louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02274103: Skype for Youth With Poorly Controlled Diabetes
Official title: Improving Health Through SkypeTM: Family-Based Intervention for Teens With Poorly Controlled Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 92
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control.


Eligibility criteria: Inclusion Criteria:

* Youth between the ages of 12 and 18 with type 1 diabetes characterized by an HbA1c value great than 9%
* Caregivers willing to participate
* Family members reading English at 5th grade level
* Willing to be randomized.

Exclusion Criteria:

* Youth with intellectual disability
* Parent or youth who doesn't speak English

Primary outcomes:
measure: HbA1c
timeFrame: Change from Baseline to 3 months and from 3 months to 6 months
Secondary outcomes:
measure: Adherence to diabetes treatment using the Diabetes Self Management Profile (DSMP) (Harris et al, 2001).
timeFrame: Change from Baseline to 3 months and from 3 months to 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Duke DC, Wagner DV, Ulrich J, Freeman KA, Harris MA. Videoconferencing for Teens With Diabetes: Family Matters. J Diabetes Sci Technol. 2016 Jun 28;10(4):816-23. doi: 10.1177/1932296816642577. Print 2016 Jul.
citation: Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.
citation: Riley AR, Duke DC, Freeman KA, Hood KK, Harris MA. Depressive Symptoms in a Trial Behavioral Family Systems Therapy for Diabetes: A Post Hoc Analysis of Change. Diabetes Care. 2015 Aug;38(8):1435-40. doi: 10.2337/dc14-2519. Epub 2015 May 26.
Clinical trial NCT01156103: Reducing Pediatric Obesity Through After-school Programs
Official title: Reducing Pediatric Obesity Through After-school Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
minority
child
physical fitness
school
physical activity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Unified School District
name: America SCORES, Bay Area
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-07-02
Enrollment: 158
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.

Detailed description: Baseline measures were collected in September 2009; midpoint measures were collected in January 2010; and final measures were collected in May 2010. Repeated measures analyses will compare trajectories for BMI, physical activity, and fitness between students in the SCORES and the usual care arms.

Eligibility criteria: Inclusion Criteria:

* 3rd-5th grade student enrolled in after-school program in San Francisco Unified School District

Exclusion Criteria:

* Uncontrolled asthma
* Unable to participate in moderate physical activity

Primary outcomes:
measure: Change in BMI z-score
timeFrame: Baseline (0 months) and 9 months
Secondary outcomes:
measure: Change in Aerobic capacity
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Kristine A Madsen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madsen K, Thompson H, Adkins A, Crawford Y. School-community partnerships: a cluster-randomized trial of an after-school soccer program. JAMA Pediatr. 2013 Apr;167(4):321-6. doi: 10.1001/jamapediatrics.2013.1071.
Clinical trial NCT03455803: Effect of CPAP Therapy on LPR Among Patients With OSAS
Official title: Effect of CPAP Therapy on Symptoms and Signs of Laryngopharyngeal Reflux Among Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngopharyngeal Reflux
Obstructive Sleep Apnea
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This study will investigate the changes in the reflux symptom index (RSI) and reflux finding score (RFS) among patients with obstructive sleep apnea after regular humidified CPAP therapy. Since these two diseases have strong associations then one may consider the possible benefits from therapy in between them.


Eligibility criteria: Inclusion Criteria:

* Patients have to stop proton pump inhibitors (PPI) therapy 1 month before enrollment in the study.
* To be eligible as LPR patients in our study, patients must have presented a RSI score \> 13 and a RFS score \> 7. These thresholds were highly correlated with pathological pH monitoring (pH \< 4)

Exclusion Criteria:

* Noncompliance for CPAP Use: According to the standard Medicare criteria to define CPAP compliance, the patients who demonstrated CPAP use ≥ 4 h/ night for ≥ 70% of the nights are considered compliant.
* Antireflux therapy during the period of the study.

Primary outcomes:
measure: Reflux symptom index (RSI) change
timeFrame: Change from the baseline RSI at 3 months of regular humidified CPAP application
measure: Reflux finding score (RFS) change
timeFrame: Change from the baseline RFS at 3 months of regular humidified CPAP application
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01468103: Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure
Official title: Laser Peripheral Iridotomy Versus Surgical Peripheral Iridectomy in Early Angle Closure:a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Pressure Changes
Peripheral Anterior Synechiae Increasing
Keywords: intraocular pressure
Peripheral anterior synechiae
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for 3 years.

Detailed description: The following will be studied:

1. To evaluate the safety of these two techniques for the treatment of angle closure.
2. To compare the anterior chamber reaction and IOP changes post surgery.
3. TO establish the UBM/ASOCT chamber angle parameters changes pre and post surgery.
4. To assess the development of PAS.

Eligibility criteria: Inclusion Criteria:

1. more than 50 years old
2. Diagnosis of either: Primary angle closure suspects, Primary angle closure in need of laser iridotomy or surgical iridectomy
3. Able to give Informed concent

Exclusion Criteria:

1. Ophthalmic diseases other than glaucoma and cataract
2. pseudophakic or aphakic patients
3. inability to attend regular follow-up assessment or to give informed written consent
4. Secondary causes of angle closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma
5. Participating in another study
6. monocular patients

Primary outcomes:
measure: intraocular pressure
timeFrame: 3 years
Secondary outcomes:
measure: Angle assessment parameters
timeFrame: 3 years
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: ZhongShan Ophthalmic Center
state: Guang Dong Province
Study officials:
affiliation: Sun Yat-sen University
name: Zhang X Lan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01436903: Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length
Official title: Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menorrhagia
Keywords: menorrhagia
dysfunctional uterine bleeding
endometrial ablation
cavatermTM
probe
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 290
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.


Eligibility criteria: Inclusion Criteria:

* CavatermTM operation because of menorrhagia
* timeframe: January 2006 till August 2009
* older than 29 years and younger than 56 years

Exclusion Criteria:

* pregnancy
* fragmentary filled questionnaire
* more than 1 CavatermTM operation

Primary outcomes:
measure: Postsurgical change in bleeding patterns dependent on cavum probe length.
timeFrame: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
measure: Postsurgical change in patient satisfaction dependent on cavum probe length.
timeFrame: Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.
Secondary outcomes:
measure: Postsurgical change in dyspareunia
timeFrame: A questionnaire will be sent in September 2010, at least after one postsurgical year.
measure: Postsurgical change in Premenstrual Syndrome
timeFrame: A questionnaire will be sent in September 2010, at least after one postsurgical year.
measure: Prevention of further gynaecological therapies
timeFrame: A questionnaire will be sent in September 2010, at least after one postsurgical year.
measure: Improvement of quality of life
timeFrame: A questionnaire will be sent in September 2010, at least after one postsurgical year.
Other outcomes:
Locations:
city: Neunkirchen
country: Austria
facility: Landesklinikum Thermenregion Neunkirchen
state: Lower Austria
Study officials:
affiliation: Medical University of Vienna
name: Beda W. Hartmann, Univ.-Doz.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498703: Azathioprine in Recurrent Implantation Failure
Official title: Azathioprine in Recurrent Implantation Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Implantation Failure
In Vitro Fertilization
Intracytoplsmic Sperm Injection
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Capital Birth Center
First posted: 2018-04-17
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Azathioprine increase pregnancy rate in patients with recurrent implantation failure


Eligibility criteria: Inclusion Criteria:

* age: 20-39
* previous 3 or more failed ivf

Exclusion Criteria:

* intrauterine anomalies
* chronic systemic illness
* chronic pelvic conditions
* sensitivety to azathioprine

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 2 weeks
Secondary outcomes:
measure: Side effects
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University, Maternity Hospital
city: Cairo
country: Egypt
facility: Capital Birth Center
Study officials:
affiliation: Capital Birth Center
name: Ahmed H Salama
role: STUDY_DIRECTOR
References:
Clinical trial NCT05274503: Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19
Official title: Serum Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Duration
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients more than 20 years old, covid positive, mechanically ventilated

Brief summary: Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is \<10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Patient data regarding demographics, comorbidities, signs and symptoms, laboratory results and complications will be collected. The occurrence of complications will be confirmed according to the following criteria: acute respiratory distress syndrome (ARDS) defined according to the Berlin definition


Eligibility criteria: Inclusion Criteria:

* •Age: more than 20 years.

  * Gender: both males and females will be included.
  * Mechanically Ventilated patients.
  * COVID 19 confirmed diagnosis

Exclusion Criteria:

* •Immunocompromised patients.

  * Oxygen saturation more than 95% without ventilation.
  * Malignancy.
  * Patients refuse to be enrolled in the study.

Primary outcomes:
measure: detection of acute respiratory distress syndrome
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University, Faculty of Medicine
Study officials:
References:
Clinical trial NCT00972803: The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
Official title: The Effects of Pistacia Mutica on De Novo Dental Plaque Formation, Gingival Inflammation and Oral Microorganisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gingivitis
Keywords: gingivitis
dental plaque
mouthrinse
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Dental plaque is a well known etiologic factor for gingivitis. Recently, herbal extracts are a matter of scientific interest to inhibit plaque accumulation on teeth. The purpose of this study was to evaluate the effects of pistacia Mutica (PM) mouth wash on de novo dental plaque plaque formation, gingival inflammation indices and oral microorganisms.


Eligibility criteria: Inclusion Criteria:

* had merely gingivitis (pocket depth≤3 mm, no attachment loss)
* without any fixed or removable oral appliances

Exclusion Criteria:

* Individuals who had a history of any relevant systemic diseases
* Individuals who had a history of any drug usage

Primary outcomes:
measure: The effects of pistacia Mutica extract (PM) on de novo plaque formation.
timeFrame: In a 4 days experimental periods followed by a 10 days wash-out periods.
Secondary outcomes:
measure: staining effects of pistacia Mutica extract in comparison to placebo or Chlorhexidine
timeFrame: In a 4 days experimental periods followed by a 10 days wash-out periods
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Drug Applied Science Center, tabriz Univ. of Medical Sciences
state: East azarbaijan
Study officials:
affiliation: Tabriz University of Medical Sciences
name: Reza Pourabbas, DDS,MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811303: Effects of Added D-fagomine on Glycaemic Responses to Sucrose
Official title: Effects of Added D-fagomine on Glycaemic Responses to Sucrose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Post-prandial Glycaemic Response
Lead sponsor: Bioglane
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response

Detailed description: This is a two treatment randomized double-blind crossover study, with each test product replicated twice.

Randomization: Subjects will be randomized to a Williams Latin square design balanced for treatment order.

Washout: 2 days or more (may return on day 3)

Run-in: High carbohydrate diet guidance (\>150 g/d) 1 day before treatment, recommend same sized dinner the previous night (no food record collection required)

Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject randomized in their place (the new subject will complete all treatments)

Subjects will report after an overnight (12 hour) fast for baseline sample collection, and will consume the test product in a fasted state.

Eligibility criteria: Inclusion Criteria:

* Male or female (not less than 40% Male)
* Aged 18 - 55 years
* Have a body mass index between 18.5 to 29.99 kg/m2
* Healthy, non-diabetic, no gastric bypass surgery
* Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Smokers
* Allergic to dairy or soy

Primary outcomes:
measure: Postprandial Glycaemic Response Index
timeFrame: 120 minutes
Secondary outcomes:
measure: Maximum Blood Glucose Concentration (C Max) Over the Baseline
timeFrame: Usually in the range of 30-45 minutes
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Reading Scientific Services Ltd.
Study officials:
affiliation: Reading Scientific Services Ltd.
name: Rungano Munyuki
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomez L, Molinar-Toribio E, Calvo-Torras MA, Adelantado C, Juan ME, Planas JM, Canas X, Lozano C, Pumarola S, Clapes P, Torres JL. D-Fagomine lowers postprandial blood glucose and modulates bacterial adhesion. Br J Nutr. 2012 Jun;107(12):1739-46. doi: 10.1017/S0007114511005009. Epub 2011 Oct 3.
citation: Amezqueta S, Galan E, Vila-Fernandez I, Pumarola S, Carrascal M, Abian J, Ribas-Barba L, Serra-Majem L, Torres JL. The presence of D-fagomine in the human diet from buckwheat-based foodstuffs. Food Chem. 2013 Feb 15;136(3-4):1316-21. doi: 10.1016/j.foodchem.2012.09.038. Epub 2012 Sep 18.
Clinical trial NCT06526403: Echocardiography-guided Oval-shaped ASD Closure
Official title: Echocardiography-Guided Percutaneous Closure of Oval-Shaped Secundum Atrial Septal Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ASD II
Percutaneous Closure
Zero-fluoroscopy
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Zero-fluoroscopy oval-shaped secundum ASD closure
Primary purpose: TREATMENT

Brief summary: Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.

Objective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.

Methods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

Detailed description: Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.

Objective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.

Methods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

Eligibility criteria: Inclusion Criteria:

* Oval-shaped secundum ASD with evidence of right ventricular overload, no significant and irreversible pulmonary arterial hypertension, no significant arrhythmia, no serious problems in other organs, and presumption of appropriate rims for device implantation

Exclusion Criteria:

* Other than stated in inclusion criteria

Primary outcomes:
measure: Success rate
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
Study officials:
References: