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NCT ID: NCT05546476 Active, not recruiting - Colorectal Cancer Clinical Trials

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

PROACC-1
Start date: November 21, 2022
Phase: Phase 2
Study type: Interventional

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

NCT ID: NCT05535712 Active, not recruiting - Clinical trials for Robotic Surgical Procedure

Single Port Robotic Lung Anatomical Resection

Start date: October 7, 2022
Phase: N/A
Study type: Interventional

This is the first human clinical study for explore the feasibility of lung anatomic resection through Da Vinci SP surgical platform

NCT ID: NCT05528510 Active, not recruiting - Colitis, Ulcerative Clinical Trials

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

ASTRO
Start date: September 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT05513703 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Start date: November 21, 2022
Phase: Phase 2
Study type: Interventional

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05512819 Active, not recruiting - Clinical trials for Pneumococcal Disease

A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan

Start date: September 16, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers. This study is enrolling participants who are: - Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study - Have a bodyweight of at least 3 kg Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age. Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.

NCT ID: NCT05507580 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

Flex-Up
Start date: May 12, 2023
Phase: Phase 4
Study type: Interventional

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis (UC), Crohn's Disease (CD), and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 4 arms. After the last study visit, there is a 30-day follow-up visit. Approximately 454 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide. The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind period. Participants will receive upadacitinib oral tablets once daily for up to 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05501418 Active, not recruiting - COVID-19 Infection Clinical Trials

Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With COVID-19

UMSC01
Start date: August 5, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to explore the safety and efficacy of using UCMSC01 in patients with COVID-19 infection via IV stem cell administration. The novelty of the current UMSC01 treatment is the single IV infusion of UMSC01 to the worldwide emergency outbreaks of COVID-19. We hypothesize that sufficient UMSC01 retention in lung may modulate the systemic inflammatory responses.

NCT ID: NCT05490914 Active, not recruiting - COVID-19 Clinical Trials

The Prognostic Factors of COVID-19 ARDS Patients and Their Long-term Follow-up of Pulmonary Function Test

Start date: July 1, 2020
Phase:
Study type: Observational

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an emerging infectious disease with high transmissibility. Around 20-25% of infected individuals develop severe COVID-19 disease requiring hospitalization and 5-8% require intubation secondary to viral pneumonia and acute respiratory distress syndrome (ARDS). Distinct features of COVID-19 ARDS were found since Nov 2019, including relatively normal lung mechanics, activation of the RAAS system, selective injury of type II alveolar cells, and presence of vasodilation vessel and micro-thrombosis. The mechanism, potential useful biomarker, and the optimal ventilation strategies for COVID-19 ARDS need to be systematically studied. This study hypothesized that the low-tidal volume ventilation strategy is effective in COVID-19 ARDS. We will retrospectively review the clinical presentation, epidemiologic data, laboratory and image examination, medication use, lung mechanics、serum biomarker, long-term pulmonary function test, and clinical outcomes in COVID-19 ARDS, influenza ARDS, and SARS ARDS patients. We will also prospectively monitor the lung function of COVID ARDS patients using personal pulmonary function devices after discharge from NTUH. The overall purpose of this study is to investigate the prognostic indicators of COVID ARDS patients and their long-term pulmonary function follow-up.

NCT ID: NCT05477732 Active, not recruiting - Stroke Clinical Trials

Effects of Bifidobacterium Longum OLP-01 Supplement on Cognitive Function, Exercise Performance, Nutritional Status and Gut Microbiota in Stroke Patients

Start date: February 12, 2021
Phase: N/A
Study type: Interventional

Stroke is a syndrome of acute, focal neurological deficit attributed to vascular injury of the central nervous system. It was the 2nd leading cause of death worldwide and accompanied by high disability rate also increases the social burden.Our research is to investigate the effects of intervention with Bifidobacterium longum OLP-01 on cognitive function, exercise performance, nutritional status and gut microbiota in stroke patients. 1. Study population: We will recruit 120 stroke patients and the inclusion criteria are: (1) Aged 20-75 years old, (2) Diagnosed with stroke more than 3 months, (3) Undergoing outpatient rehabilitation and the condition is stable. The exclusion criteria are: (1) Aphasia, dementia or depression, (2) BMI ≥ 35 kg/m2, (3) Cancer treatment in 3 months, (4) Some severe disease may interfere patients to join the study, (5) Failed to cooperate the examination and treatment because of emotion or mental condition. 2. Study design: A two-arm single-blind randomized controlled clinical trial will be performed for 12 weeks and the subjects will be divided in to 2 groups: (1) placebo group, (2) supplement group. Subjects were asked to supplement with either 2 × 1010 colony-forming unit (CFU) of Bifidobacterium longum OLP-01 powder per day or placebo for 12 weeks. Medical history, drug use and life style questionnaires were giving before intervention. Outcomes will be assess in week 0 and week 12 during intervention. 3. Outcome assessment: 1. Anthropometry data: height, weight, body mass index, waist circumference, mid-upper arm circumference, hip circumference, calf circumference, waist to hip ratio. 2. Body composition: muscle mass, body fat, basal metabolic rate. 3. Clinical data: blood pressure, stroke related characteristics. 4. Blood biochemistry: A. Nutritional status: albumin, prealbumin, transferrin. B. Glycemic profiles: fasting blood glucose, glycated hemoglobin A1c (HbA1c). C. Lipid profiles: total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG). D. Complete blood counts: white blood cells (WBC), red blood cells (RBC), hemoglobin (HB), platelet count (PLT), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC). E. WBC differential counts: neutrophils (NEUT), lymphocytes (LYM), monocytes (MONO), eosinophils (EOS), basophils (BASO). F. C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor alpha (TNF-α). 5. Gut microbiota: relative abundance, α-diversity, β-diversity. 6. Nutritional status: 3-day dietary record, mini-nutritional assessment (MNA). 7. Cognitive function: Montreal cognitive assessment (MoCA), trail-making test A and B (TMT A and B), Stroop color naming test. 8. Exercise performance: timed up and go test (TUGT), 6-min walking test. The purpose of the study is to investigate the intervention of Bifidobacterium longum OLP-01 supplement on cognitive function, physiological performance, nutritional status, and gut microbiota in stroke patients.

NCT ID: NCT05462717 Active, not recruiting - Clinical trials for Advanced Solid Tumor

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Start date: September 19, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.