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NCT ID: NCT06212050 Enrolling by invitation - Aortic Stenosis Clinical Trials

Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis

Neo2BAV
Start date: September 15, 2023
Phase:
Study type: Observational

The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis. The clinical, procedural, and imaging characteristics will be collected from patients with severe BAV stenosis, regardless of the phenotype, and treated with TAVI using the ACURATE neo2 bioprosthesis worldwide.

NCT ID: NCT06211504 Recruiting - Flexible Flatfoot Clinical Trials

Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity

Start date: April 11, 2024
Phase: Phase 4
Study type: Interventional

Background: Adult acquired flatfoot deformity (AAFD) is a deformity of the foot which leads to pain and an altered gait pattern. There are several different surgical interventions available for treatment of AAFD. One of the most common treatments for mobile AAFD is medial displacement calcaneal osteotomy (MDCO) with or without adjuvant soft tissue procedures. However, the medial displacement of the calcaneus only aims to correct the deformity in one plane despite AAFD being a deformity of three planes with hypereversion of the calcaneus, anterior translation of the talus over the calcaneus and tilting/drop of the calcaneal head. Because of these multiple forces, the healing of MDCO in the intended position can sometimes be hard to achieve and medial soft tissue is still stressed leading to recurring deformity. The investigators believe that adjuvant insertion of a sinus tarsi implant (STI) could work as an internal splint, protecting soft tissue procedures on the medial side, reversing anterior translation of the talus, opposing calcaneus eversion, and lifting talar head. This additional procedure will create a better correction of the deformity with enhanced appearance of the foot and better long-term functional results. Methods: This is a multi-center randomized controlled trial designed to assess the efficacy of STI as an adjuvant procedure to MDCO in patients with mobile AAFD (Stage IIA). Patients aged 16 to 75 years, referred to one of the orthopedic centers involved in this study, will be invited to participate if they fulfil the trials eligibility criteria. In total, 130 patients who provide informed consent will be randomized to either MDCO with STI or MDCO without STI (65 patients in each group). The included patients will be clinically and radiographically examined. They will also fill out a form before surgery and 4-5 months, 1 year and 2 years postoperatively. The form will include Self-Reported Foot and Ankle Score (SEFAS) and Euro-QoL 5 Dimensions (EQ-5D). The trials primary outcome will be change in Meary's angle. Secondary outcomes include additional radiographic changes, change in SEFAS score, EQ-5D index, pain according to visual analog scale (VAS), satisfaction assessment, clinical outcome measures, the length of postoperative sick-leave and rate of complications. Discussion: This is the first randomized controlled trial assessing the efficacy of a sinus tarsi implant as an adjuvant procedure to MDCO.

NCT ID: NCT06211049 Recruiting - Clinical trials for Primary Dysmenorrhea

Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea

Start date: December 12, 2023
Phase: Phase 3
Study type: Interventional

In this Phase III study, the herbal product Vitex agnus-castus BNO 1095 20 mg will be tested. The sponsor would like to find out if treatment with Vitex agnus-castus BNO 1095 20 mg may improve the cramping pain before or during menstruation (primary dysmenorrhea) (without an organic cause) in women and if this treatment is safe. It is tested, if the pelvic pain and other symptoms during menstruation improve in patients who are treated with Vitex agnus-castus BNO 1095 20 mg and if therefore the standard treatments for primary dysmenorrhea, for example pain relief medications will not have to be increased. The study has 2 treatment groups. Patients in one group will receive Vitex agnus-castus BNO 1095 20 mg, and patients in the other group will receive a placebo. Placebo tablets look like Vitex agnus-castus BNO 1095 20 mg tablets but have no active ingredient. Patients will be randomly assigned (like tossing a coin) to one of the 2 groups (this process is called randomization). The chance for the patients to receive Vitex agnus-castus BNO 1095 is 50%. Neither the patients nor the investigators know which product the patients are taking (this method is known as "double-blind").

NCT ID: NCT06209541 Recruiting - Anxiety Symptoms Clinical Trials

Internet-based Cognitive Behavioral Therapy: A Factorial Randomized Controlled Trial About Treatment Content and Support

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the differences in treatment outcomes between individually tailored and transdiagnostic internet-based cognitive behavioral therapy (ICBT), as well as the differences between weekly support by a specific therapist and weekly support by a team. The target group is adults (18 years or older) who experience mild to moderate depression symptoms, anxiety, stress or other psychological symptoms. The ICBT, in both types of treatment contents, consists of modules that the participants will work with for eight weeks in total. Participants will be recruited in Sweden with nationwide recruitment.

NCT ID: NCT06208150 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

MonumenTAL-6
Start date: January 22, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

NCT ID: NCT06207942 Recruiting - Clinical trials for Cognitive Impairment

Stepcare Extended Follow-up Substudy

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

NCT ID: NCT06207916 Completed - PTSD Clinical Trials

International Survey of Childbirth-Related Trauma - Swedish Part

SwIntersect
Start date: September 1, 2021
Phase:
Study type: Observational

The goal of this cross-sectional observational study is to analyze childbirth-related PTSD, traumatic birth experiences and stress symptoms postpartum. The main questions it aims to answer are: - What is the prevalence of traumatic birth experiences, PTSD and stress symptoms in a Swedish postnatal sample? - What are the risk factors for postnatal mental ill-health? Additional goals are to make cross-cultural translations of the instruments City BiTS and Birth Satisfaction Scale - Revised. Participants will answer an online surveys including several instruments measuring postnatal stress and mental ill-health.

NCT ID: NCT06206603 Recruiting - Colorectal Cancer Clinical Trials

Epigenetic Regulation of Colorectal Polyps and Cancer

Start date: January 3, 2024
Phase:
Study type: Observational

The goal of this study is to learn about the epigenetic and genetic regulation (microRNA/mRNA) of colorectal polyps and their evolvement as polyps and to colorectal cancer. Furthermore, the study aims at investigating whether certain epigenetic features, linked to polyps and/or cancer are traceable in blood samples. The main questions the study aims to answer are: 1. Are there specific microRNA/mRNA that are expressed in different types of polyps and cancers and their respective stages? 2. Is microRNA/mRNA expression in polyps and cancer traceable in blood from the same patient? 3. Is the intestinal microbiata correlated with colorectal polyps and cancer and their microRNA/mRNA expression? Type of study: clinical trial Participant population Participants consist of patients undergoing a scheduled colonoscopy where a polyp or cancer is discovered. Healthy controls, with normal colonoscopy findings will be enrolled. Biopsies will be obtained from polyps/cancers and from normal surrounding intestinal mucosa. Biopsies will be obtained from defined intestinal locations from healthy controls. Blood samples will be collected from all participants. Researchers will compare microRNA/mRNA and microbiota in patients with polyps/cancers and their respective stages as well as healthy controls. Comparisons include biopsies and blood samples.

NCT ID: NCT06205706 Recruiting - Clinical trials for Hepatocellular Carcinoma

BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors

Start date: December 4, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this first in human clinical trial is to test BI-1910 administered as single agent and in combination with pembrolizumab in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy. The main questions it aims to answer are: - how safe and tolerable is BI-1910 - what is maximum tolerated or administrated dose - to determine recommended dose for further clinical trials Participants will receive infusions of BI-1910 alone or combination with pembrolizumab every 3 weeks.

NCT ID: NCT06205290 Withdrawn - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies

Start date: January 16, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.