louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02168699: Ultrasonographic Detection of Musculocutaneous Nerve in Children
Official title: Ultrasound Imaging of Musculocutaneous Nerve in Infants, Preschoolers and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sonographic Detection of Musculocutaneous Nerve
Keywords: children
infants
musculocutaneous nerve
ultrasonography
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2014-06-20
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: Localizing the musculocutaneous nerve for neural blockade is crucial to achieve complete anesthesia of the forearm. However, in pediatric anesthesiology, the musculocutaneous nerve is unable to be blocked in up to 40-50% of cases when only neurostimulation is used, while there is limited information regarding ultrasound imaging of the musculocutaneous nerve in children.

The aim of this prospective imaging study is to investigate whether musculocutaneous nerve is visualized in childhood with the use of ultrasound imaging or not. A secondary aim of this study is to assess the percentage of its visualization according to the age.

Parental written informed consent is obtained from all participants. The children are divided into three groups according to their age: Group 1, with infants aged less than 12 months; Group 2, with toddlers and preschoolers; and Group 3, with school-aged children (6.5-12 years).

Children are placed in the supine position with the involved arm abducted at 90° and the elbow flexed at 90°. The linear probe of a portable ultrasound machine is placed at the axillary region, perpendicularly to the axillary artery. The musculocutaneous nerve is searched near the axillary artery (proximally) and its course is followed distally (into the coracobrachialis muscle). Its sonographic detection is recorded in these two sites, both proximally and distally.


Eligibility criteria: Inclusion Criteria:

* children 0-12 years old
* parental written informed consent

Exclusion Criteria:

* parental refusal
* children refusal
* previous operations to the axilla
* anatomical malformations of the axilla
* spasticity
* morbid obesity.

Primary outcomes:
measure: Assession of the ultrasonographic visualization rate of musculocutaneous nerve in children
timeFrame: Data is assessed during sonographic examination of the axillary region
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Anesthesiology, Attikon University Hospital
state: Attiki
Study officials:
References:
Clinical trial NCT06769399: Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis
Official title: Investigation of the Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Systemic Sclerosis (SSc)
Sexual Dysfunctions
Pelvic Floor Disorder
Keywords: systemic sclerosis
female sexual dysfunction
pelvic floor disorders
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 70 women with systemic sclerosis and 70 healthy women

Brief summary: Relationship Between Pelvic Floor Dysfunctions and Sexual Dysfunction in Female Patients with Systemic Sclerosis

Detailed description: Female patients with systemic sclerosis have a high incidence of pelvic floor dysfunction and sexual dysfunction.The association of sexual dysfunction in systemic sclerosis with many disease-related factors has been confirmed. There are numerous studies in the literature investigating the prevalence and risk factors of sexual dysfunction in women with SSc, the number of studies examining the prevalence and effects of pelvic floor dysfunction in SSc is limited. Moreover, no studies were identified in the literature that specifically investigate the relationship between pelvic floor dysfunction and sexual dysfunction.The aim of this study is to evaluate pelvic floor dysfunction and sexual dysfunction in women with SSc, examine the relationship between these dysfunctions, and compare the findings with data from a healthy control group.

Eligibility criteria: Inclusion Criteria:

* female gender
* being between 18-64 years old
* having a diagnosis of systemic sclerosis (SSc)
* being sexually active, and not having entered menopause

The control group will consist of healthy women aged 18-64 years who are sexually active, have not entered menopause, have no history of urological or gynecological surgeries other than cesarean section, and have no rheumatologic or severe chronic diseases.

Exclusion Criteria:

* the presence of current or past rheumatologic diseases other than SSc
* the presence of current urogynecological diseases
* a history of urological or gynecological surgeries other than cesarean section.

Primary outcomes:
measure: pelvic floor dysfunction
timeFrame: 1 day
measure: sexual dysfunction
timeFrame: 1 day
measure: Pelvic Floor Dysfunction
timeFrame: 1 day
Secondary outcomes:
measure: Functional Capacity
timeFrame: 1 day
measure: disease activity
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00525499: A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Dose-Ranging Clinical Study to Evaluate the Safety and Efficacy of ASC-J9 Cream Applied Twice Daily for 12 Weeks for the Treatment of Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne
Lead sponsor: AndroScience Corp
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 186
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.

Detailed description: Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.

Eligibility criteria: Inclusion Criteria:

* At least 12 years of age.
* Facial acne, with:

  20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Skin diseases other than acne vulgaris
* Use of oral retinoids within 6 months of Baseline Visit
* Unwilling to discontinue all other treatments for facial acne
* Unwilling to avoid excessive swimming/sun exposure and use of cosmetics

Primary outcomes:
measure: Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Fremont
country: United States
facility: East Bay Dermatology Medical Group
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Boise
country: United States
facility: Northwest Clinical Trial
state: Idaho
city: Paramus
country: United States
facility: TKL Research, Inc
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Knoxville
country: United States
facility: Dermatology Associates
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
city: Bryan
country: United States
facility: J&S Studies, Inc
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc
state: Utah
city: Lynchburg
country: United States
facility: Education and Research Foundation
state: Virginia
Study officials:
affiliation: AndroScience Corp
name: Charles CY Shih, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00303199: Study of ZIO-101 in Multiple Myeloma
Official title: A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Arsenic
Cancer study
Failed treatment
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-03-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma


Eligibility criteria: Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.

Primary outcomes:
measure: Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03
timeFrame: 6 months
measure: Phase II efficacy using EMBT criteria.
timeFrame: 6 months
measure: Safety
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetics of ZIO-101
timeFrame: 6 months
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: West Hollywood
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Bethesda
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Edmonton
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
Study officials:
References:
Clinical trial NCT05149599: Saccharomyces Cerevisiae for Irritable Bowel Syndrome
Official title: Efficacy and Safety of Saccharomyces Cerevisiae for Abdominal Pain and Discomfort in Irritable Bowel Syndrome (IBS) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Ziauddin University
Sponsor class: OTHER
Collaborators: name: Hilton Pharma
First posted: 2021-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS


Eligibility criteria: Inclusion Criteria:

* Male and female patients between 18 and 75 years of age,
* Patients having confirmed IBS according to Rome IV criteria (newly and previously non-responder to treatment),
* Pain/ discomfort score strictly above 1 and strictly below 6 as determined on a pain/ discomfort scale using arbitrary grading from 0 to 7 in 7 days preceding the inclusion visit,
* Not hypersensitive to any of the ingredients of the drug.

Exclusion Criteria:

* Patients with an organic intestinal disease (Crohn's disease, ulcerative colitis, etc.),
* Pregnant females
* Treatments likely to influence IBS (anti-depressants, opioids, and narcotic analgesics)
* Patients with chronic alcoholism, vegetarian or vegan regimens
* Eating disorders such as anorexia or bulimia
* Documented food allergies.

Primary outcomes:
measure: To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score
timeFrame: One month
Secondary outcomes:
measure: To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire
timeFrame: One month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Ziauddin University Hospital Clifton
state: Sindh
Study officials:
affiliation: DR ZIAUDDIN HOSPITAL, CLIFTON CAMPUS
name: Mehreen Siyal, MBBS, FCPS-1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092599: Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Coronary Disease
Keywords: Elevated Cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 410
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: This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.

Detailed description: The duration of treatment is 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

* Patients who do not meet specific cholesterol levels as required by the study

Primary outcomes:
measure: Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Secondary outcomes:
measure: Safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Brohet C, Banai S, Alings AM, Massaad R, Davies MJ, Allen C. LDL-C goal attainment with the addition of ezetimibe to ongoing simvastatin treatment in coronary heart disease patients with hypercholesterolemia. Curr Med Res Opin. 2005 Apr;21(4):571-8. doi: 10.1185/030079905X382004.
Clinical trial NCT01146899: FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record
Official title: FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: influenza, vaccine, clinical decision support
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-06-22
Enrollment: 6145
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Childhood influenza coverage rates are far below rates for the other childhood vaccinations. Increasing influenza vaccine coverage rates is important not only for the health of the child, but for that of the child's household and community. Yet,influenza vaccine delivery rates at pediatric clinics are low, even when the vaccine is available. The proposed project will take advantage of existing health information technology to tailor, implement and evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric providers to help improve health care decision making.


Eligibility criteria: Inclusion Criteria:

* Medical (medical doctor/nurse practitioner (MD/NP)) or nursing providers (registered nurse, licensed practical nurse (RN/LPN)) at participating practices
* Parents of a child 6 months - 18 years who is a patient at one of the participating ACN practice
* Parents fluent in English or Spanish
* Children 6 months- 18 years with visit to participating practice during influenza season

Primary outcomes:
measure: influenza vaccination
timeFrame: September through March 2011-2012
Secondary outcomes:
measure: Documentation of reason for vaccine refusal
timeFrame: Sept 2011-March 2012
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital Ambulatory Care Network
state: New York
Study officials:
affiliation: Columbia University
name: Melissa S Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockwell MS, Catallozzi M, Camargo S, Ramakrishnan R, Holleran S, Findley SE, Kukafka R, Hofstetter AM, Fernandez N, Vawdrey DK. Registry-linked electronic influenza vaccine provider reminders: a cluster-crossover trial. Pediatrics. 2015 Jan;135(1):e75-82. doi: 10.1542/peds.2014-2616.
Clinical trial NCT01513499: Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women
Official title: Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Eating Behavior
Keywords: Eating behavior
Appetite
Oxytocin
Neuropeptide
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. The effects of oxytocin administration on eating behavior in humans, which could have important implications in eating-related disorders ranging from obesity to anorexia nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of single-dose oxytocin administration investigates whether:

1. Caloric intake will decrease following administration of oxytocin versus placebo
2. Appetite will decrease following administration of oxytocin versus placebo
3. Resting energy expenditure will increase following administration of oxytocin versus placebo


Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* BMI 18.5-24.9, 25-40
* Regular breakfast eater (at least 4 times per week)
* Stable weight within the past three months

Exclusion Criteria:

* Psychiatric disease
* Use of psychotropic medications
* History of eating disorder
* History of excessive exercise within the last three months
* History of diabetes mellitus
* Active substance abuse
* Hematocrit below normal range
* Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
* History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)
* Untreated thyroid disease
* Tobacco use

Primary outcomes:
measure: Caloric intake
timeFrame: +60 minutes after drug/placebo
Secondary outcomes:
measure: Appetite
timeFrame: +55 (fasting) and +90 minutes (post-prandial) after drug/placebo
measure: Resting energy expenditure
timeFrame: +30 minutes after drug/placebo
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Lawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00175799: Validation of Severity of Illness Scoring Systems in Paediatric Intensive Care Units in Canada
Official title: Validation of Severity of Illness Scoring Systems in Paediatric Intensive Care Units in Canada Outcome: Validation and Comparison of 2 Severity of Illness Scores in Canadian PICU Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Units, Pediatric
Keywords: Observational study of physiological status at entry into PICU as a predictor of outcome, comparison of two commonly used scores (PRISM and PIM)
Data from children admitted to a Paediatric Intensive Care unit
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 10000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: All children admitted to participating PICUs over a 1 year period.

Brief summary: This is a study of the validation of severity of illness scoring systems in Paediatric Intensive Care Units (PICUs) in Canada.

Detailed description: Outcome: Validation and comparison of 2 severity of illness scores in a Canadian PICU population.

Eligibility criteria: Inclusion Criteria:

* All children admitted to participating PICUs over a 1 year period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital ICU Dept.
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: David Wensley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01604499: Building on a Point-of-purchase Intervention to Encourage Healthy Food Choices
Official title: Building on a Point-of-purchase Intervention to Encourage Healthy Food Choices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Labeling
Keywords: Healthy eating
Incentives
Feedback
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2012-05-23
Enrollment: 2672
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: This study builds on the framework of a previously implemented color-coded food labeling intervention in a hospital cafeteria by testing the incremental effectiveness of providing employees with individual feedback and incentives for increasing healthy purchases in a 3-arm randomized controlled trial. The investigators hypothesize that employees assigned to receive feedback will increase healthy purchases more than employees who receive no contact and that employees who receive feedback plus incentives will increase healthy purchases more than those who receive feedback alone.


Eligibility criteria: Inclusion Criteria:

* Employee at Massachusetts General Hospital who uses a cafeteria debit card to pay for cafeteria purchases

Exclusion Criteria:

* Employees who do not have a cafeteria debit card
* Employees with cafeteria debit card but who use it fewer than 3 times a month for the 3 months prior to start of trial

Primary outcomes:
measure: Employee purchases of healthy (green-labeled) items
timeFrame: 6 months
Secondary outcomes:
measure: Employee purchases of unhealthy (red-labeled) items
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne N Thorndike, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorndike AN, Riis J, Levy DE. Social norms and financial incentives to promote employees' healthy food choices: A randomized controlled trial. Prev Med. 2016 May;86:12-8. doi: 10.1016/j.ypmed.2016.01.017. Epub 2016 Jan 29.