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NCT ID: NCT05701150 Recruiting - Clinical trials for Advanced Solid Tumor

AIO-BNHO Comprehensive Clinico-genomics Database Network - AIO-BNHO CONNECT

CONNECT
Start date: December 8, 2022
Phase:
Study type: Observational [Patient Registry]

National, retro- and prospective, observational, multicenter clinical research platform to connect clinical and genomic data of patients with advanced (locally advanced, inoperable, or metastatic) solid tumors (excluding NSCLC, SCLC, and mesothelioma) with results from multi-gene next-generation sequencing (NGS) panels (>30 genes)

NCT ID: NCT05700929 Recruiting - Communication Clinical Trials

Evaluation of a Communication Skills Training for Nurses

KOMPAT
Start date: November 14, 2022
Phase: N/A
Study type: Interventional

The KOMPAT study aims to evaluate the effectiveness and feasibility of a needs-based communication skills training for nursing professionals in Germany and to derive recommendations for future long-term implementation. Therefore, a training program to foster communication skills of nursing professionals has been developed based on a previously conducted needs assessment and literature research. To evaluate the training a randomized controlled trail with a waitlist-control group will be conducted. It is aimed to include 180 nurses within the study, of which 90 nurse will be randomized in a stratified manner to the intervention group and 90 nurses will be randomized to the waitlist-control group. Outcomes will be assessed at baseline, post -training and 4-weeks follow-up. It is hypothesized that self-efficacy in communication with patients and further outcomes will be significantly higher among participants in the intervention group compared to participants of the waitlist-control group during post-training assessment and follow-up. The evaluation will be accompanied by a process evaluation. The training will be facilitated by a member of the research team and a nursing professional by applying the train-the-trainer approach. The KOMPAT study will be conducted at the University Medical Center Hamburg-Eppendorf.

NCT ID: NCT05700565 Recruiting - Clinical trials for Immune-related Adverse Event

Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype

PRIA
Start date: January 1, 2022
Phase:
Study type: Observational

This study is an open, monocentric study. It includes patients with irAE refractory to standard therapy or patients where corticosteroids cannot be tapered. Patients will either be treated with ECP or second line immunosuppressive therapy according to investigator's choice. Patients will be followed for 24 weeks after first treatment.

NCT ID: NCT05698680 Recruiting - Acute Gout Clinical Trials

Prednisolone Versus Colchicine for Acute Gout in Primary Care

COPAGO
Start date: January 18, 2023
Phase: Phase 4
Study type: Interventional

Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribed for pain relief during an acute gout attack. However to date, no direct comparison of efficacy of colchicine and prednisolone for the treatment of acute gout attacks has been investigated. Furthermore, majority of previous research studies were not only conducted in tertiary centres but also excluded patients with common comorbidities due to contraindications with naproxen. This pragmatic, prospective, double-blind, parallel-group, randomized, non-inferiority trial will investigate whether prednisolone (treatment drug) is comparable or only acceptably worse than treatment with colchicine (comparison drug) in patients presenting with acute gout. Patients presenting with acute gout to their general practitioners in 60 practices across 3 university sites (Greifswald, Göttingen, and Würzburg) will be invited to participate. Patients often excluded by previous studies due to contraindications with naproxen will also be able to participate. The investigators will compare the absolute levels of the most severe pain on day 3 (in the last 24 hours) measured with an 11-item numerical rating scale as the primary endpoint. Day 0 is the day patients take their study medication for the first time. They are then asked to fill out a study diary at the same time each day to quantify their pain. Pain scores will then be used as comparison between the two medications.

NCT ID: NCT05698615 Recruiting - Clinical trials for Children and Adolescents Inpatient in Psychiatric Hospital

Chess Training as add-on Intervention for Adolescents With Psychiatric and Psychosomatic Disorders

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

In the planned study, the effect of chess training on the cognitive abilities of children and adolescents with psychiatric and psychosomatic illnesses will be investigated in a naturalistic setting. Furthermore, the effects on therapy success and quality of life will be determined.Despite the thoroughly positive results, CRT has not yet been included in the official guidelines as an intervention in standard therapy; this is due, among other things, to too few studies and too little knowledge in the field of child and adolescent psychiatry. The planned study aims to fill the research gap in the field of chess training as an adjunctive intervention in children and adolescents and to provide further evidence on the relevance of CRT in child and adolescent psychiatry. The hypotheses of the proposed study are: 1. chess training as a six-week add-on intervention will improve cognitive functioning in adolescents with psychiatric/psychosomatic disorders compared to standard treatment. 2. chess training as a six-week add-on intervention improves quality of life in adolescents with psychiatric/psychosomatic disorders compared to standard treatment. 3. chess training as a six-week add-on intervention positively influences the course of therapy in adolescents with psychiatric/psychosomatic illnesses compared to standard treatment.

NCT ID: NCT05697211 Recruiting - Clinical trials for Anemia, Iron Deficiency

ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients With Heart Failure (ORION-HF)

Start date: February 21, 2023
Phase: Phase 4
Study type: Interventional

This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.

NCT ID: NCT05696717 Recruiting - Clinical trials for MSA - Multiple System Atrophy

Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy

CYPRESS
Start date: June 27, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

NCT ID: NCT05696626 Recruiting - Clinical trials for Metastatic Breast Cancer

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

ELAINEIII
Start date: October 31, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

NCT ID: NCT05695508 Recruiting - Multiple Myeloma Clinical Trials

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

HD10/DSMMXX
Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab in Combination with Daratumumab, Lenalidomide, and Dexamethasone with or without Bortezomib as Induction Therapy and Teclistamab in Combination with Daratumumab and Lenalidomide as Maintenance Therapy in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma. OBJECTIVES: The primary objective is to evaluate the safety and tolerability of Tec-DRd and Tec-DVRd as induction therapy and Tec-DR as post-transplant maintenance therapy in participants with ND-TEMM. The key secondary objective is to evaluate the efficacy of Tec-DRd and Tec-DVRd as induction therapy and Tec-DR as post-transplant maintenance therapy.

NCT ID: NCT05695248 Recruiting - Clinical trials for Hereditary Angioedema

A Study of STAR-0215 in Participants With Hereditary Angioedema

Start date: February 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.