linjc16/ctgov huggingface dataset:
HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

Study Overview
=================
Brief Summary
-----------------
Objective: The goal is to improve peginterferon sensitivity in previous poor responders. Sensitivity here means the host's ability to kill more HCV. Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.

Official Title
-----------------
An Investigator-initiated Pilot Study Using Statins to Improve the Anti-HCV Response to Peginterferon Alfa 2-b and Ribavirin in Previous Non-responders

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

Intervention / Treatment
-----------------
* Drug: statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening Exclusion Criteria: decompensated liver disease severe cardiac disease (ejection fraction < 20% or uncontrolled angina) unexplained muscle pain at time of screening pregnancy renal insufficiency (creatine clearance < 50 ml/min)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: statin<br> | Drug: statin<br>* daily statin orally for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in peginterferon response as measured by change in HCV RNA levels | The change in hepatitis C viral load in response to one injection of peginterferon will be measured with a baseline pre-study viral load and response to an injection of peginterferon; this test will be remeasured 48 weeks later. The change in viral loads over time will be assessed statistically. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response of interferon stimulated genes | The number of known interferon activated genes will be assessed by microarray from serum samples at baseline and then reassessed by microarray 48 weeks later. | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic hepatitis C, interferon
Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find a protein (ex. Polycystin 1 or mucin and cadherin like protein) in the urine that is changed after treatment of hydralazine.

Official Title
-----------------
Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients

Conditions
-----------------
Polycystic Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Hydralazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of ADPKD estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73m^2 Exclusion Criteria: History of systemic lupus erythematous or other rheumatologic disorder Baseline anti-nuclear antibody (ANA) >1:80 for females and >1:40 for males Blood pressure < 120/80 without anti-hypertensive Angina pectoris or myocardial infarction in the last 6 months Liver disease Allergy to hydralazine

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Hydralazine<br>Participants will take hydralazine twice daily for total of 6 weeks. The dose of hydralazine will be increased every 2 weeks. | Drug: Hydralazine<br>* Participants will be asked to take pills two times per day for 6 weeks. This is a dose increasing study with potential doses ranging from 5 mg two times per day to 50 mg two times per day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in polycystin-1 (PC1) |  | Change from Baseline to Week 8 | 
| Change in mucin-like protocadherin (MUPCDH) |  | Change from Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating methylated RASAL1 levels |  | Change from Baseline to Week 8 |
Vaginal Tactile Imaging for Pelvic Floor Prolapse

Study Overview
=================
Brief Summary
-----------------
The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.

Official Title
-----------------
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Other: Pre/post imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female of 21 years or older, and No prior pelvic floor surgery, and One of the following: Normal pelvic floor conditions, or POP Stage I affecting one or more vaginal compartment, or POP Stage II affecting one or more vaginal compartment, or POP Stage III affecting one or more vaginal compartment, or POP Stage IV affecting one or more vaginal compartment Exclusion Criteria: Active skin infection or ulceration within the vagina Presence of a vaginal septum; Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder; Ongoing radiation therapy for pelvic cancer; Impacted stool; Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia; Severe hemorrhoids; Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician; Current pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Pre/post pelvic floor surgery imaging<br> | Other: Pre/post imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm | Tissue elasticity is measured for entire anterior and posterior compartments | pre-surgery and post-surgery (4-6 months after surgery) measurements | 
| Pelvic floor muscle strength change after the surgery measured as a pressure dynamic feedback during muscle contractions. Unit of measure: mmHg | Muscle strength is measured during voluntary and involuntary muscle contractions, involuntary relaxation and Valsalva maneuver. | pre-surgery and post-surgery (4-6 months after surgery) measurements |
Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome

Study Overview
=================
Brief Summary
-----------------
Constipation is a common condition among patients with Guillain-Barré Syndrome. It is believed, that the constipation is caused by autonomic neuropathy. However, the severity of the constipation, and its relation to autonomic function have not previously been studied.

Official Title
-----------------
Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome

Conditions
-----------------
Constipation, Guillain-Barre Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Guillain-Barré Syndrome Ability to swallow the capsules used to assess GITT Ability to give meaningful informed consent to participate in the study Exclusion Criteria: Major abdominal disorders Severe acute comorbidity Known cancer Pregnancy Other known neurological disorder Use of laxatives one week before inclusion. (Patients will be excluded if medication with laxatives is started during the one week GITT measurement)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| GBS Patients<br>Patients with Guillain-Barré syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal transit time (GITT) [in days] |  | The measurement takes one week to perform. The investigators aim to start the measurement within one week after diagnosis. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between heart rate variability (HRV) and GITT | Linear regression with GITT as dependent variable, and high frequency power spectral density analysis of the heart rate (HF) as the independent variable. The mean HF of the first and second HRV measurement is used for this regression. | The first HRV measurement is performed within one week after diagnosis. The second is performed 7 days after the first. |
The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy.

Detailed Description
-----------------
Establish a clinical database of patients who are diagnosed with metastasis colorectal cancer in tongji hospital. Build a biological specimen banks of metastasis colorectal cancer through collecting blood samples from those patients who have reached an agreement with us. Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer. To extract DNA from the blood and explore some biomarkers that related to target therapy in metastasis colorectal cancer.

Conditions
-----------------
Neoplasms, Therapy-Associated

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastasis colorectal cancer confirmed by histologically and radiography Receive target therapy over half a year Have a measurable lesions Exclusion Criteria: 1. A history of other malignant tumors in five 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 |
| --- | --- | --- |
| overall survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Molecular Targeted Therapy, metastasis colorectal cancer, biomarker
Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

Study Overview
=================
Brief Summary
-----------------
Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.

Detailed Description
-----------------
We focused on HCV patients with or without HIV with MC who had at least one cryoglobulin level assessment before and after DAA therapy and investigated the impact of DAA therapy on cryoglobulin clearance.

Official Title
-----------------
Benefit of Direct-acting Antiviral Therapy in Hepatitis C Virus (HCV) Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

Conditions
-----------------
Hepatitis C, Chronic, Mixed Cryoglobulinemia

Intervention / Treatment
-----------------
* Drug: DAA treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatitis C virus (HCV) infected patients symptomatic or asymptomatic mixed cryoglobulinemia coinfected or not with HIV treated by direct-acting antiviral (DAA) treatment at least one cryoglobulin measurement before and after DAA Exclusion Criteria: -

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 |
| --- | --- |
| HCV patients with mixed cryoglobulinemia<br>HCV patients with or without HIV presenting a mixed cryoglobulinemia and treated with direct-acting antiviral agents | Drug: DAA treatment<br>* Patients were treated with direct-acting antiviral (DAA) treatment for 12 or 24 weeks<br>* Other names: Treatment with direct-acting antiviral agents;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cryoglobulin level at the end of therapy | The primary outcome was the cryoglobulin level at the end of direct-acting antiviral treatment (week 12 or 24 according to treatment duration) | End of treatment (12 or 24 weeks) |
Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

Detailed Description
-----------------
This study is a two-part phase I-II study. Part 1 will determine the MTD of Genasense in patients with CLL. This dose will then be tested in a non-randomized, multi-center, Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL. Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients.

Official Title
-----------------
Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia, CLL

Intervention / Treatment
-----------------
* Drug: Oblimerson sodium, G3139


Participation Criteria
=================
Eligibility Criteria
-----------------
Any age Must have received at least one chemotherapy regimen that included fludarabine Measurable disease At least 3 weeks since biological therapy or radiation therapy for chronic lymphocytic leukemia No previous stem cell transplantation At least 3 weeks since surgery

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oblimerson sodium, G3139|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
-----------------
CLL, Leukemia, Chronic, Cancer, Adult, Lymphocytic, Genasense, G3139, Genta, Bcl-2, Antisense, Oligonucleotide, oblimerson
Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease

Study Overview
=================
Brief Summary
-----------------
There is an unmet demand for the evaluation of nocturnal hypoventilation in children with NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. If an ambulatory, at home, tcCO2 monitoring device is shown to be diagnostically accurate, sleep physicians would be able to triage children on existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by international guidelines.

Official Title
-----------------
The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease

Conditions
-----------------
Sleep Disorder; Breathing-Related, Central Apnea, Neuromuscular Diseases, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Transcutaneous CO2 monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with a confirmed diagnosis of NMD that meet criteria for evaluating SDB as per international recommendations lives within the greater Toronto area. Exclusion Criteria: known diagnosis of nocturnal hypoventilation current ventilatory support physician diagnosis of active upper respiratory tract infection (fever, increased cough, rhinorrhea, increased nasal congestion, sore throat, headache, malaise and/or sneezing).

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

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

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

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: Transcutaneous CO2 monitoring<br> | Device: Transcutaneous CO2 monitoring<br>* The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of ambulatory, at home, transcutaneous CO2 (tcCO2) monitoring to diagnose nocturnal hypoventilation as compared to the gold standard, end tidal CO2 conducted during polysomnogram (PSG). |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a) Agreement of tcCO2 monitoring when worn in the ambulatory, at home, setting compared to tcCO2 recorded during a PSG in a hospital based sleep laboratory for diagnosis of nocturnal hypoventilation. | b) Correlation of the pre and post sleep capillary blood gas results with end tidal CO2 (etCO2) and tcCO2 recordings during PSG. | 9 months |
Assessment of the Effect of Age on Duration of Analgesia From Single-shot Femoral Nerve Blocks

Study Overview
=================
Brief Summary
-----------------
Cohort study to examine the effect of age on duration of analgesia in patients receiving single-shot femoral nerve block prior to surgery, by postoperative phone follow-up questionnaire.

Detailed Description
-----------------
The purpose of this study is to find out how differences in age can affect the duration of pain relief from a femoral nerve block. Complete recovery after leg surgery involves healing of tissues at the surgical site, recovery of muscle strength and range-of-motion. Some pain is normally experienced after leg surgery. At the hospital, pain is usually treated with pain medicines, and/or a nerve block procedure. A nerve block involves injecting a local anesthetic beside the nerves to numb the nerves that supply feeling to the knee joint and surrounding tissues. The choice as to whether a participant has a nerve block or not is made by the participant and their surgeon and is not determined by this research study. The study aim is to find out how long a nerve block can relieve postsurgical pain, and whether that duration is affected by the age of the participant.

Official Title
-----------------
Assessment of the Effect of Age on Duration of Analgesia From Single-shot Femoral Nerve Blocks

Conditions
-----------------
Analgesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (age >18 years) American Society of Anesthesiology physical status 1-3 Having ambulatory surgery, who have received a single-shot femoral nerve block Able to read and understand English Have access to a phone after surgery Exclusion Criteria: Pediatric patients (age <18 years) American Society of Anesthesiology physical status >3 Unable to read and understand English Unable to have access to a phone after surgery

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia | Total duration of analgesia from peripheral femoral nerve block | From time of block placement to patient to the reported end of analgesic effect, up to 72 hours |