louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01748058: Active Video Games to Promote Physical Activity in Children With Cancer
Official title: Active Video Games to Promote Physical Activity, Motor Performance and Quality of Life in Children With Cancer: an Intervention Study With 2-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
name: Tampere University Hospital
First posted: 2012-12-12
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the efficacy and feasibility of active video gaming with regard to the promotion of physical activity and motor learning in children with cancer. Experienced fatigue, body mass index and the development of metabolic risk factors during treatment are also examined.


Eligibility criteria: Inclusion Criteria:

* cancer diagnose
* treated with Vincristine in Turku University Hospital or Tampere University Hospital

Exclusion Criteria:

* other diseases limiting functional ability
* not able to communicate

Primary outcomes:
measure: Accelerometer, average counts of dynamic acceleration (physical activity)
timeFrame: 1 week at baseline and at 12 months
Secondary outcomes:
measure: Movement assessment battery for children (M-ABC-2) scores (motor performance)
timeFrame: At baseline, 2, 6, 12 and 24 months
measure: PedsQL Multidimensional Fatigue Scale scores (fatigue)
timeFrame: At baseline, 2, 6, 12 and 24 months
measure: Blood sugar
timeFrame: At baseline, 2, 6, 12 and 24 months
measure: Blood insulin
timeFrame: At baseline, 2, 6, 12 and 24 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
citation: Hamari L, Jarvela LS, Lahteenmaki PM, Arola M, Axelin A, Vahlberg T, Salantera S. The effect of an active video game intervention on physical activity, motor performance, and fatigue in children with cancer: a randomized controlled trial. BMC Res Notes. 2019 Nov 29;12(1):784. doi: 10.1186/s13104-019-4821-z.
citation: Kauhanen L, Jarvela L, Lahteenmaki PM, Arola M, Heinonen OJ, Axelin A, Lilius J, Vahlberg T, Salantera S. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up. BMC Pediatr. 2014 Apr 5;14:94. doi: 10.1186/1471-2431-14-94.
Clinical trial NCT03165058: Assessment of Colonic Epithelial Integrity With Mucosal Impedance
Official title: Assessment of Colonic Epithelial Integrity With Mucosal Impedance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified by physicians in the endoscopy center at Vanderbilt. Those patients undergoing colonoscopy for either the indication of screening colonoscopy or IBD surveillance will be asked, on the day of their colonoscopy, whether they want to participate in the study.

Brief summary: In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity changes in the colonic epithelium.

Detailed description: The intestinal epithelium functions to separate luminal contents from the interstitium. Increased intestinal permeability can represent compromise of the epithelium's integrity. Prior research has demonstrated that defects in intestinal barrier function are associated with inflammatory bowel disease (IBD) and increased intestinal permeability can be important in the maintenance of remission in IBD patients. There is currently not a convenient way to measure colonic epithelial barrier function in real time which could provide clinically relevant information .

Eligibility criteria: Inclusion Criteria:

* Men and women over the age of 18 with a diagnosis of IBD (Ulcerative Colitis or Crohn's Disease)
* Men and women undergoing screening colonoscopy (typical age would be 50 or greater but there are exceptions)

Exclusion Criteria:

* Age less than 18 years old
* Patients unable to give informed consent
* Patients with history of colonic surgeries
* Patients with history of colonic motility disorder

Primary outcomes:
measure: Mucosal Impedance Values
timeFrame: 15 minutes
Secondary outcomes:
measure: Difference in Inflamed and Normal Mucosa
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Endoscopy Laboratory
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Yash Choksi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02882958: Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate
Official title: Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Radiology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Analogic Corporation
First posted: 2016-08-30
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be single center study. Subjects will be recruited from those referred to interventional radiology for ultrasound-guided prostate fiducial placement, or those planing to undergo ultrasound-guided prostate fiducial placement in radiotherapy clinic.

Brief summary: The investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology.


Eligibility criteria: Inclusion Criteria:

* scheduled for ultrasound-guided gold seeds prostate fiducial placement prior to radiotherapy

Exclusion Criteria:

* eGFR \< 45 mL/min/1.73m2
* recent (within 4 weeks) kidney or liver transplant
* contraindication to prostate MRI
* patient with cardiac pacemaker

Primary outcomes:
measure: Prostate Volume on Actual MRI
timeFrame: Within one month after the fiducial placement
measure: Prostate Volume on US reconstruction
timeFrame: During the fiducial placement
measure: Prostate Volume based on US/EM reconstruction
timeFrame: During the fiducial placement
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anthony E. Samir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02719158: Dose Ranging Study of OTO-201 in AOMT
Official title: A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Otitis Media
AOMT
Keywords: Acute otitis media with tympanostomy tubes
OTIPRIO
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 95
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dose Ranging Study of OTO-201 in AOMT

Detailed description: This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Eligibility criteria: Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)
* Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of sensorineural hearing loss
* Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
* Subject has a history of known immunodeficiency disease

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: Up to 1 month
measure: Otoscopic Examination: Auricle and Meatus
timeFrame: Up to 1 month
measure: Otoscopic Examination: Tympanic Membrane
timeFrame: Up to 1 month
Secondary outcomes:
measure: Absence of Otorrhea
timeFrame: Up to Two Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Contact Otonomy call center for trial locations
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00612196: A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
Official title: A Randomised, Phase I, Single Dose, Placebo-Controlled, Dose Escalation Study of TB-402, A Monocloncal Antibody Directed Against FACTOR VIII, Administered Intravenously in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety and tolerability
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
Collaborators: name: BioInvent International AB
First posted: 2008-02-11
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
* No clinically important abnormal physical, laboratory, ECG findings
* Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)

Exclusion Criteria:

* Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.
* Any autoimmune disease.
* Previous allergic reaction to immunoglobulin.
* Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.
* Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.
* Abnormal platelet function or clinically significant out of range values for any coagulation tests.
* History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage.
* Screening FVIII:C \< 50%.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Cyncron Clinical Research Unit
Study officials:
affiliation: Cyncron Clinical Research Unit
name: Thomas J Jensen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verhamme P, Pakola S, Jensen TJ, Berggren K, Sonesson E, Saint-Remy JM, Balchen T, Belmans A, Cahillane G, Stassen JM, Peerlinck K, Glazer S, Jacquemin M. Tolerability and pharmacokinetics of TB-402 in healthy male volunteers. Clin Ther. 2010 Jun;32(6):1205-20. doi: 10.1016/j.clinthera.2010.06.012.
Clinical trial NCT00851396: Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls
Official title: Assessment of Influence of Vitamin D on Insulin Secretion and Sensitivity in Obese Teenage Girls (Assessment of Prevalence of Vitamin D Deficiency in Obese Teenage Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Insulin Resistance
Insulin Sensitivity
Obesity
Keywords: Vitamin D deficiency
Insulin resistance
Glucose- Insulin dynamics
Obese adolescents
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female adolescents who are menarchal BMI is 95th centile, for age and sex

Brief summary: The purpose of the study is to assess the relationship between vitamin D status and insulin- glucose dynamics in obese Adolescents. The study is intended to assess the difference in the insulin sensitivity before and after correction of vitamin D deficiency.

Detailed description: The vitamin D deficient subjects are identified initially through an existing study. Those identified with vitamin D deficiency are notified and subsequently treated with standard therapy for vitamin D deficiency as part of their clinical care. Patients who self report that they have taken the treatment are enrolled in this study. Patients will be evaluated in this study with measurement of serum 25 OH D level, PTH and oral glucose tolerance test. The study will assess if there is improvement in glucose- insulin sensitivity dynamics once the serum 25OH D level is normalized

Eligibility criteria: Inclusion Criteria:

* Female adolescents who are menarchal
* BMI is 95th centile, for age and sex
* Patients will be screened for vitamin D deficiency through an existing study.
* Those found to be vitamin D deficient will be given standard treatment of vitamin D deficiency.
* In this study, patients who self report that they had taken the treatment for vitamin D will be screened for serum 25 OH D level

Exclusion Criteria:

* Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications

Primary outcomes:
measure: The insulin secretory capacity and insulin resistance indices are the outcome of interest in this study.
timeFrame: December 2009
Secondary outcomes:
measure: We will evaluate whether the relationship of obesity and insulin resistance and the defective insulin secretory capacity is modulated by vitamin D status
timeFrame: December 2009
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital , University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ambika Ashraf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00434096: Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)
Official title: A Randomized Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity disease
cannabinoid-1 receptor
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 915
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks.

Secondary objectives are:

* To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area.
* To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.
* To evaluate the pharmacokinetics of SR141716.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) \> 25 kg/m²
* Visceral Fat Area (VFA) \> 100 cm²
* Triglycerides (TG) \> 150 mg/dL and \< 700 mg/dL, and/or HDL-cholesterol \< 40 mg/dL(Dyslipidemia)
* At least 1 criteria of the following 2 comorbidities:

  * Impaired Glucose Tolerance or Type 2 diabetes
  * Hypertension

Exclusion Criteria:

* Patient with a secondary obesity.
* Patients who have received the diet therapy for less than 8 weeks before start of the observation period.
* Patients whose body weight changed by more than the variation of ± 2kg for screening period.
* Low compliance to drug intake (\< 80%) and dietary instruction during the observation period.
* Patients with type 1 diabetes.
* Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia).
* Patients with a LDL-cholesterol \> 190 mg/dL at any of Weeks -8 or -4.
* Patients with a secondary hypertension.

Primary outcomes:
measure: body weight: relative change from baseline
timeFrame: Week 52
measure: triglycerides: relative change from baseline
timeFrame: Week 52
Secondary outcomes:
measure: HDL-cholesterol ;visceral fat area
timeFrame: Week 52
measure: Safety: Adverse events
timeFrame: study period
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01415596: The Effect of High Dose Salbutamol on Muscle Performance
Official title: The Effect of High Dose Salbutamol on Dynamic and Isometric Muscle Power and Recovery in Well-trained Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ergogenic Effects of Salbutamol in Healthy Males
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2011-08-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Many athletes use beta2-agonists as treatment of airway hyperresponsiveness during exercise. High dose beta2-agonists may have an ergogenic effect on exercise performance. We hypotheis that the beta2-agonist, salbutamol, taken in high doses can improve muscle power and recovery during exercise in well-trained athletes.


Eligibility criteria: Inclusion Criteria:

* Males
* age 18-45
* training frequency \> 10 hrs/wk
* informed consent

Exclusion Criteria:

* smoker or former smoker
* chronic diseases, as well as asthma
* allergy to the study drugs
* intake of any form of medicin or inhibited drugs during the study
* use of beta2-agonist 14 days before the intervention

Primary outcomes:
measure: Muscle power
Secondary outcomes:
measure: Muscle recovery
Other outcomes:
Locations:
city: Copenhagen NW
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT06107296: Early Perioperative Quality Of Recovery After Hip and Knee Arthroplasty: a Retrospective Comparative Cohort Study
Official title: Early Perioperative Quality Of Recovery After Hip and Knee Arthroplasty: a Retrospective Comparative Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty, Hip Replacement
Arthroplasty, Knee Replacement
Keywords: Arthroplasty
Hip Replacement
Knee Replacement
QoR-15 questionnaire
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (age ≥ 18 years) Having benefited from an ATG or ATH at Strasbourg University Hospital between March 1, 2020 and December 31, 2022

Brief summary: Hip and knee replacements are indicated to improve long-term quality of life and pain. These long-term results may depend on the quality of the initial postoperative recovery.

However, early postoperative health status after total hip arthroplasty (THA) and total knee arthroplasty (TKA) is not accurately described. Through this retrospective study, the investigators wanted to describe the perioperative state of health monitored using the QoR-15 questionnaire for THA and TKA patients from the perioperative moment to postoperative day 28.


Eligibility criteria: Inclusion Criteria:

* Adult patient (age ≥ 18 years)
* Having benefited from an ATG or ATH at Strasbourg University Hospital between March 1, 2020 and December 31, 2022
* Tracked with QoR-15 score
* Patient not opposing the reuse of his data for scientific research purposes

Exclusion Criteria:

* Refusal to participate in the study
* Patient admitted to THA for a hip fracture
* Patient admitted for multiple THA or TKA

Primary outcomes:
measure: Mean QoR-15 score at the preoperative period and postoperative days 1, 3, 14 and 28
timeFrame: At the preoperative period and postoperative days 1, 3, 14 and 28
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
Study officials:
References: