louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05479084: The Effects of Kinesio Taping in Archery
Official title: Does Kinesio Taping Affect Shooting Performance Acutely in Archery Athletes?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sports Physical Therapy
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 43
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Archery athletes

Brief summary: The aim of the study is to investigate the effects of KT on archery athletes' performance.

Detailed description: Archery is a sport that requires strength, endurance, stabilization, and coordination of the upper body and shoulder girdle muscles. Kinesio taping (KT), which increased in popularity with the use in the athletes in the 2008 summer Olympics, is commonly investigated in the literature. KT is claimed to reduce pain and edema, increase functional performance, joint position sense, and blood-lymph flow, provide stability, and improve range of motion, flexibility, and strength. The aim of the study is to investigate the effects of KT on archery athletes' performance.

Eligibility criteria: Inclusion Criteria:

* To be archery in the elite category for at least 1 year
* Attending training sessions at least 2 days a week

Exclusion Criteria:

* Having any neurological problems
* Having a Turkish-speaking and reading disability

Primary outcomes:
measure: Assessment of Archery Shooting Performance
timeFrame: 15 minutes
Secondary outcomes:
measure: Assessment of Proprioception
timeFrame: 15 minutes
measure: Evaluation of Scapular Dyskinesis
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Eylül Pınar Kısa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00466284: Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer
Official title: Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Grupo Gallego de Cancer de Pulmon
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.

STUDY OBJECTIVES

Primary: Objective response rate

Secondary: Progression free survival, Overall survival and Safety of Tarceva

Detailed description: Study Design: Phase II trial, open label, non-randomized and multicenter.

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008

Eligibility criteria: Inclusion Criteria:

* Age 18 years.
* Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
* Measurable disease.
* Written informed consent must be obtained prior to the inclusion into the trial.
* Karnofsky performance status of 80%.
* Patients must have been treated with no prior chemotherapy or radioterapy.
* Patients must have adequate bone marrow, liver and renal function.

  * Bone Marrow: WBC \> 3000 x 103/mm3,
  * Platelets \> 100 x 103/mm3,
  * Hgb \> 10.0 gm/dl,
  * ANC \>1500 x 103/mm3,
  * Hepatic:Bilirubin \< 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase \< 5 x normal,
  * Renal:Creatinine \< 1.5 mg/dl (132 µmol/l).

Exclusion Criteria:

* Female patients who are pregnant or lactating.
* Patients who have used other investigational agents within 21 days prior to study entry.
* Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
* Significant comorbidity.

Primary outcomes:
measure: Objective response rate
Secondary outcomes:
measure: Progression free survival
measure: Overall survival
measure: Safety of Tarceva
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Grupo Gallego de Cancer de Pulmon
state: A Coruña
Study officials:
affiliation: GGCP
name: Joquin Casal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casal Rubio J, Firvida-Perez JL, Lazaro-Quintela M, Baron-Duarte FJ, Alonso-Jaudenes G, Santome L, Afonso-Afonso FJ, Amenedo M, Huidobro G, Campos-Balea B, Lopez-Vazquez MD, Vazquez S. A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study. Cancer Chemother Pharmacol. 2014 Mar;73(3):451-7. doi: 10.1007/s00280-013-2370-z. Epub 2013 Dec 19.
Clinical trial NCT02960984: Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis
Official title: Effects of Neurorehabilitation on Upper Limb Performance and on Fatigue in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: University of Genova
First posted: 2016-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been shown to exhibit a number of life-altering problems such as fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These problems affect performance of many daily living activities (ADL) such as dressing, bathing, self-care, and writing, thus reducing functional independence and self-rated quality of life.

Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a combination of aerobic training and upper limb task-oriented training.

The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on upper limb performance and on fatigue in People with Multiple Sclerosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Multiple Sclerosis
* no relapses in the last three months
* Expanded Disability Status Scale (EDSS) ≤ 8;

Exclusion Criteria:

* subjects with relapses
* worsening of the pathology in the last three months
* subjects with cognitive and psychiatric disturbances
* subjects with cardiovascular disease

Primary outcomes:
measure: Change from Baseline in 9-hole peg test at 2 and 4 months
timeFrame: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
measure: Change from Baseline in Heart Rate at 2 and 4 months
timeFrame: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Gnocchi ONLUS
Study officials:
References:
Clinical trial NCT00631384: Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
Official title: Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Voluntary Counseling and Testing
HIV
HIV seronegativity
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2008-03-07
Enrollment: 1521
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this research is to evaluate the effectiveness of couples Voluntary Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT, and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women. We hypothesize that offering CVCT will not decrease uptake of VCT among women. This research will be carried out in 3 antenatal clinics in Dar es Salaam, Tanzania.


Eligibility criteria: Inclusion Criteria:

* Up to 6 months of pregnancy
* Currently married or in cohabiting union for 2+ years and co-resident with husband

Exclusion Criteria:

* In polygamous marriage
* 7 or more months pregnant

Primary outcomes:
measure: HIV Testing and receiving results
timeFrame: within one month of initial visit to ANC
Secondary outcomes:
measure: use of nevirapine
timeFrame: 3 months after testing
measure: use of protection at time of sexual intercourse
timeFrame: 3 months after HIV test
measure: domestic violence
timeFrame: 3 months after HIV test
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University College of Health Sciences
Study officials:
References:
Clinical trial NCT06164184: Interest of the Cone Beam Scanner of Temporal Bones in the Analysis of Conductive Hearing Loss
Official title: Interest of the Cone Beam Scanner of Temporal Bones in the Analysis of Conductive Hearing Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Conductive Hearing Loss
Keywords: Conductive Hearing Loss
Cone Beam
Cone beam CT
CBCT
Temporal bones
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) having performed a CT scan or a cone beam for pre- and post-operative conductive hearing loss between January 01, 2018 and December 31, 2020

Brief summary: Conductive hearing loss is very common and the incidence increases with age. Until now, the scanner was the reference examination in the etiological diagnosis of deafness.

When performing a CT scan of temporal bones for the etiological diagnosis of conductive hearing loss, the quality of the image depends on the scanner brand and the acquisition parameters.

The investigators wish to show the usefulness of the cone beam in the diagnosis of conductive hearing loss


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject having performed a CT scan or a cone beam for pre- and post-operative conductive hearing loss between January 01, 2018 and December 31, 2020
* Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject who expressed their opposition to participating in the study

Primary outcomes:
measure: Show retrospectively that the superiority of the cone beam over the scanner in the diagnosis of conductive hearing loss
timeFrame: Files analysed retrospectively from January 01, 2018 to December 31, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Radiologie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02787902: Weight Management in Mothers and Adult Daughters
Official title: Improving Communication and Collaboration for Weight Management in Mother-daughter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obese
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims.

Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from Mexican-American mother-daughter dyads. The adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors.

Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter dyads. Dyads will be randomly assigned to partner-based treatment with or without communication skills training.

Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.


Eligibility criteria: Inclusion Criteria:

* Female
* Body mass index of 25-50 kg/m2
* Mexican or Mexican-American

Exclusion Criteria:

* Pregnancy or plans to become pregnant in the next year
* 5% weight loss in the last 3 months
* History of bariatric surgery
* Serious medical condition or psychological disorder

Primary outcomes:
measure: Weight change
timeFrame: 16 weeks
Secondary outcomes:
measure: Anthropometrics
timeFrame: baseline and post-intervention (16 weeks)
measure: Blood pressure
timeFrame: baseline and post-intervention (16 weeks)
measure: Communication
timeFrame: baseline and post-intervention (16 weeks)
measure: Relationship factors (dyad, family, social networks)
timeFrame: baseline and post-intervention (16 weeks)
measure: Psychosocial factors
timeFrame: baseline and post-intervention (16 weeks)
measure: Eating behavior
timeFrame: baseline and post-intervention (16 weeks)
measure: Physical activity
timeFrame: baseline and post-intervention (16 weeks)
measure: Weight control behavior
timeFrame: baseline and post-intervention (16 weeks)
measure: Treatment attendance and adherence
timeFrame: between baseline and post-intervention (16 weeks)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
References:
Clinical trial NCT06916702: A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men
Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* Body Mass Index (BMI) of 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Further exclusion criteria apply

Primary outcomes:
measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
timeFrame: Up to Day 54
Secondary outcomes:
measure: Area under the concentration-time curve of BI 3031185 in plasma at steady state over a uniform dosing interval τ ((AUC) τ,ss )
timeFrame: Up to Day 42
measure: Maximum measured concentration of BI 3031185 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
timeFrame: Up to Day 42
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
References:
Clinical trial NCT05870202: Treatment Burden Screening Questionnaire Pilot Study
Official title: Optimizing Diabetes Care Quality for Low-Income Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
treatment burden
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Hennepin Health Care
First posted: 2023-05-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with type 2 diabetes receiving care in a safety-net primary care clinic.

