louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02107508: The Relationship Between Activity Energy Expenditure and Body Composition in School-age Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Obesity
Keywords: activity energy expenditure
body composition
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children in Shanghai

Brief summary: Obesity is increasing rapidly all over the world not only in adults but also among children. As a modifiable component of total energy expenditure (TEE) ,the amount of energy expended during physical activity plays an important role in preventing weight gain. Decreased physical activity, coupled with an over-consumption of calories, lead to the change of body composition by storing energy as fat.Although several studies have simultaneously examined body composition with energy expenditure the independent roles of body composition with activity energy expenditure (AEE) are less firmly established. It's suspected shrewdly that energy expenditure is partly influenced by the body composition. The aim of the study is to examine the relation of AEE with body composition in a population of school-age children.

Detailed description: Body composition (ie. FAT% and FFM) will be evaluated by means of bioelectrical impedance analysis (BIA) with Inbody 720 (Biospace, Seoul, South Korea). Anthropometric dimensions will be recorded for all participants according to standard procedures. Height will be recorded to the nearest 1.0mm by using a field stadiometer (Seca Corporation, Germany). FitMate metabolic system (Cosmed, Rome, Italy) will be used to estimate AEE. Subjects will be tested in a 10-minute submaximal exercise test using the FitMate systems while taking cycling test at 50 Watts on an electrically braked bicycle ergometer. Each subject will be connected to a calibrated respiratory gas analyzer, a portable metabolic analyzer designed for measurement of oxygen consumption during exercise via a face mask. Heart rate will be simultaneously measured with the use of a Cosmed wireless HR monitor to track the participant's heart rate level.

Eligibility criteria: Inclusion Criteria:

* Children in Shanghai

Exclusion Criteria:

* cardiovascular disease
* asthma
* severe disease conditions such as cancer and renal failure
* taking steroids (corticosteroids) or antidepressants

Primary outcomes:
measure: body composition
timeFrame: up to 30 days after participating in the study
Secondary outcomes:
measure: activity energy expenditure (AEE)
timeFrame: up to 30 days after participating in the study
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Qingya Tang, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000308: Dextroamphetamine-Cocaine Behavioral Intervention - 5
Official title: D-amphetamine-Cocaine Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-09-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Verifiable cocaine abstinence
timeFrame: 16 weeks of study
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: John Grabowski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04806438: Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation.
Official title: Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of nebulization versus airway nerve block technique to achieve upper airway anesthesia for diagnostic fiberoptic bronchoscopy under moderate sedation.

Detailed description: Randomization was done using computer generated tables of random numbers:

Group A (nebulized lignocaine group) as a control group (n = 60) received 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min .

Group B (nerve block group) (n = 60) received bilateral superior laryngeal nerve block and trans-tracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice.

Patient tolerance was assessed using the Global Tolerance Score, based on a visual analogue scale ( VAS).

Eligibility criteria: Inclusion Criteria:

* Patients planned for diagnostic fiberoptic procedures such as broncho-alveolar lavage, endobronchial or transbronchial biopsies, or brush cytology.

Exclusion Criteria:

* Patients less than 21yrs old and patients more than 70 yrs old.
* Severe respiratory failure (pH \< 7.35, partial arterial oxygen pressure \<55 mmHg despite supplemental oxygen).
* Upper airway surgery or radiation, allergy to lidocaine, Propofol or midazolam, or bleeding disorder.
* Hemodynamic instable patient or patient decompensated heart failure.
* Epileptic patients, severe neurological or psychiatric disorder.
* Patients requiring cryo-biopsy or endobronchial ultrasound because these procedures are performed under deep sedation including fiberoptic intubation.

Primary outcomes:
measure: Global Tolerance Score
timeFrame: First two hours in the postoperative period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01182038: The Swedish Birth Seat Trial
Official title: The Swedish Birth Seat Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Instrumental Vaginal Births
Oxytocin Augmentation for Labor
Maternal Blood Loss
Perineal Outcomes
Fetal Outcomes
Keywords: birth seat
childbirth
instrumental delivery
upright position
Lead sponsor: Helsingborgs Hospital
Sponsor class: OTHER
Collaborators: name: The Stig & Ragna Gorthon Foundation, Helsingborg
First posted: 2010-08-16
Enrollment: 1002
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether birth on a birthing seat will effect numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of artificial oxytocin for labour augmentation and fetal outcomes.


Eligibility criteria: Inclusion Criteria:

* nulliparous women who understood the Swedish language sufficiently well to receive information and give informed consent
* a normal pregnancy,singleton fetus in cephalic presentation
* spontaneous onset of labor occurring between gestational weeks 37 + 0 and 41 + 6
* Body Mass Index less (BMI) than thirty
* gestational diabetes not requiring medical treatment
* women who were planning a vaginal birth after a caesarean section (VBAC)
* women induced because of spontaneous rupture of membranes with no spontaneous contractions for longer than twenty-four hours

Exclusion Criteria:

* multiparous women
* birth before gestational week 37
* breech presentation
* maternal BMI more than 30
* multiple pregnancy
* infectious disease
* pre-eclampsia or other conditions requiring medical care

Primary outcomes:
measure: Instrumental vaginal births
timeFrame: Recorded within 6 hours postpartum
Secondary outcomes:
measure: Administration of oxytocin for augmentation of labor
timeFrame: During labor and birth up to 36 hours postpartum
measure: Postpartum blood loss
timeFrame: Up to 24 hours after birth
measure: Perineal outcomes
timeFrame: Up to 36 hours after birth
measure: Fetal outcomes
timeFrame: Up to 36 hours after birth
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborgs Hospital
state: Skane
Study officials:
affiliation: Karolinska Institutet
name: Ingegerd Hildingsson, PhD
role: STUDY_DIRECTOR
affiliation: Helsingborg Hospital, Sweden
name: Linda J Kvist, PhD
role: STUDY_CHAIR
References:
citation: Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. Striving for scientific stringency: a re-analysis of a randomised controlled trial considering first-time mothers' obstetric outcomes in relation to birth position. BMC Pregnancy Childbirth. 2012 Nov 22;12:135. doi: 10.1186/1471-2393-12-135.
citation: Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. No reduction in instrumental vaginal births and no increased risk for adverse perineal outcome in nulliparous women giving birth on a birth seat: results of a Swedish randomized controlled trial. BMC Pregnancy Childbirth. 2011 Mar 24;11:22. doi: 10.1186/1471-2393-11-22.
Clinical trial NCT05724238: The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students
Official title: The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students: A Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Keywords: Astragalus
Traditional Herb
Fatigue
Negative Emotions
Graduate Students
Young Researchers
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to determine the effect of traditional herbal supplements on general fatigue and negative emotions in generally healthy graduate students. The main questions it aims to answer are:

• Whether the traditional herbal supplements can ameliorate fatigue and negative emotions of young adults

Detailed description: Participants will:

* Take oral herbal supplements or placebo as randomized for four weeks
* Be evaluated for the fatigue, anxiety, and depression levels at baseline and four weeks after the intervention
* Record sleep variables each day for five weeks

Researchers will compare the intervention group (receiving herbal supplements) with the placebo group (receiving placebo) to see if oral herbal supplements have effects on the outcomes and to examine the anti-fatigue effect two weeks after intervention.

Eligibility criteria: Inclusion Criteria:

* Scoring at least 4 points on the dichotomous Chalder's Fatigue Scale at baseline
* Working on at least one ongoing research project and expecting to continue working for at least one month

Exclusion Criteria:

* Taking medications as:
* Antidepressants
* Anxiolytics
* CNS stimulants
* Immunosuppressants
* With underlying diseases as:
* Diabetes mellitus
* Hematologic diseases
* Other major diseases as defined my MOHW of Taiwan

Primary outcomes:
measure: Change from Baseline Fatigue Level to Four Weeks
timeFrame: At week one (baseline) and week five (four weeks after the intervention)
Secondary outcomes:
measure: Change from Baseline Sleep Quality to Four Weeks
timeFrame: At week one and week five
measure: Change from Baseline Negative Emotion Scores to Four Weeks
timeFrame: At week one and week five
measure: Change from Baseline Negative Emotion States to Four Weeks
timeFrame: At week one and week five
measure: Sleep Variables (Efficiency, Length, Midsleep time)
timeFrame: Each day from week one through week five
measure: Change from Baseline Fatigue At Each Week up to Six Weeks
timeFrame: Each week since week one until week seven
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Hsin-Jen Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05358938: Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Official title: Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Cutaneous Melanoma
Cutaneous Squamous Cell Carcinoma
Merkel Cell Carcinoma
Keywords: Exercise
Checkpoint Blockade Immunotherapy
Immunotherapy
Skin Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles


Eligibility criteria: * Inclusion Criteria:
* Age ≥ 18 years
* Able to read and speak English fluently
* Capable of giving informed consent
* Reported ability to complete 20-30 minutes moderate exercise per positive response to "can you currently walk unaided for six minutes or more?".
* Scheduled for first-time checkpoint blockade immunotherapy with FDA-approved drugs, including avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab in the absence of other therapies (e.g. targeted therapy)
* Melanoma patients (adjuvant setting)
* Melanoma patients (neoadjuvant setting)
* cuSCC patients (neoadjuvant setting)
* Merkel cell carcinoma patients (neoadjuvant setting)

Participants may also be required to have a full COVID vaccination series; the most up-to-date best practice guidelines for research at Moffitt Cancer Center will dictate the need for such a vaccination series.

Exclusion Criteria:

* Presence of medical conditions, such as severe cardiovascular disease for which an exercise intervention may not be warranted.
* Presence of major postoperative complications for which an exercise intervention may not be warranted.

Primary outcomes:
measure: Participants Consenting to Trial
timeFrame: Up to 12 months
measure: Participants Completing Exercise
timeFrame: Up to 12 months
measure: Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting
timeFrame: Up to 12 Months
measure: Pathological Complete Response (pCR) - Neoadjuvant Setting
timeFrame: Up to 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Peter Kanetsky, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05171738: Distalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations
Official title: Appraisal of Two Different Approaches of Micro-osteoperforations During Maxillary Molar Distalization Via Skeletally-anchored Distaljet Appliance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Division 1 Malocclusion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study will be directed to evaluate two approaches of micro-osteoperforations during maxillary molar distalization.

Detailed description: Maxillary molar distalization via skeletally anchored distal jet appliance randomly divided into two equal groups

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

All patients should satisfy the following criteria:-

1. Age range from 13-17 years.
2. Bilateral Class II molar relationship.
3. Skeletal Class I or mild Class II relationship.
4. Normodivergent skeletal pattern
5. No posterior crowding or diastemas.
6. Fully erupted maxillary first and second molars.
7. Congenitally missing or extracted third molars.
8. Good oral and general health.
9. No systemic disease/medication that could interfere with OTM.
10. No previous orthodontic treatment.

Exclusion Criteria:

* Exclusion criteria:

  1. Patient diagnosed to have an indication for non-extraction approach.
  2. Poor oral hygiene or periodontally compromised patient.
  3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
  4. Previous orthodontic treatment

Primary outcomes:
measure: change in molar postion
timeFrame: from start of treatment until study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al azhar university
Study officials:
References:
Clinical trial NCT04802538: Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management
Official title: A Phase 1 Clinical Trial to Assess the Performance and Safety of a Novel Ostomy Ring (OstoRing®) to Improve Ileostomy and Colostomy Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stoma Site Leakage
Keywords: ileostomy
colostomy
stoma
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Early feasibility device study
Primary purpose: DEVICE_FEASIBILITY

Brief summary: In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.

Detailed description: In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.

Eligibility criteria: Inclusion Criteria:

* Are at least 18 years of age and have full legal capacity
* Have had an end or loop ileostomy or colostomy for at least 6 months.
* Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
* Able to provide informed consent
* Have a stoma with a diameter of 57mm or less
* Change their pouching system at least two times in seven days

Exclusion Criteria:

* Unable to give informed consent.
* Are pregnant or currently breastfeeding.
* In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
* In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
* Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
* Currently suffering from a peristomal hernia.
* Known hypersensitivity toward any of the test product (OstoRing® is made of surgical grade stainless steel)
* In the last 30 days has participated or is currently participating in a clinical study
* Assessed with an ostomy skin tool score of ≥3

Primary outcomes:
measure: Pouching Equipment Wear Time/Lifespan
timeFrame: 75 days
measure: Coloplast Tool Skin Assessment Score
timeFrame: 75 days
Secondary outcomes:
measure: City of Hope Quality of Life Ostomy Questionnaire Score
timeFrame: 75 days
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem Evanston Hospital
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Eugene F Yen, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01785238: Nephronic Reduction After Neonatal Acute Renal Failure in Preterm
Official title: Renal Prognosis of Former Preterm Infants 3 to 10 Years After Neonatal Acute Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Acute Renal Failure in Preterm
Keywords: preterm infants
acute renal failure
nephronic reduction
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who have presented neonatal acute renal failure. The investigators hypothesize that signs of nephronic reduction would appear earlier in former preterm with neonatal acute renal failure than in control preterm infants.

Detailed description: 50 former preterm infants who presented acute renal failure will be evaluated between 3 to 10 years.

They will be compared to 25 control former preterm infants without renal dysfunction for signs of nephronic reduction.

At inclusion, in order to analyse renal function, all infants will have blood sampling, renal echography and blood pressure measurement. Urine sample will also be collected.

Two months later, parents will be informed on the results.

Eligibility criteria: Inclusion Criteria:

* For both group of cases (50 infants having presented acute renal failure in preterm) AND group of control cases (25 infants without this) :former preterm infant born before 33 weeks of gestational age between january 2003 and june 2010 and hospitalized in the neonatal intensive care unit of Nantes University Hospital.
* Specific to cases: neonatal acute renal failure: serum creatinine\>130 micromol/l from the third day of life.
* Control cases: no such renal dysfunction

Exclusion Criteria:

* no parental consent
* other causes of renal failure: congenital uropathy, congenital nephropathy
* congenital cardiopathy, polymalformative syndrome

Primary outcomes:
measure: microalbuminuria
timeFrame: Day 1 (at inclusion)
Secondary outcomes:
measure: measurement of blood pressure
timeFrame: Day 1 (at inclusion)
measure: measurement of length and volume of kidney by renal echography
timeFrame: day 1
measure: creatinine clearance
timeFrame: day 1
measure: calciuria
timeFrame: Day 1
measure: sodium clearance
timeFrame: day 1
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU of Nantes
Study officials:
affiliation: Nantes University Hospital
name: Emma ALLAIN-LAUNAY, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruel A, Roze JC, Quere MP, Flamant C, Boivin M, Roussey-Kesler G, Allain-Launay E. Renal outcome in children born preterm with neonatal acute renal failure: IRENEO-a prospective controlled study. Pediatr Nephrol. 2016 Dec;31(12):2365-2373. doi: 10.1007/s00467-016-3444-z. Epub 2016 Jun 22.