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NCT ID: NCT06139315 Completed - Healthy Clinical Trials

A Study to Test How Well Different Doses of BI 765845 Are Tolerated by Healthy People

Start date: June 2, 2022
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 765845 in healthy male subjects and female subjects of non-childbearing potential following intravenous administration of single rising doses.

NCT ID: NCT06138470 Recruiting - Mood Regulation Clinical Trials

Evaluation of the Effect of a Combination of Plants to Regulate Mood

Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to confirm by a randomized double-blind controlled study the interest of a combination of saffron (Saffr'Activ®) and scutellaria (Scutell'up®) on the regulation of mood.

NCT ID: NCT06138002 Recruiting - Clinical trials for Chronic Low Back Pain

Clinical Investigation to Assess the Clinical Performance of the LumbaCure® Intervention on Chronic Low Back Pain Patients.

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. The highest incidence of LBP is in people in their third decade of age. LBP is a complex disease difficult to treat as most of these cases (80 - 90 %) are classified as non-specific meaning that the pain cannot be attributed to any specific injury or pathology. Until now exercise therapy is commonly used as the treatment of choice in the revalidation program of LBP. The aim of physical treatment is to improve function and prevent disability from getting worse. LumbaCure® is a robotic system driven by a proprietary movement algorithm to induce a specific and controlled mobilization of the hips and the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain. The investigation include an intervention period of 4 weeks The main objective is to compare the impact on disability (Oswestry disability Index) and movement performance of the interventions (LumbaCure® vs physical exercises supervised by the physiotherapist) in two parallel groups of patients suffering from chronic low back pain. The investigation includes an intervention period of 4 weeks and a follow-up period of 6 months (post intervention period).

NCT ID: NCT06137729 Active, not recruiting - Clinical trials for Healthy Participants

A Study to Learn How Different Amounts and Forms of the Study Medicine PF-07899895 Are Tolerated and Act in the Body of Healthy Adults

Start date: November 17, 2023
Phase: Phase 1
Study type: Interventional

The purposes of the study are as follows: - To understand how safe and tolerable different amounts of study medicine (PF-07899895) are. - To measure the amount of PF-07899895 in blood after the medicine is taken by mouth. The study is seeking participants who: - Are male or female of 18 to 65 years of age. - Are in good health condition. - Have not had viral infections (HIV, HBV, or HCV). HIV, human immunodeficiency virus. HBV, hepatitis B virus. HCV, hepatitis C virus. - Have tested negative for tuberculosis. Participants will receive either PF-07899895 or placebo (dummy pill) by chance. In the first part of the study (Part A): - Each participant will receive a total of up to 5 doses of the medicine or placebo with at least 5 days between each dose. - After each dose, participants will stay in study clinic for 3 to 5 days. In the second part of the study (Part B): - Each participant will need to take 10 days of dosing and will stay in the study clinic for clinical checks for 13 days. The planned duration of participation from screening to follow-up in: - Part A of the study is up to 15 to 18 weeks. - Part B of the study is up to 11 weeks. Participants will also have their blood collected by the study doctors several times.

NCT ID: NCT06137131 Completed - Voice Disorders Clinical Trials

Voice Therapy With a Semi-occluded Vocal Tract

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

1. The first objective of this research is to investigate the immediate effects of three semi-occluded vocal tract (SOVT) exercises (straw phonation in air, straw phonation in 2cm water, and straw phonation in 5cm water) on (supra)glottic activity of vocally healthy participants and patients with voice disorders (dysphonia) visualized with laryngovideostroboscopy. Participants will receive a flexible laryngovideostroboscopy, both during normal phonation and during the specific SOVT exercise. These videos will be randomly and blindly evaluated by two experts using the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017). Researchers will compare the effects of these SOVT exercises on the (supra)glottic activity with the effects found in a control group producing /u/ phonation, using a randomized controlled trial. 2. The second objective of this research is to investigate the short- and long-term effects of the three SOVT therapy approaches on the (supra)glottic activity, voice quality and self-report of patients with voice disorders (dysphonia). Participants will receive a short-term intensive therapy with the specific SOVT exercise across four weeks. Immediately after the therapy program and at 1 and 3 months follow-up, the voice of the participants will be re-evaluated.

NCT ID: NCT06136702 Recruiting - Cervical Cancer Clinical Trials

ELEVATE Acceptability Study

ELEVATE AS
Start date: December 7, 2022
Phase: N/A
Study type: Interventional

This study includes a community-based, two-arm prospective acceptability study, whereby arm 1 consists of an educational session on sexual health and cervical cancer (screening) and a follow-up assessment after 3 months. Arm 2 consists of an educational session on sexual health and cervical cancer (screening) and self-sampling, additionally women will be asked to take a self-sample on-site, followed by a follow-up assessment after 3 months. Attitudes, uptake and users' experiences related to the use of a HPV self-sampling test will be assessed, additionally, the impact on looking for follow up care of self-sampling with standard cervical screening strategies will be assessed and finally the feasibility of an HPV self-sampling in hard-to-reach groups versus educational sessions and standard care will be compared (arm 1 and 2).

NCT ID: NCT06134804 Active, not recruiting - Clinical trials for Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

Engage
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.

NCT ID: NCT06134791 Recruiting - Headache Clinical Trials

Differences in Characteristics of Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.

Start date: July 1, 2023
Phase:
Study type: Observational

An observational study will be conducted to evaluate the differences in headache characteristics between a subgroup of cervicogenic headache patients with a positive and negative flexion-rotation test at the C1-C2 level. Differences may guide future treatment allocation and the use of more individualized treatment options.

NCT ID: NCT06132958 Recruiting - Endometrial Cancer Clinical Trials

Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that sacituzumab tirumotecan is superior to TPC with respect to OS.

NCT ID: NCT06130943 Completed - Suicidal Ideation Clinical Trials

Evaluation of the Quality of Telephone Calls to a Suicide Prevention Helpline

Start date: October 12, 2020
Phase:
Study type: Observational

This study adds to the existing evidence on suicide prevention helpline efficacy because it tackles some of the common limitations for helpline studies. High risk individuals were not excluded from the study, since there was no human interference in deciding if the study was offered to the lifeline callers. Most of the existing studies exclude users in high risk and acute crisis situations. The study employed the callers' own ratings on a set of questions, automatically offered within the phone system immediately before and after the call to assess the immediate impact of the call and the intervention. The automatization of the self-report measures in the telephone system reduces the burden on the operators to offer the research questions without interrupting the crisis intervention and decreases the risk of bias in caller responses. The goal of this observational study is to evaluatie the Flesmish suicide prevention helpline in people who call the helpline when feeling suicidal. The main questions it aims to answer are: 1. Has the degree to which the caller feels in crisis subsided? (Crisis in this is seen as the subjective feeling of complete emotional upset) 2. Does the caller report feeling less suicidal? (Score on selected indicators of suicidality, particularly hopelessness, entrapment, controllability, suicidal intent and social support) 3. Is the caller satisfied with the conversation? 4. Which elements in the conversation (i.e., responders' interventions) make it more or less effective, in terms of crisis level, suicidality (indicators) and caller satisfaction? 5. Which elements of the conversation do callers name as (not) helpful during the follow-up conversation? Which elements promoted progress in this, besides merely lowering the crisis level? 6. What possible (follow-up) actions do callers see as helping to sustain and/or improve the longer-term impact of the conversation with the suicide prevention helpline? Participants are asked the fill in items before the call, immediately after the call and one to two weeks after the call.