linjc16/ctgov huggingface dataset:
Acceptance of Uterus Transplantation

Study Overview
=================
Brief Summary
-----------------
Transplantation of an uterus

Detailed Description
-----------------
Uterus transplantation will be performed from live donors to patients with absolute uterine factor infertility. Organ procurement from the donor will be performed by laparotomy. Transplantation will also be performed by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.

Official Title
-----------------
Transplantation of an Uterus for Treatment of an Absolute Uterine Infertility

Conditions
-----------------
Resolve Infertility

Intervention / Treatment
-----------------
* Procedure: Uterus transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age below 40 years absolute uterine factor infertility BMI < 30 Exclusion Criteria: systemic disease psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterus transplantation<br> | Procedure: Uterus transplantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who are interested in an uterus transplantation |  | 3 years | 
| Number of patients from these who do have a potential donor |  | 3 years | 
| Number of patients from these who do have a medical indication for an uterus transplantation |  | 3 years |
A Pilot Study to Investigate the Clinical Utility of the Peregrine Monte Carlo Dose Calculation System for Radiation Therapy Treatment Planning

Study Overview
=================
Brief Summary
-----------------
The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a clinical setting will be assessed by comparing results with other fully three-dimensional programs. ROB will investigate PEREGRINE for clinical use at NCI in collaboration with Lawrence Livermore National Laboratory (LLNL).

Detailed Description
-----------------
The utility of PEREGRINE Monte Carlo calculations for radiation treatment planning in a clinical setting will be assessed by comparing results with other fully three-dimensional programs. ROB will investigate PEREGRINE for clinical use at NCI.

Official Title
-----------------
A Pilot Study to Investigate the Clinical Utility of the Peregrine Monte Carlo Dose Calculation System for Radiation Therapy Treatment Planning

Conditions
-----------------
Neoplasm

Intervention / Treatment
-----------------
* Procedure: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients with documented malignancy requiring standard radiotherapy OR patients with a benign condition for whom radiotherapy is indicated. EXCLUSION CRITERIA: Documented connective tissue disease or Ataxia Telangiectasia. Cognitively impaired patients who cannot give informed consent. Other medical conditions deemed by the PI to make the patient ineligible. Patients requiring emergent radiotherapy. Patients who are not able to undergo a CT scan.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Radiotherapy|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
-----------------
External Beam Radiotherapy, TCP, DVH, NTCP, 3-D Programming
Evaluation of Group Health Teaching With Video in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Objective:Health videos and group education to allow patients to a correct understanding of diabetes and insulin treatment. Method: Standards and number of patients: The patients received subcutaneous insulin injection, estimated 30 people enrolled. Experimental Design and Methods: Screening out-patient treatment with insulin use, HbA1c> 8% or poor postprandial glucose (PPG) At the time of the visits, invite the patient to participate in the Video group education on insulin therapy By answering some questions about insulin injections, such as: do not know how to perform; afraid of the pain; fear of inconvenience, give patients time to complete the questionnaire.

Detailed Description
-----------------
Diabetes is a long-term chronic disease. The patients need to correct knowledge and action lifestyle in order to achieve effective blood glucose control. Upon the general control of diabetic patients in Taiwan, however, glycosylated hemoglobin (HbA1c) is not satisfactory. One of the important reasons is the low rate of insulin injection. For the use of insulin, the patient has many misconception. The patients in the clinic need to spend a lot of time to explain and description, but the results are not necessarily good. So we hope that in this part of the health education activities through organized groups Videos to assist doctors and patients as a bridge of communication, to enhance diabetes doctor thus contributing to glycemic control results.

Official Title
-----------------
Evaluation of Group Health Teaching With Video in Diabetic Patients

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to sign the informed consent Age over 20 years old HbA1c>8% or PPG) > 200 mg/dl even under insulin therapy Exclusion Criteria: Vegetation status Inability of visual or hearing contact with the video program

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video<br> | Behavioral: Video<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 3 months |
DC Vaccine Combined With CIK Cells in Patients With SCLC

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously preclinical research with DC combined with CIK cells, the investigators plan to perform the clinical trial.

Official Title
-----------------
Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Extensive-Stage Small- Cell Lung Cancer: a Phase I/II Study

Conditions
-----------------
Small- Cell Lung Cancer

Intervention / Treatment
-----------------
* Biological: adenovirus-transfected autologous DC vaccine plus CIK cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically confirmed diagnosis of Small- Cell Lung Cancer Age >18 years at time of consent Received standardized treatment of Small-Cell Lung Cancer Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks KPS (Karnofsky performance scale) >60 Patient's written informed consent No severe viral or bacterial infections Predicted survival >3 months Exclusion Criteria: Clinically relevant diseases or infections (HBV, HCV, HIV) Females who are pregnant or nursing Immunosuppressant treatment Currently participating in another clinical trial Unfit for participating in this clinical trial in investigators' opinions

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: adenovirus-transfected autologous DC vaccine plus CIK cells|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective rate response (CR+PR) as measured by RECIST criteria |  | 4 weeks after DC/CIK treatment] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events |  | 3 days within DC/CIK treatment |
Serum BDNF Role as a Biomarker for Stroke Rehabilitation

Study Overview
=================
Brief Summary
-----------------
This study aims to develop the quantitative biomarker to establish the individualized strategy in stroke rehabilitation. Brain-derived neurotrophic factor (BDNF) acts on certain neurons of the central nervous system (CNS) helping to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. BDNF in CNS can be assessed by analysing serum BDNF. The final objective of this study is to demonstrate a role of biomarker of BDNF in stroke rehabilitation to establish the individualized strategy.

Detailed Description
-----------------
Serum BDNF, proBDNF and MMP-9 in all participants will be measured before and after the comprehensive inpatient rehabilitation during subacute stroke phase. At 3 months after stroke onset, serum BDNF, proBDNF and MMP-9 will also be measured. In addition, motor impairment with Fugl-Meyer assessement will be assessed at same time points with serum analysis. We will compare potential serum biomarkers with motor impairment in stroke patients

Official Title
-----------------
Serum BDNF Role as a Biomarker for Stroke Rehabilitation

Conditions
-----------------
Stroke, Biomarker, Rehabilitation, BDNF

Intervention / Treatment
-----------------
* Procedure: Conventional inpatient rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral stroke patients admission to the rehabilitation department before 1 month after stroke onset mild to severe motor impairment at time of transferring to the rehabilitation department Exclusion Criteria: Progressive or unstable stroke Pre-existing and active major neurological disease Pre-existing and active major psychiatric disease Advanced liver, kidney, cardiac, or pulmonary disease A terminal medical diagnosis consistent with survival < 1 year) Pregnant or lactating woman

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Conventional inpatient rehabilitation|comprehensive inpatient rehabilitation for 2 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum BDNF | serum BDNF level | At 2 weeks after the comprehensive inpatient rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum proBDNF | Serum proBDNF level | At 2 weeks after the comprehensive inpatient rehabilitation | 
| MMP-9 | MMP-9 level | At 2 weeks after the comprehensive inpatient rehabilitation |
Effect of Preoperative Curcumin in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients

Detailed Description
-----------------
Patients diagnosed with breast cancer will be supplemented with either curcumin or placebo for a minimum period of 2 weeks and may be extended up to 4 weeks prior to their surgery.

Official Title
-----------------
Effect of Preoperative Curcumin in Breast Cancer Patients

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

Intervention / Treatment
-----------------
* Dietary Supplement: Curcumin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with operable breast cancer Life expectancy of at least 3 months Adequate organ function No allergy to curcumin Provides consent to participate in trial and adhere to the study protocol Exclusion Criteria: Receiving concomitant radiotherapy, hormonal, immune therapy or other investigational drugs Uncontrolled concurrent illness Patient of anti platelet medications Pregnant / breast feeding Patients who are unable or unwilling to take curcumin, herbal remedies, or non-prescription medications Patients with bleeding tendency, bleeding disorders and abnormal bleeding/clotting profile
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br>Capsules, taken orally, 8g per day (Bi-daily dosing) | Dietary Supplement: Curcumin<br>* Natural compound, active ingredient of turmeric, in bi-daily dosing<br>|
| Placebo Comparator: Placebo<br>Capsules, taken orally, bi-daily dosing | Other: Placebo<br>* Placebo tablets at bi-daily dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour infiltrating lymphocytes (TILs) | Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group | For 2 to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FOXP3 | Immunohistochemistry analysis | For 2 to 4 weeks | 
| CD68 | Immunohistochemistry analysis | For 2 to 4 weeks |
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.

Official Title
-----------------
A Single-Center Evaluation of Retaine™ Ophthalmic Emulsion in the Management of Tear Film Stability and Ocular Surface Staining in Patients Diagnosed With Dry Eye

Conditions
-----------------
Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: Retaine™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age; Provide written informed consent; Have a reported history of dry eye; Have a history of use or desire to use eye drops; Exclusion Criteria: Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Have used Restasis® within 30 days of Visit 1; Be a woman who is pregnant, nursing or planning a pregnancy; Be unwilling to submit a urine pregnancy test if of childbearing potential; Have a known allergy and/or sensitivity to the test article or its components; Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Retain 1-2 drops, bilaterally, BID | Drug: Retaine™<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Film Break-Up Time |  | Day 15 | 
| Ocular surface damage as measured by fluorescein staining |  | Day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
Evaluation of Web-based Transition Education to Enhance Transition Readiness

Study Overview
=================
Brief Summary
-----------------
The study looks to learn more about the helpfulness of web-based transition education and its effect on transition readiness and health service utilization in the adolescent and young adult congenital heart disease population.

Official Title
-----------------
Evaluation of Web-based Transition Education to Enhance Transition Readiness and Health Service Utilization in Adolescents/Young Adults With Congenital Heart Disease

Conditions
-----------------
Transition, Congenital Heart Disease, Pediatric Congenital Heart Disease

Intervention / Treatment
-----------------
* Behavioral: Web-based Educational Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with congenital heart disease Ages 13-25 Routine outpatient cardiology follow-up visit Exclusion Criteria: New patients to cardiology clinic Patients being evaluated for an acute medical problem Patients who do not speak English Severe neurocognitive impairment that precludes ability to complete the questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based Educational Intervention<br>This group of participants will be given access to a web-based educational resource in addition to the standard of care. | Behavioral: Web-based Educational Intervention<br>* A web-based educational tool, created for patients with congenital heart disease, will be given to patients using an ipad. This additional educational tool will be used with the standard of care visit with provider.<br>|
| No Intervention: Standard of Care<br>This group will be given only the standard of care during their clinic visit. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transition readiness score, as measured by transition readiness survey | The transition readiness survey is used to measure a participant's self-reported knowledge about their health and readiness to take charge of their healthcare. Each item is scored from 1 to 5, where 1 means No, I do not know how and 5 means Yes, I always do this when I need to. The overall score is determined by calculating the sum of all questions on a 100 point scale. A higher score indicates greater readiness for transition. | baseline, 12 months |
Comparison of Three Corneal Horizontal Marking Techniques Using iTrace™

Study Overview
=================
Brief Summary
-----------------
Before astigmatism reducing surgery, accurate corneal horizontal marking before surgery is important. Due to new corneal topographic method, iTrace™ surgical workstation, precise evaluation of corneal horizontal marking is available. In this study the investigators compared three known corneal horizontal making techniques and evaluate accuracy of each methods using iTrace™.

Conditions
-----------------
Corneal Horizontal Marking.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were scheduled to have cataract surgery Age between 50 to 85 years Exclusion Criteria: With an underlying corneal or conjunctival disorder

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 86 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 |
| --- | --- |
| Group 1<br>Group 1 : Bare eye marking group | |
| Group 2<br>Group 2 : Pendulum attached marker group | |
| Group 3<br>Group 3 : Horizontal slit beam assisted marker group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The vertical height deviation and rotational axis misalignment amount of each three marking techniques, evaluated by iTrace surgical workstation. | Nasal and temporal marked spots saved in iTrace surgical workstation program. | Within 10 minutes after corneal horizontal marking. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toric marking, Corneal horizontal marking