linjc16/ctgov huggingface dataset:
Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4 weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during therapy and for four weeks following therapy.

Detailed Description
-----------------
This is a multi-center, randomized, investigator and subject blinded, placebo-controlled eight week study, including a four week treatment period and a four week follow-up period. Three cohorts of HCV positive subjects will be studied in a sequential manner.

Official Title
-----------------
A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

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

Intervention / Treatment
-----------------
* Drug: FK788


Participation Criteria
=================
Eligibility Criteria
-----------------
The following criteria is a brief summary of Criterion required for trial participation. Inclusion Criteria Has chronic hepatitis C virus infection and has previously received at least three months of treatment with any approved therapy and failed to respond, relapsed or did not tolerate therapy Has positive HCV RNA by RT-PCR Has abnormal ALT levels (at least 2 X ULN) Has liver biopsy within past 2 years consistent with chronic hepatitis, no evidence of non-alcoholic steatohepatitis or cirrhosis, and at least mild inflammation Has normal liver function indicated by: PT =< 2 sec. prolonged compared to the ULN, Albumin >= 3.5 g/dL, Total bilirubin =< 1.5 mg/dL ANA titer =< 1:160 Exclusion Criteria Has positive skin test for tuberculosis Has ALT value >= 300 IU/L Has abnormal hematological parameters indicated by: ANC < 1500/mm3 and Platelets < 100,000/mm3 Has creatinine > 1.5 X ULN AFP > 50 ng/mL and evidence of hepatocellular carcinoma on ultrasound Is a carrier of the hepatitis B surface antigen (HBsAg), positive for HIV-1 and/or HIV-2 antibodies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FK788|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV
Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.

Study Overview
=================
Brief Summary
-----------------
The stress of orthotopic living donor liver transplantation in patients with cirrhosis could induce worsening of an already recorded myocardial dysfunction or may be associated with a new myocardial dysfunction in patients previously having normal myocardial functions, therefore this study will be designed for intra-operative detection of new onset ventricular dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver transplant recipient and the possible contribution of several hemodynamic and oxygenation parameters in the generation of any cardiovascular function impairment will be also investigated and to determine the impact of ventricular dysfunction on early (7 PO days) graft function, 28 days survival and patient outcomes.

Official Title
-----------------
Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.

Conditions
-----------------
Liver Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult recipient Exclusion Criteria: massive blood transfusion grade III esophageal varices

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| hemodynamic monitoring |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft function |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recipient
Enhancing Renal Graft Function During Donor Anesthesia

Study Overview
=================
Brief Summary
-----------------
Renal transplantation is now recognized as the treatment of choice for patients with end-stage renal disease. An optimum anesthetic regimen should enhance the function and perfusion of the transplanted kidney. The aim of this study is to assess & compare the effectiveness of 3 different modalities in this respect: Mannitol, Dopamine and adequate hydration.

Official Title
-----------------
Renal Graft Functional Enhancement During Donor Anesthesia: A Comparative Study of 3 Modalities

Conditions
-----------------
Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia

Intervention / Treatment
-----------------
* Procedure: Mannitol infusion
* Procedure: Dopamine infusion
* Procedure: Adequate hydration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: end-stage renal disease, for living-donor kidney transplantation Exclusion Criteria: severe cardiac or hepatic dysfunction coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using computer & sealed envelope randomization, patients are assigned to receive either Mannitol [M group; n=20], Dopamine [D group; n=20] or adequate hydration [C group; n=20]
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M group<br>Mannitol infusion | Procedure: Mannitol infusion<br>* Infusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes.<br>|
| Active Comparator: D group<br>Dopamine infusion | Procedure: Dopamine infusion<br>* Infusion of Dopamine at a dose of 4 microg/kg/min to the renal graft donor after induction of anesthesia till ligation of the renal artery.<br>|
| Active Comparator: C group<br>Adequate hydration | Procedure: Adequate hydration<br>* Infusion of Ringer Acetate at a rate of 15 ml/kg/hr to the renal graft donor after induction of anesthesia till ligation of the renal artery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative creatinine clearance | Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mannitol, Dopamine, Perfusion, Renal graft donor, Anesthesia
Home PT vs FORCE PT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a web-based platform or paper manual is a safe and effective alternative to outpatient physical therapy after total knee replacement.

Official Title
-----------------
Unsupervised Home Exercise With and Without a Web-based Recovery Platform as Compared to Traditional Outpatient Physiotherapy After Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Other: Home PT via web-based platform
* Other: Home PT via paper manual
* Other: outpatient PT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Any patient undergoing unilateral, primary TKA Exclusion Criteria: Patients without access to the Internet Patients without access to outpatient PT Revision or conversion TKA Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.

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 |
| --- | --- |
| Active Comparator: Home PT via web-based platform<br>unsupervised, home rehabilitation delivered by a web-based platform | Other: Home PT via web-based platform<br> <br> |
| Active Comparator: Home PT via paper manual<br>unsupervised, home rehabilitation delivered by a paper manual | Other: Home PT via paper manual<br> <br> |
| Active Comparator: outpatient PT<br>outpatient physical therapy | Other: outpatient PT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Range of Motion | Measured in degrees from 0-130 | 1 month post surgery |
Cardiac Autonomic Function For Risk Stratification in the Emergency Room

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to test the hypothesis that impaired cardiac autonomic function predicts adverse outcome in unselected patients presenting in the emergency ward.

Official Title
-----------------
Risk Stratification in the Emergency Room by Cardiac Autonomic Function

Conditions
-----------------
Autonomic Nervous System Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - presenting at the emergency department of the University Hospital of Tübingen

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 |
| --- | --- | --- |
| In-hospital mortality |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac mortality |  | 10 days | 
| transfer to intensive care unit |  | 10 days | 
| hospital discharge |  | 48 hours | 
| duration of hospital stay |  | within 30 days | 
| costs of health care |  | 30 days | 
| 180 day mortality |  | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergency care, cardiac autonomic function, deceleration capacity
Iloprost Therapy in Patients With Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.

Official Title
-----------------
Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Drug: Iloprost (Ilomedin, BAYQ6256)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who fulfill the internationally defined criteria of critical limb ischemia; Patients who are not eligible for vascular surgery or angioplasty interventions and Patients who are treated with iloprost infusion. The treating physician has decided iloprost treatment before study enrollment. Exclusion Criteria: Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.

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 |
| --- | --- |
| Group 1<br> | Drug: Iloprost (Ilomedin, BAYQ6256)<br>* Prescription and treatment of Iloprost will be decided by physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of limb pain at rest assessed by visual analogue scale | Pain relief will be defined as complete relief of pain while off analgesics | At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ulcer healing |  | at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) | 
| Collection of interventional / surgical procedures including 1) Rate of revascularization procedures; 2) Minor amputations; 3) Frequency and height of major amputations |  | at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) | 
| Mortality and/or severe cardiovascular events (AMI, stroke) |  | at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) | 
| Hemodynamic measurements: peripheral arterial blood flow and pressure on ankle / hallux level by Doppler scanner |  | at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) | 
| Changes of transcutaneously measured tissue oxygen tension values |  | at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical limb ischaemia, Iloprost, Quality of life, Visual analogue scale
Treatment of Recurrent Bladder Cancer With Dendritic Cells

Study Overview
=================
Brief Summary
-----------------
Treatment of recurrent bladder cancer with dendritic cells

Official Title
-----------------
Treatment of Recurrent Bladder Cancer With Autologous Monocyte-derived Dendritic Cells

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Biological: Dendritic cells
* Other: Standard treatment according to the Clinical protocols


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of pTa bladder cancer; Patient who require repetitive transurethral resection; Expression of muc-1/wt-1 by the tumor; EGOC 0-3; Exclusion Criteria: any medical condition which can be associated with the high risk for the patient; pregnancy/lactation; chronic infections, including hepatitis B/C, tuberculosis, HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dendritic cells<br>Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells | Biological: Dendritic cells<br>* Autologous dendritic cells primed with muc-1/wt-1 peptides<br>Other: Standard treatment according to the Clinical protocols<br>* Standard treatment of bladder cancer according to the Clinical protocols<br>|
| Active Comparator: Control<br>Patients with the recurrent bladder cancer receiving standard treatment | Other: Standard treatment according to the Clinical protocols<br>* Standard treatment of bladder cancer according to the Clinical protocols<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy evaluation | 1 year relapse free survival | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder Cancer, Dendritic cells
Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)

Study Overview
=================
Brief Summary
-----------------
30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and functional (Stress Index>1) conditions of hyperinflation even with Plateau pressure (Pplat) < 30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more protective ventilation. In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my allow the reduction of Tidal Volume (Vt) and Pplat.

Detailed Description
-----------------
Aim of the study was to verify the efficacy of CO2-removal technique in reducing Vt and consequently Pplat to obtain a Stress Index value equal to 1.

Conditions
-----------------
Adult Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Procedure: protective ventilation with CO2 removal technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS patients with Pplat >= 26 during NIH protective ventilation protocol Exclusion Criteria: Age < 18 years Brain injury and patients with intracranial pressure > 20 mmHg Pregnancy Immunodepressed patients Patients already enrolled in other trials Renal replacement therapy BMI > 40 Contraindication anticoagulation treatment Morphological abnormalities of femoral veins NYHA III-IV Burns BSA>30% Hepatic failure (grade C Child)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Procedure: protective ventilation with CO2 removal technique|In ARDS patients, presenting a Pplat ≥ 26 cmH2O, Vt was lowered (reaching a Pplat < 26) with CO2-removal veno-venous pump-driven bypass support for 48 consecutive hours with a pH > 7,30 or at least 72 hours from the beginning of the extracorporeal treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary inflammatory mediator reduction |  | within the first 72 hours after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Insufficiency, CO2 removal, protective ventilation, ARDS
Monitoring Cellular Immunity After Kidney and Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
After transplantation, if insufficient immunosuppression is achieved, rejection and graft loss follows. If to much immunosuppression is given, the patient suffers risk for infections and malignancies. Despite careful dosing and monitoring of drug levels, the biological effects of the immunosuppression given is difficult to predict and varies significantly. As a result, the degree of immunosuppression (or immunosuppressive status) remains unknown and clinical problems related to under- or over-immunosuppression are common. Thus, a method to determine the degree of immunosuppression would be of great and direct clinical importance and the results would be improved. T cells are the principal cells of the immunesystem causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell reactivity could reflect the biological effects of the immunosuppression and the immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence against viral diseases. Therefore, data on virus specific T cell reactivity could aid in diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a clinically useful method to monitor cellular immunity and the degree of immunosuppression after transplantation by determinations of the specific T cell reactivity to several clinically relevant viruses.

Official Title
-----------------
Monitoring Cellular Immunity After Kidney and Liver Transplantation

Conditions
-----------------
Terminal Kidney Failure, Terminal Liver Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing kidney or liver transplantation at the Karolinska University Hospital Exclusion Criteria: Abscence of informed consent

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 |
| --- | --- |
| Kidney transplant<br> | |
| Liver transplant<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell reactivity to viral antigens |  | Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplantation, Immunological monitoring, Immunological risk, T cell reactivity, Cellular immunity