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Намерени 4,781 изпитвания Стр. 220 от 240
Активно (без набиране) Фаза 1/2
A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies
Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Relapsed/Refractory AML

This is a study to assess the safety of increasing dose levels of bexmarilimab when combined with standard of care (SoC) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML); Phase 1 aims to identify the recommended phase 2 dose (RP2D) of bexmarilimab based on safety, tolerability and pharmacological activity; Phase 2 will investigate the preliminary efficacy of the combination treatment in selected indications from Phase 1.

Начало: 02.06.2022 Край: 01.03.2027 Възраст: от 18 г.
Finland, United Kingdom, United States Faron Pharmaceuticals Ltd NCT05428969
Активно (без набиране) Фаза 1
IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor
Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer

The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed. Primary objective: * To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab Secondary objectives: * To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab * To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab * To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab

Начало: 19.05.2022 Край: 01.12.2029 Възраст: от 18 г.
Germany Immatics Biotechnologies GmbH NCT05359445
Активно (без набиране)
Translation and Validation of a Swallowing Assessment Scale for Neurogenic Dysphagia
Dysphagia

The Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. Validating the MUCSS in Italian would aid in better managing neurogenic dysphagia patients.

Начало: 12.05.2022 Край: 22.05.2026 Възраст: 18–90 г.
Italy IRCCS San Camillo, Venezia, Italy NCT07503145
Активно (без набиране) Фаза 1
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Breast Cancer

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

Начало: 11.05.2022 Край: 01.12.2026 Възраст: от 18 г. Лечение
Australia, Belgium, Canada +9 Eli Lilly and Company NCT05307705
Активно (без набиране) Фаза 1
P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
Multiple Myeloma

Phase 1 study comprised of open-label, dose escalation, multiple cohorts of P-BCMA-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed / refractory Multiple Myeloma (RRMM).

Начало: 05.05.2022 Край: 01.03.2042 Възраст: от 18 г.
United States Poseida Therapeutics, Inc. NCT04960579
Активно (без набиране) Фаза 2
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack specificity and carry significant side-effects. We previously discovered the depletion of glutathione in lymphocytes of patients with SLE and associated this metabolic change with the elevation of the mitochondrial transmembrane potential. This study will titrate to tolerance during an initial 3 month open label period and then subjects will be randomized to one of 2 arms. It was determined by statistical analysis that each group must have 105 subjects. All subjects will be enrolled and evaluated for tolerance of NAC between dosages of 2.4 g/day and 4.8 g/day for 3 months. After A 3-month open-label dose-titration phase, SLE subjects will be randomized into 2 groups of 105 subjects either to continue the tolerated dosage of NAC or switched to equal number of placebo capsules. There will be up to seven study visits per SLE subject, including the screening and wash out visits. Visits 2-6 will be scheduled three months apart. The study will last 13 months with the wash-out visit. Each subject will donate approximately 100 ml of blood for biomarker studies at each visit. Healthy control subjects will donate blood at the same time. They will be matched to the SLE subjects by gender, age within 10 years, and ethnicity. Their blood will be used as reference for biomarker assays. There is a consent form required to participate in the phase II study.

Начало: 05.05.2022 Край: 30.09.2028 Възраст: от 18 г.
United States State University of New York - Upstate Medical Universi NCT00775476
Активно (без набиране)
Weight, Energy, Lipids, and the Liver (WELL) Study
Nonalcoholic Fatty Liver

The research study is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in hepatic lipid accumulation, visceral adipose tissue and postprandial lipid, markers of inflammation and energy metabolism in participants who consume 3 study foods per day for 16 week, while maintaining their body weight.

Начало: 02.05.2022 Край: 01.12.2026 Възраст: 22–80 г.
United States Ohio State University NCT05199948
Активно (без набиране) Фаза 4
The PASTDUe Nutrition Ecosystem Project (PASTDUe)
Diet, Healthy Food Nutrition Intensive Care +9

This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge.

Начало: 25.04.2022 Край: 20.02.2027 Възраст: от 18 г.
United States Duke University NCT05127109
Активно (без набиране)
The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes
Diabetes Mellitus

To assess the efficacy of the REST model in facilitating adoption and sustained use of CGM, in older adults with Type 1 diabetes (T1D) or Type 2 Diabetes (T2D) on complex insulin regimens. To examine barriers and enablers for the implementation feasibility of the REST intervention model using a mixed-methods approach. To assess the impact of REST model on economic factors and quality of life measures. The goal of this study is to facilitate the adoption of continuous glucose monitoring (CGM) in older adults (≥65 years) with diabetes mellitus (DM) on complex insulin regimens, and additionally, to build a framework for sustained CGM use over time using a novel patient-centered model - the REST model.

Начало: 20.04.2022 Край: 01.05.2026 Възраст: от 65 г.
United States Joslin Diabetes Center NCT05337826
Активно (без набиране) Фаза 3
Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts
Kidney Transplantation in Highly Sensitized Patients

An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior to desensitized with imlifidase and subsequent kidney transplantation. Two non-comparative reference cohorts are included to assess the impact of differences in post-transplantation management and outcome in less sensitized patients.

Начало: 19.04.2022 Край: 01.04.2026 Възраст: 18–75 г.
Austria, Belgium, Czechia +8 Hansa Biopharma AB NCT05369975
Активно (без набиране)
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Начало: 13.04.2022 Край: 21.11.2028 Възраст: 18–80 г.
United Kingdom, United States AtriCure, Inc. NCT05393180
Активно (без набиране)
Outcomes of a Higher vs. Lower Hemodialysate Magnesium Concentration (Dial-Mag)
Kidney Diseases End-Stage Kidney Disease Hemodialysis

Many patients on hemodialysis have low levels of magnesium. Magnesium is needed to keep the heart, kidneys, and other organs working properly. Patients with low serum magnesium concentration have a higher risk of death, heart issues, muscle cramps and fractures. There are several reasons why patients on dialysis have low levels of magnesium-these include poor diet, medication interference, and the dialysis procedure itself, which leaches small amounts of magnesium from the blood during each treatment. One way to make sure that patients on dialysis are getting enough magnesium is to increase its concentration in the dialysate. The investigator would like to do a randomized controlled trial to determine the effect of increasing the concentration of magnesium in the dialysate on the risk of people on dialysis dying or being admitted to the hospital due to heart issues. The investigator thinks increasing the magnesium in the dialysate will help patients live longer, have fewer hospitalisations related to heart disease and patients may also experience less cramping associated with dialysis. This simple adjustment to the dialysis procedure can be done at little to no cost and may even reduce overall healthcare costs. If the investigator can show that increasing magnesium in the dialysate improves patients' health, then it could become the standard of care for dialysis centres.

Начало: 04.04.2022 Край: 01.04.2026 Възраст: от 18 г.
Canada London Health Sciences Centre Research Institute OR Law NCT04079582
Активно (без набиране) Фаза 4
Long-term Follow-up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA)
Spinal Muscular Atrophy

A multi-center, longitudinal, prospective, non-comparative study to investigate the long-term safety and effectiveness of risdiplam, prescribed based on clinician judgment as per the Evrysdi® U.S. Package Information (USPI) in adult and pediatric participants with SMA. In this study, participants will be followed for approximately 24 months from enrollment or until withdrawal of consent, loss to follow-up, or death. Participants who discontinue risdiplam may still remain in the study if they agree to continue participating in the follow-up assessments. An optional sub-study was planned to assess the feasibility, acceptability, and adherence of remote assessment of motor and bulbar functions in participants with SMA using wearable and smartphone-based biosensors. This substudy was withdrawn upon implementation of protocol version 4.

Начало: 29.03.2022 Край: 31.12.2026
Puerto Rico, United States Genentech, Inc. NCT05232929
Активно (без набиране)
Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women
Smoking Cessation Pregnancy Communication Research

The investigators propose to conduct a combined intervention that pairs SMS smoking cessation messages for patients with individualized training for OB clinicians to improve quit rates among pregnant smoking. The aim is to determine the effect of the intervention versus control on smoking cessation outcomes on patient smoking cessation. The investigators will recruit patients at their first OB visit who report smoking at Duke and Pitt. Patients in both the control and intervention arm will receive smoking cessation support messages throughout their pregnancy. OB clinicians in the intervention arm will receive tailored smoking cessation counseling training. Clinicians in both arms will receive a one-time 5 A lecture. The investigators will analyze smoking cessation outcomes and audio recordings. This is a minimal risk study.

Начало: 25.03.2022 Край: 31.05.2026 Възраст: от 18 г.
United States Duke University NCT04985903
Активно (без набиране)
Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT
Coronary Artery Disease Optical Coherence Tomography Stent

Investigators aimed to evaluate efficacy and safety of expansion capacity of zotarolimus-eluting Stent assessed by optical coherence tomography (OCT) in vivo study.

Начало: 23.03.2022 Край: 31.12.2026 Възраст: от 19 г.
South Korea Yonsei University NCT05340361
Активно (без набиране)
Efficacy of the Apollo System for Children With ADHD
Attention Deficit Disorder With Hyperactivity

To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

Начало: 18.03.2022 Край: 15.08.2027 Възраст: 8–17 г.
United States Michigan State University NCT05308706
Активно (без набиране)
Korea Comirnaty Post-marketing Surveillance
COVID-19 Vaccines Adverse Effects SARS-CoV-2 +1

This study will collect information on the safety of BNT162b2 products for subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS).

Начало: 18.03.2022 Край: 24.01.2027 Възраст: от 6 г.
South Korea Pfizer NCT05032976
Активно (без набиране) Фаза 2
A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer
Rectal Neoplasms Rectal Cancer

This study will evaluate the efficacy and safety of atezolizumab plus tiragolumab or atezolizumab alone following neoadjuvant chemoradiotherapy (nCRT) in participants with locally advanced rectal cancer (LARC). The study consists of a safety run-in phase and a randomization phase. Participants enrolled in the safety run-in phase will receive atezolizumab + tiragolumab following nCRT. Upon determination of the safety of the treatment regimen, the study will be proceed to the randomization phase. Participants will be randomized in a 1:1 ratio to the atezolizumab + tiragolumab arm or atezolizumab arm.

Начало: 18.03.2022 Край: 10.11.2026 Възраст: от 18 г.
China Hoffmann-La Roche NCT05009069
Активно (без набиране) Фаза 3
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
HER2 Positive Breast Cancer

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

Начало: 07.03.2022 Край: 28.09.2027 Възраст: от 18 г. Лечение
Australia, Austria, Belgium +20 Seagen, a wholly owned subsidiary of Pfizer NCT05132582
Активно (без набиране) Фаза 2
A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma
Basal Cell Carcinoma

The purpose of this study is to find out if radiation therapy (RT) guided by the new reflectance confocal microscopy (RCM)/optical coherence tomography (OCT) device is an effective treatment for basal cell carcinoma (BCC). The researchers will also look at the side effects from RT guided by the RCM/OCT device. In addition, will determine the quality of life before and after treatment by having the participant fill out questionnaires.

Начало: 03.03.2022 Край: 01.03.2027 Възраст: от 18 г.
United States Memorial Sloan Kettering Cancer Center NCT05294120
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