
Search Clinical Trials
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A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Amgen
Prurigo Nodularis
The main objective of the study will be to evaluate the efficacy of rocatinlimab compared
with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and
overall clinical assessment score (US only). expand
The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only). Type: Interventional Start Date: Jul 2024 |
DISCOVERY of Risk Factors for Type 2 Diabetes in Youth
George Washington University
Diabetes Mellitus Type 2, Childhood-Onset
The goal of the DISCOVERY study is to provide innovative critical information regarding
the unique natural history of glycemic control, insulin sensitivity, and β-cell function,
and their mechanistic determinates, in obese adolescents at risk for developing type 2
diabetes. expand
The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes. Type: Observational Start Date: Oct 2024 |
Comparison of Procedural Sedation in TEE
University of Alabama at Birmingham
Anesthesia
The objective of this proposal is to conduct a prospective randomized study comparing the
utility of sedating patients undergoing transesophageal echocardiographic studies with a
novel, recently-FDA-approved sedative agent, remimazolam, versus the sedative used in our
current practice at UAB, propo1 expand
The objective of this proposal is to conduct a prospective randomized study comparing the utility of sedating patients undergoing transesophageal echocardiographic studies with a novel, recently-FDA-approved sedative agent, remimazolam, versus the sedative used in our current practice at UAB, propofol. This study will investigate whether remimazolam offers any benefit over current care vis-à-vis hemodynamics or efficiency/throughput. This study will be conducted at the University of Alabama at Birmingham. All outpatients and inpatients scheduled for elective/non-emergent TEE in the UAB Heart and Vascular Center TEE lab will be considered for enrollment. Type: Interventional Start Date: Feb 2025 |
Sex, Hormones and Identity Affect Nociceptive Expression
University of Alabama at Birmingham
Pain
Gender Identity
The Investigators have recently published on differences in pain sensitivity measures
between cis and trans individuals in the local area. The investigators observed the
anticipated differences in pain sensitivity between CM and CW (CW > CM), but found that
the TW were phenotypically similar to CW1 expand
The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW > CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma. Type: Observational Start Date: Mar 2023 |
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants1
Bristol-Myers Squibb
Systemic Lupus Erythematosus
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib
compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE)
population. expand
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population. Type: Interventional Start Date: Jan 2023 |
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease (COPD)
This study will evaluate the efficacy and safety of astegolimab compared with placebo in
participants with chronic obstructive pulmonary disease (COPD) who are former or current
smokers and have a history of frequent exacerbations. expand
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations. Type: Interventional Start Date: Dec 2022 |
COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide
University of Alabama at Birmingham
Multiple Myeloma
Similar to the paradigm established in other hematologic malignancies that are considered
curable, the achievement of MRD(-) status is necessary for long term disease control in
MM. The fact that the majority of patients remain MRD (+) after induction therapy and
AHCT points to the opportunity to d1 expand
Similar to the paradigm established in other hematologic malignancies that are considered curable, the achievement of MRD(-) status is necessary for long term disease control in MM. The fact that the majority of patients remain MRD (+) after induction therapy and AHCT points to the opportunity to deploy novel agents with complementary mechanism of action and favorable toxicity profile to reach and maintain MRD (-) status. Given its favorable toxicity profile, the convenience of oral administration, and compelling single agent activity even in heavily pretreated MM, iberdomide is likely amenable to long term therapy in patients with high-risk of relapse/progression identified by the persistence of MRD(+). The investigators intend to develop combination(s) of iberdomide with other agents with complementary mechanism of action in the consolidation setting post AHCT in order to achieve and sustain MRD (-). Type: Interventional Start Date: Jan 2023 |
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
NRG Oncology
Stage III Colon Cancer
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery
for colon cancer. expand
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer. Type: Interventional Start Date: Mar 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
BeiGene
B-cell Malignancy
Marginal Zone Lymphoma
Follicular Lymphoma
Non-Hodgkin Lymphoma
Waldenström Macroglobulinemia
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1
monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety
expansion of selected doses, and a Phase 2 (expansion cohorts) expand
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts) Type: Interventional Start Date: Sep 2021 |
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored1
Novartis Pharmaceuticals
Sickle Cell Disease
This is a multi-center multi-national rollover study to allow continued access to
crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab
treatment in a Novartis-sponsored study (parent study) and are benefiting from the
treatment as judged by the investigator. expand
This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator. Type: Interventional Start Date: Jun 2021 |
Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone Formers
University of Alabama at Birmingham
Kidney Stone
This protocol seeks to determine if weight reduction with the Optifast VLCD program leads
to reduced contribution of endogenous oxalate synthesis to the urinary oxalate pool in
obese calcium oxalate stone formers. expand
This protocol seeks to determine if weight reduction with the Optifast VLCD program leads to reduced contribution of endogenous oxalate synthesis to the urinary oxalate pool in obese calcium oxalate stone formers. Type: Interventional Start Date: Dec 2021 |
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic L1
Genmab
Relapsed/Refractory Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Richter's Syndrome
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody
also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be
studied as:
- Monotherapy, or
- Combination therapy for relapsed/refractory chronic lymphocytic leukemia (R/R CLL):1 expand
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: - Monotherapy, or - Combination therapy for relapsed/refractory chronic lymphocytic leukemia (R/R CLL): - epcoritamab + venetoclax - epcoritamab + pirtobrutinib - Combination therapy for Richter's Syndrome (RS): - epcoritamab + lenalidomide - epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine [Oncovin®] and prednisone). The study includes participants with R/R CLL/small lymphocytic lymphoma (SLL) and participants with RS. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Participants with RS are only included in the expansion phase. Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, pirtobrutinib, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein). Study details include: - Study duration will be up to 5 years after the last participant's first treatment in the trial. - The treatment duration for each participant will be between 12 months (1 year) and 24 months (2 years), depending upon the treatment arm assigned. - The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study. All participants will receive active drug; no one will be given placebo. Type: Interventional Start Date: Nov 2020 |
IV Gallium Study for Patients with Cystic Fibrosis Who Have NTM (ABATE Study)
Chris Goss
Nontuberculous Mycobacterium Infection
The purpose of this study is to assess the safety and tolerability of two 5-day infusion
cycles of IV gallium in adult patients with CF who are infected with NTM.
Funding Source - FDA Office of Orphan Products Development (OOPD) expand
The purpose of this study is to assess the safety and tolerability of two 5-day infusion cycles of IV gallium in adult patients with CF who are infected with NTM. Funding Source - FDA Office of Orphan Products Development (OOPD) Type: Interventional Start Date: Jun 2021 |
Belimumab With Rituximab for Primary Membranous Nephropathy
National Institute of Allergy and Infectious Diseases (NIAID)
Membranous Nephropathy
Nephrotic Syndrome
The primary objective of this study is to evaluate the effectiveness of belimumab and
intravenous rituximab co-administration at inducing a complete or partial remission (CR
or PR) compared to rituximab alone in participants with primary membranous nephropathy.
Background:
Primary membranous neph1 expand
The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy. Background: Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life. Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine. Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects. In this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again. Belimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome. Type: Interventional Start Date: Mar 2020 |
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneo1
AiCuris Anti-infective Cures AG
HSV Infection
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety
in immunocompromised subjects with acyclovir resistant or acyclovir susceptible
mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a
loading dose of 400 mg as first dose to rapid1 expand
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved). Type: Interventional Start Date: May 2017 |
Making Healthy Habits Stick
University of Tennessee
Cancer
Physical Activity
Cancer Survivor
Cancer Survivorship
The aim of this project is to help increase physical activity maintenance in cancer
survivors who are more likely to experience health disparities and social disadvantages. expand
The aim of this project is to help increase physical activity maintenance in cancer survivors who are more likely to experience health disparities and social disadvantages. Type: Interventional Start Date: Jan 2025 |
A Study of CT-388 in Participants Who Are Overweight or Obese with Type 2 Diabetes Mellitus
Carmot Therapeutics, Inc.
Overweight or Obese
Type 2 Diabetes Mellitus (T2DM)
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group
dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high
doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM). expand
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM). Type: Interventional Start Date: Nov 2024 |
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not B1
Gilead Sciences
HIV-1-infection
The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an
oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of
Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current
standard-of-care treatment bicteg1 expand
The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48. Type: Interventional Start Date: Oct 2024 |
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
The George Washington University Biostatistics Center
Obstetrical Complications
Labor and Delivery Complication
Cesarean Delivery
This is a phase-III multi-center double-blind randomized controlled trial of 8,000
individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to
either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive
standard of care preoperative antibiotics1 expand
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection. Type: Interventional Start Date: Nov 2024 |
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)
National Cancer Institute (NCI)
Cervical Carcinoma
Human Papillomavirus Infection
This clinical trial evaluates the use of self-collected vaginal samples for human
papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical
excisional procedures to improve cervical cancer prevention. HPV is a common virus which
usually causes infections that last only a fe1 expand
This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements. Type: Interventional Start Date: Jun 2024 |
"Prapela® SVS Incubator Pad for Apnea of Prematurity
Tufts Medical Center
Apnea of Prematurity
The study proposes to complete the development of and then establish the safety,
efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic
vibrotactile stimulation (SVS) that will provide a complementary treatment and the first
improvement in the clinical management of a1 expand
The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay. Type: Interventional Start Date: Feb 2025 |
A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the T1
AbbVie
Hypothyroidism
This study will evaluate the efficacy and safety of Armour Thyroid treatment compared
with synthetic T4 in subjects who have primary hypothyroidism and are currently
stabilized (i.e., in-range thyroid-stimulating hormone [TSH]) on synthetic T4 treatment.
This study will also therefore evaluate the1 expand
This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone [TSH]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy. Type: Interventional Start Date: Apr 2024 |
Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease
UniQure Biopharma B.V.
Fabry Disease
This is an open-label, multi-center study to evaluate safety, tolerability, and
exploratory efficacy of a single dose of intravenously-administered AMT-191. The plan is
to investigate 2 sequential dose cohorts with 3-6 Participants per cohort. Participants
will continue receiving regularly schedule1 expand
This is an open-label, multi-center study to evaluate safety, tolerability, and exploratory efficacy of a single dose of intravenously-administered AMT-191. The plan is to investigate 2 sequential dose cohorts with 3-6 Participants per cohort. Participants will continue receiving regularly scheduled enzyme replacement therapy (ERT) until they meet the criteria for withdrawal. Type: Interventional Start Date: Jun 2024 |
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Part1
AbbVie
Bipolar I Disorder
Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with
significant morbidity and mortality defined by episodes of mania and depression (or
symptoms of both at once, known as mixed features). This prospective, observational study
will examine effectiveness, functioning and1 expand
Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices. Cariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study. Participants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks. Type: Observational Start Date: Apr 2024 |
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