linjc16/ctgov huggingface dataset:
Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant

Study Overview
=================
Brief Summary
-----------------
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).

Detailed Description
-----------------
Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.

Official Title
-----------------
A Prospective Randomized Multi-Center Study of the Use of the Organ Recovery Systems LifePort® Liver Transporter (LLT) System With Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplants (Perfusion to Improve Liver Outcomes in Transplantation)

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Device: Hypothermic machine perfusion
* Device: Static cold storage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation De novo liver transplant recipient Written informed consent required Exclusion Criteria: Subject is a multi-organ transplant recipient Subject is antibodies blood group (ABO) liver incompatible Subject has severe systemic infection Subject is Human Immunodeficiency Virus (HIV) positive Subject has acute/fulminant liver failure Subject is pregnant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypothermic Machine Perfusion<br>Hypothermic Machine Perfusion with Organ Recovery Systems LLT system | Device: Hypothermic machine perfusion<br>* Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution<br>|
| Active Comparator: Static Cold Storage<br>Standard of Care - Static Cold Storage | Device: Static cold storage<br>* Static cold storage (standard of care)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in each arm with Early Allograft Dysfunction (EAD) | EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) >2000IU/L or Alanine Aminotransferase (ALT) > 2000 IU/L | 7 days |
Taurine in Peripartum Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
Taurine as an adjunct for early left ventricular recovery in peripartum cardiomyopathy

Official Title
-----------------
Taurine for Early Left Ventricular Recovery in Peripartum Cardiomyopathy

Conditions
-----------------
Peripartum Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: Taurine Solution
* Dietary Supplement: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peripartum Cardiomyopathy Exclusion Criteria: Other identifiable cause for heart failure low LVEF ≤ 25% sepsis autoimmune disease severe chronic disease malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taurine<br> | Drug: Taurine Solution<br>* Taurine Solution<br>|
| Placebo Comparator: Saline<br> | Dietary Supplement: Normal Saline<br>* Normal Saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of the left ventricular ejection fraction >10 % | improvement of the left ventricular ejection fraction >10 % | 1 week |
Systemic Inflammation Versus Acute Pain in Total Knee Arthroplasty (TKA)

Study Overview
=================
Brief Summary
-----------------
In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA).

Detailed Description
-----------------
The correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA) is evaluated. Level of systemic inflammatory markers (CRP and IL6) are measured preoperatively and 4 and 24 hours postoperatively. These measurements are correlated to postoperative pain (a detailed assessment of pain at rest and during ambulation). We pole blood-samples collected prospectively (from two data set)

Official Title
-----------------
The Relation Between Systemic Inflammatory Markers and Acute Pain in TKA

Conditions
-----------------
Other Acute Postoperative Pain, Systemic Inflammatory Response Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective unilateral primary total knee arthroplasty Able to speak and understand danish Able to give informed consent Exclusion Criteria: Alcohol or medical abuse Allergies to local anesthetics or methylprednisolone Age < 18 years old Daily use of strong opioids or glucocorticoids Pregnancy or breastfeeding (fertile women) Bilateral / revision arthroplasty Dementia or other cognitive dysfunction Diabetic neuropathy, rheumatoid arthritis, and neurologic or psychiatric diseases potentially influencing pain perception

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 |
| --- | --- |
| Total knee arthroplasty<br>Patients operated with elective, unilateral total knee arthroplasty. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammation vs. pain | The correlation between pain and systemic inflammatory markers (CRP and IL6) | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute postoperative pain, systemic inflammation, CRP, IL6
Prevention of Iron Deficiency in 2nd Year of Life

Study Overview
=================
Brief Summary
-----------------
Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be followed up as a control group. Following a nutritional questionnair, parents of all babies will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up blood count will be taken from all participating babies 3 months after recruitment. The study aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The hypothesis is that babies who receive iron supplementation in the 2nd year of life are less likely to develop iron deficiency or anemia.

Official Title
-----------------
Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency

Conditions
-----------------
Iron Deficiency, Anemia

Intervention / Treatment
-----------------
* Drug: Ferripel-3 - iron polysaccharide complex for prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy babies without iron deficiency Exclusion Criteria: Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease

Ages Eligible for Study
-----------------
Minimum Age: 8 Months
Maximum Age: 18 Months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ferripel-3 - iron polysaccharide complex for prevention|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
-----------------
Iron supplementation, Babies, Prevention
The Prone XLIF. A Pilot Study

Study Overview
=================
Brief Summary
-----------------
Observational prospective study to evaluate the feasibility, effectiveness and the rate of complications of the XLIF (Extreme Lateral Interbody Fusion) performed in prone position to treat spinal diseases of the lumbar region.

Official Title
-----------------
The Prone XLIF. An Observational Pilot Study Based on Prospective Study

Conditions
-----------------
Spinal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Patients suffering from lumbar spinal disease that requires a circumferential fusion Patients suitable to undergo spinal fusion with an XLIF technique (according to the label indication/contraindications) Patients who are willing and able to provide written informed consent to surgery and study Exclusion Criteria: a congenital or post-traumatic vertebral abnormality at the target level patients with a previous abdominal retroperitoneal surgery patients that refuses/not suitable to undergo a XLIF surgery in prone position subjects that are unable to provide a written informed consent to surgery and study subjects that are unable to will or intend pregnant women (declared before 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Registration of intraoperative complications during surgery | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | Evaluation of clinical outcomes using Oswestry Disability Index (ODI) questionnaire. It is a scaled questionnaire from 0 to 100 in which the higher the value, the worst the outcome. | in 5 days from surgery - 6 months follow-up | 
| Length of surgery | Evaluation of length of surgery | intraoperative | 
| Subsidence rate | Evaluation of subsidence rate at postoperative x-ray | in 5 days from surgery | 
| Visual Analogic Score (VAS) leg and back | Evaluation of clinical outcomes using the VAS score, going from 0 to 10, where 0 means no pain and 10 the worst pain possible. | in 5 days from surgery - 6 months follow-up |
The Long Term Impact of Initiating Pramipexole Versus Levodopa in Early Parkinson's Disease (CALM-PD Cohort Study)

Study Overview
=================
Brief Summary
-----------------
To determine the long-term consequences (8 years) of initiating patients with Parkinson's disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England (S/E) scale 8 years after randomization.

Official Title
-----------------
Unblinded, Multicenter, Prospective Follow-up of Long-term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: No intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Available 301 subjects enrolled in the CALM-PD study. Exclusion Criteria: Those not enrolled in the CALM-PD study.
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>Available 301 subjects enrolled in CALM-PD Available 82 subjects enrolled in CALM-PD imaging substudy | Other: No intervention.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England. |  | 8 years from date randomized in CALM study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our secondary specific aim is to develop and estimate a structural model that will allow us to uncover the causal pathways through which treatments effect outcomes. |  | 8 years from randomization of CALM-PD study |
Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to rule out a harmful effect of zinc supplementation in HIV-1-infected children. The null hypothesis is that zinc supplementation will increase plasma HIV RNA levels.

Detailed Description
-----------------
A randomized, double-blind, placebo-controlled equivalence trial of zinc supplementation was conducted at Grey's Hospital in Pietermaritzburg, South Africa. Ninety-six HIV-1-infected children were randomly assigned to receive 10 mg of elemental zinc as sulfate or placebo daily for 6 months. Baseline measurements of plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were established at two study visits prior to randomization, and measurements were repeated 3, 6 and 9 months after starting supplementation. Plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were compared before and after supplementation.

Official Title
-----------------
Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: zinc supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infection 6 to 60 months of age Not receiving antiretroviral therapy Cared for as outpatients at Grey's Hospital Exclusion Criteria: Receiving antiretroviral therapy

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 60 Months

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zinc supplementation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean difference in log10 HIV-1 viral load at each visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean difference in percentage of CD4+ T-cells at each visit |  |  | 
| number of illness visits |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zinc, HIV, children
Observational Study to Assess the Efficacy and Safety of NovoRapid™ Flexpen™

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data in diabetic patients with acute hyperglycemia using NovoRapid™ FlexPen™ as per normal clinical practice.

Official Title
-----------------
A Prospective, Open-Labelled, Non-Controlled, Observational Study to Assess the Efficacy and Safety of NovoRapid™ FlexPen™ in the Treatment of Acute Hyperglycemia: A Post-Marketing Surveillance Study

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes mellitus (according to product labelling) Exclusion Criteria: Hypoglycaemia Hypersensitivity to insulin aspart or to any of the excipients (according to product labelling)
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: insulin aspart<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of Insulin Aspart among Filipino patients |  | 1-month follow-up for outpatients; 1 month or upon discharge for inpatients whichever comes first |
Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.

Official Title
-----------------
Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

Conditions
-----------------
Biliary Cancer, Cholangiocarcinoma

Intervention / Treatment
-----------------
* Drug: Gemcitabine, Irinotecan, Panitumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract measurable disease available tumor tissue for investigational immunohistochemical evaluations ECOG PS 0-2 No prior chemotherapy, biologic therapy or radiation therapy Age Eighteen and older Lab values per protocol Exclusion Criteria: Life expectancy less than three months Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment Prior therapy, which affects or targets the EGF pathway Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer Recovery from major surgery within three weeks of the start of study treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br>Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities. | Drug: Gemcitabine, Irinotecan, Panitumumab<br>* Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival Rate at Five Months |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate From Combination Chemotherapy |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biliary Cancer, Cholangiocarcinoma, Panitumumab
An Observational Study of Avastin and Conventional Chemotherapy in Patients >/= 70 Years of Age With Previously Untreated Metastatic Colorectal Cancer (AVAPLUS)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the use of Avastin (bevacizumab) and conventional chemotherapy in patients >/= 70 years of age with previously untreated metastatic colorectal cancer. Data will be collected from each patient from initiation of treatment until disease progression occurs (minimum follow-up 12 months).

Official Title
-----------------
Prospective Non-interventional Study to Collect Data on the Use of Avastin and Conventional Chemotherapy for the Treatment of Previously Untreated Metastatic Colorectal Cancer in Patients >/= 70 Years

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/ 70 years of age Previously untreated metastatic colorectal cancer Patient considered suitable to receive chemotherapy with or without Avastin Exclusion Criteria: Participation in any other clinical trial or study with the exception of participation in registries

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration in patients receiving chemotherapy with Avastin as first-line therapy in daily clinical practice |  | approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration in patients receiving chemotherapy alone as first-line therapy in daily clinical practice |  | approximately 24 months | 
| Safety: Incidence of adverse events/adverse events of special interest |  | approximately 24 months | 
| Clinical/demographic patient characteristics at baseline |  | approximately 24 months | 
| Dosage/regimen |  | approximately 24 months | 
| Correlation between Comprehensive Geriatric Assessment (CGA) scores and initial treatment |  | approximately 24 months |