linjc16/ctgov huggingface dataset:
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital

Study Overview
=================
Brief Summary
-----------------
Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.

Official Title
-----------------
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital

Conditions
-----------------
Cholangitis, Liver Cirrhosis, Biliary, Cholestasis, Liver Diseases, Liver Cirrhosis, Bile Duct Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016. Exclusion Criteria: Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary biliary cholangitis during January 2001 to July 2016<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of demographics, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years. |  | Up to 16 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse outcome free survival of the PBC cohort during the 16 years. |  | Up to 16 years. |
Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections

Study Overview
=================
Brief Summary
-----------------
In this cross-sectional study the investigators will examine two populations: young adults with (ages 18-35) and older adults (ages 65 and over) with diabetes who are on > 2 insulin injections per day. The sample size for this observational study will be up to 125 patients. The investigators will issue a Common Sensing GoCap bluetooth-enabled pen cap that fits on the end of Solostar Lantus and Apidra insulin pens; this pen cap registers the position of the insulin pen plunger and automatically sends confirmation of dose delivery to a smartphone app.

Conditions
-----------------
Insulin, Diabetes, Medication Adherence, Technology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes or insulin-requiring Type 2 diabetes > 2 insulin injections Age 18-35 or older than 65 years Use of glargine insulin as basal insulin Stable insulin doses for past 3 months Exclusion Criteria: Previous tape/adhesive allergies with CGM sensors Visual or cognitive impairment with inability to self-administer insulin

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 |
| --- | --- | --- |
| Number of Missed Insulin Doses |  | 4 week use of blue tooth pen cap | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, insulin, medication adherence
Evaluation of the Dose Received by the Prostate With in Vivo Dosimetry in Patients Treated With Daily IGRT Associated With IMRT Using Two Repositioning Techniques for Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (IGRT) associated with intensity modulated radiation therapy (IMRT) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.

Detailed Description
-----------------
10 participants will receive a cone beam computed tomography (CBCT) repositioning, while the other 10 will receive a kV imaging of fiducial marker repositioning. The principal objective is to evaluate and compare the dose received by the prostate using two repositioning techniques.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: CBCT
* Other: fiducial marker (kV imaging)
* Radiation: IGRT Associated With IMRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male > 18 years carcinoma of the prostate histologically confirmed OMS 0-1 localized stage favorable, intermediate and unfavorable groups according to NCCN or D'Amico classification patients must have signed a written informed consent form patients must be affiliated to a Social Health Insurance. Exclusion Criteria: metastasis indication for pelvic radiation anticoagulant therapy lateral or bilateral hip replacement patient receiving an adult protective services Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CBCT<br>cone beam computed tomography (CBCT) repositioning | Other: CBCT<br>* 10 participants will receive a cone beam computed tomography (CBCT) repositioning<br>Radiation: IGRT Associated With IMRT<br> <br> |
| Other: fiducial markers<br>kV imaging of fiducial marker repositioning | Other: fiducial marker (kV imaging)<br>* 10 participants will receive a kV imaging of fiducial marker repositioning.<br>Radiation: IGRT Associated With IMRT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dosimetry (measurement of the absorbed dose, delivered to prostate, by ionizing radiation) |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Raypilot dosimetry, CBCT (cone beam computed tomography)
Zonulo-hyaloido-vitrectomy for Malignant Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the zonulo-hyaloido-vitrectomy for malignant glaucoma through an anterior approach.

Conditions
-----------------
Malignant Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent the zonulo-hyaloido-vitrectomy for malignant glaucoma through an anterior approach Exclusion Criteria: systemic disease or inflammation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure | The intraocular pressure is measured by the non-contact tonometer. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malignant glaucoma, zonulo-hyaloido-vitrectomy
Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Detailed Description
-----------------
Randomized clinical trials have demonstrated that the recurrence of DCIS is low and most of the recurrence occurs around the tumor bed. Besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. However, whether or not partial breast irradiation is safety in DCIS is still unknown. The purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Official Title
-----------------
Phase II Study of Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery

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

Intervention / Treatment
-----------------
* Radiation: partial breast irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 18 65 years old Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3) Treated with breast conserving surgery Tumor bed is labeled with Titanium clips No malignancy history ECOG score 0 1 Written informed consent Exclusion Criteria: DCIS of both breast invasive breast cancer Multicentric disease Patients underwent mastectomy Previous radiation therapy of breast Medical contraindication for radiotherapy Pregnant or nursing suspicious calcification after surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| partial breast irradiation<br> | Radiation: partial breast irradiation<br>* The prescription dose is 40.5Gy in 15 fractions in 3 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ipsilateral breast tumor recurrence |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of contralateral breast tumor after PBI |  | 5 years | 
| Disease free survival |  | 5 years | 
| Overall survival |  | 5 years | 
| radiation-induced toxicity of breast assessed by CTCAE v4.0 |  | baseline, 3 months, 6 months, and every half year to 5 years | 
| Complications |  | baseline，1，2，3，4，5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, partial breast irradiation, DCIS
Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.

