linjc16/ctgov huggingface dataset:
Risk of Post Transfusion Hepatitis C Virus Infection

Study Overview
=================
Brief Summary
-----------------
To determine the risk of transfusion-transmitted hepatitis C virus (HCV) in cardiac surgery patients before and after donor screening for anti-HCV and surrogate markers of non-A, non-B hepatitis (NANBH). Also, to characterize donors who were HCV seronegative and who lacked surrogate markers at the time of donation, but whose recipient seroconverted to HCV.

Detailed Description
-----------------
BACKGROUND: In the early 1990s, posttransfusion NANBH, mainly caused by HCV, was the most common serious complication of transfusions, occurring in 2-5 percent of transfusion recipients. About 50 percent of those infected developed chronic hepatitis, of whom, 10 to 20 percent developed cirrhosis. Hepatocellular carcinoma had been reported to occur in some. This study provided the first evaluation of the effectiveness of donor screening for anti-HCV by the then recently licensed HCV antibody test and surrogate markers of NANBH. It also provided a precise estimate of the risk of transfusion-transmitted HCV. The results allowed examination of risk factors for HCV infected donors who were seronegative at the time of donation. DESIGN NARRATIVE: The study was a nonconcurrent prospective, seroepidemiologic study. To estimate the incidence of HCV infection, six-month postoperative serum samples were tested for antibody to HCV. Preoperative samples corresponding to positive postoperative sera were also tested. The donors of a patient who received blood screened for HCV, i.e., a donation since May, 1990, and seroconverted in the six months since transfusion were located and retested for antibodies to HCV. The donors were administered a questionnaire designed to ascertain risk factors for HCV infection. A sample of donors who were HCV positive at the time of donation were given the same questionnaire. Comparison of these three groups of donors (i.e., seropositives, donors tested negative but implicated in seroconversion, seronegatives) allowed an investigation of factors associated with false negative screening results. Analytical methods included standard methods for contingency tables and both conditional and unconditional logistic regression. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Hepatitis, Viral, Human, Blood Transfusion, Blood Donors

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.

Official Title
-----------------
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices

Conditions
-----------------
Peri-operative Mortality

Intervention / Treatment
-----------------
* Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with indications for elective TEVAR Exclusion Criteria: Incapability to provide consent Patients not eligible for TEVAR Pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated patients<br> | Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)<br>* Aortic aneurysm exclusion through endovascular procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Post-operative mortality (intra-operatory and up to 30 days post-surgery) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications during follow-up | 24 months |
Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.

Official Title
-----------------
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: soluble human insulin
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years Exclusion Criteria: Patients with an end-stage renal failure Patients with a serious liver disease Patients with concomitant malignant disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: soluble human insulin<br>* Observational study; use of the products as in the normal clinical practice conditions<br>* Other names: Actrapid;|
| B<br> | Drug: biphasic insulin aspart<br>* Observational study; use of the products as in the normal clinical practice conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of major hypoglycaemic events reported as serious adverse drug reactions |  | after 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious and non serious drug reactions |  | during 26 weeks | 
| Number of serious adverse event |  | during 26 weeks | 
| Number of all major (daytime and nocturnal) hypoglycaemic events |  | during 26 weeks | 
| Number of major hypoglycaemic events related to omission of a meal after injection |  | during 26 weeks | 
| Number of major hypoglycaemic events related to physical exercise of at least 30 min duration |  | during 26 weeks | 
| Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit |  | after 26 weeks | 
| Weight and waist circumference change |  | during 26 weeks | 
| Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level |  | after 26 weeks | 
| Quality of Life (QoL) |  | after 26 weeks |
Study of E3810 for Healthy Japanese Male (Under Fasting Condition)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting condition.

Detailed Description
-----------------
The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1, Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.

Official Title
-----------------
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Fasting Condition)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: rabeprazole
* Drug: rabeprazole
* Drug: rabeprazole
* Drug: rabeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19. Exclusion criteria: Subjects with allergy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: rabeprazole<br>* 10 mg normal tablet<br>|
| Experimental: 2<br> | Drug: rabeprazole<br>* Type 1 granule containing rabeprazole 10 mg<br>|
| Experimental: 3<br> | Drug: rabeprazole<br>* Type 2 granule containing rabeprazole 10 mg<br>|
| Active Comparator: 4<br> | Drug: rabeprazole<br>* Type 3 granule containing rabeprazole 10 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC) |  | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring |  | 13 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rabeprazole, Japan, healthy Japanese male
Sodium Intake in Ecuadorian Population

Study Overview
=================
Brief Summary
-----------------
This study is aim to determine the sodium intake in Ecuadorian population that is an unknown information at present. For that, 24h urine samples will be collected from 130 subjects working either at tue USFQ or HDLV to measure sodium excretion.

Official Title
-----------------
Sodium Urinary Excretion Measurement in Ecuadorian Population

Conditions
-----------------
Dietary Habits, Risk Factor, Cardiovascular, Nutritional Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Urinary sodium excretion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: None Exclusion Criteria: unable to provide informed consent unable to provide 24-hr urine excretion sample those with a known history of heart or kidney failure, stroke, and liver disease those using diuretics, multivitamins, NSADs, or prostaglandins during the last two weeks pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Urinary sodium excretion|Urinary sodium and potassium were measured using the Ion-Selective Electrode (ISE) indirect Na-K-Cl for Gen.2 (Roche Diagnostic, Switzerland).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary sodium excretion | Amount of sodium in 24h urine collection | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sodium intake, Urinary sodium excretion
Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks

Official Title
-----------------
Maintenance of Benefit After 8-Week and 52-Week Treatment With Atomoxetine Hydrochloride in Adolescents With ADHD

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have ADHD. Must be 13-16 years of age. Must be able to swallow capsules. Expected to achieve score of 70 or more on IQ test Willing and reliable to keep appts. for clinic visits and test Exclusion Criteria: Treatment within last 30 days with a drug that has not received regulatory approval for any indication. Patients who weigh less than 40 kg or greater than 70 kg. Patients with documented history of Bipolar I or II disorder, or psychosis Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 16 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

| Intervention/Treatment |
| --- |
|Drug: Atomoxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the relationship between different dosing titrations & tolerability at 4 wks, & efficacy at 8 wks; effect of atomoxetine on adaptive,family functioning, academic performance, GPA, health status,health risk behaviors at 8 wks & 52 wks |  |  |
Predicting Effective Therapy in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.

Official Title
-----------------
Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response

Conditions
-----------------
Pancreatic Cancer, Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: CTC isolocation and analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC, AJCC stage IV disease at time of enrollment. Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with or without investigational agents. Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic adenocarcinoma is permitted. ECOG performance status 0-2. A minimum age of 18 years old. Exclusion Criteria: Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma Known to be HIV positive on antiretroviral therapy Prior organ allograft Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

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 |
| --- | --- |
| Participants with Stage IV Pancreatic Cancer<br> | Diagnostic Test: CTC isolocation and analysis<br>* Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage IV Pancreatic Cancer, FOLFIRINOX, gem/nab-P chemotherapy, 17-042
Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 1)

Study Overview
=================
Brief Summary
-----------------
The research is aimed to explore the needs of clinical patients and their caregiver,so as to provide suggestions to the designer of the communication system.

Detailed Description
-----------------
To promote and develop a smart communication system is helpful to patients with amyotrophic lateral sclerosis (ALS),especially for stage 3 and stage 4 (late stage). Through the needs assessment, the research is aimed to explore the needs of clinical patients and their caregiver,so as to provide suggestions to the designer of the communication system.

Official Title
-----------------
Taipei Veterans General Hospital

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ALS Taiwanese and used traditional Chinese(Mandarin). If they were older than age 20 years. Exclusion Criteria: Frontotemporal dementia, severe depression, or schizophrenia. If they cannot complete the questionnaire with researchers or family members help.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Amyotrophic Lateral Sclerosis Supportive Care Needs (ALSSCN) | The ALSSCN consisted of 37 items with seven domains: physical, psychological, emotional, spiritual, social, informational, and practical needs. | 2018.10.01 2020.04.31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic lateral sclerosis, ALS, communication, needs
Surgical Classification of Abnormal Placentation

Study Overview
=================
Brief Summary
-----------------
Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.

Conditions
-----------------
Adherent Placenta

Intervention / Treatment
-----------------
* Device: Trans- abdominal sonography
* Device: Trans-vaginal sonography
* Procedure: post-operative pathological specimen examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abnormal placental site (placenta previa) Exclusion Criteria: refusal to participate in the study cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>the included pregnant females will undergo trans-abdominal sonography as well as trans-vaginal sonography , to diagnose the abnormal placentation and the results will be compared to the intra- operative as well as the pathological examination of the specimen. | Device: Trans- abdominal sonography<br> <br> Device: Trans-vaginal sonography<br> <br> Procedure: post-operative pathological specimen examination<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss |  | 24 hours |
Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study

Study Overview
=================
Brief Summary
-----------------
This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).

Detailed Description
-----------------
This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081). This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic liver cirrhosis. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, occurrence of adverse events and serious adverse events, clinical laboratory tests, vital sign, physical examinations.).

Official Title
-----------------
Long-term Follow-up Study of Livercellgram in Alcoholic Liver Cirrhosis Patients Who Completed Livercellgram Phase 2 Study

Conditions
-----------------
Alcoholic Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who treated with Livercellgram and completed the Livercellgram phase 2 study. Subjects who can agree to participate in the long term observation study by oneself. Exclusion Criteria: Not Applicable

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no Intervention<br>Long-term follow up of no intervention group | |
| 1-time injection group<br>Long-term follow up of 1-time injection group | |
| 2-time injection group<br>Long-term follow up of 2-time injection group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations | Tumor Marker Test Occurrence of Adverse Events and Serious Adverse Events Clinical Laboratory Tests Vital Sign Physical Examinations | 5-year(+30 days) |