linjc16/ctgov huggingface dataset:
A Holistic Dietary Intervention for Persons With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
People with spinal cord injury are at increased risk for overweight and obesity, type 2 diabetes, cardiovascular disease and decreased quality of life compared With able bodied. This pilot aims to assess the impact of a nutrition intervention that combines several methods to help people change their lifestyle. The pilot project combines individual interviews and personal lifestyle goals (diet) with group classes for people with long-standing spinal cord injury. In addition to nutrition theory and practical exercises for diet-planning, motivational interviewing and mindfullness are incorporated into the course. The course is interdisciplinary, but is led primarily by a dietitian. Data is collected before the course starts and right after the 9-week course ends. The measurements involves self-perceived quality of life, food diary, weight, waist circumference and body composition (measured by BIA and DXA).

Official Title
-----------------
PILOT: A Holistic Dietary Intervention for Persons With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Behavioral: A holistic dietary intervention for persons with spinal cord injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years Long-standing Spinal Cord Injury (> 2 years after injury) Motivated for lifestyle change

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: A holistic dietary intervention for persons with spinal cord injury|A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | Short-term: 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet behaviour |  | Short-term: 9 weeks |
OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China

Study Overview
=================
Brief Summary
-----------------
The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. Professional Clinical Accuracy is defined as accuracy of the system when used by a trained healthcare professional.

Official Title
-----------------
A Multi-centre, Open Clinical Evaluation to Determine Professional Clinical Accuracy Comparing the OneTouch® Verio™Pro+ Blood Glucose Results With the YSI 2300 Analyzer.

Conditions
-----------------
Blood Glucose Measurement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age. Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes) Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study. Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure. Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure. Subject agrees to provide demographic and medical history information and give access to medical records where appropriate. Exclusion Criteria: Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products. Subject has already participated in this study. Subject is known pregnant

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 |
| --- | --- | --- |
| • Obtain professional clinical accuracy data for the OneTouch® Verio™Pro+ blood glucose monitoring meter in comparison with a standard laboratory reference (YSI 2300 glucose analyzer) using a capillary blood sample and a venous sample | August 20,2012 October 14,2012 | 56days |
Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment

Study Overview
=================
Brief Summary
-----------------
Vitamin A deficiency remains a major public health problem in developing country worldwide. Young Children are considered to be at greatest risk of deficiency. However, there is little information on the vitamin A requirement of Chinese children. In the present study, about 400 children aged between 4 and 9 years old in a kindergarten and an elementary school of Shiyan City were screened before admission by questionnaire and anthropometric measurement. The vitamin A status of children was assessed by serum vitamin A level, relative dosage reaction and stable-isotope dilution technique. At the same time, their dietary vitamin A intakes were estimated by weighted-food dietary survey. The dietary vitamin A requirement in young children was determined on the basis of dietary vitamin A intakes in Children with adequate vitamin A level.

Official Title
-----------------
Estimating Dietary Vitamin A Requirement in Chinese Children by Stable-isotope Dilution Technique

Conditions
-----------------
Vitamin A Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: well-nourished children with normal serum retinol(>=1.40umol/L) Exclusion Criteria: ongoing or previous illnesses, having taken nutritional supplements within 3 months, positive results in the fat absorption test or parasite test, increased level of CRP (> 8 mg/L), or lower serum level of retinol (< 1.40 umol/L)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 9 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 |
| --- | --- |
| 4-6 years old group<br> | |
| 7-9 years old group<br> | |

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
-----------------
Vitamin A, Dietary requirement, Dietary records, Deuterated retinol dilution technique, Chinese children, Dietary intake of vitamin A, Vitamin A liver reserves
Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure

Official Title
-----------------
A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients With Type II Diabetes Mellitus.

Conditions
-----------------
Hypertension

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients at screening must be insulin producing Type II diabetics (C peptide positive). Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure) Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments. Patients must be on stable antidiabetic regimen (drug treated or diet alone). Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone). Exclusion criteria: Patients using beta-blocker therapy.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: carvedilol|nan|
|Drug: metoprolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 5 months |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure at 3 and 5 months Body weight at 3 and 5 months Lab levels (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months. |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, beta-blockers, Type 2 diabetes
A National Registry on Chinese Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Cystic fibrosis (CF) is a rare autosomal recessive disease involving multiple organs, especially the lungs and digestive organs. It is most commonly seen in Caucasians. Only a few Chinese CF patients have been described in literature, taking into account the large population of China. The main objectives of this study are to accurately evaluate the prevalence of CF, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in China.

Official Title
-----------------
A National Registry on Clinical Manifestations, Genetics, Interventions, and Outcomes in Chinese Patients With Cystic Fibrosis (CF-CHINA)

Conditions
-----------------
Pulmonary Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfilled WHO clinical diagnostic criteria for CF; Was in a stable phase with no respiratory infections for nearly 4 weeks; Subjects (or their guardians) signed informed consent. Exclusion Criteria: Patients with other bronchiectasis who did not meet the inclusion criteria; Those with severe cardiac or renal disease
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 |
| --- | --- | --- |
| Change in spirometry (FEV1 and FVC) of lymphangioleiomyomatosis patients. | Spirometry will be evaluated at baseline and through study completion, an average of 3 years. | 10 years |
Fluorescent Visualization in Early Oral Cancer

Study Overview
=================
Brief Summary
-----------------
Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.

Conditions
-----------------
Oral Squamous Cell Carcinoma or Severe Dysplasia

Intervention / Treatment
-----------------
* Procedure: resection of oral cancer
* Procedure: resection of oral cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proven invasive oral cancer or severe dysplasia / Cis invasive cancer must be T1 or T2 no prior history of oral cancer / treatment of oral cancer Exclusion Criteria: prior history of oral cancer unable to provide informed consent lesion not able to be completely visualized by FV

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Resection<br>Oral resection will be guided by usual practice. This involves identifying the tumour with white light and then marking surgical margins and resection the primary cancer. | Procedure: resection of oral cancer<br>* Oral cancer will be resected.<br>Procedure: resection of oral cancer<br>* Oral cancer will be resected<br>|
| Experimental: FV Guided Resection<br>The oral resection will be guided by fluorescent visualization (FV). | Procedure: resection of oral cancer<br>* Oral cancer will be resected.<br>Procedure: resection of oral cancer<br>* Oral cancer will be resected<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease specific survival | disease specific 5 year survival | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral cancer, oral dysplasia
Value of Physical Capacity Tests in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. Demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity. Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an expected average of 12 weeks between first and second assessment.

Official Title
-----------------
Prospective Observational Cohort Study of the Value of the Six Minute Walk Test and Handgrip Strength in Lung Cancer Patients Undergoing Chemotherapy

Conditions
-----------------
Non Small Cell Lung Cancer, Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non small cell lung cancer stage I-IV Small cell lung cancer Patients >18 years WHO performance status 0-2 undergoing chemotherapy Exclusion Criteria: unstable angina during the previous month myocardial infarction diagnosed within the last month not approval for physical activity by primary oncologist inability to provide informed consent.

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 |
| --- | --- |
| lung cancer patients<br>Non Small Cell Lung Cancer, Small Cell Lung Cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality - Survival time | Prognostic value of the six minute walk and handgrip strength on mortality | time from first chemotherapy treatment to death, assessed after 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength |  | before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment. | 
| Self reported exercise behavior |  | before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment. | 
| Six minute walk test |  | Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment. |
A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult Japanese male subjects.

Official Title
-----------------
A Blinded, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Doses of ABT-072

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: ABT-072
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overall healthy adult Japanese males Exclusion Criteria: Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab). Positive screen for drugs of abuse, alcohol, or cotinine. Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder. Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABT-072 Tablet<br>ABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3 | Drug: ABT-072<br>* See arm description for more information<br>|
| Placebo Comparator: Placebo<br>Placebo Tablet, QD, single doses, groups 1-3 | Drug: Placebo<br>* See arm description for more information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessment | Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring. | Day 1 to Day 4 and Day 15. | 
| Pharmacokinetic profile evaluation | Single Dose Pharmacokinetic profile evaluation | Day 1 to Day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV Infections, Healthy Volunteers
Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block

Study Overview
=================
Brief Summary
-----------------
To evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty.

Official Title
-----------------
Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block With Sciatic Nerve Block After Total Knee Arthroplasty

Conditions
-----------------
Arthropathy of Knee Joint

Intervention / Treatment
-----------------
* Procedure: PC-FNB with basal administration of local anesthetics
* Procedure: PC-FNB without basal local anesthetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients older than 20 yrs old scheduled for total knee arthroplasty Exclusion Criteria: none

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With basal local anesthetics<br> | Procedure: PC-FNB with basal administration of local anesthetics<br>* Administration of 0.2% ropivacaine for femoral nerve block with 3 ml/h of basal dose, 5ml bolus by the patient, 60 minutes of lock out time.<br>* Other names: PC-FNB with basal ropivacaine administration;|
| Experimental: Without basal local anesthetics<br> | Procedure: PC-FNB without basal local anesthetics<br>* Administration of 0.2% ropivacaine for femoral nerve block without basal dose, with 8 ml bolus by the patient, 60 minutes of lockout time.<br>* Other names: PC-FAB without basal ropivacaine administration;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores by use of numerous rating scale (NRS) |  | 4 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose of local anesthetics |  | 4 days after the surgery |
Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.

Official Title
-----------------
Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: E2 transdermal (Julina, BAY86-5435)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Julina for postmenopausal osteoporosis Exclusion Criteria: Patients who are contraindicated based on the product label
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Drug (incl. Placebo) | Drug: E2 transdermal (Julina, BAY86-5435)<br>* Patients in daily life treatment receiving Julina for postmenopausal osteoporosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and serious adverse events in subject who received Julina |  | After Julina administration, upto 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease, hysterectomy) and dose of Julina |  | At baseline and after Julina administration, upto 3 years | 
| Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse |  | At baseline and at end of Julina treatment, upto 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Julina, Postmenopausal osteoporosis