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NCT ID: NCT04991935 Recruiting - Clinical trials for Eosinophilic Esophagitis

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.

NCT ID: NCT04989439 Recruiting - Ultrasonography Clinical Trials

Comparison of Computertomography Scan, Electrical Impedance Tomography, and Ultrasound of the Lung in Infants

Start date: July 19, 2021
Phase:
Study type: Observational

The study focuses on regional lung examination, in particular on the differentiation between collapsed and hyperinflated lung areas. The purpose of the study is to elaborate common and discriminative elements between different lung imaging modalities in infants and to generate hypotheses for the bedside use of EIT and LUS in infants.

NCT ID: NCT04987307 Recruiting - Ulcerative Colitis Clinical Trials

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: January 31, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.

NCT ID: NCT04985526 Recruiting - Clinical trials for Polymorphic Light Eruption

Skin Microbiome and Polymorphic Light Eruption

PLE_microbio
Start date: May 7, 2021
Phase: N/A
Study type: Interventional

Polymorphic light eruption (PLE) is the most common form among UV-inducible disorders with a prevalence of approximately 11-21% worldwide and a clear predisposition of women. Usually, within several hours after an intense UV exposure, most likely in spring or early summer, the formation of itchy skin lesions particularly at the upper arms and V-neck and neck is distinctive for PLE. It has been suggested that the development of a potential photo-induced antigen may initiate a delayed-type hypersensitivity reaction in PLE (causing the skin rash) and the microbiota of the skin may be involved. We thus hypothesized that eliminating the microbiota of the skin by disinfection may affect the formation of PLE. The concept of this study covers a combined interindividual and intraindividual half-body comparison of the skin reactions of disinfected and contralateral non-disinfected areas upon UV exposure in PLE patients and healthy subjects.

NCT ID: NCT04976153 Recruiting - Fecal Incontinence Clinical Trials

Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

Fidelia
Start date: May 11, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.

NCT ID: NCT04975997 Recruiting - Multiple Myeloma Clinical Trials

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

EXCALIBER-RRMM
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT04975308 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

EMBER-3
Start date: October 4, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

NCT ID: NCT04973137 Recruiting - Clinical trials for Light Chain (AL) Amyloidosis

A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

AFFIRM-AL
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

NCT ID: NCT04972708 Recruiting - Covid19 Clinical Trials

Genetics of COVID-19 Risks & Resilience in Bipolar Disorder

BIPCOVID
Start date: July 1, 2021
Phase:
Study type: Observational

BIPGEN is a cross-sectional study on the genetics of bipolar disorder. As a subproject of BIPGEN, BIP-COVID is a cross-sectional genetics study about risks & resilience in the COVID-19 (Coronavirus disease) pandemic in bipolar disorder (BD) and healthy controls at the Medical University of Graz. Study participants with BD and controls from the well-established BIPLONG and BIPGEN studies will undergo a special BIP-COVID visit, which will include a COVID-19 specific online Lime survey about the psychological burden in the COVID-19 crisis, a COVID-19 antibody test (IgM and IgG), inflammation markers and isolation of DNA from fasting blood. Genotyping of DNA will be done with the GSA V.3 array. Genetic analyses (Polygenic Risk Scores of I. Stress or Major Depression and II. COVID-19 infection established with the programs PLINK, PRSice and R) will be used to analyze the genetic mechanisms of COVID-19 pandemic associated psychological symptoms and COVID-19 infection risk. Systems biology methods will be used to depict protective pathways against COVID-19 infection (e.g. Lithium pathways) and against COVID-19 associated psychiatric symptoms.

NCT ID: NCT04967248 Recruiting - Clinical trials for Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

Start date: June 21, 2023
Phase:
Study type: Observational

This is a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.