louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01639807: Clinical Evaluation of Efficacy of SLT to Topical Medication in Lowering IOP
Official title: A Prospective, Randomized, Controlled Clinical Trial Comparing Topical Medical Therapy With Selective Laser Trabeculoplasty in South Indian Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: Open Angle Glaucoma or Ocular hypertension
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2012-07-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Selective laser trabeculoplasty (SLT) and topical medications for initial treatment of open-angle glaucoma /Ocular Hypertension based on intraocular pressure reduction, treatment side effects, quality of life measures and costs in South Indian Population.

Detailed description: Selective laser trabeculoplasty (SLT), a lasering procedure, is equal to or better than using medication for lowering eye pressure,leading to a better quality of life and being less costly.

Eligibility criteria: Inclusion Criteria:

Diagnosis: POAG, PXF glaucoma, pigmentary glaucoma or mixed mechanism POAG with a narrow angle, (if laser PI \> 3 months ago) defined by standard examination criteria Adequate visualization of angle structures (i.e. clear media and cooperative patient) On no glaucoma medications OU \> 1 month On no systemic medications known to IOP (steroids) Visual acuity \> 6/24 OU Age - more than 35 yrs and less than 72 yrs

Exclusion Criteria:

A cumulative lifetime use of eye drops for glaucoma that exceeded 14 days; Used any eye drops for glaucoma in the 3 weeks before baseline I visit (washout from \< 14 days of use will be permitted); CIGTS visual field score that exceeds 16 in either eye; Evidence of ocular disease other than glaucoma that might affect the measurements of IOP, assessment of visual function, visual field testing Proliferative diabetic retinopathy Previous intraocular surgery one or both eyes except laser PI more than 3 months ago and cataract extraction with PC IOL more than 4 months ago.

Undergone ophthalmic laser (other than laser PI \> 3 months ago), refractive, conjunctival, or intraocular surgery in either eye; Would likely require cataract surgery within 6 months of randomization Current or expected use of corticosteroids

Primary outcomes:
measure: Intra Ocular Pressure
timeFrame: 24 months
Secondary outcomes:
measure: Quality of life
timeFrame: 24 months
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Aravind Eye Hospital,Madurai.
name: GEORGE V PUTHURAN, M.B.B.S, M.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Clinical trial NCT06668207: Carbohydrate Quality and Its Impact on Athletic Enjoyment and Burnout
Official title: Evaluation of the Effect of Carbohydrate Quality on Physical Activity Enjoyment and Burnout in Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athlete
Keywords: Carbohydrate quality
sport
physical activity
burnout
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 139
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample in Ankara, Turkey

Brief summary: This study aimed to evaluate the effect of carbohydrate quality on enjoyment of physical activity and burnout in athletes. Data were collected from 139 active athletes aged 19 to 35 years using a Demographic Structure Questionnaire, the Athlete Burnout Questionnaire (ABQ), and the Physical Activity Enjoyment Scale (PACES). Carbohydrate quality was assessed using food frequency data, and the results were analyzed with SPSS 24 software.

Detailed description: Objective: The aim of this study was to evaluate the effect of carbohydrate quality on enjoyment of physical activity and burnout in athletes.

Method: A total of 139 active athletes aged 19 to 35 years participated in the study. Participants completed a Demographic Structure Questionnaire, the Athlete Burnout Questionnaire (ABQ), and the Physical Activity Enjoyment Scale (PACES). To assess carbohydrate quality, food frequency data were collected, and scores were based on fiber intake, the whole-to-total grain ratio, glycemic index, and solid-to-total carbohydrate ratio, each evaluated on a scale from 1 to 5 points. The resulting scores were categorized into five quartiles, with Q5 indicating the highest and Q1 the lowest carbohydrate quality. Data were analyzed using SPSS 24 software.

Eligibility criteria: Inclusion Criteria:

* Only athletes who are actively participating in sports
* Age range of 19 to 35 years
* Voluntary participation

Exclusion Criteria:

-Individuals engaging in irregular physical activity

Primary outcomes:
measure: Evaluating carbohydrate quality
timeFrame: Basaline
Secondary outcomes:
measure: Athlete Burnout Questionnaire (ABQ)
timeFrame: Basaline
measure: Physical Activity Enjoyment Scale (PACES)
timeFrame: Basaline
measure: Sociodemographic characteristics
timeFrame: Basaline
measure: Body Mass Index (BMI)
timeFrame: Basaline
measure: Body weight
timeFrame: Basaline
measure: Height
timeFrame: Basaline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
References:
Clinical trial NCT06319807: GrowWell - Responsive Bottle Feeding
Official title: Using Digital Health Technologies to Prevent Obesity Among Infants of Parents Receiving Nutrition Assistance Benefits.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bottle Feeding
Keywords: obesity prevention
Women, Infants, and Children )WIC)
infant growth
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads.

Detailed description: Assess the feasibility and acceptability of a digital intervention aimed at increasing responsive infant feeding behaviors, beginning 1 month postpartum and continuing through 3-months postpartum, among a prospective cohort of women receiving WIC benefits.

Use qualitative methods to explore barriers and facilitators to participation in a digital infant feeding intervention among women receiving WIC benefits during early postpartum

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* as a smartphone and an email address
* willing to send and receive daily text messages
* can read and write in English
* child is \<=6 weeks

Exclusion Criteria:

* participating in in a different research study that, in the opinion of the investigator, would conflict or would otherwise be too problematic if the subject were to participate in this study
* planning to leave North Carolina in the next 6 months
* subjects who do not have the capacity to give legally effective consent
* any medical or congenital condition that would interfere with infant feeding or growth (ie, Down syndrome or cleft lip or palate)

Primary outcomes:
measure: Engagement - average text message completion rate
timeFrame: Week 12
Secondary outcomes:
measure: Satisfaction Scores - Acceptability
timeFrame: Week 12
measure: Satisfaction Scores - Frequency
timeFrame: Week 12
measure: Satisfaction Scores - Timing
timeFrame: Week 12
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Melissa C Kay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atrium Health Wake Forest Baptist
name: Sarah M Shelton, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT03129607: A Study in Postoperative Pancreatic Fistula
Official title: An Observational Retrospective Study in Postoperative Pancreatic Fistula
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: POPF
Classification system
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 300
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: Participants with diagnosed POPF

Brief summary: The International Study Group of Pancreatic Surgery (ISGPS) issued the definition and classification system of postoperative pancreatic fistula (POPF), and received widespread recognition. Currently, it has become an important reference for clinical treatment of POPF.

Detailed description: The definition of POPF released by ISGPS in 2016 still seems to have certain deficiency. For example, in both definitions in 2005 and 2016, the re-operation is used as an important judgment index of "Grade C POPF". But a unified standard or consensus is still lacked for the indication of POPF re-operation, which may finally impact the diagnosis of "Grade C POPF". Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

* Must have a diagnosis of POPF;
* Aged 18 or older;
* Of either sex.

Exclusion Criteria:

* No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial.

Primary outcomes:
measure: Pancreatic fistula
timeFrame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Secondary outcomes:
measure: Hospital stays
timeFrame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
measure: Number of hospitalizations
timeFrame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
measure: Mortality
timeFrame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Ting-Bo Liang, phD
role: STUDY_CHAIR
References:
Clinical trial NCT03539107: Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery
Official title: Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Pelvic Organ Prolapse
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.


Eligibility criteria: Inclusion Criteria:

* All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)

Exclusion Criteria:

* Patients who require prolonged Foley catheter or suprapubic catheter

Primary outcomes:
measure: Failure rate
timeFrame: Up to 2 days post op
Secondary outcomes:
measure: False pass rate
timeFrame: up to 30 days after discharge.
measure: Force of stream (FOS)
timeFrame: Up to 2 days post op.
measure: Force of stream (FOS)
timeFrame: Up to 2 days post-surgery.
measure: Patient Satisfaction Questionnaire for Voiding Assessment-method used
timeFrame: Up to 2 days post-surgery.
measure: Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions
timeFrame: Up to 2 days post-surgery.
measure: Patient Satisfaction Questionnaire for Voiding Assessment-recommend method
timeFrame: Up to 2 days post-surgery.
measure: Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method
timeFrame: Up to 2 days post-surgery.
measure: Patient Satisfaction Questionnaire for Voiding Assessment-preferred method
timeFrame: Up to 2 days post-surgery.
measure: Postoperative pain score
timeFrame: One day post-surgery.
measure: Urinary tract infection (UTI)
timeFrame: Up to 30 days post surgery.
measure: Post-operative complications
timeFrame: Up to 30 days post-surgery.
measure: Length of hospital stay
timeFrame: Up to 2 days post-surgery.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Harmanli Oz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Clinical trial NCT04662307: An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness
Official title: An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lifestyle, Sedentary
Keywords: cardiac rehabilitation
cardiorespiratory fitness
aerobic exercise
endurance training
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A small group of healthy subjects with sedentary lifestyle is recruited to validate the ICRS. They receive training with ICRS three sessions a week, for a total of 12 sessions. The outcome assessments are performed before and after the training.
Primary purpose: TREATMENT

Brief summary: Contemporary cardiopulmonary rehabilitation programs often utilize cycling ergometer, involving one-on-one heart rate monitoring by physiotherapists to ensure that patients reach the target training intensity during training sessions. However, the process is frequently described as monotonous and boring, resulting in early fatigue of therapists and patients as well as poor compliance, leading to undertraining and suboptimal outcomes.

This study aims to test the feasibility of the "Intelligent Cardiopulmonary Training System (ICRS)" and a novel indicator of measuring the adherence to training intensity. The ICRS was developed with the idea to provide machine-based supervision on the user's heart rate during training. It provides moderate-intensity continuous training with a cycling ergometer. This system automatically adjusts the paddling resistance according to the user's real-time heart rate, and helps to improve the user's adherence to pre-determined training intensity without trainer's watch. The automation of intensity adjustment has its potential for conditions in which supervision is not feasible.


Eligibility criteria: Inclusion Criteria:

1. Sedentary healthy people

Exclusion Criteria:

* Patients whose heart rate can not be used as the indicator of training intensity (eg, ar-rhythmia, atrial fibrillation, beta-blockers users)
* With any reason that the patient is not suitable to undergo
* Patients who are unable to do cycling due to musculoskeletal problems
* Patients who can not follow the instruction of trainers due to cognitive or emotional-problems.
* Patients whose medical condition is not unstable.

Primary outcomes:
measure: Peak oxygen consumption (VO2-peak)
timeFrame: 4 weeks
Secondary outcomes:
measure: Peak workload
timeFrame: 4 weeks
measure: percentage of time (%time) within the pre-determined target heart rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Department of rehabilitation, WanFang Hospital
Study officials:
affiliation: Wan-Fang Hospital, Taipei Medical University
name: Yen-Nung Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00714207: Evaluation of Adolescent Smoking Cessation Programs
Official title: Evaluation of Adolescent Smoking Cessation Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Status
Keywords: adolescents
smoking
smoking cessation
tobacco use
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Truth Initiative
First posted: 2008-07-14
Enrollment: 407
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if a school-based multi-session group smoking cessation program is more effective than a single session group program.

Detailed description: The investigators reformatted two group smoking cessation programs (the NOT program of the American Lung Association and Kicking Butts), both of which involve 50 minute sessions delivered once weekly, into a program that could be delivered during school lunch periods (25-30 minutes) twice weekly. Smoking status was subsequently assessed over the 12 month period following the intervention,

Eligibility criteria: Inclusion Criteria:

* Students who indicated they smoked cigarettes and wanted to quit

Exclusion Criteria:

* Students referred as part of a disciplinary requirement to stop smoking

Primary outcomes:
measure: Self reported quit status (Student identifies self as non-smoker and no smoking for 30 days)
timeFrame: End of program and 1, 3, 6 and 12 months later
Secondary outcomes:
measure: Salivary cotinine level
timeFrame: End of program and 1, 6 and 12 months later
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Northwestern High School
state: Maryland
city: Baltimore
country: United States
facility: Walbrook High School
state: Maryland
city: Baltimore
country: United States
facility: Patterson High School
state: Maryland
city: Baltimore
country: United States
facility: Southern High School/Digital Harbor
state: Maryland
city: Columbia
country: United States
facility: Long Reach High School
state: Maryland
city: Columbia
country: United States
facility: Hammond High School
state: Maryland
city: Ellicott City
country: United States
facility: Mount Hebron High School
state: Maryland
city: Ellicott City
country: United States
facility: Howard High School
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Alain Joffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joffe A, McNeely C, Colantuoni E, An MW, Wang W, Scharfstein D. Evaluation of school-based smoking-cessation interventions for self-described adolescent smokers. Pediatrics. 2009 Aug;124(2):e187-94. doi: 10.1542/peds.2008-2509. Epub 2009 Jul 27.
Clinical trial NCT06717607: Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL
Official title: Comparing Visual Outcomes in Matched Patients Receiving a Low Cylinder Power Toric IOL or a Non-toric IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract and IOL Surgery
Keywords: Toric IOL
Lead sponsor: Ifocus Oyeklinikk
Sponsor class: NETWORK
Collaborators: name: Alcon Research
First posted: 2024-12-05
Enrollment: 43
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if visual function is improved with implantation of a low-cylinder toric intraocular lens, relative to a non-toric intraocular lens.

Detailed description: The Clareon(R) T2 IOL and the Clareon (R) non-toric IOL will be randomly implanted in subjects determined to be appropriate for the T2 IOL. Visual acuity, low contrast acuity and contrast sensitivity will be measured 3 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* candidate for cataract surgery, suitable for implantation with a low cylinder toric IOL

Exclusion Criteria:

* pathology that would confound outcomes, previous ocular surgery

Primary outcomes:
measure: Uncorrected distance visual acuity (UDVA)
timeFrame: 3 months
Secondary outcomes:
measure: Mean refraction, spherical equivalent (MRSE)
timeFrame: 3 months
measure: Manifest refractive cylinder
timeFrame: 3 months
measure: Percentage of eyes with <= 0.25 D of refractive cylinder
timeFrame: 3 months
measure: Percentage of eyes with <= 0.50 D of refractive cylinder
timeFrame: 3 months
measure: Corrected distance visual acuity
timeFrame: 3 months
measure: Mesopic contrast sensitivity
timeFrame: 3 months
measure: Photopic contrast sensitivity
timeFrame: 3 months
measure: Low contrast visual acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Haugesund
country: Norway
facility: Ifocus øyeklinikk
Study officials:
affiliation: Ifocus Oyeklinikk
name: Kjell Gunnar Gundersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: