louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04273087: Characterization of a Clinical Subpopulation With Autism Spectrum Disorder
Official title: Characterization of a Clinical Subpopulation With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Lead sponsor: Stalicla SA
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 236
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cincinnati Children's Hospital Primary Care Clinic

Brief summary: The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.


Eligibility criteria: Inclusion Criteria:

* Participants previously diagnosed with ASD (DSM-5) supported by either autism diagnostic interview revised (ADI-R) or Autism Diagnostic Observation Scale (ADOS-2) scores
* Available health records within the first 2 years of life
* Participants must have a parent or reliable caregiver who agrees to provide information about the participant

Exclusion Criteria:

* Genetically identified ASD (syndromic form of autism, e.g. fragile X)
* Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit

Primary outcomes:
measure: Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: CCHMC
name: Craig A Erickson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04097587: Parental Education and Children's Screen Time
Official title: Parental Educational Intervention Reduces Screen Time and Improves Sleep Disturbances and Attention Problems in Preschool Children: a Clustered Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screen Time
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 129
Sex: ALL
Minimum age (years): 48
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A clustered randomized controlled study with a parallel-group design.
Primary purpose: PREVENTION

Brief summary: The study was to investigate the efficacy of a parental educational program on reducing screen use, and improving sleep quality and psychosocial adaptations in children aged 4-6 years.

Detailed description: A total of 129 parent-child dyads were randomly allocated to two groups: experimental group (receiving parental education, n=63), and control group (daily activities, n=66). Data were collected before and after intervention. Instruments included screen time, Children's Sleep Habits Questionnaire, and Pediatric Symptom Checklist-17. A linear mixed model analysis was used to examine the efficacy of education intervention.

Eligibility criteria: Inclusion Criteria:

* children aged 4\~6 years with screen time of ≥ 2 h/day.

Exclusion Criteria:

* cerebral palsy,
* mental retardation
* psychosis
* Down's syndrome
* chronic disease
* hearing impairment.

Primary outcomes:
measure: screen time
timeFrame: one week assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Su-Ru Chen
Study officials:
References:
citation: Zhao J, Zhang Y, Jiang F, Ip P, Ho FKW, Zhang Y, Huang H. Excessive Screen Time and Psychosocial Well-Being: The Mediating Role of Body Mass Index, Sleep Duration, and Parent-Child Interaction. J Pediatr. 2018 Nov;202:157-162.e1. doi: 10.1016/j.jpeds.2018.06.029. Epub 2018 Aug 9.
Clinical trial NCT02788487: Randomized Cross-over TRD and CPAP for OSA
Official title: A Randomized Cross-over Study of Tongue Retaining Device and Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.

Detailed description: The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively. Wash-in period 1 week and Wash-out periods 1 week are required before start each treatment.

Eligibility criteria: Inclusion Criteria:

1. OSA patients aged over 18 years old at Siriraj hospital
2. Apnea-hypopnea index (AHI) 5 - 30 events/ h or AHI \> 30 events/h but lowest Oxygen saturation \> 70%
3. Positive consented form

Exclusion Criteria:

1. Patients with severe periodontal diseases
2. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
3. total sleep time less than 2 hour during previous sleep study
4. Patients who could not tolerate the side effects of CPAP or TRD
5. Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.

Primary outcomes:
measure: apnea-hypopnea index (AHI)
timeFrame: 3 weeks
Secondary outcomes:
measure: Functional outcomes of sleep questionnaire (FOSQ ) score
timeFrame: 3 weeks
measure: Epworth sleepiness score (ESS) scores
timeFrame: 3 weeks
measure: lowest oxygen saturation during sleep test at home
timeFrame: 3 weeks
measure: side effects questionnaire
timeFrame: 3 weeks
measure: satisfaction and preference of device questionnaire
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Anuch - Durongphan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banhiran W, Durongphan A, Keskool P, Chongkolwatana C, Metheetrairut C. Randomized crossover study of tongue-retaining device and positive airway pressure for obstructive sleep apnea. Sleep Breath. 2020 Sep;24(3):1011-1018. doi: 10.1007/s11325-019-01942-z. Epub 2019 Nov 21.
Clinical trial NCT00163787: Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation
Official title: Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Keywords: mobility
falls
activity level
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Austin Health
First posted: 2005-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: All participants attend for two testing sessions at either Royal Talbot Rehabilitation Centre or the centre where they received inpatient physiotherapy services.

All participants will be tested at discharge and at six months post discharge. Personnel used to score and administer the balance tests at six months will be blinded to pre-test scores, subject background, as well as, mobility and fall history in the six months post discharge.

At discharge participants will perform two successful Four Square Step Tests (FSST, and will be videotaped performing the Timed Up and Go Test (TUGT. The turn measure will be scored from this TUGT. Participants will also complete the Locomotor Capabilities index (LCI).

At the six-month test participants repeat balance and mobility tests and LCI, as well as being interviewed to ascertain fall history since discharge.

Detailed description: Subjects:

All unilateral trans-tibial amputees with prosthesis at discharge, who are over 18 years of age, willing to participate and give informed consent. Subjects will be excluded if visually unable to perform tests, cognitively unable to follow testing procedures or being discharged into supported accommodation.

Identify scores for unilateral trans-tibial amputees for; FSST, TUGT and turn measure items: (1) steps, (2) time and (3) steadiness \& fluency of movement.

Evaluate the validity, predictive value, sensitivity \& specificity of the balance and mobility measures for falls and community ambulation with trans-tibial amputees.

Eligibility criteria: Inclusion Criteria:

* over 18 years unilateral transtibial amputee

Exclusion Criteria:

* visually unable to perform tests cognitively unable to perform tests unable to provide informed consent not being discharged into supported accommodation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health Royal Talbot Rehabilitation Centre
state: Victoria
Study officials:
affiliation: Austin Health Royal Talbot Rehabilitation Centre
name: Wayne Mr Dite, MAppSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01423487: Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea
Official title: Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea:a 24-week, Randomized, Placebo-controlled, Double-blind, Fixed-dose Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Weight Gain
Amenorrhea
Keywords: Metformin
Risperidone
Prevention
weight gain
Amenorrhea
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Some previous studies has demonstrated that Metformin can improve the weight gain which caused by antipsychotics. An our study, which will be published, also found that Metformin can improve the amenorrhea for patients with antipsychotics, approximately 60% patients recovery period. So the present study was designed to investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.


Eligibility criteria: Inclusion Criteria:

1. age 18-40 years.
2. diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I.
3. At screening, patients were required to have total score ≥60 on Positive and Negative Syndrome Scale (PANSS) and ≥4 on the Clinical Global Impression-severity scale (CGI-S).
4. treat with Risperidone.
5. Never participate in a diet control nor in other weight loss programs, and have a normal Period.
6. Written informed consents could be obtained from patients(or their Legal guardian).

Exclusion Criteria:

1. Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded.
2. Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded.
3. At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded.
4. Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance.

Primary outcomes:
measure: Change from Baseline in weight at 24 weeks
timeFrame: baseline, 8 week, 16 week, 24 week
Secondary outcomes:
measure: Change from Baseline in menstruation at 24 weeks
timeFrame: baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute of The Second Xiangya Hospital
state: Hunan
Study officials:
affiliation: Mental Health Institute of The Second Xiangya Hospital, Central South University
name: Jing-Ping Zhao, Dr., Ph.D.
role: STUDY_CHAIR
References:
citation: Wu RR, Zhao JP, Jin H, Shao P, Fang MS, Guo XF, He YQ, Liu YJ, Chen JD, Li LH. Lifestyle intervention and metformin for treatment of antipsychotic-induced weight gain: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):185-93. doi: 10.1001/jama.2007.56-b.
Clinical trial NCT05977387: Pediatric Kidney Transplant
Official title: Pediatric Kidney Transplant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Renal Disease
Pediatric ALL
Kidney Transplant; Complications
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from 0 to 18 years who underwent renal transplant for ESRD

Brief summary: End-stage renal disease (ESRD) is a rare disease in children. Renal transplantation (RT) is the treatment of choice for ESRD in the pediatric population. In France, around 100 pediatric kidney transplants are performed each year. The aim was to evaluate the surgical management of TR and the long-term results.

Detailed description: End-stage renal disease (ESRD) is a rare pathology in children, whose gold standard treatment is a kidney transplant. In France, around 100 pediatric kidney transplants are performed every year.

Although the first adult kidney transplants were performed in 1954, pediatric renal transplantation was considered unsafe compared with dialysis, which was preferred. In the 1980s, improved graft selection, optimized pre-transplant management and a better understanding of the immune system led to the development of pediatric kidney transplantation.

Despite considerable progress, graft survival in these long-lived patients remains a major challenge.

The aim of this study is to evaluate surgical practices in the four French pediatric transplant centers, and to define risk factors for surgical complications.

Eligibility criteria: Inclusion Criteria:

* All pediatric patients who underwent renal transplantation in one of the 4 centers

Exclusion Criteria:

* Multi organ transplant

Primary outcomes:
measure: Surgical outcomes
timeFrame: 10 years
Secondary outcomes:
measure: Surgical complications
timeFrame: 10 years
measure: Graft Survival
timeFrame: 10 years
measure: Return to dialysis
timeFrame: 10 years
measure: Retransplantation
timeFrame: 10 years
measure: Death
timeFrame: 10 years
Other outcomes:
Locations:
city: Bron
country: France
facility: l'hôpital mère-enfant de Lyon
city: Nantes
country: France
facility: l'hôpital mère enfant de Nantes
city: Paris
country: France
facility: l'hôpital Robert Debré
city: Paris
country: France
facility: l'hôpital Necker Enfants malades.
Study officials:
References:
Clinical trial NCT01043887: Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)
Official title: A Single Dose Study to Investigate the Pharmacokinetics of Ridaforolimus in Patients With Hepatic Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Hepatic Insufficiency
Keywords: Healthy Volunteers
Hepatic Insufficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Ariad Pharmaceuticals
First posted: 2010-01-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the pharmacokinetics of ridaforolimus including the area under the concentration-time curve (AUC\[0-infinity\]) and maximum concentration (Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.


Eligibility criteria: Inclusion Criteria:

Hepatic Patients:

* Female patient is of non-child bearing potential
* Apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health
* Patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis

Healthy Subjects:

* Female subject is of non-childbearing potential
* Subject is in good health

Exclusion Criteria:

Hepatic Patients and Healthy Subjects:

* Works a night shift and is not able to avoid night shift work during the study
* Has a history of stroke, seizure or major neurological disease
* Has a history of cancer
* Is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study
* Consumes excessive amounts of alcohol or caffeine
* Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Primary outcomes:
measure: Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.
timeFrame: 288 hours postdose
measure: Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.
timeFrame: 288 hours postdose
measure: Tmax of a Single Oral Dose of Ridaforolimus.
timeFrame: 288 hours postdose
measure: Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.
timeFrame: 288 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03005587: Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation
Official title: Impact of Acute Decompensation in Patients of Cirrhosis With or Without Prior Decompensation - A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Decompensation in Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 0
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: Chronic liver disease patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver \& Biliary Sciences, India.

Brief summary: This a prospective observational study in Chronic Liver Disease patients admitted or seen in OPD, Department of Hepatology, Institute of Liver and Biliary Sciences, India. The study will be conducted in a period of three months starting September 2016 in sample size of 80 . A detailed proforma including history and examination and routine blood investigations will be noted. The patients will undergo close follow up at 0, 7, 15, 30, 45, 60, 90 days and similar activities will be repeated at every visit.


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation.
2. Age 18-70 years
3. Valid consent

Exclusion Criteria:

1. HepatoCellular Carcinoma
2. Admitted and survival less than 48 hrs
3. Pregnant
4. Acute Liver Failure
5. Post transplant

Primary outcomes:
measure: Spontaneous recovery or liver transplant or death in both groups
timeFrame: 90 days
Secondary outcomes:
measure: Cause of acute decompensation
timeFrame: 3 months
measure: Severity and duration of prior as well as present decompensation
timeFrame: 3 months
measure: Improvement in severity assessment Indices Model for End Stage Liver Disease in both groups.
timeFrame: 3 months
measure: Causes of death in both groups
timeFrame: 3 months
measure: Profile of patient undergone transplant in both groups
timeFrame: 3 months
measure: Sepsis in both groups
timeFrame: 3 months
measure: Systemic Inflammatory Response Syndrome in both groups
timeFrame: 3 months
measure: Improvement in severity assessment Indices Child Pugh Turcotte in both groups.
timeFrame: 3 months
measure: Improvement in severity assessment Indices Sequential Organ Failure Assessment in both groups
timeFrame: 3 months
measure: Improvement in severity assessment Indices Acute Physiology and Chronic Health Evaluation II in both groups
timeFrame: 3 months
measure: Improvement in severity assessment Indices CLIF score in both groups
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences.
state: Delhi
Study officials:
References:
Clinical trial NCT04868487: Effectiveness of Health Literacy Education
Official title: Effectiveness of Health Literacy Education for Nursing Students in Turkey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy Level
Keywords: health literacy
nursing education
undergraduate student
education
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To determine the effect of health literacy education given to nursing students. The study was conducted at two university nursing departments in Turkey between December 2018 and March 2019. A total of 206 nursing students, 103 in the intervention and 103 in the control group, were included in the study. Health literacy education, consisting of four sessions, was given to the intervention group.


Eligibility criteria: Inclusion Criteria:

* Inadequate (0-25 points) health literacy level
* Problematic-limited (25-33 points) health literacy level
* Accepting to participate in the research
* Accepting to participate in the research

Exclusion Criteria:

* Adequate (33-42 points) health literacy level
* Excellent (42-50 points) health literacy level
* Foreign language students with limited language proficiency
* Visual-hearing disability
* Having a neuropsychiatric disease

Primary outcomes:
measure: Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
timeFrame: before the implementation
measure: Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
timeFrame: one week after the implementation
measure: Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
timeFrame: three months after the implementation.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
state: Çubuk
Study officials:
References:
citation: Akca A, Ayaz-Alkaya S. Effectiveness of health literacy education for nursing students: A randomized controlled trial. Int J Nurs Pract. 2021 Oct;27(5):e12981. doi: 10.1111/ijn.12981. Epub 2021 Jun 1.