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A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive...
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
Seagen Inc.
Carcinoma, Non-Small-Cell Lung
This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC).
Participants in this study must have cancer that has spread through their body or can't
be removed with surgery. Participants in this study must have been treated with no more
than a platinum-based chemotherapy and an... expand
This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin (SGN-B6A), which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease. Type: Interventional Start Date: Feb 2024 |
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People...
Pfizer
Advanced or Metastatic Breast Cancer
The purpose of this study is to learn about the safety and how effective the study
medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of
treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one
that is unlikely to be cured or taken care... expand
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: - are 18 years of age or older; - are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; - have advanced or metastatic breast cancer after taking other treatments before this study; - have not taken or need to take medications that are not allowed by the study protocol; - do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: - Fulvestrant alone taken as shot into the muscle. - Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: - imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. - the study doctor thinks the participant is no longer benefitting from the study medicine. - has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. - the participant chooses to stop taking part. Type: Interventional Start Date: Jan 2024 |
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
The University of Texas Health Science Center, Houston
Spina Bifida; Fetus
Myelomeningocele
Myeloschisis
The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical
approach to cover spina bifida spinal cord developmental defects using cryopreserved
human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch. expand
The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch. Type: Interventional Start Date: Sep 2023 |
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
National Institute of Allergy and Infectious Diseases (NIAID)
HIV I Infection
Transgender women (TW) are a key population and priority for HIV treatment. More research
is needed to develop evidence-based clinical guidance when it comes to choosing
antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy (FHT).
Concerns about ART interacting with FHT and... expand
Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART interacting with FHT and decreasing its effectiveness can lead to decreased ART adherence and increased viral loads. The GET IT RiGHT trial aims to address concerns about drug-drug interactions (DDIs) between ART and FHT while providing access to hormonal therapy to TW living with HIV. Data suggest that access to FHT improves adherence to HIV treatment and decreases treatment interruptions. This is an open-label, non-randomized, 3-group trial of adult TW and other individuals identifying as female or transfeminine but with male sex assigned at birth living with HIV. Participants will be on ART at entry and receive study-supplied 17-β estradiol for FHT for 48 weeks. The primary objectives of the study are to 1) assess whether TW continue to achieve therapeutic concentrations of ART while receiving FHT for 48 weeks and 2) assess whether serum estradiol concentrations on FHT (across a range of estradiol doses) vary between boosted and un-boosted ART regimens. Type: Interventional Start Date: Jan 2024 |
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in...
Jazz Pharmaceuticals
Tuberous Sclerosis Complex Associated Neuropsychiatric Disease
The purpose of this study is to investigate behavioral and other co-occurring outcomes
with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous
sclerosis complex (TSC) who experience seizures. expand
The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures. Type: Interventional Start Date: Jun 2023 |
A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis...
Genentech, Inc.
Idiopathic Pulmonary Fibrosis
Systemic Sclerosis With Lung Involvement
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with
placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in
participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Participants who complete 52-weeks of... expand
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Type: Interventional Start Date: May 2023 |
A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
Pfizer
Pneumonia
The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate
vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia
(RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae
that cause pneumonia) included in... expand
The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine. This study is seeking participants who: - are male or female ≥65 years of age. - are hospitalized with physician suspicion of community acquired pneumonia (CAP). - have pneumonia confirmed with imaging like a chest x-ray Participants will be asked to provide demographic and medical history information, and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae. We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC. Participants will actively take part in the study for about 1-2 days. Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review. Type: Observational Start Date: Oct 2022 |
Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia...
The University of Texas Health Science Center, Houston
Anhedonia
The purpose of this study is to investigate whether transcranial direct-current
stimulation (tDCS) will engage reward-related brain circuitry, more specifically the
uncinate fasciculus (UF) tract, which connects the orbitofrontal cortex (OFC) and nucleus
accumbens (NAcc) regions. Also to evaluate... expand
The purpose of this study is to investigate whether transcranial direct-current stimulation (tDCS) will engage reward-related brain circuitry, more specifically the uncinate fasciculus (UF) tract, which connects the orbitofrontal cortex (OFC) and nucleus accumbens (NAcc) regions. Also to evaluate whether the changes in the fractional anisotropy (FA) of the UF tract are associated with changes of clinical symptoms of anhedonia and finally to investigate the moderation role of simulated electric fields (EFs) in an association between FA of the UF and symptoms of anhedonia. Type: Interventional Start Date: Oct 2022 |
EUS-RFA PANCARDINAL-1 Trial
The University of Texas Health Science Center, Houston
Pancreatic Ductal Adenocarcinoma (PDAC)
The objectives of this study are to determine the feasibility, tolerability, and
treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus
standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal
adenocarcinoma (PDAC). Endoscopic ultrasound (EUS)... expand
The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective. Type: Interventional Start Date: Aug 2021 |
Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV
University of California, San Francisco
NAFLD
NAFLD-HIV
Hiv
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated
with fat accumulation that ranges from benign, non-progressive liver fat accumulation to
severe liver injury, cirrhosis, and liver failure. NAFLD is the most common liver disease
in US adults and the second leading... expand
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. NAFLD is the most common liver disease in US adults and the second leading cause for liver transplantation in the US. The natural history of NAFLD in the general population has been well described, with those with non-alcoholic fatty liver (NAFL, or simple steatosis) destined to have rare incidence of hepatic events compared to those with non-alcoholic steatohepatitis (NASH), who are at high risk for future development of cirrhosis, liver cancer and liver failure. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002, through the mechanism of RFA-DK-01-025, to further the understanding of diagnosis, mechanisms, progression and therapies of NASH. The NASH CRN effort has resulted in numerous seminal studies in the field. However, NASH CRN studies have systematically excluded persons living with HIV (PLWH), as NAFLD in these persons was thought to be different from that in the general population due to HIV, ART, concomitant medications, and co-infections. This has resulted in major knowledge gaps regarding NAFLD in the setting of HIV. This ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), HNC 001 goal is to examine the prevalence of hepatic steatosis and NAFLD in a large, multicenter, and multiethnic cohort of PLWH (Steatosis in HIV Study) Type: Observational Start Date: Jul 2021 |
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
Boston Scientific Corporation
Aortic Stenosis
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for
transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic
stenosis who are indicated for TAVR. expand
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. Type: Interventional Start Date: Jun 2019 |
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
The purpose of this study is to compare the efficacy, safety, and durability of two
different strategies to treat participants with a history of sub-optimal adherence and
control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and
all-oral standard of care (SOC). expand
The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC). Type: Interventional Start Date: Mar 2019 |
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
The George Washington University Biostatistics Center
Obstructive Sleep Apnea of Adult
Preeclampsia
Obstetrical Complications
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive
sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a
reduction in the rate of hypertensive disorders of pregnancy. expand
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy. Type: Interventional Start Date: Aug 2018 |
A Culturally Adapted, Social Support-Based, Physical Activity Interventions for South Asian Indian Women...
The University of Texas Health Science Center, Houston
Sedentary Behavior
The purpose of this study is to assess the feasibility and acceptability of a peer-based
dyadic social support health coaching physical activity (PA) intervention in inactive
South Asian Indian (SAI) and to explore preliminary effects of the intervention on
intermediate outcomes: self-reported and... expand
The purpose of this study is to assess the feasibility and acceptability of a peer-based dyadic social support health coaching physical activity (PA) intervention in inactive South Asian Indian (SAI) and to explore preliminary effects of the intervention on intermediate outcomes: self-reported and objective moderate-to-vigorous physical activity (MVPA), social support, and self-efficacy . Type: Interventional Start Date: Nov 2023 |
Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
InflaRx GmbH
Pyoderma Gangrenosum
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to
investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma
gangrenosum expand
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum Type: Interventional Start Date: Aug 2023 |
Comprehensive Outcomes for After Cancer Health
Pack Health
Ovarian Cancer
Breast Cancer
Lung Cancer
Gastric Cancer
Survivorship
This study intends to explore feasibility, acceptability, and outcomes related to the use
of a digital health coaching intervention for individuals who have completed primary
therapy for cancer. Up to 500 individuals with diverse cancer diagnoses will be enrolled
across up to 5 clinical sites to participate... expand
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 500 individuals with diverse cancer diagnoses will be enrolled across up to 5 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy. Type: Interventional Start Date: Jun 2022 |
Pilot Study of Virtual Reality Therapy for Students With Anxiety
The University of Texas Health Science Center, Houston
Anxiety
The purpose of this study is to assess changes in self-reported anxiety over the course
of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as
well as examine the feasibility and acceptability of a relatively short and time
intensive VR intervention (i.e.,six sessions... expand
The purpose of this study is to assess changes in self-reported anxiety over the course of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as examine the feasibility and acceptability of a relatively short and time intensive VR intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms in college students. Type: Interventional Start Date: Apr 2022 |
Combination Intraventricular Chemotherapy Pilot Study: 5-Azacytidine (5-AZA) and Trastuzumab Infusions...
The University of Texas Health Science Center, Houston
Fossa Ependymoma
The purpose of this study is to establish the safety and tolerability of simultaneous
infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or
resection cavity in patients with recurrent posterior fossa ependymoma and to assess the
antitumor activity of simultaneous infusions... expand
The purpose of this study is to establish the safety and tolerability of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma and to assess the antitumor activity of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients based upon imaging studies and lumbar cerebrospinal fluid (CSF) cytology. Type: Interventional Start Date: Jul 2021 |
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 after multiple sessions of... 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 after multiple sessions of treatment. Type: Interventional Start Date: Apr 2021 |
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 |
Infusion of Panobinostat (MTX110) Into the Fourth Ventricle in Children and Adults With Recurrent Medulloblastoma
The University of Texas Health Science Center, Houston
Medulloblastoma
The purpose of this study is to establish the safety of infusions of panobinostat
(MTX110) into the fourth ventricle of the brain or tumor resection cavity in patients
with recurrent medulloblastoma and to assess the antitumor activity of simultaneous
infusions of panobinostat (MTX110) into the fourth... expand
The purpose of this study is to establish the safety of infusions of panobinostat (MTX110) into the fourth ventricle of the brain or tumor resection cavity in patients with recurrent medulloblastoma and to assess the antitumor activity of simultaneous infusions of panobinostat (MTX110) into the fourth ventricle of the brain or resection cavity in patients with recurrent medulloblastoma based upon MRI scans and lumbar cerebrospinal fluid (CSF) cytology. Type: Interventional Start Date: Apr 2020 |
Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing
durations of induced hypothermia are associated with an increasing rate of good
neurological outcomes and to identify the optimal duration of induced hypothermia for
neuroprotection in comatose survivors of cardiac... expand
A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest. Type: Interventional Start Date: May 2020 |
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild...
Cardiac Dimensions, Inc.
Functional Mitral Regurgitation
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
The objective of this prospective, randomized, blinded clinical trial is to assess the
safety and efficacy of the Carillon Mitral Contour System in treating heart failure with
functional regurgitation (FMR). expand
The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR). Type: Interventional Start Date: Jan 2018 |
HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development...
University College, London
Huntington's Disease
HDClarity will seek at least 2500 research participants at different stages of
Huntington's disease (HD). The primary objective is to collect a high quality CSF sample
for evaluation of biomarkers and pathways that will enable the development of novel
treatments for HD. The secondary objective is... expand
HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development. Type: Observational Start Date: Jan 2017 |
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