louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06662487: The Effect of Free Weight Resistance Training and Body Composition on Cognition
Official title: The Effect of Free Weight Resistance Training and Body Composition on Cognitive Function Explored Through Eye Tracking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Lead sponsor: Pontificia Universidad Catolica de Valparaiso
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study, titled The Effect of Free Weight Resistance Training (FWRT) on Cognitive Function Explored through Eye Tracking, will be a randomized double-blind clinical trial aimed at evaluating how FWRT influences cognitive processing in healthy young adults. Eye-tracking technology will be used to measure reading metrics and DXA scans will be used to measure body composition before and after a 10-week FWRT intervention.

Participants will be randomly assigned to either an experimental group, which will undergo a 10-week FWRT program, or a control group. This study will provide insights into the potential benefits of free weight resistance training on the cognitive performance of text processing tasks.


Eligibility criteria: Inclusion Criteria:

* University students between the ages of 18 and 30.
* Healthy individuals with no recent participation (last six months) in physical training programs.
* Normal or corrected-to-normal vision.

Exclusion Criteria:

* Physical or health limitations that prevent participation in a resistance training program.
* Current involvement in other physical training programs.
* Visual impairments that cannot be corrected with glasses or contact lenses.

Primary outcomes:
measure: Cognitive Measures (Eye-Tracking Metrics)
timeFrame: Up to 10 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Valparaiso
country: Chile
facility: Pontificia Universidad Católica de Valparaíso,
Study officials:
References:
Clinical trial NCT06949787: To Compare Sweeping of Membranes Versus Expectant Management for Spontaneous Onset of Labor and Vaginal Delivery.
Official title: Comparison of Spontaneous Onset of Labor and Vaginal Delivery in Post-date Primigravida Undergoing Sweeping of Membranes Versus Expectant Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-Term Pregnancy
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is planned to fill the gaps regarding the effectiveness of sweeping of membranes versus expectant management in terms of spontaneous onset of labor and vaginal delivery in post-date primigravida.

Detailed description: This study is important as it provides localized data on the effectiveness and practicality of membrane sweeping in a low-resource setting, which is underrepresented in current literature. Potential benefits of this research may include reduced need for formal labor induction, lower healthcare costs, and improved maternal and neonatal outcomes. The findings may enhance clinical practices by offering an evidence-based, patient-friendly approach to managing postdate pregnancies, particularly in resource-limited settings where induction facilities are constrained.

Eligibility criteria: Inclusion Criteria:

* Primigravid women
* Aged between 18 and 40 years
* Gestational age ≥40 weeks, confirmed by ultrasound or early dating scan
* Singleton pregnancies
* Cephalic presentation

Exclusion Criteria:

* Multiple gestations
* Fetal distress or anomalies detected on ultrasound
* Contraindications to vaginal delivery (e.g., placenta previa, previous uterine surgery)
* Previous uterine scar

Primary outcomes:
measure: Spontaneous onset of labor and vaginal delivery
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Attock
country: Pakistan
facility: Combined Military Hospital
state: Punjab
Study officials:
affiliation: Combined military hospital, Attock, Pakistan
name: Aisha Ashraf
role: PRINCIPAL_INVESTIGATOR
affiliation: Combined military hospital, Attock, Pakistan
name: Tahir Ashraf, FCPS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02050087: The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair
Official title: The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Rupture
Keywords: Rotator cuff
Rehabilitation
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.

Detailed description: Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.

Eligibility criteria: Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -

Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.

Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration \>grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.

-

Primary outcomes:
measure: We define Western Ontario Rotator Cuff (WORC) index at 12 months after surgery as the primary endpoint
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diaconal Hospital
Study officials:
affiliation: Lovisenberg Diaconal Hospital, Oslo, Norway
name: Sigbjørn Dimmen, MD, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT02337387: A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
Official title: A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 28
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause.

This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.


Eligibility criteria: Inclusion Criteria:

* Part A: Overtly healthy postmenopausal (PMP) females
* Part B: PMP women who are currently taking oral bisphosphonates for prevention or treatment of osteoporosis
* Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m\^2)

Exclusion Criteria:

* Have known allergies to blosozumab, its constituents, or related compounds
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* History of breast carcinoma
* Fracture of a long bone within 1 year of screening
* Have used teriparatide within 3 years prior to screening

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 85
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
timeFrame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
measure: Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B
timeFrame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B
timeFrame: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance
state: Florida
city: Evansville
country: United States
facility: Covance Clinical Research Inc
state: Indiana
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02937987: Dietary Intake, Eating Behavior, Physical Activity Level and Their Relationships With Glycemic and Weight Control in Hong Kong Chinese Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus in Obese
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hong Kong Chinese T2DM patients referred to the Prince of Wales Hospital (PWH) diabetes centre

Brief summary: The objective of this study is to describe and examine the dietary intake, eating behavior and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association with weight and glycemic control at baseline and 1 year follow-up. The investigators hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern and low physical activity level are associated with poorer glycemic and weight control, and there will be no improvement with weight and glycemic control under usual care after 1 year.


Eligibility criteria: Inclusion Criteria:

1. Male or female of Chinese ethnicity
2. Diagnosis of T2DM
3. Able to read Chinese and give informed written consents

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. End-stage renal failure requiring dialysis or chronic kidney disease (CKD) stage 4 or above
3. Malignancy diagnosed within 3 years
4. Pregnancy or lactation
5. Any medical illness or condition as judged by the investigators as ineligible to participate the study

Primary outcomes:
measure: Change of HbA1c
timeFrame: 1 year
measure: Change of Weight
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01450787: Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics
Official title: Prevalence of Dry Eyes in Diabetics Compared to Non Diabetics
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dry Eyes
Keywords: dry eyes
diabetes
Lead sponsor: COA Research Foundation, INC
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-10-12
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Existing clinic population from our practice

Brief summary: The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This might help identify a group of patients at greater risk for dry eye complications. Diabetics have been shown to have poor ocular surface healing and might benefit from dry eye therapy earlier if they are shown to be at greater risk for dry eyes.

Detailed description: Dry eye disease is one of the most common eye problems seen in ophthalmology. Diabetics are at high risk for multiple eye problems, including retinopathy and glaucoma. They also have been shown to have poor ocular surface healing. I would like to evaluate the prevalence of dry eye disease in diabetics to see if they are also at greater risk for the known complications of dry eye disease. If so, they might benefit from early intervention.

Eligibility criteria: Inclusion Criteria:

* 50 patients with diabetes, 25 without diabetes over the age of 40

Exclusion Criteria:

* current use of glaucoma drops or currently within the postoperative period from eye surgery

Primary outcomes:
measure: Conjunctival Staining Score
timeFrame: at the time of the evaluation
Secondary outcomes:
measure: Tear Film Osmolarity
timeFrame: at the time of the exam
Other outcomes:
measure: OSDI Score
timeFrame: at the time of the exam
measure: Schirmer Score
timeFrame: at the time of the exam
measure: Tear Break-up Time
timeFrame: at the time of the exam
measure: Corneal Staining
timeFrame: at the time of the exam
Locations:
city: Columbus
country: United States
facility: Columbus Ophthalmalogy Associates
state: Ohio
Study officials:
affiliation: COA Research Foundation
name: Kenneth A Beckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00196287: Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Female Patients
Official title: Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Female Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Assessment, risk
autonomic nervous system
Gender
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study was to investigate differences in risk prediction in female post-infarction patients.


Eligibility criteria: Inclusion Criteria:

acute myocardial infarction; female gender

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: 1. Medizinische Klinik, Klinikum rechts der Isar
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Georg Schmidt, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Petra Barthel, MD
role: STUDY_DIRECTOR
affiliation: Deutsches Herzzentrum Muenchen
name: Axel Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schomig A. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999 Apr 24;353(9162):1390-6. doi: 10.1016/S0140-6736(98)08428-1.
citation: Barthel P, Schneider R, Bauer A, Ulm K, Schmitt C, Schomig A, Schmidt G. Risk stratification after acute myocardial infarction by heart rate turbulence. Circulation. 2003 Sep 9;108(10):1221-6. doi: 10.1161/01.CIR.0000088783.34082.89. Epub 2003 Aug 25.
citation: Makikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Schmidt G, Huikuri HV. Prediction of sudden cardiac death after acute myocardial infarction: role of Holter monitoring in the modern treatment era. Eur Heart J. 2005 Apr;26(8):762-9. doi: 10.1093/eurheartj/ehi188. Epub 2005 Mar 18.
citation: Bauer A, Guzik P, Barthel P, Schneider R, Ulm K, Watanabe MA, Schmidt G. Reduced prognostic power of ventricular late potentials in post-infarction patients of the reperfusion era. Eur Heart J. 2005 Apr;26(8):755-61. doi: 10.1093/eurheartj/ehi101. Epub 2005 Jan 26.
Clinical trial NCT03062787: Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee
Official title: Early Effect of Cingal® Compared to Monovisc® in Patients With Osteoarthritis of the Knee (EEFFEK Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Pharmascience Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of Cingal® (study arm) with a single injection of Monovisc® (control arm).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years of age
* Diagnosed with osteoarthritis of the knee
* Candidate for an intra-articular injection (single joint, unilateral) of Monovisc® or Cingal® as part of their routine clinical care and in accordance with the locally approved label

Exclusion Criteria:

* Previous intra-articular injection within the last 6 months from enrolment
* Known hypersensitivity to cortico-steroids, hyaluronic acid or any component of Cingal® or Monovisc®
* Infectious, traumatic or neoplasic component of knee pathology
* Surgery of the knee within the last 6 months or scheduled surgery in the next two months from enrolment
* Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned.
* Patients with known bleeding disorders
* Patient currently treated with oral steroids or opioids
* Patients that, in the investigators' opinion, are unlikely to comply with protocol
* Pregnant or nursing women or women who suspect they might be pregnant.

Primary outcomes:
measure: Compare the local pain reduction after a single injection of Cingal® or Monovisc® over a 6 weeks period in patients with osteoarthritis of the knee assessed with the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 6 weeks post injection
Secondary outcomes:
measure: Compare the maximum pain reduction by treatment arm
timeFrame: 6 weeks post injection
measure: Compare the time to maximum pain reduction by treatment arm
timeFrame: 6 weeks post injection
measure: Change in stiffness and physical function
timeFrame: 6 weeks post injection
measure: Overall change of WOMAC score
timeFrame: 6 weeks post injection
measure: Time to maximum WOMAC score reduction
timeFrame: 6 weeks post injection
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Site 04
state: Ontario
city: Hamilton
country: Canada
facility: Site 03
state: Ontario
city: Kanata
country: Canada
facility: Site 02
state: Ontario
city: Laval
country: Canada
facility: Site 05
state: Quebec
city: Quebec City
country: Canada
facility: Site 01
state: Quebec
Study officials:
affiliation: McMaster University
name: Mohit Bhandari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06048887: Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers
Official title: A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Crinetics Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.


Eligibility criteria: Inclusion Criteria:

* Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study
* Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential
* ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening

Exclusion Criteria:

* Use of topical, nasal, inhaled, or oral corticosteroids.
* Use of any investigational drug within the past 60 days.
* Have a medically significant illness within 30 days prior to screening.
* Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.
* Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
* Unstable psychological disorder ≤1 year prior to Screening.

Primary outcomes:
measure: Percentage of subjects with treatment-emergent adverse events
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20
measure: Proportion of participants with a clinically significant safety laboratory observation
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20
Secondary outcomes:
measure: Pharmacokinetics (AUC)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20
measure: Pharmacokinetics (Cmax)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20
measure: Pharmacokinetics (Tmax)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20
measure: Pharmacokinetics (T1/2)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20
Other outcomes:
measure: Change in ACTH-stimulated serum cortisol
timeFrame: Part 1 - Day 1; Part 2 - Day 10
measure: Change in serum cortisol
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20
Locations:
city: Miami
country: United States
facility: QPS-Miami Research Associates
state: Florida
Study officials:
References: