linjc16/ctgov huggingface dataset:
Severe Obesity Outcome Network Cohort (SOON)

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery. More accurately the questions addressed are: What are the determinants of the sleep habits (sleep duration, chronotype) and of their evolution What are the determinants of sleep breathing disorders (sleep apnea, obesity hypoventilation syndrome) and of their evolution

Detailed Description
-----------------
Adult obese patients, attempting a tertiary medical center for the management of their obesity, are asked to participate in a cohort study. Data issued from routine clinical practice are collected. Medical history and actual medical condition: Type 2 or type 1 diabetes Dyslipidemia Hypertension Cardiovascular diseases Steatohepatitis/cirrhosis Gastric disorders Nutritional deficiency Obstructive sleep apnea/Obesity hypoventilation syndrome All patients who do not have a previously known sleep apnea syndrome are evaluated by nocturnal polygraphy. Lifestyle and sleep habits, as well as social and economic characteristics, are assessed by questionnaires. Patients are asked to provide blood sample to constituate a serum bank and gene bank. Patients are asked, if undergoing bariatric surgery, to provide subcutaneous and visceral fat. When patients benefit from bariatric surgery, follow-up data are collected at 3 months, 6 months, 12 months after bariatric surgery and yearly after that for at least 5 years.

Official Title
-----------------
Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.

Conditions
-----------------
Obesity, Obstructive Sleep Apnea, Sleep

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Class II or class III obesity (BMI ≥ 35 kg/m²). Only patients undergoing surgery to realize a second surgical line of management of their obesity may have a lower BMI, if the surgical recovery is motivated by a technical defect of the first assembly. Exclusion Criteria: Refusal to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep breathing disorders | Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep habits | Evolution of sleep habits during obesity care, especially after bariatric surgery | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Obstructive Sleep Apnea, Sleep Habits, Bariatric Surgery, Cohort
Stem Cell Therapy in Incurable Neurological Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.

Official Title
-----------------
Autologous Bone Marrow Mononuclear Cell Therapy for Incurable Neurological Disorders

Conditions
-----------------
Neurological; Disorder, Nervous System

Intervention / Treatment
-----------------
* Biological: Stem Cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed cases of incurable neurological disorders age above 6 months Exclusion Criteria: presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus malignancies bleeding tendencies pneumonia renal failure severe liver dysfunction severe anemia [Hemoglobin < 8] any bone marrow disorder space occupying lesion in brain other acute medical conditions such as respiratory infection and pyrexia pregnancy lactation

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cell<br>Bone marrow mononuclear cell transplantation | Biological: Stem Cell<br>* Intrathecal autologous bone marrow mononuclear cell transplantation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in various clinical symptoms of neurological disorders | Change in various symptoms such as muscle strength, limb strength, ambulation, neck holding, bladder bowel management, spasticity, sensation, speech, etc depending on the disorder will be recorded at 1 year follow up. Percentage analysis of each symptom will be carried out to study the benefits of stem cell therapy on them. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous mononuclear cell therapy, Incurable Neurological Disorders, Stem cells
COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES OF ADOLESCENT PREGNANCİES

Study Overview
=================
Brief Summary
-----------------
ABSTRACT Adolescent pregnancy rates are gradually increasing in the recent decades. As a reason of war nutritional difficulties, language differences and difficulty in applying to the health institution causes lack of prenatal care. As a reason of absence of prenatal care, associated medical complications can occur. 525 adolescent women who gave birth to singletons agreed to participate in this study. Data on maternal demographic and obstetric characteristics as well as neonatal outcomes were analyzed. In conclusion, adolescent pregnancy continues to be an important social problem due to the health support needs. However, the results of our present study are important in terms of showing that the perinatal care is quietly improved in Turkey.

Official Title
-----------------
COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES BETWEEN SYRIAN ADOLESCENT REFUGEES AND LOCAL TURKISH ADOLESCENT CITIZENS.

Conditions
-----------------
Adolescent Development, Pregnancy Related

Intervention / Treatment
-----------------
* Other: vaginal delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14-16 y Age Exclusion Criteria: over 16 years

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: vaginal delivery|normal vaginal spontaneous delivery|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaginal delivery rate |  | 2 years |
High Energy Formula Feeding in Infants With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Detailed Description
-----------------
Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Official Title
-----------------
High Energy Formula Feeding in Infants With Congenital Heart Disease

Conditions
-----------------
Growth Failure, Neurodevelopmental Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: High energy formula
* Dietary Supplement: Standard formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants >35 weeks of gestational age infants with CHD İnfants fed with formula feeding Exclusion Criteria: Major congenital abnormalities except CHD infants could not be fed enterally

Ages Eligible for Study
-----------------
Minimum Age: 8 Days
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High energy formula<br>High energy formula (Similac) | Dietary Supplement: High energy formula<br>* The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)<br>* Other names: High energy formula (Similac);|
| Active Comparator: Standard formula<br>Standard formula | Dietary Supplement: Standard formula<br>* The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental evaluation | Neurodevelopmental evaluation will be assessed by Bayley-II Scale at corrected age of 12-18 months. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital heart disease, Growth,Neurodevelopment
Prevalence of CVC-associated Sepsis and Use of Blood Cultures in Berlin - Brandenburg

Study Overview
=================
Brief Summary
-----------------
Structured web-based survey in selected hospitals with intensive care units in Berlin- Brandenburg to collect data on the overall number of blood cultures (used) and the prevalence of (positive blood cultures in patients with) CVC - associated sepsis.

Detailed Description
-----------------
The use of CVC represents one of the major risk factors for sepsis, a highly prevalent disease in ICUs. Blood cultures obtained prior to antibiotic administration are part of the SSC Resuscitation Bundle and essential for the outcome of the patient. The CDC criteria to diagnose sepsis do not take into account the overall number of blood cultures obtained and thus, lead to an underestimation of the true incidence of sepsis. Up to now, few data is available on the total number of blood cultures obtained and the relation to the incidence of sepsis in German ICUs.

Official Title
-----------------
Retrospective Analysis of Proven Bacteremia, CVC-associated Infections and Sepsis

Conditions
-----------------
Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intensive care units of hospitals in the INABBRA alliance. Patients with bacteremia. Exclusion Criteria: Hospitals without intensive care unit.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INABBRA<br>Participating intensive care units of hospitals in the INABBRA alliance. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of blood cultures drawn and total number of positive findings in ICUs | Retrospective analysis of cases with positive bloodculture among patients in ICU setting compared to the total amount of blood cultures taken in the same period of time and same hospital. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence on CVC - associated sepsis/CLABSIs |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, catheter, blood stream infection, blood culture
Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer

Official Title
-----------------
Observational Retrospective Trial on Sequential Hormonal Therapy in Patients

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non metastatic Prostate Cancer previous treatment with bicalutamide 150mg biochemical relapse/progression Exclusion Criteria: use of other treatments for Prostate Cancer
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal sensitivity to second line treatment for CaP after Bicalutamide |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median duration of second and third line treatments; |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
second line, Prostate Cancer, bicalutamide, biochemical relapse/progression in patients with Prostate Cancer treated with bicalutamide 150mg
Use of Convalescent Plasma for COVID-19

Study Overview
=================
Brief Summary
-----------------
The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.

Official Title
-----------------
Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Biological: Convalescent Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented COVID-19 infection by nasal pharyngeal sampling COVID-19 disease falling into one of the following groups: Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index </=300mmHg High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease Exclusion Criteria: History of IgA deficiency History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Critical Patients<br> | Biological: Convalescent Plasma<br>* 200-425mL convalescent plasma donated by patients previously positive for COVID-19<br>|
| Other: Severe Patients<br> | Biological: Convalescent Plasma<br>* 200-425mL convalescent plasma donated by patients previously positive for COVID-19<br>|
| Other: High Risk<br> | Biological: Convalescent Plasma<br>* 200-425mL convalescent plasma donated by patients previously positive for COVID-19<br>|
| Other: Health Care Providers<br> | Biological: Convalescent Plasma<br>* 200-425mL convalescent plasma donated by patients previously positive for COVID-19<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection | Number of patients who survived the covid infection after treatment on study. | 30 days after initial treatment |
Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

Study Overview
=================
Brief Summary
-----------------
Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery

Detailed Description
-----------------
RCT involving patients who have severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).

Official Title
-----------------
Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial

Conditions
-----------------
Knee Osteoarthritis, Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: bariatric surgery followed by total knee replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 Exclusion Criteria: previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical weight loss<br>sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement | Procedure: bariatric surgery followed by total knee replacement<br>* The only intervention is the randomization of the priority of the 2 procedures.<br>|
| No Intervention: Standard of Care<br>dietary and lifestyle counseling prior to total knee replacement | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, mobility and quality of Life | Knee Injury and Osteoarthritis Outcome Score (KOOS4) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Replacement, Knee, Bariatric Surgery
Comparison of Intubation Conditions Between the Gliderite and the S-Guide

Study Overview
=================
Brief Summary
-----------------
Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.

Detailed Description
-----------------
Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways. The primary endpoint will be time necessary for intubation, secondary endpoints will be injuries, ease of use and subjective assessment.

Official Title
-----------------
Comparison of Intubation Conditions Between the Gliderite and the S-Guide in Patients With Simulated Difficult Airways

Conditions
-----------------
Nasal Obstruction, Lumbar Stenosis, Familial

Intervention / Treatment
-----------------
* Device: Tracheal intubation with Gliderite
* Device: Tracheal intubation with S-guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery necessitating general anesthesia and orotracheal intubation Exclusion Criteria: History or criteria of difficult intubation Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tracheal intubation with Gliderite<br>Gliderite will be used for intubation | Device: Tracheal intubation with Gliderite<br>* Tracheal intubation with Gliderite<br>|
| Experimental: Tracheal intubation with S-Guide<br>S-Guide will be used for intubation | Device: Tracheal intubation with S-guide<br>* Tracheal intubation with S-guide<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time necessary to intubate | Time needed to pass tracheal tube through vocal cords | 50 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized questionnaire assessing injury after intubation | Assessment of discomfort after procedure | 50 seconds | 
| Standardized questionnaire assessing ease of use of the intubation | assessment by doctor of ease of intubation | 50 seconds | 
| Subjective ease of use of the intubation assessed by questionnaire | assessment by doctor of ease of intubation | 50 seconds |