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NCT ID: NCT05422365 Recruiting - Clinical trials for Primary Immune Thrombocytopenia

Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults

Start date: June 2022
Phase: Phase 3
Study type: Interventional

The study will involve patients with chronic immune thrombocytopenia. This disease is diagnosed in the presence of isolated thrombocytopenia (decrease in platelet count only), except for other reasons. The addition of "chronic" means that the disease lasts more than 12 months. Patients included in the study will receive Bioven, 10% solution for infusion according to the protocol for the use of IVIG in ITP - at a dose of 0.8-1.0 g / kg 1 time per day for 2 consecutive days, the course dose of 1.6-2.0 g / kg according to the "Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG)", rev. 3, 28 June 2018. After administration of the investigational drug, patients will be under medical supervision for 28 days. The stay of patients in the study - at least 4 weeks.

NCT ID: NCT05409066 Not yet recruiting - Clinical trials for Follicular Lymphoma (FL)

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

Start date: September 7, 2022
Phase: Phase 3
Study type: Interventional

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (intravenous infusion of rituximab up to 5 cycles and oral capsules of lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). 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: NCT05372939 Active, not recruiting - Ulcerative Colitis Clinical Trials

Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)

Start date: February 5, 2021
Phase: Phase 2
Study type: Interventional

Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.

NCT ID: NCT05339906 Recruiting - Stammering Clinical Trials

Study of the Effect of the Auditory Stimulation on Stuttering Symptoms in Patients With a Deficit of Spectral Power in the EEG Beta Frequency Band

Start date: May 25, 2021
Phase: N/A
Study type: Interventional

In this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective EEG spectral power changes.

NCT ID: NCT05338086 Recruiting - Clinical trials for Postmenopausal Women With Osteoporosis

A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)

Start date: March 31, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis

NCT ID: NCT05322668 Completed - Solar Lentigo Clinical Trials

Tolerance of Cyto-selective Difluoroethane-based Cryotherapy

Start date: January 17, 2022
Phase: N/A
Study type: Interventional

Cryotherapy is more and more used to improve skin appearance. Devices using difluoroethane, manufactured by CRYONOVE PHARMA, are already available on the local and international markets, e.g. CRYOBEAUTY MAINS and CRYOBEAUTY CORPS. However, the cryogenic gas (conventional cryotherapy - liquid nitrogen) creates a dermabrasion of the skin surface and person receiving this kind of treatment presents an impaired skin during a few days following the treatment as temporary damage of stratum corneum, erythema, scars, burns. Following the side effects occurring after conventional cryotherapy application, it seems interesting for the sponsor to select other sequences of a cryogenic spray (4 prototypes of devices) which could be used for lentigo treatment with a same benefit for the consumers without any safety outcomes. This study will assess the use of different prototypes with a sequence of application of cryogenic gas which reaches a higher temperature than those which used with the reference device, in order to increase the acceptability of the device. (CS4_3) proof of concept, interventional, monocentric, aims to evaluate the tolerance of cryotherapy treatments applied on healthy skin on the back of the hands. The main objective of the study is to evaluate on phototype V and VI, the tolerance of 4 different conditions of cryotherapy treatments (4 prototypes) applied on healthy skin on the back of the hands.

NCT ID: NCT05307692 Recruiting - Alzheimer Disease Clinical Trials

A Study of Seltorexant in Participants With Probable Alzheimer's Disease

Start date: May 19, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of seltorexant versus placebo on the sum of Agitation and Aggression domain scores (A plus A) of the Neuropsychiatric Inventory-Clinician rating (NPI-C) in participants with probable Alzheimer's Disease (AD) with clinically significant agitation/aggression.

NCT ID: NCT05281601 Recruiting - SARS-CoV-2 Clinical Trials

AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics

Start date: March 21, 2022
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years.

NCT ID: NCT05259215 Completed - Stroke Clinical Trials

Predicting Independent Walking Ability Using the Simplified Stroke Rehabilitation Assessment of Movement, Berg Balance Scale, Barthel Index for Activities of Daily Living in Individuals Post Stroke

Start date: January 1, 2020
Study type: Observational

Cohort observational retrospective pilot study by design. The purpose of this study was to determine a cut scores to predict independent ambulation for the Simplified Stroke Rehabilitation Assessment of Movement, Berg Balance Scale, Barthel Index for Activities of Daily Living.

NCT ID: NCT05251909 Recruiting - Clinical trials for Eosinophilic Gastroenteritis

Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

Start date: January 18, 2022
Phase: Phase 3
Study type: Interventional

This is a 3-part study. Part A and B have identical designs and are randomized, double-blinded, placebo-controlled studies, which will include patients with eosinophilic gastritis and/or duodenal-only disease. Part A will be enrolled first, followed by Part B. After completing Part A or Part B, participants will continue to Part C - open-label benralizumab treatment period.