louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00302289: B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients
Official title: B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: green tea
caffeine
tyrosine
energy expenditure
energy intake
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Science, Toxicology & Technology, San Francisco, California
First posted: 2006-03-14
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary aim was to measure the effect of green tea extract, tyrosine and caffeine on energy expenditure, appetite ratings and spontaneous energy intake together with recording of side effects in healthy normal weight subjects.

Detailed description: Background: Long-term weight maintenance of a weight loss is often unsuccessful. Often a weight regain is observed in most studies that could indicate that most subjects are not able to change their eating habits. There is a need for simple and safe methods to prevent weight gain and re-gain i.e. by increasing thermogenesis and decrease spontaneous energy intake (EI). Studies have shown that nutritional and food-related non-nutritional factors influence the adjustment of EI and EE as the compounds can enhance the diet-induced thermogenesis (DIT) and suppress appetite.

Method: The present study was designed as a 4-way crossover, randomised, placebo controlled, dou-ble-blind study. Each treatment was separated by \>3 d washout period. All treatments were administered as tablets containing either 500 mg green tea extract (whereof 125 mg cate-chins), 400 mg tyrosine, 50 mg anhydrous caffeine, or placebo.

on each test day body weight and composition was assessed. All participants underwent a 4.5-h assessment of energy expenditure by indirect calorimetry in a ventilated hood. Energy intake recorded of an ad libitum pasta salad brunch served after the last hood measurement

Subjects: Twelve healthy lean (20\<BMI\<25) weight stable non-smoking subjects between 18-40 years of age were tested 4 times each with a wash-out period of at least 3 days.

Eligibility criteria: Inclusion Criteria:

* Twelve healthy and normal-weight men (age: 23.72.6 y, BMI: 22.41.8 kg/m2) participated in the study. They were weight stable (within 3-kg in last 3 mo), non-smoking, non-athletic, and had no use of dietary supplements or frequent use of medication.

Exclusion Criteria:

-

Primary outcomes:
measure: heart rate
measure: blood pressure
measure: enegy expenditure
measure: energy intake
measure: subjective appetite sensations
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, The Royal Veterinary and Agricultural University
Study officials:
affiliation: Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
name: Astrup Arne, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347789: Effectiveness of a Procedure for Previously Failed Glaucoma Surgery
Official title: Efficacy of Transconjunctival Mitomycin-C in Needle Revisions of Failing Trabeculectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: glaucoma
trabeculectomy
filtering bleb revision
intraocular pressure
needling procedure
mitomycin C
Lead sponsor: Glaucoma Research & Education Group
Sponsor class: OTHER
Collaborators: name: PharmaLogic Development, Inc.
First posted: 2006-07-04
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Transconjunctival mitomycin-C in needle bleb revision may be an effective procedure to treat cases with a previously failed trabeculectomy. We will investigate approximately 100 consecutive cases with follow up of up to 9 years. We anticipate that this procedure is an effective, safe, and appropriate option for successful glaucoma treatment.

Detailed description: The healing process after filtering surgery for glaucoma may cause an unsuccessful outcome for the trabeculectomy procedure. In order to control the rising intraocular pressure due to the failed trabeculectomy, medications may be restarted and/or filtering surgery may need to be repeated. Our primary research showed that transconjunctival mitomycin-C in needle bleb revision may be an effective procedure to control this situation.

This retrospective study will follow over 100 patients from May 1997 to May 2006. This long-term follow up will help assess the future role of this technique in glaucoma practices.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of glaucoma
* Failed filtering procedures- defined as intraocular pressure exceeded target pressure thus inducing possible further optic nerve damage

Exclusion Criteria:

- Needling combined with other ocular surgical or laser treatments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Glaucoma Center of San Francisco
state: California
Study officials:
affiliation: Glaucoma Reseach & Education Group
name: Andrew G. Iwach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06747689: Association Between Sleep Quality and Self-Care in Heart Failure Patients
Official title: Effect of Sleep Quality on Self-Care in Patients with Heart Failure: a Longitudinal Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Sleep Quality
Self Care
Cognitive Function
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from the cardiology clinic of Dokuz Eylül University Hospital.

Brief summary: The research will be conducted as a prospective and relational study to longitudinally investigate the effect of sleep quality on self-care in patients with heart failure (HF) and to evaluate the relationship between self-care, sleep quality, and cognitive functions. The sample size was calculated using the multiple linear regression model with the G\*Power Version 3.1 program. Based on a medium effect size of 0.15, an alpha of 0.05, a power of 0.95, and 18 predictors, the sample size was determined to be 188. Considering a potential dropout rate of 10%, it was decided to complete the study with a minimum of 207 participants.

Data will be collected from patients who apply to the Dokuz Eylül University Cardiology Outpatient Clinic and meet the inclusion criteria. After signing the informed consent form, participants will be followed up at baseline, the 1st month, the 3rd month, and the 6th month by telephone. The Statistical Package for Social Sciences (SPSS) 24.0 will be used to analyze the numerical data of the research. Descriptive statistics, including number, percentage, mean, and standard deviation, as well as inferential statistics such as the χ2 test, t-test for independent groups, and multiple linear regression, will be employed in the data analysis.


Eligibility criteria: The study will include patients who:

* Are diagnosed with heart failure according to international guidelines,
* Are aged 18 years or older,
* Can communicate via phone, and
* Are willing to participate in the study.

Exclusion Criteria:

The study will exclude patients who:

* Have been hospitalized within one month prior to inclusion,
* Have experienced major psychological trauma or stress in the last three months,
* Have serious comorbidities or malignant cancers,
* Have advanced hearing impairment,
* Are using prescription drugs for insomnia or psychiatric conditions,
* Work night shifts, or
* Reside in nursing homes.

Primary outcomes:
measure: Sleep quality
timeFrame: From December 2024 to January 2026
measure: Self Care
timeFrame: From December 2024 to January 2026
Secondary outcomes:
measure: Cognitive Fuction
timeFrame: From December 2024 to January 2026
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital
Study officials:
References:
Clinical trial NCT03456089: Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing
Official title: Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Urinary Bladder, Neurogenic
Urodynamics
Keywords: urodynamics
neurogenic
bladder
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.

Detailed description: For patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. This monitoring is currently done by in-office urodynamics testing (UDS). This testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions.

This study utilizes a novel pressure monitoring device which is portable and hooks to the end of a standard urinary catheter. The investigators will be investigating if this device can achieve similar pressure measurements as UDS. The investigators hope is that this device will provide similar measurements to UDS, and can be developed as a home bladder-pressure monitoring tool.

This study will enroll children with neurogenic bladder who are currently undergoing UDS as part of their regular care. The measurements will be taken as part of the standard UDS protocol (with insertion of the UDS catheter) and will then be compared to the values obtained with UDS testing.

Eligibility criteria: Inclusion Criteria:

* must have diagnosed neurogenic bladder
* undergoing urodynamics testing as part of routine clinical care

Exclusion Criteria:

-None

Primary outcomes:
measure: Bladder Pressure
timeFrame: During UDS testing
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics, Department of Urology
state: Iowa
Study officials:
affiliation: MD
name: Chris Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02789189: Nedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent and Metastatic Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic nasopharyngeal carcinoma


Eligibility criteria: Inclusion Criteria:

* biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VII,or recurrent disease after chemotherapy and/or radiotherapy; 18 years or older; without other malignancy; proper functioning of the major organs.

Exclusion Criteria:

* allergic to nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 months.

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02707289: Retrospective Collection of PillCam SB Movies
Official title: Retrospective Collection of PillCam SB Movies for Capsule Transit Time Analysis (OCEAN Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease, Crohn Disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2016-03-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to two hundred un-identified PillCam SB movies that were created between the year 2008 and the date the study was approved by the IRB, will be collected

Brief summary: Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites, during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected. Capsule transit time in the different sections of the GI will be evaluated.

Detailed description: Up to two hundred un-identified PillCam SB movies that were created between the year 2008 and the date the study was approved by the IRB, will be collected from 2 clinical sites, Sourasky and Sheba medical centers during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected. Capsule transit time in the different sections of the GI will be evaluated by internal readers.

Eligibility criteria: Inclusion Criteria:

Videos collected from any PillCam SB procedure

Exclusion Criteria:

None

Primary outcomes:
measure: Transit time in the different sections of the GI according to PillCam SB movies (minutes)
timeFrame: Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: The Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Abraham Eliakim, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01134289: Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block
Official title: An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Complex Regional Pain Syndrome
Keywords: complex regional pain syndrome
lumbar sympathetic blockade
photoplethysmography
diagnostic lumbar sympathetic blockade
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to compare the alternative current and the direct current signal changes of photoplethysmography between both feet during one side lumbar sympathetic block.

The hypothesis is that signal changes occur earlier than other indices to decide whether it is successful following lumbar sympathetic block on only one-side.


Eligibility criteria: Inclusion Criteria:

* Physically examined for complex regional pain syndrome on lower extremity,
* Scheduled for diagnostic lumbar sympathetic blockade.

Exclusion Criteria:

* Graded as ASA 3 or higher,
* Below 18 or above 70 years of age, or
* Had any other contraindication for regional anesthesia.

Primary outcomes:
measure: Index of sympathetic block
timeFrame: 1 minute at intervals from baseline through end of procedure
Secondary outcomes:
measure: skin temperature changes
timeFrame: 1 minute at intervals during procedure
measure: electrocardiogram
timeFrame: 1 minute at intervals from baseline through end of procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06312189: Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
Official title: Open-Label Study of Valbenazine for the Treatment of Chorea Associated With Huntington Disease in Canada
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Chorea, Huntington
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada.


Eligibility criteria: Key Inclusion Criteria:

* Participated in Study NBI-98854-HD3006 and completing dosing through the Week 156 visit; or were actively participating, receiving study treatment, and completed an early termination visit Study NBI-98854-HD3006 at the time of the study closure at sites in Canada.
* Participants of childbearing potential must agree to use contraception consistently while participating in the study until 30 days after last dose of the study treatment.

Key Exclusion Criteria:

* Have difficulty swallowing
* Are currently pregnant or breastfeeding
* Have a medically significant abnormality, physical examination finding, clinically significant laboratory abnormality

Primary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 106
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Neurocrine Clinical Site
state: British Columbia
city: Ottawa
country: Canada
facility: Neurocrine Clinical Site
state: Ontario
city: Toronto
country: Canada
facility: Neurocrine Clinical Site
state: Ontario
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT03483389: Alcohol and Immune Response
Official title: Immune Activation and Neurodegeneration in HIV Infection and Heavy Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol; Harmful Use
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study investigates how alcohol affects the immune system and behavior in healthy adults. The study also will examine how an individual's typical drinking habits may affect the immune system's response to alcohol.


Eligibility criteria: Inclusion Criteria:

* Ages 21-55 years
* Able to speak and read English
* Regular use of alcohol
* Weight \> or = to 110 lbs and body mass index (BMI) in the 18.5-30 kg/m2 range
* No self-reported use of drugs

Exclusion Criteria:

* Currently seeking treatment for alcohol or drug use
* Chronic disease
* Use of certain medications
* GI disorders
* Daily/near-daily use of NSAIDs
* Positive urine test for certain drugs
* History of withdrawal symptoms precipitated by alcohol abstinence
* Clinical Institute Withdrawal Assessment for Alcohol score greater than or equal to 10
* History of seizures
* Current major psychiatric disorder
* History of adverse reaction to standard blood draw
* Inability to abstain from tobacco for 8 hours
* Inability to abstain from cannabis for 48 hours
* Pregnant, breastfeeding, or may become pregnant

Primary outcomes:
measure: Plasma lipopolysaccharide (pg/ml)
timeFrame: 0-4 hours
measure: Plasma lipopolysaccharide binding protein (ng/ml)
timeFrame: 0-4 hours
measure: Soluble cluster of differentiation 14 (ng/ml)
timeFrame: 0-4 hours
measure: Soluble cluster of differentiation 163 (ng/ml)
timeFrame: 0-4 hours
Secondary outcomes:
measure: Response time in ms
timeFrame: 0-4 hours
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References:
Clinical trial NCT06537089: Comparative Study Between Using WHO Labour Care Guide & Modified WHO Partograph
Official title: Comparative Study Between Using WHO Labour Care Guide & Modified WHO Partograph in Reducing Primary Cesarean Section in Primiparous Women in Active First Stage of Labour.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Labor Onset and Length Abnormalities
37 or More Completed Weeks of Gestation
First Birth
Keywords: labour Monitoring
primiparous
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This randomized controlled study will be conducted on 230 low-risk pregnant women admitted in labor in the labor room (LR) in kasr Alainy hospital.

Enrollment at the time of admission as per inclusion and exclusion criteria. After informed consent, randomization and allocation to study and control groups will be conducted using a computer- generated sequence, and enrollment continues until the desired sample size of 115 is reached in each group.

Brief summary: This randomized clinical trial is based on comparing the efficiency of modified WHO partographs vs. the new WHO labour care guide in monitoring and assessing the outcome of labour.

Detailed description: A group of primiparous women in first stage of labour will be randomized into two groups then monitored during first stage of labour. First group will be monitored by modified WHO partograph. The rest of participants will be monitored by WHO labour care Guide. The labour will be monitored regarding progress rate, mode of delivery.

Eligibility criteria: Inclusion Criteria:

* Primiparous women.
* Term gestation between 37 and 40 weeks.
* Maternal age from 18 -35 years
* Body mass index BMI of 18.5 to 29.9 kg/m2
* Cephalic presentation. 6. Active first stage of labour

Exclusion Criteria:

* Women with any medical comorbidities, such as (hypertension, diabetes mellitus, renal disease, or pulmonary disease).
* Women with presence of any obstetrical complications, such as preterm birth, multiple gestation, breech presentation, postdated pregnancy, or bad obstetrical history.
* women who were given intrapartum epidural analgesia.

Primary outcomes:
measure: Rate of primary caesarean section
timeFrame: First and second stage of labour
Secondary outcomes:
measure: Duration of active phase of first stage of labour
timeFrame: First stage of labour
measure: Duration of second stage of labour
timeFrame: Second stage of labour
measure: need for oxytocin use
timeFrame: First stage of labour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: kasr Al Aini, Faculty of Medicine, Cairo University
state: Old Cairo
Study officials:
References: