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NCT ID: NCT04896372 Recruiting - Clinical trials for Psychological Well-being

The ACTyourCHANGE Study Protocol for Adolescents

ACTyourCHANGE
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

This Randomized Controlled Trial (RCT) aims to evaluate the effectiveness of a brief Acceptance and Commitment Therapy (ACT)-based-intervention combined with treatment as usual (TAU) compared to TAU only in improving psychological conditions in a sample of adolescents with obesity (body mass index, BMI > 97th centile for age and sex). Fifty consecutive adolescents (12-17 years) of both genders with obesity will be recruited among the patients hospitalized in a clinical center for obesity rehabilitation and randomly allocated into two experimental conditions: ACT + TAU vs TAU only. Both groups will attend a three-week in-hospital multidisciplinary rehabilitation program for weight loss. The ACT + TAU condition comprises a psychological intervention based on ACT combined with a standard psychological assessment and support to the hospitalization. The TAU comprises the standard psychological assessment and support to the hospitalization. At pre- to post-psychological intervention participants will complete the Avoidance and Fusion Questionnaire for Youth, the Psychological Well-Being Scale, the Depression Anxiety Stress Scale, the Difficulties in Emotion Regulation Scale, and the Emotional Eating subscale of the Dutch Eating Behavior Questionnaire. Repeated-measures ANOVAs (2x2) will be conducted. The study will assess the effectiveness of a brief ACT-based intervention for adolescents with obesity.

NCT ID: NCT04896008 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

ZENITH
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.

NCT ID: NCT04895917 Recruiting - AL Amyloidosis Clinical Trials

Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis

DarPAL
Start date: June 23, 2021
Phase: Phase 2
Study type: Interventional

This study aims at establishing a new powerful combination of daratumumab and pomalidomide as rescue treatment for patients with R/R AL amyloidosis.

NCT ID: NCT04895748 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies

Start date: November 30, 2021
Phase: Phase 1
Study type: Interventional

This is first in human study of DFF332, a small molecule that targets a protein called HIF2α. By acting on HIF2α, DFF332 may be able to stop the growth of certain types of cancer. DFF332 will be tested at different doses as single agent and in combination with Everolimus (RAD001, an mTOR inhibitor), and also in combination with Spartalizumab (PDR001, an anti-PD1) plus Taminadenant (NIR178, an adenosine A2A receptor antagonist), in patients with advanced clear cell renal cell carcinoma and other malignancies with HIF stabilizing mutations.

NCT ID: NCT04895722 Recruiting - Colorectal Cancer Clinical Trials

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)

Start date: June 25, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

NCT ID: NCT04895709 Recruiting - Melanoma Clinical Trials

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Start date: May 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

NCT ID: NCT04895436 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

ReVenG
Start date: March 28, 2022
Phase: Phase 2
Study type: Interventional

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. 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: NCT04895358 Active, not recruiting - Breast Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

Start date: June 18, 2021
Phase: Phase 3
Study type: Interventional

The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.

NCT ID: NCT04895176 Not yet recruiting - Heart Failure Clinical Trials

incidenCe and predictOrs of heaRt fAiLure After Acute coronarY Syndrome: CORALYS

CORALYS
Start date: June 1, 2021
Phase:
Study type: Observational

Single-cohort retrospective study evaluating the incidence and prognostic markers of heart failure following acute coronary syndrome treated by percutaneous coronary intervention

NCT ID: NCT04895111 Recruiting - Clinical trials for Sarcoidosis, Pulmonary

Endobronchial Ultrasound Strain Elastography in Sarcoidosis

Start date: May 10, 2021
Phase:
Study type: Observational

Strain elastography (SE) is an imaging method used for the measurement of relative tissue elasticity through qualitative (color pattern) or semi-quantitative methods (strain ratio or strain histogram). Very recently, the first pilot study has provided preliminary evidence that EBUS-SE elastography may help identify fibrotic lymph nodes in sarcoidosis and that sampling lymph nodes characterized by low strain elastography, that is "stiff" nodes, is associated with an increased risk of retrieving an inadequate sample (i.e. a sample which is not representative of the lymph node tissue). The investigators hypothesize that an EBUS-SE pattern indicative of lymph node stiffness will be associated with less granulomas and more fibrosis.