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Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Biohaven Therapeutics Ltd.
Focal Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of
refractory focal epilepsy.
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The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Type: Interventional Start Date: May 2024 |
Semaglutide for Post-Smoking Cessation Weight Management
The University of Texas Health Science Center, Houston
Obesity
Overweight
Cigarette Smoking
This trial will examine the effect of semaglutide 2.4mg on changes in body weight, body
composition, and peripheral and central mechanisms that control appetite, satiety, and food
intake in the context of smoking cessation.
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This trial will examine the effect of semaglutide 2.4mg on changes in body weight, body composition, and peripheral and central mechanisms that control appetite, satiety, and food intake in the context of smoking cessation. Type: Interventional Start Date: Apr 2024 |
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe...
Nektar Therapeutics
Moderate to Severe Atopic Dermatitis
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind,
4-arm study to assess the effect of pegylated-recombinant-human interleukin-2
(rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis.
The estimated duration... expand
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 15-35 days for screening and then up to approximately day 378 (last dose on day 280 + 98 days safety follow-up) for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period. Type: Interventional Start Date: Oct 2023 |
An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency...
The University of Texas Health Science Center, Houston
Respiratory Tract Infections
The purpose of this study is to evaluate overall changes in patient management and
longer-term resource utilization between control and test arms, including (but not limited
to) additional work-up (including other diagnostic tests and consults), antimicrobial
treatments, disposition... expand
The purpose of this study is to evaluate overall changes in patient management and longer-term resource utilization between control and test arms, including (but not limited to) additional work-up (including other diagnostic tests and consults), antimicrobial treatments, disposition decisions and hospital length of stay (LOS) Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic...
Bristol-Myers Squibb
Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278
in participants with Idiopathic Pulmonary Fibrosis.
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Sep 2023 |
Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
The University of Texas Health Science Center, Houston
Anesthesia
The purpose of this study is to assess the feasibility of SafeLM as a primary airway device
and as a conduit for intubation with and without the use of a bougie
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The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie Type: Interventional Start Date: Sep 2023 |
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Chimerix
H3 K27M
Glioma
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase
3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether
treatment with ONC201 following frontline radiotherapy will extend overall survival and
progression-free... expand
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy. Type: Interventional Start Date: Jan 2023 |
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease...
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Celiac Disease
This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic
(PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).
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This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD). Type: Interventional Start Date: Nov 2022 |
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung...
Boehringer Ingelheim
Scleroderma, Systemic
This study is open to adults aged 18 and older or above legal age who have systemic
sclerosis. People can participate if they have a specific subtype called diffuse cutaneous
systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis
can also... expand
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects. Type: Interventional Start Date: Nov 2022 |
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant...
St. Jude Children's Research Hospital
Hematopoietic Cell Transplant
Solid Organ Transplant
Respiratory Viral Infection
The participants are being asked to take part in this clinical trial, a type of research
study, because the participants are scheduled to receive or have recently received a
hematopoietic cell transplant (HCT) or a solid organ transplant (SOT).
Primary Objective... expand
The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: - To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. - To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors . Type: Observational Start Date: Dec 2022 |
A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute...
Biogen
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab)
compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus
Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and
the... expand
The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B]. Type: Interventional Start Date: Sep 2022 |
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical...
The University of Texas Health Science Center, Houston
Anesthesia
The purpose of this study is to assess and compare the conditions for tracheal intubation
obtained with Modified Time Principle Induction (MTPI) and that obtained with classic
induction (CI). This study will compare the efficiency of tracheal intubation with the two
induction... expand
The purpose of this study is to assess and compare the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events. Type: Interventional Start Date: Aug 2022 |
A Study of mRNA-3745 in Adult and Pediatric Participants With Glycogen Storage Disease Type 1a (GSD1a)
ModernaTX, Inc.
Glycogen Storage Disease
The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via
intravenous (IV) administration in adult and pediatric participants with GSD1a.
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The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via intravenous (IV) administration in adult and pediatric participants with GSD1a. Type: Interventional Start Date: Jun 2022 |
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Occlutech International AB
Stroke
Patent Foramen Ovale
The objective of this study is to investigate whether percutaneous PFO closure with the
Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore®
Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and
device/procedure... expand
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE). Type: Interventional Start Date: Apr 2022 |
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation...
