louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04629365: Effects of Ketogenic Diet in Body Builders
Official title: Effects of Two Months of Ketogenic Diet on Body Composition, Muscle Strength and Blood Parameters in Competitive Natural Body Builders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Body Weight
Keywords: ketogenic diet
body builders
athletes
body composition
hormones
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 19
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: the study sought to investigate the influence of 8 weeks of a very low carbohydrate ketogenic diet on body composition, muscle strength, muscle area and blood parameters in competitive natural body builders.

Detailed description: nineteen natural body builders were randomly assigned to a ketogenic diet (KD) group or to a normal diet group (ND) with a traditional meal pattern. The two diets were isocaloric and included the same amount of protein per kg of body weight; but differed in the distribution of fats and carbohydrates; the latter were kept below 5% daily (less than 50g/day) in the KD group while represented 55% of the caloric intake in the WD group During the experimental period, training loads were similar in the two groups. Athletes were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, muscle strength and blood parameters were measured.

Eligibility criteria: Inclusion Criteria:

* at least 5 years of training experiences
* competing in recognized body building category

Exclusion Criteria:

* adherence to special diets
* use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
* use of medications (steroids)
* diabetes or metabolic diseases

Primary outcomes:
measure: Fat Mass
timeFrame: 8 weeks
measure: Lean Body Mass
timeFrame: 8 weeks
measure: Maximal muscle strength
timeFrame: 8 weeks
Secondary outcomes:
measure: blood glucose
timeFrame: 8 weeks
measure: testosterone
timeFrame: 8 weeks
measure: inflammatory cytokines
timeFrame: 8 weeks
measure: resting metabolism
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
affiliation: University of Padova
name: Antonio Paoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177565: Autologous Stem Cell Therapy for Fracture Non-union Healing
Official title: Autologous Stem Cell Therapy for Fracture Non-union Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-union of Fractures
Keywords: Non-union
fracture
bone marrow stem cells
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Keele University
First posted: 2014-06-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

Detailed description: Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.

Eligibility criteria: Inclusion Criteria:

* An established non-union according to the US Food \& Drug Administration criteria14.
* Non-union following fracture of tibia or femur suitable for synthetic bone grafting.

Exclusion Criteria:

1. Skeletal immaturity.
2. Pregnant or breast-feeding.
3. Non-union following pathological fractures.
4. Positive to Hepatitis B, Hepatitis-C or HIV.
5. Infection during BMSC culture.

Primary outcomes:
measure: Radiological assessment of new callus and fracture bridging
timeFrame: 12 months
Secondary outcomes:
measure: EQ-5D
timeFrame: 12 months
Other outcomes:
Locations:
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic Hospital
state: Shropshire
Study officials:
affiliation: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
name: James Richardson, FRCS MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04053465: Heat Acclimation, Hand Cooling Efficacy, and Adaptation Maintenance.
Official title: The Effect of Heat Acclimation on Repeated Bouts of Strenuous Heat Stress, Hand Cooling Efficacy, and the Maintenance Thereof.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heat
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study had three aims:

1. To determine the impact of consecutive days of exercise on thermoregulation and cardiovascular strain.
2. To determine the efficacy of a hand cooling device to cool individuals throughout a heat acclimation period.
3. To assess the maintenance of thermoregulatory and cardiovascular adaptations derived from heat acclimation during a 25-day intermittent exercise-heat exposure protocol.

Detailed description: Participants completed 14 days of exercise heat acclimation in either a hot or cool environment, followed by a heat or cool exercise exposure every 5th day for 25 days. Cardiovascular, thermoregulatory, and perceptual strain were measured throughout exercise each day. Hydration assessment and stress response via blood biomarkers were measured before and after exercise. Aerobic capacity was measured before and after heat acclimation as well as after the intermittent exercise-heat exposure. Hand cooling was implemented periodically during exercise-heat stress visits to determine cooling efficacy before and after heat acclimation.

Eligibility criteria: Inclusion Criteria:

* no chronic health problems
* no previous history of exertional heat stroke within the past 3 years
* no history of cardiovascular, metabolic or respiratory disease
* no current musculoskeletal injury that limits physical activity

Exclusion Criteria:

* women
* exercise less than once per week
* VO2max \< 45 ml/kg/min

Primary outcomes:
measure: Internal Body Temperature
timeFrame: 5 days
Secondary outcomes:
measure: Heart Rate
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Connecticut
name: Douglas J Casa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pryor RR, Pryor JL, Vandermark LW, Adams EL, Brodeur RM, Armstrong LE, Lee EC, Maresh CM, Casa DJ. Short term heat acclimation reduces heat strain during a first, but not second, consecutive exercise-heat exposure. J Sci Med Sport. 2021 Aug;24(8):768-773. doi: 10.1016/j.jsams.2021.03.020. Epub 2021 Apr 6.
Clinical trial NCT02111265: THe Comparison of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients
Official title: The Comparison of Efficacy and Safety of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients --A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adrenal Suppression
Hemodynamic Instability
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Chinese Medical Association
First posted: 2014-04-11
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients


Eligibility criteria: Inclusion Criteria:

1. Written informed consent.
2. Scheduled for Endotracheal intubated and general anesthesia for general surgery patients.
3. Age 60-75 yrs.
4. American Society of Anesthesia (ASA) classification I-II.
5. Expected time of surgery is less than 3 hours. -

Exclusion Criteria:

1. Body mass index is more than 36kg/m2.
2. Systolic blood pressure≥180 mm Hg or \<90 mm Hg，diastolic blood pressure≥110 mm Hg or \< 60 mm Hg.
3. Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis.
4. Long term used hormone or adrenal suppression.
5. Allergy to trial drug or other contraindication.
6. Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation.
7. Abuse of narcotic analgesia or suspected.
8. Neuromuscular diseases.
9. Mentally unstable or has a mental illness.
10. Malignant Hyperthermia.
11. Pregnant or breast-feeding women.
12. Attended other trial past 30 days. -

Primary outcomes:
measure: Effect Compartment Concentration
timeFrame: From the beginning of induction to paitens'left of PACU, up to 4 hours
Secondary outcomes:
measure: vital signs
timeFrame: From the beginning of induction to skin closure, up to 3 hours
measure: The amount of drugs
timeFrame: From the beginning of induction to skin closure, up to 3 hours
measure: Adrenal function
timeFrame: From entering the operating room to 48 h after induction of anesthesia.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesia, Second Affiliated Hospital of Xi'an Jiaotong University
name: He Jiaxuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01400165: Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations
Official title: Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Therapeutic Equivalency
Human Experimentation
Bioequivalence
Brand name
Generic
Healthy volunteers
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Generic describes a pharmaceutical product that does not have a brand name or trademark. Generic medications should be the equivalent of brand medications. Only their price should be different. The active ingredient of the generic medication has to be within a window of 80 to 125% of the original in the blood. There are reports that this standard is not always followed after the medication has been on the market. Indeed, it was observed that some patients previously stable on original medications relapsed when switched to a generic. Several factors could account for this problem. Such problems have been reported for Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and the original brands will be examined for these three medications. The three original medications used in this study are the Visken, the Seroquel, and the Desyrel. The three generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all available on the Canadian market by prescription.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

Exclusion Criteria:

* Psychiatric disorder
* Hepatic disease
* Renal disease
* Gastrointestinal disease
* Hematological disease
* Smokers
* Physical and/or neurological disease
* Positive urine drug screen
* Abnormal blood pressure
* Abnormal Electrocardiogram
* Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
* Taking medication
* Have donated 50 mL to 499 mL whole blood within 30 days and more than 499 mL whole blood within 56 days preceding entry into this study

Primary outcomes:
measure: Plasma levels of Medication
timeFrame: 0 to 48 hours after drug ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa, Institute of Mental Health Research
state: Ontario
Study officials:
affiliation: University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
name: Pierre Blier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit
name: Franck Chenu, PharmD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977365: Effectiveness of Child Centered Counseling on Child Nutrition Status
Official title: Effectiveness of Child Centered Counseling on Child Nutrition Status. A Cluster Randomized Trial in Rural Burkina Faso.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Cluster Randomized Trial,
Nutrition counseling,
Caretaker's knowledge
Child growth,
Prevention,
Acute malnutrition
Lead sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
Sponsor class: OTHER_GOV
Collaborators: name: Institute of Tropical Medicine, Belgium
First posted: 2013-11-06
Enrollment: 2341
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis N°1: The "children growth promotion based on approach centered on their specific needs" enhances caretakers and health workers skills, knowledge and practices on breastfeeding, complementary feeding and child care.

Hypothesis N°1: children growth promotion based on approach centered on their specific needs" approach improves children growth and health.


Eligibility criteria: -Inclusion Criteria: all women of childbearing age in the third trimester of pregnancy, living in the study area for at least one year at the time of the inclusion and who gave informed consent.

Exclusion Criteria:

Primary outcomes:
measure: Incidence of acute malnutrition
timeFrame: 18 months
Secondary outcomes:
measure: Incidence of Diarrhea, fever, Acute respiratory infection
timeFrame: 18 months
Other outcomes:
measure: incidence of exclusive breastfeeding rates
timeFrame: 18 months
measure: Child dietary diversity score
timeFrame: 18 months
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Institut de Recherche en Sciences de la Santé
state: Kadiogo
Study officials:
References:
Clinical trial NCT04667065: Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery
Official title: Evaluation of a Remotely Guided Physical Preparation by a Physical Activity Teacher Adapted With the Help of a Smartwatch Before Bronchial Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: smartwatch, lung cancer operation, physical exercices
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient with non-small cell bronchial cancer with indication of curative surgical resection.
Primary purpose: OTHER

Brief summary: This is a study of a preoperative rehabilitation program with remotely guided high-intensity exercises by physical activity teachers adapted to a smartwatch in patients with operable lung cancer.


Eligibility criteria: Inclusion Criteria:

* Major patient, age ≥ 18
* Patient with non-small cell operable bronchial cancer without indication of neo-adjuvant chemotherapy
* Affiliated with a social security plan
* VEMS \< 80% and/or DLCO\<80%
* High-intensity training achievable for at least 10 days before surgery
* Acceptant to participate in the protocol
* Ability to follow the STIMUL program of education focused on adapted physical activity
* Have a smartphone that can download the mobile app
* have the ability to understand, read and write French

Exclusion Criteria:

* Patient unable to consent: under guardianship or curatorship
* Patient refusing surgery
* Non-operable patient due to comorbidities or unseable tumour
* Poor understanding of the smartwatch
* Severe cognitive or psychiatric disorders
* Pregnancy in progress

Primary outcomes:
measure: Measure of VO2 max .
timeFrame: 1 day before surgery
Secondary outcomes:
measure: Number of patients who used the remotely guided physical preparation
timeFrame: one day before surgery
measure: maximum distance covered in the 6-minute walking t
timeFrame: one day before surgery
measure: post-surgery complications
timeFrame: At 1 month and 3 months
measure: number of individuals who participated in the physical activity program
timeFrame: one day before surgery
measure: post surgery intubation duration
timeFrame: At 1 month
measure: number of days at hospital
timeFrame: At 3 months
measure: number of days with oxygen
timeFrame: At 1 month and 3 months
measure: (forced expiratory volume
timeFrame: At 1 month and 3 months
measure: capacity of carbon monoxide
timeFrame: At 1 month and 3 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre hospitalier intercommunal de Créteil
Study officials:
References:
Clinical trial NCT02845765: Fundus Oculi and Erectile Dysfunction
Official title: Evaluation of Vascularization of the Fundus Oculi in Patients With Erectile Dysfunction as Barometer of Patient's Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
ED
Fundus Oculi
Retinal Vascularization
International Index of Erectile Function Questionnaire
IIEF
Dynamic Vessel Analyzer
DVA
Phosphodiesterase type 5 Inhibitor
PDE5Is
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * n. 40 patients with erectile dysfunction haracterized by the inability to develop or maintain an erection of the penis during sexual activity
* n. 20 subject healthy volunteers without erectile dysfunction or ocular desease

Brief summary: The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED.

Detailed description: The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED.

In this monocentric, prospective, observational case-control study 40 eyes of 40 patients affected by erectile dysfunction and 20 healthy age-matched controls will be enrolled.

Patients will undergo DVA examination at baseline and 6 months after PDE5I therapy. Healthy subjects will be examined with DVA at baseline only.

Eligibility criteria: Inclusion Criteria:

* Subjects with erectile dysfunction diagnosis (organic and psychogenic);
* Subjects with Erectile Dysfunction diagnosis defined by IIEF score ≤ 25
* Subjects with stable partner for at least 6 months and sexually active.
* Subjects aged between 40 - 60 years;
* Signature of informed consent for patients

Exclusion Criteria:

* Subjects with ED secondary diagnosis to hormonal alterations (i.e. hypogonadism, hypo / hyperthyroidism, hyperprolactinemia);
* Subjects with a diagnosis of ED post-traumatic and iatrogenic, since after pelvic surgery;
* Subjects suffering from any ocular pathology that involves use of contact lenses and / or glasses;
* Subjects smoking;
* Individuals with uncontrolled systemic diseases;
* All persons who do not confirm at least one criterion for inclusion.

Primary outcomes:
measure: Static and dynamic retinal vessels diameter
timeFrame: Baseline and after 6 month of therapy
Secondary outcomes:
measure: International Index of Erectile Function (IIEF) Questionnaire
timeFrame: After 6 month of therapy
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Raffaele
state: MI
Study officials:
affiliation: University Vita-Salute, San Raffaele Hospital - Milan
name: Andrea Salonia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03390465: Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
Official title: An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-Drug Interaction
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.


Eligibility criteria: Inclusion Criteria:

* A healthy Male adults aged 19-50 years

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease.
* Hypersensitivity to ingredient of IP and other medication, food.
* Participation in any other study within 3months.
* History of whole blood donation within 2months and Apheresis 1month.

Primary outcomes:
measure: Cmax
timeFrame: 0~48hours after medication
Secondary outcomes:
measure: AUCt
timeFrame: 0~48hours after medication
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
affiliation: Inje University
name: Eun-Young Kim
role: PRINCIPAL_INVESTIGATOR
References: