linjc16/ctgov huggingface dataset:
China Rural Hypertension Control Project 2014

Study Overview
=================
Brief Summary
-----------------
China Rural Hypertension Control (CRHC) Project is a cluster randomized trial aims to test the effectiveness of a standardized protocol-based treatment program on hypertension control in rural China.

Official Title
-----------------
Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man and women aged 40 years or older. Mean systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg; and/or use of antihypertensive medications.Mean blood pressure is based on three measurements at two separate days at least two days apart and within one month. Permanent residents in the study villages. Do not plan to emigrate in the next 2 years. Exclusion Criteria: Unable to provide consent. Treated for malignant tumor and life expectancy<2 years judged by study physician. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control. Diagnosted psychiatric patients.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| a composite outcome of cardiovascular disease and all-cause mortality |  | up to 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular diseases |  | up to 2-year | 
| Fatal and non-fatal stroke |  | up to 2-year | 
| Fatal and non-fatal myocardial infarction |  | up to 2-year | 
| Hospitalized or treated heart failure |  | up to 2-year | 
| Cardiovascular death |  | up to 2-year | 
| Change in mean systolic and diastolic blood pressure |  | up to 2-year | 
| Proportion of hypertension control |  | up to 2-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, rural, China, protocol-based treatment
EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis

Conditions
-----------------
Autoimmune Pancreatitis

Intervention / Treatment
-----------------
* Device: Procore-Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient age 18 years and older patients with suspicion of autoimmune pancreatitis (based on the findings in EUS and MRI) Exclusion Criteria: unable to obtain informed consent ASA class 4 and 5 known pregnancy contraindication for endoscopy or for biopsy sampling patients with high suspicion on pancreatic cancer (based on the findings in radiology and EUS)

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procore Needle<br> | Device: Procore-Needle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic yield | Number of patients with adequate tissue sample (which allows definitive diagnosis) | 6 months |
Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Single Pre-Operative Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged 60 years or older. Invasive ductal carcinoma. Unifocal disease. Tumors less than 2cm. No clinical evidence of nodal disease. Estrogen receptor status (ER) positive. Her2 negative. Exclusion Criteria: Age less than 60 years. BRCA 1 and/or BRCA 2 mutation. Tumour histology limited to lobular carcinoma only. Neoadjuvant hormonal manipulation or chemotherapy. More than one primary tumour in different quadrants of the same breast. Inability to view tumor on imaging.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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: Single Pre-Operative Radiation Therapy<br> | Radiation: Single Pre-Operative Radiation Therapy<br>* Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic toxicity | Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale | 2 years | 
| Cosmetic outcome | Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, early breast cancer, partial breast irradiation, preoperative radiation
Buprenorphine Disposition and Cyclosporine

Study Overview
=================
Brief Summary
-----------------
The determine the effect of cyclosporine on buprenorphine disposition

Detailed Description
-----------------
Subjects studied on four occasions: Intravenous buprenorphine Sublingual buprenorphine Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days

Official Title
-----------------
Influence of Cyclosporine on Buprenorphine Disposition

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

Intervention / Treatment
-----------------
* Drug: buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-50 yr old Good general health with no remarkable medical conditions BMI < 33 Provide informed consent Exclusion Criteria: Known history of liver or kidney disease Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affecting CYP3A Females who are pregnant or nursing Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction) Direct physical access to and routine handling of addicting drugs in the regular course of duty (a routine exclusion from studies of drugs with addiction potential)

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>Subjects will be studied on four occasions. Sessions and drugs are: Intravenous buprenorphine Sublingual buprenorphine Cyclosporine plus intravenous buprenorphine Cyclosporine plus sublingual buprenorphine | Drug: buprenorphine<br>* Session 1 Intravenous buprenorphine: 0.2 mg over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3 Intravenous buprenorphine 0.2 mg over 1 hr beginning 1 hr after starting cyclosporine Session 4 Sublingual buprenorphine: 2 mg after cyclosporine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Buprenorphine Plasma Cmax |  | 96 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
buprenorphine, CYP3A
Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.

Official Title
-----------------
Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: Lysozyme hydrochloride
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria; Patients were eligible for inclusion in the study if they were over 20 years of age and below 85 years of age, and had a smoking history, a diagnosis of COPD, a ratio of FEV1 to forced vital capacity(FVC) of less than 70%, and a documented history of at least one exacerbation leading to any treatment within the previous year. Exclusion criteria; Patients with egg allergy Patients with domiciliary oxygen therapy Patients with pneumonia or pulmonary tuberculosis Patients with severe cardiovascular disorder,severe kidney disorder, severe hepatic disorder, severe hematological disorder. Patients with cancer.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 84 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lysozyme hydrochloride<br> | Drug: Lysozyme hydrochloride<br>* LYL 90mg capsule: Three times daily for 52 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching Placebo capsule: Three times daily for 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute exacerbation of COPD |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yearly reduction in FEV1 and QOL assessed by CAT |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lysozyme hydrochloride, COPD
Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding

Study Overview
=================
Brief Summary
-----------------
Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. To examine how anthocyanin absorption and metabolism may be affected this study will examine urinary excretion of anthocyanins over one month, followed by a one week washout, and then one more dose of blueberry juice.

Official Title
-----------------
Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding

Conditions
-----------------
Bioavailability

Intervention / Treatment
-----------------
* Other: Blueberry Juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provided written consent (see: Information and Consent Form) Fluent in English Complete a confidential medical questionnaire (Appendix 6) Able and willing to abide by the dietary restrictions as described Able and willing to abide by the urine collection protocols as described Exclusion Criteria: No written consent No confidential medical questionnaire Unable to comply with diet restrictions and other study requirements

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: anthocyanin-free diet<br>Maintain anthocyanin-free diet throughout study. Day 1 to day 30, consume daily 250 ml single strength blueberry juice containing 229 mg anthocyanins, taken either as 1 morning dose or 1/3 dose morning, 1/3 mid-day and 1/3 evening. At d 31-38 continue anthocyanin-free diet. On d 39 consume daily dose. | Other: Blueberry Juice<br>* Dietary intervention<br>* Other names: Single strength wild blueberry juice, commercially prepared.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthocyanins and Phase 2 anthocyanin conjugates in urine |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White blood cell gene expression at start and end of study |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anthocyanin, bioavailability, urine, long-term
A Study of RO4917523 in Patients With Treatment Resistant Depression

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability and efficacy of RO4917523, in comparison to placebo, in patients with treatment-resistant depression. Following a washout period from existing anti-depressant medication, cohorts of patients will be randomized to receive daily oral RO4917523 at up to five different doses (according to the safety and tolerability observed at the lower doses during the study), or placebo. The anticipated time on study treatment is 10 days (in an inpatient unit), and the target sample size is <100 individuals.

Official Title
-----------------
An Exploratory Fixed Dose Randomized Double Blind Parallel-group Placebo-controlled Study of the Safety and of the Therapeutic Effects of Ro 4917523 in Patients With Treatment- Resistant Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO4917523


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-65 years of age; recurrent major depressive disorder, without psychotic features; at least 3 lifetime treatment failures, at least 2 of which must have occurred within the current depressive episode; baseline minimal severity defined by a HAM-D score of 18 or above; willing to be hospitalized for at least 16 consecutive days. Exclusion Criteria: history of bipolar disorder, schizoaffective disorder or schizophrenia; history of psychosis, including psychotic depression; significant past or present neurological disorder, including seizures, stroke and/or head trauma.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO4917523<br>* orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* po daily for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: MADRS score |  | From baseline to day 10 | 
| Symptoms of treatment-resistant depression |  | Throughout study |
The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

Study Overview
=================
Brief Summary
-----------------
Fifty patients will get probiotics (109 bacteria [L. acidophilus, B. bifidum, S. thermophilus, L. rhamnosus, L. casei] in 2 capsules) and half will get placebo (2 capsules that look the same like the probiotic capsules and will contain microcrystalline cellulose, artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff will be blinded to the identity of the study medications. Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed. Each individual will be studied for changes in biochemical inflammatory and immunological markers and changes in flow medicated diameter that will be measured by the brachial artery method (that is evaluating endothelial function). Every patient will be evaluated for his/her ability to produce endothelial progenitor stem cells (EPCs).

Official Title
-----------------
The Effect of Probiotics on Bowel Disease

Conditions
-----------------
Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Dietary Supplement: probiotics
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ulcerative colitis and crohns' disease Exclusion Criteria:. notable caveats are that arteries smaller than 2.5 mm

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: probiotics|Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.|
|Dietary Supplement: placebo|Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Truelove and Witts Classification of Ulcerative Colitis |  | 2 years | 
| Crohn's disease activity index (CDAI) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease activity index, CDAI
Comparison of Atrophogenic Effect of Hydrocortison 1% Cream and Pimecrolimus 1% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHz Ultrasound of Uninvolved Skin in Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead skin

Official Title
-----------------
Comparison of Atrophogenic Effect of Hydrocortison 1% Cream and Pimecrolimus 1% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHz Ultrasound of Uninvolved Skin in Patients With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: pimecrolimus 1% cream
* Drug: hydrocortison 1% cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 years diagnosis of atopic dermatitis (Hanifin & Rajka Criteria) patients with atopic dermatitis not affecting the forehead Exclusion Criteria: pregnancy / nursing mothers women in reproductive age without adequate contraception severe atopic dermatitis (IGA >= 4) UV-Therapy in past 4 weeks patients receiving any topical treatment on the face in past 6 month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: 1<br> | Drug: pimecrolimus 1% cream<br>* twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks<br>* Other names: Elidel 1% cream;|
| Active Comparator: 2<br> | Drug: hydrocortison 1% cream<br>* twice a day one fingertip at a 2 times 2 cm2 area of uninvolved skin on the lateral forehead for 4 weeks<br>* Other names: Hydrogalen cream;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of epidermis |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of dermis |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atopic dermatitis, pimecrolimus, hydrocortison, Optical Coherence Tomography