louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05749796: Investigation of the Relationship Between Development, Neurological Assessment and Object Permanence in High Risk Infants.
Official title: Investigation of the Relationship Between Development, Neurological Assessment and Object Permanence in High Risk Infants.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant Development
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants aged 7-16 months with risk factors

Brief summary: The aim of the study is to examine the relationship between development, neurological assessment and object permanence in risky infants aged 7-16 months. The sample of the study will consist of babies between 7-16 months at risk (preterm, low birth weight, asphyxia, hyperbillirubinemia, etc.). Inclusion criteria for the study: Between 7-16 months, having at least one risk factor. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder. Parents who agreed to participate in the study will be asked to fill out the demographic information questionnaire. Object permanence scale, Bayley III infant and toddler development scale and Hammersmith infant neurologic assessment will be applied to infants.


Eligibility criteria: Inclusion Criteria:

* Between 7-16 months, having at least one risk factor

Exclusion Criteria:

* Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder

Primary outcomes:
measure: Object Permanence Scale
timeFrame: Baseline
measure: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales
timeFrame: Baseline
measure: Hammersmith infant neurological assessment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Study officials:
References:
Clinical trial NCT03807596: Hyaluronic Acid With Scaling & Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2
Official title: Adjunctive Use Of Hyaluronic Acid With Scaling & Root Planing In Treatment of Chronic Periodontitis Patients With Diabetes Mellitus Type 2: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 38
Maximum age (years): 56
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling \& root planing (SRP) in patients with chronic periodontitis \& diabetes mellitus type 2.

Detailed description: Thirty subjects with chronic periodontitis \& diabetes mellitus type 2 were included in this randomized clinical trial. These subjects were randomly allocated into test \& control equal groups. The test group comprised fifteen patients who received SRP with subgingival application of Hyaluronic acid as an adjunct. The control group included fifteen patients who received SRP alone. Plaque index (PI), gingival index (GI), probing depth (PD) \& clinical attachment level (CAL) were measured \& documented at baseline, 6 weeks \& 12 weeks intervals.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic periodontitis and type 2 diabetes mellitus
* Minimum of 20 teeth
* Clinical attachment level (CAL) ≥ 3 mm
* Probing depth (PD) ≥ 4 mm.

Exclusion Criteria:

* Pregnant females
* Smokers

Primary outcomes:
measure: Gain in clinical attachment level
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Gihane G Madkour, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03912896: Taekwondo for Children With Autism Spectrum Disorder
Official title: Taekwondo for Children With Autism Spectrum Disorder: The Impact on Social Interaction Skills in Everyday Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: taekwondo
Autism Spectrum Disorder
occupational therapy
Social interaction skills
child participants
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 6
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study uses a mixed methods design to understand the effectiveness of using taekwondo as an intervention for children with ASD and its effect on social interaction skills and everyday life. Qualitative research emphasizes that meaning can be explained and interpreted only by those who experience it. A pretest-posttest design will be used to describe what occurs after the introduction of the taekwondo intervention and understand the changes that occur after exposure. Collecting information through the lived experiences and observations from the parents will be collated with the pre and post results of the children participants' social interaction skills.

Qualitative data will be collected through pre and post semi-structured interviews with the parents to understand their observations of their child before and after completing the taekwondo program. Interviews will also be conducted with the child to understand their perspectives on physical activity participation. Interview questions will also explore how the effectiveness of the program has impacted the children's engagement in daily activities.

Quantitative research will be collected through pre and post results from the Autism Social Skills Profile-2 (\[ASSP\] assessment that will be completed by the parents. The ASSP-2 provides a comprehensive measure of social functioning for children and adolescents with ASD.


Eligibility criteria: Inclusion Criteria:

* Formal diagnosis of autism spectrum disorder (ASD)
* Able to follow and understand English verbal instructions during the screening process.
* No experience or prior experience with martial arts.
* Able to walk and move without using adaptive equipment

Exclusion Criteria:

* Physical disabilities that would prevent participation in taekwondo (e.g. wheelchair bound)

Primary outcomes:
measure: Subject response to taekwondo
timeFrame: Change between baseline and week 7.
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma LInda University Health
state: California
Study officials:
affiliation: Loma Linda University Health
name: Julie Kugel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04323696: Comparison of Staple Line Suturing in Laparoscopic Sleeve Gastrectomy
Official title: Comparison of Staple Line Suturing Reinforcement Methods in Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Sleeve Gastrectomy
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients who underwent laparoscopic sleeve gastrectomy from March 2020 till February 2021 will be included
Primary purpose: OTHER

Brief summary: Sleeve gastrectomy (SG) involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. Recently SG is viewed as a multi-purpose bariatric procedure that restricts the stomach size to induce satiety and resects fundal ghrelin-producing cells to decrease appetite. However, the risk of staple line leak and bleeding remains one of its challenging complications. Despite the fact that there are a large number of studies assessing various methods of making the staple line secure, there is to date, no consensus on which technique is best for reducing the risk of stapler line bleeding and leak. Hence, this study aims to compare staple line suturing reinforcement methods in sleeve gastrectomy using plication and over-sewing techniques.


Eligibility criteria: Inclusion Criteria:

- Patients at our Bariatric Clinic fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic sleeve gastrectomy as primary bariatric procedure will be evaluated for possible inclusion

Exclusion Criteria:

1. Age \< 18 or \> 65
2. BMI \< 35 and \> 60 kg/m2
3. American Society of Anesthesiologists (ASA) score \> 3
4. Concurrent surgical procedure including:

   1. ventral hernia repair
   2. cholecystectomy
   3. hiatal hernia repair with posterior cruroplasty
   4. extensive lysis of adhesions
   5. other procedures that mandate addition of 'trocar(s)' or 'feeding tube'

Primary outcomes:
measure: Immediate and early post-operative complication
timeFrame: 0-30 days
Secondary outcomes:
measure: Immediate and early post-operative complication
timeFrame: 0-30 days
measure: Immediate and early post-operative complication
timeFrame: 0-30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01869296: The Effect of Endoscope Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial
Official title: The Effect of Endoscopy Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Effect of Endoscope Water Pump Flow Rates
Keywords: unsedated
water immersion colonoscopy
endoscope water pump flow rates
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the cecal intubation rate between two endoscopy water pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy examination in unsedated patients undergoing diagnostic colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Adult \> 18 years old with indication for colonoscopy, such as chronic diarrhea, chronic constipation, hematochezia, chronic lower abdominal pain, positive fecal occult blood test, and other change of bowel habit symptoms indicative of need for diagnostic colonoscopy examination

Exclusion Criteria:

* Patients refuse to participate, patient with obstructive lesion in the colon distal of the cecum, patients with experienced of colon resection, hemodynamically unstable, severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure), patients with fecal obstruction (whatever the causes) so that impossible to pass the scope through the obstructed segment.

Primary outcomes:
measure: cecal intubation rate
timeFrame: 1.5 years
Secondary outcomes:
measure: Cecal intubation time
timeFrame: 1.5 years
measure: Abdominal discomfort score
timeFrame: 1.5 years
measure: Willingness to repeat
timeFrame: 1.5 years
measure: Causes of unsuccessful
timeFrame: 1.5 years
measure: Abdominal compression
timeFrame: 1.5 years
measure: Position change
timeFrame: 1.5 years
measure: Diagnostic lesions
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Dr. Sardjito General Hospital
state: Special Region of Yogyakarta
Study officials:
affiliation: Div of Gastroenterology and Hepatology, Dept of Internal Medicine,Fac of Medicine, Gadjah Mada University/Dr.Sardjito General Hospital,Yogyakarta,Indonesia
name: Putut Bayupurnama, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bayupurnama P, Ratnasari N, Indrarti F, Triwikatmani C, Maduseno S, Nurdjanah S, Leung FW. Endoscope-connected water pump with high flow rates improves the unsedated colonoscopy performance by water immersion method. Clin Exp Gastroenterol. 2018 Jan 12;11:13-18. doi: 10.2147/CEG.S152669. eCollection 2018.
Clinical trial NCT01722396: Pharmacogenetics of Vitamin D Supplementation in Tuberculosis
Official title: The Pharmacogenetics of Vitamin D Supplementation in Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tuberculosis
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Heart of England NHS Trust
First posted: 2012-11-06
Enrollment: 62
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Previous studies of vitamin D supplementation have suggested there may be differences in response between individuals. This study is an open label study of vitamin D supplementation in patients with active or latent tuberculosis in which active disease patients take 100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex vivo markers of vitamin D response. Latent patients will only be studied for vitamin D response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells will be related to polymorphisms in the DBP gene, and that this may relate to clinical response in terms of post supplementation vitamin D level.


Eligibility criteria: Inclusion Criteria:

* Age 16 or above
* Microbiologically or histologically confirmed active tuberculosis
* Clinically confirmed latent tuberculosis

Exclusion Criteria:

1. Patients being managed with regimes outside standard NICE guidance
2. Drug resistant MTb
3. HIV positive
4. Known intolerance of vitamin D
5. Sarcoidosis
6. Hyperparathyroidism or nephrolithiasis
7. Taking vitamin D supplementation in the two months preceding enrolment
8. Baseline serum corrected calcium \>2.65 mmol/L
9. Current haemodialysis
10. Children, pregnant or breastfeeding individuals
11. Concomitant benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy

Primary outcomes:
measure: Change in post supplementation vitamin D level
timeFrame: 8,16 and 24 weeks
Secondary outcomes:
measure: Ex vivo responses of monocytes to vitamin D
timeFrame: 0 and 8 weeks
measure: Ex vivo responses of T cells to vitamin D
timeFrame: 0 and 8 weeks
Other outcomes:
measure: Serum levels of inflammatory markers
timeFrame: 0, 8 , 16 and 24 weeks
measure: Serum levels of calcium
timeFrame: 0,8, 16 and 24 weeks
measure: TB score
timeFrame: 0,8.16 and 24 weeks
Locations:
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Trust
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Alice Turner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04787458: Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery
Official title: Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery(ABC) : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 65
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: There have been reports that abdominal binder use after laparoscopic or open surgery affects postoperative respiratory function, walking performance, and pain but no study has evaluated binder use solely for laparoscopic cholecystectomy surgery. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of abdominal binders after laparoscopic cholecystectomy by comparing postoperative outcomes in two patient groups.

Detailed description: Abdominal binders help to prevent postoperative complications, however, their use is controversial because of a lack of evidence for their effectiveness and because they also confer disadvantages. The purpose of this randomized controlled trial was to compare the effects of abdominal binder after laparoscopic cholecystectomy on pain, degree of comfort, time until ambulation, walking ability, return of bowel function, and diet resumption.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* American Society of Anesthesiologists Physical Status classification I and II

Exclusion Criteria:

* history of ventral hernia
* walking disability
* chronic obstructive respiratory disease
* malignancy
* chronic pain syndrome
* open conversion
* inability to complete the questionnaire

Primary outcomes:
measure: degree of comfort
timeFrame: Until dischage, an average of 2.5 days
measure: postoperative pain
timeFrame: 12 hours after surgery
measure: postoperative pain
timeFrame: 24 hours after surgery
measure: postoperative pain
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Postoperative hospital stay
timeFrame: Until dischage, an average of 2.3 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References:
Clinical trial NCT03678558: Oocyte Vitrification Aided With Cytochalasin B
Official title: Cytochalasin B for Oocyte Vitrification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
First posted: 2018-09-19
Enrollment: 612
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Using the cytoskeleton Stabilizer the Cytochalasin B would improve the outcome of oocyte vitrification.


Eligibility criteria: Inclusion Criteria:

* indication for oocyte vitrification

Exclusion Criteria:

-

Primary outcomes:
measure: survival after thawing
timeFrame: 6 days of culture
Secondary outcomes:
measure: fertilization rate
timeFrame: 6 days of culture
measure: Rates of blastocyst formation and quality
timeFrame: 6 days of culture
measure: embryo utilisation rate
timeFrame: 6 days of culture
measure: clinical pregnancy rate
timeFrame: three months
measure: ongoing pregnancy rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: IbnSina IVF Center, IbnSina Hospital
Study officials:
References:
Clinical trial NCT00021658: Effects of Pesticide Exposure on Neurodevelopment/Growth/Respiratory Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Exposure
Keywords: Epidemiology
pesticide
asthma
children
exposure
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
Collaborators: name: Clinica de Salud
name: Natividad Medical Center
First posted: 2001-08-01
Enrollment: 550
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: Exposure and health study of pesticide and allergen exposures to pregnant women and children. Intervention study is planned after assessment is completed.

Detailed description: Exposure assessment and pathway analysis of organophosphate pesticides to low income pregnant women and children living in the Salinas valley of California. Health study investigating neurodevelopment, growth, and asthma in children.

Eligibility criteria: * Female, at least 18 years of age.
* Live in Salinas valley in California.
* Pregnant.
* Medical eligible.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salinas
country: United States
facility: CHAMACOS Field Office
state: California
Study officials:
affiliation: University of California at Berkeley
name: Brenda Eskenazi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California at Berkeley
name: Asa Bradman, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03460158: Prospective Evaluation of Facial Cosmetic Procedures
Official title: Prospective Evaluation of Minimally Invasive Facial Cosmetic Procedures Through Measured Volumetric Changes and Patient Reported Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cosmetic Techniques
Keywords: facial filler
Retylane
aesthetic improvement
volumizing fillers
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2018-03-09
Enrollment: 101
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.

Detailed description: Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes.

This study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days).

Eligibility criteria: Inclusion Criteria:

* Female patients 40 - 65 years of age

Exclusion Criteria:

* Male patients
* Prior surgical facial rejuvenation procedures
* Facelift
* Neck lift
* Blepharoplasty
* Facial fat grafting
* Prior minimally invasive rejuvenation procedure ≤ 12 months
* Known contraindications to devices or drugs used in this study
* Facial paralysis
* Congenital facial asymmetry
* Pregnant women
* Patient actively taking blood thinners

Primary outcomes:
measure: Patient Satisfaction With Validated FACE-Q Aesthetics Survey
timeFrame: 2 week post injections
Secondary outcomes:
measure: Correlate Patient Satisfaction With Volumetric Measurements
timeFrame: upto 90 days
measure: Volumetric Changes of Treatment
timeFrame: immediately post injection, 2 weeks, 4 weeks, and 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania Health System
name: Ivona Percec, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: