linjc16/ctgov huggingface dataset:
Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine if patients receiving (iNO) will have increased liver function and less damage from IR than patients who do not receive (iNO).

Official Title
-----------------
Randomized, Blinded, Controlled Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts.

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

Intervention / Treatment
-----------------
* Procedure: Inhaled Nitric Oxide (iNO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver Transplant Exclusion Criteria: Living donor transplants

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo and Study<br> | Procedure: Inhaled Nitric Oxide (iNO)<br>* iNO or placebo will be administered at 40 ppm during the procedure starting when the Warm Ischemia Time begins - liver from ice. Stop when patient transported to ICU<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the role of iNO in early ischemia reperfusion injury in marginal liver grafts during human orthotopic liver or liver/kidney transplantation. |  | 24 hours to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iNO group will show accelerated restoration of liver allograft function following liver transplantation and this may translate to better clinical outcomes. Marginal grafts may function better in the treated group |  | 1 month to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver transplant
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture

Study Overview
=================
Brief Summary
-----------------
At present our current practice is to provide a course of oral iron therapy for those patients with a post-operative haemoglobin which is below normal, but not severe enough to require a blood transfusion. Such a practice is not without side effects from the iron tablets, namely ingestion, nausea, diarrhoea, constipation. There is little evidence in the literature to support the current practice of using iron, with only one small randomised trial suggesting such therapy is unnecessary. We propose to recruit 300 patients recovering from a hip fracture with a post-operative haemoglobin below 11g/l. For those patients willing to enter the study, half will be given oral iron therapy (ferrous sulphate 200mg twice daily) for one month. The haemoglobin will be checked when the patients attends the hip fracture clinic at 6 weeks after discharge.

Official Title
-----------------
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Drug: Ferrous sulphate tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with anaemia after surgery for a hip fracture Exclusion Criteria: absence of anaemia, inability to provide consent

Ages Eligible for Study
-----------------
Minimum 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no treatment<br>no iron given | |
| Experimental: ferrous sulphate<br>iron given | Drug: Ferrous sulphate tablets<br>* 200mg twice daily for four weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 week hemoglobin |  | 6 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay side effects of therapy mortality |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip fracture, iron therapy, anaemia
A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes

Study Overview
=================
Brief Summary
-----------------
A retrospective molecular diagnostic review on wound care outcomes. The time periods include March, April, May of 2010.The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing

Detailed Description
-----------------
The null hypothesis would be that the introduction of molecular methods did not statistically affect patient outcomes. To study this hypothesis, our chief information technologist would query the database for any patients who are admitted during that time period. This period of time designated is March, April and May 2010.

Official Title
-----------------
A Retrospective Study Of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes

Conditions
-----------------
Wounds

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been treated at SWRWCC during the months of March, April, or May 2010. Exclusion Criteria: Patients who were not treated at SWRWCC during the time frame of March, April or May 2010.

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 |
| --- | --- |
| No treatment<br>Patient records would be extracted from the electronic health record system of Southwest Regional Wound Care Center and placed in a separate bin. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The retrospective review would analyze the days of healing during the timeframe, upon the introduction of molecular diagnostic testing. | To study this hypothesis, our chief information technologist would query the database for any patients who are admitted during that time period. This period of time designated is March, April and May 2010. | 1 yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
molecular methods
ALFApump System Post Marketing Surveillance Registry

Study Overview
=================
Brief Summary
-----------------
This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.

Official Title
-----------------
ALFApump System Post Marketing Surveillance Registry, In Support of the Following Indication: Automated Removal of Excess Peritoneal Fluid Into the Urinary Bladder in Patients With Cirrhosis or Malignancy, With Persistent or Refractory Ascites

Conditions
-----------------
Liver Cirrhosis, Refractory Ascites, Malignant Ascites

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory or recurrent ascites and liver cirrhosis or malignancy written informed consent Exclusion Criteria: < 18 years pregnant not able to use the Smart charger
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 |
| --- | --- | --- |
| Safety | To monitor the safety of the ALFApump System | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical performance | To monitor clinical performance of the ALFApump System | 24 months | 
| clinical impact | To monitor the clinical impact of the ALFApump System | 24 months | 
| usability | To assess the usability of the ALFApump System | 1 month |
Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Our hypothesis is that this automated point-of-care urine diagnostic device will be able to accurately determine a patient's pregnancy status at least 95% of the time.

Official Title
-----------------
Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Diagnostic Test: Pregnancy test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age 18 years and older, upper age limit of 45 years Female patient Patients undergoing any procedures for pregnancy diagnosis and confirmation English speaking The following special population will be included: Pregnant women Exclusion Criteria: Adults unable to consent Individuals who are not yet adults (infants, children, and teenagers) Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant female<br>Patient has been determined pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University. | Diagnostic Test: Pregnancy test<br>* Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy<br>|
| Non-pregnant female<br>Patient has been determined not pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University. | Diagnostic Test: Pregnancy test<br>* Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy in determining pregnancy status | Compare qualitative pregnancy test results generated by Voyant's device with urine pregnancy test result(s) and, if applicable, serum pregnancy test results performed at Northwestern University. From this comparison, we will determine the accuracy of Voyant's device. We will be using the same urine sample used at Northwestern. | Time of collection - 1 month post collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Urine Testing, Medical Diagnostics
Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.

Official Title
-----------------
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours

Conditions
-----------------
Acquired Bleeding Disorder, Cirrhosis

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII
* Drug: activated recombinant human factor VII
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis (Child-Turcotte Score A, B, or C) Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours Exclusion Criteria: Portal vein thrombosis Clinically documented DVT (deep venous thrombosis) Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke Present renal insufficiency requiring dialysis

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br> | Drug: activated recombinant human factor VII<br>* An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery<br>|
| Experimental: High dose<br> | Drug: activated recombinant human factor VII<br>* An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* An initial placebo bolus dose followed by placebo every second hour until completion of surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The RBC transfusion requirements |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of transfusion product units |  |  | 
| Change in coagulation-related parameters |  |  | 
| Adverse events |  |  |
Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment

Conditions
-----------------
Hyperlipidemia, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: NK-104-CR
* Drug: Livalo® IR
* Drug: Placebo (for NK-104-CR)
* Drug: Placebo (for Livalo® IR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients with primary hyperlipidemia or mixed dyslipidemia Patients for whom lipid-lowering therapy is indicated according to NCEP ATPIII Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 weeks before randomization and throughout study participation Exclusion Criteria: Homozygous familial hypercholesterolemia; Any conditions which may cause secondary dyslipidemia. Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >9%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NK-104-CR<br>NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks. | Drug: NK-104-CR<br>* NK-104-CR 8 mg for 52 weeks<br>Drug: Placebo (for Livalo® IR)<br>* Livalo® IR 4 mg placebo for 52 weeks<br>|
| Active Comparator: Livalo® IR<br>Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks. | Drug: Livalo® IR<br>* Livalo® IR 4 mg daily for 52 weeks<br>Drug: Placebo (for NK-104-CR)<br>* NK-104-CR 8 mg placebo for 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Low-density lipoprotein cholesterol (LDL-C) |  | Baseline to Week 12 endpoint |
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

Study Overview
=================
Brief Summary
-----------------
Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and cervicovaginal samples will be taken most mornings around the AM dose. Two visits,  14 hrs in length will be required on Day 1 and 7. The purpose of this study is to measure how much raltegravir is found in the genital tract after taking it orally.

Detailed Description
-----------------
This study is looking at blood and cervicovaginal fluid (CVF) samples of healthy volunteers taking raltegravir. The purpose of this study is to measure the extent that raltegravir penetrates into other body compartments, such as the genital tract. Subjects will take the study drug for 7 days, a total of 10 visits to the research center will be required. A screening visit will occur on no more than 28 days On Days 1 and 7 the subject will stay in the research center for approximately 12 hours for scheduled blood and CVF sampling. Days 3-6 and 8-9 will involve a short visit to the research center for one pre-dose blood and CVF sample before the morning dose. A follow up visit will occur about 7-10 days after last dose.

Official Title
-----------------
A Phase 1, Open-Label Study, Investigating First-Dose and Steady-State Pharmacokinetics of Raltegravir in the Genital Tract of HIV Uninfected Women

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Raltegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pre-menopausal female subjects Between the ages of 18 and 49 years With an intact uterus and cervix (Healthy is defined as no irregular menstrual cycles or clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Exclusion Criteria: Negative serum pregnancy test at screening and should be using at least one method of contraception Body Mass Index (BMI) of approximately 18 to 30 kg/m^2 And a total body weight > 50 kg (110 lbs)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>No control group, only one active arm with subjects taking Raltegravir. | Drug: Raltegravir<br>* 400mg raltegravir BID x 7 days<br>* Other names: Isentress;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug levels in CVF and blood plasma |  | Day 1-9 |
Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen

Study Overview
=================
Brief Summary
-----------------
Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns young sportsmen. Consequences are limitation in physical and sporting activities and at work. Main objective: to compare water and traditional rehabilitation after cruciate ligament injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities development.

Detailed Description
-----------------
Secondary objectives: to compare algo-functional and sport, social and job come back date between both groups. Multicentric randomised trial comparing two therapy protocols in knee cruciate ligament injury. After surgery, 2 weeks rehabilitation; 3 weeks conventional rehabilitation (group 1) or rehabilitation in water (group 2). Data will be collected at inclusion (before surgery), 2 weeks, 1 month, 2 months and 6 months after surgery.

Official Title
-----------------
Comparison Between Two Rehabilitation Programs (Conventional and Aquatic) After Cruciate Ligament Injury in Sportsmen

Conditions
-----------------
Cruciate Ligament Injury, Balance Control

Intervention / Treatment
-----------------
* Other: Usual protocol
* Other: Spa protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, 18-49 years, indication of knee anterior cruciate ligament reconstruction. Exclusion Criteria: other recent lower limb sprain, history of neurological disease (stroke, central or peripheral degenerative disease), psychtrope or antihypertensive drugs, aquatic activities contra-indication (cutaneous).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual protocol<br>2 weeks conventional rehabilitation 3 weeks conventional rehabilitation | Other: Usual protocol<br> <br> |
| Active Comparator: Spa protocol<br>2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation | Other: Spa protocol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posturography composite score | Postural control during quiet stance will be evaluated without and with sensory conflict by a sensory organization test | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cruciate ligament injury, Balance control, Rehabilitation, Spa therapy, Sport