Brief summary: The main objective of this study is to develop and evaluate a clinic-based pilot intervention to optimize patient-centered diabetes care for low income patients at risk for low quality diabetes care and poor outcomes.

Detailed description: Single arm trial of a brief screening tool to identify areas of treatment burden in patients with diabetes, which will then be used as a tool in a primary care clinician visit discussion. We will assess (primary outcome) the acceptability and feasibility of 1. recruitment and retention processes; 2. screening tool usability; and (secondary outcomes) 3. outcome assessments. Data will include systematic tracking of recruitment and retention efforts, baseline and follow-up participant data, post-visit surveys of clinicians and participants, and patient participant qualitative interviews.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older, a diagnosis of T2DM, receiving primary care in a participating clinic, and having an in-person clinic visit with a participating trained clinician.

Exclusion Criteria:

* Cognitive impairment, residing in a nursing home, and pregnancy (to avoid recruiting patients with gestational diabetes).

Primary outcomes:
measure: Feasibility of the clinical trial
timeFrame: Baseline to 6 month follow up
measure: Acceptability
timeFrame: Baseline to 6 month follow up
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Baseline and 6 month follow up
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Community University Health Center
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin Health Care - Whittier Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT05735002: Promoting Early Diagnosis of Chronic Mesenteric Ischemia
Official title: PRomoting Early Diagnosis Of Chronic Mesenteric ISchEmia by a Mesenteric Artery Calcium Score Based Risk Stratification and Detection of Postprandial Mucosal Ischemia by Butyrate Breath Testing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Mesenteric Ischemia
Keywords: breath test, chronic mesenteric ischemie, calcium scoring
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with suspicion of CMI

Brief summary: CMI is an incapacitating disease and timely diagnosis remains problematic. Despite the substantial compensatory capacity of the mesenteric circulation CMI is relatively common, its incidence being comparable to other well-known diseases like Crohn's disease.

Diagnostic tools are needed for two purposes since the exclusion of CMI currently requires a cumbersome complication-prone diagnostic workup and since a definitive diagnosis is mainly established per exclusionem. First, a sensitive test is desirable to rule out CMI and avoid excessive diagnostic investigations. Quantification of mesenteric arterial calcification on computed tomography (CT) seems suitable for this purpose, synonymous with the coronary artery calcium score. Second, a specific test is required confirming CMI by detection of mucosal ischemia during a meal, when oxygen demand peaks. A breath test, based on the requirement of oxygen to absorb and metabolize 13C-butyrate in the enterocyte, could detect mucosal ischemia

Objective: Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by butyrate breath testing

Study design: Multicentre prospective cohort studies.


Eligibility criteria: Inclusion Criteria:

* Patients with a clinical suspicion of CMI referred to to Maagdarm Ischemie Centrum Rotterdam (MICR).
* Patients ≥ 18 years

Exclusion Criteria:

* Patients who are unable to give informed consent
* Patients with previous mesenteric artery revascularization
* No available CT imaging and contraindications for CT imaging (e.g. pregnancy)
* Common origin of the celiac artery and superior mesenteric artery
* Known delayed gastric emptying
* Known and untreated small intestinal bacterial overgrowth

Primary outcomes:
measure: Breath test
timeFrame: 2023-2025
measure: calcium scores
timeFrame: 2023-2035
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06256302: Transverses Abdominis Plane Block Versus Local Wound Infiltration in Total Abdominal Hysterectomy
Official title: Transverses Abdominis Plane Block Versus Local Wound Infiltration for Postoperative Pain Management in Patients Undergoing Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the transverses abdominis plane block outcome versus local wound infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Age range 18 to 50 years
* Female
* ASA I \& II
* Undergoing Abdominal Hysterectomy under General anaesthesia

Exclusion Criteria:

* Hepatic failure (assessed on clinical signs and symptoms, elevated liver enzymes and ultrasound findings showing loss of normal texture of liver) or renal failure (a GFR of 15 or less)
* Allergy or contraindication to study drugs on history
* Drug abuse or addiction
* Bleeding tendency

Primary outcomes:
measure: Pain score
timeFrame: 24 hours of surgery.
Secondary outcomes:
measure: Analgesia consumption
timeFrame: During 24 hours of surgery
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Muhammad Arif
state: Sindh
Study officials:
affiliation: Ziauddin University
name: Muhammad Arif
role: PRINCIPAL_INVESTIGATOR
References: