linjc16/ctgov huggingface dataset:
Closure of the Appendix Stump in Laparoscopic Appendectomy

Study Overview
=================
Brief Summary
-----------------
Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.

Detailed Description
-----------------
Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups were compared for cost effectiveness.

Official Title
-----------------
Hem-o-lok Clips Versus ıntracorporeal Knotting for Closure of the Appendix Stump in Laparoscopic Appendectomy: Prospective Randomized Study

Conditions
-----------------
Appendicitis, Surgery

Intervention / Treatment
-----------------
* Procedure: clips
* Procedure: knotting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute appendicitis Exclusion Criteria: under 18 years of age other patology in addition to appendiceal pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clips<br>Closure of the appendix stump with hem-o-lok clips | Procedure: clips<br> <br> |
| Experimental: knotting<br>Closure of the appendix stump with intracorporal knotting. | Procedure: knotting<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost effectiveness | cost of treatment from surgery to discharge | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis; Laparoscopic Surgery; Cost Effectiveness
Permissive Hypercapnia and Brain Development in Premature Infants

Study Overview
=================
Brief Summary
-----------------
In the US, every year approximately 30,000 infants are born very prematurely, with birth weight less than 1000 grams. These infants usually require ventilators to help them breath normally during the first few weeks of life. Although the ventilator is lifesaving, it can also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury. Importantly, there is new research showing that high carbon dioxide may cause brain injury. In our proposed research, we will use magnetic resonance imaging methods to evaluate the brain in 40 very premature infants at term-equivalent age (Half of them had permissive hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has adverse effect on brain development.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infants with birth weight 401-1000 g Exclusion Criteria: Those with complex congenital anomalies, central nervous system malformations, chromosomal abnormalities, or hydrops fetalis

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 5 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br> | |
| hypercapnia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI |  | 0 |
An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine clinical setting. Treatment decisions are made by the physician and reflect the physician's current standard of care.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: OPTIVE PLUS®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of dry eye Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice Exclusion Criteria: None

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 |
| --- | --- |
| OPTIVE PLUS®<br>Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. | Drug: OPTIVE PLUS®<br>* Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® | Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied). | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® | The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied). | Week 4 | 
| Tear Break Up Time (TBUT) | TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film. | Baseline, Week 4 | 
| Schirmer Score | The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. | Baseline, Week 4 |
Precision Medicine Study on Cardiovascular Disease (PRECISE)

Study Overview
=================
Brief Summary
-----------------
Cardiovascular diseases are the leading cause of death in China and have become a financial burden on society under the traditional medical model. A new and sustainable medical model is needed to solve this dilemma, for which precision medicine models have great potential. Monogenic cardiovascular disease is the first field to be broken through in precision medicine at this stage, and it is also the field where precision medicine is most likely to be successfully transformed into clinical application, including genetic diagnosis, molecular typing, risk stratification, genetic interruption and individualized treatment.

Detailed Description
-----------------
In this study, patients with monogenic cardiovascular disease are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood, saliva, urine and feces for all patients, and myocardium for patients receive cardio myectomy surgery . Genetic testing will be performed to identify novel disease genes, genetic risk factors and potential therapy targets.

Official Title
-----------------
Precision Medicine Study on Cardiovascular Disease (PRECISE)

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with monogenic cardiovascular diagnosed according current practice guideline. Exclusion Criteria: Patients who refuse to sign the informed consent or decline follow-up.
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 |
| --- | --- | --- |
| number of participants with cardiovascular deaths | including sudden cardiac death and deaths due to heart failure and stroke. | an average of 5 years | 
| number of participants with all-cause death | deaths due to all cause. | an average of 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with heart failure | progress to level III or IV in New York Heart Association class. | an average of 5 years | 
| number of participants with stroke | including cerebral infraction and hemorrhage | an average of 5 years | 
| number of participants with malignant arrhythmia | including ventricular fibrillation and ventricular tachycardia | an average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
monogenic cardiovascular disease, clinical outcomes, genomics, genetic diagnosis, risk stratification
Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

Study Overview
=================
Brief Summary
-----------------
Little is known about the clinical significance of chronic alanine aminotransferase (ALT) elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and second to find associated factors with significant fibrosis and cirrhosis. In a second longitudinal part we intend to assess fibrosis progression within 1 and 3 years.

Official Title
-----------------
Prevalence of Liver Fibrosis and Progression of Liver Fibrosis in HIV-infected, Hepatitis C (HCV) and Hepatitis B (HBV) Seronegative Patients With Chronic Alanine Aminotransferase (ALT) Elevation

Conditions
-----------------
HIV Infection and Chronic Alanine Aminotransferase Elevation

Intervention / Treatment
-----------------
* Other: Fibroscan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Case patients: HIV-1 infection no hepatitis B and C coinfection chronic alanine aminotransferase (ALT) elevation after 1.1.2007 signed informed consent no other common cause of liver disease Control patients: HIV-infection no hepatitis B and C coinfection no ALT elevation after 1.1.2002, the date when ALT values were regularly collected in the Swiss HIV Cohort Study (SHCS) no known chronic liver disease Exclusion criteria: please see inclusion criteria

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 |
| --- | --- |
| unexplained chronic ALT elevation<br>Case patients: HIV-infected, unexplained chronic alanine aminotransferase (ALT) elevation | Other: Fibroscan<br>* Fibroscan and Serum Fibrose-marker<br>* Other names: Fibroscan and Serum Fibrose-marker;|
| always normal ALT<br>Control patients: HIV-infected, always normal ALT values | Other: Fibroscan<br>* Fibroscan and Serum Fibrose-marker<br>* Other names: Fibroscan and Serum Fibrose-marker;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liverfibrosis |  | 3 years |
Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization

Study Overview
=================
Brief Summary
-----------------
Problems of compatibility between a mother and her child are frequent. The most well-known case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which can induce severe anemia of the fetus. The investigators recently proved that incompatibility between mother and child can concern an organ leading to a tissular alloimmunization. For example, neonatal membranous glomerulonephritis (a kidney disease) can result from this mechanism. The purpose of this network is to detect and study neonatal diseases induced by tissular fetomaternal alloimmunization. The detection of these diseases will be performed by the mother's serum analysis.

Official Title
-----------------
Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization

Conditions
-----------------
Glomerulonephritis, Membranous, Neonatal Diseases and Abnormalities, Hemochromatosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers having a child suffering from: Neonatal membranous glomerulonephritis Unexplained neonatal tubular defect Unexplained thrombotic microangiopathy Neonatal hemochromatosis Exclusion Criteria: Any cause explaining the child's disease
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fetomaternal tissular alloimmunization, Mothers having a child suffering from:, neonatal membranous glomerulonephritis, unexplained neonatal tubular defect, unexplained thrombotic microangiopathy, neonatal hemochromatosis
Study Evaluating DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
To compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with MDD.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study of DVS-233 SR and Venlafaxine ER in Adult Outpatients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: DVS-233 SR
* Drug: Venlafaxine ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients. Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article Subjects must have a primary diagnosis of major depressive disorder Exclusion Criteria: Treatment with DVS-233 SR at any time in the past Treatment with venlafaxine (immediate release [IR] or ER) within 90 days of study day 1 Known hypersensitivity to venlafaxine (IR or ER)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: DVS-233 SR|nan|
|Drug: Venlafaxine ER|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.

Official Title
-----------------
Phase III Study of Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) Versus Irinotecan Monodrug as Second-line Treatment in Metastatic Colorectal Cancer Patients

Conditions
-----------------
Colorectal Carcinoma

Intervention / Treatment
-----------------
* Drug: Irinotecan
* Drug: 5-fluorouracil
* Drug: Leucovorin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin) at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria have adequate bone marrow, hepatic, and renal function Exclusion Criteria: patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection previously received irinotecan dihydropyrimidine dehydrogenase (DPD) enzyme adequate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: FOLFIRI<br>5-fluorouracil,folinate combined with irinotecan | Drug: Irinotecan<br>* 180 mg/m2 iv gtt, d1<br>Drug: 5-fluorouracil<br>* 5-FU 400mg/m2 iv, 2400mg/m2 civ 46h<br>* Other names: 5-FU;Drug: Leucovorin<br>* 400mg/m2 iv gtt,d1<br>* Other names: LV;|
| Active Comparator: IRINOTECAN<br>irinotecan | Drug: Irinotecan<br>* 180 mg/m2 iv gtt, d1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 6 months | 
| overall response rate |  | 2 months | 
| Number of Participants with Adverse Events |  | 2 months | 
| quality of life questionnaire |  | 2 months |
Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)

Study Overview
=================
Brief Summary
-----------------
Prevailing microorganisms causing neonatal sepsis in neonatal intensive care unit of Assiut University children Hospital Methods prospective study conducted in the neonatal intensive care unit in Assiut university children hospital.

Detailed Description
-----------------
Sepsis remains a leading cause of death in the intensive care units and in all age groups worldwide.sepsis was defined as the host's immune response(systemic inflammatory response syndrome) to injury and/or infectious stimuli in the presence of a known(or strongly suspected) infection .early onset neonatal sepsis occurs in utero or might become infected when exposed to potentially pathogenic bacteria,viruses,or fungi during passage through the birth canal.

Official Title
-----------------
Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)

Conditions
-----------------
Neonatal SEPSIS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both preterm and full term neonates both early onset and late onset neonatal sepsis Exclusion Criteria: Genetic diseases immunocompromized neonates Neonates of diabetic mothers Neonates of HIV mothers

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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 |
| --- | --- | --- |
| Prevention of neonatal sepsis | Recognition of prevailing microorganisms causing neonatal sepsis in neonatal intensive care units to take preventive measures against it to decrease the incidence of neonatal sepsis | From september2017 to september 2018 |
Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

Official Title
-----------------
Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Decapeptyl Daily
* Drug: pregnyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intra-cytoplasmic sperm injection (ICSI) patients below 38 years 1,2 or 3 rd IVF-cycle Exclusion Criteria: polycystic ovary syndrome (PCOS) patients patients with endocrinological diseases or problems

Ages Eligible for Study
-----------------
Maximum Age: 38 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hCG<br>5000 IU Pregnyl SC | Drug: pregnyl<br>* 5000 IU SC<br>|
| Active Comparator: hCG and GnRH agonist<br>5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC | Drug: Decapeptyl Daily<br>* Decapeptyl 0.2 mg SC once 1day<br>* Other names: Gonapeptyl;Drug: pregnyl<br>* 5000 IU SC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MII Oocytes | the number of mature oocytes retrieved | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | the number of pregnancies obtained, wich still is the most important issue for the patients | 12 weeks | 
| Patients With Cryopreserved Embryos |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian hyper stimulation syndrome (OHSS), metaphase II oocytes (MII), good quality embryo's, implantation, pregnancy