Official Title
-----------------
Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate 15 mg sterile suspension
* Other: Photodynamic Therapy (PDT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients of any race, either gender, aged 50 years and above, diagnosed with subfoveal CNV due to AMD with best corrected logMAR visual acuity of 20/40 (snellen equivalent) to 20/400 (Snellen equivalent) in the study eye. Clinically relevant concomitant diseases will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Active Comparator: Anecortave and Sham PDT<br> | Drug: Anecortave Acetate 15 mg sterile suspension<br> <br> Other: Photodynamic Therapy (PDT)<br> <br> |
| Active Comparator: PDT and Sham Anecortave Acetate<br> | Drug: Anecortave Acetate 15 mg sterile suspension<br> <br> Other: Photodynamic Therapy (PDT)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Maintaining Vision |  | Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, age-related macular degeneration, Anecortave, Acetate, Wet form of age-related macular degeneration
Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Study Overview
=================
Brief Summary
-----------------
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

Official Title
-----------------
An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA

Conditions
-----------------
Systemic Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Drug: MRA(Tocilizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997) Patients aged at least 2 years old and less than 20. Patients aged less than 16 years old at time of onset Exclusion criteria Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 19 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MRA(Tocilizumab) | Drug: MRA(Tocilizumab)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS |  | whole period | 
| Safety:Incidence and severity of adverse events and adverse drug reactions |  | whole period | 
| Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration |  | whole period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS |  | whole period |
Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

Study Overview
=================
Brief Summary
-----------------
Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat) have provided conflicting results with some in vitro and ex vivo studies consistent with non toxicity and other suggestive of toxicity. We recently reported results of a single administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while assessing symptoms and changes of intestinal permeability. Although results of intestinal permeability were inconclusive Tm, but not other type of gluten, was clinically well tolerated. The aim of the present study was to assess safety of 60 days of administration of Tm (100 grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on clinical, serological and histological parameters in Celiac Disease patients on remission after 1 year of GFD.

Official Title
-----------------
Phase II Study on Safety of 60 Days Administration of Triticum Monococcum in Patients With Celiac Disease on Remission in Gluten Free Diet

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Triticum monococcum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Celiac patients on Gluten Free Diet (GFD) for at least one year Strict adherence to GFD Negative Celiac related serology Normal duodenal Histology defined as Marsh Class 0-II Willing to participate and adhere to study protocol Sign of the informed consent Exclusion Criteria: Pregnancy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triticum monococcum<br>60 days of daily administration of 100 grams of water biscuits of Triticum monococcum | Dietary Supplement: Triticum monococcum<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic: 4 duodenal biopsies obtained and classified according to Marsh | After 60 days of daily administration of Tm endoscopic biopsies were performed and reviewed by the same experienced pathologist | Baseline, Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS) |  | Baseline, Day 30, Day 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac Disease, Gluten, Gluten free diet, Triticum monococcum
Plasma Immunity of Mild SARS-CoV-2 Omicron and Delta Pandemic in Thailand

Study Overview
=================
Brief Summary
-----------------
The investigators assessed the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation.

Detailed Description
-----------------
The investigators aimed to assess the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation. The investigators compared the population between the age groups 12-18 years, 18-45 years and over 45 years to monitor the symptoms of coronavirus patients treated in home isolation and long-term symptoms including factors related to the patient's recovery in the past, present, and future.

Official Title
-----------------
The Study of Treatment Outcome and Immunogenicity of mild-to Moderate COVID-19 Patients During the Delta vs. the Omicron Pandemic

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with infected with the novel coronavirus disease 2019 (COVID-19) who has been end of self-quarantine at Siriraj Hospital more than 21 days. Thai nationality, able to read and write Thai language able to use telephone and line to communicate Exclusion Criteria: 1. people who received additional vaccination after leaving quarantine before the day of the immunization test

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-SARS-CoV-2 RBD IgG | Anti-RBD IgG (BAU/mL) | Baseline | 
| Anti-SARS-CoV-2 NP | Anti-SARS-CoV-2 NP (PRNT50 titer) | Baseline | 
| Cycle threshold of the first PCR test | Cycle threshold (Ct) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of vaccine injection | Number of vaccine injection | Baseline | 
| Type of vaccine injection | Type of vaccine injection | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, antibody, immunity, home isolation, vaccine