louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00232401: The Circadian Rhythm of Urine Output in Healthy Infants
Official title: The Circadian Rhythm of Urine Output in Healthy Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: urine
circadian rhythm
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2005-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old.

Detailed description: The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old.

Eligibility criteria: Inclusion Criteria:

* Healthy children, free of medication

Exclusion Criteria:

* History of urinary diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: Aarhus University Hospital
name: Birgitte Mahler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06748001: Avapritinib Rollover Study
Official title: An Open-label, Multicenter, Rollover Study in Patients Who Participated in an Avapritinib Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Mastocytosis, Systemic
Keywords: Indolent Systemic Mastocytosis
ISM
Advanced Systemic Mastocytosis
AdvSM
Rollover study
Lead sponsor: Blueprint Medicines Corporation
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.


Eligibility criteria: Inclusion Criteria:

* Participated in a Blueprint Medicines sponsored avapritinib clinical study. The Sponsor reserves the right to not roll over patients who have been on drug hold for an extended time period.
* Completed End of Trial / End of Study (EOT/EOS) visit in the parent study and demonstrated compliance with the parent study requirements.
* Continue to clinically benefit from treatment with avapritinib.
* Able to give written informed consent.
* Agree to continue to use highly effective contraception as defined in this protocol.
* Female patients of childbearing potential must have negative highly sensitive serum pregnancy test within 20 days before the first dose of avapritinib. Women of nonchildbearing potential do not require this test.

Exclusion Criteria:

* Participant is participating in another interventional study.
* Participant is unwilling or unable to comply with study procedures and study restrictions.
* Participant is breastfeeding.

Other protocol-defined criteria apply.

Primary outcomes:
measure: Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation
timeFrame: Up to approximately 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (UZA)
city: Salerno
country: Italy
facility: A.O.U. San Giovanni di Dio e Ruggi d'Aragona di Salerno
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Oslo
country: Norway
facility: Oslo University Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust - St Thomas Hospital
Study officials:
References:
Clinical trial NCT05280301: Multicenter Sous Vide Frostbite
Official title: Assessment of Sous Vide Water Baths for Acute Rewarming of Frostbitten Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frostbite
Frostbite of Hand
Frostbite of Foot
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of using sous vide devices for heating and maintaining the circulating warm water bath used in the rewarming of acute frostbite.

Detailed description: Frostbite can be a devastating and limb threatening injury. Treatment involves active rewarming in a warm water bath at a consistent temperature, but maintaining the correct temperature water is clinically challenging. Currently these water baths are created and monitored manually - leading to poor rewarming and inefficient use of resources. The "sous vide" device offers an alternative to the manual water bath method. The specific aim of our study is to evaluate the safety, efficacy, and feasibility of use of the sous vide device in patients with extremity frostbite in a multicenter prospective cohort. Data demonstrating the ability of the sous vide device to warm and precisely maintain water bath target temperatures, in addition to expanded evidence of the safety of this modality, will support the broader use of sous vide devices in frostbite care.

Eligibility criteria: Inclusion Criteria:

* Age 18 or up
* Age \<17 with parent or guardian consent
* Ability to understand English
* Ability to provide consent to the study
* Acute frostbite of the hands and/or feet

Exclusion Criteria:

* Children under age 18 without parent or guardian
* Frostbite that has already thawed
* Frostbite of tissue other than hands or feet
* Inability to understand English
* Inability to provide consent

Primary outcomes:
measure: Rewarming
timeFrame: Up to 90 minutes
measure: Time to rewarm in minutes
timeFrame: Up to 90 minutes
Secondary outcomes:
measure: Ease of Use: Provider review
timeFrame: Immediately after rewarming, up to 90 minutes
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Nicholas Daniel, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06426901: Effects of Tan Tui Exercises on Strength and Performance of Football Players.
Official title: Effects of Tan Tui Exercises on Strength and Performance of Football Players.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Football Players
Keywords: Agility
Quickness
Change direction
Skills
Strength
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group1 ,experimental group group 2 control group
Primary purpose: OTHER

Brief summary: Randomized controlled trial (RCT) to investigate the effects of Tan Tui exercises on the strength and performance of football players. Tan Tui can provide football players with a well-rounded approach to physical and mental development, which can contribute to enhanced performance, injury prevention, and personal improvement both on and off the field there is limited study available on the effectiveness of Tan Tui exercises.

Detailed description: Tan Tui training develops mental fortitude, focus, and discipline. Football players can benefit from better concentration, emotional resilience, and the capacity to remain calm under pressure. While football generally focuses on offensive and defensive strategies, mastering Tan Tui self-defense techniques can teach players with real abilities for personal protection off the field. Tan Tui can help with injury prevention by increasing flexibility and body awareness. Tan Tui practitioners are frequently more equipped to avoid strains and sprains. The meditative aspects of Tan Tui training can help football players manage stress and anxiety, improving their mental well-being and overall quality of life.