The University of Texas Health Science Center, Houston
Pain Management
The purpose of this study is to compare the effectiveness of innovative intervention of
breathing controlled electrical stimulation (BreEStim) and conventional electrical
stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb
amputation.... expand
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation. Type: Interventional Start Date: Apr 2021 |
Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess...
AbbVie
Endometriosis
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing
age. Endometriosis affects daily activities, social relationships, sexuality and sexual
activity, and mental health. This study will evaluate how well elagolix in combination with
combined... expand
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Aug 2020 |
Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection...
The University of Texas Health Science Center, Houston
Root Canal Treatment
The purpose of this study is to understand and learn better the efficacy of GentleWave and
obtain histological evidence of the efficacy of this new technology done in-vivo
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The purpose of this study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo Type: Interventional Start Date: Jul 2024 |
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
Edwards Lifesciences
Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System
in patients with symptomatic severe tricuspid regurgitation who have been determined to be at
an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the... expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team Type: Interventional Start Date: Dec 2019 |
Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD)
Edison Leung
Bipolar Disorder
The purpose of this study is to compare the efficacy and side effects magnetic seizure
therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and
Treatment Resistant Depression (MST-TRD).
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The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD). Type: Interventional Start Date: May 2024 |
Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Patients With Recurrent Posterior Fossa...
The University of Texas Health Science Center, Houston
Recurrent Ependymoma
This study seeks to determine the optimum dose frequency of 5-Azacytidin (5-AZA) infusions
into the fourth ventricle of the brain. The study's primary objective is to establish the
maximum tolerated dose for infusions of 5-Azacytidine into the fourth ventricle in patients... expand
This study seeks to determine the optimum dose frequency of 5-Azacytidin (5-AZA) infusions into the fourth ventricle of the brain. The study's primary objective is to establish the maximum tolerated dose for infusions of 5-Azacytidine into the fourth ventricle in patients with recurrent ependymoma. The study's secondary objective is to assess the antitumor activity of 5-Azacytidine infusions into the fourth ventricle based upon imaging studies and cytology. Type: Interventional Start Date: Feb 2019 |
PARTNER 3 Trial - Aortic Valve-in-Valve
Edwards Lifesciences
Aortic Stenosis
Aortic Stenosis, Severe
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra
transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
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This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve. Type: Interventional Start Date: Jan 2017 |
Methotrexate and Etoposide Infusions Into the Fourth Ventricle in Children With Recurrent Posterior Fossa...
The University of Texas Health Science Center, Houston
Brain Tumor Recurrent
The goal of this clinical research study is to establish the safety of simultaneous infusions
of methotrexate and etoposide into the fourth ventricle of the brain or resection cavity in
patients with recurrent malignant posterior fossa brain tumors. These tumors include
medulloblastoma,... expand
The goal of this clinical research study is to establish the safety of simultaneous infusions of methotrexate and etoposide into the fourth ventricle of the brain or resection cavity in patients with recurrent malignant posterior fossa brain tumors. These tumors include medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor or other malignant brain tumor with recurrence or progression involving anywhere in the brain and/or spine. Patients' disease must have originated in the posterior fossa of the brain. Type: Interventional Start Date: Oct 2016 |
Couple-Based Meditation for Metastatic Lung Cancer Patients and Their Partners
M.D. Anderson Cancer Center
Lung Cancer
Objectives:
Our specific aims are to:
Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with
metastatic lung cancer and their partners.
Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and... expand
Objectives: Our specific aims are to: Aim 1: Examine the feasibility of a couple-based meditation program in 50 patients with metastatic lung cancer and their partners. Aim 2: Establish the initial efficacy of a couple-based meditation program in patients and their partners regarding physical, psychological, and spiritual quality of life outcomes. Type: Interventional Start Date: Apr 2016 |
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
Novo Nordisk A/S
Obesity
This study will look at how well CagriSema compared to Tirzepatide helps people lower their
body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that
combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors.
Participant... expand
This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant. Type: Interventional Start Date: Nov 2023 |
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's...
Emalex Biosciences Inc.
Tourette Syndrome
The primary objective of this study is to evaluate the long-term safety and tolerability of
ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of
age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's... expand
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS). Type: Interventional Start Date: Aug 2023 |
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