linjc16/ctgov huggingface dataset:
Health Effects of Coffee Consumption

Study Overview
=================
Brief Summary
-----------------
Epidemiological studies have indicated a positive health impact of coffee. Nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. Moreover, there is a lack of knowledge about the properties of different coffees and their influence on weight development. Therefore, we tested the effect of two coffees differing in their alkyl pyridine content over a period of 3 months on weight development.

Detailed Description
-----------------
Participants were randomly associated to two groups, a test coffee group and a control coffee group. After coffee abstinence of 1 months, participants in both groups got a coffee machine and coffee pads for three months. Clinical data have been assessed before and after coffee abstinence and after 3 months of coffee consumption.

Official Title
-----------------
Health Effects of Coffee Consumption

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: test coffee
* Dietary Supplement: control coffee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-69 years BMI ≥27 kg/m2 coffee consumption of ≥3 cups per day Exclusion Criteria: new diagnosed type 2 diabetes during the last 6 months severe diseases with hospital stay during the last 3 months change of body weight of more than 2 kg per week during the last 4 weeks smoking cessation during the last 3 months or planned during the study acute infects chronical diseases with except of type 2 diabetes mellitus regular pharmacological therapy with except of oral antidiabetic medication or contraception lack of contraception in women breastfeeding physical activity of more than 1 hour per day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test coffee<br>test coffee | Dietary Supplement: test coffee<br>* test coffee with higher alkyl pyridine content<br>|
| Active Comparator: control coffee<br>control coffee | Dietary Supplement: control coffee<br>* control coffee with regular alkyl pyridine content<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | body weight | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, body weight, coffee
The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population

Study Overview
=================
Brief Summary
-----------------
A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population.

Detailed Description
-----------------
A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population. The subjective visual quality of clarity and comfort were determined using a questionnaire when first wearing the glasses and after 1week.

Official Title
-----------------
The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population

Conditions
-----------------
Myopia, Refractive Errors

Intervention / Treatment
-----------------
* Other: The free-toroidal design lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: health volunteers their spherical refraction from -0.50 to -8.00 Diopter, with the cylinder diopter less than -3.00 Diopter best corrected visual acuity (BCVA)≥ 20/20 in both eyes stable refraction (no change greater than 0.5 Diopter within two years) Exclusion Criteria: if they had Aphakic or intraocular lens eyes, had a history of trauma, active eye disease or ocular surgery, serious systemic diseases, or had a wearing history of corneal contact lenses.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The free-toroidal design lenses|Participants were asked to wear the new design lenses (the free-toroidal design lenses) for 1 week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clarity score | The clarity score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better | baseline visit time | 
| The comfort score | The comfort score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better | baseline visit time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of foveal and peripheral visual acuity | Accuracy of foveal and peripheral visual acuity was assessed by the eye movement tracking device | baseline visit time |
Impact of Covid-19 in Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer. The population of congenital heart disease (CHD) might also be at risk, however, no data is available in this group of patients. CHD is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with CHD exceeds the number of children, with an increasing prevalence of complex CHD. Approximately 200,000 children and 250,000 adults are living with a CHD in France today. The French Society of Cardiology, coordinator of this study, issued recommendations on March 14, 2020 for the French CHD population on the basis of expert opinions based essentially on the data published in the general population. Nevertheless, there is a need to provide scientific data on the impact of Covid-19 in the pediatric and adult CHD population. This study aims to assess the morbidity, the mortality and the risk factors associated with Covid-19 in patients with CHD in France

Official Title
-----------------
Impact of Covid-19 in Congenital Heart Disease - COVID-CHD

Conditions
-----------------
Congenital Heart Disease, Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient with CHD as defined in the international classification ACC-CHD Covid-19 infection over the study period Exclusion criteria: - Patient with genetic heart disease (cardiomyopathy, hereditary rhythmic 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 |
| --- | --- | --- |
| Prevalence of Covid-19 infection in the overall CHD population | Prevalence of Covid-19 infection in the overall CHD population | through study completion, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Covid-19 infection per CHD sub-group | Prevalence of Covid-19 infection per CHD sub-group | through study completion, an average of 2 weeks | 
| Cardiovascular complications | Cardiovascular complications | through study completion, an average of 2 weeks | 
| Other complications | Other complications | through study completion, an average of 2 weeks | 
| Number of deaths | Number of deaths | through study completion, an average of 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital heart disease, Covid-19, Adults, Peadiarics
Diet and Exercise in Overweight Children Postburn

Study Overview
=================
Brief Summary
-----------------
Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.

Official Title
-----------------
The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation

Conditions
-----------------
Obesity, Burns

Intervention / Treatment
-----------------
* Behavioral: Behavior modification, Nutrition Education, Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10-18 years old BMI > or = 95th percentile > 1 year postburn and out of pressure garments Live within 100 minle radius of SHC Informed consent and HIPPA form signed Parent/guardia willing to make time commitment Exclusion Criteria: Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame Physical/health condition that precludes regular exercise Significant mental health diagnosis Advised by MD not to exercise Thyroid disease, routine steroid use,pregnancy Unable to understand the instructions/content of program

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior modification, Nutrition Education, Exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 12 and 24 months following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fitness level |  | 12 and 24 months following intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics
ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether Aggressive duplex surveillance after vascular access surgery with native vein for hemodialysis can increase the maturation rate of arteriovenous fistula. This study will be conducted as a single center, prospective, 1:1 randomized study. Enrolled patients will be randomized as a control group (Physical exam at 2 and 4 weeks after surgery) and duplex group (duplex study and physical exam at 2 and 4 weeks after surgery). Maturation of arteriovenous fistula will be evaluated at 8 weeks after surgery by duplex in all patients.

Official Title
-----------------
ENhancing Maturation of Autogenous Arteriovenous Hemodialysis Access by Aggressive surveillaNCe With Duplex and Endovascular Treatment

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Procedure: Duplex ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: end stage renal disease newly formed hemodialysis access with native vein 20 70 years Exclusion Criteria: hemodialysis access surgery with ePTFE graft hemodialysis access surgery with basilic vein transposition hemodialysis access surgery with brachial vein transposition cephalic vein < 2.5mm in diameter radial artery diameter <2.0mm in radiocephalic arteriovenous fistula

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duplex<br>Patients in this group will be examed by duplex ultrasonography at 2 and 4 weeks after surgery | Procedure: Duplex ultrasonography<br> <br> |
| No Intervention: physical exam<br>According to the K/DOQI guideline, patients will be examed by vascular access surgeon at 2 and 4 weeks after surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodialysis access maturation rate |  | 8 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors predicting maturation failure |  | 8 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
duplex study, hemodialysis access, maturation rate, endovascular intervention
Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

Study Overview
=================
Brief Summary
-----------------
The current surgical procedure for breast diseases places an emphasis on the conservation of breast skin in order to provide more optimal reconstruction. The purpose of this study is to use portable, non-contact optical imaging device developed at the Beckman Laser Institute called Spatial Frequency Domain Imaging to detect the changes in a skin during reconstructive surgery procedure and healing process.

Detailed Description
-----------------
The researchers can use Spatial Frequency Domain Imaging instrument to measure the concentration of blood flow in the skin tissue and can determine of the changes that observed in the properties of the mastectomy flap that may be delay in healing process. The imaging device can determine the change from baseline measurement to the development of skin necrosis, wound infection, or implant extrusion.

Official Title
-----------------
Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

Conditions
-----------------
Disorders of Skin Grafts and Flaps

Intervention / Treatment
-----------------
* Device: Spatial Frequency Domain Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and female 18 years and older scheduled for breast reconstructive surgery. Exclusion Criteria: Minor and pregnant women

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: Spatial Frequency Domain Imaging|Spatial Frequency Domain Imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin flap healing |  | up to 6 months |
Portuguese Registry on Interventional Cardiology

Study Overview
=================
Brief Summary
-----------------
The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of clinical and interventional practice recommendations for diagnosis and treatment of coronary disease and monitoring its evolution.

Detailed Description
-----------------
Cardiovascular disease remains the main cause of death in Portugal and approximately one quarter of these are directly to ischemic heart disease. In order to better characterize percutaneous coronary intervention in Portugal, the Portuguese Society of Cardiology has promoted the Portuguese registry on percutaneous coronary intervention. This will include all adult patients (≥ 18 years), eligible for percutaneous coronary intervention (PCI) in accordance with PCI state-of-art recommendations (including unstable and stable coronary disease). The Cardiology department where the patient has been hospitalized is responsible for the patient inclusion in the study. Excluded patients are those in whom the preferred treatment is Coronary Artery Bypass Graft (CABG), age under 18 years or life expectancy of less than 12 months.

Official Title
-----------------
Portuguese Registry on Interventional Cardiology

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with: stable angina or, stabilized angina pectoris or, atypical chest pain or, no chest pain but with documented silent ischemia At least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium Eligible for PCI Informed consent Exclusion Criteria: Patients in whom the preferred treatment is CABG; Contra-indication to dual antiplatelet therapy Coronary artery disease precluding PCI A life expectancy of less than 1 year Age under 21

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Major adverse cardiac event rate (MACE) MACE: A composite of all cause death, documented Myocardial Infarction (MI), unplanned hospitalization leading to urgent revascularization. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total mortality | Total mortality at 12 month | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI, Coronary disease, Ischemia
Follow-up of Bone Quality in Long-Term Bone Marrow Transplant Survivors

Study Overview
=================
Brief Summary
-----------------
Brittle and broken bones can occur after organ transplantation. However, the long-term effects of bone marrow transplantation on bone health and the risk of breaking bones are not well understood. This study will help to assess how common it is for those who have received a bone marrow transplant to have fractures. It will also investigate blood tests related to bone health. This will be done by measuring bone mineral density and obtaining blood tests.

Official Title
-----------------
Follow-up of Bone Quality in Long-Term Bone Marrow Transplant Survivors

Conditions
-----------------
Osteoporotic Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the initial Assessment of skeletal status following allogeneic bone marrow transplantation Study (HSC97-632-408). Able and willing to sign informed consent. Exclusion Criteria: All of the contacted long-term BMT survivors that are willing to participate will be included in this study
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 |
| --- | --- | --- |
Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that angiogenesis is very important for these tumors to progress. Preclinical data is suggesting this. This is why we we prospectively want to treat these patients with avastin (and doxorubicin). However, local control is of major concern. Therefore, patients are initially treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this study.

Detailed Description
-----------------
Patients with Anaplastic Thyroid Cancer have a poor prognosis. We will treat the patients initially with our standard radiochemotherapy, which consists of doxorubicin 20mg fixed dose/week and hyperfractionated radiotherapy 1,6 Gy twice daily up to 46 Gy in total. The first week during radiotherapy, they will also receive Avastin 15mg/kg. 1-2 weeks after radiotherapy patients will undergo surgery of their primary tumor. After this standard therapy patients can be included in this study. Treatment is 20 mg fixed dose doxorubicin q1w and avastin 15mg/kg q3w. Treatment will continue maximum 6 months or until progress or until intolerable side effects occur.

Official Title
-----------------
Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Conditions
-----------------
Thyroid Neoplasms, Carcinoma, Thyroid Cancer, Metastatic Cancer

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cytologically or histologically verified anaplastic thyroid cancer completed standard therapy operated with R0 or R1 surgery Performance Status 0-2 (if pulmonary mets PS 0-1) normal wound healing neutrophils > 1,5 million/ml platelets > 100 million/ml bilirubin < 2 ULN creatinin < 150mikromol/L Exclusion Criteria: PS 3-4 (if pulmonary mets 2-4) R2 resection of primary tumor
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemotherapy<br>Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months. | Drug: Bevacizumab<br>* Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w<br>* Other names: Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 2-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adjuvant, Anaplastic thyroid cancer