linjc16/ctgov huggingface dataset:
Adherence of Stalevo, Entacapone and Levodopa

Study Overview
=================
Brief Summary
-----------------
To test if combining two antiparkinson drugs into a single tablet improves accuracy of medicine intake by the patient. To test if patients with Parkinson's disease who take medicines at regular time intervals have smoother symptom control.

Official Title
-----------------
Study of Adherence of Stalevo, Entacapone and Levodopa

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Parkinson's disease aged between 18 and 85 years fulfilling UK Brain Bank criteria. Current levodopa therapy prescribed on a regular basis three or more times per day but requiring entacapone because of 'wearing off' Able to manipulate electronic monitoring bottles and complete questionnaires Exclusion Criteria: Current use of compliance aid such that study participation would be detrimental to patient's adherence Pregnancy or breast feeding Excess alcohol (over 21 units per week for women and 28 units for men) Mini mental state examination of less than 26. Severe depression (Geriatric depression score over 20)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 Effect of Obesity on Venous Puncture Pain

Study Overview
=================
Brief Summary
-----------------
Before surgery, patients will fill the Beck anxiety, distress tolerance test and Pain katastrophizing test. Patients will be divided into two groups according to BMI> 30kg / m2 (Group A) and BMI <30kg / m2 (Group B). Compared to body weight, venous vascular pain of the groups will be compared.

Detailed Description
-----------------
Seventy patients will be randomized to two groups(BMI> 30kg / m2 (Group A) and BMI <30kg / m2 (Group B) during peripheral venous cannulation (PVC). The patients' visual analog scores will be measured during peripheral venous cannulation.

Official Title
-----------------
Assessment of the Effect of Obesity on Venous Puncture Pain

Conditions
-----------------
Pain, Cannulation, Body Mass Index

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery Exclusion Criteria: Patients with a history of anxiety disorders or hearing problem and preoperative pain, emergency surgery

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients that BMI> 30kg / m2 (Group A)<br>Venous puncture pain on patients that Body mass index > 30kg / m2 | |
| Patients that BMI< 30kg / m2 (Group B)<br>Venous puncture pain on patients that Body mass index < 30kg / m2 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | pain intensity | one month |
Leptin and Ghrelin in ICU

Study Overview
=================
Brief Summary
-----------------
Enteral alimentation is the preferred modality of support in critical patients who have acceptable digestive function and are unable to eat orally, but the advantages of continuous versus intermittent administration are surrounded by controversy. This prospective, randomised study was designed to compare two enteral feeding methods with respect to changes in levels of leptin and ghrelin in ICU.

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Other: enteral feeding by nasogastric tube.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: who were unable to ingest an oral diet given decision on enteral feeding Exclusion Criteria: Carcinomatosis irreversible coma death or discharge before 14 days of observation contraindication to enteral feeding intolerance to the prescribed nutrients or infusion regimen burn multiple trauma morbid obesity end stage liver or renal or lung disease severe sepsis or septic shock patients with percutaneous endoscopic gastrostomy immunosuppressive drug use severe hemodynamic instability massive blood transfusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intermittent feeding<br>Bolus infusion - The total daily feeding period was also 4-6 times a day. | Other: enteral feeding by nasogastric tube.<br>* method of administration enteral feeding by nasogastric tube.<br>|
| Active Comparator: continuous feeding<br>Continuous infusion - The daily desired amount was offered continuously for 20 hours a day. | Other: enteral feeding by nasogastric tube.<br>* method of administration enteral feeding by nasogastric tube.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum leptin concentration at three weeks in ICU |  | first, 7th, 14th and 21th day | 
| Change from baseline in serum ghrelin concentration at three weeks in ICU |  | first, 7th, 14th and 21th day in ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leptin levels, ghrelin levels
Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Proof of Concept Study of Zileuton IR in Patients With Moderate to Severe Facial Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Zileuton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe facial acne vulgaris 20 to 60 facial inflammatory lesions 10 to 200 facial non-inflammatory lesions No more than 3 facial nodular cystic lesions Exclusion Criteria: Uncontrolled systemic disease Use of systemic or topical acne therapy within 14 days of study Use of systemic retinoids within past 2 years Skin diseases that interfere with acne counts Active liver disease Screening elevations in liver function tests Positive serology for hepatitis B or C Use of theophylline, warfarin, or propranolol within 7 days of study Use of Singulair or Accolate within 14 days of study Female patients who are pregnant or nursing

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Zileuton|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of inflammatory lesions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's global assessment scale |  |  | 
| Change in number of non-inflammatory lesions |  |  | 
| Change in total numbers of lesions |  |  | 
| Change in sebum production |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukotrienes, inflammation
25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders

Study Overview
=================
Brief Summary
-----------------
Evaluation of 25- Hydroxyvitamin D levels in pregnant women in Austria and potential related disorders Hypothesis: Austrian pregnant women are Vitamin D deficient Present vitamin D supplementation in pregnancy is insufficient Vitamin D deficiency is associated with pregnancy related disorders like preeclampsia

Official Title
-----------------
25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders

Conditions
-----------------
Vitamin d Deficiency, Preeclampsia, Preterm Delivery, Gestational Hypertension, Gestational Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18 years informed consent Exclusion Criteria: chronic hypertension kidney disease lupus erythematodes diabetes mellitus malabsorption syndrome hyperparathyroidism surgery on the thyroid gland

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

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

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 |
| --- | --- | --- |
| 25- Hydroxyvitamin D and relation to development of preeclampsia |  | over course of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25 Hydroxyvitamin D in newborn |  | once at delivery |
Comparison Study of Core Temperature Thermometry Systems

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.

Detailed Description
-----------------
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of premarket notification [510(k)] submissions for clinical electronic thermometers and ISO/IEC 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

Official Title
-----------------
Deep Tissue Thermometry 510(k) Premarket Notification Trial

Conditions
-----------------
Thermometry Device Comparisons

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Subjects with skin disruptions on the forehead, dysautonomia, spinal cord injury, or taking barbiturates, thyroid preparations, antipsychotics, or who have had a recent (1wk) immunization
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A1 - up to 1 month<br>Age group 0 up to 1 month | |
| A2 - 1 to 3 months<br>Age group from 1 month to 3 months | |
| A3 - 3 months to 1 year<br>Age group from 3 months to 1 year | |
| B - 1 year to 5 years<br>Age group from older than 1y and younger than 5 years | |
| C - 5 years to 12 years<br>Age group from older than 5y and younger than 12 years | |
| D - 12 years to 21 years<br>Age group from older than 12 years and younger than 21 years | |
| E - 21 years and older<br>Age group older than 21 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature Agreement in Degrees Celsius. | Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures. | Upon enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thermometry, Deep Tissue Temperature, Core Temperature, Body Temperature, Rectal Temperature, Oral Temperature
Osteoporosis and Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The goals of the trial are: To determine the prevalence of osteoporosis in subgroups of COPD patients. To look for risk factors of osteoporosis in COPD patients. To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients.

Detailed Description
-----------------
Background: Osteoporosis is defined as a systemically skeletal disorder characterized by a low bone mass and deterioration of the micro-architecture of the bone and is therefore associated with a higher risk of fractures. Large epidemiological studies to determine the incidence and prevalence of osteoporosis in COPD patients in different stages of their disease are not available. The etiology of osteoporosis in COPD patients is complex and depends on multiple factors. Goals of the Trial: To determine the prevalence of osteoporosis in subgroups of COPD patients. To look for risk factors of osteoporosis in COPD patients. To create sub-groups for prospective research concerning the effects of bisphosphonates on osteoporosis variables in COPD patients. Study Design: Patients diagnosed with COPD (according to the American Thoracic Society [ATS] guidelines and divided in stages according to the Global Initiative on Obstructive Lung Diseases [GOLD]-classification) who visit the out-patient clinic of pulmonology of the Catharina Hospital Eindhoven will be asked to participate in the trial. A database will be created (prospectively) of the (medical) information about these patients, which will be analysed retrospective. To gather information we will use the medical records, a questionnaire, a blood sample, long function testing including a 6-minute walking test and a DEXA-scan.

Official Title
-----------------
Osteoporosis and COPD (Making of a Database)

Conditions
-----------------
COPD, Osteoporosis, Osteopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Men and women COPD according to the ATS-guidelines, divided in severity according to the GOLD criteria Written consent Exclusion Criteria: Age < 18 years No written 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?
-----------------
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
-----------------
COPD, Osteoporosis, Osteopenia, Glucocorticoids, GOLD, BODE
Elevated Triglyceride Levels and Later Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Subjects with elevated serum triglycerides in the 4th Tromso study in 1994/1995 were re-examined with an oral glucose tolerance test to see predictive value of triglycerides regarding development of type 2 diabetes

Official Title
-----------------
Elevated Triglyceride Levels and Later Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants in the 4 Tromso study 1994 and with elevated serum triglyceride levels Exclusion Criteria: type 2 diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| participants in the 4th Tromsø study<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with type 2 diabetes diagnosed with oral glucose tolerance test (OGTT) |  | At study enrollment in 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relation between serum 25(OH)D levels and blood glucose levels at OGTT |  | At study enrollment in 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, triglycerides, type 2 diabetes
Surveillance Study of Viral Infections Following Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
The present study was conducted to study the impact community acquired respiratory virus (CARV) infections in an outpatient setting on graft function of lung transplant recipients. The study was aimed to identify risk factors for CARV infections. The study was further intended to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.

Detailed Description
-----------------
Informed consent was obtained from the LTx recipients and the study was approved of by the institutional review board of Hannover medical school. LTx recipients are screened for CARV infections during the cold season (end October until end April) in a single-centre outpatient clinic. Symptoms of upper (URTI) and lower respiratory tract infections (URTI) are recorded by questionnaires and findings. Nasopharyngeal and oropharyngeal swabs (NOS) were performed to detect RV-antigens by immunofluorescence testing (IFT) of respiratory-syncytial virus (RSV), adenovirus, parainfluenza (PIV), influenza and cultures for CARV are performed. BAL was performed when clinically indicated and processed by IFT. Multiplex-PCR to detect 14 CARV are processed in symptomatic patients. In addition blood samples are monitored at each contact to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.

Official Title
-----------------
Season Surveillance Study of Viral Infections in Lung Transplant Recipients

Conditions
-----------------
Lung Transplantation, Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Paramyxoviridae Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults 18-70 years lung transplantation (including single, double, combination and re-do transplants) Exclusion Criteria: refused consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bronchiolitis obliterans syndrome |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute rejection |  | 1 year | 
| Incidence of hospitalisation |  | 1 year | 
| Incidence of graft loss (death or re-do-transplantation) |  | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung transplantation, Bronchiolitis Obliterans, Epstein-Barr Virus Infections, Paramyxoviridae Infections, Herpesviridae
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months

Detailed Description
-----------------
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Official Title
-----------------
A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 3 Clinical Trial of ALLO-ASC-DFU-301

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Biological: ALLO-ASC-DFU
* Procedure: Vehicle sheet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: 1. Subjects who are considered not suitable for the study by the principal investigator.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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 |
| --- | --- |
| ALLO-ASC-DFU<br>Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-301 | Biological: ALLO-ASC-DFU<br>* Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.<br>|
| Vehicle sheet<br>Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-301 | Procedure: Vehicle sheet<br>* Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of systemic tolerance through incidence of abnormal laboratory test results |  | Up to 9 months | 
| Evaluation of incidence of clinically significant change in physical examination and vital signs |  | Up to 18 months | 
| Evaluation of localized tolerance through incidence of clinically significant change about treatment area |  | Up to 24 months | 
| Evaluation of incidence of adverse events |  | Up to 24 months |