linjc16/ctgov huggingface dataset:
Effect of Cherry Concentrate on Vascular Function

Study Overview
=================
Brief Summary
-----------------
Acute effect of cherry concentrate consumption on flow mediated dilatation in healthy young men

Official Title
-----------------
Effect of Cherry Concentrate on Vascular Function

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Cherry versus placebo concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no prescription medications Exclusion Criteria: prescription medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cherry<br>Cherry concentrate | Dietary Supplement: Cherry versus placebo concentrate<br>* Acute cherry concentrate<br>|
| Placebo Comparator: Placebo<br>Placebo concentrate | Dietary Supplement: Cherry versus placebo concentrate<br>* Acute cherry concentrate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilatation |  | Change from baseline to 3 hours post dietary supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular function (laser doppler flowmetry) |  | Change from baseline to 3 hours post dietary supplementation | 
| Plasma nitrite concentration |  | Change from baseline to 3 hours post dietary supplementation |
A Prospective Cohort Study of IgG4RD in China

Study Overview
=================
Brief Summary
-----------------
This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.

Detailed Description
-----------------
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration. In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.

Official Title
-----------------
Cohort Study of Patients With IgG4-Related Disease

Conditions
-----------------
IgG4-related Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Age 18-75 years old with informed consent Patients with IgG4-RD: swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; elevated serum IgG4 (>1.35 g/L) histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed); exclusion of other diseases. Exclusion Criteria: Females planning to bear a child recently or with childbearing potential Concurrent severe and/or uncontrolled and/or unstable diseases Patient with malignancy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IgG4-RD<br>Patients with IgG4-RD, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis (Mikulicz disease and Küttner's tumor), inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response | Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgG4-related disease, IgG4-RD
18670 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay ,UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment-Darkening Dose (MPPD).

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987518)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF(Self History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY987518<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987518)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number - SR15-72_V27-010).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
TeleRehabilitation for Patients With Chronic Respiratory Failure.

Study Overview
=================
Brief Summary
-----------------
It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Despite overwhelming evidence of the benefits of exercise training, only a very small percentage of eligible people have ever completed a program. Alternative modes of exercise training are needed to improve equity of access for patients with chronic respiratory disease. So TeleRehabilitation, using information and communication technologies to provide distance exercise training services, may be an answer.

Official Title
-----------------
Clinical Benefits of TeleRehabilitation in Chronic Respiratory Failure Patients.

Conditions
-----------------
Chronic Respiratory Disease, Exercise

Intervention / Treatment
-----------------
* Other: telerehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic respiratory disease patients Patients with dyspnea or exercise intolerance. Stable patients at home. Patients who can use a computer (after explanations) and have adequate hearing and vision. Collection of the patient's non-objection Exclusion Criteria: Life expectancy <3 months. Absolute contraindication to performing physical activity Hospitalization for exacerbation in the two months prior to inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Control Group<br>Chronic respiratory patients who undergo a home-based exercise training program with a rehabilitation coach supervision. | |
| Tele Group<br>Chronic respiratory patients who undergo a home-based exercise training program online. | Other: telerehabilitation<br>* Patients undergo an online exercise training program via a certified host of health data website.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise tolerance | number of steps during 6 minute stepper test | 3 month after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise tolerance | number of steps during 6 minute stepper test | 6 month and one year after inclusion | 
| VQ-11 | questionnaire, Minimum = 11, maximum = 55; higher score means worth outcome | 3, 6 month and 1 year after inclusion | 
| physical activity quantity | questioning patients on their physical activity quantity | 3, 6 month and 1 year after inclusion |
Neurocutaneous Melanocytosis Registry

Study Overview
=================
Brief Summary
-----------------
This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).

Official Title
-----------------
Prospective Registry of Patients With Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement

Conditions
-----------------
Cutaneous Melanocytic Neoplasm, Large Cutaneous Melanocytic Nevi, Neurocutaneous Melanocytosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with LCMN, defined as: Dark-colored patch of skin present at birth Can be located anywhere on the individual's skin May include satellite lesions May be associated with hypertrichosis OR, in absence of cutaneous involvement: histologically or radiographically confirmed CNS melanocytosis. Any age at diagnosis. Signed informed consent by a patient, or parent/legal guardian. Deceased patients can be included provided that parent/legal guardian is contacted at least 6 months after the death of the child and not on the child's birthday or anniversary of death. Pathology review at MSK is not mandatory to confirm the diagnosis of LCMN or NCM. We will not require pathology analysis of leptomeningeal deposits in patients where characteristic skin lesions are present and melanosis of the meninges is radiographically evident. However, if pathology samples have already been obtained as part of a patient's evaluation and treatment at another institution, tissue samples will be requested for review and confirmation of the diagnosis. Exclusion Criteria: Informed consent has not been provided.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neurocutaneous Melanocytosis<br>Participants will have Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide |  | Up to 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NCM, LCMN, large cutaneous melanocytic nevi, neurocutaneous melanocytosis, 20-363, Memorial Sloan Kettering Cancer Center
Monitoring the Prevalence of E.R Admissions and Hospitalizations as a Result of Drug Related Problems (DRPs)

