louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01564290: Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
Official title: Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Diarrhea
Acute Gastroenteritis
Keywords: acute diarrhea
probiotics
children
Lead sponsor: Centro Pediatrico Albina de Patino
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 54
Sex: ALL
Minimum age (years): 10
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.

Detailed description: Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, considering the advances in treatment, Lactobacillus Rahmnosus has being well described as a probiotic who reduces the number of days of hospitalization and also de the severity.

Objectives: To evaluate the effect of the probiotic yogurt in the treatment of children who are between 10 months and 3 years old with acute non-dysenteric diarrhea.

Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive Lactobacillus Rahmnosus in a yogurt presentation and the other one will receive Sacharomyces boulardii in a lyophilized form ; the parameters of evaluation are going to be the number of diarrhea stools by day, number of vomiting episodes, hours with fever, nutritional and immunization state.

Eligibility criteria: Inclusion Criteria:

* All acute diarrhea

Exclusion Criteria:

* Severe malnourishment
* Severe dehydration
* Systemic infections

Primary outcomes:
measure: Duration of diarrhea
timeFrame: five days
Secondary outcomes:
measure: Duration of fever
timeFrame: five days
measure: duration of vomiting
timeFrame: five days
measure: duration of hospitalization
timeFrame: five days
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: Centro Pediatrico Albina Patino
Study officials:
affiliation: Centro Pediatrico Albina Patino
name: Giuseppe E Grandy, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Pediatrico Albina Patino
name: Richard M Soria, MD
role: STUDY_DIRECTOR
affiliation: Centro Pediatrico Albina Patino
name: Sdenka Jose, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01871090: Remote Device Interrogation In The Emergency Department
Official title: Remote Device Interrogation In The Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Cardiovascular Disease
Heart Failure
Arrhythmias, Cardiac
Keywords: Remote Monitoring
Remote Care
Cardiac Resynchronization Therapy
Pacemaker
Implantable Cardioverter Defibrillator
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will enroll up to 100 patients total.

Expected duration of the study is 6 months. Once enrolled the patient will participate in the study for the duration of the Emergency Department stay, until discharged or admitted to the hospital.


Eligibility criteria: Inclusion Criteria:

1. Present to Emergency Department with an implanted pacemaker or defibrillator.
2. Are 18 years of age or older, or of legal age to give informed consent specific to state law.
3. Are willing and able to provide informed consent for study participation.

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to Interrogation
timeFrame: On day of Emergency Department admission
Secondary outcomes:
measure: Time to Clinical/Treatment Decision
timeFrame: On day of Emergency Department admission
Other outcomes:
measure: Length of Emergency Department Stay
timeFrame: On day of Emergency Department admission
Locations:
city: Zanesville
country: United States
facility: Genesis Healthcare System
state: Ohio
Study officials:
affiliation: Los Angeles Biomedical Research Institute at Harbor - UCLA
name: Marc Girsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04798690: Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
Official title: Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Growth Hormone Deficiency
Idiopathic Short Stature
Turner Syndrome
Small for Gestational Age
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 2500
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Short stature by GHD or ISS or TS or SGA

Brief summary: This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.


Eligibility criteria: Inclusion Criteria:

* Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA)
* Children who has official height record at least 6 months prior

Exclusion Criteria:

* Children with Epiphyseal closure

Primary outcomes:
measure: Long term safety assessed through the adverse events
timeFrame: Up to 2 years after epiphyseal closure
Secondary outcomes:
measure: Change of annualized height velocity
timeFrame: Up to 2 years after epiphyseal closure
measure: The difference between target height and final height
timeFrame: Up to 2 years after epiphyseal closure
measure: Changes in Height SDS
timeFrame: Up to 2 years after epiphyseal closure
measure: Changes in skeletal maturity
timeFrame: Up to 2 years after epiphyseal closure
measure: Changes in IGF-1
timeFrame: Up to 2 years after epiphyseal closure
measure: Changes in IGFBP-3
timeFrame: Up to 2 years after epiphyseal closure
measure: Changes in BMI SDS
timeFrame: Up to 2 years after epiphyseal closure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
state: Seodaemun-gu
Study officials:
References:
Clinical trial NCT02547090: Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy
Official title: The Effect of Two Surgeons on Blood Loss and Operative Time in Cerebral Palsy (CP) Patients Undergoing Posterior Spinal Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 50
Sex: ALL
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: The study group consisted of 25 consecutive patients with CP and progressive neuromuscular scoliosis who underwent PSF in 2012 with the use of a two surgeon team. The control group consisted of a consecutive series of patients with CP who underwent PSF by a single surgeon from 2008-2010 at the same institution. The control group was a cohort of patients matched for age, gender, weight and Cobb angle.

Brief summary: Background:

Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. The purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population.

Methods:

This is a prospective, matched cohort analysis with a consecutive series of patients with CP who underwent PSF, with two attending surgeons, in 2012. These are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests (significance set a p\<0.05).


Eligibility criteria: Inclusion Criteria:

* Cerebral palsy
* neuromuscular scoliosis requiring posterior spinal fusion (\>50 degree Cobb)
* PSF from 2008-2012 at Phoenix Children's Hospital
* GMFCS IV or V

Exclusion Criteria:

* Diagnosis other than CP
* GMFCS I-III
* Previous spine deformity surgery

Primary outcomes:
measure: Complications due to PFS surgery
timeFrame: Post-operative hospital stay (up to 12 days)
Secondary outcomes:
measure: Surgical time
timeFrame: intraoperative
measure: Estimated blood loss
timeFrame: intraoperative
measure: Length of Stay
timeFrame: During hospitalization (up to 12 days)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01262690: A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
Official title: A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cachexia
Keywords: First-in-human (FIH)
Single Ascending Dose (SAD) Study
TAM-163
PF-05230901
Cachexia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* History of seizures, including childhood seizures.
* History of movement disorders or related neurological conditions.
* History of head trauma associated with loss of consciousness.

Primary outcomes:
measure: Incidence and severity of adverse events.
timeFrame: 35 days
measure: Incidence and severity of clinical laboratory abnormalities.
timeFrame: 35 days
measure: Mean change from baseline in vital signs.
timeFrame: 35 days
measure: Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.
timeFrame: 35 days
measure: Incidence and severity of findings during the neurological examination.
timeFrame: 35 days
Secondary outcomes:
measure: Plasma concentrations
timeFrame: 14 days
measure: Anti-drug antibodies
timeFrame: 35 days
measure: Appetite and food consumption
timeFrame: 13 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06725290: Dry Eye Disease With Isotretinoin ISOTRETINOIN
Official title: Digital Assessment of Dry Eye Diseases in Acne Vulgaris Patients Receiving Isotretinoin Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acne Vulgaris
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Acne patients on isotretinoin

Brief summary: The study aims to explore the effects of isotretinoin therapy on the dry eye parameters in acne vulgaris patients \& determine if it is dose-dependent or not.

Detailed description: To measure the tear film, the eye lid thickness, the meibomian gland function and to do objective tests for comparison

Eligibility criteria: Inclusion Criteria:

* Moderate to severe acne on isotretinoin

Exclusion Criteria:

* Occular diseases causing dry eye
* Pregnant females

Primary outcomes:
measure: Total ocular surface disease index (OSDI) SCORE
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02831790: The Fontan Education Study: A Randomized Control Trial
Official title: The Fontan Education Study: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Fontan Education Study is a cluster randomized controlled trial evaluating the impact of a novel education program in combination with usual care, versus usual care alone, on preparing parents of children undergoing Fontan surgery for the challenges of the postoperative course.


Eligibility criteria: Inclusion Criteria:

* children who are planned to undergo Fontan surgery within 4-6 weeks and their parent(s)/guardian(s)

Exclusion Criteria:

* parents with \< grade 6 level of English reading.

Primary outcomes:
measure: Parent's State Anxiety Inventory (STAI)-State score preoperatively
timeFrame: within 1 week preceding surgery
Secondary outcomes:
measure: STAI-State score postoperatively
timeFrame: 1 week and 1 month postoperatively
measure: Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively
timeFrame: 1 week and 1 month postoperatively
Other outcomes:
measure: Semi-structured interviews postoperatively
timeFrame: 1 Month Postoperatively
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Andrew S Mackie, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04295590: Impact of Augmenting Exercise Intensity vs. Frequency
Official title: Impact of Augmenting Exercise Intensity vs. Frequency on Peak Work Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Training
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Queen's University
First posted: 2020-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the impact of augmenting exercise intensity and augmenting exercise frequency on peak work rate. Participants will complete exercise tests and provide 8 skeletal muscle samples following a within-subjects randomized crossover design utilizing single-leg cycling. Both training periods will be 4 weeks long and skeletal muscle biopsies will be collected from both legs before and after each training period. All exercise sessions will be supervised, take place in the investigator's laboratory, and occur on stationary bikes.


Eligibility criteria: Inclusion Criteria:

* Recreational active (\<3 hours per week of aerobic exercise)
* Willing to provide skeletal muscle biopsies

Exclusion Criteria:

* Cardiovascular or metabolic disease
* Athletes or individuals exceeding 3 hours per week of aerobic exercise
* Smokers

Primary outcomes:
measure: Peak work rate
timeFrame: Before exercise training on two days (~7 and 6 days before first training session; ~24 hours apart), and after exercise on two days (~48-96 hours after the last training session; ~24 hours apart)
Secondary outcomes:
measure: Peak oxygen uptake
timeFrame: Before exercise training on two days (~7 and 6 days before first training session; ~24 hours apart), and after exercise on two days (~48-96 hours after the last training session; ~24 hours apart)
measure: Maximal citrate synthase activity
timeFrame: Before exercise training (~7 days before first training session), and after exercise training (~48-72 hours after the last training session)
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's Muscle Physiology Lab in the School of Kinesiology and Health Studies at Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Brendon J Gurd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06541990: Psychoeducational Intervention for Patients With Hepatocellular Carcinoma
Official title: HARMONY: A Psychoeducational Intervention to Reduce Psychological Distress and Improve Quality of Life for Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Cirrhosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to refine and pilot test HARMONY, a psychoeducational intervention for patients with newly diagnosed hepatocellular carcinoma (HCC).

Detailed description: There are two parts of this study. Study Part 1 is an open pilot study to refine HARMONY prior to larger-scale testing in a randomized controlled trial (RCT) setting. Study Part 1 is purely descriptive, as the investigators will use the data to refine HARMONY before proceeding to Study Part 2.

Study Part 2 is a pilot RCT to assess the feasibility and acceptability of conducting a randomized trial of HARMONY versus enhanced usual care. Participants will complete a baseline survey and then be randomized to HARMONY versus enhanced usual care (a supportive care resource guide). This record reflects the clinical trial component (Study Part 2), as feasibility and acceptability outcomes will be collected for this phase only.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* New diagnosis of HCC within the last three months
* Clinical, radiographic, and/or pathologic diagnosis of concomitant cirrhosis
* Ability to complete study procedures English

Exclusion Criteria:

* Significant uncontrolled hepatic encephalopathy
* Cognitive impairment, or psychiatric disorder which will interfere with study participation
* Patients near the end of life for whom hospice is recommended

Primary outcomes:
measure: Feasibility: enrollment rate
timeFrame: 12 weeks
measure: Feasibility: retention rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06661590: Nutritional Language Model
Official title: Comparative Analysis Between Artificial Intelligence vs. Human Generated Nutrition Messages for Colorectal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Disease State or Condition
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Colorectal cancer survivors often face unique nutritional challenges and require support in their recovery and long0term health. While human experts have traditionally provided that support, there has been an increase in the use of Large Language Models (LLM) in medicine and in nutrition. The LLM offers a potential supplementary resource for generating personalized nutritional advice, specifically in personalized messaging. However, the efficacy and reliability of these AI-generated messages in comparison to human expert advice remain underexplored specific to this population.

This study aims to compare the nutrition-related content generated by popular LLMs-ChatGPT, Claude, Gemini, and Co-Pilot-against messages crafted by human experts. By evaluating the generated content in terms of readability, thematic relevance, medical relevance, perceived effectiveness, and implementation of participants' clinical practice, this research will provide insights into the strengths and limitations of using AI for nutritional guidance in colorectal cancer care.


Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* Currently practicing Registered Dietitian Nutritionist with at least five years of experience working with oncology patients and survivors in their practice.
* Must have access to computer and internet access.

Exclusion Criteria:

* Non-English speakers, as the study materials and assessments are in English.
* Experts with conflicts of interest related to any of the LLMs that are being evaluated.

Primary outcomes:
measure: Outcome Measure Title: Readability of Nutrition Messages
timeFrame: 8 to 12 months
measure: Outcome Measure Title: Thematic Relevance of Nutrition Messages
timeFrame: 8 to 12 months
measure: Outcome Measure Title: Medical Relevance to Colorectal Cancer Survivors
timeFrame: 8-12 months
measure: Outcome Measure Title: Perceived Effectiveness of Nutrition Messages
timeFrame: 8-12 months
measure: Outcome Measure Title: Potential for Implementation in Clinical Practice
timeFrame: 8-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: The Hormel Institute - University of Minnesota, Medical Research Center
state: Minnesota
Study officials:
affiliation: Hormel Institute
name: Annie Lin, RD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hormel Institute
name: Glen Morris, PhD
role: STUDY_CHAIR
References:
citation: Shah NH, Entwistle D, Pfeffer MA. Creation and Adoption of Large Language Models in Medicine. JAMA. 2023 Sep 5;330(9):866-869. doi: 10.1001/jama.2023.14217.