linjc16/ctgov huggingface dataset:
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation

Study Overview
=================
Brief Summary
-----------------
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.

Official Title
-----------------
Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation

Conditions
-----------------
Liver Preservation

Intervention / Treatment
-----------------
* Device: OCS Liver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered male or female primary Liver transplant candidate Age ≥18 years old Signed: written informed consent Exclusion Criteria: Acute, fulminant liver failure; Prior solid organ or bone marrow transplant; Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl (>265 mmol/L) for >2 weeks and/or requiring hemodialysis; Multi-organ transplant; Ventilator dependent; Dependent on > 1 IV inotrope to maintain hemodynamics; Malignancy excluding HCC; Infection.

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: OCS Liver<br>OCS Liver will be used to preserve the donor liver | Device: OCS Liver<br>* OCS Liver will be used to preserve the donor liver<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of donor livers preserved by OCS in a near physiologic state. |  | Within 1 day of organ retrieval | 
| Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted |  | Within 1 day of organ retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of donor livers maintained in a metabolically active and functioning state during preservation. |  | Within 1 day of organ retrieval | 
| Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation. |  | Within 1 day of organ retrieval | 
| Frequency of liver graft-related serious adverse events |  | 30 days after transplantation |
Polycystic Ovary Syndrome - Improving Outcomes

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome affects a striking 9-18% of Australian reproductive aged women and has been associated with a number of metabolic abnormalities. Given the strong correlation between metabolic abnormalities and increased sympathetic activity, we hypothesise that reducing this activity using medication (moxonidine) can help improve the metabolic abnormalities, and therefore improve outcomes in polycystic ovary syndrome.

Official Title
-----------------
Polycystic Ovary Syndrome - Targeting the Sympathetic Nervous System to Improve Outcomes

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Moxonidine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight and class I obese pre-menopausal women Diagnosis of PCOS by Rotterdam criteria Exclusion Criteria: Any current medication pregnancy or the desire to become pregnant BMI > 35 a history of type I diabetes, secondary hypertension not due to PCOS cardiovascular, cerebrovascular, liver or thyroid disease severe mental illness.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br> | Drug: Moxonidine<br>* 0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Encapsulated lactose powder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microneurography | Microneurography is a technique developed to measure the sympathetic activitiy directly from the peroneal nerve. Microneurography will be performed at baseline visit and at 3 months follow up visit. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood biochemistry measurement | To assess the metabolic function of the participants we will be drawing fasting blood samples for biochemical analysis. These test will be performed at baseline and 3 months follow up visit | 3 months | 
| Oral glucose tolerance test | A standard 75g glucose tolerance test will be performed. Venous blood will be taken before and 2 hours after the glucose drink was given. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Ovary syndrome, PCOS, sympathetic nervous system, moxonidine
A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.

Study Overview
=================
Brief Summary
-----------------
This is a prospective/retrospective, observational follow-up study of effects of fatty liver on chronic hepatitis B. Patients will join this study who undergo transient elastography with liver stiffness (LS) and CAP measurements or Ultrasonic examination. All recruited subjects will undergo comprehensive clinical, anthropometric and laboratory assessments at the time when transient elastography or Ultrasonic examination is performed. We plan to compare the relationship between chronic hepatitis B and non-alcoholic fatty liver disease. Patients will be divided into several groups based on the demand.

Official Title
-----------------
A Prospective/Retrospective, Observational Follow-up Study of Chronic Hepatitis B With Non-alcoholic Fatty Liver Disease.

Conditions
-----------------
the Effect of NAFLD on CHB

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years, chronic hepatitis B patients - Exclusion Criteria: patients with chronic hepatitis C or D and human immunodeficiency virus co-infection, excessive alcohol intake (≥30 g/d for men, ≥20 g/d for women), other chronic liver diseases (e.g. primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease), or on medications known to induce hepatic steatosis (including corticosteroids, methotrexate, and tamoxifen), and pregnancy. -

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 |
| --- | --- | --- |
| disease progression | the effect of NAFLD on CHB | 3 years to 10 years |
Development and Evaluation of an Adult Burn Prevention Program

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effectiveness of a targeted burn prevention message on burn safety knowledge and behavior.

Detailed Description
-----------------
Flammable liquid burns comprise 23% of admissions to our burn center. This was a project to test the uptake of the message Don't be a Flaming Fool delivered via multi-media campaign.

Official Title
-----------------
Development and Evaluation of an Adult Burn Prevention Program

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Other: multimedia burn awareness campaign


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male 16 years of age or older Exclusion criteria males less than 16 years of age females

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exposure to multi-media campaign<br>A multimedia campaign highlighting dangers of gasoline and fire was delivered to an intervention region in the state of Queensland | Other: multimedia burn awareness campaign<br>* Television commercials x4 delivered 86 times over 10 days plus logo in print media daily in two papers in two cities<br>* Other names: burn prevention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in burn safety knowledge at 3 months | The changes in knowledge regarding the dangers of using petrol or gasoline before and after a media campaign | Pre intervention, 3 months post intervention | 
| Changes in burn safety knowledge at 12 months | The changes in knowledge regarding the dangers of using petrol or gasoline before and after a media campaign | pre-intervention and 12 months post-interevention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention, burn, adult, health promotion, evaluation, media
To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients

Study Overview
=================
Brief Summary
-----------------
This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.

Official Title
-----------------
A Research Study to Describe the Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS). An Assessment of Two Case Studies

Conditions
-----------------
ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient and/or legal guardian must be willing and able to give written informed consent and id the patient is not an adult and able to read and write, the patient is willing to give written informed assent Eculizumab treatment initiated as personal importation for aHUS in 201 Exclusion Criteria: Not Applicable
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 |
| --- | --- | --- |
| Change in platelet count from baseline |  | 26 weeks |
Retrospective Assessment of the Morphology of Acetabular Defects: A 3D Reconstruction Approach

Study Overview
=================
Brief Summary
-----------------
In this study, we aim to develop a statistical shape model and use it to reconstruct the shape of acetabula with severe defects (Paprosky 3a-3b). This will allow us to visualise and assess the morphology of the missing bone. In future studies we will use the obtained results to improve the design of acetabular implants for revision surgery.

Official Title
-----------------
Retrospective Assessment of the Morphology of Acetabular Defects: A 3D Reconstruction Approach

Conditions
-----------------
Hip Arthrosis, Hip Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Trainings dataset for statistical shape model: Patients where a bilateral CT of the hip was performed with unilateral pathologies. We aim to include an equal amount of scans from each gender and varying ages. Dataset of defect acetabula used for reconstruction: Patients who received a CT scan of the hip after removal of a primary/revision implant (e.g. patients where debridement was performed due to infection.) Patients where the defect can be classified as a Paprosky 3a or 3b defect.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy hip population<br> | |
| Hip defect population<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D morphology | Compare the 3D morphology of acetabular defects (missing bone) with traditional 2D classifications using CT images of patients with various degrees of bone defects. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip revision surgery
The Lymphocyte/Neutrophil Ratio as a Prognostic Index for Short Term Outcome in the ICU Admitted COVID-19 Adult Patients

Study Overview
=================
Brief Summary
-----------------
ry outcome includes the correlation between lymphocyre /neurtophll ratio (LNR) and mortality rate during hospital stay in the ICU admitted COVID 19 patients. ry outcome(s) include the LNR and its correlation with ICU stay, the need for mechanical ventilation, renal impairment.

Detailed Description
-----------------
In December 2019,the COVID-19 virus has been mainly breaking out in Wuhan in China as pneumonia affecting patients . Common clinical features During hospitalization started to appear including acute respiratory infection , inflammatory reaction , fever, pneumonia, cough, fatigue , anosmia . The patient known suspected if he has a clinical picture of viral pneumonia, exposure history, and radiographic findings [CT] or [MRI] chest consistent with COVID-19 pneumonia. the gold standard and the Final diagnosis (PCR) positivity for the presence of coronavirus . The immune response to respiratory infection causes neutrophils to collect inside the lung especially the alveoli. Neutrophils aggregation may lead to collateral tissue damage and cytotoxicity. According to Previous studies apoptosis of lymphocytes occurred due to the release of anti-inflammatory cytokines resulting in lymphopenia. high levels of circulating neutrophils have been demonstrated in COVID-19 patients( A lot of literatures and studies have demonstrated the value of what is called neutrophil/ lymphocyte ratio (LNR) as a simple prognostic ratio correlated to morbidity and mortality. Up to our knowledge, there is no study utilized such ratio in COVID-19 ICU admitted patients, so that, this study has been built

Official Title
-----------------
The Lymphocyte/Neutrophil Ratio as a Prognostic Index for Short Term Outcome in the ICU Admitted COVID-19 Adult Patients

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (aged ≥18 years) Patients who need non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation) Exclusion Criteria: Previous diagnosis of severe liver or kidney failure. Patients with Human Immunodeficiency Virus (HIV) infection. Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts. Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes. Patients with bone marrow depression.

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 |
| --- | --- | --- |
| The Lymphocyte/neutrophil ratio | The Lymphocyte/neutrophil ratio as a prognostic index for short term outcome in the ICU admitted COVID-19 adult patients | up to 30 days |
Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty

Study Overview
=================
Brief Summary
-----------------
This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.

Official Title
-----------------
Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty

Conditions
-----------------
Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: Total Knee prothesis e motion PS Pro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient having signed informed consent Patients over 18 for which a Total Knee Prosthesis with e.motion® PS Pro was decided Patients willing to participate in a 5 years follow-up Exclusion Criteria: Active or suspected infection Tumor on the concerned knee Patient vulnerable and under legal protection

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

| Intervention/Treatment |
| --- |
|Device: Total Knee prothesis e motion PS Pro|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate at 5 years of the e motion PS Pro | The endpoint is the revision of at least one of the prosthesis components. If a patient withdraws from the study for any reason, counts as the end date for the survival of the implant of the last day on which the implants were well known even in place. | the survival rate will be evaluated 6-12 weeks; 1; 2; 3; 4 and 5 years after the knee arthroplasty |
Protection From Gender-based Violence in Cote d'Ivoire

Study Overview
=================
Brief Summary
-----------------
There is some evidence that suggests that economic empowerment and challenging gender inequalities and prevailing ideas on masculinities will lead to a decrease in levels of partner violence. However, there is still a gap in our understanding of what elements are required. This project evaluates whether participation within a savings group and a discussion group confronting gender norms will lead to an increase in women's individual agency and decision-making ability that will improve their economic independence and decrease intimate partner violence in their homes.

Official Title
-----------------
Protection From Gender-based Violence in Cote d'Ivoire

Conditions
-----------------
Domestic Violence, Family and Household

Intervention / Treatment
-----------------
* Behavioral: VSLA + Gender dialogue groups


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No Prior experiences with microcredit programs 18+ Source of stable income Exclusion Criteria: 18+ prior experience with microcredit

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSLA + gender dialogue groups: treatment<br> | Behavioral: VSLA + Gender dialogue groups<br>* Dialogue groups discussing household discussion making and gender norms facilitated by IRC.<br>|
| Active Comparator: VSLA only: control<br> | Behavioral: VSLA + Gender dialogue groups<br>* Dialogue groups discussing household discussion making and gender norms facilitated by IRC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess differences in past year, self-reported intimate partner violence (physical and sexual)between treatment and control groups. This will be assessed using the CTS-2 scale |  | 24 months post baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gender norms, Financial Autonomy, Economic Well-being
Development of Preterm Infant Gut Microbiome

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature

Detailed Description
-----------------
Preterm birth, defined as childbirth occurring at less than 37 completed weeks, is a major determinant of neonatal mortality and morbidity and has long-term adverse consequences for health. The human microbiome is the collective genome of the immense ecosystem of trillions of microbes and is considered to have a coevolved relationship with the immune system and fundamental roles in multiple aspects of human physiology. Little is known about the developmental of the gut microbiome in preterm infants as they grow and mature. One hundred premature infants born in Rambam healthcare campus in Haifa, Israel, will be recruited to the study and 100 term healthy infants will be recruited as controls. Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study. Fecal samples will be collected during the hospital stay and in follow-up visits. Blood samples will be taken during the hospital stay. The investigators will analyze the data from this clinical cohort using computational and experimental approaches for extracting novel information on microbiome composition and development, gene function, metabolic pathways and metabolite production.

Official Title
-----------------
Development of Preterm Infant Gut Microbiome

Conditions
-----------------
Premature Infants

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature and term infants born in Rambam healthcare campus in Haifa, Israel Exclusion Criteria: Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm infants<br>100 preterm infants | Other: No intervention<br>* No intervention<br>|
| Term infants<br>100 term healthy infants | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut microbial abundance over time | Preterm infants and full-term infants fecal DNA at different time points | One year |