louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00263900: TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit
Official title: Exploratory Study of the Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit and Their Impact on the Assumption of Responsibility of the Suspect Children of a Viral Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Respiratory Syncytial Viruses
Keywords: Influenza A
Influenza B
RSV
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-12-09
Enrollment: 377
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.


Eligibility criteria: Inclusion Criteria:

* Age less than 5 years
* Isolated fever and/or
* Infection of the higher air routes (congestive otitis, feverish rhinitides, tracheitis or laryngitis) and/or infection of the lower air routes (cough, pneumonia, bronchitis, asthma)
* Signed consent form

Exclusion Criteria:

* Evocative clinical of a urinary and/or bacterial infection
* Purulent acute otitis media
* Typical acute bronchiolitis
* Suspicion of acute lobar pneumonia
* Acute gastro-enteritis
* Anginas
* Serious chronic respiratory pathology
* Other infection whose etiologic viral diagnosis is established
* Congenital or acquired immunizing deficits
* Congenital cardiopathy

Primary outcomes:
measure: Assessments of quick diagnostic test of the Influenza virus and the SRV to measure the utility and the impact of those tests on the care of children in emergency unit
timeFrame: time of support at the emergnecy unit
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Urgences pédiatriques
city: Caen
country: France
facility: Urgences pédiatriques CHU de Caen
city: Le Havre
country: France
facility: POSU pediatrique
city: Rouen
country: France
facility: Urgences pédiatriques - CHU ROUEN
Study officials:
affiliation: University Hospital, Rouen
name: Christophe MARGUET, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02644200: Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis
Official title: Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis: a Prospective, Randomized, Single-blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gastroenteritis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. The aim of this study was to compare the efficacy and safety of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in children with acute gastroenteritis.

This is a single-blind, prospective, randomized and parallel study performed in two Pediatric Services of tertiary referral hospitals. Patients, ages 3 to 36 months with acute gastroenteritis randomized to receive an oral rehydration solution (OR), or an oral rehydration solution plus gelatin tannate (OR+G). The primary outcomes evaluated were: the number of bowel movements after 48 and 72 hours after initiating treatments. Secondary outcomes were: duration of diarrhea (days), stool characteristics and adverse events. Other clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two treatments were also recorded.


Eligibility criteria: Inclusion Criteria:

* Children of both sex, aged 3 months to 5 years of age
* Clinical diagnosis of acute gastroenteritis, as defined by having at least 3 loose stools within the previous 24 hours and/or a change in stool consistency to loose or liquid according to Bristol Stool Form Scale for Children (m-BSFS-C) lasting for no longer than 3 days.

Exclusion Criteria:

* patients with gastroenteritis lasting more than 5 days
* patients with chronic gastrointestinal conditions
* patients receiving other antidiarrheal drugs within 2 weeks prior to enrollment (i.e. antibiotics, probiotics, salicylates, loperamide, racecadotril, disomectite)

Primary outcomes:
measure: Number of stools
timeFrame: 48 hours
Secondary outcomes:
measure: Duration of diarrhea after treatment initiation in the 2 arms
timeFrame: 48 hours, 72 hours
measure: Time to normalization of stool consistency
timeFrame: 48 hours, 72 hours
measure: Number of visits to the emergency room
timeFrame: 7 days
measure: Growth
timeFrame: 7 days
measure: Adverse events treatment related
timeFrame: 7 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Pediatrics, Sapienza University of Rome
state: RM
Study officials:
References:
citation: Mennini M, Tolone C, Frassanito A, Midulla F, Cucchiara S, Aloi M. Gelatin Tannate for Acute Childhood Gastroenteritis: A Randomized, Single-Blind Controlled Trial. Paediatr Drugs. 2017 Apr;19(2):131-137. doi: 10.1007/s40272-016-0207-z.
Clinical trial NCT00065000: Impact of Non-Commercialism Policy in Seattle Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-07-18
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes

Brief summary: This is a 3-year pilot study funded by National Institute of Health will assess and evaluate obesity-related health outcomes of a real-life policy decision, recently voted on and adopted by the Seattle School Board.


Eligibility criteria: Inclusion: All students who attend Cleveland and Rainier Beach high schools are eligible.

Exclusion: Those who are no longer attending those schools.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Donna Johnson, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01404000: Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Iodinated Activated Charcoal
Official title: Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Lung Disease
Lead sponsor: PharmaLundensis AB
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study s to determine whether treatment with Iodinated Active Charcoal can improve lung function and physical capacity in patients with chronic obstructive lung disorders. The rational for the study is the observation that COPD patients have an increased tissue load of mercury interfering with the function by NeuroEpithelial Endocrine (NEE) cells in the respiratory tract. Mercury binding to these NEE cells leads to an increased smooth muscle tonus and a reduced response to bronchodilator treatment. Initial observational data have shown an improved lung function and improved functional capacity after treatment motivating a larger placebo controlled POC study


Eligibility criteria: Inclusion Criteria:

* Male and \>1 year post-menopausal, or surgically sterile female.
* 45-80 years old.
* Smokers and ex-smokers, at least 15 pack years.
* COPD according to GOLD II. FEV% \< 70 Post beta2-agonist FEV1 \>50 \< 80 % of predicted value
* CO diffusion capacity \< 75 %.
* Active symptomatic COPD with a COPD assessment test (CAT) score \>10.

Exclusion Criteria:

* Alpha-1 antitrypsin deficiency
* Iodine allergy
* Abnormal thyroid function
* Severely reduced kidney function (Cystatin C \> 1.5 mg/L.
* Exacerbation within 4 weeks prior to the study.
* Use of per oral steroids within 4 weeks prior to the study.
* Alcohol/drug abuse.
* Psychiatric disease.
* Severe cardio-vascular or other severe disease, according to the clinical investigator.
* Oxygen treatment.
* Participation in another ongoing clinical trial or participation in drug

Primary outcomes:
measure: Exercise Endurance time (EET) on constant workload 75% of maximum capacity
timeFrame: At baseline and after 8 weeks intervention
Secondary outcomes:
measure: Change in lung function FEV / FVC
timeFrame: At baseline and after 8 weeks intervention
measure: HrQoL
timeFrame: At baseline and after 8 weeks intervention
measure: Test of thyroid function
timeFrame: At baseline and after 8 weeks intervention
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Dept of Respiratory Medcine & Allergology, Skane University Hospital
Study officials:
affiliation: Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden
name: Leif Bjermer, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02948400: Virtual Reality by Mobile Phone: Improving Child Pedestrian Safety
Official title: Virtual Reality by Mobile Phone: Improving Child Pedestrian Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Pedestrian Safety
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Drexel University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-10-28
Enrollment: 500
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will conduct a non-inferiority clinical trial to evaluate whether children trained in pedestrian safety amidst a Google Cardboard virtual environment achieve equivalent levels of pedestrian safety to children trained in a full semi-immersive virtual pedestrian environment


Eligibility criteria: Inclusion Criteria:

* children ages 7-8 and their families
* one sibling per family, randomly chosen if multiple siblings are eligible
* children and parent speak English

Exclusion Criteria:

* disabilities that prohibit participants from valid understanding of or participation in the experimental protocol
* families that plan to move more than 50 miles away over the next year
* families unable to commit to frequent visits required in the study protocol

Primary outcomes:
measure: Risky Crossings
timeFrame: 3.5 months after baseline (about 1 week after completion of all training)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Youth Safety Lab, University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT02304900: Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
Official title: Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens with a refractive implant. Two colors of implants are available: white implants, filtering out ultraviolet and yellow implants, filtering and more blue light. No clinical data are available to assert the superiority of an implant according to its color and the choice is made according to the preference of the surgeon and / or "markets".

It is established in humans that blue light has an important role on the secretion of melanopsin, a key mediator of the circadian cycle. This "clock" regulates most neuroendocrine functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the impact of these neuro endocrine functions of the installation of a blue light filter into the eyes of patients operated thus arises.


Eligibility criteria: Inclusion Criteria:

* female or male subject
* subject between 60 and 90 years old
* Visual acuteness \< or = with 2 eyes
* Indication operating of the cataract

Exclusion Criteria:

* NA

Primary outcomes:
measure: Variation between before and 2 months after surgery sleep time
timeFrame: 2 months
Secondary outcomes:
measure: Variation between before and 2 months after surgery the number of hours of sleep
timeFrame: 2 months
measure: Variation between before and 2 months after surgery of the quality of sleep
timeFrame: 2 months
measure: Variation between before and 2 months after surgery the mood evaluation score
timeFrame: 2 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Service d'Ophtalmologie
city: Loches
country: France
facility: Service d'Ophtalmologie, Centre Hospitalier Paul Martinais
city: Tours
country: France
facility: Service d'Ophtalmologie
Study officials:
References:
Clinical trial NCT00254800: The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females
Official title: The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2005-11-17
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.


Eligibility criteria: Inclusion Criteria:

* Pre-menopausal female of child-bearing potential.
* Body Mass Index (BMI) between 19 and 35 kg/m\^2, inclusive.

Exclusion Criteria:

* On implanted contraceptives for 6 months, or injectable contraceptives for 12 months prior to the study.
* Evidence of diabetes mellitus.
* Participation in a study involving administration of an investigational compound within the past 3 months.

Primary outcomes:
measure: Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax
timeFrame: Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48
Secondary outcomes:
measure: Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax
timeFrame: Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48
measure: Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies.
timeFrame: Baseline through Day 84
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: Kothare PA, Seger ME, Northrup J, Mace K, Mitchell MI, Linnebjerg H. Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial. BMC Clin Pharmacol. 2012 Mar 19;12:8. doi: 10.1186/1472-6904-12-8.
Clinical trial NCT02551900: A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients
Official title: A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Vascular Function
Water Exercise
Warm Water
Cold Water
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Warm water based cycling exercise training would more favorable than cold water based cycling exercise training and land based cycling exercise in vascular function in type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria included type 2 diabetes (as defined by the American Diabetes Association), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, and no previous exercise training in the past 6 months. All participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.

Exclusion Criteria:

* Participants were excluded if they dropped out or completed less than 80% of the training schedule.

Primary outcomes:
measure: Change from baseline in glycemic control
timeFrame: Baseline, 12 weeks
measure: Change from baseline in vascular reactivity
timeFrame: Baseline, 12 weeks
measure: Change from baseline in cutaneous blood flow
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change from baseline in physical fitness
timeFrame: Baseline, 12 weeks
measure: Change from baseline in physical fitness
timeFrame: Baseline, 12 weeks
measure: Change from baseline in physical fitness
timeFrame: Baseline, 12 weeks
measure: Change from baseline in physical fitness
timeFrame: Baseline, 12 weeks
measure: Change from baseline in blood chemistry
timeFrame: Baseline, 12 weeks
measure: Change from baseline in blood chemistry
timeFrame: Baseline, 12 weeks
measure: Change from baseline in blood chemistry
timeFrame: Baseline, 12 weeks
measure: Change from baseline in Peripheral arterial stiffness
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Si Racha
country: Thailand
facility: Laemchabang stadium, Sukhumvit Rd
state: Chon Buri
Study officials:
affiliation: Faculty of Sport Science Chulalongkorn University
name: Daroonwan Suksom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268800: Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy
Official title: Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy, a Sensitive Method for Identifying Resistant AML Clones
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AML
Keywords: AML
Induction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 50
Sex: ALL
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: Adults (\>18) AML patients

Brief summary: Personalization of AML therapy, require a reliable mechanism for accurate characterization of patient specific leukemia phenotype and genotype. Patient's specific leukemic phenotype or in practical clinical term, patient's leukemia sensitivity to induction therapy, should best investigated in-vivo during induction. Elimination of circulating leukemic blasts from peripheral blood by day 5 was shown to discriminate between good responders with superior long term survival and poor responders with poor outcome. However, many AML patients have no circulating blasts at diagnosis and even in those who have, elimination rate of it from peripheral blood was never correlated with actual response in bone marrow.

Currently, the only available source for patient's specific leukemia profile, is the bone marrow sample at diagnosis. Since leukemic blasts are heterogeneous and come from multiple different clones, "on diagnosis" marrow consist a spectrum of chemotherapy sensitive and resistance clones. Clones may vary by their molecular abnormalities and results from "on diagnosis" marrow may overlook minor resistant but existing clones. Long term prognosis is determined by those resistant clones and though our interests should be focused into the abnormalities of these clones. Residual blasts on day 5 marrow may better represent the profile of patient's leukemic resistant clones.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute myeloid leukemia other than APL
* Age \> 18
* Patient's considered by their physician "fit" for intensive induction therapy

Exclusion Criteria:

* Withdrawal of informed consent or inability to consent
* Previous allogeneic transplantation.
* One of the following lab values persistent from presentation to day 5:

  * Serum creatinine \> 2mg/dl, Direct bilirubin \> 2mg/dl
  * SGOT (AST) \> x4 upper limit of normal
  * Left ventricular ejection fraction \< 40% as assessed 2-D echocardiogram
  * Coagulation abnormalities (INR \> 1.6, PTT \> x1.5 normal range)

Primary outcomes:
measure: complete remission
timeFrame: 30-54 days
Secondary outcomes:
measure: Overall survival
timeFrame: two years
measure: relapse rate
timeFrame: two years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
Study officials:
affiliation: Rambam Health Care Campus
name: Yishai Ofran, MD
role: PRINCIPAL_INVESTIGATOR
References: