louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06360016: Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs
Official title: Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Regulation
Impulsive
Attention Difficulties
Emotion Regulation
Keywords: self regulation
recreational activities
preschoolers
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: University of Malaga
First posted: 2024-04-11
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pre and post-test with the control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants.

Detailed description: The study titled "Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs" focuses on the influence of structured recreational activities on the development of self-regulation skills among preschool children. Self-regulation is a crucial ability, facilitating children's academic performance, social behaviors, and emotional well-being.

RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants.

Eligibility criteria: Inclusion Criteria: Attending at least 22 sessions -

Exclusion Criteria:

-

Primary outcomes:
measure: Self-Regulation Assessment
timeFrame: Pre-post test (before implemention and up to 24 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: Özlem Yalçın Kişi, Student
role: STUDY_CHAIR
References:
Clinical trial NCT05798416: Effect of Inhalation of Low Dose CO2 on Exercise Performance at High Altitude
Official title: Effect of Supplement of CO2 Using Novel Portable Device on Exercise Performance at High Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Altitude
Inhalation; Gas
Acute Mountain Sickness
Keywords: High altitude
Exercise performance
CO2 inhalation
Lead sponsor: State Key Laboratory of Respiratory Disease
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High altitude (\>2400 m) is associated with decreased atmosphere pressure leading to hypoxia which in turn impairs exercise capacity and causes acute mountain sickness (AMS). It is noted that adding CO2 might be beneficial to improve hypoxia and exercise performance at high altitude. However, no device is currently available that can supply a constant low dose of CO2 during free movement at high altitude. We have recently invented a portable device which is small and light enough for supplement of low dose CO2 during field exercise at high altitude.

Detailed description: Objective: To determine whether the supplement of low-dose CO2 by the novel device could improve exercise performance at high altitude.

Methods: The lowlanders (\<500m) who have no history of travelling to high altitude (\>1000m) a year before the study will be recruited. And the subjects who are high-altitude residents and have not left high altitude over the last twelve months will also be recruited for the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during endurance shuttle walking test (ESWT). Blood gases will be measured before and after inhalation of CO2. ESWT time, ventilation per minute (VE), blood oxygen saturation (SPO2), and end-tidal CO2 concentration (ETCO2) will be measured during exercise and will be compared during inhalation of CO2 and during inhalation of ambient air.

Eligibility criteria: Inclusion Criteria:

1. Healthy lowlanders (\<500m) who have no history to travel to high altitude (\>1000m) a year before the study.
2. Healthy high altitude (4500m) residents who have not left the inhabited area over the last twelve months before the study.

Exclusion Criteria:

1. Subjects with cardiovascular diseases, respiratory diseases and neuromuscular diseases which could affect exercise.

Primary outcomes:
measure: Change of the distance in walking test
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The Affiliated Hospital og Guangzhou Medical University
name: Yuanming Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05996016: Gut and Vaginal Microbiota Profile Study for HIV Women
Official title: A Cohort Study Among HIV Infected Women：Exploring the Regulatory Mechanism of Gut and Vaginal Microbiota in HPV Infection and Cervical Lesion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV
HIV Infections
Vaginal Microbiota
Keywords: HPV
Women With HPV infection
vaginal microbiota
gut microbiota
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 400
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with HIV Infection from 6 HIV care centers across CHINA, including Beijing, Zhejiang, Guangxi, Yunan, Shanxi and Shandong.

Brief summary: Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually contributes to variable cervical lesions. we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.

Detailed description: Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually contributes to variable cervical lesions. Besides the HPV co-infection, microbiota study recently reveals that the changes of vaginal bacteria spectrum might also be related with cervical disease in WLHIV. However, data on HPV prevalence in WLHIV and its associated cervical lesion incidence is still limited in China. Moreover, the causal relationship between vaginal microbiota and cervical lesion in WLHIV is not clear. Here, we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.

Eligibility criteria: Inclusion Criteria:

* HIV women （including pregnant）;
* sign consent paper

Exclusion Criteria:

* virgin or maiden

Primary outcomes:
measure: HPV infection incidence
timeFrame: 0, 6m, 12m, 24m, 36m
measure: cervical lesions
timeFrame: 0, 6m, 12m, 24m, 36m
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China
name: Wei Lyu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02701816: Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femoropopliteal Artery Disease
Keywords: Peripheral Artery Disease
Femoropopliteal Artery
Nitinol Stent
Restenosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Femoropopliteal artery disease

Brief summary: * Prospective, single-arm, multi-center registry study
* A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
* Patients will be followed clinically for 12 months after the procedure.
* Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.
* Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.
* Quality of life by standardized questionnaires (at baseline \& at 1 \& 12 months)


Eligibility criteria: Inclusion Criteria:

1. Age 19 years of older
2. Symptomatic peripheral artery disease:

   * Moderate or severe claudication (Rutherford category 2 or 3)
   * Critical limb ischemia (Rutherford category 4-5)
3. Femoropopliteal artery lesions with stenosis \> 50%
4. ABI \< 0.9
5. Patients with signed informed consent

Exclusion Criteria:

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
5. Bypass graft lesions
6. Age \> 85 years
7. Severe hepatic dysfunction (\> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
12. Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Primary outcomes:
measure: Primary patency rate
timeFrame: 12 months after the index procedure
Secondary outcomes:
measure: Target lesion revascularization rate
timeFrame: 12 months
measure: Stent fracture rate
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT01149616: Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Official title: Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Post Operative Pain
Nausea
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 82
Sex: ALL
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 the study is to determine the opiate sparing effects of intravenously administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with well known antiemetic effects. However, the analgesic effects of dexamethasone have not been adequately researched. Following surgery, patients are typically discharged home with PO opiates to manage post-operative pain. The investigators believe that by using VAS (Visual Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1) when compared to placebo.

Detailed description: Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing ambulatory knee arthroscopy surgery
* Must provide phone contact number and agree to phone followup on post operative day 1

Exclusion Criteria:

* Patients with major systemic disease
* Allergy or intolerance to study drug

Primary outcomes:
measure: Post Operative VAS Pain Scale
timeFrame: 24 hours
Secondary outcomes:
measure: Amount of Postop Narcotic Usage
timeFrame: 24 hours
measure: Postop Nausea
timeFrame: 24 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Lauren Fisher, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04742816: Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients
Official title: Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Sub-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transgender
Renal Function
Hormone Replacement Therapy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: iohexol
Primary purpose: DIAGNOSTIC

Brief summary: Will use a subset of the main study cohort of transgender or non-binary individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values, renal biomarkers, drug levels and directly measured renal function.

Detailed description: This cross-sectional sub-study will use a subset of the main study cohort of transgender (TG) or non-binary (NB) individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values (serum estradiol, estrone, free/total testosterone), renal biomarkers, drug levels (measured by tenofovir diphosphate, TFV-DP, and emtricitabine triphosphate, FTC-TP, on dried blood spot cards and urine) and directly measured renal function (iohexol clearance).

Eligibility criteria: Inclusion Criteria:

* HIV-uninfected
* Identifying as transgender or nonbinary (TG/NB)
* Age ≥ 18 years (adult)
* At risk of acquiring HIV
* Calculated creatinine clearance (CRCL) ≥ 60 mL/minute
* Taking emtricitabine/tenofovir alafenamide
* Willing to receive a small dose of iohexol
* Willing to provide 30 mL blood and a urine sample

Exclusion Criteria:

* Allergy to iohexol
* Use of concurrent medications that may interfere with iohexol such as metformin, amiodarone or beta-blockers
* Anuric or unable to produce 30 mL of urine
* Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives

Primary outcomes:
measure: Iohexol clearance
timeFrame: Day 1
Secondary outcomes:
measure: Blood concentration of tenofovir
timeFrame: Day 1
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego AntiViral Research Center (AVRC)
state: California
Study officials:
affiliation: UC San Diego AntiViral Research Center (AVRC)
name: Nimish Patel, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06874816: Masseter Thickness, Bruxism, and Oral Behaviors in Chronic Neck Pain
Official title: Does Your Jaw Tell the Story of Your Pain? Masseter Muscle Thickness, Bruxism, and Oral Behaviors in Chronic Non-Specific Neck Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neck Pain
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of 30 patients diagnosed with chronic non-specific neck pain and 30 healthy volunteers, aged between 18 and 65 years.

Brief summary: A total of 30 patients aged 18-65 years who present with chronic non-specific neck pain and 30 healthy volunteers will be included in the study. Patients with symptoms persisting for at least 3 months will be eligible for inclusion. Necessary information will be provided to all participants, and informed consent will be obtained.

To assess pain severity before treatment, participants will be asked to rate their complaints using the Visual Analog Scale (VAS), a linear scale for pain assessment. The Neck Disability Index will be used to determine the level of disability.

The Jaw Functional Limitation Scale-20 (JFLS-20), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15: Physical Symptoms, Generalized Anxiety Disorder-7 (GAD-7), and the Oral Behaviors Checklist-included in Axis 2 of the DC/TMD form developed for evaluating temporomandibular joint dysfunction-will be used to assess patients' psychosocial characteristics and parafunctional habits.

Additionally, masseter muscle thickness will be evaluated using ultrasonographic measurement.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with chronic non-specific neck pain
* Aged between 18-65 years
* Symptoms persisting for at least 3 months

Exclusion Criteria:

* Pregnancy
* Presence of psychiatric or neurological diseases
* Use of psychiatric medications
* Cognitive impairment
* History of neck injection or surgery within the last 6 months
* Presence of rheumatic diseases
* Spinal stenosis
* Cervical disc herniation
* Advanced degeneration detected in radiological imaging
* History of fracture or surgery in the temporomandibular joint
* Presence of inflammatory, rheumatologic diseases, or malignancy affecting the t--emporomandibular joint

Primary outcomes:
measure: Masseter Muscle Thickness
timeFrame: 0 day
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 0 day
measure: Neck Disability Index
timeFrame: 0 day
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 0 day
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 0 day
measure: Jaw Functional Limitation Scale-20 (JFLS-20)
timeFrame: 0 day
measure: Oral Behaviors Checklist
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
References:
Clinical trial NCT02779816: Adaptive Device for Insulin Pens for Arthritic Patients
Official title: Exploring the Utility of a Novel Adaptive Device for Commercially Available Insulin Pens in Patients With Arthritis or Hand Deformities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Arthritis
Keywords: Diabetes Mellitus
Arthritis
Lead sponsor: Levenson, David I., M.D.
Sponsor class: INDIV
First posted: 2016-05-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Approximately 34 subjects will be enrolled in an unblinded cross-over design. For one week, they will use the adaptive pen device and for the next week, they will use just the insulin (or other medication) pen. This will be repeated for another one week period each. At the end of each week, the subjects will fill out a questionnaire regarding their experiences and any suggestions for improvements for the design of the pen device.

Detailed description: This study is of an unblinded crossover design. Each patient will be randomly assigned to initiate a one week observation period with either the pen alone or the pen with the device. The following week, the patient will switch to the other assignment. This will be repeated one more time for a total of two weeks with the device and two weeks without it.

At the end of every week, the patients will be given a questionnaire to fill out. Questions will include a measurement of their satisfaction with their insulin (or other medication) delivery system for that week. Patients will be instructed to continue their usual dosage of medication as prescribed by their physician. If the patients have any problems with the device or feel uncomfortable with it, they are instructed to discontinue use of the device and continue using their pen as usual.

The patients may keep the device at the end of the study. The questionnaires that the patients fill out will be the primary source documents.

Eligibility criteria: Inclusion Criteria:

* Currently using a pen to administer medication at least once a week
* Currently are having some difficulty (self reported) using their pens because of dexterity issues

Exclusion Criteria:

* Woman of child-bearing age who are known to be pregnant
* People who are unable or unwilling to sign the informed consent document
* Patients who do not understand the proper use of the device after sufficient instruction
* Anyone in the Principal Investigator's judgment who cannot properly use the device

Primary outcomes:
measure: Visual analog scale for ease of use
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: East Coast Medical Associates
state: Florida
Study officials:
affiliation: East Coast Medical Associates
name: David I Levenson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03683316: Work of Breathing and Kangaroo Mother Care
Official title: The Impact of Kangaroo Mother Care on Work of Breathing Indices and Oxygen Saturation Stability in Very Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infant
Work of Breathing
Oxygen Saturation
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 29
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very low birth weight infants in the NICU who meet inclusion criteria.

Brief summary: To compare work of breathing and oxygen saturation before, during, and after kangaroo mother care in preterm very low birth weight (VLBW) infants stable on non-invasive respiratory support.


Eligibility criteria: Inclusion Criteria:

* Very low birth weight infants (those less than 1500g at birth)
* Respiratory insufficiency
* \>4d PMA
* Stable and receiving non-invasive respiratory support for ≥12 hours (NC, HFNC or CPAP)
* Requiring ≤40% supplemental FiO2

Exclusion Criteria:

* Infants with skeletal, neuromuscular or abdominal surgical disorders that may affect the accuracy of work of breathing measurements
* Infants who do not meet criteria to participate in kangaroo mother care

Primary outcomes:
measure: Change in work of breathing
timeFrame: 2 hours
Secondary outcomes:
measure: Oxygen saturation
timeFrame: 2 hours
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services, Inc
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Kelley Kovatis, MD
role: STUDY_DIRECTOR
References: