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NCT ID: NCT05142189 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

LuCa-MERIT-1
Start date: June 17, 2022
Phase: Phase 1
Study type: Interventional

This First-in-human (FIH) trial for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with cemiplimab or docetaxel in patients with advanced or metastasized non-small cell lung cancer (NSCLC) and unresectable NSCLC after chemoradiotherapy (CRT). Furthermore, the trial aims to establish the safety and feasibility of BNT116 in combination with cemiplimab and chemotherapy (carboplatin+paclitaxel) as neo-adjuvant treatment in resectable NSCLC followed by surgery and adjuvant BNT116 + cemiplimab. The trial will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.

NCT ID: NCT05142124 Recruiting - Clinical trials for Out-of-hospital Cardiac Arrest

German Cardiac Arrest Registry

G-CAR
Start date: July 21, 2021
Phase:
Study type: Observational [Patient Registry]

In Germany, 70.000 to 100.000 patients suffer from out-of-hospital cardiac arrest (OHCA) every year. More than half of these are due to cardiac causes. Despite the medical progress over the last decades, rates of survival with good neurological outcome remain low. For many below-mentioned issues, no adequate evidence from randomized trials is available. Therefore, a systematic and standardized recording of the pre-clinical, clinical and post-clinical treatment course and of the clinical outcomes of OHCA patients is essential to improve patient care. Aim of the German Cardiac Arrest Registry (G-CAR) is to achieve a better understanding of the disease entity, leading to an optimized treatment of OHCA patients. The recorded data include information on demographic and psychosocial aspects, course of the disease, clinical, laboratory and other examinations as well as treatment modalities in patients with OHCA due to a cardiac cause.

NCT ID: NCT05140239 Recruiting - Atopic Dermatitis Clinical Trials

Effects of Abrocitinib Treatment on Skin Barrier Function

AbroSkib
Start date: September 1, 2022
Phase:
Study type: Observational

Effects of abrocitinib treatment of atopic dermatitis on skin barrier function.

NCT ID: NCT05139836 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World Setting

UP-TAINED
Start date: December 13, 2021
Phase:
Study type: Observational

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 will assess the real-world effectiveness of upadacitinib on early and sustained response along adolescent and adult participants with AD. This study also aims to understand upadacitinib utilization patterns in real-world clinical practice. Upadacitinib (RINVOQ) is approved in the EU for the treatment of moderate to severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Approximately 772 adolescent and adult participants with AD will be enrolled at up to 200 sites in Germany. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. The overall duration of the study is approximately 2 years. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

NCT ID: NCT05139602 Recruiting - Clinical trials for Hidradenitis Suppurativa

A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy

Start date: December 28, 2021
Phase: Phase 2
Study type: Interventional

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy. Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. In the Main Study, participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide. In the Sub-study, participants will be put in 1 of 2 groups, called treatment arms. Both arms will receive treatment at different dosing intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic therapy will be enrolled in the study at certain sites. In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week or every other week for 36 weeks. 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 and diaries.

NCT ID: NCT05139342 Recruiting - Parkinson Disease Clinical Trials

Evaluation of the Efficacy of a Two-week EMST on Dysphagia in Parkinsonian Patients

EMST-PS
Start date: November 15, 2021
Phase: N/A
Study type: Interventional

This is an interventional therapy study designed to evaluate the efficacy of a two-week intervention, i.e. training with a specialized exhalation training device (called expiratory muscle strength training; EMST150 or EMST75; Aspire Products, Gainsville, FL) on swallowing function in patients with neurodegenerative Parkinsonian disorders. This study involves a routine endoscopic evaluation of swallowing (FEES) to diagnose dysphagia before and after the intervention. Between the two FEES, a two-week exhalation training program takes place, which the patients perform independently following instructions from a speech and lanuage pathologist. In addition demographic and disease-specific data and two questionnaires (Swallowing Disturbance Questionnaire for Parkinson's disease patients, SDQ-PD, and Swallowing specific Quality Of Life Questionnaire SWAL-QoL) are recorded.

NCT ID: NCT05138172 Recruiting - Clinical trials for Temperature Management During Sedation for Endoscopic Retrograde Cholangiography

Forced Air Heating to Prevent Hypothermia During Endoscopic Retrograde Cholangiography

FAIRHEC
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

The aim of this prospective observational study is to evaluate the role of a convective warming blanket to prevent hypothermia during sedation for an endoscopic retrograde cholangiography (ERC).

NCT ID: NCT05138133 Recruiting - Lupus Nephritis Clinical Trials

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

IRIS
Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

NCT ID: NCT05138094 Recruiting - Neoplasm Metastasis Clinical Trials

LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

LIVACOR
Start date: August 6, 2021
Phase: N/A
Study type: Interventional

The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.

NCT ID: NCT05133973 Recruiting - Diabetes Clinical Trials

Feasibility Study of a Transdermal Continuous Glucose Monitoring (CGM) System in Diabetic Patients

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

A single centered, prospective, double blinded study enrolling 12 Type I diabetic patients (+ up to 4 replacements) in two cohorts. Patients will wear multiple FiberSense CGM systems for 28 days, with total duration of the participation up to 8 weeks (screening + active phase + follow up). The primary aims of the study are assessment of the safety and tolerability of the FiberSense CGM system during the wearing time together with characterization of the system performance when compared to capillary blood samples.