louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04564105: Simulation Training and Teamwork Concerning Intubation on the Icu
Official title: The Influence of Simulation Education on Action of the Group Managing Patient's Airway on the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: intubation
simulation
airway management
education
video-record
checklist
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: University of Turku
First posted: 2020-09-25
Enrollment: 104
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: OTHER

Brief summary: To assess effects of the simulation education on the group intubating patients in the iCU, in this prospective study investigators will video-record real-life intubations and simulations. From videos will be assessed correlation of technical and non-technical skills before and after the education and performance in real-life vs simulation intubation.

Detailed description: The aim of this trial is to study the effects of simulation education on the action of the group managing patient's airway in the intensive care unit (ICU). Before simulations investigators will video-record 20 real-world intubations. Consequently will be run simulations to whole staff of the ICU. After the education further 20 real-world intubations will be recorded. Also simulations are recorded. From the videos investigators assess technical and non-technical skills of the group before and after simulation education, correlations between groups and influence of the education on action of the group. On the first part of the study, hypothesis is that group's good non-technical skills improve also technical skills. On the second part of the study hypothesis is that performing well in simulation correlates with performing well in real-world situation and teams with less experience the correlation is stronger.

Eligibility criteria: Inclusion Criteria:

-intubations in the icu operated by staff who have given informed consent to this study

Exclusion Criteria:

* intubations in the icu operated by anybody who have rejected video-recording
* intubations in the icu, when patient or patient being unable, close relative has denied permission to use video in this study
* intubated patient is a child, a prisoner, under military service, under forensic psychiatric evaluation, or patient can't give informed consent for example because of the cognitive impairment
* patient is isolated

Primary outcomes:
measure: correlation between technical and non-technical skills
timeFrame: 2 years
measure: correlation of group performance between simulation and real-life intubations
timeFrame: 2 years
Secondary outcomes:
measure: change of the group performance
timeFrame: 2 years
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: PaijatHame Central Hospital
Study officials:
affiliation: University of Turku
name: Miretta Tommila
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01102205: Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease
Official title: Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hashimoto Disease
Lead sponsor: Vakif Gureba Training and Research Hospital
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult with Hashimoto disease in euthyroid or subclinical hypothyroid state and healthy control.

Brief summary: Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.

Detailed description: oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1 PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be repeated except PON1 phenotyping.

Eligibility criteria: Inclusion Criteria:

* age more than 18 years

Exclusion Criteria:

* inability to give a written consent
* other conditions and drug usage affect oxidative stress

Primary outcomes:
measure: Poxidative stress markers
timeFrame: After levotren therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Vakif Gureba Training and Research Hospital
Study officials:
affiliation: vakif gureba TRH,fatih,istanbul,turkey.specialist in internal medicine
name: Mehmet ali Cikrikcioglu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01767805: Impact of Culture Conditions on the Embryo Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Development
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 790
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare different culture conditions. The effect of the type of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5% versus 20%) will be evaluated on the embryo quality


Eligibility criteria: Inclusion Criteria:

* embryos of patients younger than 36 years old

Exclusion Criteria:

* embryos of patients older than 36 years old

Primary outcomes:
measure: embryo quality
timeFrame: day 1- day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven, Catholic University Leuven
city: Leuven
country: Belgium
facility: University Hospital Leuven, Catholic University Leuven
Study officials:
References:
Clinical trial NCT04284605: Effects Exercise Training in Patients With Pituitary Adenoma
Official title: Effects of Aerobic Training Combined With Strength Training and Yoga on Biochemical Factors, Physical Performance and Quality of Life in Patients With Pituitary Adenoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Adenoma
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study planned to investigate the effects of aerobic training combined with strengthening training and yoga on biochemical factors, physical performance and quality of life in people with pituitary adenoma. The hypotheses are; H1: Aerobic training combined with strengthening training is effective on biochemical factors in people with pituitary adenoma.

H2: Aerobic training combined with strengthening training is effective on physical performance in people with pituitary adenoma.

H3: Aerobic training combined with strengthening training is effective on quality of life in people with pituitary adenoma.

H4: Yoga is effective on biochemical factors in people with pituitary adenoma. H5: Yoga is effective on physical performance in people with pituitary adenoma. H6: Yoga is effective on quality of life in people with pituitary adenoma. H7: Aerobic training combined with strengthening training and yoga is effective on biochemical factors, physical performance and quality of life in people with pituitary adenoma.


Eligibility criteria: Inclusion Criteria:

* volunteers
* macroadenomas
* at least 1 hormonal axis affected
* Karnofsky Perfomance Scale between 70-100
* 18-65 years
* approved by cardiologists

Exclusion Criteria:

* regular exercise habit
* acute pain in many part of the body
* additional neurologic condititons
* any rheumatological and immunologic conditions

Primary outcomes:
measure: Biochemical Factors
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Çankaya
Study officials:
References:
Clinical trial NCT05778305: Effect of Dexmedetomidine on Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome
Official title: Effect of Dexmedetomidine on Stress-induced Changes in Hemodynamics and Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Effect of Drug in CABAG Patients
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 50 patients of both sexes undergoing elective CABG surgery will be randomly divided into 2 groups, study group (Dex) group and control group (C) to determine the effect of dexmedetomidine on the peri-operative hemodynamic changes during CABG surgery.

Detailed description: The effect of dexmedetomidine during CABG surgery is studied regarding Ventricular function, pre bypass and post bypass using the transoeophageal echo (TEE), post-operative by transthoracic echocardiography (TTE) on day of surgery and after extubation.

Incidence of intraoperative and post operative ischemia and arrhythmias using Electrocardiogram (ECG) as well as the length of ICU and hospital stay.

Eligibility criteria: Inclusion Criteria:

* undergoing elective CABG surgery

Exclusion Criteria:

* Patient refusal

  * Dementia patients
  * Poor ventricular function with ejection fraction below 40%
  * Asthmatic patients
  * Uncontrolled diabetic patients with HbA1c above 8
  * Combined surgeries (CABG+ valves)
  * Emergency surgeries.
  * Pre-existing arrhythmia
  * Patients with renal impairment
  * Patients with hepatic impairment
  * Patients with heart block
  * Off-pump CABG

Primary outcomes:
measure: Intra-operative ventricular function.
timeFrame: Intraoperative
measure: post-operative ventricular function.
timeFrame: Up to 24 hours postoperative
Secondary outcomes:
measure: hemodynamics
timeFrame: Immediate postoperative and up to 24 hours postoperative
measure: hemodynamics
timeFrame: Immediate postoperative and up to 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abassia
Study officials:
References:
Clinical trial NCT00908505: Comparison Between RTX (Biphasic Cuirass Ventilator) and Physiotherapy in Cystic Fibrosis Patients
Official title: Comparison Between bi-Phasic Negative Pressure Ventilator Therapy and Physiotherapy in Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
physiotherapy
pulmonary function test
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of different mucous clearance techniques in cystic fibrosis patients

Detailed description: Cystic fibrosis (CF) is associated with chronic progressive lung disease that may lead to respiratory failure.Bi-Phasic Cuirass Ventilation (BPCV) is a form of non-invasive respiratory support, which can provide negative pressure ventilation as well as high frequency chest wall oscillations and cough mode.The standard therapy for CF patients to release mucous is treatment by a physiotherapist. In this study we will compare the effect of BPCV with regular physiotherapy by full pulmonary function testing prior and post treatment.

Eligibility criteria: Inclusion Criteria:

* CF patients over 7 years old

Exclusion Criteria:

* Hemoptysis
* Pregnancy

Primary outcomes:
measure: Pulmonary function test
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: David Shoseyov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01782105: Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation
Official title: Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Weight Gain During Pregnancy
Gestational Diabetes
Keywords: weight gain
healthy lifestyle
gestational diabetes
adipokins
glycemic regulation
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Diabetes Québec
name: Fonds de la Recherche en Santé du Québec
First posted: 2013-02-01
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study are:

* Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on:

  * weight gain in pregnancy
  * the levels of maternal and fetal adipokines and
  * glycemic control maternal and fetal.
* Determine whether the adoption of healthy lifestyles in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.


Eligibility criteria: Inclusion Criteria:

* be aged ≥ 18 years,
* have a pre-pregnancy BMI ≥ 25 kg/m2,
* be at risk of developing a gestational diabetes mellitus (a history of gestational diabetes mellitus or glucose 1 hour post-50g \> 7.1 mmol/L.

Exclusion Criteria:

* Pre-pregnancy diabetes detected in the first trimester (A1c \> 6.5%, fasting glucose \> 7.0 mmol/L, random blood glucose\> 11.1 mmol/L, glucose \> 10.3 mmol/L 1 hour post-50g)
* twin pregnancy
* taking medications that can affect blood sugar or weight,
* practice ≥ 150 minutes of physical activity per week
* against formal-indication for physical activity.

Primary outcomes:
measure: Weight change during pregnancy
timeFrame: Weeks 12, 24, 36 of gestation
Secondary outcomes:
measure: Levels of maternal and fetal adipokines
timeFrame: Weeks 12, 24 of gestation and at delivery (in cord blood)
measure: Maternal and fetal glycemic control
timeFrame: Weeks 12, 24 of gestation and at delivery
measure: Determine whether the adoption of healthy lifestyle in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.
timeFrame: Weeks 12, 24 of gestation and at delivery (cord blood)
measure: Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale.
timeFrame: throughout the study
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Marie-France Hivert, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03619798: Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings
Official title: Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings: a Multi-Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diagnoses Disease
Lead sponsor: Silver Lake Research Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns, children, and adults from neonatal intensive care clinics, maternity wards, and other clinics at various low-, medium-, and high-resource study centers in multiple countries.

Brief summary: Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening. However, sickle cell disease is most prevalent in low-resource regions of the world, where newborn screening is rare due to the cost and logistical burden of laboratory-based methods. In many such regions, \>80% of affected children die, undiagnosed, before the age of five years. A convenient and inexpensive point-of-care test for sickle cell disease is thus crucially needed. In this study we will conduct a blinded, multicenter, prospective diagnostic accuracy study of HemoTypeSC(TM), an inexpensive 15-minute point-of-care immunoassay for detecting sickle cell disease, hemoglobin C disease, and trait phenotypes in newborns, children, and adults.


Eligibility criteria: Inclusion Criteria:

* Agrees to be enrolled (or has parent/guardian approval to be enrolled)

Exclusion Criteria:

* Previous sickle cell screening

Primary outcomes:
measure: Positive for Hemoblogin A, S, or C
timeFrame: Immediate (investigational test) to one week (reference test)
measure: Negative for Hemoglobin A, S, or C
timeFrame: Immediate (investigational test) to one week (reference test)
measure: Positive for Hemoglobin AA, AS, AC, SS, SC, or CC
timeFrame: Immediate (investigational test) to one week (reference test)
measure: Negative for Hemoglobin AA, AS, AC, SS, SC, or CC
timeFrame: Immediate (investigational test) to one week (reference test)
Secondary outcomes:
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Silver Lake Research Corporation
state: California
Study officials:
References:
Clinical trial NCT01775605: Study of Use of Synera for Pain During Local Skin Infiltration With Lidocaine Before Epidural Placement
Official title: Randomized Study of the Use of Synera for Pain Relief During Local Lidocaine Needle Skin Infiltration for Epidural Placement in Subjects Undergoing Elective Cesarean Section.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Anxiety
Keywords: Subject
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Local infiltration with lidocaine prior to epidural placement for cesarean section, although brief, can be painful. This pain can lead to increased anxiety and distress, adversely affecting patient's overall experience. This study proposes to examine the application of Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety.

The primary objective of this study is to determine the effect of the Synera on maternal experience during epidural placement. The efficacy of Synera pain patch in reducing subject pain during skin infiltration with lidocaine prior to epidural placement in subjects presenting for scheduled cesarean section will be assessed.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old;
* Undergoing pre-scheduled cesarean section;
* Expected singleton birth;
* BMI \<=35kg.m-2;

Exclusion Criteria:

* Undergoing emergency cesarean section;
* Complications during pregnancy;
* History of hypersensitivity to study medication(lidocaine or tetracaine) or para-aminobenzoic acid;
* Allergies to bird proteins, feathers, or egg products; or any other skin allergies; dermatitis an open wound at the patch site or a history of difficult epidural placement;

Primary outcomes:
measure: Rating of pain intensity upon lidocaine infiltration
timeFrame: 30 minutes (following patch placement , upon lidocaine infiltration)
Secondary outcomes:
measure: Subject anxiety
timeFrame: 1 hour (Upon admission to surgical holding area and after epidural placement)
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore Unniversity Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Alan Strobel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177605: Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Problems
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2010-08-09
Sex: ALL
Minimum age (years): 9
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness, stool patterns and growth of two cow's milk-based beverages for children.


Eligibility criteria: Inclusion Criteria:

* Child 9 - 48 months of age
* Child has consumed a cow follow-on milk during the 48 hours prior to enrollment
* Child's weight for age is within the 10th -90th percentiles
* Child's length for age is within 10th - 90th percentiles
* Signed informed consent obtained

Exclusion Criteria:

* Children who are receiving predominantly breast-milk
* Serious concurrent illness
* Children with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Children with a history of underlying metabolic or chronic disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the participant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Federal University of Bahia School of Medicine
state: Bahia
Study officials:
References: