linjc16/ctgov huggingface dataset:
Treat Primary and Metastatic Liver Tumors

Study Overview
=================
Brief Summary
-----------------
The use of Radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. Methodist Dallas Medical Center has a large volume of IR procedures with Radioembolization and the investigators feel it is imperative to understand the outcomes, risks and benefits of the therapy in order to formulate recommendation to other centers.

Detailed Description
-----------------
A retrospective chart review of patients who have the diagnosis of intrahepatic cholangiocarcinoma. Only patients treated at MDMC are included and data will be obtained from Meditech and Epic. A non-identified database of cases with the diagnosis of intrahepatic cholangiocarcinoma already treated with radiospheres will be created and compared with cases treated by other means. Intrahepatic cholangiocarcinoma is the second most common primary malignancy of the liver. The standard therapy has been resection but many cases are not resectable due to comorbidities or other poor surgical candidacy factors. Most of these patients end up getting chemotherapy which can be toxic and sometimes poorly tolerated. Intrarterial glass or resin radioembolization has been used and published from only 3 centers in the medical literature and it has been shown to be a reasonable alternative to the above options. At MDMC, this therapy has been used effectively and it is important to describe the investigator's experience.

Official Title
-----------------
Radioembolization to Treat Primary and Metastatic Liver Tumors

Conditions
-----------------
Intrahepatic Cholangiocarcinoma, Liver Tumor, Metastatic Cancer, Metastatic Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the diagnosis of intrahepatic cholangiocarcinoma from January 2006 until April 2017 at Methodist Dallas Medical Center (MDMC) Patients 18 years old or older Exclusion Criteria: Patients without the diagnosis of intrahepatic cholangiocarcinoma Patients under 18 years of age

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 |
| --- | --- | --- |
| review the outcomes of patients treated with radiospheres | Patient survival | January 2006 until April 2017 | 
| time to recurrence | time to recurrence | January 2006 until April 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrarterial glass, Radiospheres, Liver Cancer, Intrahepatic
Quality of Life of TEP vs Lichtenstein Hernioplasty

Study Overview
=================
Brief Summary
-----------------
To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty

Detailed Description
-----------------
Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.

Official Title
-----------------
The Comparison of the Quality of Life and Outcomes in Patient's With Reducible Inguinal Hernias: Laparoscopic Totally Extra-peritoneal (TEP) Versus Modified Lichtenstein Hernioplasty

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Open Lichtenstein Hernioplasty
* Procedure: Laparoscopic TEP Hernioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Both genders Unilateral inguinal hernias Reducible inguinal hernias Elective setting Exclusion Criteria ASA Physical Status (American Society of Anaesthesiologists) Grade > 2 Recurrence Inguinal-scrotal hernias Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery Pregnancy Refusal for general anaesthesia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open modified Lichtenstein repair<br>Patients will undergo open repair of their inguinal hernias | Procedure: Open Lichtenstein Hernioplasty<br> <br> |
| Active Comparator: Laparoscopic TEP inguinal hernia repair<br>Patients will undergo laparoscopic repair of their inguinal hernias | Procedure: Laparoscopic TEP Hernioplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Carolina Comfort Scale | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time |  | 12 months | 
| Duration of hospitalization |  | 12 months | 
| Complications |  | 12 monthts | 
| Recurrence | Recurrence of hernia after repair | 12 months |
Prevalence of Pituitary Incidentaloma in Relatives of Patients With Pituitary Adenoma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine genetic links among blood-relatives and between spouses of patients with pituitary tumors.

Detailed Description
-----------------
The purpose of the family study is to investigate the genetic basis for the development of pituitary tumors by assessing the prevalence of pituitary tumors in relatives of probands with the disease as compared to the prevalence in unrelated spouses sharing a similar environment.

Official Title
-----------------
Prevalence of Pituitary Incidentaloma in Relatives of Patients With Pituitary Adenoma

Conditions
-----------------
Pituitary Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients harboring secretory or non-secretory adenomas and/or siblings and/or spouses Exclusion Criteria: patient without consenting siblings and/or siblings and/or spouses

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pituitary, Adenoma, Tumor, Acromegaly, Prolactinoma, Cushing's
Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

Detailed Description
-----------------
The duration of treatment is 12 weeks.

Official Title
-----------------
A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine

Conditions
-----------------
Shingles

Intervention / Treatment
-----------------
* Biological: zoster vaccine live (Oka/Merck)
* Biological: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who are at least 60 years of age with a history of varicella (shingles) Females must have been postmenopausal. Exclusion Criteria: Subjects who did not previously participate in the main study of this protocol. Subject had shingles since their 6 month follow-up visit in main phase of study.

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

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

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

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 |
| --- |
|Biological: zoster vaccine live (Oka/Merck)|nan|
|Biological: Comparator: placebo (unspecified)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VZV ELISPOT response  6 weeks after 1 and 2 doses |  | 6 weeks after 1 and 2 doses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo |  | 1 through 3 years after vaccination |
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.

Official Title
-----------------
Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Procedure: ovarian cancer surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years Karnofsky> 80, or ASA I-II Primary ovarian adenocarcinoma, or primitive peritoneal No retroperitoneal lymph node> 2cm (CT; MRI) Complete surgical staging Stage III-IV FIGO classification Indication of systemic chemotherapy before surgery or post surgery Exclusion Criteria: Non Invasive Cancer non-epithelial or borderline cancer Pregnancy Previous pelvic lymphadenectomy or aortic-cava for a disease other than ovarian cancer Contraindication to Platinum and Paclitaxel Borderline Ovarian Tumor tumor recurrence Incomplete surgery, resectable lesion, Surgery sub optimal (R> 1cm)

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lymphadenectomy<br>after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy | Procedure: ovarian cancer surgery<br> <br> |
| No Intervention: no lymphadectomy<br>after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival with out recurrence |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, ovarian cancer, lymphadectomy
The Effect of「GTT-EGCG」on Acne Women

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the therapeutic effects of green tea extract on acne treatment and related hormone peptides by a double-blinded, randomized and controlled clinical trial.

Detailed Description
-----------------
change in acne lesions counts, hormone, quality of life

Official Title
-----------------
The Effect of「GTT-EGCG」on Acne Women

Conditions
-----------------
Acne Lesion Counts

Intervention / Treatment
-----------------
* Dietary Supplement: green tea extract EGCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient 20 to 45 years of age moderate or severe acne vulgaris as defined by the Investigator's Global Assessment (IGA; score of 3 or 4 on a scale from 0 to 5) Exclusion Criteria: Received systemic retinoid or hormone treatment in the previous 3 months. Abnormal liver enzymes or kidney function tests (1.5 times higher than the upper normal limit) abnormal blood chemistry Pregnant or breast feeding women or the intention of becoming pregnant Concurrent systemic illness PCOS Very severe acne(IGA score5)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: green tea extract EGCG<br>experimental: green tea extract EGCG, 500mg , tid, 4 weeks | Dietary Supplement: green tea extract EGCG<br>* EGCG, 500mg, tid, 4 weeks<br>|
| Placebo Comparator: cellulose<br>Placebo Comparator: cellulose, 500 mg tid, 4 weeks | Dietary Supplement: green tea extract EGCG<br>* EGCG, 500mg, tid, 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acne lesion counts |  | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life, SF-12 |  | four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne, EGCG, green tea
Analysis of Biopsies With Antibody Mediated Rejection According to the Therapy Response

Study Overview
=================
Brief Summary
-----------------
In adult kidney transplant recipients a therapy-responder and non-responder phenotype by antibody mediated rejection will be precisely defined according to clinical and histological characteristics such as creatinine, proteinuria and Banff-classification. Twenty-five patients will be selected each in the therapy-responder and non-responder group. Their stored Formalin Fixed Paraffin Embedded (FFPE) biopsies will be (re)-classified according to the most recent Banff classification. Using Nanostring Technology the gene transcription of therapy-responders versus non-responders will be analyzed and compared to serological and clinical parameters.

Official Title
-----------------
Transcriptome Analysis of Stored Biopsy Samples in Clinically Precisely Phenotyped Therapy-responders Versus Non-responders Diagnosed With Antibody Mediated Rejection

Conditions
-----------------
Antibody-mediated Rejection

Intervention / Treatment
-----------------
* Diagnostic Test: Transcriptome Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant patients at the University Hospital of Zurich between 01.01.2008 - 31.12.2016 with histologically suspected or confirmed ABMR Written consent for further use of data for research purposes Exclusion Criteria: Age at transplantation < 18 years Combined organ transplantation (incl. Kidney-Pancreas, Kidney-Liver, Kidney-Heart) Incomplete laboratory and/or clinical data Recurrence of the initial disease Insufficient Biopsy Material for NanoString Analysis Documented refusal of further data analysis for research purpose

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 |
| --- | --- |
| Therapy Responders<br> | Diagnostic Test: Transcriptome Analysis<br>* Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies<br>|
| Non-Responders<br> | Diagnostic Test: Transcriptome Analysis<br>* Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptome | mRNA | 02.15.2018-03.01.2018 |
The Feasibility of PetCO2 Prediction Hypotension Under Spinal Anesthesia for Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Maternal hypotension is a common side effect after spinal anesthesia for cesarean delivery.Decreased vascular resistance and cardiac output, due to sympathetic blockade1and blood pooling in blocked areas of the body respectively, are main causes of spinal anaesthesia-induced hypotension during Caesarean delivery. Cardiac output, which has shown to be a better predictor of organ and placental perfusion than arterial blood pressure.Few studies have measured CO after spinal anesthesia in the maternal population.This is largely because of the lack of availability of accurate and reproducible noninvasive measurement techniques. Up to now, preventing hypotension has continued to focus on arterial blood pressure variables, fluid, and ephedrine requirements as markers of cardiovascular status, because these are more easily measured. Investgators hypothesized that CO and PetCO2, in parturients with the degree of hypotension during spinal anaesthesia, would also have a positive and significant association.

Official Title
-----------------
The Feasibility of PetCO2 Prediction Hypotension Under Spinal Anesthesia for Cesarean Section

Conditions
-----------------
Hypotension, Carbon Dioxide

Intervention / Treatment
-----------------
* Procedure: spinal anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full-term gestation (>36 and <41 weeks of gestation) with a singleton pregnancy Exclusion Criteria: emergency cases placenta praevia preeclampsia cardiovascular or cerebrovascular disease morbid obesity with a BMI≥40 contraindications to spinal anaesthesia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| hypotension<br> | Procedure: spinal anesthesia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| value of PetCO2 and changes in artery pressure |  | up to 4 weeks |
Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® in Korean Patients With Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations: Unexpected adverse drug reactions Frequency and nature of adverse events (AEs) Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of Metalyse® was also assessed.

Official Title
-----------------
Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® (Tenecteplase) in Korean Patients With Acute Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Metalyse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metalyse<br>weight-adjusted dose | Drug: Metalyse<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality after the Metalyse® Injection |  | 30 days | 
| Outcome assessment - 'Improvement' or 'Failure' | 'Improvement' was defined as survival on 30 days and 'Failure' as death on 30 days after the Metalyse treatment. | 30 days | 
| Number of patients with adverse events |  | up to 30 days |
Hypoxia in Flight Simulation in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to determine whether obese adults,obese (BMI>30 kg/m2) with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic chamber test.

Official Title
-----------------
Hypoxia in Flight Simulation in Obese Patients

Conditions
-----------------
Obesity, COPD, OHS

Intervention / Treatment
-----------------
* Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years patients with COPD (GOLD I-IV Group A-D) with obesity (BMI> 30kg/m2), obese healthy adults with BMI> 30kg /m2, patients with Obesity hypoventilation syndrome informed consent provided Exclusion Criteria: patients less than BMI <30 kg/m2 with or without COPD, OHS Age < 18 years pregnancy, lactation any medical, psychological or other condition restricting the patient's ability to provide informed consent participation in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| obese healthy adults<br>persons with BMI> 30 kg/m2 | Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS<br> <br> * Other names: flight simulation;|
| obese COPD patients<br>COPD-patients (GOLD I-IV Group A-D) with BMI> 30 kg/m2 | Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS<br> <br> * Other names: flight simulation;|
| OHS-patients<br>patients with defined OHS: BMI>30 kg/m2 and sleep related breathing disease, no COPD | Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS<br> <br> * Other names: flight simulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| desaturation (SaO2 in %) in flight simulation in obese patients |  | one hour each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| desaturation (SaO2 in %) in hypoxic chamber test versus hypoxia altitude Simulation test |  | one hour each patient |