Eligibility criteria: Inclusion Criteria Male Player

* Player of academy from last 1 year
* Aged 18-35 years.
* BMI (19-29)

Exclusion Criteria:

* • Surgical History

  * Fracture History
  * Meniscal pathology
  * Knee injury due to trauma

Primary outcomes:
measure: Hand Held Dynamometer
timeFrame: 6 weeks
Secondary outcomes:
measure: Agility T-Test
timeFrame: 6th week
Other outcomes:
Locations:
city: Dīr
country: Pakistan
facility: Timergara Football club
state: KPK
Study officials:
affiliation: Riphah International University
name: Riafat Mehmood
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00411801: Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
Official title: A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Thrombotic Thrombocytopenic Purpura (TTP)
Keywords: bleeding disorder
universal plasma
plasma
plasma exchange
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2006-12-15
Enrollment: 8
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: Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific. Transfusing a patient with an incorrect blood group may have fatal consequences. Uniplas is a universally applicable human plasma, which can be administered irrespective of the patient's blood group. This study will test the safety and efficacy of Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and above.
* Definite diagnosis of acute thrombotic thrombocytopenic purpura (TTP).
* Thrombocytopenia.
* Diagnostic signs of microangiopathic hemolytic anemia.

Exclusion Criteria:

* Congenital thrombotic microangiopathies.
* Alternative secondary cause for microangiopathy.
* Co-morbid illness limiting life expectancy to less than 3 months independent of TTP.
* Patients known to be HIV positive.
* Patients known to have lupus.
* Refusal to accept blood products.

Primary outcomes:
measure: Change from baseline in (log) platelet count 1 month after treatment initiation
timeFrame: Baseline to Month 1
Secondary outcomes:
measure: Percentage of participants who died at 1 and 3 months after treatment initiation
timeFrame: Baseline to Month 3
measure: Percentage of participants with a complete response (CR), a partial response (PR), a non-response (NR), or a transient response (TR) after the first treatment cycle and at 1 month
timeFrame: Baseline to Month 1
measure: Total volume of plasma exchange fluid administered during treatment cycles up to 1 month
timeFrame: Baseline to Month 1
measure: Time to reach maximum platelet count
timeFrame: Baseline to the end of the study (up to 7 months)
measure: Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study
timeFrame: Baseline to the end of the study (up to 7 months)
Other outcomes:
Locations:
city: Centreville
country: United States
facility: Contact Octapharma for Facility Details
state: Virginia
Study officials:
affiliation: Octapharma
name: Wolfgang Frenzel, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02714101: Equine-assisted Occupational Therapy for Children With Autism Spectrum Disorder
Official title: Effects of Hippotherapy on the Motivation and Social Interaction/Social Communication of Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with Autism Spectrum Disorder have difficulty engaging in activities. This study examined the effects of equine-assisted occupational therapy for 7 children with ASD ages 4 to 8 years. A multiple baseline design was used. For each child, there were 9 to 11 baseline assessments, 9 to 12 intervention sessions, and 4 follow-up sessions.

Detailed description: Children with Autism Spectrum Disorder (ASD) have difficulty engaging in activities. Based on the literature, the unique features of horses may be beneficial to children with ASD. There is limited research supporting the use of horses in occupational therapy interventions. This study examined the effects of equine-assisted occupational therapy for 7 children with ASD ages 4 to 8 years. A multiple baseline design was used. For each child, there were 9 to 11 baseline assessments (gross and fine motor play activities), 9 to 12 intervention sessions, and 4 follow-up sessions (gross and fine motor play activities). Intervention sessions were 40 to 60 minutes long and consisted of time spent on the horse and in horse related activities. Children were videorecorded in all conditions. Trained coders scored randomly selected segments of the video recording. Inter-rater reliability was good.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Autism spectrum disorder by a multidisciplinary team,
* between ages 3 and 8,
* understand basic English,
* willing to ride a horse, no horse riding in the past 3 months.

Exclusion Criteria:

* severe of repeated aggressive behaviour,
* comorbidities such as deafness that would interfere with intervention.

Primary outcomes:
measure: Rater coding of engagement
timeFrame: One 5 minute segment per session for five months
Secondary outcomes:
measure: Rater coding of enjoyment
timeFrame: One 5 minute segment per session for five months
Other outcomes:
Locations:
Study officials:
References:
citation: Llambias C, Magill-Evans J, Smith V, Warren S. Equine-Assisted Occupational Therapy: Increasing Engagement for Children With Autism Spectrum Disorder. Am J Occup Ther. 2016 Nov/Dec;70(6):7006220040p1-7006220040p9. doi: 10.5014/ajot.2016.020701.
Clinical trial NCT00537901: First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study
Official title: First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum - International Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Rectal Neoplasms
Keywords: Colon and Rectum Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic cancer of colon or rectum

Primary outcomes:
measure: Effectiveness
timeFrame: overall
Secondary outcomes:
measure: Quality of life
timeFrame: overall
Other outcomes:
Locations:
Study officials:
affiliation: KFSH & RC
name: Shouki Bazarbashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05394701: Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids
Official title: Comparing the Pharmacological Profile of Enteric Coated and Non-Enteric Coated Capsules Containing Omega 3 Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetics
Keywords: Bioavailability
Pharmacokinetics
Omega-3 fatty acids
Fish Oil
Lead sponsor: Factors Group of Nutritional Companies Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to investigate the uptake/gastrointestinal absorption of fatty acids in healthy adult volunteers by using enteric coated and non-enteric coated soft capsules containing omega 3 fatty acids. Pharmacokinetic parameters such as AUC and Cmax, as well as any adverse events are recorded.

As secondary objective, the short-term effects of Omega-3 supplementation on blood lipid parameters in healthy volunteers are evaluated using a Cholestech LDX analyzer to measure cholesterol and related lipids.


Eligibility criteria: Inclusion Criteria:

* Age 21-65
* healthy, good physical condition

Exclusion Criteria:

* Pregnancy or breast-feeding
* Gastrointestinal conditions
* Acute or chronic liver disease
* Acute or chronic kidney disease
* Acute or chronic cardiovascular disease
* Allergy or Intolerance to gluten
* Allergy or Intolerance to fish or shellfish
* Use of medications (e.g., anticoagulants/ blood thinners such as warfarin; blood lipid-lowering agents such as statins)
* Use of Fish oil supplements
* Use of any form of nicotine or tobacco
* Alcohol and substance abuse history
* Participation in another investigational study

Primary outcomes:
measure: AUC: the area under the concentration-time curve
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
measure: Cmax: maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
measure: Tmax: the time point of maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Secondary outcomes:
measure: Effects on blood lipid parameters
timeFrame: 0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose
measure: Changes in blood lipid concentrations
timeFrame: 0 (Baseline; pre-dose), 3, 6, 12, 24, 48, 72, 96, 120 hours post-dose
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: ISURA
state: British Columbia
Study officials:
affiliation: Isura
name: Julia Solnier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02693301: Effects of an Exercise Program for Children With Asthma
Official title: Effects of an Intra-hospital Exercise Program for Children With Asthma and Respiratory Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Respiratory symptoms
Exercise program
Functional capacity
Body composition
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 53
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: exercise program in the pulmonary function and cardiorespiratory fitness in children with asthma and respiratory symptoms

Detailed description: This study aims to analyze the effects of an exercise program in the pulmonary function, cardiorespiratory fitness, diet quality index, physical activity, body composition, muscle function, agility, and psychological health in a group of children with asthma and respiratory symptoms

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Asthma following the GEMA 2009 criteria (Spanish Guide for Asthma Management) at least 6 months prior to the study.
* Complete successfully both Cardiorespiratory and Functional Tests.

Exclusion Criteria:

* Diagnosed with other chronic respiratory disease or condition
* Diagnosed with any chronic disease including cardiovascular diseases.
* Reduced mobility
* Uncooperative
* Poor adherence to medication

Primary outcomes:
measure: Change in Pulmonary Function (Lung Function)
timeFrame: Baseline, 2 months, and 3 months
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline, 2 months, and 3 months
measure: Change in Muscle Strength
timeFrame: Baseline, 2 months, and 3 months
measure: Change in Quality of life and anxiety status
timeFrame: Baseline, 2 months, and 3 months
measure: Change in anxiety
timeFrame: Baseline, 2 months, and 3 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 2 months, and 3 months
measure: Change in Waist-to-Height index
timeFrame: Baseline, 2 months, and 3 months
measure: Change in anthropometric outcomes
timeFrame: Baseline, 2 months, and 3 months
measure: Change in Body Composition
timeFrame: Baseline, 2 months, and 3 months
measure: Changes in Physical Activity using questionnaires
timeFrame: Baseline, 2 months, and 3 months
measure: Change in Agility walking
timeFrame: Baseline, 2 months, and 3 months
measure: Change in Agility stairs.
timeFrame: Baseline, 2 months, and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesus
Study officials:
affiliation: Universidad Europea de Madrid
name: Margarita Perez Ruiz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01145001: Enhancing a High School Based Smoking Cessation Program
Official title: Contingency Management for Smoking Cessation in Adolescent Smokers - Phase IV, Enhancing a High School Based Smoking Cessation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: smoking
adolescents
contingency management
nicotine replacement therapy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-16
Enrollment: 154
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.


Eligibility criteria: Inclusion Criteria:

* High School aged
* Desire to quit smoking
* Smoking \>5 cigarettes per day
* Able to read and write in English

Exclusion Criteria:

* Current dependence on other substances
* Medical conditions that would contraindicate the use of a nicotine patch

Primary outcomes:
measure: Abstinence Rates at the End of Treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Continuous Abstinence During Treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CMHC
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: