linjc16/ctgov huggingface dataset:
Effects of Different Surgical Methods to Treat Obesity

Study Overview
=================
Brief Summary
-----------------
Obese patients have an increased risk for developing severe metabolic disorders. This risk can only partly be reduced by weight reduction. The investigators have in a pilot study investigated if removal of abdominal fat (visceral) in addition to weight loss has additional beneficial effects on the metabolic profile and weight loss. This study aims to further investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic effects.

Official Title
-----------------
Metabolic Effects of Different Surgical Methods to Treat Obesity

Conditions
-----------------
Obesity, Type 2 Diabetes, Insulin Sensitivity

Intervention / Treatment
-----------------
* Procedure: Omentectomy
* Procedure: Gastric bypass operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index over 40 kg/m2 Body mass index over 35 kg/m2 with obesity associated co-morbidities such as type 2 diabetes and/or additional cardiovascular risk factors - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Gastric bypass operation without omentectomy. | Procedure: Gastric bypass operation<br> <br> |
| Active Comparator: Omentectomy<br>Gastric bypass operation in conjunction with removal of greater omentum | Procedure: Omentectomy<br> <br> Procedure: Gastric bypass operation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity at 2 Years | Insulin sensitivity measured by hyperinsulinemic euglycemic clamp | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition at Two Years |  | 2 years postoperative | 
| Blood Pressure at 2 Years |  | 2 years postoperative | 
| Body Mass Index at 2 Years |  | 2 years postoperative | 
| Blood Lipids |  | 2 years postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric Surgery, Obesity, Insulin Sensitivity
Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study

Study Overview
=================
Brief Summary
-----------------
To analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.

Official Title
-----------------
Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study

Conditions
-----------------
Postnatal Growth Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Individualized fortification of breast milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight ≤ 1500g and gestational age < 32weeks Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h Exclusion Criteria: Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities Babies with enterostoma or short gut syndrome Fluid restriction below Renal disease Sepsis Necrotizing enterocolitis Hepatic dysfunction

Ages Eligible for Study
-----------------
Maximum Age: 32 Weeks

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: Individualized fortification of breast milk<br> | Dietary Supplement: Individualized fortification of breast milk<br>* Lactose, fat and protein content will be measured prior to breast milk fortification. Subsequently, breast milk for preterm infants will individually fortified adjusted by using data from milk analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth | weight gain will be accessed three times per week | from inclusion at postmentrual age <32 weeks until 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enteral energy intake | caloric intake by enteral feeding will be assesed daily | from inclusion at postmentrual age <32 weeks until 36 weeks | 
| growth, tolerance, morbidity | gains in length and head circumference will be assessed weekly, tolerance and morbidity throughout study | from inclusion at postmentrual age <32 weeks until 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postnatal development, Breast milk fortification, Composition of breast milk
Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

Study Overview
=================
Brief Summary
-----------------
Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.

Detailed Description
-----------------
will be a randomized trial

Official Title
-----------------
Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial

Conditions
-----------------
Perinatal Asphyxia

Intervention / Treatment
-----------------
* Drug: Erythropoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Babies with severe perinatal asphyxia with moderate to severe HIE in the immediate neonatal period Exclusion Criteria: Babies with congenital malformations Small for gestational age babies Babies with chromosomal anomalies

Ages Eligible for Study
-----------------
Maximum Age: 6 Hours

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: erythropoietin, perinatal asphyxia,<br>Treatment group | Drug: Erythropoietin<br>* 500 units /kg /day every other day for 5 doses<br>* Other names: erhthropoietin beta;|
| Placebo Comparator: Normal saline, perinatal asphyxia<br>Normal saline on alternate days for 5 doses starting from first 6 hours of life | Drug: Erythropoietin<br>* 500 units /kg /day every other day for 5 doses<br>* Other names: erhthropoietin beta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or moderate or severe disability at 18-22 months of age |  | 18-22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Severe disability was defined as GMFCS grade of level 3-5, hearing impairment requiring hearing aids, bilateral cortical visual impairment with no useful vision or Bayley Mental Development Index Score less than 70. Moderate disability was defined as Bayley Mental Developmental Index Score between 70-84 and any one of the following criteria: GMFCS grade of level 2, hearing impairment with no amplification or persistent seizure disorder. | 18-22 months | 
| Bayley psychomotor development index |  | 18-22 months months | 
| Hearing loss at 18-22 months |  | 18-22 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perinatal asphyxia, erythropoietin
The Johns Hopkins Heartburn Center Registry

Study Overview
=================
Brief Summary
-----------------
A multi-center, multi-year registry of patients with gastroesophageal reflux disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.

Detailed Description
-----------------
This registry is a prospective, multicenter registry of patients undergoing diagnostic evaluation and/or treatment of gastroesophageal reflux disease and associated diseases and complications. Patients who are eligible will have disease and therapy-specific data collected throughout treatment and long-term (5-year) follow-up. Electronic data capture via REDCap will be utilized for all sites.

Official Title
-----------------
The Johns Hopkins Heartburn Center Registry

Conditions
-----------------
Gastroesophageal Reflux Disease, Barrett Esophagus, Laryngopharyngeal Reflux, Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred GERD patients willing to participate in long term follow-up (5 years) Exclusion Criteria: Potential participants will be excluded if unwilling or unable to complete surveillance questionnaires through this registry

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 |
| --- | --- | --- |
| Demographic and clinical data obtained via chart review and questionnaires | Establish a registry with collected data related to patients undergoing diagnostic evaluation and treatment of GERD and its associated diseases in multiple academic and community settings. | 5 years |
Determination of Normal Values for the Star Excursion Balance Test (SEBT) in Handball Players

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to determine normal values for SEBT in young national or international handball women players for determining specific level for SEBT to predict risk of injury

Official Title
-----------------
Determination of Normal Values for the Star Excursion Balance Test(SEBT) in National or International Handball Young Women Players

Conditions
-----------------
Handball Players

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women age from 14 to 18 years old national or international level for handball Exclusion Criteria: no french language players who don't understand the instructions to perform the test Refusal to perform the test

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determination of normal values for SEBT | star excursion balance test : it is a functionnal test for predicting the risk of injury | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hand ball, evaluation, risk of injury, women
The Effect of Probiotics on Infections in Toddlers

Study Overview
=================
Brief Summary
-----------------
Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children. The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

Detailed Description
-----------------
Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children. Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

Official Title
-----------------
The Effect of Probiotics on Infections in Toddlers

Conditions
-----------------
Diarrhoea, Respiratory Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: probiotics
* Dietary Supplement: probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010 Gestational age > 36. weeks Exclusion Criteria: Chronical heart or lung conditions Short Bowel Syndrome CVC (Central Venous Catheter)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 7 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Dietary Supplement: probiotics<br>* placebo<br>|
| Active Comparator: 2<br> | Dietary Supplement: probiotics<br>* 0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fewer infections |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Infections, Children
Central Blood Pressure in Adolescents and Young Adults

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate in adolescents and young adults: the 24h diurnal variation of ambulatory central blood pressure the association of central compared to peripheral blood pressure with indices of asymptomatic target-organ damage

Official Title
-----------------
Diurnal Variation of Central Blood Pressure in Adolescents and Young Adults and Association With Indices of Asymptomatic Target-organ Damage

Conditions
-----------------
Healthy, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents and young adults (age range 12-25 years) Exclusion Criteria: Subjects with any acute or significant chronic disease, with evidence of secondary hypertension, or on regular drug treatment will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficients (r) between 24h ambulatory central blood pressure and indices of target-organ damage | Correlation coefficients (r) will be determined for the relationship between central blood pressure and indices of target-organ damage (left ventricular mass index, carotid intima-media thickness, pulse wave velocity). Also, these coefficients will be compared with z-statistic with the respective ones for the peripheral blood pressure. | Assessment of each individual will require up to 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central blood pressure, Ambulatory blood pressure monitoring, Target-organ damage, Adolescents and young adults
Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital

Study Overview
=================
Brief Summary
-----------------
To study the quality of life of patients earlier diagnosed for cervical cancer and cervical intraepithelial neoplasia (CIN).

Detailed Description
-----------------
In Thailand, age standardized incidence is 20.9 per 100,000 women-year. Treatment-related survival gain are experienced by side-effect that may reduce quality of life (QoL). We therefore, study the quality of life of patients earlier diagnosed for cervical cancer patients.

Official Title
-----------------
Quality of Life in Thai Women Diagnosed Cervical Cancer at King Chulalongkorn Memorial Hospital

Conditions
-----------------
Quality of Life, Cervical Cancer, Cervical Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thai patients aged more than 15 years old. Diagnosed of cervical intraepithelial neoplasia (CIN) or cervical cancer with pathological confirmation. If she has more than one diseases, the most severe will be considered as diagnosis. Not suffered from confusion or reduced level of consciousness or unable to communicate. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 Years

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

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 |
| --- | --- | --- |
The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy in detecting esophageal pathology compared to standard endoscopy.

Detailed Description
-----------------
This will be a single centre feasibility study performed at Nottingham University Hospitals NHS Trusts. We will assess the accuracy of MACE compared to gastroscopy in diagnosing Barretts oesophagus and esophageal varices. Patients will have both tests on the same ay, with the endoscopic findings compared.

Official Title
-----------------
The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study

Conditions
-----------------
Barrett's Oesophagus, Oesophageal Varices

Intervention / Treatment
-----------------
* Device: Magnet assissted capsule endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Due to have a clinically indicated gastroscopy Barrett's oesophagus/ oesophageal varices or Controls Able to give informed consent Exclusion Criteria: Unable to give consent Pregnant Pacemaker swallowing difficulties

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: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MACE<br>MACE procedure | Device: Magnet assissted capsule endoscopy<br>* Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day<br>|
| Active Comparator: OGD<br>Clinically indicated gastroscopy | Device: Magnet assissted capsule endoscopy<br>* Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuarcy | endoscopic | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comfort | questionnaire | 2 weeks |
Metabolic Evaluation of Nutrition in Rett Syndrome

Study Overview
=================
Brief Summary
-----------------
Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The pathological mechanism is barely understood. Although feeding difficulties may play a part in this, other constitutional factors as altered metabolic processes are suspected. Irregular breathing is a common clinical feature, reflecting the immaturity of the brainstem in RTT. The primary pathophysiology is a defective control mechanism of carbon dioxide exhalation that leads to chronic respiratory alkalosis or acidosis. We assume that chronic respiratory acidosis or alkalosis causes derangement of the metabolic equilibrium in RTT females with important nutritional consequences. The aims of this pilot study are to describe the nutritional status of the RTT girls and to examine the consequences of a chronic respiratory acidosis or alkalosis on metabolic processes as a possible cause of impaired nutritional status.

Official Title
-----------------
A Systematic Metabolic Approach to the Evaluation of Nutrition in Rett Syndrome According to the Cardiorespiratory Phenotype in Dutch Rett Girls

Conditions
-----------------
Rett Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of RTT (meeting consensus diagnostic criteria (Hagberg et al, 2002)); MECP2-mutation; Complete neurophysiological work-up. Exclusion Criteria: Male gender.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rett syndrome girls<br>The study population consists of a well-defined group of Dutch RTT thirteen girls with complete clinical, molecular and neurophysiological work-up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. What is the nutritional status of the RTT girls? 2. Can metabolic alterations caused by chronic respiratory acidosis or alkalosis be detected? |  | Once. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rett syndrome., Nutritional status., Metabolic alterations.