louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00720161: Metformin in Children With Motor Deficit
Official title: Metformin in Children With Motor Deficit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spina Bifida
Neuromuscular Diseases
Keywords: metformin, spina bifida, duchenne, insulin resistance
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obesity with insulin resistance in the paediatric population provides an increasing challenge. Children with neurological or neuromuscular diseases are even more prone to obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated with a decrease in physical fitness and a further increase in body fat. In this study we want to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese patients with neurological or neuromuscular diseases. Metformin is a well-established insulin sensitizer.

Detailed description: Obesity with insulin resistance in the paediatric population provides an increasing challenge. Children with neurological or neuromuscular diseases are even more prone to obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated with a decrease in physical fitness and a further increase in body fat. In this study we want to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese patients with neurological or neuromuscular diseases. Metformin is a well-established insulin sensitizer.

Eligibility criteria: Inclusion Criteria:

* Patients with neurogenic or myogenic motor deficit, clinically obese or who had excessively gained weight over the last year.

Exclusion Criteria:

* Exclusion criteria were known type 1 or type 2 diabetes mellitus and contraindications to metformin therapy.

Primary outcomes:
measure: insulin resistance
timeFrame: 12 months
Secondary outcomes:
measure: fat
timeFrame: 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
state: Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: kristina m casteels, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Srinivasan S, Ambler GR, Baur LA, Garnett SP, Tepsa M, Yap F, Ward GM, Cowell CT. Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: improvement in body composition and fasting insulin. J Clin Endocrinol Metab. 2006 Jun;91(6):2074-80. doi: 10.1210/jc.2006-0241. Epub 2006 Apr 4.
Clinical trial NCT02168361: The SIM-SOF Trial for Hepatitis C
Official title: The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Keywords: cirrhosis
Lead sponsor: Center For Hepatitis C, Atlanta, GA
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.

Detailed description: Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.

Must have Child's Class A cirrhosis/compensated and no history of decompensation

Eligibility criteria: Inclusion Criteria:

* chronic hepatitis c,
* cirrhosis biopsy-proven, or via fibrotest,
* CPT score less than 7,
* genotype 1a,
* INR 2.3 or less,
* serum albumin greater than 2.7 gm/dL,
* total bilirubin less than 3 gm/dL,
* platelet count 50,000 per cubic milliliter or more
* GFR \>50 ml/min

Exclusion Criteria:

* non genotype 1a,
* history of CPT class B or C or decompensation or history of same,
* HIV or HBV coinfection,
* prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,
* uncontrolled psychiatric or cardiopulmonary disorders,
* planning pregnancy or unwilling/unable to practice contraception

Primary outcomes:
measure: Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
timeFrame: 12 weeks post-therapy
Secondary outcomes:
measure: Serum HCV RNA Level
timeFrame: 4 and 12 weeks into therapy
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Center for Hepatitis C
state: Georgia
Study officials:
affiliation: Center for Hepatitis C
name: Brian L Pearlman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31.
Clinical trial NCT00438061: Effect of Abdominal Obesity on Lipoprotein Metabolism
Official title: Effect of Weight Loss on Lipoprotein Metabolism in Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Dyslipidemia
Insulin Resistance
Keywords: Lipoprotein metabolism
Cardiovascular disease
Obesity
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 40
Sex: MALE
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: Abdominal obesity is strongly associated with dyslipidemia, which may account for the associated increased risk of atherosclerosis and coronary disease. Weight reduction is suggested to be a preferred and effective first-line strategy to correct lipid abnormalities, particularly in overweight/obese subjects. This improvement may be related to the effect of reduction in abdominal fat mass on apoB and apoA-I metabolism, but this remains to be fully demonstrated.

Hypothesis: Reduction in abdominal fat mass by weight loss decreases apoB concentration and raises HDL-cholesterol chiefly by increasing LDL-apoB fractional catabolic rate (FCR), as well as decreasing HDL apoA-I, respectively.

Detailed description: We examined the mechanism of the effect of weight loss through dieting on LDL and HDL metabolism in abdominally obese men. LDL apoB-100 and HDL apoA-I kinetics were studied using a primed-constant infusion of 1-\[13C\]-leucine in a controlled, dietary intervention trial of 16 weeks duration in middle-aged, obese men with the metabolic syndrome. Isotopic enrichment in apoB and apoA-I was measured by gas chromatography-mass spectrometry and fractional turnover rates estimated using multi-compartmental modelling.

Eligibility criteria: Inclusion Criteria:

* Obesity was defined as a body mass index (BMI) \>28kg/m2 and visceral visceral obesity (waist to hip ratio\> 1.0 or waist circumference \>100 cm)

Exclusion Criteria:

* Diabetes mellitus,
* Proteinuria,
* Hypothyroidism,
* Abnormal liver enzymes,
* Major systemic illness,
* A history of alcohol abuse,
* A family history of hyperlipidemia or premature coronary artery disease or were taking medication known to affect lipid metabolism.

Primary outcomes:
measure: Primary: Fractional catabolic and production rates of LDL-apoB and HDL-apoA-I (before and after 16 week treatments)
Secondary outcomes:
measure: Secondary: Cholesterol; Triglyceride; LDL-cholesterol; Adipocytokines; Genetic polymorphism
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: Dick C Chan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Gerald F Watts, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01615861: Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Official title: Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-06-11
Enrollment: 103
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases

* V4 (6M) endpoint: primary analysis
* V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis


Eligibility criteria: Inclusion Criteria:

* Subjects must have clear intraocular media other than cataract in the study eye.
* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.

Exclusion Criteria:

* Subjects with ocular malformation in the study eye.
* Subjects who have had previous surgery in the study eye.
* Subjects with uncontrolled glaucoma in either eye.
* Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
* Subjects using medications known to potentially complicate cataract surgery.

Primary outcomes:
measure: Visual Acuity
timeFrame: 6 months
Secondary outcomes:
measure: Incision size
timeFrame: 6 Months
measure: Refraction
timeFrame: 6 Months
measure: Visual Acuity
timeFrame: 6 Months
measure: EPCO
timeFrame: 24 Months
measure: Lens decentration
timeFrame: 6 Months
measure: Laser capsulotomy
timeFrame: 24 Months
Other outcomes:
Locations:
city: Labege
country: France
facility: Bausch & Lomb
Study officials:
References:
Clinical trial NCT06310161: Light Therapy in End Stage Kidney Disease
Official title: Bright Light Therapy to Treat Fatigue in End Stage Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment.

Detailed description: In a single site, 2-arm (Bright Light Therapy group; Dim Light Group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of Bright Light Therapy compared to Dim Light Therapy in subjects with end stage kidney disease who are receiving hemodialysis to treat fatigue.

* To compare the effects of bright light therapy to dim light therapy on fatigue severity.
* To explore the effects of bright light therapy to dim light therapy on salivary cortisol.
* To compare the effects of bright light therapy to dim light therapy on insomnia, depression and quality of life.
* To test the effects on bright light therapy to dim light therapy on physical activity levels.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to initiation of any study mandated procedure
2. Male and female participants ≥ 18 years of age
3. Diagnosis end stage kidney disease with hemodialysis 3 times/week for at least 1 month
4. Fatigue Severity Scale (FSS) \> 9 at enrollment
5. Home refrigerator for salivary cortisol storage

Exclusion Criteria

1. Eye disorders: cataracts, glaucoma, retinal disorders (e.g. macular degeneration)
2. Participants with photosensitivity (e.g. epilepsy)
3. Hospitalized or acutely ill

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Lea Ann Matura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05219461: Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndromes
Lead sponsor: Daewoong Bio Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-02
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects

Detailed description: Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop

Eligibility criteria: Inclusion Criteria:

* Healthy male aged from 20 to 51 at screening test
* Weight 50kg \~100kg BMI 18-27
* Those who are fully understood, voluntarily decided to participate and signed prior to screening
* Those who are deemed suitable for participating in clinical trial due to lab tests, physical exam etc

Exclusion Criteria:

* Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: 14 days from baseline
Secondary outcomes:
measure: PK characteristics
timeFrame: 14 days from baseline
measure: PK characteristics
timeFrame: 14 days from baseline
measure: PK characteristics
timeFrame: 14 days from baseline
measure: PK characteristics
timeFrame: 14 days from baseline
measure: PK characteristics
timeFrame: 14 days from baseline
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT05379361: Program Development Study for Emotional Intelligence
Official title: Program Development Study for Developing Emotional Intelligence for Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Intelligence
Nursing
Education
Nurse's Role
Keywords: Emotional intelligence
Program Development
Students
Nursing
Education
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: For qualified nursing care, emotional intelligence skills of nurses should be developed during their vocational training. This research was carried out in order to develop and evaluate the Emotional Intelligence Training Program based on the Bar-On Emotional Intelligence Model for nursing students in line with Demirel's program development model.

Detailed description: The experiment was planned in a randomized controlled experimental design with placebo, control group (pretest-posttest control pattern), blind technique. It is a research with a mixed pattern, since the individual in-depth interview method, one of the qualitative research methods, is also used in the research together with quantitative methods. The research was carried out with first-year nursing faculty students (N: 250) of a university.

The Emotional Intelligence training program created and was applied to the experimental group in the specified period. In order to minimize the risk of interaction, a different training program was simultaneously applied to the placebo group.

Eligibility criteria: Inclusion Criteria:

* The average score of the students on the emotional intelligence scale is in the range of 1-4 points.
* Willingness to participate in the study

Exclusion Criteria:

* Have received or receiving professional psychological or psychiatric support

Primary outcomes:
measure: Emotional Intellligence Skills
timeFrame: Baseline (Before Education Program, posttest (2 weeks after education program ended)
Secondary outcomes:
measure: Training Program Evaluation Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul Univesity Cerrahpasa
name: Nil Küçük Yüceyurt, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01644461: A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)
Official title: A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Facial Wrinkles (Nasolabial Folds)
Lead sponsor: Kasiak Research Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment to end of study.


Eligibility criteria: Inclusion Criteria:

* Subjects (male and female), aged 18 to 40 years (both inclusive).
* Subjects willing to refrain from any other treatment for Nasolabial Folds.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

* Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc
* Subjects with history of Connective tissue disease
* Subjects with autoimmune diseases
* Subjects unwilling to or unable to comply with the study protocol.
* Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days

Primary outcomes:
measure: Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile
timeFrame: Day 0, End of Study - 3 months
Secondary outcomes:
measure: Global Aesthetic Improvement Scale
timeFrame: Day 0, End of study - Month 3
Other outcomes:
measure: Photographic assessments
timeFrame: Day 0, Month 1, Month 2, End of study - Month 3
measure: Physician's assessment scores
timeFrame: End of Study - 3 months
measure: Patient's assessment scores
timeFrame: End of Study - 3 months
Locations:
city: Thane
country: India
facility: Kasiak Research Pvt Ltd
state: Maharashtra
Study officials:
affiliation: Dr Rachita's Skin, Trichology & Aesthetic Centre
name: Rachita Dhurat, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kapadia Multispeciality Hospital
name: Geetanjali Shetty, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01028261: Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obese
Obesity
Overweight
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.

Detailed description: This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.

Eligibility criteria: Inclusion Criteria:

* Obese, otherwise healthy females
* Post menopausal or infertile
* Weight ≥ 50 kg
* BMI ≥ 32 and ≤ 45 kg/m2

Exclusion Criteria:

* Use of weight loss agents in the past month
* History of eating disorder
* History of diabetes or other endocrine disorder
* History of gastric bypass
* Current smokers
* Unstable body weight during the past 3 months

Primary outcomes:
measure: Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
timeFrame: Approximately 2 months
Secondary outcomes:
measure: Weight
timeFrame: Approximately 2 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Q-Pharm Clinics, Royal Brisbane and Women's Hospital
state: Queensland
city: Heidelberg
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
affiliation: Zafgen, Inc.
name: James E Vath, PhD
role: STUDY_DIRECTOR
References: