louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06431035: Caffeine & Bodybuilding Dehydration Ability
Official title: Effect of Caffeinated Chewing Gum on Dehydration Ability in Bodybuilding Athletes: a Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Placebo
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The participants were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design.
Primary purpose: TREATMENT

Brief summary: 15-20 trained bodybuilding athletes were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight.

Detailed description: The purpose of this study was to investigate the effect of caffeinated chewing gum on dehydration ability in bodybuilding athletes. Methods: 15-20 trained bodybuilding athletes were divided into caffeine gum trial (CAF) and placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 5 mg/kg of caffeine) or placebo gum (PL) for 10 minutes. After rested for 15 minutes, Participants used the bicycle to adjust the pedal resistance and speed according to their own feelings until they were dehydrated to 2% of their original body weight. Record time from exercise to completion of dehydration, heart rate, HRV, energy expenditure, fat oxidation rate and carbohydrate oxidation rate.

Eligibility criteria: Inclusion Criteria:

* having won the top 8 places in a national competition,
* having no cardiovascular or joint diseases
* being an adult male

Exclusion Criteria:

* no top 8 finishes at national level
* cardiovascular or joint disease, or any other condition that could be impaired by exercise
* female and underage participants
* previous caffeine allergy

Primary outcomes:
measure: dehydration speed
timeFrame: 15 minutes after intervention
Secondary outcomes:
measure: energy expenditure
timeFrame: 15 minutes after intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
affiliation: National Taiwan University of Sport
name: ChihHui Chiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01843335: Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
Official title: Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Aortic Aneurysm
Endoleak
Keywords: Cardiovascular Diagnostic Technique
Ultrasound
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: SINTEF Health Research
First posted: 2013-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in follow-up after endovascular implantation of abdominal aortic prothesis, Central Norway

Brief summary: X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate information about endoleak after EVAR. Benefits of CEUS over CT include less radiation exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent application and decrease in the cost of EVAR follow-up. This study is designed to investigate if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to gain experience with the technique and to introduce CEUS as an alternative for detection of endoleak in this hospital.


Eligibility criteria: Inclusion Criteria:

* in follow-up after endovascular implantation of abdominal aortic prothesis

Exclusion Criteria:

* None

Primary outcomes:
measure: Detection of endoleak with CEUS
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: National Taiwan Normal University
name: Reidar Brekken, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02492035: Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting
Official title: Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
lifestyle
clinical trials
primary care setting
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Fondation IUCPQ
name: CSSS-VC
name: GMF-UMF Laval-Québec
First posted: 2015-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The Canadian hypertension education program recommends increased physical activity, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, and reduction in sodium and alcohol intake for treatment and prevention of hypertension. Objective: To describe patients participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a family medicine primary care setting. Design: Descriptive study. Participants: The study aims to recruit 60 sedentary hypertensive patients to participate in a 6-month randomized-controlled trial. To be eligible, patients must be ≥18 years of age, sedentary (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood pressure measurements \[ABPM\]), non-smoker, non-diabetic and without dyslipidemia. Intervention: Patients are recruited by health care professionals of the family medicine unit and are thereafter randomized to one of four intervention groups: 1) standard medical care (control), 2) improved diet (DASH diet), 3) physical activity, or 4) both improved diet and physical activity. Patients are evaluated (pre, mid and post intervention), monitored, and educated by the interdisciplinary health care team that includes a physician, a kinesiologist, a nutritionist and a nurse, depending on the intervention group. T-tests and descriptive statistics were used to analyse data. This study will document the efficacy of a primary care lifestyle intervention program on cardiometabolic and hypertension risk factors.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Sedentary (7-day measured steps/day and self-report)
* Arterial hypertensive (based on 24-h ambulatory blood pressure measurements \[ABPM\])

Exclusion Criteria:

* secondary hypertension
* diabetes
* dyslipidemia
* cardiovascular diseases with complications
* smoker

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: GMF-UMF Laval-Québec
Study officials:
affiliation: Laval University
name: Caroline Rhéaume, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01484535: Aspiration for Pain Relief Following Ankle Fracture
Official title: Aspiration for Pain Relief Following Ankle Fracture: A Prospective Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fracture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the effect of hematoma aspiration in patients with acute ankle fractures.


Eligibility criteria: Inclusion criteria:

* AO/OTA fracture classification 44
* Closed fracture
* Injury within 24 hours of presentation
* Skeletally mature
* Able to provide consent to participate in study

Exclusion Criteria:

* Any concomitant injuries affecting Numerical Rating Scale
* Soft tissue wounds at aspiration sites that compromise ability to aspirate
* Patient not able to complete pain medication log
* Patient not able to participate in follow up

Primary outcomes:
measure: Pain as rated by numerical rating scale (NRS) scores in the emergency department and in the first 72 hours from the time of initial evaluation.
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of volumetric increase of the injured ankle compared to the uninjured ankle.
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen Sems, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04338035: Fertility in Untreated Rectosigmoid Endometriosis
Official title: Fertility in Patients With Untreated Rectosigmoid Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Bowel Endometriosis
Endometriosis, Rectum
Endometriosis Colon
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rectosigmoid endometriosis not undergoing surgical treatment

Brief summary: Several studies investigated the reproductive outcomes after surgical treatment of colorectal endometriosis, mainly segmental colorectal resection. Little information is available on the spontaneous fertility of patients with bowel endometriosis. This study aims to evaluate the fertility of patients affected by rectosigmoid endometriosis who did not undergo previous surgical treatment.


Eligibility criteria: Inclusion Criteria:

* Desire of conception
* Diagnosis of rectosigmoid endometriosis by transvaginal ultrasonography (TVS) and magnetic resonance imaging enema (MR-e)

Exclusion Criteria:

* Previous surgery for endometriosis
* Diagnosis of hydrosalpinx at imaging
* Previous conception
* Abnormal semen parameters of male partners

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 4-9 weeks after conception
measure: Live birth rate
timeFrame: 22 weeks after conception
Secondary outcomes:
measure: Number (%) of patients conceiving spontaneously/by Assisted Reproductive Technology
timeFrame: Immediately after diagnosis of clinical pregnancy
measure: Number (%) of patients undergoing vaginal delivery/delivering by cesarean section
timeFrame: 22-42 weeks after conception
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
References:
citation: Remorgida V, Ferrero S, Fulcheri E, Ragni N, Martin DC. Bowel endometriosis: presentation, diagnosis, and treatment. Obstet Gynecol Surv. 2007 Jul;62(7):461-70. doi: 10.1097/01.ogx.0000268688.55653.5c.
Clinical trial NCT02755935: CI532 - Early Experience Study
Official title: Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss, Bilateral
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.

Detailed description: To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.

Eligibility criteria: Inclusion Criteria:

* Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
* Post-linguistically deafened
* Ability to complete age appropriate testing

Exclusion Criteria:

* Previous cochlear implantation in the ear to be implanted
* Pre-linguistically deafened (onset of hearing loss at less than two years of age)
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Diagnosis of retro-cochlear pathology
* Diagnosis of auditory neuropathy
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
* Unwillingness or inability to comply with all investigational requirements
* Additional cognitive handicaps that would prevent participation on all study requirements

Primary outcomes:
measure: Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
timeFrame: 3 months postactivation of the sound processor
measure: Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
timeFrame: 3 months post-activation
Secondary outcomes:
Other outcomes:
Locations:
city: Skokie
country: United States
facility: NorthShore University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Center for Hearing and Balance
state: Missouri
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas Ear Institute
state: Texas
Study officials:
References:
Clinical trial NCT02118935: Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance
Official title: Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Measures of Tolerance
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: University of Kansas Medical Center
First posted: 2014-04-21
Enrollment: 161
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.


Eligibility criteria: Inclusion Criteria:

* Singleton, 14-35 days of age at baseline
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula-fed
* Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Feeding difficulties or formula intolerance
* Maternal history of illicit drug use or psychiatric disease

Primary outcomes:
measure: Sleep Measures (Amount of time awake and asleep in a 72 hour period)
timeFrame: 14 weeks
measure: Infant State (Infant behavior over a 72 hour period)
timeFrame: 14 weeks
Secondary outcomes:
measure: Achieved Weight
timeFrame: 14 weeks
measure: Achieved Length
timeFrame: 14 weeks
measure: Achieved Head Circumference
timeFrame: 14 weeks
measure: Formula Intake
timeFrame: 14 weeks
measure: Fecal microbiome
timeFrame: Baseline and 112 days of age
measure: Medically-confirmed Adverse Events
timeFrame: 14 weeks
measure: Salivary Cortisol levels
timeFrame: 70 and 120 days of age
measure: Temperament - Infant Behavior Questionnaire
timeFrame: Once at 112 days of age
measure: Sleep Characteristics
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatrics
state: Connecticut
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: Kansas City
country: United States
facility: Universty of Kansas Medical Center
state: Kansas
city: Woburn
country: United States
facility: Woburn Pediatrics
state: Massachusetts
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel
state: Ohio
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
Study officials:
affiliation: Mead Johnson Nutrition
name: Carol Lynn Berseth, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05591235: Effect of Metformin, Dapagliflozin, Combination of Metformin and Pioglitazone in Patients With Type 2 Diabetes
Official title: Effect of Metformin, Dapagliflozin, Fixed Combination of Metformin and Pioglitazone in Overweighted Patients With Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type2diabetes
Insulin Resistance
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although, a number of drugs are promising treatment strategies for insulin resistance, a critical question arises to which drug benefits patients with type 2 diabetes more from reduced insulin resistance and consequent glycemic control. In this study, we aim to evaluate the effect of metformin, dapagliflozin and the fixed-dose combination of metformin and pioglitazone (500mg metformin plus 15mg pioglitazone) on insulin sensitivity and glycemic control in overweight patients with newly diagnosed type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Willing to participate in this present study;
* Regular diet and exercise;
* Age 18 to 60 years;
* Screening glycated hemoglobin (HbA1c) \> 9.0%;
* Body mass index (BMI) ≥ 24.0 kg/m2

Exclusion Criteria:

* Other forms of diabetes;
* Insulin allergy or intolerance of metformin, pioglitazone and dapagliflozin;
* Renal dysfunction (estimated glomerular filtration rate \< 45 mL/min);
* Severe liver disease or elevated transaminases (2.5-fold the upper limit);
* History of alcohol dependence or drug abuse in the past 5 years;
* Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
* Acute infection or stress state 1 month prior to this study;
* Pregnancy or lactation;
* History of diabetic ketoacidosis (DKA) within the previous year;
* Psychiatric disease;
* Other comorbid serious condition including severe heart and pulmonary disease, heart failure of New York Heart Association class IV, and tumors.

Primary outcomes:
measure: Insulin resistance
timeFrame: week 5
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04013035: Cervical Length on Pregnancy Termination
Official title: The Impact of Fetal Viability and Cervical Length on Pregnancy Termination Outcomes in Nulliparous Second Trimester Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Loss
Keywords: Cervix
Length
Viability
prostaglandin
Termination
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nulliparous pregnant women at 13-26 weeks of gestation will be included in the study.

Brief summary: Cervical length is used as a parameter to predict cervical insufficiency and onset of labor. However, its role in predicting abortion induction is unclear.To investigate the impact of cervical length measurement and fetal viability on second trimester pregnancy termination duration in nulliparous pregnant women.

Detailed description: Cervical length and fetal viability were evaluated prior to second trimester pregnancy termination due to various indications. nulliparous pregnant women through 13 and 26 gestational weeks in whom pregnancy termination was conducted within 72 hours after admission were included in the study. The subjects were grouped into two groups according to fetal viability.

Eligibility criteria: Inclusion Criteria:

-Nulliparous pregnant women at 13-26 weeks of gestation

Exclusion Criteria:

* Patients with multiple gestations,
* multiparous patients or
* patients that had uterine gynecologic surgery

Primary outcomes:
measure: cervical length measurement
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References: