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NCT ID: NCT04457401 Active, not recruiting - Clinical trials for Menstrual Discomfort

Probiotic and Gastrointestinal Symptoms Due to Menstruation in Healthy Women

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

In this double blind, parallel study, female participants who are on an oral contraceptive will consume either a probiotic or placebo supplement for approximately 8 weeks. Menstrual cramp and abdominal pain severity, as measured by the visual analog scale, will be assessed daily. A subgroup of participants will be asked to provide vaginal swab and stool samples to assess microbial communities.

NCT ID: NCT04457310 Active, not recruiting - Clinical trials for Early Course Schizophrenia Spectrum Disorder

A Translational and Neurocomputational Evaluation of a Dopamine Receptor 1 Partial Agonist for Schizophrenia

Start date: March 2, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will test whether CVL-562 (PF-06412562), a dopamine 1 partial agonist novel compound, affects working memory neural circuits in patients with early episode schizophrenia. The overall aim is to establish neuroimaging biomarkers of the Dopamine Receptor 1/Dopamine Receptor 5 Family (D1R/D5R) target engagement to accelerate development of D1R/D5R agonists in humans to treat cognitive impairments that underlie functional disability in schizophrenia, a key unaddressed clinical and public health concern.

NCT ID: NCT04457284 Active, not recruiting - Clinical trials for Colorectal Adenocarcinoma

Temozolomide, Cisplatin, and Nivolumab in People With Colorectal Cancer

Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

This study will test whether the combination of cisplatin, nivolumab, and temozolomide is an effective treatment for in people with advanced and/or metastatic colorectal cancer that is mismatch repair-proficient (MMR-proficient). The researchers will also look at how safe the study drug combination is in participants.

NCT ID: NCT04457232 Active, not recruiting - Prostate Carcinoma Clinical Trials

Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation

FAPI PET Prost
Start date: September 9, 2020
Phase: Phase 1
Study type: Interventional

This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.

NCT ID: NCT04456764 Active, not recruiting - Fatigue Clinical Trials

The Sleep and Teamwork in EMS Study

SaFTiE
Start date: September 16, 2020
Phase: N/A
Study type: Interventional

More than half of Emergency Medical Services (EMS) workers report work-related mental and physical fatigue. Odds of injury among fatigued EMS workers are nearly double that of non-fatigued workers. There is a compelling need to reduce fatigue among EMS workers, yet few EMS organizations have a formal fatigue management program and many may not be cost-effective or evidence-based. This trial addresses national goals of the National Occupational Research Agenda (NORA) and tests a novel approach to fatigue risk management that is easily scalable to large workforces and low-cost for employers of shift workers.

NCT ID: NCT04456673 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

NOTUS
Start date: July 6, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

NCT ID: NCT04456127 Active, not recruiting - Scar Clinical Trials

CO2 Laser Revision for Burn Related Donor Site Scars

Start date: January 21, 2020
Phase: N/A
Study type: Interventional

Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).

NCT ID: NCT04455750 Active, not recruiting - Clinical trials for Castration-Resistant Prostate Carcinoma

A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy

CASPAR
Start date: February 19, 2021
Phase: Phase 3
Study type: Interventional

This randomized, placebo-controlled phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.

NCT ID: NCT04455620 Active, not recruiting - Solid Tumor Clinical Trials

BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors

Start date: January 26, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic (PD) trial of BNT151 with expansion cohorts in various solid tumor indications. The trial consists of Part 1, Part 2A and Part 2B with adaptive design elements: The monotherapy dose escalation, (Part 1) of this clinical trial will enroll patients with various solid tumors that are metastatic or of advanced unresectable stage for whom there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy. The Part 1 of the trial also plans to implement a dedicated biomarker cohort in BNT151 monotherapy: The Biomarker Cohort will recruit patients at selected sites in the US only. The objective of the cohort is to observe PD activity and drug-induced changes in the blood and tumor. During combination dose escalation (Part 2A), patients of different specific solid tumors (one cohort per indication) will be enrolled and treated with a combination of BNT151 and the respective standard of care (SoC) treatment. Part 2B is the expansion phase where a predefined number of patients in each indication cohort will be treated with the confirmed recommended phase II dose (RP2D) of BNT151 in combination with respective SoC.

NCT ID: NCT04455295 Active, not recruiting - Clinical trials for Electroencephalography

Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.