Search Clinical Trials
Sponsor Condition of Interest |
---|
A Study on TLC590 for Managing Postsurgical Pain
Taiwan Liposome Company
Postsurgical Pain Management
This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics,
and safety profile of TLC590 across various surgical procedures. Researchers aim to
determine the maximum tolerated dose (MTD) of TLC590 via Safety Monitoring Committee
(SMC).
The study evaluates TLC590 in bunionectomy,... expand
This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics, and safety profile of TLC590 across various surgical procedures. Researchers aim to determine the maximum tolerated dose (MTD) of TLC590 via Safety Monitoring Committee (SMC). The study evaluates TLC590 in bunionectomy, laparoscopy-assisted open ventral hernia repair, breast augmentation, abdominoplasty, and total knee arthroplasty models. Additionally, it determines the relative bioavailability of TLC590 to ropivacaine injection. Type: Interventional Start Date: Oct 2024 |
A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted...
Pfizer
Gram-negative Bacterial Infection
The purpose of this study is to learn about the safety and effects of ATM-AVI for the
possible treatment of infections caused by a type of bacteria called gram-negative
bacteria.
The study medicine is a combination of an antibiotic, aztreonam (ATM), and another
medicine, avibactam (AVI), which... expand
The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria. The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections. The study will include newborns and infants up to 9 months of age who are admitted in the hospital. The study is conducted in 2 parts: Part A and Part B. In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount. In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria. Type: Interventional Start Date: Sep 2024 |
EchoTip AcuCore Post-Market Clinical Study
Cook Research Incorporated
Adenocarcinoma
Neuroendocrine Tumors
Hepatocellular Carcinoma
Cholangiocarcinoma
Malignant Lymphoma
The purpose of collecting this data is to continue to learn more about the EchoTip
AcuCore and the device's ability to produce the desired favorable effect and if there are
any undesired outcomes that may be related to the EchoTip AcuCore. expand
The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore. Type: Observational Start Date: Aug 2024 |
tRNS Treatment for ADHD Symptoms
Innosphere
ADHD
A randomized, sham-controlled, double-blind clinical trial to examine the safety and
effectiveness of tRNS on unmedicated pediatric patients (7-12 years) with ADHD. Subjects
will undergo either tRNS or sham treatment for 10 days during a two-week period in a
home-simulated environment. Each treatment... expand
A randomized, sham-controlled, double-blind clinical trial to examine the safety and effectiveness of tRNS on unmedicated pediatric patients (7-12 years) with ADHD. Subjects will undergo either tRNS or sham treatment for 10 days during a two-week period in a home-simulated environment. Each treatment session is 20 minutes, during which their attention will be maintained using a software game. Type: Interventional Start Date: Jul 2024 |
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 Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer (Be6A...
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, 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 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 |
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care...
The University of Texas Health Science Center, Houston
Anemia
The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to
reduce RBC transfusions in medical intensive care unit (ICU) and Intermediate care unit
(IMU) patients with low hemoglobin compared with standard size tubes, to compare the
intervention and the control groups in... expand
The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to reduce RBC transfusions in medical intensive care unit (ICU) and Intermediate care unit (IMU) patients with low hemoglobin compared with standard size tubes, to compare the intervention and the control groups in regards to: ICU length of stay (LOS), ICU mortality, hospital LOS, and hospital mortality and to assess the acceptability of small phlebotomy tubes in adult ICU and IMU patients. Type: Interventional Start Date: Jul 2023 |
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With...
Hoffmann-La Roche
Huntington Disease
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with
placebo in participants with prodromal and early manifest Huntington's Disease expand
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease Type: Interventional Start Date: Feb 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 625 individuals with diverse cancer diagnoses will be enrolled
across up to 8 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 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 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 |
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
National Institute of Allergy and Infectious Diseases (NIAID)
Multiple Sclerosis
This study is a prospective, multi-center, randomized, double blinded, placebo-controlled
study of OCR treatment-discontinuation in patients with early RMS. All eligible
participants will be initiated on OCR using the standard approved administration schedule
of two 300 mg infusions separated by 14... expand
This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6,12, 18, and 24. At Month 24, participants will be randomized (2:1) to one of two Arms with randomized treatment beginning at Month 30: Arm 1: placebo infusions every 6 months; or Arm 2: OCR infusions every 6 months. The treatment period will be for a total of 48 months. Type: Interventional Start Date: Jan 2023 |
Ketorolac in Palatoplasty
The University of Texas Health Science Center, Houston
Cleft Lip and Palate
The purpose of this study is to see if the addition of IV Ketorolac to usual care
multi-modal pain therapy compared to usual care will improve oral intake post-operatively expand
The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively Type: Interventional Start Date: Sep 2021 |
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
United Therapeutics
PAH
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Hypertension
Connective Tissue Diseases
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of
ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or
PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1
PAH. expand
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. Type: Interventional Start Date: Aug 2018 |
MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against
a control group of similar patients... expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
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 |
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 |
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 |
Choline Effects - Pre-symptomatic AD
Paul E Schulz
Alzheimer Disease
The purpose of this study is to test the safety, tolerability, and effects of choline in
people with increased risk of Alzheimer's Disease (AD), also known as pre-symptomatic AD.
Choline is a dietary supplement, but is being investigated to see if it has any effects
on the progression to AD. expand
The purpose of this study is to test the safety, tolerability, and effects of choline in people with increased risk of Alzheimer's Disease (AD), also known as pre-symptomatic AD. Choline is a dietary supplement, but is being investigated to see if it has any effects on the progression to AD. Type: Interventional Start Date: Jun 2023 |
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Klus Pharma Inc.
Solid Tumor
The purpose of this study is to evaluate the efficacy and safety of combination of SKB264
and Pembrolizumab in patients with selected solid tumors including cervical cancer,
urothelial cancer, ovarian cancer, prostate cancer. expand
The purpose of this study is to evaluate the efficacy and safety of combination of SKB264 and Pembrolizumab in patients with selected solid tumors including cervical cancer, urothelial cancer, ovarian cancer, prostate cancer. Type: Interventional Start Date: Jan 2023 |
Exenatide for Smoking Cessation and Prevention of Weight Gain
The University of Texas Health Science Center, Houston
Smoking Cessation
Weight Gain
The purpose of this study is to determine if exenatide improves end-of-treatment smoking
abstinence rates and to determine if exenatide mitigates post-cessation weight gain. expand
The purpose of this study is to determine if exenatide improves end-of-treatment smoking abstinence rates and to determine if exenatide mitigates post-cessation weight gain. Type: Interventional Start Date: Dec 2022 |
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 |
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 |
Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)
The University of Texas Health Science Center, Houston
Schizophrenia
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive
transcranial magnetic stimulation (rTMS) from H coil for improving white matter
integrity. expand
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity. Type: Interventional Start Date: May 2024 |
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With...
Jnana Therapeutics
Phenylketonuria
The goal of Parts A and B of this Phase 1, first-in-human, randomized study is to assess
the safety, tolerability, and pharmacokinetics (PK) of single (SAD) and multiple (MAD)
ascending doses of oral JNT-517 in healthy participants. In Part C, the goal is to
evaluate the differences in bioavailability... expand
The goal of Parts A and B of this Phase 1, first-in-human, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of single (SAD) and multiple (MAD) ascending doses of oral JNT-517 in healthy participants. In Part C, the goal is to evaluate the differences in bioavailability between a tablet and suspension formulation of JNT-517 and the food effect in healthy volunteers. All participants in Part C will receive JNT-517. The goal of Part D is to assess the safety, tolerability, PK, and effect on urinary Phe and other amino acids of JNT-517 in participants with phenylketonuria (PKU). Participants in Part D will receive either JNT-517 or placebo and will be blinded to their treatment assignment. The study consists of 4 parts: - Part A: SAD in healthy participants -randomized, double-blind, placebo-controlled - Part B: MAD in healthy participants (14 days)-randomized, double-blind, placebo-controlled - Part C: Relative bioavailability of 2 formulations and food effect in healthy participants-randomized, open-label - Part D: Phase 1b in participants with PKU (4 weeks)-randomized, double-blind, placebo-controlled In each part, participants will complete a Screening Period, a Treatment Period, and a Follow-up Period for safety. Type: Interventional Start Date: Oct 2022 |
- Previous
- Next