linjc16/ctgov huggingface dataset:
Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.

Detailed Description
-----------------
Ocular surface damage caused by severe ocular surface diseases. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications

Official Title
-----------------
Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.

Conditions
-----------------
Ocular Surface Disease

Intervention / Treatment
-----------------
* Procedure: Cultivated mucosal epithelial transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology Exclusion Criteria: Age under 18 Active ocular infection, Severe dry eye, Uncontrolled glaucoma Immunocompromised host Pregnancy

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: Cultivated mucosal epithelial transplant<br>Cultivated mucosal epithelial transplantaion to limbal deficiency patients | Procedure: Cultivated mucosal epithelial transplantation<br>* cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery |  | Three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Limbal deficiency, Cultivated limbal transplantation, Ex vivo limbal transplantation, Cultivated autologous mucosal epithelial transplantation
A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria

Study Overview
=================
Brief Summary
-----------------
This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.

Official Title
-----------------
An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria

Conditions
-----------------
Chronic Cold Urticaria

Intervention / Treatment
-----------------
* Drug: THB001


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Women and Men ages 18-75 Diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment Positive cold stimulation test assessed by TempTest® at the Screening and Baseline visits Considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ECG recording Willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions Key Exclusion Criteria: A diagnosis of acute urticaria or non-cold chronic inducible urticaria Ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others) A positive test for pregnancy, HIV, Hepatitis B or Hepatitis C Clinical laboratory values outside of the normal ranges at the Screening visit History of any clinically significant abnormality that would contraindicate participation There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THB001 Dose Level A<br> | Drug: THB001<br>* 100 mg capsules for oral administration<br>|
| Experimental: THB001 Dose Level B<br> | Drug: THB001<br>* 100 mg capsules for oral administration<br>|
| Experimental: THB001 Dose Level C<br> | Drug: THB001<br>* 100 mg capsules for oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by the incidence and severity of adverse events | Safety evaluations will include analyses of adverse events by treatment group | From Day 1 through Week 12 |
Onco-liq: Kit for Breast Cancer Diagnosis.

Study Overview
=================
Brief Summary
-----------------
Onco-liq is a novel diagnosis kit for early breast cancer detection in blood based in liquid biopsies and microRNAs. This innovative kit will allow improving the accuracy of cancer diagnosis which will impact on health, reducing the patient mortality and health costs. To develop this kit, it has been finished the preclinical PHASE I: in laboratory animals; PHASE II: exploratory clinical phase for the discovery of candidate biomarkers in breast cancer patients and PHASE III: clinical validation of biomarkers showing that Onco-liq has 95% specificity. Currently it is been setting up a pilot test for breast cancer to enrol 500 woman volunteers without previous cancer diagnosis that go to the annual medical control. The results of the pilot test will give the accuracy for breast cancer early diagnosis and the management of Onco-liq positive patients.

Official Title
-----------------
Onco-liq: Kit for Breast Cancer Diagnosis.

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

Intervention / Treatment
-----------------
* Diagnostic Test: Onco-liq: kit for breast cancer diagnosis.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women patients performing gynecological control Between 50-70 years old Without personal history of oncological disease Informed consent signed Exclusion Criteria: Patients who don´t meet the inclusion criteria. Active infection with SARS-CoV-2 (COVID-19).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PPHM-0000-21<br>50-70 year old female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control. | Diagnostic Test: Onco-liq: kit for breast cancer diagnosis.<br>* Onco-liq is a novel diagnosis kit for early breast cancer diagnosis in blood, based on liquid biopsies and miRNAs. The main advantage of this kit is that miRNAs released from the tumor into the bloodstream can be detected in the plasma of patients even when the tumor is undetectable by other methods.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNA levels in plasma | miRNA levels in plasma will be determined by RT-qPCR using ΔΔCT method. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liquid biopsy, breast cancer, early diagnosis, microRNAs.
Non-Invasive Management of Chronic Venous Insufficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: -item one to use two new non-invasive technologies to evaluate scarring and swelling associated with chronic venous insufficiency. The study hypothesis: - item one non-invasive technologies can provide a tool for assessing risk of ulcer development based on the tissue edema and alteration.

Official Title
-----------------
Non-Invasive Management of Chronic Venous Insufficiency

Conditions
-----------------
Venous Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants with CVI with CEAP class 4 or higher participants with no CVI class 0 Exclusion Criteria: open ulcers or lower extremity amputation diabetics with HbA1C greater than 7.0 arterial occlusive disease BMI greater than 35 any connective tissue disorder (lipodermatosclerosis and fibrosis) participants with metallic prosthesis or implants participants with renal impairment pregnancy inability or refusal to wear compression stockings prescribed by physician (CVI patients only)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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 |
| --- | --- |
| CVI<br>Varicose veins, varicose veins with leg swelling, venous stasis skin color changes, no open ulcers | |
| No treatment<br>Subjects with no venous disease CEAP (clinical etiology antomy pathophysiology)Class 0 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide device development to assess tissue changes associated with chronic venous insufficiency |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare device development to existing clinical measurement |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
edema, blood supply, lower legs, venous stasis
Evaluation the Operative Procedure Among Patients That Suffer From Tear of the Distal Tendon of the Biceps

Study Overview
=================
Brief Summary
-----------------
Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the art treatment is surgical procedure. Objective: Evaluation of the Surgical procedure among patients that suffered from Methods: The investigators will review files from 2003-2010 of patients that gone through the operation. The investigators will record pre-operation and post-operation process including complications and rehabilitation. The investigators will invite them to the clinic for exams, clinical questionnaires.

Conditions
-----------------
Biceps Tendon Rupture

Intervention / Treatment
-----------------
* Procedure: tear of the distal tendon in the biceps muscle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.see population description Exclusion Criteria: 1. Unwillingness to come to the clinic visit.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgery, biceps tear<br> | Procedure: tear of the distal tendon in the biceps muscle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.

Official Title
-----------------
Phase II Study of MP-424 in Patients With (Genotype 1b) Hepatitis C

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: MP-424 (Telaprevir)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with genotype 1b chronic hepatitis C Patients naive to the concomitant medications with interferon Exclusion Criteria: Patients diagnosed with decompensated cirrhosis Patients diagnosed with positive HBs antigen in the test

Ages Eligible for Study
-----------------
Minimum Age: 20 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: MP-424<br> | Drug: MP-424 (Telaprevir)<br>* Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)<br>* Other names: Telaprevir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration |  | 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis C, Protease Inhibitor
Risk Factors for Post Operative Nausea and Vomiting(PONV) in Patients Underwent Gynecological Operation Under General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Risk factors for postoperative nausea and vomiting(PONV) such as past history of PONV and/or motion sickness, non-smoking status, female gender, planned opiate use for post-operative analgesia were identified in white people. Whereas, risk factors for PONV in female patient with mongolian race were not clear. As a different life style and genetic background, new risk factors may associate with PONV in this population. The present study is a prospective cohort study to identify risk factors for PONV within 24 postoperative hours in chinese female patients underwent gynecology operative under general anesthesia.

Official Title
-----------------
A Observational Cohort Study to Identify Risk Factors for Post Operative Nausea and Vomiting Following General Anesthesia in Female Patient Underwent Gynecological Operation

Conditions
-----------------
Anesthesia, General, Elective Gynecological Operation, Chinese Female Patient, Adult

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old Chinese female patient Exclusion Criteria: Unstable vital sign Patients under mechanical ventilation Patients under sedition (RASS=<-2)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| PONV group<br>patients with postoperative nausea and vomiting | |
| Control group<br>patients without postoperative nausea and vomiting | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting |  | within 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative shivering |  | within 24 postoperative hours | 
| Postoperative pain score with Numerical Rating Scale (NRS-11) |  | within 24 postoperative hours | 
| Time to full recovery of intestinal function |  | within 24 postoperative hours | 
| Preoperative and postoperative fasting time |  | within 24 postoperative hours | 
| Length of postoperative hospital stay and Length of hospital stay |  | before discharge | 
| Total health care costs |  | before discharge | 
| Postoperative delirium in recovery room |  | within PACU stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, General, Elective Gynecological Operation, Chinese female patient, Adult
Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Study Overview
=================
Brief Summary
-----------------
In cancer patients, the increase of troponin I soon after chemotherapy is a strong predictor of left ventricular dysfunction and poor cardiologic outcome. This information provides a rationale for the development of prophylactic strategies directed against chemotherapy-induced cardiotoxicity (CTIC). Activation of the renin-angiotensin system has been proved to be involved in the development and progression of cardiac dysfunction in several clinical settings, and has been suggested to have a role in the occurrence of CTIC. We investigated the role of treatment with ACE-inhibitors in the prevention of CTIC in high-risk cancer patients.

Official Title
-----------------
Prevention of Chemotherapy-induced Cardiotoxicity in High-risk Patients

Conditions
-----------------
Cardiotoxicity, Chemotherapeutic Toxicity

Intervention / Treatment
-----------------
* Drug: Enalapril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients undergoing high-dose chemotherapy showing early release of Troponin I Exclusion Criteria: Contraindication to ACE-inhibitors On-going therapy with beta-blockers, ACE-inhibitors, angiotensin-receptors blockers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enalapril arm<br>treatment with enalapril | Drug: Enalapril<br>* enalapril orally administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chemotherapy-induced cardiotoxicity |  | 12 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events, including death. |  | 12 month period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy induced cardiotoxicity, Troponin, Heart failure
CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.

Detailed Description
-----------------
Patient with HNPCC syndrome confirmed by a mutation (MLH1, MSH2, MHS1) are involved in the study. Patient have 2 colonoscopy back to back. The second coloscopy is associated to chromoscopy with carmin indigo. Endoscopist are randomised for the colonoscopy with chromoscopy and are un-awarded of the result of the first colonoscopy. Histopathology of the polyp are noted. The follow up were 1 month.

Official Title
-----------------
Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Syndrome: Assessment of Coloscopy With Chromoscopy Benefit

Conditions
-----------------
Colorectal Neoplasms, Hereditary Nonpolyposis

Intervention / Treatment
-----------------
* Procedure: Colonoscopy with chromoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with MLH1, MSH2 or MSH6 mutation. Patients concerned by early detection colonoscopy. Exclusion Criteria: Coloscopy of tracking since less 1an occlusive Syndrome contra-indicating the preparation for a total coloscopies Colectomies medical Conditions or serious illnesses contra-indicating a coloscopy of screening pregnant Woman or nursing Anomaly of coagulation contra-indicating the realization of biopsies and/or the exeresis of the lesion colorectal

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Colonoscopy with chromoscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pre-cancer lesions or early cancer detected. |  | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomopathologic criteria (size of lesions, …). |  | during the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer, HNPCC, Diagnosis, Coloscopy, Chromoscopy, Indigo carmine, Colorectal Neoplasms, Hereditary Nonpolyposis