linjc16/ctgov huggingface dataset:
Maintenance Programme After Weight Loss

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.

Official Title
-----------------
Effect of Maintenance Programme on the Long Term Weight Reduction in Severely Obese Patients. A Randomized Controlled Trial

Conditions
-----------------
Weight Loss, Morbid Obesity

Intervention / Treatment
-----------------
* Behavioral: weight loss programme with maintenance programme
* Behavioral: weight loss programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 35 kg/m2 or more Age 18-65 years Exclusion Criteria: Type 1 diabetes Major alcohol problem Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Treatment B includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). Treatment lasts 17 weeks and after that there will be one and two year control visits including weighing and questionnaires for eating behavior and quality of life. | Behavioral: weight loss programme<br> <br> |
| Experimental: 1<br>Treatment includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). After that a maintenance programme starts with monthly sessions for one year. Weight loss, quality of life, and eating behavior will be assessed at the end of the maintenance program and one year later. | Behavioral: weight loss programme with maintenance programme<br>* After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight result |  | 2 years after weight loss phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life and eating behavior |  | 2 years after active weight loss | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maintenance therapy
Development and Validation of Multi-nuclear Magnetic Resonance Imaging and Spectroscopy for Whole Body Human Applications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and refine the techniques for using magnetic resonance imaging and magnetic resonance spectroscopy to understand the composition and function of the human body

Official Title
-----------------
Development and Validation of Multi-nuclear Magnetic Resonance Imaging and Spectroscopy for Whole Body Human Applications

Conditions
-----------------
Human Body Composition, Human Body Function

Intervention / Treatment
-----------------
* Other: To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips Magnet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age 12 - 89 Healthy (self assessed) Weight under 350lbs Able to walk 50 yards without stopping Able to travel to hospital for study visits Able to follow a 3-step command Able to remain in Magnetic Resonance (MR) scanner for up to 2 hours Exclusion Criteria: Have internal metal medical devices, including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws, metal fragments in your eye, or non-removable jewelry such as rings. Are unwilling or unable to complete the imaging procedures for the duration of the MRI scan due to claustrophobia or other reason. Serious mental illness that might preclude subject's ability to comply with study treatment Life expectancy of less than 1 year Are pregnant or plan on becoming pregnant in the next 8 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips Magnet|Outside standard MR instrumentation there will be no interventions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole body fat quantification |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Microstructure | A high resolution image of the structure of fat tissue. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnetic resonance imaging, magnetic resonance spectroscopy
NIRS Levels of Infants in Neonatal Intensive Care

Study Overview
=================
Brief Summary
-----------------
Aim: This study was conducted to determine the effect of nursing care practices on the Near Infrared Spectroscopy (NIRS) levels of premature infants in the neonatal intensive care unit (NICU). Materials and Method: This is a cross-sectional, analytical study. It was conducted over the period March 1 - April 26, 2019 in the Neonatal Intensive Care Unit (NICU) of Eskişehir Osmangazi University (ESOGU) Health Practices and Research Hospital. We did not calculate sample size, but included in the study, after the parents had been informed about the research, the entire universe of neonates in the NICU who matched the inclusion criteria during the period March 1 - April 26, 2019. The study was completed with 40 neonates. Data collection was performed with a Descriptive Data Form, and a Procedures Performed Chart. The data were evaluated with the IBM SPSS 24 package program.

Official Title
-----------------
The Effect Of Nursıng Practıces On The Near Infrared Spectroscopy Levels Of Premature Infants

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Behavioral: nursing care practices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates younger than a gestational age of 37 weeks Those monitored in an open or closed incubator Exclusion Criteria: Intubated neonates connected to a mechanical ventilator Infants of a gestational age of 37 weeks or more Infants under sedation Infants with neurological illness (e.g., hypoxic ischemic encephalopathy, hydrocdphalus)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 40 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| infants receiving nursing care<br> | Behavioral: nursing care practices<br>* To determine the effect of nursing care practices on Near Infrared Spectroscopy (NIRS) levels in premature babies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nursing practices | Change of nursing practices on Near Infrared Spectroscopy levels | 24 hours |
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer

Study Overview
=================
Brief Summary
-----------------
Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies. Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment. A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND. The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND. The investigators designed prospective randomized controlled study as a pilot study. The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.

Official Title
-----------------
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Drug: Floseal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gynecologic cancer patients who need laparotomic bilateral PLND Exclusion Criteria: Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Floseal<br>application of floseal to one side of pelvis after pelvic lymphadenectomy | Drug: Floseal<br>* application of floseal on intervention arm<br>|
| No Intervention: Control<br>counter-site of pelvis; no intervention after pelvic lymphadenectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of pelvic lymphocele | Frequency of ipsilateral pelvic lymphocele at post-operative 6th month. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative drainage | left and right post-operative drainage | post-operative 3 days | 
| lymphedema | lymphedema symptoms and sign at post-operative 3 and 6 month | post-operative 3 and 6 month |
Natural Course and Prognosis of Hospitalized Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to evaluate the natural course and prognosis of hospitalized patients with liver cirrhosis.

Detailed Description
-----------------
The aim of this prospective study is to collect data on hospitalized patients with liver cirrhosis at four institutions in Korea (Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, Chosun University Hospital, and National Medical Center). If patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status [RFH-NPT], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. The research database will be updated, every 6 months, to include data on patients' disease outcomes and follow-up care.

Official Title
-----------------
Natural Course and Prognosis of Hospitalized Patients With Cirrhosis: a Prospective, Multicenter, and Observational Study

Conditions
-----------------
Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with liver cirrhosis Admission to the hospital because of cirrhotic complications such as uncontrolled ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, hepatocellular carcinoma, acute kidney injury, bacterial infection, acute liver failure, and etc. Exclusion Criteria: Admission to the hospital without cirrhotic complications Patients who refuse the follow-up of outpatient department

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| All-cause mortality | Death from any cause | Up to 2 years | 
| Liver-related mortality | Death from liver disease | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause of admission to hospital | Prevalence of cause of admission to hospital | At baseline |
Prospective Registry for Patients With Chest Pain in Emergency Department

Study Overview
=================
Brief Summary
-----------------
monocentric, prospective registry collection of clinical data of all patients with chest pain in emergency department and follow-up after 30 days

Detailed Description
-----------------
An unselected patient-population with chest pain entering through the emergency department participate in a diagnostic survey where a chest pain algorithm based mainly on risk scores (Grace, TIMI, Heart) verifying the diagnostic forecasting power (sensitivity, specificity, negative and positive predictive value) of biomarkers, risk scores and imaging methods for diagnosing of potential life-threatening disease.

Official Title
-----------------
Prospective Registry for Patients With Chest Pain in Emergency Department

Conditions
-----------------
Chest Pain

Intervention / Treatment
-----------------
* Device: CT Thorax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years old chest pain written confirmation of participants or legal representative Exclusion Criteria: thorax trauma

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Chest Pain<br>An unselected patient-population with chest pain in emergency department | Device: CT Thorax<br>* CT Thorax (GE Revolution with chest pain algorithm)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic forecast of biomarkers, risk scores and computer tomography | Diagnostic forecast compared to the initial suspected diagnosis and discharge diagnosis | From admission to emergency unit discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity in result of biomarkers, risk scores and imaging methods | During diagnostic procedure | 
| Specificity | Specificity in result of biomarkers, risk scores and imaging methods | During diagnostic procedure | 
| Positive predictive value | Positive predictive value in result of biomarkers, risk scores and imaging methods | During diagnostic procedure | 
| Negative predictive value | Negative predictive value in result of biomarkers, risk scores and imaging methods | During diagnostic procedure | 
| Major adverse cardiac events (MACE) | outcome is measured by coronary intervention, coronary bypass and death within 30 days | From admission to emergency unit until 30 days after or death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest Pain
Analysis of Genetic Factors Which May Influence the Course of HIV Infection

Study Overview
=================
Brief Summary
-----------------
Patients with HIV an have a variable course of their infection. We are trying to identify factors which worsen or ameliorate the course of the disease. Such factors may be related to metabolism (breakdown) of drugs or to iron handling by the body.

Detailed Description
-----------------
Patients with HIV can have a variable course and the disease may be influenced by polymorphisms in drug metabolism and disposition genes such as MDR1 and CYP3A4. In addition, reports have linked changes in the course of the disease with iron status, with high iron being detrimental. We will study polymorphisms in these genes and correlate with clinical course in HIV patients and also with phenotype of drug resistance and disease parameters (such as CD4 counts and opportunistic infections).

Official Title
-----------------
Genetic Influences on the Course and Response to Treatment of HIV: Contribution of Polymorphisms in Drug Metabolism and Disposition Genes and Haptoglobin Polymorphisms

Conditions
-----------------
HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of HIV Exclusion Criteria: under 18 years of age

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 |
| --- | --- | --- |
Study of Rebamipide Eye Drops to Treat Dry Eye

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

Detailed Description
-----------------
There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptoms.

Official Title
-----------------
Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 26 Week Study

Conditions
-----------------
Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: Rebamipide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have symptoms of dry eye for a minimum of 6 months must be able to sign and date an informed consent Exclusion Criteria: presence of anterior segment disease glaucoma or ocular hypertension using Restasis use of topically instilled ocular medications during study use of contact lenses history of ocular surgery within 12 months females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception presence of Stevens-Johnson syndrome any anticipated change in medication through-out study concurrent involvement in another study or previous receipt of this drug cannot be safely be weaned off of ocular medications

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rebamipide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eye, keratoconjunctivitis sicca
The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children.

Official Title
-----------------
The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children

Conditions
-----------------
Upper Respiratory Tract Infection

Intervention / Treatment
-----------------
* Dietary Supplement: probiotic
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic<br>dietary supplement | Dietary Supplement: probiotic<br> <br> |
| Placebo Comparator: placebo<br>dietary supplement without probiotic | Dietary Supplement: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| upper respiratory tract infections |  | study period, 12 weeks |