louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01934946: Rehabilitation Care for Hip Fracture
Official title: Effectiveness of Post Acute Rehabilitation Care for Hip Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fracture
Keywords: hip fracture
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2013-09-04
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no adequate rehabilitation was given. The aim of the study is to compare the effectiveness of different types of post acute rehabilitation care for hip fracture.

Detailed description: Method: This study will recruit 150 peoples with hip fracture from hospitals in Taipei from Jan 1, 2014 to Dec 31, 2014. The subjects from wards are randomly divided into group A, B and Group C. Each group includes 50 cases of hip fracture. Group C received 14 days hospitalization for comprehensive rehabilitation and 6 times home rehabilitation services within 3 months; Group B received 14 days hospitalization for comprehensive rehabilitation and Group A was control group.

Eligibility criteria: Inclusion Criteria:

1. more than 60 years old,
2. hip fracture s/p within 3 months,
3. potential for rehabilitation.

Exclusion Criteria:

1. Active infection, such as pneumonia, UTI, osteomyelitis, wound infection
2. Other uncontrolled medical condition, such as, dyspnea on exertion, acute renal failure, acute coronary syndrome, acute heart failure, uncontrolled diabetes, active malignancy, DVT, possibility of pulmonary embolism, acute psychosis
3. No caregiver
4. No potential for rehabilitation, such as severe dementia, poor cognition, poor cooperation and motivation, poor family support
5. ESRD on Hemodialysis

Primary outcomes:
measure: Pain scale
timeFrame: 2 weeks and 3 months after intervention
Secondary outcomes:
measure: Barthel Activity of Daily Living
timeFrame: 2 weeks , 3 months after intervention
Other outcomes:
measure: Harris Hip Score
timeFrame: 2 weeks , 3 months after intervention
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Taipei City Hospital
name: MUJUNG KAO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01616446: Pharmacokinetics of Cyclosporin in Nephrotic Syndrome
Official title: PHARMACOKINETICS OF CYCLOSPORIN - A MICROEMULSION IN CHILDREN WITH IDIOPATHIC NEPHROTIC SYNDROME
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotic Syndrome
Keywords: cyclosporin
nephrotic syndrome
pharmacokinetics
children
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Iidiopathic nephrotic syndrome followed in the Pediatric Nephrology Unit of Instituto da Criança-HCFMUSP

Brief summary: The purpose of this study is to evaluate whether there are differences in the pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease in children.

Detailed description: This is a prospective study on ten children using Cyclosporin-A (CSA) microemulsion to treat idiopathic nephrotic syndrome (INS), with normal renal function, who achieved complete remission with CSA. The objective is to compare the pharmacokinetic (PK) parameters of CSA in INS during remission and relapse of the disease. The PK profile of CSA was evaluated with the 12-hour area under the time-concentration curve (AUC0-12) using seven time-point samples. This procedure was done on each patient during remission and relapse with the same CSA dose in mg/kg/day. The AUC0-12 was calculated by trapezoidal rule. All PK parameters and the resumed 4-hour area under the time-concentration curve (AUC0-4) were correlated with AUC0-12. This study is very important because the cyclosporin is a nephrotoxic drug with narrow therapeutic window.

Eligibility criteria: Inclusion Criteria:

* children with steroid-resistant nephrotic syndrome and steroid-dependent nephrotic syndrome in use of cyclosporine
* renal function evaluated by creatinine clearance estimated by stature ≥ 90 ml/min/1.73m2
* cyclosporine trough level (C0) between 50 and 150 ng/ml
* complete remission with cyclosporine according to the guidelines of International Society of Kidney Diseases in Children

Exclusion Criteria:

* renal and hepatic function abnormalities
* presence of infectious disease
* clinical or histological signs of CSA nephrotoxicity and suspicious of non-compliance

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade de Sao Paulo
Study officials:
References:
citation: Henriques Ldos S, Matos Fde M, Vaisbich MH. Pharmacokinetics of cyclosporin--a microemulsion in children with idiopathic nephrotic syndrome. Clinics (Sao Paulo). 2012 Oct;67(10):1197-202. doi: 10.6061/clinics/2012(10)12.
Clinical trial NCT00582946: Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
Official title: Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hearing Impairment
Keywords: Hearing Loss, Eardrum, Transducer, Hearing in Noise
Lead sponsor: EarLens Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2007-12-28
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. These include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. Current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. We plan to achieve our goal by reducing to practice three key enabling concepts. The first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. The second is to increase the output bandwidth of the hearing aid. The third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. First phase includes verification the capability of the system to deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing loss in the target fitting range.


Eligibility criteria: Inclusion Criteria:

* Hearing loss less than 60 dB at any frequency, no conductive hearing loss

Exclusion Criteria:

* Collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss

Primary outcomes:
measure: Maximum Effective Sound Pressure Level (MEPO)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Ear Lens Corporation
state: California
Study officials:
affiliation: Ear Lens Corporation
name: Sunil Puria
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perkins R, Fay JP, Rucker P, Rosen M, Olson L, Puria S. The EarLens system: new sound transduction methods. Hear Res. 2010 May;263(1-2):104-13. doi: 10.1016/j.heares.2010.01.012. Epub 2010 Jan 29.
Clinical trial NCT01343446: Sleep Impairment and Coping Style in Diabetes
Official title: Sleep Impairment Can Influence The Coping Style Of Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Sleep Disorders
Coping Skills
Keywords: Sleep impairment, Coping Style, Diabetes Mellitus
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Followed-up in Cerrahpasa Clinics of Diabetes Patients with diabetes Patients with/without diabetic complication Patients suffer from sleep impairment

Brief summary: To examine the effect of sleep impairment on coping style of patients with diabetes

Detailed description: Abstract Objective: To examine the effect of sleep impairment on coping style of patients with diabetes Research Design and Methods: A total of 105 patients (40 male, 65 female) with diabetes mellitus were recruited from outpatient diabetic clinics in 2011 February. All patients were asked to fill the sociodemographic inquiry, Epworth Sleepiness Scale and Coping Style Inventory.

Eligibility criteria: Inclusion Criteria:

- Patients with diabetes longer than 6 months

Exclusion Criteria:

- Complications as a congestive heart failure, chronic renal failure

Primary outcomes:
measure: Coping style of Patients with Diabetes suffer from Sleep Disorder
timeFrame: Up to 1 week (Patients at follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Diabetes and Metabolism Outpatients Clinic of Cerrahpasa School of Medicine
Study officials:
affiliation: Department of Psychiatry, Cerrahpasa School of Medicine
name: Murat Emül, Assoc.Prof.
role: STUDY_DIRECTOR
References:
citation: Luyckx K, Seiffge-Krenke I, Hampson SE. Glycemic control, coping, and internalizing and externalizing symptoms in adolescents with type 1 diabetes: a cross-lagged longitudinal approach. Diabetes Care. 2010 Jul;33(7):1424-9. doi: 10.2337/dc09-2017. Epub 2010 Mar 31.
Clinical trial NCT04320446: Caffeine Increases Maximal Fat Oxidation During Exercise in Endurance-trained Men: is There a Diurnal Variation
Official title: Caffeine Increases Maximal Fat Oxidation During Exercise in Endurance-trained Men: is There a Diurnal Variation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Metabolism
Athletic Performance
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Maximal fat oxidation during exercise (MFO) and the intensity of exercise that elicits MFO (Fatmax) has been recognized as potential determinants of endurance performance.

The purpose of this study was to determine the possible interaction between the effects of diurnal variation (morning vs. afternoon) and caffeine ingestion on MFO, Fatmax and VO2 max in endurance-trained men. Specifically, the investigators sought to elucidate whether the stimulant actions of caffeine could reverse the decrements of MFO and Fatmax observed in the morning.

Detailed description: Body weight, height, body composition (DXA), exercise test (MFO and VO2max assessment) will be measured during the 4 evaluations.

Participants were randomized into 4 exercise test conditions:

1. Exercise test in the morning with placebo intake
2. Exercise test in the evening with placebo intake
3. Exercise test in the morning with caffeine intake
4. Execrise test in the evening with caffeine intake

Eligibility criteria: Inclusion Criteria:

* Having a body mass index (BMI) ranged from 18.5 to 28 kg/m2
* not suffering any specific disease which can be aggravated by physical exercise
* having previous experience in endurance training (i.e. self-reporting at least 2 years of cycling or running training including more than 3 training sessions/week).
* Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.

Exclusion Criteria:

* Being smoker
* Taking medication or drugs
* Any non-controlled medical condition which could influence results or could be worsened by the participation in the study
* Are deemed unsuitable by the investigator for any other reason, that prevent data collection.

Primary outcomes:
measure: MFO
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: FATmax
timeFrame: Through study completion, an average of 1 month
measure: VO2max
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Instituto Mixto Universitario Deporte Salud
Study officials:
affiliation: Universidad de Granada
name: Jonatan Ruiz Ruiz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramirez-Maldonado M, Jurado-Fasoli L, Del Coso J, R Ruiz J, Amaro-Gahete FJ. Caffeine increases maximal fat oxidation during a graded exercise test: is there a diurnal variation? J Int Soc Sports Nutr. 2021 Jan 7;18(1):5. doi: 10.1186/s12970-020-00400-6.
Clinical trial NCT04018846: The Future of Revascularization Using a Bioprotec Graft
Official title: The Future of the Revascularization Using a Bioprotec Graft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: Peripheral Artery Disease
Revascularization
Graft
Vein
Artery
Limb
Amputation
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Grafted patient with a vascular BIOPROTEC graft in case of a Peripheral artery disease.

Brief summary: The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.

Detailed description: The BIOPROTEC grafts are controverted: they are useful in some cases, but they are known as frequently broken or thrombosed. However they are always posed in a complicated situations, in a fragile patients who have ever had many of revascularizations or in an infectious state (which is supportive of the pseudoaneurysm and thrombosis) Despite the frequent use of this graft in France, the results have never been published.

Eligibility criteria: Inclusion Criteria:

* ≥ Eighteen years old.
* Critical ischemia (Phase 4-6 of Rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable.

Exclusion Criteria:

* Pregnant woman.
* Patient with an acute ischemia.
* Patient with an exceeded ischemia.

Primary outcomes:
measure: The Limb rescue rate one year after a BIOPROTEC graft
timeFrame: Two years
Secondary outcomes:
measure: The revascularization permeability rate
timeFrame: Two years
measure: The amputation rate
timeFrame: Two years
measure: Infection resistance rate
timeFrame: Two years
Other outcomes:
Locations:
city: Cergy-Pontoise
country: France
facility: Cntre Hospitalier René Dubos
Study officials:
affiliation: Pitié Salpêtrière Vascular Surgery Service
name: Jean-Michel DAVAINE, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01425346: ClearPath DS-120 Clinical Study Protocol
Official title: Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmic, Healthy Eyes
Keywords: Ophthalmic, healthy eye, fluorescence, lens
Lead sponsor: Freedom Meditech
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 128
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, normal subject population with healthy eyes as determined by standard comprehensive ophthalmic examination.

Brief summary: The goal of this study is to measure lens fluorescence in normal subjects at various chronological ages that could serves as a guide to clinicians in determining changes in eye health. A measure of lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.


Eligibility criteria: Inclusion Criteria:

* Persons between the ages of twenty-one (21) and seventy (70). Best efforts shall be made to include as many patients as possible between the ages of thirty-five (35) and sixty (60).
* Subject must be able to read or understand and give informed consent.
* Pass the medical health history and comprehensive ophthalmic examination (which is determined by the investigator if the test subject has a normal ophthalmic examination and is in overall good health). Ophthalmic examination includes a clinical evaluation of the subject's eyes and a complete manifest refraction producing a best aided visual acuity of \<20/40.

Exclusion Criteria:

* Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye.
* Subject has been clinically diagnosed with cataracts in the study eye.
* Subject has had a fluorescence angiogram within the last six months.
* Subject has undergone a treatment using photodynamic drugs within the last year.
* Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam.
* Subject was fit with contact lens within the last 30 days.
* Subject has ocular surface (dry eye) disease.
* Subject is unable to cooperate with or understand clinical instructions.
* Subject is unable to complete test sequence

Primary outcomes:
measure: Lens fluorescence
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Optometry Practice
state: California
Study officials:
affiliation: San Diego Optometry Practice
name: Stephen W. Lum, O.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05992246: The Ratio of Femoral Vein Diameter to Femoral Artery Diameter to Predict Fluid Responsiveness in Children
Official title: The Validity of the Ratio of Femoral Vein Diameter to Femoral Artery Diameter to Predict Fluid Responsiveness in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Fluid Overload
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 85
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preoperative children with ASA physical status 1-2, 2-10 years of age scheduled for elective surgery with signs of moderate to severe dehydration for assessment of fluid status just before induction of general anaesthesia

Brief summary: The hypothesis of the study will be that the ratio of femoral vein diameter to femoral artery diameter will have correlation with fluid status in pediatrics.

Detailed description: Proper administration of intravenous fluids is an important part of treating circulatory failure in children and affects the clinical outcome of the management of the child's emergency. Giving a small amount of fluid will cause tissue hypoperfusion and worsen organ dysfunction and cause ischemia. On the other hand, excess fluid interferes with oxygen delivary, exacerbates treatment outcomes, increases complications, and extends both the length of the stay in intensive care and mortality. The use of bedside ultrasound by pediatric intensive care physicians has become so critical in recent years that it is now a component of physical examination in ICUs

Eligibility criteria: Inclusion Criteria:

* children with American society of anaesthesiologist physical status 1-2
* 2-10 years of age
* scheduled for elective surgery
* signs of moderate to severe dehydration

Exclusion Criteria:

* Patients with mild dehydration.
* Patients with history of significant comorbid conditions or previous laparotomy.
* Congenital heart disease.
* Heart failure.
* Disorder of venous return like arteriovenous fistula, DVT or Varicose veins.
* Increase intra-abdominal pressure.

Primary outcomes:
measure: Measurement of changes in the ratio of femoral vein diameter to femoral artery diameter
timeFrame: immediate preoperative period before the induction of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of medicine, Tanta university
state: El Gharbyia
Study officials:
affiliation: tanta university, faculty of medicine
name: sameh Fathi, MD
role: STUDY_DIRECTOR
References: