linjc16/ctgov huggingface dataset:
Effect of Body Weight Change to Surgical ICU Outcomes

Study Overview
=================
Brief Summary
-----------------
Aims of study Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in 28 days Determination cut point of maximum weight change to outcome treatment

Detailed Description
-----------------
Study type : Prospective observational study Location : General surgical intensive care unit Inclusion criteria : All admission patient with expected survive more than 24 hours Exclusion criteria : Patient died within 24 hours or who could not be weighed.

Official Title
-----------------
Effect and Determinant Level of Admission Body Weight and Daily Weight Change and Prognoses of Critically and High Risk Surgical Patients

Conditions
-----------------
Body Weight, Weight Change

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All admitted ICU patients expected survive more than 24 hours Exclusion Criteria: All expected ICU patients survive less than 24 hours All patient cannot be weighed.

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 |
| --- | --- | --- |
| In Hospital Mortality | 28 days mortality if patient still have be admitted in hospital. | within 28 days after ICU admission to dead | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re Intubation Within 72 Hours | Patient who need re-intubation within 72 hours | ICU complications up to 28 days after ICU admission | 
| Acute Kidney Injury | New acute kidney injury in ICU | Acute kidney injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body weight, Body mass index, Weight change, ICU outcomes
A Comparison of Two Devices for Measuring the Central Thickness of the Cornea Before and After Surgery (CECOT)

Study Overview
=================
Brief Summary
-----------------
Corneal topography allows the measure of the radii of curvature and of the thickness of the cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal irregularities such as a keratoconus, or too thin corneas which are a contra-indication for laser refractive surgery. Several types of corneal topographers are commercially available. Some as the Orbscan(r), operate by analyzing the image of the patterns of a Placido disk associated with a light slit, allowing the collection of thousands of points of the anterior and posterior surface of the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary cameras which capture images of the whole anterior segment of the eye. The aim of this study is to compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the central corneal pachymetry measurements measured pre- and postoperatively.

Conditions
-----------------
Disorders, Refractive

Intervention / Treatment
-----------------
* Device: Central corneal thickness measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for whom a LASIK refractive surgery is planned Exclusion Criteria: hyperopic patient another refractive surgery technique pregnant or lactating woman patient's opposition to participation in the study, according to the law on research into routine care patient under a measure of legal protection absence of affiliation to social security

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

| Intervention/Treatment |
| --- |
|Device: Central corneal thickness measurement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of the Orbscan and Pentacam topographs, evaluated by the intra-class correlation coefficient, for the measure of the difference of the central thickness of the cornea before and after surgery. |  | one month |
Evaluation of a Weight Management Program

Study Overview
=================
Brief Summary
-----------------
This retrospective chart review and data abstraction will evaluate and quantify the effectiveness of a comprehensive weight management program. The hypothesis is that the program will positively affect weight, weight-related comorbidities and medication use.

Official Title
-----------------
A Multicenter, Retrospective Study to Evaluate the Effectiveness of the OPTIFAST Weight Management Program

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Comprehensive weight management program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Records of the first 40 study center participants who enrolled in the OPTIFAST Program from January 1, 2006 through June 30, 2006 Records of subjects who completed the active weight loss phase of the program Records where data is available through the transitional phase of the program Exclusion Criteria: Concurrent use of appetite suppressants or other weight loss medications
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Comprehensive weight management program<br> | Other: Comprehensive weight management program<br>* Full meal replacement, behaviorial modification, medical monitoring, exercise.<br>* Other names: OPTIFAST Program;|

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
-----------------
Obesity, Meal replacement, Obesity treatment, Weight management
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
Biojector 2000 Open-Label Safety Study (BOSS) to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: enfuvirtide [Fuzeon]
* Drug: enfuvirtide [Fuzeon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >=16 years of age; current or former Fuzeon user who may benefit from needle-free administration of Fuzeon; naive to use of the B2000 device; positive test results for human immunodeficiency virus infection. Exclusion Criteria: patients naive to Fuzeon; inability to self-inject Fuzeon, or no reliable caregiver to administer injections; evidence of active, untreated, opportunistic infections.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: 1<br> | Drug: enfuvirtide [Fuzeon]<br>* 90mg sc bid by Biojector 2000 NFID for 8 weeks<br>|
| Experimental: 2<br> | Drug: enfuvirtide [Fuzeon]<br>* 90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint (pain, induration, nodules/cysts) |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs and ISRs |  | Throughout study |
Rhodiola Rosea for Coronary Microvascular Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of rhodiola rosea on coronary flow reserve and symptoms in patients with microvascular angina pectoris, and to evaluate adverse drug reactions. Long-term clinical follow-up of 1 to 3 years was conducted to evaluate the effect of rhodiola rosea on long-term adverse cardiovascular events in patients with coronary microvascular disease.

Official Title
-----------------
The Efficacy and Safety of Rhodiola Rosea in Patients With Coronary Microvascular Disease

Conditions
-----------------
Coronary Microvascular Disease

Intervention / Treatment
-----------------
* Drug: Rhodiola Rosea Capsules
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; Coronary normal or stenosis < 20%; Ischemic depression in ST segment during resting or exercise; Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0; Subjects or their guardians agreed to participate in this study. Exclusion Criteria: Previous myocardial infarction or PCI or CABG treatment; A history of heart failure or LVEF < 50%; Severe arrhythmia; Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy; A history of stroke within half a year; Diabetes difficult to control; Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm; Familial hypercholesterolemia; Takayasu arteritis, Kawasaki disease or coronary artery malformation; Pregnant or nursing, or having the intention to give birth within one year; Hepatic or renal dysfunction; Other diseases which may cause serious risks to patients; Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines; Allergic to contrast agents or blood products; Patients who participated in clinical research of other drugs within 3 months before being selected.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhodiola Rosea Capsule<br> | Drug: Rhodiola Rosea Capsules<br>* 0.28g per capsule, 0.56g once (2 capsules), three times a day<br>|
| Placebo Comparator: Placebo Capsule<br> | Drug: Placebo<br>* 2 placebo capsules once, three times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Coronary Flow Reserve |  | 1 year |
Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
The robotic thyroidectomy (RT) has excellent cosmetic and several functional results. But there were no definite evidence of oncological safety of robotic thyroidectomy yet. To assure the surgical completeness of robotic thyroidectomy, the investigators compared robotic thyroidectomy and conventional open thyroidectomy (OT) by means of the postoperative radioactive iodine (RAI) uptake of possible remnant thyroid tissue and stimulated TG level.

Official Title
-----------------
Comparative Study of Surgical Completeness After Robotic Thyroidectomy Versus Conventional Open Thyroidectomy

Conditions
-----------------
Papillary Thyroid Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 20years papillary thyroid carcinoma patients who underwent conventional open or robotic bilateral total thyroidectomy at YUHS(Yonsei University Health System) patient who underwent postoperative low doe (30mCI) RAI ablation therapy at YUHS Exclusion Criteria: pregnant, lactating women patient who underwent postoperative low dose RAI at another hospital patient with distant metastasis patient who underwent combined operation with bilateral total thyroidectomy (ex) Modified radical neck dissection, selective neck node excision d/t lateral neck node metastasis patient who underwent High dose (more than 30 mCI) RAI therapy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Group 1 : conventional open thyroidectomy group (papillary thyroid carcinoma patient who underwent conventional open bilateral total thyroidectomy procedure and postoperative low dose RAI therapy) | |
| Group 2<br>Group 2 : robotic thyroidectomy group (papillary thyroid carcinoma patient who underwent robotic bilateral total thyroidectomy procedure and postoperative low dose RAI therapy) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical completeness of conventional open thyroidectomy and robotic thyroidectomy | check remnant thyroid uptake at Diagnostic RAI scan and stimulated serum thyroglobulin level | 12 months after low dose RAI albation therapy |
COVID-19 Vaccine Induced Adaptive Immune Responses

Study Overview
=================
Brief Summary
-----------------
The coronavirus disease 2019 (COVID-19) caused by the infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)，resulting in more than 82 million confirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoing pandemic still poses unprecedented global threat to public health system worldwide. On December 31, 2020, the joint prevention and control agency of China Council announced that Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by National Medical Products Administration, and the protection rate was 79.34%. So far, more than 198 vaccines were currently in preclinical or clinical development. The investigators aimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2 Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2 vaccine Induced adaptive immune responses.

Official Title
-----------------
Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses

Conditions
-----------------
SARS-CoV-2, Vaccine, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and aged between 18 to 59 years Exclusion Criteria: High-risk epidemiology history within 14 days before enrollment SARS-CoV-2 specific IgG or IgM positive in serum Positive PCR test for SARS-CoV-2 from pharyngeal or anal swab samples Axillary temperature of more than 37·0°C Known allergy to any vaccine component Thyroid disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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 |
| --- | --- | --- |
| Concentration of anti-SARS-CoV-2 neutralizing antibody in serum |  | 2 years | 
| Concentration of serum anti-SARS-CoV-2 binding antibody |  | 2 years | 
| Rate of anti-SARS-CoV-2 T cell response |  | 2 years | 
| The rate of SARS-CoV-2 infection |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of anti-SARS-CoV-2 B cell response |  | 2 years |
The PAH Disability and Bothersomeness Questionnaire

Study Overview
=================
Brief Summary
-----------------
To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.

Detailed Description
-----------------
A 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure (PROM) in PAH.The first two steps have been completed (qualitative study and Delphi consensus study) leading to the development of a provisional 37-items questionnaire. A reduction of items in this provisional questionnaire and the validation of the final questionnaire are the goals of the current study.

Official Title
-----------------
Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire

Conditions
-----------------
Pulmonary Arterial Hypertension (PAH)

Intervention / Treatment
-----------------
* Other: 37-items questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with idiopathic and heritable PAH; patients over 18; male and female; NYHA Functional Class I, II, III & IV; Written consent signed Patients with a good understanding of the French - language Patient affiliated with a social security scheme Exclusion Criteria: Patients under 18 years of age Patients with other pathologies associated with PAH (Group 1) Patients with other forms of pulmonary hypertension (groups 2, 3, 4 and 5) Non-consenting patients Patients who do not have a good understanding of the French language

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary Arterial Hypertension patients<br> | Other: 37-items questionnaire<br>* Patient will answer the PAH-DBoQ questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cronbach's alpha≥ 0.7 | Internal consistency of the PAH Disability and Bothersomeness Questionnaire will be assessed with Cronhbach's alpha | at the end of the study (an average of 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low rate of answers (≤95%) | low rate of answers will help reducing the number of questionnaire's items | at the end of the study (an average of 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Questionnaire, Disability assessment, Bothersomeness, Pulmonary Arterial Hypertension, patient-reported outcome measure, New York Heart Association (NYHA) functional class
Evaluating Yoga for Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.

Detailed Description
-----------------
Back problems are among the most prevalent conditions affecting adults and are a leading reason for using complementary or alternative medical (CAM) therapies. Despite the common use of CAM therapies for back pain, little is known about how they compare with conventional treatments. This study will lay the groundwork for a full-scale trial that compares yoga with conventional exercise and usual care for chronic low back pain. This study will randomize 30 people with chronic low back pain to each of the following groups: yoga, a conventional therapeutic exercise program, and usual care. There will be 12 weeks of weekly treatment and follow-up assessments via phone at 6, 12, and 26 weeks to measure each treatment's impact on symptoms, function, quality of life, and utilization and costs of back pain related care.

Official Title
-----------------
Evaluating Yoga for Chronic Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Yoga
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Group Health Cooperative enrollee Uncomplicated low back pain At least moderate pain levels Exclusion criteria: Sciatica persisting 3 or more months after physician visit History of cancer (other than nonmelanoma skin cancer) Severe disk problems Unstable medical conditions Back surgery within past 3 years Physically unable to do the yoga or exercise classes and homework Unable to attend classes Currently doing yoga Taken exercise class for back pain within past year Currently in litigation for back pain Seeking other treatment for back pain

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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

| Intervention/Treatment |
| --- |
|Behavioral: Yoga|nan|
|Behavioral: Exercise|nan|

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

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