SEA-TGT) in Patients With Advanced Cancer
Seagen Inc. Non-small Cell Lung Cancer Gastric Carcinoma Classical Hodgkin Lymphoma Diffuse Large B-cell Lymphoma Peripheral T-cell Lymphoma
This trial will look at a drug called SGN-TGT (also known as SEA-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It... expand

This trial will look at a drug called SGN-TGT (also known as SEA-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SGN-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-TGT works to treat solid tumors and lymphomas. The study will have three groups or "parts." Part A of the study will find out how much SGN-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SGN-TGT with the PD-1 inhibitor pembrolizumab works to treat solid tumors and lymphomas. PD-1 inhibitors are drugs that can be used to treat these types of cancer.

Type: Interventional

Start Date: May 2020

open study

Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast...
National Cancer Institute (NCI) Breast Adenocarcinoma Metastatic Breast Adenocarcinoma Recurrent Breast Carcinoma Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7
This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as paclitaxel, work in... expand

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as paclitaxel, 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. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.

Type: Interventional

Start Date: Mar 2019

open study

Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma
National Cancer Institute (NCI) Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma Recurrent Burkitt Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma
This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, use substances... expand

This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

Type: Interventional

Start Date: Jun 2016

open study

Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain
Drexell Hunter Boggs Brain Metastases Small Cell Lung Cancer
This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC). expand

This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC).

Type: Interventional

Start Date: Aug 2019

open study

Phase 2 Clinical Trial of Crizotinib for Children and Adults With Neurofibromatosis Type 2 and Progressive...
University of Alabama at Birmingham Neurofibromatosis 2 Progressive Vestibular Schwannoma (VS)
Subjects with Neurofibromatosis Type 2 (NF2) and progressive vestibular schwannoma (VS) will be treated with crizotinib administered orally. Crizotinib will be taken continuously until disease progression or unacceptable toxicity, in continuous treatment cycles of 28 days each,... expand

Subjects with Neurofibromatosis Type 2 (NF2) and progressive vestibular schwannoma (VS) will be treated with crizotinib administered orally. Crizotinib will be taken continuously until disease progression or unacceptable toxicity, in continuous treatment cycles of 28 days each, for a maximum of 12 cycles.

Type: Interventional

Start Date: Feb 2020

open study

Heart Failure Optimization Study
Zoll Medical Corporation Sudden Cardiac Death Sudden Cardiac Arrest Heart Failure Heart Failure Low Output
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved.... expand

This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.

Type: Observational

Start Date: Mar 2017

open study

Timing of Inguinal Hernia Repair in Premature Infants
Vanderbilt University Medical Center Inguinal Hernia Premature Birth of Newborn
The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia. expand

The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.

Type: Interventional

Start Date: Jun 2013

open study

Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer
University of Alabama at Birmingham Metastatic Colon Cancer
This clinical study will investigate the utility of PET imaging with [89Zr]Panitumumab for imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node involvement. If promising, this data will be used to design larger trials. expand

This clinical study will investigate the utility of PET imaging with [89Zr]Panitumumab for imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node involvement. If promising, this data will be used to design larger trials.

Type: Interventional

Start Date: Mar 2019

open study

Acceptance and Commitment Therapy for Family Caregivers of People With Dementia
University of Alabama at Birmingham Psychological Distress
The pilot project aims to investigate the feasibility and the preliminary efficacy of a guided online acceptance and commitment therapy (ACT) intervention for distressed family caregivers of people with dementia. A one-group pretest-posttest design (n=15) will be used to investigate... expand

The pilot project aims to investigate the feasibility and the preliminary efficacy of a guided online acceptance and commitment therapy (ACT) intervention for distressed family caregivers of people with dementia. A one-group pretest-posttest design (n=15) will be used to investigate the potential effects of the 10 weekly online ACT intervention session on caregivers' outcomes at posttest (10 weeks).

Type: Interventional

Start Date: Jul 2020

open study

Dual Energy CT as a Noninvasive Method to Screen for Gastroesophageal Varices
University of Alabama at Birmingham Gastroesophageal Varices
Cirrhosis leads to portal hypertension and development of gastroesophageal varices, which are the most common cause for bleeding in cirrhosis and a major cause of death. The American Association for the Study of Liver Disease (AASLD) recommends screening endoscopy every 2... expand

Cirrhosis leads to portal hypertension and development of gastroesophageal varices, which are the most common cause for bleeding in cirrhosis and a major cause of death. The American Association for the Study of Liver Disease (AASLD) recommends screening endoscopy every 2 years to evaluate for gastroesophageal varices, and annual surveillance for those with small varices on endoscopy. Unfortunately, endoscopy is costly, requires sedation, is poorly tolerated, is subject to high inter-observer variability, and is associated with risks that include bleeding, esophageal injury and aspiration. Noninvasive methods for evaluation of gastroesophageal varices are needed. CT is noninvasive, rapid, less expensive than endoscopy, requires no sedation, provides a quantitative measure of the size of the varices, and allows for assessment of para-esophageal varices, varices in other body locations, ascites, other signs of portal hypertension, patency of liver vasculature, and detection, diagnosis and staging of hepatocellular carcinoma. Single-Energy CT (SECT) has relatively high accuracy in prospective studies for detection of any and large varices but is associated with suboptimal contrast opacification of gastroesophageal varices. Dual-Energy CT with the GE scanners with GSI Xtream (DECT) improves the contrast-to-noise ratio by 60% compared to SECT and is currently standard of care at UAB for evaluation of cirrhosis. The primary objective of this study is to determine the accuracy of DECT for detecting any varices and high-risk varices. The study hypothesis is that the accuracy (AUROC) of DECT will be >0.90 and >0.95 for detecting any and high-risk varices in a prospective pilot study (N=50) that uses endoscopy as the reference standard. This will be a single-center pilot observational prospective IRB-approved study. A total of 50 adult patients presenting to UAB Endoscopy for surveillance endoscopy to detect and grade gastroesophageal varices will be enrolled.

Type: Interventional

Start Date: Jun 2019

open study

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by...
National Cancer Institute (NCI) Metastatic Melanoma Recurrent Melanoma Stage III Cutaneous Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7
This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage... expand

This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

Type: Interventional

Start Date: Jul 2015

open study

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before...
National Cancer Institute (NCI) Acral Lentiginous Melanoma Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Mucosal Melanoma Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with... expand

This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.

Type: Interventional

Start Date: Dec 2018

open study

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis
Incyte Corporation Relapsed or Refractory Primary Myelofibrosis Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis)
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy for participants with relapsed or refractory myelofibrosis. expand

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy for participants with relapsed or refractory myelofibrosis.

Type: Interventional

Start Date: Oct 2020

open study

Randomized, Double-blind, Efficacy, and Safety Study of Doravirine/Islatravir (DOR/ISL) in Treatment-naïve...
Merck Sharp & Dohme Corp. HIV-1 Infection
This is a phase 3, randomized, controlled, double-blind clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection.... expand

This is a phase 3, randomized, controlled, double-blind clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary hypothesis is that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

Type: Interventional

Start Date: Feb 2020

open study

Diet and Exercise After Pancreatic Cancer
University of Alabama at Birmingham Pancreatic Cancer
Determine feasibility of a randomized controlled trial (RCT) in pancreatic (& other foregut) cancer patients comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes. expand

Determine feasibility of a randomized controlled trial (RCT) in pancreatic (& other foregut) cancer patients comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.

Type: Interventional

Start Date: Aug 2017

open study

Early Treatment of Cytokine Storm Syndrome in Covid-19
University of Alabama at Birmingham Cytokine Storm COVID-19
This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection. expand

This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.

Type: Interventional

Start Date: Jul 2020

open study

A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant...
Clovis Oncology, Inc. Metastatic Castration Resistant Prostate Cancer
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide,... expand

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

Type: Interventional

Start Date: Jun 2017

open study

Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
NICHD Neonatal Research Network Apnea of Prematurity
The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization. expand

The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

Type: Interventional

Start Date: Feb 2019

open study

Optimizing Anesthesia for Post Partum Tubal Ligations
University of Alabama at Birmingham Pregnancy Related
In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study.... expand

In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.

Type: Interventional

Start Date: Aug 2019

open study

Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Inspire Medical Systems, Inc. Obstructive Sleep Apnea
Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective... expand

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis. In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.

Type: Observational [Patient Registry]

Start Date: Oct 2016

open study