louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04451512: Comparison of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.
Official title: A Prospective Observational Study of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Polyps/Colonoscopy/Colorectal Neoplasms
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study.

Brief summary: Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study, signed by endoscopic treatment written informed consent for surgery, patients with detailed tracking and record the basic information and information related to the operation, postoperative lack of region and edge endoscopic observation carefully no residue, additional excision may be took if necessary，after resection specimen inspection, and in 6 months review colonoscopy, assess whether there is residual or recurrence of polyps.Main outcome: technical success rate (no other auxiliary resection), complete resection rate, secondary outcome: intraoperative and postoperative complications, polypectomy time and related costs, influential factors of incomplete resection.Research significance: The effectiveness, safety and cost-effectiveness of cold and hot snare resection of 10-19mm colorectal polyps were compared, and the influencing factors of incomplete polyps resection were analyzed, so as to provide evidence for the decision on the best method of medium-size polyps resection.


Eligibility criteria: Inclusion Criteria:

1. colorectal polyps sized 10≤ diameter ≤19 mm;
2. Boston bowel prepare score: 5-9;
3. The patients all signed the informed consent of endoscopic treatment.

Exclusion Criteria:

1. Complicated with inflammatory bowel disease, P-J syndrome or familial polyposis;
2. Complicated with malignant tumors;
3. polyp size is uncertain;
4. Currently taking aspirin, warfarin or other anticoagulants.

Primary outcomes:
measure: Technical success rate
timeFrame: 2020.07.31
measure: Complete resection rate
timeFrame: 2021.01.31
Secondary outcomes:
measure: Intraoperative and postoperative complications
timeFrame: 2021.01.31
measure: Polypectomy time
timeFrame: 2021.01.31
measure: related costs of treatment
timeFrame: 2021.01.31
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The second affiliated hospital of xi'an jiaotong university
state: Shaanxi
Study officials:
References:
Clinical trial NCT06919146: After-school Game-Based Physical Activity Program Improves Physical Fitness of 9-10-Year-Old Children
Official title: A 12-week Afterschool Game-Based Physical Activity Program Improves Physical Fitness of 9-10-Year-Old Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Game
Physical activity
Afterschool program
Physical fitness
Lead sponsor: Eskisehir Technical University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 130
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a parallel-group, a simple randomized controlled trial
Primary purpose: OTHER

Brief summary: This study investigates the effect of an afterschool game-based physical activity program (AGPAP) on children's PF. This study was randomized controlled trial involving 120 children from a state school in Eskisehir/Turkey. The CONSORT checklist was used in this study. The sample of 9-10 years children (n = 120) was divided into groups by randomization. The intervention consisted of AGPAP. For PF, handgrip strength, curl-ups, sit-and-reach, standing long jump, and 10-meter running speed tests were applied.


Eligibility criteria: Inclusion Criteria:

1. being 9-10-year-old,
2. volunteering,
3. permission from the child's parents,
4. not having any amputations or permanent disabilities in their bodies,
5. not having chronic or acute diseases,
6. not using a support device.

Exclusion Criteria:

1. any discomfort during measurements,
2. the child does not want to participate in the measurement,
3. the child does not participate in the practices due to any disability or discomfort,
4. not reaching 80% participation in the program.

Primary outcomes:
measure: Body Mass Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Handgrip strength test
timeFrame: 12 weeks
measure: Standing long jump test
timeFrame: 12 weeks
measure: Curl-ups test
timeFrame: 12 weeks
measure: The sit and reach test
timeFrame: 12 weeks
measure: 10-meter running speed test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Odunpazari
country: Turkey
facility: Eskisehir Tecnical University
state: Eski̇şehi̇r
Study officials:
affiliation: ESKISEHIR TECNICAL UNIVERSITY
name: ELVİN ONARICI GÜNGÖR, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05811546: Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric Carcinoma
Official title: Immunohistochemical Evaluation of DNA Methylation and Histone Modification in H. Pylori Associated Gastric Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Formalin-fixed-paraffin-embedded tissue blocks from resected specimens and endoscopic guided biopsies of intestinal type gastric carcinoma, H. Pylori associated gastritis, and non-H. Pylori gastritis.

Brief summary: The goal of this cross-sectional study is to evaluate epigenetic modifications in gastric carcinogenesis, mainly in H. pylori gastritis vs gastric carcinoma. The main question\[s\] it aims to answer are:

* How does H. pylori infection cause gastric cancer?
* Can DNA methylation and other epigenetic changes predict and affect the development of gastric cancer? Formalin-fixed-paraffin-embedded tissue specimens will be obtained and reviewed for comparison between epigenetic changes in H. pylori gastritis and gastric adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Resected specimens and endoscopic guided biopsies of intestinal type gastric carcinoma, H. Pylori associated gastritis, and non-H. Pylori gastritis with:
* Available full clinical data: (age, sex, complaint, findings in clinical examination).
* Full data of previous endoscopy and radiology.

Exclusion Criteria:

* Cases of diffuse type gastric carcinoma.
* Any case of gastric cancer, H. Pylori associated gastritis, non-H. Pylori gastritis, benign gastric lesions with missing clinical, endoscopic, radiologic or follow-up data.
* Cases with no available H\&E stained slides or formalin fixed paraffin embedded block.

Primary outcomes:
measure: Difference in DNMT1 and EZH2 expression.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT06878846: The Relationship of Critical Shoulder Angle With Proprioception and Disability
Official title: The Relationship of Critical Shoulder Angle With Proprioception and Disability in Patients With Subacromial Impingement
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rotator Cuff Impingement Syndrome
Shoulder Impingement Syndrome
Subacromial Impingement Syndrome
Keywords: shoulder joint
critical shoulder angle
proprioception
disability
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2025-03-17
Enrollment: 58
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paitents with Level I-II Subacromial Impingement Syndrome

Brief summary: With this study it will determined that the effect of critical shoulder angle which will be obtained from the MRI images of patients with Subacromial Impingement Syndrome on proprioception and disability level.

Detailed description: Critical shoulder angle (CSA) is defined as the intersection angle between two lines which are drawn from inferior border of glenoid cavity to superior border of glenoid cavity and from inferior border of glenoid cavity to inferolateral border of acromion. Higher CSA is accepted a predisposing factor for degenerative shoulder diseases. Increase in CSA means more shear forces reflects on shoulder joint which also causes overload on the RC tendon. Increase of degeneration in shoulder joint may cause decreased proprioception. As a result of degeneration, the level of disability will be increased. At the end of this study, the relationship among critical shoulder angle, proprioception and disability could be more clearly interpreted.

Eligibility criteria: Inclusion Criteria:

* Being between 25-70 years of age.
* Being Level I-II Subacromial Impingement
* Having shoulder pain for 3 months.

Exclusion Criteria:

* Having a shoulder operation before.
* Having Cardiovascular, Rheumatological or Neurological Disease
* Having Cervical Spine Disease
* Having Physiotherapy Treatment in last 6 months.
* Having a trauma, fracture, total Rotator Cuff rupture, Frozen Shoulder on shoulder joint

Primary outcomes:
measure: Critical Shoulder Angle
timeFrame: Baseline (The evaluation will be conducted only once)
Secondary outcomes:
measure: Shoulder Proprioception
timeFrame: Baseline (The evaluation will be conducted only once)
measure: Disability
timeFrame: Baseline (The evaluation will be conducted only once)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim University
state: Cankaya
Study officials:
References:
Clinical trial NCT05667246: Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine
Official title: Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Terbinafine Adverse Reaction
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.

Detailed description: Terbinafine is a common oral medication used for moderate to severe nail onychomycosis. On the terbinafine package insert, it states that terbinafine can reduce clearance of caffeine by 19%. However, the clinical effects of this finding in patients have yet to really be studied. Decreased clearance of caffeine can physically present with measurable signs such as an increased blood pressure or increased heart rate, as well as less measurable symptoms of GI upset, irritability, headache, insomnia. As a result, dermatologists do not always know how to counsel patients taking terbinafine on their caffeine intake. Hence, recommendations vary as no studies have been done on whether caffeine consumption while taking terbinafine is associated with clinical outcomes, such as measurable changes in blood pressure or heart rate.

This will be a preliminary single-blind randomized control clinical study. Patients being started on oral terbinafine by video visit will be approached for enrollment in the study. Patients will be provided with the baseline survey, to assess demographic information, BMI, and daily caffeine intake. Patients with a history of hypertension and anxiety will not be enrolled per the exclusion criteria. If the patient's blood pressure or heart rate are abnormal, they will be removed from the study

We hypothesize that there would be significant changes in blood pressure or heart rate in patients consuming caffeine while taking terbinafine.

Eligibility criteria: Inclusion Criteria:

* Patient of any gender at least 18 years of age
* Diagnosed with onychomycosis
* Planning to start oral terbinafine

Exclusion Criteria:

* Pregnant or breastfeeding
* Any history of anxiety or hypertension
* Any patient with an inability to give consent

Primary outcomes:
measure: Change in Blood Pressure
timeFrame: Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
measure: Change in Heart Rate
timeFrame: Baseline, 30 min after consuming caffeine, 60 minutes after consuming caffeine
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Shari Lipner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06668246: Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS)
Official title: Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Refractive Errors
Ametropia
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 41
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6 to 16 years old patients followed in the Brest University Hospital Center, in France, between the 1st of November 2022 and the 30th of April 2023 and requiring a cycloplegic refraction not presenting an exclusion criteria

Brief summary: This study aimed to compare refractive measurements using Vision-S™ 700, an immersive and compact phoropter with a tunable-focus lens, and Vision-R™ 800, a phoropter with a tunable-focus lens without immersion, with cycloplegic refraction serving as the gold-standard.

This a retrospective study aimed to enroll 41 children, aged 6 to 16 years, who underwent refractive assessments with Vision-S™ 700, Vision-R™ 800, and cycloplegic refraction. The primary objective involves a comparison of the spherical equivalent between both devices and compared to cycloplegic refraction. Secondary outcomes include the analysis of astigmatism components (J0° and J45°) and subgroup analyses in myopic and hyperopic children.


Eligibility criteria: Inclusion Criteria:

* 6 to 16 years old patients followed in the Brest University Hospital Center, in France, between the 1st of November 2022 and the 30th of April 2023 and requiring a cycloplegic refraction not presenting an exclusion criteria

Exclusion Criteria:

* age below 6 years or above 16 years
* presence of other ophthalmological pathologies rather than ametropia
* non-French language proficiency, and absence of parental authorization

Primary outcomes:
measure: Spherical equivalent
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT00618046: Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizures
Epilepsy
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess bioequivalence of a potential generic 600 mb oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose, administered with food.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with any known enzyme altering drugs.
* History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two Period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetics Clinical Applications, Inc .
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Dennis Morrison, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00902746: Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis
Official title: Phase3, Open-Label, Long-Term, NSAID-Add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea Associated With Endometriosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.


Eligibility criteria: Inclusion Criteria:

* Dysmenorrhea associated with endometriosis

Exclusion Criteria:

* Severe hepatopathy
* Pregnant woman

Primary outcomes:
measure: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)
timeFrame: 52 weeks
Secondary outcomes:
measure: Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nissay Hospital,Osaka,Japan
name: Naoki Terakawa, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03983746: Effect of Core Stability Exercises and Treadmill Training on Balance in Children With Down Syndrome
Official title: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Introduction: Core stability exercises and treadmill training play a crucial role in physical therapy interventions and have an effect on balance in children with Down syndromes (DS), whether core stability exercises or treadmill training has more effect on improve balance has not been investigated yet. The aim of the study was to investigate the effect of core stability training versus treadmill exercises on balance in children with Down syndrome. Methods: Forty-five children with Down syndrome included in the study. The children aged 4-6 years, and they were equally divided randomly into three groups (A), (B) and (C). Group A received traditional physical therapy intervention strategies to facilitate the balance of participated children. Group (B) received same as the group (A), with additional core stability exercises training. Group (C) received same intervention strategies as group (A) in conjunction with a treadmill exercise program. The children's balance was evaluated using the Berg Balance Scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice a week, for eight consecutive weeks.


Eligibility criteria: Inclusion Criteria:

* Able to recognize commands given to them,
* Able to understand our verbal command and encouragement, and
* Able to stand and walk independently without repeated falling

Exclusion Criteria:

* Any neurological or musculoskeletal disorders (signs of epilepsy and instability of atlantoaxial joint),
* Any mobility disorders
* Any cardiac anomalies
* Any vision or hearing loss

Primary outcomes:
measure: Functional Balance
timeFrame: 30 minutes
measure: Overall Stability Index
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Cairo
Study officials:
References:
Clinical trial NCT03335046: Home Visits to Optimize Medical and Educational Success Among Sacramento Schoolchildren With Asthma
Official title: Project HOMES: Home Visits to Optimize Medical and Educational Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Chronic School Absenteeism
Keywords: Home Visit
School Absenteeism
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 11
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized wait-list control trial. Participants will be randomized to the intervention or control arm for the study observation period. At the conclusion of the observation period, the control group will receive the intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will establish a multi-disciplinary home visitation team consisting of a medical provider and school teacher or staff member, and will evaluate whether a series of visits from this team will help decrease school absenteeism among children with asthma.


Eligibility criteria: Inclusion Criteria:

* Students in elementary school (K-6) in the Sacramento City Unified School District
* Identified as at risk for chronic absenteeism based on previous year and/or first 8 weeks of school year
* Have a current diagnosis of asthma

Exclusion Criteria:

* Underlying chronic conditions such as cystic fibrosis, chronic lung disease with oxygen dependence, immunodeficiency syndromes

Primary outcomes:
measure: Missed School Days
timeFrame: One academic year
Secondary outcomes:
measure: Healthcare Utilization
timeFrame: One academic year
measure: Asthma Symptom Report
timeFrame: One academic year
measure: Asthma Control Test
timeFrame: One academic year
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
References: