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NCT ID: NCT06030440 Recruiting - Clinical trials for Squamous Cell Carcinoma of the Oral Cavity

De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

DIREKHT2
Start date: January 26, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.

NCT ID: NCT06029972 Recruiting - Ulcerative Colitis Clinical Trials

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

PALEKONA
Start date: December 5, 2023
Phase: Phase 2
Study type: Interventional

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

NCT ID: NCT06029725 Recruiting - Photoaging Clinical Trials

RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The appearance of the aging skin is influenced by different factors including by the reduced elasticity and increased laxity of the skin, the decreasing volume as well as pigmentation disorders and dilated vascular markings. Currently, there are different methods available to treat the aging skin. Here, the combined treatment of radiofrequency micro needling (RFMN) and thulium laser has been commonly used in clinical practice. The aim of this clinical study is to investigate the efficacy, patient satisfaction, safety of RFMN and thulium laser treatment in patients with facial, age-related skin laxity, wrinkles, and pigmented lesions.

NCT ID: NCT06029595 Recruiting - Uncontrolled Asthma Clinical Trials

Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy

TANGO
Start date: November 26, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)

NCT ID: NCT06028971 Recruiting - Clinical trials for Distal Femur Fracture

Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series

Start date: January 30, 2024
Phase:
Study type: Observational

The goal of this observational multicenter case series is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care.

NCT ID: NCT06028555 Recruiting - Contraception Clinical Trials

International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study

INAS-NEES
Start date: June 28, 2023
Phase:
Study type: Observational

Multinational, comparative, prospective, active surveillance study that follows two cohorts. The primary objective of the study is to characterize and compare the risks of E4/Drospirenone (DRSP) with levonorgestrel-containing combined oral contraceptives (EE/LNG) in a study population that is representative of the actual users of these preparations. The main clinical outcome of interest is venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE). Secondary objectives include measuring the occurrence of unintended pregnancy, assessing the risk of arterial thromboembolism (ATE), describing the drug utilization pattern, describing the baseline risk profile for VTE and ATE, and investigating outcomes associated with foetal exposure to E4/DRSP.

NCT ID: NCT06028464 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of BI 1810631 in the Blood

Start date: September 11, 2023
Phase: Phase 1
Study type: Interventional

The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in plasma.

NCT ID: NCT06028438 Active, not recruiting - Clinical trials for Arthritis, Rheumatoid

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

DAISY
Start date: August 15, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.

NCT ID: NCT06028230 Recruiting - Clinical trials for Hidradenitis Suppurativa

A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

ZEN
Start date: September 29, 2023
Phase: Phase 2
Study type: Interventional

This is a parallel, Phase 2, 2-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years. Study details include: - Screening period: up to 4 weeks (30 days) - Treatment duration: up to 16 weeks - Follow-up period: up to 4 weeks - Total study duration: up to 24 weeks - Number of visits: 14

NCT ID: NCT06027385 Completed - Clinical trials for Spinal Muscular Atrophy

Genetic Newborn Screening for Cystinosis and Spinal Muscular Atrophy

GENESIS1
Start date: January 15, 2018
Phase: N/A
Study type: Interventional

Newborn screening in Germany is a voluntary program. Cystinosis and spinal muscular atrophy (SMA) are rare autosomal recessive diseases. They are inherited in an autosomal recessive manner, i.e. both parents carry a defective gene. Neither disease can be detected early by the methods established in routine newborn screening. However, common genetic mutations are known for both diseases. The aim of the study presented here is to provide the scientific basis for molecular genetic newborn screening for cystinosis and SMA. In particular, to investigate whether inclusion of these diseases in general newborn screening should be recommended. The participating screening laboratories for this project are Labor Becker & Kollegen, Munich, Germany and Screening Laboratory Hannover, Germany. Hospitals that send their dry blood spot cards for routine newborn screening to these laboratories will receive an offer to participate in the pilot project. Participation is free of charge. Parents who wish to participate in this pilot project will receive an information sheet explaining the screening process and objectives. A parent and the treating physician sign the information sheet as documentation of informed consent. Their signature and informed consent are required for the pilot. Routine NBS according to German pediatric guidelines involves the collection of dried blood spot cards 36-72 hours after birth. Molecular genetic screening in the pilot project will be performed with the same dried blood spot card used for routine newborn screening. In cystinosis, genetic testing for the 3 most common mutations in Germany will be performed. In SMA, a homozygous deletion of exon 7 in the SMN gene is detected by a PCR test. The molecular genetic test is performed on the same day as routine newborn screening.Normal findings are not reported to parents. However, they can contact the laboratories to inquire about them. Parents of newborns with two mutations in the cystinosis gene or with a homozygous deletion of exon 7 in the SMN gene are immediately informed of the disease by a physician. Further diagnostics to confirm the disease will be organized close to home. The study started on Jan. 15, 2018, and recruitment was completed on Sept. 30, 2022.