linjc16/ctgov huggingface dataset:
Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

Study Overview
=================
Brief Summary
-----------------
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.

Official Title
-----------------
Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: Color fundus photography
* Drug: Mydriatic Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older; a diagnosis of diabetes mellitus; and understanding of study and provision of written informed consent. Exclusion Criteria: Persistent visual impairment or sudden vision loss in one or both eyes; History of uncorrected media opacity in one or both eyes; History of retinal vascular disease other than diabetic eye disease; History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract; Subject has contraindications for mydriatic medications or is unwilling or unable to dilate; Subject is currently enrolled in an interventional study of an investigational device/drug; or Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or result in ungradable 4-wide field stereoscopic mydriatic fundus photographs.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Color fundus photography|Subjects will undergo fundus photography before and after administration of mydriatic agent.|
|Drug: Mydriatic Agent|Subjects will be administered mydriatic medication to dilate their pupils.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME). | The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures. | 1 visit |
Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
The objective of this program is to improve post-acute care coordination for necessary social services for patients leaving the hospital after recovering from an episode of decompensated heart failure.

Official Title
-----------------
A Novel Strategy for Addressing Social Barriers to a Successful, Sustained Discharge From the Hospital for Acute Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Managed Services


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-99 years Resident of Missouri or Kansas Current inpatient admission for acute heart failure Exclusion Criteria: Under 18 years or over 99 years of age

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Of Care - No Managed Services<br>Subjects receive standard medical care and follow-up after hospital discharge | |
| Experimental: Managed Services After Discharge<br>Subjects receive in-home assessment and care coordination/connection with community resources after hospital discharge | Other: Managed Services<br>* coordination of care and assistance with community resources (food, transportation)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in all-cause re-hospitalization | reduction in all-cause re-hospitalization via improved post-acute care coordination | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure
Effect of Healing Touch on the Experience of Women Undergoing Treatment for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To learn what effect, if any, Healing Touch (a gentle, non-invasive form of energy work that promotes relaxation and can help manage the side effects of chemotherapy and radiation), has on physical symptoms, mood, and qualify of life for women undergoing treatment for breast cancer.

Official Title
-----------------
Effect of Healing Touch on the Experience of Women Undergoing Treatment for Breast Cancer

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

Intervention / Treatment
-----------------
* Procedure: Healing Touch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Patients undergoing treatment for breast cancer. Age 18 or over. Participants in Healing Partners Program. Exclusion Criteria:- Patients not under the care of a physician. Patients not able to come to regular healing touch sessions.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Healing Touch|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect Healing Touch has on physical symptoms, mood and quality of life for women undergoing treatment for breast cancer. |  | Baseline, 3 months, 6 months |
Implication of a Mobile Team of Palliative Care and Reality of the Palliative Approach in the Units

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to estimate the impact of the implication of a Mobile Team of Palliative Care (EMSP) on the palliative strategy in the units with concerned patients. The Mobile Team of Palliative of Foch hospital Care was created in March, 2011.

Official Title
-----------------
Implication of a Mobile Team of Palliative Care and Reality of the Palliative Approach in the Units

Conditions
-----------------
Death, Palliative Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients died between July, 2013 and September, 2014 and for which at least one opinion of the EMSP was required Exclusion Criteria: None

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 |
| --- | --- | --- |
| Time between specific treatments discontinuation and patient death |  | 6 months maximum |
Extension Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
This study (Unique Protocol ID: ZGJAK020) as an extension of the ongoing Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (Unique Protocol ID:ZGJAK020) study. After completion of ZGJAK018 study, the study will be directly extend with an open-label design.

Official Title
-----------------
A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Adult Patients With Moderate to Severe Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Drug: Jaktinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects voluntarily sign the informed consent form. Patients who participated in ZGJAK018. Exclusion Criteria: Subjects who are unsuitable to the trial, as identified by the investigator.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib<br>Patients will administer the study product twice per day for 24 weeks, for the safty assessment. | Drug: Jaktinib<br>* 75mg BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects reporting treatment-emergent adverse events | Patients with treatment-emergent adverse events/all patients *100% | Baseline through week 24 |
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).

Official Title
-----------------
A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea

Conditions
-----------------
Peripheral T-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: SP-02L (darinaparsin for injection)
* Drug: SP-02L (darinaparsin for injection)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean patients aged ≥ 20 years of age at the day of obtaining the informed consent Patients with histologically confirmed diagnosis of the following: PTCL, not otherwise specified (PTCL-NOS) Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative) Angioimmunoblastic T-cell Lymphoma (AITL) Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy) Have at least 1 evaluable lesion Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Life expectancy of at least 3 months

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP-02L<br> | Drug: SP-02L (darinaparsin for injection)<br>* Cohort 1: Darinaparsin 300 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.<br>Drug: SP-02L (darinaparsin for injection)<br>* Cohort 2: Darinaparsin 300 mg/m2 for 5 consecutive days every 21 days (5 days therapy, 16 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicity and adverse events |  | 12 or 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response (overall response) |  | 2 and 4 cycles | 
| Plasma concentration-time profile | Cmax, Area under curve, Tmax, t1/2, Clearance and Volume of distribution | 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15 |
Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.

Official Title
-----------------
A Randomized, Blinded, Phase IIb Trial of Telbivudine (LdT) Versus the Combination of Telbivudine and Valtorcitabine (Val-LdC) in Patients With Chronic Hepatitis B

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: telbivudine
* Drug: valtorcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical history compatible with compensated chronic hepatitis B Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide at anytime. Other protocol-defined exclusion criteria may apply.

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

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

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: telbivudine|nan|
|Drug: valtorcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Follow-up Home Visits With Nutrition

Study Overview
=================
Brief Summary
-----------------
To assess the effect on geriatric patients of follow-up home visit including nutrition. The hypothesis is that this can prevent hospital readmissions, and has a positive impact on functional abilities and quality of life

Detailed Description
-----------------
Before and after the intervention the participants nutritional status, hand grip strength, functional abilities, well-being, dietary intake, level of tiredness,and activities of daily living will be assessed

Official Title
-----------------
Follow-up Home Visits With Nutrition (OHE)

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: individual nutritional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Geriatric patients in nutritional risk Exclusion Criteria: Dementia Expected readmissions Terminal disease Non-Danish speaking

Ages Eligible for Study
-----------------
Minimum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: individual nutritional therapy|individual nutritional therapy provided by a registered dietician by means of three follow-up home visits|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital readmissions |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
follow-up home visit, Geriatric Disorder, rehabilitation
The Third Epidemiological Research of Refractory Wounds in China

Study Overview
=================
Brief Summary
-----------------
This study is a cross-sectional survey in patients who underwent treatment of chronic cutaneous wounds from a nationally representative sample in our hospital from January 2018 to December 2018．

Detailed Description
-----------------
Chronic cutaneous wounds represent a major health care burden in China However, limited information exists regarding the epidemiologic changes associated with recent social and economic devdopment．We designed a cross-sectional survey in patients who underwent treatment of chronic cutaneous wounds from a nationally representative sample in our hospital from January 2018 to December 2018．

Official Title
-----------------
The Third Epidemiological Research of Refractory Wounds in China

Conditions
-----------------
Wound of Skin

Intervention / Treatment
-----------------
* Other: a cross-sectional survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who underwent treatment of chronic cutaneous wounds in our hospital from 1/2018-12/2018． Exclusion Criteria: - No
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: a cross-sectional survey|Collect the data of this year and compare it with that of ten years ago|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence of chronic cutaneous wounds among hospitalized patients | All the patients with refractory wounds on the body surface | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cause of disease | diabetes, trauma or other. | 1 year | 
| Bacterial etiology | patients had results of bacterial cultivation | 1 year | 
| Treatment expense | Treatment was paid by the patients, social medical insurance, commercial medical insurance, or free medical care． | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cutaneous wounds, epidemiology, China
The Change of the Tetanus Antibody Titer After Single Injection of Td and Simultaneous Injection of TIG With Td

Study Overview
=================
Brief Summary
-----------------
The investigators want to determine whether TIG influences the formation of tetanus antibody after simultaneous tetanus vaccination according to age and the time-interval of the last tetanus vaccination.

Detailed Description
-----------------
When an injured patient visits the ED, unnecessary injection of tetanus immunoglobulin (TIG) may cause side effects and also increase the medical expense.5 Further, the opportunity of assessing a rising tetanus antibody titer may be missed after simultaneous injection of tetanus-diphtheria vaccine (Td) and TIG. According to age, the elevation of the tetanus antibody titer after tetanus prophylaxis might be not equivalent because of different levels of basal immunity and the time-interval of the last tetanus vaccination. Therefore, we wanted to determine whether TIG influences the formation of tetanus antibody after simultaneous tetanus vaccination according to age and the time-interval of the last tetanus vaccination.

Official Title
-----------------
the Change of the Tetanus Antibody Titer After Single Injection of Tetanus Vaccine and Simultaneous Injection of Tetanus Immunoglobulin With Tetanus Vaccine?

Conditions
-----------------
Tetanus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult volunteers Exclusion Criteria: immunocompromised febrile allergy to the vaccine constituents previous tetanus immunization within 5 years medical and non-medical employees

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 89 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 |
| --- | --- |
| Td ,Td and TIG<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in tetanus antibody titer at 4weeks, 6 months and 12months | The tetanus antibody titers were determined by ELISA and the results were reported in IU/mL. The measurement of tetanus antibody titer at 4 weeks should be needed to check the peak titer after vaccination. the change of tetanus antibody titers were calculated by geometric mean titers(GMTs), and we compared the GMTs between the groups(Td vs Td-TIG)at baseline, 4weeks, 6months, and 12 months by independent T-test. | Baseline, 4 weeks, 6 months, 12 months |