Study Overview
=================
Brief Summary
-----------------
To research the prevalence and nature of DRP (Drug Related Problems) associated hospitalizations (hospitalizations due to problems\adverse effects of the medication treatment) . Analyzing the main reasons for DRP associated E.R admissions\hospitalizations. identifying drug involved and percentage of DRP associated hospitalizations. Monitoring the length of DRP associated hospitalizations. Evaluating LOS to hospitalized. Financial and other aspects will be measured.

Conditions
-----------------
Drug Related Problems Associated Hospitalizations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Possible DRP based on the current literature, patient questionnaire and drug history, related laboratories test values, ICD-9 coding. Exclusion Criteria: DRP cannot be established or suspected based on the assessment of the patient's lab results, symptoms, drug treatment and patient's questioning as well as physician diagnosis

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 |
| --- | --- | --- |
Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be safely given in combination with a low fixed dose of Capecitabine and a limited volume of radiation in patients with non-small cell lung cancer.

Detailed Description
-----------------
The purpose of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of Oxaliplatin in combination with Capecitabine and radiation in subjects with non-small cell lung cancer.

Official Title
-----------------
Phase I Study of Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) and Concurrent Radiation Therapy (XELOX-RT) in Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small Cell Lung

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven non-small cell lung cancer inoperable Stage III A or B NSCLC must have measurable disease by RECIST criteria no more than one prior chemotherapy for advanced disease ECOG Performance Status of 0, 1, or 2 must be able to swallow pills or have a working gastric feeding tube and no evidence of malabsorption negative serum beta-HCG test and under active contraception (for females of childbearing potential) no known allergies to any of the study drugs willingness to sign an informed consent Exclusion Criteria: women who are pregnant or breastfeeding ANC of less than 1500/mm3 platelet count of less than 100,000/mm3 estimated creatinine clearance of less than 50 cc/min (as measured by the Cockcroft-Gault equation) bilirubin of less than 2mg/dl SGPT of greater than 2x nl peripheral neuropathy of Grade 2 or higher more than one previous chemotherapy and previous radiation therapy to the chest a history of CHF/MI or other significant cardiac history within the last six months

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin|nan|
|Drug: Capecitabine|nan|

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
-----------------
non-small cell lung cancer, oxaliplatin, capecitabine, XELOX-RT
Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.

Detailed Description
-----------------
SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with Diabetes Mellitus, it is important to determine the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.

Official Title
-----------------
A 12 Week, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: SK3530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of type 1 or type 2 diabetes. Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period. Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period. Exclusion Criteria: Lab abnormality. Uncontrolled diabetic mellitus(HbA1c > 12%). High or low blood pressure, orthostatic hypotension. Hyper- or hypo-thyroidism.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Placebo as a substitute of SK3530 100mg<br>|
| Experimental: 2<br> | Drug: SK3530<br>* SK3530 100mg<br>* Other names: Mvix;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire |  | 0, 4, 8, 12week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the score from : 1) IIEF Q3 & Q4, 2) other domains of IIEF, 3) Sexual Encounter Profile(SEP)Q2 and Q3, 4) Life Satisfaction Checklist, 5) Global Efficacy Assessment Question(GEAQ) |  | 0, 4, 8, 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile dysfunction, Diabetes Mellitus, SK3530
Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs

Study Overview
=================
Brief Summary
-----------------
Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of smartphone video-based telehealth in the management of Crohn's disease patients

Detailed Description
-----------------
Patients were examined by two gastroenterologists (HY, AED) either at a video conference based visit or face to face visit in outpatients clinics. We used the WhatsApp business application.The online visit notion was the same as traditional face-to-face visit except physical examination.

Official Title
-----------------
Implementation and Evaluation of Smartphone-Based Videoconferance Telehealth for Patients With Crohn's Disease

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Other: real time online video visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study group included patients with documented Crohn's disease, based on clinical, endoscopic, and histologic findings Patient between 18-80 years old Participants who have been receiving treatment for more than six months Exclusion Criteria: Patients were excluded from the study if they had no internet connection Unable to use smartphones because of blindness, deafness, or mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard face to face visit<br>This group will receive a traditional outpatient visit | |
| Experimental: Online visit<br>This group will receive a smartphone-based real-time video conference visit | Other: real time online video visit<br>* Participants have received an online visit by a smartphone application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction score with the video visits | Measurement of satisfaction with RAND Visit Specific Questionnaire (VSQ9),Minimum score 0 poor and maximum score is 5 represents excellent, | the day after the visit |