louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00982917: Stamp-in-Safety Playground Safety Project
Official title: Stamp-in-Safety Playground Safety Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury Prevention
Keywords: playground
injury prevention
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Kohl's Cares for Kids Safety Network
First posted: 2009-09-23
Enrollment: 71
Sex: ALL
Minimum age (years): 3
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Playground injuries are common at childcare centers. Adequate adult supervision is an important component to reducing playground injuries in preschool children. The investigators studied the Stamp-in-Safety Program, an intervention to improve adult supervision and reduce children's risky playground behaviors.

Detailed description: Using a non-equivalent control group design, we evaluated the Stamp-in-Safety program which increases the quality of adult supervision and rewards children for safe play. In an urban childcare center, 71 children, ages 3-5 years, and 15 teachers participated in the study. The primary outcome measures were teacher verbalizations (warnings, explanations, redirects), teacher location (core, outskirts, or fringe of playground), risk taking behaviors by children (using equipment appropriately), and number of injuries on the playground.

Eligibility criteria: Inclusion Criteria:

* teachers at childcare center
* students at childcare center

Exclusion Criteria:

* not affiliated with childcare center

Primary outcomes:
measure: Improve adult supervision on playgrounds
timeFrame: 5 weeks
Secondary outcomes:
measure: Decrease preschool children's risky behaviors on playgrounds
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: ST. Vincent De Paul Childcare Center
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Karen Sheehan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03813017: Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Official title: Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Rheumatoid Arthritis
Atherosclerosis, Coronary
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2019-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted in Ziv Medical Center, Safed, Internal Medicine Department A, on 100 patients with rheumatoid artheritis

Brief summary: Cardiovascular disease is a leading cause for morbidity and mortality in general population. The incidence of cardiovascular disease and their poor outcome is well documented in a broad spectrum of connective tissue diseases, especially in rheumatoid arthritis (RA). The risk of incident CVD is increased by 48% in patients with RA compared to the general population.

RA is associated with 50% increase in the mortality in patients with cardiovascular disease (CVD). One reason is the more frequent cardiovascular risk factors in RA patients compared with the general population. Patients with RA have a high risk of premature cardiovascular disease (CVD). The aim of the present study is to assess whether there are non-invasive measures that might predict arteriosclerosis in RA patients.


Eligibility criteria: Inclusion Criteria:

1. 18-70 years old (except for women till 75 years old)
2. Absence of established CVD:

   * Myocardial Infarction p/h
   * PCI with balloon and/or stent
   * Intermittent claudication
   * PAD / intervention
   * CAS /intervention
3. Signed informed consent form
4. Documented diagnosis of rheumatoid arthritis

Exclusion Criteria:

1. Known CVD
2. Pregnancy

Primary outcomes:
measure: Cardiovascular disease risks in patient with theumatoid arthritis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02784717: Xarelto on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study
Official title: Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: rivaroxaban,
non-interventional,
atrial fibrillation,
stroke prevention,
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2016-05-27
Enrollment: 3055
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban within approved indication to prevent stroke or non-CNS systemic embolism has been made.

Brief summary: This non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China.

Detailed description: 3000 patients will be provided with free drug.It is planned to have an interim analysis(IA) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). To end or continue enrolling patients will be decided based on the IA result and the evaluation comments from CFDA.

Eligibility criteria: Inclusion Criteria:

* Female and male patients ≥ 18 years of age diagnosed with non-valvular atrial fibrillation
* Patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism was made as per investigator's routine treatment practice

Exclusion Criteria:

* NA

Primary outcomes:
measure: Number of Major bleeding events
timeFrame: Up to 30 months
Secondary outcomes:
measure: Number of Symptomatic thromboembolic events
timeFrame: Up to 30 months
measure: Number of Non-major bleeding
timeFrame: Up to 30 months
measure: Treatment satisfaction questionnaire
timeFrame: Up to 30 months
measure: Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories
timeFrame: Up to 30 months
measure: Number of each reason for any switch from or interruption of rivaroxaban treatment
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: HangZhou
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05709717: Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
Official title: Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perianal Fistula
Perianal Crohn Disease
Anal Fissure
Rectovaginal Fistula
Perianal Fistula Due to Crohn's Disease
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with complex perianal disease

Brief summary: Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median \& interquartile range (IQR)


Eligibility criteria: Inclusion Criteria:

Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's disease

Exclusion Criteria:

-

Primary outcomes:
measure: Clinical Healing
timeFrame: 1 year
measure: MRI healing
timeFrame: 1year
Secondary outcomes:
measure: Fecal continence
timeFrame: 1 year
measure: Quality of life (general and related to perianal diseases)
timeFrame: 1 year
measure: Costs
timeFrame: 1 year
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Chief of Colorectal Surgery
name: Michel Adamina, MD, PD, MSc, EMBA HSG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01882517: Lipid-lowering Effect of Plant Stanol Yogurt
Official title: The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of investigational products on serum LDL cholesterol.

Detailed description: Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well known.

Study was monitored by Foodfiles

Eligibility criteria: Inclusion Criteria:

* subjects must voluntarily sign the informed consent
* subjects must be male or female aged 20 to 70 years
* subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week)

Exclusion Criteria:

* subjects using lipid lowering medication
* subjects using ezetimibe
* subjects with bile acid sequestrant medication
* subjects with statin therapy
* subjects using other medication significantly influencing on lipid values
* subjects with diagnosis type 1 or type 2 diabetes
* severe obesity (BMI\>35.0 kg/m2)
* serum fasting triglycerides \> 4.0 mmol/l
* subjects with any hepatic or renal disorder according to medical history
* subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
* subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
* subjects who have history of temporal ischemic attack or stroke within six months prior to screening
* subjects who have a history of cancer or other malignant disease within the past five years
* subjects with abnormal values of health screening variables measured at screening visit: serum gamma-glutamyltransferase\> 2 x upper limit, serum alkaline phosphatase\> 2 x upper limit or other abnormality in laboratory evaluations considered as clinically significant in the opinion of the study physician
* subjects who are consuming more than 15 portions of alcohol / week
* subjects who are pregnant or lactating
* subjects using Benecol, Becelpro.activ, Danacol or other plant sterol enriched products within 30 days before visit 2
* subjects with severe lactose intolerance, milk allergy or any other intolerance to the ingredients of test products
* celiac disease

Primary outcomes:
measure: Change in serum LDL cholesterol
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT06953024: Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test
Official title: Validation of Self Testing Using the INSTI Multiplex HIV1/2 Syphilis Antibody Test
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Syphilis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to validate the percent agreement of the INSTI Multiplex Human Immunodeficiency (HIV) 1/2 syphilis antibody (Ab) test (INSTI POCT) when used as a self-test by patients compared to conventional serologic testing.


Eligibility criteria: Branch #1: Participants known to have an HIV infection - Inclusion criteria:

• Previously documented positive HIV serology

Branch #2: Participants known to have a history of syphilis infection - Inclusion criteria:

• Documented positive syphilis serology

Branch #3: Participants with no known HIV or syphilis infections - Inclusion criteria:

• No documented positive HIV or syphilis serology

Exclusion criteria:

Unable to speak and understand English

Primary outcomes:
measure: Percent agreement of the INSTI HIV/syphilis POCT when used to self-test for antibodies to HIV 1/2 and syphilis when compared to conventional serologic results.
timeFrame: Determined at the end of the implementation period (approximately 6 months).
measure: Participant-rated clarity of instructional materials and satisfaction with INSTI HIV/syphilis self-testing
timeFrame: Immediately after self-testing (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04953624: Appetite and Related Factors in Patients With ALS
Official title: Detection of Appetite and Analysis of Related Factors in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS patients

Brief summary: Chinese cnaq scale was used to evaluate the appetite changes of Chinese ALS patients; Objective to investigate the related factors of appetite changes in ALS patients; Objective to investigate the effect of anorexia on the progression and survival of ALS patients.

Detailed description: 1. With the consent of the original author, the scale was translated and back translated, and the Chinese version of the scale was determined after communication and confirmation with the original author.
2. Cnaq was used to measure the appetite of the patients, and hads was used to measure the anxiety and depression of the patients;
3. Analyze the proportion of loss of appetite in ALS group, compare the differences of clinical characteristics such as ALSFRS-R score, weight, BMI value, cognitive status such as ECAs score between patients with loss of appetite and patients without loss of appetite in ALS group, and conduct correlation analysis.
4. The patients were followed up every three months until they were unable to eat or end-point events (invasive ventilator or death), and the correlation between cnaq and disease progression and survival was analyzed.

Eligibility criteria: Inclusion Criteria:

* ALS patients diagnosed as probable, or definite according to the revised El Escorial criteria

Exclusion Criteria:

* there are other chronic consumption diseases such as severe digestive system diseases, thyroid diseases, diabetes and so on.

Primary outcomes:
measure: ALSFRS-R score
timeFrame: 3 months
measure: ALSFRS-R score
timeFrame: 6 months
measure: ALSFRS-R score
timeFrame: 12 months
measure: Food intake
timeFrame: 3 months
measure: Food intake
timeFrame: 6 months
measure: Food intake
timeFrame: 12 months
measure: invasive ventilator or death
timeFrame: 3 months
measure: invasive ventilator or death
timeFrame: 6 months
measure: invasive ventilator or death
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00165724: Alzheimer's Disease Long-term Follow-up Study (ALF Study)
Official title: Alzheimer's Disease Long-term Follow-up Study (ALF Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 114
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open study for efficacy and safety of donepezil treatment during 48 weeks


Eligibility criteria: Inclusion criteria

* Men or women aged 40 to 90
* Diagnosis of dementia according to DSM-IV
* Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
* Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
* Patients were generally healthy and ambulatory or ambulatory aided
* Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
* Patients have useful MRI results 3 months before screening

Exclusion

* If they have evidence of TIA or major infarction
* Epilepsy patients
* If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
* If they sensitive to acetylcholinesterase
* If they taken concomitant medication which were not allowed

Primary outcomes:
measure: ADAS-cog
Secondary outcomes:
measure: MMSE, CDR, GDS, NPI, ADL, SSDQ
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Bobath Memorial Hospital
city: Bundang
country: Korea, Republic of
facility: Bundang Seoul National University Hospital
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji University Hospital
Study officials:
affiliation: Eisai Korea Inc.
name: Jiheed Mun
role: STUDY_DIRECTOR
References:
Clinical trial NCT01009424: A Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Official title: A Multi-center, Placebo-controlled, Double Blind Multiple-ascending Dose Study in a Leapfrog Design to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of RO5024118 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: COPD
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 40-70 years of age, inclusive.
* Body Mass Index 18-32 kg/m2, inclusive.
* Female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. Male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose.
* Diagnosis of moderate-to-severe COPD (GOLD Stage II-III).

Exclusion Criteria:

* Current smoker or history of smoking in the last three months.
* Use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise.
* History of cardiac conduction abnormalities or ventricular tachyarrhythmias.
* Exacerbation of COPD within 8 weeks before first dosing.

Primary outcomes:
measure: To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population
timeFrame: 18 days per arm
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: