louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03191331: Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.
Official title: Intervention Study on Dietary Changes in Relation to Weight Gain and Prevalence of Gestational Diabetes During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Gestational Diabetes
Weight Gain
Overweight and Obesity
Keywords: dietary intervention
gestational weight gain
gestational diabetes
overweight
obesity
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group and control group.
Primary purpose: PREVENTION

Brief summary: The aim of this pilot study is to conduct a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the effect of the intervention on gestational weight gain and the prevalence of gestational diabetes between the intervention and control groups.

Detailed description: Half of the women are allocated to the intervention group and another half for the control group. The intervention group will get written material of healthy diet during pregnancy as well as emphasized nutritional guidance given by public health nurses at each visit in the maternity care clinic. There will also be two group meetings with a dietitian. The control group will get the same written material, but otherwise basic care and guidance at each visit in the maternity care clinics. The collected data of both groups include the information on weight gain, the result of an oral glucose tolerance test and 4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES).

Eligibility criteria: Inclusion Criteria:

* Age less than 35 years
* BMI 25 or over
* healthy, no chronic medical conditions
* singleton pregnancy
* first trimester of pregnancy at the time of recruitment

Exclusion Criteria:

* Age 35 and older
* BMI less than 25
* chronic medical conditions
* multiple pregnancy
* pregnancy at second or third trimester at the time of recruitment

Primary outcomes:
measure: gestational weight gain (GWG)
timeFrame: from first to third trimester of pregnancy, gestational weeks
Secondary outcomes:
measure: gestational diabetes mellitus (GDM),
timeFrame: gestational weeks 12-16
measure: eating habits
timeFrame: 1st, 2nd and 3rd trimester of pregnancy, gestational weeks
measure: eating habits
timeFrame: 1st, 2nd and 3rd trimester, gestational weeks
measure: Eating habits
timeFrame: 1st, 2nd and 3rd trimester, gestational weeks
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Neulamäki antenatal care clinic
city: Kuopio
country: Finland
facility: Pyörö antenatal care clinic
Study officials:
affiliation: University of Eastern Finland, Department of Nursing Science
name: Reeta Lamminpää, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04155931: The Effect of Intraoperative Body Temperature on Postoperative Nausea and Vomiting in Pediatric Patients
Official title: The Effect of Intraoperative Body Temperature on Postoperative Nausea and Vomiting in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Body Temperature
Postoperative Nausea and Vomiting
Keywords: perioperative body tempreture
hypothermia
PONV
Postoperative nausea and vomiting
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA1 group, 80 children, both sexes, aged 6 months to 7 years

Brief summary: The aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.

Detailed description: Undesirable hypothermia is that the perioperative body temperature is below 36 ° C. Perioperative heat loss is higher in pediatric patients than in adult patients. One of the most common side effects of general anesthesia is nausea and vomiting. The aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.We planned to perform prospectively in 80 children with ASA I according to the American Society of Anesthesia (ASA) Anesthesia Risk Scale between 6 months and 7 years of age in both sexes who underwent inguinal hernia, undescended testes and hydrocele surgery. In all patients, heating blanket was placed on the operation table and standard heat was used. After the placement of the LMA, a nasopharyngeal heat probe was placed for central body temperature measurement and monitored throughout the operation. Mean arterial pressure, heart rate and body temperature were recorded. Demographic data, type of operation, duration of operation and intraoperative fentanyl requirement of all cases were recorded. Analgesic and antiemetic requirements, presence of nausea and vomiting (according to numerical sequence scale) were recorded in the recovery room at 6, 12 and 24 hours postoperatively

Eligibility criteria: Inclusion Criteria:

* ASA1 group
* Aged 6 months to 7 years
* lower abdominal and urological surgery

Exclusion Criteria:

* Upper abdominal surgery
* ASA 2-3 group
* postoperative nausea and vomiting history

Primary outcomes:
measure: hypothermia
timeFrame: intraoperative
measure: Postoperative Nausea and vomiting
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Postoperative Pain
timeFrame: Postoperative 24 Hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: İsmail Sümer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02043431: Electronic Medical Records and Genomics
Official title: Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Heart failure
Electronic medical records
Genomics
Biobank
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2014-01-23
Enrollment: 1000
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: The elegible individuals are patients of a tertiary cardiology hospital

Brief summary: The purpose of this study is to develop a biobank containing samples of 2,000 patients treated in a tertiary cardiology hospital containing electronic medical records and genetic data in genome-wide scale for performing genetic association studies for validation and development of medical decision routines that help the clinical management of heart failure patients.

Detailed description: Patients between 18 and 80 years old with heart failure diagnosis of different etiologies and left ventricular ejection fraction \< 50% in the past 2 years will be eligible for enrollment on the cohort. After consent, patients will be submitted to clinical baseline, echocardiographic, cardiography impedance and biochemical evaluation. Study data will be collected and managed using Research Electronic Data Capture (REDCap) tools. The follow up will take place every 6 months to assess cardiovascular outcomes (all-cause mortality, cardiovascular mortality, hospitalization for worsening heart failure and current medication use). Initial analytical strategy will focus on the establishment of the accuracy of electronic medical records extraction protocols for main predictor factors of morbidity and mortality in heart failure.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years old
* Heart failure diagnosis of different etiologies
* Left ventricular ejection fraction \< 50% in the past 2 years

Exclusion Criteria:

* Patients with impaired cognition due to advanced dementia syndrome or severe psychiatric disorder
* Patients without telephone access
* Patients that refused to participate

Primary outcomes:
measure: all cause mortality
timeFrame: six and twelve months after inclusion.
Secondary outcomes:
measure: cardiovascular mortality
timeFrame: six and twelve months after inclusion.
Other outcomes:
measure: Hospitalization for any cause
timeFrame: six and twelve months after inclusion.
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute - Clinical Hospital - University of São Paulo Medical School
Study officials:
affiliation: Heart Institute - Clinical Hospital - University of São Paulo Medical School
name: Alexandre C Pereira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01610531: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma
Official title: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients at Risk for Melanoma
Keywords: Cohort
Melanoma
targeted screening
risks function
cost effectiveness
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 4118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.


Eligibility criteria: Inclusion Criteria:

* patients more than 18 years old,
* consulting their GP,
* assessed at risk for melanoma according to the SAMScore
* signed the consent.

Primary outcomes:
measure: Prevalence ratios between those of the COPARIME cohort and those of the general population.
timeFrame: 5 years
Secondary outcomes:
measure: Probability to develop a melanoma at one year.
timeFrame: 1 years
measure: Cost ratio for a screened melanoma.
timeFrame: 5 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Jean-Michel NGUYEN, Doctor
role: STUDY_CHAIR
References:
citation: Rat C, Hild S, Gaultier A, Khammari A, Bonnaud-Antignac A, Quereux G, Dreno B, Nguyen JM. Anxiety, locus of control and sociodemographic factors associated with adherence to an annual clinical skin monitoring: a cross-sectional survey among 1000 high-risk French patients involved in a pilot-targeted screening programme for melanoma. BMJ Open. 2017 Oct 5;7(10):e016071. doi: 10.1136/bmjopen-2017-016071.
citation: Rat C, Grimault C, Quereux G, Dagorne M, Gaultier A, Khammari A, Dreno B, Nguyen JM. Proposal for an annual skin examination by a general practitioner for patients at high risk for melanoma: a French cohort study. BMJ Open. 2015 Jul 29;5(7):e007471. doi: 10.1136/bmjopen-2014-007471.
citation: Rat C, Quereux G, Grimault C, Gaultier A, Khammari A, Dreno B, Nguyen JM. Melanoma incidence and patient compliance in a targeted melanoma screening intervention. One-year follow-up in a large French cohort of high-risk patients. Eur J Gen Pract. 2015 Jun;21(2):124-30. doi: 10.3109/13814788.2014.949669. Epub 2014 Aug 20.
Clinical trial NCT01334931: Use of Large Field of View During Image Acquisition for Coronary Angiography
Official title: Preferential Use of Large Field of View During Image Acquisition for Coronary Angiography With Flat Detector Technology: a Simple Step to Reduce Radiation Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Exposure to Ionizing Radiation
Occupational Exposure to Radiation
Radiation Injury
Keywords: Exposure to Ionizing Radiation
Occupational Exposure to Radiation
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronary angiography exposes patients and physicians to ionizing radiation. The purpose of this study is to evaluate the routine use of large field of view during image acquisition for coronary angiography. Patients with indication of diagnostic coronary angiography will be randomized for the use of either large field of view during image acquisition or medium field of view. Patients, physician and nurse radiation exposure will be measured by digital dosimeter.


Eligibility criteria: Inclusion Criteria:

* Indication of diagnostic coronary angiography for suspected coronary artery disease
* Sign written consent form

Exclusion Criteria:

* Therapeutics procedures
* Urgency/emergency procedures
* Previous CABG
* Severe valvular disease

Primary outcomes:
measure: Patient's radiation exposure
timeFrame: 24 hours
Secondary outcomes:
measure: Physician and nurse radiation exposure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: RS
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Cristiano O Cardoso, MD, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT02055131: Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis
Official title: a Comparative Study of Aspirin Either at Fixed Dose or at a Dose Titrated by Platlet Function Analyzer(PFA-100) vs Placebo in Primary Prevention of Vascular Access for Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thrombosis
Keywords: vascular access
hemodialysis
aspirin resistance
PFA-100
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This is a prospective study consisting in testing whether systematic use of aspirin is beneficial for primary prevention of vascular access for hemodialysis attested by doppler ultrasound exam. The investigators will study aspirin resistance in the population of patients undergoing hemodialysis. The investigators will test sensibility of resistant patients to aspirin dose escalation. PFA-100 is the biologic test used in this study to define aspirin resistance.

Detailed description: Three groups of dialysed patients will be included in this study. The first is the placebo group, the second is the aspirin group fixed dose and the last group includes patients receiving a dose of aspirin titrated by the result of PFA-100.

At the end of this study the investigators will be able to identify whether systematic antiaggregation is suitable for a vascular access for hemodialysis. The investigators will also conclude which is better for patients fixed dose or aspirin dose escalation determined by the result of PFA-100. The study will analyse the prevalence of aspirin resistant patients in this particular population of dialysed patients.

Eligibility criteria: Inclusion Criteria:

* dialysed patients
* vascular access aged less than one year
* no serious complication of the vascular access previously such as hemorrhagic complication and tight stenosis

Exclusion Criteria:

* pregnant and breastfeeding women
* patients receiving at baseline other antiaggregant or anticoagulant
* patient not allowed to be treated by aspirin
* systolic blood pressure\> 200 mmhg
* diastolic blood pressure\>115 mmhg
* liver failure

Primary outcomes:
measure: number of fistula thrombosis in patients receiving a dose of aspirin titrated by the result of PFA-100 compared to placebo and fixed dose aspirin
timeFrame: 1 year
Secondary outcomes:
measure: number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients.
timeFrame: 1 year
Other outcomes:
measure: incidence and severity of aspirin complications in dialysed patients
timeFrame: 1 year
Locations:
city: Monastir
country: Tunisia
facility: clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir
Study officials:
name: Nouira Samir, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03856931: Behaviours and Emotions in Preschoolers
Official title: Behaviours and Emotions in Preschoolers - Detecting Mental Health Problems in Preschool Children in a Primary Care Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Wellness
Emotional Problem
Behavioural Problem
Post Partum Depression
Keywords: mental health
preschool
SDQ
parental depression
Lead sponsor: TARGetKids!
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Unity Health Toronto
First posted: 2019-02-27
Enrollment: 183
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TARGet Kids! (The Applied Research Group for Kids) is a research project enrolling healthy children aged 0-5 years during their primary-care health supervision visits with their primary care physician who is a Community Physician Collaborator with the TARGetKids! primary-care practice-based research network. The BeEPS study will recruit participants from within the TARGet Kids! cohort.

Brief summary: In this TARGet Kids! Study, we want to find out whether a short questionnaire can be used to help find out about mental health problems in preschool age children.

Detailed description: Research indicates that more than 1 in 10 preschoolers have significant social, emotional and behavioural problems also known as mental health problems. Unfortunately, parents and doctors rarely identify mental health problems in young children in order to begin treatment. We are testing a short five-minute questionnaire completed by parents to see if this may help a doctor notice if a child has social, emotional and behavioural problems.

In addition, we also hope to find out if the presence of feelings of stress and depression in on or both parents may be associated with mental health problems in their preschool child.

This study is being conducted by researchers at SickKids and St. Michael's Hospital.

Eligibility criteria: Inclusion Criteria:

1. Child is between age 2 to 4 years.
2. Parent is the primary caretaker for the child and is able to speak, read and understand English well enough to complete the forms and the PAPA interview.
3. Either one or both parents (primary caretakers) are available to participate in the study.

Exclusion Criteria:

1. Children with associated health conditions affecting growth (e.g. failure to thrive, cystic fibrosis);
2. Children with any acute or chronic conditions except for asthma and high functioning autism;
3. Children with severe developmental delay;
4. Children with a gestational age of less than 32 weeks;
5. Families who are not fluent in English.

Primary outcomes:
measure: Total difficulties score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Alice Charach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00783731: Low Dose of Midazolam is Superior to Conventional Dose for Rapid Sequence Intubation in Emergency Department (ED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-11-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Midazolam has been used in rapid sequence intubation for a long time, and the recommended dose is 0.1mg/kg. In some studies, however, the reduced dose has been used with the concern of hemodynamic instability. We would like to investigate that the low dose midazolam could be used rather than the standard recommended dose, and also compare it to the etomidate, recently used sedatives, with respect to the side effects and the easy performance of intubation.


Eligibility criteria: Inclusion Criteria:

* patients who need rapid sequence intubation in emergency room

Exclusion Criteria:

* in hypotension(systolic blood pressure less than 90 mmHg
* severe trauma patients
* pregnant
* allergic to midazolam, etomidate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, Emergency room
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
Study officials:
References:
Clinical trial NCT00759031: Investigation of Dental Plaque and Gingival Index
Official title: Investigation of Dental Plaque and Gingival Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.


Eligibility criteria: Inclusion Criteria:

* Be aged 18 to 65 years inclusive
* Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
* Give written informed consent
* Be in good general health
* Must discontinue oral hygiene for 24-hrs.after initial appointment.
* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental visits/procedures
* Advanced periodontal disease
* 5 or more decayed, untreated dental sites
* Diseases of the soft or hard oral tissues
* Orthodontic appliances
* Abnormal salivary function
* Use of drugs that can currently affect salivary flow
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn)
* Pregnant or breastfeeding.
* Participation in another clinical study in the month preceding this study
* Allergic to common dentifrice ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Primary outcomes:
measure: Gingival Margin Plaque Index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Boston University School of Dental Medicine
state: New York
Study officials:
name: Patricia Corby, DDS
role: PRINCIPAL_INVESTIGATOR
References: