louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01732705: High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes
Official title: Effect of High Intensity Interval Training (HIT) on Insulin Sensitivity in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Insulin sensitivity
High intensity interval training
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2012-11-26
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.

Detailed description: Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes, but implies a considerable time commitment. High intensity interval training (HIT) is time-efficient exercise consisting of repeated bouts of short duration high intensive workloads. The aim of this study is to determine the effect of HIT in patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of HIT.

Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be measured after completion of the overall training program by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during training period for measuring of muscle glycogen content, and muscle biopsies for further analysis obtained during the experimental day.

Eligibility criteria: Inclusion Criteria:

* 10 subjects with Type 2 diabetes. 10 healthy control subjects.
* BMI 28-35
* diet or tablet treatment for diabetes

Exclusion Criteria:

* regular physical activity
* diseases other than type 2 diabetes
* insulin treatment

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 2 days after last training session (day 17)
Secondary outcomes:
Other outcomes:
measure: Glycogen content in skeletal muscle
timeFrame: 17 days. Before and after training session day 1, 7 and 15. Before and immediately after isoglycemic, hyperinsulinemic clamp day 17.
Locations:
city: Copenhagen
country: Denmark
facility: Xlab, Department of Biomedical Sciences, University of Copenhagen
Study officials:
affiliation: Xlab, Department of Biomedical Sciences, University of Copenhagen
name: Flemming Dela, MD. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dela F, Ingersen A, Andersen NB, Nielsen MB, Petersen HHH, Hansen CN, Larsen S, Wojtaszewski J, Helge JW. Effects of one-legged high-intensity interval training on insulin-mediated skeletal muscle glucose homeostasis in patients with type 2 diabetes. Acta Physiol (Oxf). 2019 Jun;226(2):e13245. doi: 10.1111/apha.13245. Epub 2019 Feb 14.
Clinical trial NCT01904305: Clinician Ability to Predict the Presence of Nosocomial Pneumonia Based on Bronchoscopic Findings
Official title: Clinician Ability to Predict the Presence of Nosocomial Pneumonia Based on Macroscopic Examination of Bronchoscopic Findings in Critically Ill Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: Pneumonia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians working in the Surgical Intensive Care Unit

Brief summary: This study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients.

Detailed description: This study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients. Bronchoscopies will be videotaped. The clinician doing the procedure will make prediction as to whether the patient, in fact, has pneumonia. In addition, at least one other physician will view the videotape and predict whether the patient has pneumonia.

Once laboratory results are available, the physician predictions will be compared against the definitive laboratory determination

Eligibility criteria: Inclusion Criteria:

* Critical Care staff and fellows of the Departments of Anesthesia and Surgery

Exclusion Criteria:

* Refusal of consent

Primary outcomes:
measure: Presence or absence of hospital-acquired pneumonia
timeFrame: At first clinical suspicion of pneumonia. Average of hospital Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Bryce RH Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02686905: Vitamin Supplementation After Bariatric Surgery
Official title: Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complications of Bariatric Procedures
Avitaminosis
Lead sponsor: California State Polytechnic University, Pomona
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives in this study are to provide information on the efficacy of transdermal supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric patients, and to determine short-term body composition, HbA1c and fasting plasma glucose outcomes for patients after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* patients currently approved for vertical sleeve or gastric bypass bariatric surgery
* female patients should not be pregnant or plan to become pregnant

Exclusion Criteria:

* metal objects in the body
* current weight greater than 600lbs
* previous bariatric (revision) surgery

Primary outcomes:
measure: Fasting Blood Glucose
timeFrame: 3 months
measure: Calcium Blood Value
timeFrame: 3 months
measure: Iron Blood Value
timeFrame: 3 months
measure: Vitamin B12 Blood Value
timeFrame: 3 months
measure: Vitamin D Blood Value
timeFrame: 3 months
measure: HbA1c Blood Value
timeFrame: 3 months
measure: Fat Mass Measurement
timeFrame: 3 months
measure: Fat Free Mass Measurement
timeFrame: 3 months
measure: Weight Measurement
timeFrame: 3 months
measure: Waist Circumference
timeFrame: 3 months
measure: Hip Circumference
timeFrame: 3 months
Secondary outcomes:
measure: Height
timeFrame: 3 months
measure: Total Body Water
timeFrame: 3 months
Other outcomes:
Locations:
city: Brea
country: United States
facility: Oliak Center for Weight Loss
state: California
Study officials:
affiliation: Cal Poly Pomona
name: Bonny Burns-Whitmore, DrPH, RD
role: STUDY_DIRECTOR
affiliation: Oliak Center for Weight Loss
name: David M Oliak, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00335205: A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.
Official title: A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar I and II Depression.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bipolar Disorder
Major Depressive Disorder
Keywords: ropinirole
dopamine
D2
depression
bipolar
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Jerusalem Mental Health Center
First posted: 2006-06-09
Enrollment: 60
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: We hypothesize that depressed patients who have not responded to their current antidepressant medication will respond to the addition of ropinirole to their current regimen at a rate better than placebo.

Detailed description: Most pharmacologic treatments of depression rely on serotonergic and/or noradrenergic mechanisms. Yet, evidence both from animal studies and from human trials suggests a role for dopaminergic pathways and particularly for dopamine D2-like receptors in the treatment of depression. In recent years, two new selective agonists of dopamine D2-like receptors have come into clinical use for the treatment of parkinsonism. Preliminary evidence suggests that these drugs might be useful as antidepressants. We are testing whether one of these agonists, ropinirole, is an effective augmentation strategy in depressed patients in a double-blind, randomized, controlled trial. We are recruiting unipolar and bipolar patients who remained depressed (modified Hamilton Depression Rating Scale score greater than 16) despite at least 4 weeks of treatment with an adequate dose of antidepressant medication. Patients receive either 2mg of oral ropinirole or placebo twice daily added on to their current medication and are evaluated weekly over 7 weeks and are assessed weekly using two depression rating scales.

Eligibility criteria: Inclusion Criteria:

* DSM-IV Major Depression OR Bipolar I or II Disorder - Currently Depressed
* One month of a stable, adequate dose of antidepressant medication
* Bipolar patients must have a mood stabilizer
* At least 18 years old
* Modified HDRS-21 more than 16 (Scores reverse vegetative symptoms.)
* Informed Consent

Exclusion Criteria:

* CVA
* Antipsychotic Medication
* Drug or Alcohol Abuse
* Active Suicidality
* Rapid Cycling Bipolar Disorder
* Neurologic or Dementing Illness
* Psychosis
* Parkinsonism
* Pregnancy

Primary outcomes:
measure: Hamilton Depression Rating Scale Score
Secondary outcomes:
measure: Montgomery Asberg Depression Rating Scale Score
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Jerusalem Mental Health Center
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center, Dept. of Psychiatry
Study officials:
affiliation: Jerusalem Mental Health Center
name: Leon Grunhaus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03375905: Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
Official title: Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: ethnic Japanese
Lead sponsor: Sommetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.


Eligibility criteria: Inclusion Criteria:

* both parents ethnically Japanese, or one parent Japanese and the other east-Asian
* PSG (polysomnogram) done within the previous 12 months that shows an AHI of 10-50/hr and \<80% of apneas and hypopneas are obstructive
* cNEP collar fits and is well-tolerated

Key exclusion Criteria:

* BMI \>34
* abnormalities in neck structure
* sleep disturbance other than obstructive sleep apnea
* serious medical illness
* pregnancy

Primary outcomes:
measure: proportion of sustained responders
timeFrame: two weeks after initiation of treatment
Secondary outcomes:
measure: proportion of initial responders
timeFrame: at PSG 1, one day
measure: AHI comparison with qualifying PSG
timeFrame: one day, on three separate study occasions
measure: ODI comparison with qualifying PSG
timeFrame: one day, on three separate study occasions
measure: SpO2 <90% comparison with qualifying PSG
timeFrame: one day, on three separate study occasions
measure: CGI of sleep
timeFrame: three months, and two weeks, respectively
measure: CGI of satisfaction with the cNEP device
timeFrame: after two weeks of treatment
measure: Treatment-emergent adverse events
timeFrame: two weeks
Other outcomes:
Locations:
city: Kaneohe
country: United States
facility: The Sleep Lab
state: Hawaii
Study officials:
affiliation: The Sleep Lab, Kaneohe, HI
name: Jamil S Sulieman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04916405: Standardized Management of Pregnancy Weight of Twin Pregnancy
Official title: Standardized Management of Pregnancy Weight of Twin Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Weight of Twin Pregnancy
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There are few studies on the optimal value of pregnancy weight gain for twin pregnancy in China.At present, China has not put forward guidelines for the appropriate value of weight gain in twin pregnancy, and the lack of standards for weight gain during pregnancy in clinical application or disease prevention and control seriously restricts the health management of pregnant women.In order to effectively control a series of adverse consequences caused by improper weight gain of women during twin pregnancy, it is urgent to establish the appropriate value of weight gain during twin pregnancy, which will also fill the gap in this field in China.


Eligibility criteria: Inclusion Criteria:

* 18-45 years
* Twin pregnancy
* pregnancy weeks ≤ 6 weeks

Exclusion Criteria:

* adverse pregnancy history
* kidney disease

Primary outcomes:
measure: Weight gain of women during twin pregnancy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05985005: The Effectiveness of a Chatbot-facilitated High Alert Medication Education for 2-year Post Graduate Nurses
Official title: The Effectiveness of a Chatbot-facilitated High Alert Medication Education for 2-year Post Graduate Nurses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Education, Nursing
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2023-08-09
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study involves three stages. In the first stage, qualitative research design is used to understand clinical nurses' learning needs on high alert medication. In the second stage, " high alert medication knowledge inventory " and " high alert medication safety inventory " will be developed based on the literature and results from qualitative study in the stage one. In the third stage, randomized control trail study design will be used. The nursing staffs in the experimental group receive " online simulation of high alert medication safety training ", the staffs from the control group receive classroom teaching regarding high alert medication". A total of 124 nurses will be invited to participate in this study, 62 subjects will be assigned in each group . After the intervention, we will examine the learning effectiveness.


Eligibility criteria: Inclusion Criteria:

1. Nursing staff who are licensed and have passed the Medication Safety Course for Newcomers to independently perform drug delivery techniques.
2. Nursing staff who are willing to participate in this research and complete the research consent form.

Exclusion Criteria:

1. Not fully involved in the study
2. Nursing staff not involved in dispensing medicine

Primary outcomes:
measure: high alert medication knowledge inventory
timeFrame: Change from Baseline high alert medication knowledge inventory at 1 months
measure: high alert medication safety inventory
timeFrame: Change from high alert medication safety inventory at 1 months
measure: Learning Engagement Scale
timeFrame: Change from high alert medication safety inventory at 1 months
Secondary outcomes:
measure: Learning satisfaction
timeFrame: through study completion, an average of 1 Week
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: He Ting-I
Study officials:
References:
Clinical trial NCT04792905: Exploratory Study of Apple Watch Electrocardiographic Diagnostic Performance Enhanced by an Artificial Intelligence Algorithm
Official title: Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Cardiologs Technologies
Sponsor class: INDUSTRY
First posted: 2021-03-11
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 participants: patients hospitalized for ablation or cardioversion or patients having cardiac rhythm consultation and who have expressed non-opposition to participate to the study

Brief summary: This observational exploratory prospective study will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

Detailed description: After being informed about the study, participants hospitalized for ablation or cardioversion or having a cardiac rhythm consultation at the investigational center will have Apple Watch ECG recordings done simultaneously with 12-lead ECG measurements performed in accordance with the existing in-stay subject monitoring protocol. AI-AW will be compared to standard manual 12-lead ECG reviewed by cardiologists for AF detection.

Eligibility criteria: Inclusion Criteria:

* Patient aged 22 or older, able and willing to participate in the study
* Patient admitted to hospital for ablation, cardioversion or cardiac electrophysiological exploration or who come for regular rhythmology consultations
* Patient who has read the information note and has given his or her consent before any procedure related to the study
* Patient affiliated to social security

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
* Subject related to the investigator or any other staff member directly involved in the conduct of the study
* Patient incapable of giving consent, minor or adult patient protected by law

Primary outcomes:
measure: Performance of AF detection
timeFrame: 1 day
Secondary outcomes:
measure: AW versus AI-AW
timeFrame: 1 day
measure: AI-AW versus AI-12lead
timeFrame: 1 day
Other outcomes:
Locations:
city: Massy
country: France
facility: Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
Study officials:
affiliation: Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
name: Laurent Fiorina, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02031705: Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation
Official title: Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation for Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Fibrillation
Catheter ablation
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 366
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus ablation on atrial fibrillation itself is unclear.

Detailed description: Researchers hypothesized that an organized activation pattern around the tricuspid annulus during atrial fibrillation indicated a mother reentrant circuit that could be terminated by a cavocaval isthmus ablation, thus preventing atrial fibrillation. The objectives of the present study were to evaluate the effectiveness of isthmus ablation in preventing atrial fibrillation and to identify predictors of its success.

Eligibility criteria: Inclusion Criteria:

* Scheduled ablation for paroxysmal atrial fibrillation

Exclusion Criteria:

* Typical atrial flutter
* History of artificial tricuspid valve surgery

Primary outcomes:
measure: Freedom of AF and Af
timeFrame: 1 year after catheter ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul st. mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: SungHwan Kim, MD
role: STUDY_DIRECTOR
References:
citation: Kim SH, Oh YS, Choi Y, Hwang Y, Kim JY, Kim TS, Kim JH, Jang SW, Lee MY, Joung B, Choi KJ. Long-Term Efficacy of Prophylactic Cavotricuspid Isthmus Ablation during Atrial Fibrillation Ablation in Patients Without Typical Atrial Flutter: a Prospective, Multicentre, Randomized Trial. Korean Circ J. 2021 Jan;51(1):58-64. doi: 10.4070/kcj.2020.0174. Epub 2020 Sep 14.
Clinical trial NCT02811705: Life Quality Study for PFAPA Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PFAPA Syndrome
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with PFAPA syndrome compare to patient with FMF syndrome

Brief summary: This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.


Eligibility criteria: Inclusion Criteria:

* PFAPA syndrome patients or FMF patients

Exclusion Criteria:

* Participation refusal

Primary outcomes:
measure: Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves
timeFrame: 1 day
Secondary outcomes:
measure: Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness
timeFrame: 1 day
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Centre hospitalier de Versailles
city: Paris
country: France
facility: CH de Bicètre
Study officials:
References: