louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01158495: Outcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function Testing
Official title: Differentiating Outcome Measures in Infant and Early Childhood Lung Disease Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants/young children with cystic fibrosis, primary ciliary dyskinesia, or other chronic lung disease, followed at our CF Center or Pulmonary Clinics

Brief summary: To implement a new method of performing chest CT imaging in young children at Packard Children's Hospital entitled controlled ventilation infant/young child chest CT scanning. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.


Eligibility criteria: Inclusion Criteria:1) Infants and young children (age \<= 3 months to \< 5 years) and either 2) or 3) below.

2) Respiratory condition (e.g. cystic fibrosis (CF), primary ciliary dyskinesia, bronchopulmonary dysplasia, asthma, or other pulmonary condition) and under the care of a pediatric pulmonologist at LPCH.

3) Oncology condition (e.g. young children with or without cancer, who are being screened for lung metastasis) and are being followed by pediatric oncologists at LPCH.

4) For minors, informed consent by parent or legal guardian.

5) Ability to comply with study visit procedures as judged by the investigator. Exclusion Criteria:1) Acute wheezing and/or respiratory distress at Study visit.

2) Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit.

3) Oxygen saturation \< 90% on room air at study visit.

4) Any medical condition that in the opinion of the investigator precludes subject participation.

Primary outcomes:
measure: Quantitative CT air trapping & airway measurements
timeFrame: 6 mo
Secondary outcomes:
measure: Functional residual capacity (FRC) & Lung Clearance Index (LCI).
timeFrame: 6 mo
measure: Differences between Quantitative CT air trapping & airway measurements & multibreath washout (MBW) FRC and LCI.
timeFrame: 6 mo
measure: Correlation between LCI and quantitative air trapping
timeFrame: 6 mo
measure: Correlation between bronchial wall thickness measurements/bronchiectasis measurements and LCI/FRC
timeFrame: 6 mo
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Terry Earl Robinson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05575895: Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers
Official title: Evaluation of Systemic Microvascular Reactivity After Ingestion of an Energy Drink in Young Male Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Function
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2022-10-12
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy male volunteers with no relevant findings in the medical history

Brief summary: Purpose: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. Their consumption is rising worldwide, with only few conflicting studies examining their vascular effects in young adults. We evaluated microvascular reactivity (MR) before and after ED in young healthy male volunteers.

Methods: Systemic MR was evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis before, 90 and 180 minutes after the consumption of one can of ED or the same volume of water (control), followed by postocclusive reactive hyperemia (PORH).

Detailed description: Energy drinks (EDs) are nonalcoholic beverages whose main ingredients are sugar, taurine, and caffeine. These products are marketed as boosters of mental and physical performance and are increasingly used in Western societies. Case reports of adverse effects related to ED consumption have been described in healthy young individuals, including coronary artery vasospasm, and myocardial infarction. These data suggest that endothelial dysfunction (EDysf) plays a role in ED cardiovascular effects and have prompted studies with conflicting results. The present study evaluated the microvascular reactivity (MR) after ingestion of one can of ED compared to a control, in young healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

* healthy male volunteers with no relevant findings in the medical history

Exclusion Criteria:

* being a competitive athlete;
* being on regular medication;
* using illicit drugs;
* being allergic to coffee, taurine or any of the components of the selected energy drink; - -
* having a body mass index ≥ 30 kg/m2.

Primary outcomes:
measure: Endothelium-dependent skin microvascular reactivity
timeFrame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology, Ministry of Health, Brazil
city: Rio de Janeiro
country: Brazil
facility: Eduardo Tibiriçá
Study officials:
References:
Clinical trial NCT00766714: Efficacy Study of the Embryo Transfer Catheter
Official title: The Efficacy of the Embryo Transfer Catheter in IVF and ICSI is Operator-Dependent: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility (IVF Patients)
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-10-06
Enrollment: 1446
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A prospective randomized trial comparing Cook K-SOFT-5100 and Frydman classical catheter 4.5 for embryo transfer in human IVF/ICSI was performed. Three experienced operators participated in the trial, using a fixed distance transfer protocol. Primary endpoint was clinical pregnancy rate, secondary endpoints were rates of difficult transfer and of catheter failure. Patients were randomized by a computer program immediately prior to embryo transfer.


Eligibility criteria: Inclusion Criteria:

* patients undergoing embryo transfer in our IVF program between 2000 and 2005

Exclusion Criteria:

* patients not giving consent were excluded

Primary outcomes:
measure: Clinical pregnancy rates
timeFrame: End of study
Secondary outcomes:
measure: Rates of difficult transfer
timeFrame: End of study
measure: Catheter failure rate
timeFrame: End of study
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Petra De Sutter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yao Z, Vansteelandt S, Van der Elst J, Coetsier T, Dhont M, De Sutter P. The efficacy of the embryo transfer catheter in IVF and ICSI is operator-dependent: a randomized clinical trial. Hum Reprod. 2009 Apr;24(4):880-7. doi: 10.1093/humrep/den453. Epub 2008 Dec 18.
Clinical trial NCT01311414: Effect of Cafedrine/Theodrenaline and Urapidil on Cerebral Oxygenation
Official title: Effect of Cafedrine/Theodrenaline and Urapidil During Carotid Endarterectomy on Cerebral Oxygenation Measured by Near Infrared Spectroscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebral Ischemia
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During clamping of one internal carotid artery for endarterectomy, blood flow through this vessel has to be compensated by collateral arteries including the contralateral internal artery and vertebral arteries. In 7 % of all patients undergoing carotid endarterectomy this collateral flow is not sufficient to maintain adequate cerebral perfusion during clamping and ischemic brain damage is likely to emerge. To maximize cerebral blood flow during clamping, increase of blood pressure is a common procedure and routine at our institution. Increasing blood pressure can be enabled by tapering a mixture of Cafedrine und Theodrenalin (Akrinor®) until the designated blood pressure is reached. After declamping, the blood pressure has to be reduced to normal values to avoid postoperative hyperperfusion syndrome. This is enabled by tapering urapidil until normal blood pressure is achieved.

It has been shown that cerebral oxygenation measured by near infrared spectroscopy is reduced by intravenous application of norepinephrine. Otherwise, intravenous nitroglycerine increases cerebral oxygenation during cardiopulmonary bypass. Hence, cafedrine/theodrenalin and urapidil may also have an effect on cerebral perfusion. In this prospective randomized study the effect of cafedrine/theodrenalin and urapidil on cerebral oxygenation measured by near infrared spectroscopy is investigated.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for carotid endarterectomy

Exclusion Criteria:

* Cerebral disease

Primary outcomes:
measure: Cerebral oxygenation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT01943214: Prospective Cohort Study of the Body Constitution Among Type II Diabetes Mellitus Patients
Official title: Prospective Cohort Study of the Body Constitution Among Type II Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Body constitution
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 type II diabetes mellitus patients recruited from the Endocrinology \& Metabolism out patient clinic of Taichung Veterans General Hospital.

Brief summary: By analyzing the relationship between the body constitution and the progression of Type II diabetes mellitus, its morbidities, mortality and the impact of the life quality, we try to provide an useful tool, body constitution, to stratify the patients accordingly for individualized health care.

Detailed description: The study participants are recruited from the Diabetes Shared Care Network of the Taichung Veterans General Hospital (Taichung, Taiwan)

Eligibility criteria: Inclusion Criteria:

* patient diagnosed as Type II diabetes mellitus by Endocrinology specialist.
* aged from 20 to 75 years old.
* clear conscious, willing to join the program.

Exclusion Criteria:

* Severe mental illness, which lead to unable to fulfill the questionaire
* Major surgical intervention,medical events (such as acute myocardial infarction, cerebral vascular accident...et al.,), chemotherapy or radiation therapy within past one month , which made body constitution measurement unavailable.

Primary outcomes:
measure: Body constitution of type II diabetes mellitus patients
timeFrame: Two years follow up after being recruited
Secondary outcomes:
measure: All cause mortality of type II diabetes mellitus patients
timeFrame: Two years follow up after being recruited
measure: Life quality of diabetes mellitus patients
timeFrame: Two years follow up after being recruited
measure: Diabetic retinopathy of type II diabetes mellitus patients
timeFrame: Two years follow up after being recruited
measure: Diabetic nephropathy of type II diabetes mellitus patients
timeFrame: Two years follow up after being recruited
measure: Diabetic neuropathy of type II diabetes mellitus patients
timeFrame: Two years follow up after being recruited
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Chia I Tsai, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03997214: The Impact of Inspiratory Muscle Strength Training
Official title: The Impact of Inspiratory Muscle Strength Training on Weaning Parameters Among Ventilator-dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Dependency
Lead sponsor: Fooyin University
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. The experimental group received the intervention of respiratory muscles training 5 times/ a week for 6 weeks. The control group received normal care. The intervention was adjusted trigger sensitivity to 10% of the first recorded Maximal Inspiratory Pressure at the start of training, then increased the ventilator trigger sensitivity and training duration weekly. The largest of ventilator trigger sensitivity is not over 40% of the initial Maximal Inspiratory Pressure and the timing of training duration is no longer than 30 minutes.


Eligibility criteria: Inclusion Criteria:

* Age \>20y/o
* Vital signs stable
* MIP \<20cmH2O
* Ventilator FiO2\<40%, PEEP \<8
* Ventilator mode:PSV or SIMV

Exclusion Criteria:

* Patient or family refuse

Primary outcomes:
measure: Maximal inspiratory pressure
timeFrame: 7 weeks
measure: Tidal volume
timeFrame: 7 weeks
measure: Minute ventilation volume
timeFrame: 7 weeks
measure: Rapid shallow breathing index
timeFrame: 7 weeks
measure: Oxygenation index.
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Shinghou Hospital
state: Fengshan
Study officials:
affiliation: Fooyin
name: Hsiao-Yun Chang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01004614: Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
Official title: An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.


Eligibility criteria: Inclusion Criteria:

* Healthy;
* Body Mass Index (BMI) of 18 to 28 kg/m2;
* total body weight within the range of 50 to 100 kg

Exclusion Criteria:

* History of regular alcohol consumption exceeding 14 drinks/week
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 10 cigarettes per day

Primary outcomes:
measure: Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)
timeFrame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)
timeFrame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
measure: Apparent Terminal Elimination Phase Rate Constant (Kel)
timeFrame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
measure: Apparent Terminal Elimination Half-Life (T-half)
timeFrame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
measure: Mean Residence Time (MRT)
timeFrame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01346995: The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
Official title: The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* aged between 20 to 35 years
* healthy
* untrained (non-regular exercise participation \[i.e. \< 1 day/week\])

Exclusion Criteria:

* symptomatic musculoskeletal diseases
* history of traumatic injuries to muscles, tendons or joints of the lower extremity
* knee joint pain within a month prior to enrollment

Primary outcomes:
measure: Isokinetic knee muscle strength
timeFrame: At baseline and after 8 weeks of exercise
Secondary outcomes:
measure: One-leg chair rise
timeFrame: At baseline and after 8 weeks of exercise
Other outcomes:
Locations:
Study officials:
References:
citation: Sorensen TJ, Langberg H, Hodges PW, Bliddal H, Henriksen M. Experimental knee joint pain during strength training and muscle strength gain in healthy subjects: a randomized controlled trial. Arthritis Care Res (Hoboken). 2012 Jan;64(1):108-16. doi: 10.1002/acr.20618.
Clinical trial NCT01176695: Efficacy and Safety of a Fish Oil Containing Lipid Emulsion
Official title: A Randomized, Double Blind, Controlled, Parallel Group, Multicenter Study on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion vs. a Medium and Long Chain Lipid Emulsion in Patients Undergoing Elective Abdominal Surgery of Moderate Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parenteral Nutrition
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare a fish oil containing lipid emulsion against a medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and safety during postoperative parenteral nutrition.


Eligibility criteria: Inclusion Criteria:

* Patients considered for open abdominal surgery of moderate severity, e.g.. radical operation for stomach cancer or pancreaticoduodenal surgery
* Male and female patients ≥18 and \<85 years of age
* Indication for total parenteral nutrition therapy: for at least 5 consecutive days after operation
* Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study.

Exclusion Criteria:

* General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid intake and output, inadequate cellular oxygen supply)
* General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency
* Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
* Other

Primary outcomes:
measure: To investigate on the efficacy of fish oil on the nutrition status
timeFrame: day 1 to day 6
measure: To investigate on the efficacy of fish oil on an inflammatory parameter
timeFrame: day 1 to day 6
Secondary outcomes:
measure: Incidence of postoperative complications
timeFrame: 6 days
measure: Liver function
timeFrame: 6 days
measure: Coagulation parameters
timeFrame: 6 days
measure: Blood chemistry
timeFrame: 6 days
measure: SIRS
timeFrame: 6 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hospitals
city: Nanjing
country: China
facility: Nanjing Hospital
Study officials:
affiliation: Nanjing Hospital
name: Ning Li, Prof. MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: