louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02521025: Bedrest, Feeding Pattern, and Insulin Sensitivity
Official title: The Impact of Continuous Versus Intermittent Feeding on Changes in Insulin Sensitivity During Bed-rest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophy, Disuse
Insulin Resistance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the present study, the investigators will assess the impact of two different feeding patterns (continuous vs intermittent) on insulin sensitivity and muscle mass following bedrest.

Detailed description: In the present study, the investigators will assess the impact of two different feeding patterns on insulin sensitivity and muscle mass following bedrest. Healthy, young males will be fed in a continuous (no breaks in food supply) or intermittent (in boluses throughout the day) manner.

Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 and 35
* Recreationally active

Exclusion Criteria:

* Type 2 diabetes
* Performing progressive resistance training in 6 months prior to study
* Back/knee/leg problems
* Hypertension
* Use of certain anticoagulants
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs
* Blood donation in past 3 months

Primary outcomes:
measure: Change in insulin sensitivity (measured as glucose infusion rate during hyperinsulinaemic-euglycaemic clamp)
timeFrame: 7 days bedrest
Secondary outcomes:
measure: Change in muscle mass (measured as upper leg muscle cross-sectional area with CT scan)
timeFrame: 7 days bedrest
measure: Change in lean tissue (measured via DEXA scan)
timeFrame: 7 days bedrest
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre+
name: Luc van Loon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez JT, Dirks ML, Holwerda AM, Kouw IWK, van Loon LJC. Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest. Eur J Appl Physiol. 2020 Sep;120(9):2083-2094. doi: 10.1007/s00421-020-04431-4. Epub 2020 Jul 10.
citation: Dirks ML, Miotto PM, Goossens GH, Senden JM, Petrick HL, van Kranenburg J, van Loon LJC, Holloway GP. Short-term bed rest-induced insulin resistance cannot be explained by increased mitochondrial H2 O2 emission. J Physiol. 2020 Jan;598(1):123-137. doi: 10.1113/JP278920. Epub 2019 Dec 26.
citation: Dirks ML, Smeets JSJ, Holwerda AM, Kouw IWK, Marzuca-Nassr GN, Gijsen AP, Holloway GP, Verdijk LB, van Loon LJC. Dietary feeding pattern does not modulate the loss of muscle mass or the decline in metabolic health during short-term bed rest. Am J Physiol Endocrinol Metab. 2019 Mar 1;316(3):E536-E545. doi: 10.1152/ajpendo.00378.2018. Epub 2019 Jan 15.
Clinical trial NCT01436825: Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
Official title: A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilia A
Keywords: Haemophilia A
Factor VIII
Pharmacokinetic
Computer Tool validation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 69
Sex: ALL
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 severe haemophilia A defined as residual factor VIII activity \< 1%
* or Patient with moderate haemophilia A (residual factor VIII activity \>1% and \<5%) with clinical signs of frequent, severe bleeding episodes
* Patient treated prophylatically with the same plasma or recombinant factor VIII for at least 6 months

Brief summary: OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical profile.

The study takes place during a single visit, at the time of patient enrollment in the study


Eligibility criteria: Inclusion Criteria:

* Patient with severe haemophilia A defined as residual factor VIII activity \< 1%
* or Patient with moderate haemophilia A (residual factor VIII activity \>1% and \<5%) with severe clinical profile
* Patient treated in prevention with the same plasma or recombinant factor VIII for at least 6 months
* Patient whose inclusion visit is performed during a routine visit including a measurement of plasma residual factor VIII :c level
* In the medical file (retrospective data) the pharmacokinetic parameters are available and have been obtained from a PK analysis of factor VIII level performed with the same anti haemophilic factor than the one used on the inclusion day

Exclusion Criteria:

* Patients with haemophilia B

Primary outcomes:
measure: The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool
timeFrame: after 1 month
measure: The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool
timeFrame: after 1 month
measure: The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool
timeFrame: after 1 month
Secondary outcomes:
measure: The dosage of factor VIII calculated by OPTIMS calculator
timeFrame: within 48 hours after enrollment
measure: The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire
timeFrame: within 48 hours after enrollment
Other outcomes:
Locations:
city: Many Locations
country: France
city: Many Locations
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04753125: Interventions for Enhancing Adherence to Syphilis Treatment and Follow-up: Study Protocol for the Health Information and Monitoring of Sexually Transmitted Infections (SIM) Randomized Controlled Trial
Official title: Interventions for Enhancing Adherence to Syphilis Treatment and Follow-up: Study Protocol for the Health Information and Monitoring of Sexually Transmitted Infections (SIM) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Syphilis
Keywords: Prevalence
Incidence
Men who have sex with men
Protocol
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance. The recruitment of participants will be done by invitation, and tests will be performed in a mobile unit in locations accessible to large populations. The goal is to perform 10,000 quick tests, with results confirmed by venereal disease research laboratory (VDRL) tests. Patients with a confirmed diagnosis according to VDRL test results will be randomized in one of three monitoring arms: follow-up by telephone, follow-up via a game in a smartphone app, or conventional follow-up by a health professional. All analyses will follow the intention-to-treat principle.


Eligibility criteria: Inclusion Criteria:

* All adults aged 18 years and older with sorologic test positive for syphilis

Exclusion Criteria:

* Participants who did not return after three contact attempts will be excluded from the study,
* pregnant women
* participants who are not able to provide contact information
* participants who are illiterate
* participants those who underwent syphilis treatment within the previous three months.

Primary outcomes:
measure: complince of treatment
timeFrame: ut to 12 months (July 2023)
measure: complince of exams
timeFrame: up to 12 months (July 2023)
Secondary outcomes:
measure: identify behavioral risk factors for non-adherence to treatment
timeFrame: upt to 12 months (July 2023)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05631925: Comparison of Two Different Anesthesia Methods in IVF Procedure
Official title: Comparison of Two Different Anesthesia Methods During Oocyte Retrieval for in Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oocyte Retrieval
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study; during the oocyte retrieval procedure, it was aimed to compare two different general anesthesia methods, in which propofol was administered as infusion according to the patient's Bispectral index system (BIS) value or in bolus doses according to the patient's clinic.The hypothesis of the study; during the oocyte retrieval process, when propofol is administered as an infusion and accompanied by BIS monitoring, adequate anesthesia level will be achieved with less amount of bolus doses according to the clinical condition of the patient.

Detailed description: 130 patients over the age of 18, ASA I-II, who underwent oocyte retrieval for IVF treatment were included in the study. The patients divided into two groups. In induction, 2mg/kg fentanyl, 40mg lidocaine and 2mg/kg propofol administered to all patients. Patients in group 1; propofol added in bolus doses of 0.5mg/kg. Doses determined according to the clinical condition of the patient. Patients in group 2; propofol administered as 10mg/kg/hour infusion. The infusion dose adjusted so that the Bispectral index (BIS) is in the range of 40-60.

Eligibility criteria: Inclusion Criteria:

* Over 18 years
* ASA I-II
* Patients who underwent oocyte retrieval for IVF treatment

Exclusion Criteria:

1. The patient does not want to participate
2. ASA \> II patients
3. Patients under 18 years of age
4. Patients who are allergic to the drugs used
5. Patients with mental illness
6. Patients with alcohol or substance addiction

Primary outcomes:
measure: Propofol
timeFrame: up to 1 hour
Secondary outcomes:
measure: Observer's assessment of sedation scale (OSS)
timeFrame: up to 1 hour
measure: (Post Anesthetic Discharge Scoring System) PADSS
timeFrame: up to 6 hour
measure: (Satisfaction of patients) STF 1
timeFrame: up to 6 hour
measure: (Satisfaction of gynecologist) STF 2
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Kozyatagi Hastanesi
Study officials:
affiliation: Acibadem University, Acibadem Kozyatagi Hastanesi
name: Sevgi Bilgen
role: STUDY_CHAIR
References:
Clinical trial NCT00398125: Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
Official title: A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infection, Human Immunodeficiency Virus
HIV-1 Infection
Keywords: GSK364735
HIV-1
integrase inhibitor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults


Eligibility criteria: Inclusion criteria:

* Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL.
* Baseline CD4 cell count greater than 100.
* Females must be of non-childbearing potential
* Not have received antiretroviral therapy in the 12 weeks prior to first dose.

Exclusion criteria:

* Must not be infected with hepatitis B or C.
* Patients must not have any acute laboratory abnormality.
* Must not have any active CDC (Centers for Disease Control and Prevention)Category C disease (1993), except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.

Primary outcomes:
measure: Change in viral load
timeFrame: from Day 1 to Day 11
measure: Amount of drug in blood
timeFrame: on Days 1 and 10.
Secondary outcomes:
measure: Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
timeFrame: throughout the study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Newark
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05582525: COVID-19 Vaccines and the Development of New LUTS
Official title: Relationship Between the Coronavirus 2019 Disease (COVID-19) Vaccines and the Development of New Lower Urinary Tract Symptoms: A Cross-sectional Study on Medical Students.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccine Adverse Reaction
Lower Urinary Tract Symptoms
Keywords: COVID-19 Vaccines
LUTS
Medical students
Lead sponsor: The Hashemite University
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 341
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical students

Brief summary: This study was conducted to check whether coronavirus disease 2019 (COVID) vaccines have a relationship with LUTS or not in a healthy and mostly medically free population.


Eligibility criteria: Inclusion Criteria:

1. Medical Student
2. Having had a COVID-19 Vaccine

Exclusion Criteria:

None

Primary outcomes:
measure: New Lower Urinary Tract Symptoms
timeFrame: 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zarqa
country: Jordan
facility: The Hashemite University
Study officials:
affiliation: The Hashemite University
name: Jad K AlSmadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802525: A Low-fat Diet Combined With Moderate-intensity Aerobic Exercise Versus Low-fat Diet, Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
Official title: A Low-fat Diet Combined With Moderate-intensity Aerobic Exercise is More Effective Than a Low-fat Diet or Aerobic Exercise Alone on Dyslipidemia and Depression Status in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It was defined that exercise and dietary interventions are used to control dyslipidemia and depression in obese individuals, whilst rare investigations have examined the concurrent effects of a low-fat diet and moderate-intensity aerobic exercise training (MIAET) on dyslipidemia and depression in obese patients. Hence, we assessed the potential influences of a low-fat diet combined with MIAET on blood lipids and depression in those individuals.


Eligibility criteria: Inclusion Criteria:

* age of 30-50 years
* clinical diagnosis with obesity (BMI˃30)
* mild to moderate depression
* impaired blood lipids
* no use of medications last 6-12 months
* no smoking

Exclusion Criteria:

* neuromuscular, endocrinal, musculoskeletal, cardiovascular disorders
* severe depression
* patients using medications of dyslipidemia, depression, or obesity last 6-12 months.

Primary outcomes:
measure: Body Mass Index
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
References:
Clinical trial NCT00275925: Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures
Official title: A 24-Week Prospective, Open-Label, Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Adult Patients With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy, Partial Seizures
Keywords: partial epilepsy, oxcarbazepine, adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-01-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.


Eligibility criteria: Inclusion Criteria:

* males and females, 18 - 70 years of age;
* diagnosis of epilepsy, partial seizures;
* ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous therapy with antiepileptic drugs

Exclusion Criteria:

* progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
* non-epileptic seizures;
* drug or alcohol dependence during a year prior to screening;

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Epileptic activity at electroencephalography in rest
measure: Flash light and hyperventilation test with electroencephalography
measure: Frequency of epileptic episodes according to patient's diary
measure: Electrocardiogram analysis for rhythm and conduction
measure: Blood test for sodium, hepatic enzymes and blood cells
Secondary outcomes:
measure: Quality of Life assessment at baseline, last visit
measure: Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients with partial seizures
measure: Rate of patients with total and partial control of epilepsy
measure: Rate of patients requiring additional antiepileptic drugs
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Epilepsy Department of the Moscow Research Institute of Psychiatry
city: Moscow
country: Russian Federation
facility: Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University
city: Moscow
country: Russian Federation
facility: Neurology and Neurosurgery Department of the Russian State Medical University
city: Moscow
country: Russian Federation
facility: Neurology Department of I.M. Sechenov Moscow Medical Academy
city: Moscow
country: Russian Federation
facility: Neurology Department of Pediatric faculty of the Russian State Medical University
city: Moscow
country: Russian Federation
facility: Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy
city: Saint Petersburg
country: Russian Federation
facility: Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT05071625: CT Guided Percutaneous Vertebroplasty for Vertebral Non-union Following Posterior Fixation
Official title: A Retrospectice Evaluation of the Feasibility and Usefulness of a Percutaneous Vertebroplasty Performed on Patients Treated With Posterior Fixation Suffering Non-union After a Traumatic Non-neurologic Vertebral Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Fracture
Vertebral Trauma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with a percutaneous vertebroplasty in our centre between 01/07/2015 and 01/07/2020 under combined CT/fluoroscopy guidance

Brief summary: Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option.

The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation.

All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.


Eligibility criteria: Inclusion Criteria:

* PVP performed between July 2015-July 2020 under combined CT and fluoroscopy guidance;
* Previous PF for traumatic non-neurological thoracolumbar vertebral fracture;
* Imaging evidence of vertebral non-union;
* Pain and functional impairment persisting for more at least one month after PF;
* Informed patient consent for PVP procedure under CT and fluoroscopy guidance;
* Previous multidisciplinary case discussion between spine surgeons and interventional radiologists.

Exclusion Criteria:

* Age inferior to 18 years old
* Absence of complications due to orthopaedic hardware;

Primary outcomes:
measure: Effectiveness of the procedure assessing consolidation and pain reduction 1 month after percutaneous vertebroplasty
timeFrame: 18 months
Secondary outcomes:
measure: Technical success of the percutaneous vertebroplasty
timeFrame: 18 months
measure: Safety of the procedure
timeFrame: 18 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
Study officials:
References: