louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02815878: Enhance Wellness for Individuals With Long-Term Physical Disabilities
Official title: Project Enhance for Adults Aging With Long-Term Physical Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Muscular Dystrophy
Post-polio Syndrome
Spinal Cord Injury
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 240
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project is an adaptation trial, testing the efficacy of an evidence-based community wellness program, Enhance Wellness (http://www.projectenhance.org/enhancewellness.aspx), in a sample of middle and older-aged adults living with multiple sclerosis, spinal cord injury, post-polio syndrome and muscular dystrophy.

Detailed description: This is a quasi-experimental project, comparing the effects of Enhance Wellness in a sample of adults aged 45 years or older and living with long-term physical disability, to two quasi-control groups: a sample of adults without long-term disability participating in Enhance Wellness, and a sample of adults with long-term disability not participating in Enhance Wellness. Outcomes are collected pre-intervention and post-intervention, approximately 6-months apart.

Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis, Muscular Dystrophy, Post-Polio Syndrome, or Spinal Cord Injury diagnosis (Group 1 and 3)
* Living in King County, Washington (Group 1 only)
* Ability to read and understand English

Exclusion Criteria:

* Active suicidal ideation
* Requires the use of a mechanical ventilator to breathe or speak

Primary outcomes:
measure: Questionnaire: Level of reported self-efficacy as measured by the University of Washington Self-Efficacy Scale Questionnaire
timeFrame: 6-months
measure: Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form
timeFrame: 6-months
measure: Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ivan R Molton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100878: Exercise and Neural Response to Food Cues in Children
Official title: Effect of Exercise on the Neural Response to Food Cues and Energy Intake in Lean and Obese Adolescents
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Exercise Condition (EX)
Control Session (CON)
Lead sponsor: Université Blaise Pascal, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 0
Sex: MALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Lean and obese adolescents will be recruited accodring to the international curves for obesity. they will be between 12 to 15 years old and will have no medical limitations to complete exercise testings.

Brief summary: Physical exercise has been shown to significantly reduce subsequent energy intake in obese adolescents but not in lean, without altering their appetite feelings. Although previous studies have pointed out the role of gastric peptides in this post exercise nutritional response, some recent work question the role of the neural system in the post exercise drive to eat. This study tends to explore whether or not an acute bout of exercise can affect the neural response to food cues in adolescents, obese or lean.

Detailed description: After a medical inclusion, the adolescents will have to realise a DXA to assess their body composition and a submaximal exercise to evaluate their aerobic capacities.

They will have then to enter the laboratory on 2 different occasions in a randomized order from 8am to 330pm: At 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) a cycling exercise or 2) remaining sitting fpr one hour. after the one hour sitting station or the exercise bout, they will be asked to complete a computer task while and electroencephalogram will be recorded. This computer task consists in visual recognition of rare pictures compared to frequent ones (oddball method). at 1215 they will be offered ad libitum meals. At regular intervals through the day, their appetite feelings will be assessed using Visual analogue scales.

Ad libitum energy consumption will be assessed by investigators and recorded for each participants.

Eligibility criteria: Inclusion Criteria:

* male
* 12-15 years old
* BMI defining obesity (Cole et al., 2000)
* Not being under diet restriction
* Information and consent forms have to be signed by the adolescent and his legal representative
* being registered to the national social security system

Exclusion Criteria:

* Being under medication
* contraindication to exercise
* smokers
* dieting

Primary outcomes:
measure: Neural response to food cues
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aubiere
country: France
facility: Laboratory AME2P
Study officials:
References:
Clinical trial NCT02026778: Comparison of the Effect of Ondansetron and Combined Ondansetron and Betahistine on Postoperative Nausea and Vomiting After Gynecological Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea and Vomiting
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many patients undergoing gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists such as ondansetron. Involvement of multiple types of receptors and factors may be a reason for inadequate control of PONV with a single agent. Betahistine, a histamine antagonist at H1 receptor and antagonist at H3 receptor, is widely used as a treatment of dizziness. Dizziness is one of the cause of nausea and vomiting. This study is to compare the effects of ondansetron and combined ondansetron and betahistine in preventing PONV in high-risk patients receiving intravenous opioid-based patient-controlled analgesia (IV-PCA) after gynecological laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for elective gynecological laparoscopic surgery
* American society of Anesthesiologists physical class I, Ⅱ, between the ages of 20 and 70 years

Exclusion Criteria:

* hepatorenal disease
* BMI \> 35 kg/m2
* allergy to ondansetron or betahistine
* gastrointestinal disease
* vomiting within 24h
* administration of antiemetics or opioids within 24h
* QT prolongation (QTc \> 440ms)
* Pheochromocytoma
* pregnant
* problem with communication

Primary outcomes:
measure: postoperative nausea and vomiting
timeFrame: at postoperative 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04841278: Utility of Combined EUS and ERCP Procedures in the Evaluation of Liver Graft Dysfunction
Official title: Utility of Combined EUS and ERCP Procedures in the Evaluation of Liver Graft Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Liver Graft Dysfunction
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single prospective arm with historical controls as comparator
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this investigator-initiated study is to determine whether a single-step session that combines endoscopic ultrasound (which may further include liver biopsy and needle-guided cholangiography) with endoscopic cholangiopancreatography (ERCP) can facilitate in the management of liver graft dysfunction. All patients will undergo the same procedural protocol.

Detailed description: Liver graft dysfunction can arise from many disease processes, which include biliary obstruction, rejection, infection and ischemia. Battery of tests, and at times empiric therapy, is necessary to obtain final diagnosis. This results in waste of time and medical resources that can lead to delay in care, which may ultimately translate to increase morbidity and mortality, as well as increase in cost.

In this protocol, the investigators propose utilization of interventional endoscopy for the diagnosis and treatment of liver graft dysfunction. Use of endoscopic ultrasound (EUS) with possible liver biopsy and cholangiography, and endoscopic retrograde cholangiopancreatography in one session may facilitate diagnosis and treatment. All patients enrolled in this protocol will undergo the same procedural protocol. The quality of care metrics in these patients (such as length of stay, cost, mortality, etc), will be compared to that of historical controls.

Eligibility criteria: Inclusion Criteria:

* All hospitalized patients with liver graft dysfunction

Exclusion Criteria:

* Thrombocytopenia (platelets \<50.000/mL) until corrected
* Coagulopathy (international normalized ratio (INR) \>1.5) until corrrected
* Use of thrombolytic or anti-platelet agents within 5-7 days of the procedure.
* Any with known bleeding diathesis will be excluded. (e.g. disseminated intravascular coagulation (DIC), von-Willebrand disease, hemophilia).
* Those who had recent prior liver biopsy or EUS/ERCP will be excluded.
* Those with active bacteremia will be excluded, at least until treated.
* For this initial study, those with altered GI tract anatomy (e.g. those with hepaticojejunostomy or gastro-jejunostomy) will be excluded

Primary outcomes:
measure: Time to final diagnosis
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University
name: Alexander W Jahng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03155178: In Vivo Preoperative Skin Preparation Persistence Evaluation
Official title: 96-hour Antimicrobial Persistence Assessment Following Exposure to Saline and Blotting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Recovery of Skin Flora Post-product Application
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2017-05-16
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.

Detailed description: Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.

Eligibility criteria: Inclusion Criteria:

* Subjects of any race
* Subjects in good health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Primary outcomes:
measure: Measurement of Skin Flora Recovery Post-prep Application
timeFrame: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment
Secondary outcomes:
measure: Change in Skin Flora Relative to 10 Minutes Post-prep Application
timeFrame: 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment
Other outcomes:
measure: Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
timeFrame: Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment
Locations:
Study officials:
affiliation: Evic / Eurofins
name: Rozalia Olsavszky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01043978: Prevention of Overfeeding During Infancy
Official title: Prevention of Overfeeding During Infancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 231
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overall goal of this project is to identify strategies to prevent overfeeding during infancy. One objective is to evaluate the impact on intake of allowing the infant greater control over the amount consumed when feeding from a bottle. This will be accomplished via the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows the infant to self-regulate milk flow. The second objective is to evaluate the relationship between parental feeding styles and infant intake.


Eligibility criteria: Inclusion Criteria:

* Infant born at \> 37 weeks gestation
* Infant weighed \>2500 g at birth
* Infant is apparently healthy
* Mother speaks English
* Mother is 18 years of age or older
* Mother/infant pair lives within a 10-mile radius around the UC Davis Medical Center in Sacramento, CA
* Mother plans to use a bottle (at least occasionally) to feed her infant before he/she is 3 months old.

Primary outcomes:
measure: Intake
timeFrame: per feed
Secondary outcomes:
measure: Growth
timeFrame: 4 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Kathryn G Dewey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03560778: Comparisons of Urodynamic, Bladder Diary, Quality of Life Parameters Between OAB-wet and OAB-dry Female Patients
Official title: Comparisons of Urodynamic, Bladder Diary, Quality of Life Parameters Between OAB-wet and OAB-dry Female Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder, Overactive
Keywords: Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urodynamics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 623
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with OAB who completed a 3-day bladder diary and underwent urodynamic studies at the urogynecologic outpatient clinics of the Department of Obstetrics and Gynecology of a medical center

Brief summary: A small bladder capacity and more frequent urgency episodes were predictors of OAB-wet, and the above findings might indicate that OAB-wet and OAB-dry are a continuum of OAB. Older age, high maximum flow rate, high detrusor pressure at maximum flow rate and the presence of urodynamic stress incontinence were also independent predictors for OAB-wet, and the above might indicate that OAB-wet and OAB-dry have at least partly different underlying pathophysiologies.

Detailed description: Aims: To identify factors predicting the presence of OAB-wet and to further derive the underlying pathophysiology in OAB-wet vs. OAB-dry.

Methods: Between September 2007 and September 2013, the medical records of women with OAB who completed a 3-day bladder diary and underwent urodynamic studies in a tertiary referral center will be reviewed. OAB-wet will be diagnosed in patients who complained of at least one episode of urgency incontinence in the previous month; otherwise, OAB-dry is diagnosed. Multivariate logistic regression analysis will be used to predict the presence of OAB-wet.

Eligibility criteria: Inclusion Criteria:

1. The diagnosis of overactive bladder disease
2. Female patient of more than 20 year-old

Exclusion Criteria:

1. Dominant symptoms with stress urinary incontinence (SUI)
2. Regular urethral catheterization or intermittent self-catheterization
3. Urinary tract infection or chronic inflammation in the previous 2 weeks
4. Bladder calculus
5. A history of pelvic radiotherapy
6. A preexisting malignant pelvic tumor.

Primary outcomes:
measure: Compare the difference of urodynamic parameters between OAB-wet and OAB-dry
timeFrame: 1 week
measure: Compare the difference of bladder diary parameters between OAB-wet and OAB-dry
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05473078: Attitudes of General Practitioners in Lorraine Towards Prediabetes
Official title: Attitudes of General Practitioners in Lorraine Towards Prediabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreDiabetes
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: general practitioners

Brief summary: Screening for the risk factors of type 2 diabetes is a part of the primary prevention approach. Pre-diabetes is one of the modifiable risk factors; however, it remains under-diagnosed. Our aim was to analyse the attitudes of general practitioners in Lorraine towards prediabetes


Eligibility criteria: Inclusion Criteria:

* General practitioner
* Practice in Lorraine
* Installed or substitute
* Exclusively private practice or mixed activity

Exclusion Criteria:

* Retired physicians
* General practitioners working exclusively in hospital

Primary outcomes:
measure: Evaluate the attitudes by general practitioners towards pre-diabetes
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: University Hospital of Nancy
Study officials:
References:
Clinical trial NCT05081778: Dissociative Disorders in Obesity (Dissobe)
Official title: Dissociative Disorders in Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Dissociative Disorder
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-10-18
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese population with a body mass index over 30kg/m2 Minimum age : 18 years-old Patients consulting for the first time at CELIOBE and wishing a medical or surgical course.

Brief summary: THe aim of this study is to determine the frequency of dissociative tendencies in the obese population treated at the CELIOBE (Liberal Center for Obesity Support) at Hôpital Privé La Louvière among patients consulting for the first time and looking for a medical or surgical course. The DES scale of Carlson and Putman will be used.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Obesity defined by a Body Mass Index (BMI) ≥ 30 kg / m2
* Patient seen in consultation at CELIOBE for the first time for the management of an overweight problem, wishing for surgical or medical care
* Patient having been informed and not opposing to this research
* Patient affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Psychotic antecedents: Schizophrenia, Schizoaffective disorders, Hallucinatory psychoses, Brief psychotic attacks
* Addictive behaviors (alcohol, drug addiction)
* Drug use
* Taking antipsychotics and mood stabilizers
* Dissociative identity disorders proven
* Bipolar disorders or severe mental illness
* Understanding troubles
* Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent
* Pregnant, breastfeeding or parturient woman

Primary outcomes:
measure: The degree of dissociative tendencies
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital privé La Louvière
state: Haut De France
Study officials:
References:
Clinical trial NCT03116178: PVI Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries
Official title: Pleth Variability Index Based Intraoperative Fluid Management in Head and Neck Free Flap Reconstructive Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Free Tissue Flaps
Keywords: Fluid therapy
oximetry
thromboelastography
intraoperative/method
monitoring
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Intraoperative fluid given according to BMI in group B and according to pulse oximeter- derived pleth variability index(MASIMO RAINBOW PULSE CO OXIMETRY) in group G. Comparison of haemodynamics, urine output,blood lactate levels, blood sugar, flap sugar and coagulation profile between the two groups.

Detailed description: A sample size of 80 taken and computer generated random allocation done to divide the patients in two groups(40 each). Head and neck onco surgery patients undergoing resection and reconstruction with radial artery free flap and antero lateral thigh free flap of duration 4-6 hours taken for surgery.

Group B to receive intravenous fluid according to body weight stating at the rate 6-8 ml/kg/hr.

Group G to receive intravenous fluid according to Pleth variability index value(4-11).Blood loss up to 10% replacement by colloids.

Comparison of following parameters:

Demography, haemodynamics,urine output .blood lactate, ph, oxygenation index ,thromboelastography (TEG), blood sugar, flap sugar .

Eligibility criteria: Inclusion Criteria:

* All patients undergoing radial and anterolateral free flap

Exclusion Criteria:

* Duration of surgery \> 6hrs
* BMI \> 30
* Patients on anti platelet drugs
* Patient refusal

Primary outcomes:
measure: Changes in TEG waveform tracing as obtained from TEG 5000 Hemostasis analyser system
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
citation: Yu Y, Dong J, Xu Z, Shen H, Zheng J. Pleth variability index-directed fluid management in abdominal surgery under combined general and epidural anesthesia. J Clin Monit Comput. 2015 Feb;29(1):47-52. doi: 10.1007/s10877-014-9567-5. Epub 2014 Feb 21.