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Displaying 1 - 20 of 1027

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Monica Rocha
Open Actively Recruiting

Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment

The goal of this clinical trial is to learn if colchicine reduces levels of proteins indicating inflammation in the blood in individuals with calcium pyrophosphate deposition (CPPD) disease. The trial will also test the effect of colchicine on joint symptoms in CPPD disease. The main questions it aims to answer are:

  • Does colchicine reduce the level of interleukin 18 (IL-18) in the blood of individuals with CPPD disease?
  • Does colchicine reduce pain scores in individuals with CPPD disease?

Researchers will compare colchicine once daily to a placebo (a look-alike pill that contains no drug) to see if colchicine works to treat CPPD disease.

Participants will:

  • Take colchicine or a placebo every day for 6 months
  • Visit the clinic 3 times in 6 months for joint examinations, surveys, and blood tests. Each visit will last 2-3 hours.
  • Speak on the telephone with researchers for about 4 times over 6 months. Each phone call will last about 5 minutes.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Michelle Ramirez, Aima Ohiwerei
Open Actively Recruiting

A Culturally-Tailored Mobile Health and Social Media Physical Activity Intervention for Improving Physical Activity in Hispanic or Latino/Latina Adolescent and Young Adult Childhood Cancer Survivors, Walking Juntos Study

This clinical trial tests the impact of a culturally-tailored home-based physical activity program on physical fitness in Hispanic or Latino/Latina adolescent and young adult (AYA) childhood cancer survivors. After treatment for cancer, some AYA survivors experience long-term effects from the cancer and its treatment including weight gain, fatigue and decreased physical fitness. Hispanic or Latino/Latina survivors may have a higher risk of these effects compared to non-Hispanics. Regular physical activity helps maintain healthy weight, energy levels and overall health. Participating in a culturally-tailored home-based physical activity program may help increase physical activity in Hispanic or Latino/Latina AYA childhood cancer survivors.

Phase: Phase 2
Primary Purpose: Prevention
Gender: All
Age Group: Adults, Children
Contact: Mikayla Henderson
Open Actively Recruiting

A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC).

This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Alexis Nauden
Open Actively Recruiting

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)

In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney.

Antibody-mediated rejection (AMR) is when a person's immune system attacks a transplanted organ, like a new kidney. In the person receiving the transplant, their immune system creates specific antibodies. Antibodies are proteins that help the body fight infections. In people with AMR, these antibodies mistakenly see the new organ as a threat and damage its blood vessels. This can cause the new organ to fail.

In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works in participants with kidney transplants who experience AMR compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. All participants in this study will have active AMR or AMR that has lasted for at least 6 months after their kidney transplant.

The main question that researchers want to answer is:

  • How many participants have biopsy results showing that their transplanted kidney tissue looks normal or near normal after 24 weeks of treatment?

Researchers will also learn about:

  • How long it takes before the participants' disease gets worse
  • How long the participants' urine protein levels stay low
  • Kidney biopsy scores to check for blood vessel inflammation at 6 months and 1 year
  • How many people have no blood vessel inflammation at these times
  • Changes in donor deoxyribonucleic acid (DNA) levels in blood from the start of treatment
  • Biopsy test scores for signs of rejection and inflammation at 6 months and 1 year
  • Changes in kidney function from the start of treatment
  • How many people have biopsy results showing their kidney tissue looks normal again
  • How long the transplanted kidney keeps working
  • How many participants have medical problems during the study
  • How many participants show signs of another type of kidney transplant rejection called T-cell-mediated rejection (TCMR) at Week 24 and Week 52
  • How do results from vital signs, electrocardiograms (ECGs), and blood and urine tests change over time
  • How felzartamab is processed by the body
  • How many participants develop antibodies against felzartamab in the blood

The study will be done as follows:

  • Participants will be screened to check if they can join the study. This will take up to 42 days.
  • There will be 2 parts in this study.
  • Part A of the study is "double blind." This means that neither the participants, study doctor, or site staff know if the participants received the study drug or a placebo. During Part A, participants will be randomized to receive up to 9 doses of either felzartamab or placebo.
  • Part B of the study is "open label." This means that the participants, study doctor, and site staff know which study drug the participant is receiving. During Part B, all participants from Part A will receive up to 9 doses of felzartamab.
  • All doses will be given through an "intravenous" infusion. This means it will be given into a vein. The dose the participants receive will depend on their body weight.
  • Part A will last up to 24 weeks. Part B will last up to 28 weeks. In total, participants will have up to 21 study visits and will be in the study for about 1 year.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Rana Nikbakht Malvajerdi
Open Actively Recruiting

A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Maria Zamudio
Open Actively Recruiting

Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections

The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.

Phase: Phase 3/Phase 4
Primary Purpose: Prevention
Gender: Female
Age Group: Adults
Contact: Irma Franco-Gonzalez
Open Actively Recruiting

Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)

The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Ross Divinagracia, Miriam Urrutia
Open Actively Recruiting

DPTX3186 in Wnt Pathway Activated Solid Tumors

This is a first-in human clinical study of DPTX3186 in subjects with Wnt-pathway activated solid tumors where no other treatments exist. The study will evaluate safety, pharmacokinetics, and initial activity of DPTX3186, as well as explore pharmacodynamic parameters to identify potential biomarkers of efficacy

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Lisa-Maria Yonemoto
Open Actively Recruiting

SuperSaturated Oxygen Comprehensive Observational Registry

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility, infarct size reduction, and cost-effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice.

Gender: All
Age Group: Adults
Contact: Ladda Douangvila-Chhan
Investigator: Rushi Parikh, MD
Open Actively Recruiting

A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma

A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R/R NHL

Phase: Phase 1/Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Efrata Negatu, Marvin Valencia
Open Actively Recruiting

Human Laboratory Study of Apremilast for Alcohol Use Disorder

Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.

Secondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Jessica Jenkins
Investigator: Lara Ray, PhD
Open Actively Recruiting

Biomarkers of Non-Response to CSF1R Inhibitors in Tenosynovial Giant Cell Tumor

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Phase: N/A
Age Group: Adults
Contact: Christopher Hamad
Investigator:
CHRISTOPHER HAMAD
Open Actively Recruiting

A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors

This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.

Phase: Phase 1
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Lisa-Maria Yonemoto
Open Actively Recruiting

CorEvitas™ Psoriasis (PSO) Rapid Response Non-Interventional Study

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Yvonne Nong, Hamida Askaryar
Open Actively Recruiting

Gut Microbial ?-Glucuronidase and Arylsulfatase as Determinants of Estrogen Bioavailability and Vasomotor Symptoms in Postmenopausal Women

This study has not yet been registered on ClinicalTrials.gov, which is currently a pre-requisite for display of detailed eligibility criteria.

Age Group: Adults
Contact: Regan Cortessis
Investigator: Lin Chang, MD
Open Actively Recruiting

Pivotal Study of Voro Urologic Scaffold

The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.

The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.

Phase: Phase 2
Primary Purpose: Treatment
Gender: Male
Age Group: Adults
Contact: Ankush Sachdeva
Open Actively Recruiting

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.

The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine [T3] or free triiodothyronine [FT3]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

Phase: Phase 2
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Kennedi Lipscomb
Open Actively Recruiting

A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD

The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Lloyd Liang
Open Actively Recruiting

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.

Phase: Phase 3
Primary Purpose: Treatment
Gender: All
Age Group: Adults
Contact: Madeleine Manahan