linjc16/ctgov huggingface dataset:
Waist Circumference in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Metabolic syndrome including increased body mass index or waist circumference is known to be a risk factor of cardiovascular disease. However, the relationship between body mass index or waist circumference and clinical outcome after cardiac surgery has not been fully elucidated.

Detailed Description
-----------------
Along with body mass index, which is determined with height and weight, waist circumference reflects abdominal obesity and may increase cardio-metabolic risk and all-cause morbidity/mortality. In this observational study, we will review the electronic medical records of patients underwent cardiac surgery and assess their waist circumference, measured on preoperative computed tomography, as well as body mass index. The relationship between body mass index or waist circumference and mortality after cardiac surgery will be analysed.

Official Title
-----------------
Association Between Waist Circumference or BMI and Clinical Outcome in Cardiac Surgery

Conditions
-----------------
Obesity, Abdominal

Intervention / Treatment
-----------------
* Procedure: cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery between 2004 and 2016 at Seoul National University Hospital Exclusion Criteria: Patients without information on height, weight, or waist circumference from abdominal computed tomography

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cardiac surgery|The relationship between body mass index or waist circumference and clinical outcome in patients undergoing cardiac surgery will be assessed|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality after cardiac surgery | through study completion, average 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mortality, waist circumference, body mass index, cardiac surgery
Myopia Prevalence in Canadian School Children - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine the prevalence of nearsightedness in Canadian school children living in the Waterloo Region.

Official Title
-----------------
Myopia Prevalence in Canadian School Children - a Pilot Study

Conditions
-----------------
Myopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has had a parent/legal guardian read the study consent form and who agrees to allow them to participate in the study by signing the consent form Has had the letter of assent for children explained to them, the child has agreed to participate and the letter has been signed by the study investigator and the child Has provided the completed Questionnaire (Appendix 4A for parents to complete on behalf of their children in school grades 1 and 2, 6 and 7; Appendix 4B for children to complete that are in school grades 11 and 12) Is currently in school grades 1 and 2, 6 and 7 or 11 and 12 Is willing and able to follow instructions and maintain the appointment schedule Exclusion Criteria: Has not given verbal assent to participate Has known sensitivity to the diagnostic pharmaceuticals to be used in the study Has undergone refractive error surgery or orthokeratology Has serious medical disorders or eye diseases/abnormalities such as amblyopia and cataract or a cognitive inability to conduct the tests

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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 |
| --- | --- |
| School Grades 1+2<br>Children currently enrolled in grades 1 and 2 | |
| School Grades 6+7<br>Children currently enrolled in grades 6 and 7 | |
| School Grades 11+12<br>Children currently enrolled in grades 11 and 12 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children with spherical equivalent refraction of at least -0.50D in at least one eye |  | Day1 |
A Study of RO5036505 in Patients With Moderate to Severe Asthma

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of RO5036505 in patients with inadequately controlled moderate to severe asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is 50-100 individuals.

Official Title
-----------------
A Multi-center, Randomized, Double-Blind, Multiple-Dose, Placebo-controlled Asthma Control Study Evaluating the Efficacy, Safety, and Tolerability of RO5036505 in Subjects With Moderate-to-Severe Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: RO5036505
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-70 years of age moderate to severe asthma for >/=2 years ACQ score >/= 1.5 ICS and LABA regimen at moderate to high dose non-smokers Exclusion Criteria: oral corticosteroid use within 4 weeks prior to screening current escalating immunotherapy acute infection/antibiotic therapy within 4 weeks prior to screening, or chronic infection pulmonary disease other than asthma therapy with any approved monoclonal antibody or biologic agent within 12 months prior to screening previous exposure to investigational monoclonal antibodies or biologics

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO5036505<br>* 380mg iv infusion once weekly for 8 weeks<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* iv infusion once weekly for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACQ questionnaire, spirometry assessments, PEFR |  | every week up to day 95 | 
| Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters |  | assessed every week, laboratory parameters every 3-4 weeks, up to day 95 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance |  | sampling every week up to day 95 |
Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.

Official Title
-----------------
A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Drug: carvedilol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices. Exclusion Criteria: Any contra-indication to beta-blockers Any past EVL or sclerotherapy Any past history of surgery for portal hypertension Significant cardio or pulmonary co-morbidity Any malignancy Refusal to participate in the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carvedilol<br>Tablet 6.25 mg BD | Drug: carvedilol<br>* Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD.<br>|
| Placebo Comparator: placebo<br>Placebo tablets 2 BD | Drug: Placebo<br>* The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportions of patients who develop esophageal varices at 1 year in each group. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient dying in a period of one year |  | 1 year | 
| Number of patients needing discontinuation of therapy due to adverse effects. |  | 1 year | 
| Reduction in Hepatic Venous Pressure Gradient in both groups |  | 1 year |
Natural History Study of Adult Patients With Paroxysmal Nocturnal Hemoglobinuria of High-risk Hemolysis in China

Study Overview
=================
Brief Summary
-----------------
This is a single-center observational study conducted in adult patients with paroxysmal nocturnal hemoglobinuria of high-risk hemolysis. This observational study consists of two parts, one part is retrospective study which aims to collect medical chart data to calculate the mean change or mean incidence rates of LDH, hemoglobin, PNH-related symptoms and PNH-related events over 6 months. The other part is cross-sectional study to detect the total C5 level in PUMCH at the latest follow-up visit in eligible PNH patients with high-risk hemolysis, to show the difference between eligible PNH patients and healthy people and to explore the related clinical factor influencing high-level total C5 using logistic regression model.

Official Title
-----------------
Natural History Study of Adult Patients With Paroxysmal Nocturnal Hemoglobinuria of High-risk Hemolysis in China

Conditions
-----------------
Paroxysmal Nocturnal Hemoglobinuria, Natural History Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the diagnostic criteria for paroxysmal nocturnal hemoglobinuria; Age ≥ 18 years old; PNH clone size of granulocytes or monocytes (CD59 or Flaer) ≥ 10%; LDH≥1.5 ULN; Accompanied by at least one PNH-related symptoms: fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia symptoms, major adverse vascular events (including thrombosis), dysphagia, erectile dysfunction; Transfusion-dependent PNH patients; There are at least 6 months consecutive data of diagnosis and treatment after the data collection time point; Patients agreed to participate in the study by signing informed consent or giving oral informed consent. Exclusion Criteria: Patients are under the treatment of the C1/C3/C5 complement inhibitors currently or in the past; Patients have received bone marrow transplantation; platelet count <30*10 9/L or absolute neutrophil count <0.5*10 9/L; Patients have clinically significant heart, liver, or lung diseases, or have related medical history. Patients have comorbidities of rheumatoid disease, HIV infection, active HBV infection, HCV infection and other diseases that affect the body's immune function; Severe missing data in the records of diagnosis and treatment after the data collection time point; Other patients who are not suitable to participate in the study.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean change of LDH | the mean change of LDH over 6 months | 6 months |
Doppler Flow Classification of Saint-Bonnet

Study Overview
=================
Brief Summary
-----------------
Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease

Detailed Description
-----------------
Patients who have Doppler ultrasound scanning in clinical practice currently have a systematic record of Doppler flow on arterial axes of the aorta and right and left lower limbs. The investigators will analyze a posteriori Doppler flow of patients by classifying them using the 3 classifications. The patient will have no constraints related to this study since the recordings are currently performed in clinical routine.

Official Title
-----------------
Doppler Flow Classification of Saint-Bonnet : A Non Interventional Clinical Trial

Conditions
-----------------
Peripheral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years; Social insured Patients referred in the department for any arterial examination of the lower limbs. Exclusion Criteria: - Patient unfit to understand the instructions of the study

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 |
| --- | --- | --- |
| Doppler flows | The difference between the number of unclassified Doppler flows using the Saint-Bonnet classification and the number of unclassified flows using the Spronk et al. This comparison will be done using the Mc Nemar test. | Baseline |
Outcome of Bariatric Surgery in Patients With BMI Greater Than 60 .

Study Overview
=================
Brief Summary
-----------------
Patients that underwent any type of bariatric surgery with BMI more than 60 will recruited for follow up that includes: actual weight, other surgeries and conversions, co-morbidities status, medications and satisfaction.

Detailed Description
-----------------
Patients that underwent bariatric surgery for BMI =60 or greater were considered for the study. The type of surgery were be analyze related to weight loss. Complication and operation difficulty will be assessed. Co morbidities and treatment results post surgery will be considered as also, need for revisional surgery/

Official Title
-----------------
Is Bariatric Surgery Effective in Super-super Morbid Obese Patients?

Conditions
-----------------
Bariatric Surgery Candidate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI above 60 Any bariatric surgery performed including revision Exclusion Crite ria: Tourist patients Patients under 18 years old -

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 |
| --- | --- |
| Sleeve gastrectomy operation<br>Outcome of patients that underwent sleeve gastrectomy with BMI greater than 60. | |
| Gastric bypass operation<br>Outcome of patients that underwent gastric bypass with BMI greater than 60. | |
| Gastric Band operation<br>Outcome of patients that underwent gastric banding with BMI greater than 60. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss after bariatric surgery | change in bodyweight following the surgery (kg) | from 1 to 12 years | 
| co-morbidities rate following surgery | prevalence of diseases linked to obesity (hypertension, diabetes, sleep apnea) | from 1 to 12 years |
Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)

Study Overview
=================
Brief Summary
-----------------
NEC is a serious inflammatory bowel disease, which almost only strikes infants with low birth weight and low gestational age. The morbidity and mortality rates are high, and early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of intragastric microdialysis and whether it is able to select patients, who may benefit from either medical or surgical therapy. The aim of intraperitoneal microdialysis is to evaluate whether changes in intraperitoneal microdialysis reflect the clinical outcome after laparotomy.

Detailed Description
-----------------
Neonates who are hospitalized because of suspicion of NEC are subjected to intragastric microdialysis during the observation period. The catheter is placed in the stomach via the naso-oesophageal route. If surgery is necessary a microdialysis catheter is placed in the peritoneal cavity prior to wound closure. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient. A total of 20 patients will be included in this pilot study. The results of the intragastric and peritoneal microdialysis will be compared with the clinical course, s-lactate, radiological and pathological findings in each patient.

Official Title
-----------------
Intragastric and Intraperitoneal Microdialysis in Infants With NEC

Conditions
-----------------
Necrotizing Enterocolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates who are hospitalized because of suspicion of NEC. Neonates who has surgery because of NEC. Exclusion Criteria: Non-acceptance from the child's parents or custody holder

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 6 Months

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Necrotizing Enterocolitis, Intragastric microdialysis, Peritoneal microdialysis, Infants
Safety Study of PI-0824 to Treat Pemphigus Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe.

Detailed Description
-----------------
Pemphigus vulgaris (PV) is an autoimmune disease affecting approximately 40,000 people worldwide. People with PV produce antibodies that attack the cells of the skin, resulting in blisters which, if left untreated, can lead to devastating infections and discomfort. Currently, most doctors who treat patients with PV will prescribe high-dose steroids and drugs that suppress the immune system in an effort to decrease the production of these antibodies. Unfortunately these medications are associated with serious and difficult side effects that often result in the discontinuation of their use. Peptimmune, Inc. has developed a new therapy for the treatment of PV, PI-0824. The goal of this therapy is to reduce the production of antibodies that cause PV blisters by acting only on the disease causing components of the immune system. It is hoped that use of PI-0824 will reduce or potentially eliminate the need for high dose steroids and drugs that suppress the immune system.

Official Title
-----------------
An Open-Label, Dose-Escalation, Phase I Clinical Study to Assess the Safety of PI-0824 in Patient With Pemphigus Vulgaris Requiring Daily Corticosteroid Therapy

Conditions
-----------------
Pemphigus Vulgaris

Intervention / Treatment
-----------------
* Drug: PI-0824


Participation Criteria
=================
Eligibility Criteria
-----------------
Currently experiencing a stable disease course and medication regimen. Currently taking daily corticosteroid therapy for PV.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PI-0824|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |