linjc16/ctgov huggingface dataset:
6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there are persisting antibodies against Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or confirm mathematical models accordingly.

Detailed Description
-----------------
Japanese Encephalitis (JE) is a potentially devastating mosquito-borne viral disease. The JE virus (JEV), a Flavivirus, is endemic to many regions in Asia, and while JE is primarily a pediatric disease in the endemic regions, travelers from non-endemic regions to Asia are usually naïve to the virus and may be at risk for contracting JE at any age. The present study aims to investigate antibody titers at approximately 6 years after the third dose of JE vaccine (JE-VC), in a cohort of participants from an earlier booster dose trial, to strengthen the statistical model of the duration of protection after the booster.

Official Title
-----------------
Neutralizing Antibody Titers 6 Years After the Third Dose of Inactivated Japanese Encephalitis Vaccine and Projected Duration of Protection

Conditions
-----------------
Post Other Specified Vaccination Encephalitis

Intervention / Treatment
-----------------
* Other: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who received a booster dose of JE-VC in study IC51-311 Subjects who are willing to give written informed consent to participate in the trial Exclusion Criteria: Subjects who received a further dose of any Japanese Encephalitis Vaccine since study IC51-311 Severe immunosuppression (as result of medical conditions or medication) since study IC51-311, such as history of radiation therapy or cytostatic therapy simultaneous participation in another clinical study

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>1 blood draw | Other: Blood draw<br>* One-time blood draw<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) for JEV neutralizing antibodies determined by PRNT |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection Rate (SPR) defined as rate of subjects with JEV neutralizing antibody titers ≥1:10 in a PRNT |  | 1.5 years |
PROM by AmnioQuick Duo+ in Egyptian Women

Study Overview
=================
Brief Summary
-----------------
Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The diagnosis of PPROM is made by a combination of examination, patient history and some simple tests.

Detailed Description
-----------------
Premature rupture of the fetal membranes (PROM) is the rupture of the amniotic membranes with release of the amniotic fluid prior to the onset of labour. PROM may be subdivided into term -PROM (TPROM, i.e. PROM after 37 weeks of gestation) and preterm PROM (PPROM, i.e. PROM prior to 37 weeks of gestation). PPROM occurs in approximately 3% of pregnancies and is responsible for a third of all preterm births.The diagnosis of PPROM is made by examination , patient history and simple testing. Patient history has an accuracy of 90% for the diagnosis of PPROM

Official Title
-----------------
Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+

Conditions
-----------------
PROM (Pregnancy)

Intervention / Treatment
-----------------
* Diagnostic Test: AmnioQuickDuo+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant ladies with PROM from 20- 37 weeks Exclusion Criteria: Gestational Age >37 wks Non reassuring CTG Signs of chorioamnonitis ( Fever , maternal or fetal tachycardia , Foul cervical discharge , uterine tenderness or high TLC ) Antepartum hemorrhage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| PPROM from 20- less than 28 weeks<br>pregnant ladies with PROM from 20 - 28 weeks | Diagnostic Test: AmnioQuickDuo+<br>* AmnioQuickDuo+ kit for detection of PROM<br>|
| PROM from more than 28 weeks - less than 37 weeks<br>pregnant ladies with PROM from more than 28- less than37 weeks | Diagnostic Test: AmnioQuickDuo+<br>* AmnioQuickDuo+ kit for detection of PROM<br>|
| control group pregnant ladies in labour after 37 weeks<br>control group pregnant ladies in labour after 37 weeks with rupture of membrane in labour or in cs | Diagnostic Test: AmnioQuickDuo+<br>* AmnioQuickDuo+ kit for detection of PROM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+ | the accuracy of amnioQuick to diagnose PROM | within a week |
Phytosterol Supplementation and Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.

Detailed Description
-----------------
This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation. The study recruited 72 men and women 20-70 years of age with mild hypercholesteremia (>130 mg/dl LDL-C). They were assigned to 1 of 2 groups. Participants ingested the supplement or a placebo for 12 weeks, with an interim assessment at 6 weeks. Participants agreed to maintain current diet, medication, and exercise habits and to not donate blood during the trial.

Official Title
-----------------
Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk

Conditions
-----------------
Hypercholesteremia

Intervention / Treatment
-----------------
* Drug: phytosterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild hypercholesteremia, sign informed consent, not donate blood, maintain diet and exercise habits Exclusion Criteria: BMI <18.5 or >34.9, recent blood donation, serious or life-threatening disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ingestion of the supplement will result in reduced LDL cholesterol. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LDL-C, phytosterol
Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives

Study Overview
=================
Brief Summary
-----------------
This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.

Official Title
-----------------
Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives: Pilot Testing of the MSSC Physician Safe Sleep Taskforce Caregiver Incentive Toolkit

Conditions
-----------------
Safe Sleep Education

Intervention / Treatment
-----------------
* Other: Wearable Blanket (Sleep Sack)
* Other: Incentive Item


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent of 1-month old baby Over the age of 18 Be able to speak and read English Exclusion Criteria: -

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable Blanket<br>subjects randomized to this group will receive a wearable blanket (sleep sack) that contains a safe sleep message. | Other: Wearable Blanket (Sleep Sack)<br> <br> |
| Active Comparator: Control Group<br>subjects randomized to this group will receive an incentive item (such as a University of Kansas Pediatrics water Bottle) that does not contain the safe sleep message. | Other: Incentive Item<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dichotomous sleep variable (safe vs unsafe) | change measured using safe sleep quiz questionnaire | Change from Baseline to 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine which incentive item provided is most effective in reinforcing the safe sleep message | determination to be assessed using questionnaire completed by caregiver | Change from Baseline to 2 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sudden Infant Death Syndrome, SIDS, safe sleep, safe sleep message
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Study Overview
=================
Brief Summary
-----------------
Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.

Official Title
-----------------
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Conditions
-----------------
Colorectal Cancer, Metastatic Liver Cancer, Liver Metastases

Intervention / Treatment
-----------------
* Procedure: Liver transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 and ≤ years Good performance status, ECOG 0 or 1 Resected adenocarcinoma in colon or rectum (R0 resection) Unresectable liver metastases No extrahepatic disease Normal blood tests Response to ≤ 2 lines of chemotherapy (RECIST criteria) ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list Signed informed consent Exclusion Criteria: Body mass index ≥ 30 Positive HIV or HCV Pregnancy at the time of inclusion BRAF mutated status Deterioration of general condition (10% weight loss in the prior 6 months) Other malignancy with disease free survival < 5 years Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected. Palliative resection of primary colorectal adenocarcinoma Liver metastases size > 5 cm (in the last imaging technique) CEA > 80 ng/ml (at time of enrolment in waiting list) No neoadjuvant chemotherapy treatment General contraindication to liver transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liver transplanted patients<br> | Procedure: Liver transplantation<br>* Chemotherapy and liver transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| five year overall survival (OS) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one year disease free survival (DFS) |  | 1 year | 
| three year disease free survival (DFS) |  | 3 years | 
| five year disease free survival (DFS) |  | 5 years | 
| Quality of life using EORTC questionnaires: QLQ-C30 |  | 1 year | 
| Quality of life using EORTC questionnaires: QLQ-C30 |  | 3 years | 
| Quality of life using EORTC questionnaires: QLQ-C30 |  | 5 years |
Factors Associated With Coronary Heart Disease in African Americans in the Jackson Heart Study

Study Overview
=================
Brief Summary
-----------------
Coronary heart disease (CHD) is the leading cause of deaths that are related to cardiovascular disease in the United States, and Mississippi's CHD mortality rate is the highest in the nation. This study will examine data from the Jackson Heart Study to determine the effect of socioeconomic status and psychosocial factors on CHD risk in African Americans in Mississippi.

Detailed Description
-----------------
CHD is a disease that is characterized by narrowing of the coronary arteries that supply blood to the heart. As a result, insufficient amounts of oxygen and nutrients reach the heart, which can cause chest pain or heart attack. Studies have shown that people's socioeconomic status is associated with their health, and that African Americans experience the highest rates of heart disease in the U.S. The Jackson Heart Study (JHS) is currently being conducted in Jackson, Mississippi, and is studying the factors that influence the development of cardiovascular disease in African American men and women. This study will examine data from the JHS to determine the effect of socioeconomic status and psychosocial factors on CHD risk in African Americans in Mississippi. This study will recruit participants from the JHS only. Participants will report to the study site at least once for 4.5 hours for baseline measurements. Visits will include measurements of body size and blood pressure, an electrocardiogram, an echocardiogram, an ultrasound of the carotid artery, blood and urine collection, a lung function test, and interviews regarding health status and sociocultural aspects of life. Follow-up evaluations will occur 5 and 10 years after starting the study. Outcomes will include self-report and electrocardiogram-defined CHD, as well as measures of various social and psychological factors.

Official Title
-----------------
Disparities in CHD in the Jackson Heart Study

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in the Jackson Heart Study Diagnosis of coronary heart disease Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 84 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Racial Disparities, Psychosocial Risk Factors, Neighborhood Socioeconomic Status, CVD, CHD
Prosthetic Arthroplasties in Weight-bearing Shoulders

Study Overview
=================
Brief Summary
-----------------
Repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the weight-bearing shoulder. Under these conditions, arthroplasty is subject to significant constraints; such an indication in this condition is always discussed. The objective of this study was to evaluate the medium-term clinical and functional outcomes of anatomical and reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair use.

Official Title
-----------------
Prosthetic Arthroplasties in Weight-bearing Shoulders in Individuals With Long-term Wheelchair Use

Conditions
-----------------
Prosthetic Arthroplasties

Intervention / Treatment
-----------------
* Procedure: Shoulder arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients not walking or rarely walking, long-term users of a wheelchair before the intervention, and surgery on at least one shoulder by anatomical or reverse prosthesis Exclusion criteria: Patient walking without aid Shoulder surgery other than arthroplasty

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 |
| --- |
|Procedure: Shoulder arthroplasty|Surgery consisting in replacement of gleno-humeral joint by a shoulder prosthesis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of joint mobility | Evolution of joint mobility | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of searches for early implant loosening | number of searches for early implant loosening | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paraplegia, Shoulder prosthesis, spinal cord injury, wheelchair
The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the intake of kiwi fruits will reduce systolic and diastolic blood pressure compared to intake of apples. The investigators hypothesize that the increased intake lutein or other components in the kiwi fruit will enhance nitric oxide bioavailability and lead to vascular relaxation.

Detailed Description
-----------------
An interesting finding in the Oslo Antioxidant Study was that intake of 3 kiwi fruits reduced blood pressure in a clinical significant manner compared to controls. The mechanism for the blood pressure reducing effect of kiwi or the responsible components are not elucidated. However, plasma lutein levels and antioxidant capacity measured by the ferric reducing antioxidant power was increased in the kiwi group. Moreover, gene expression was also altered by the increased intake of kiwi.

Official Title
-----------------
The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression in Mildly Hypertensive Subjects

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Kiwi fruits
* Other: Apple


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic blood pressure 130-159 mmHg Diastolic blood pressure 85-99 mmHg Body mass index <35 kg/m2 Exclusion Criteria: Systolic blood pressure >160 mmHg or <129 mmHg Diastolic blood pressure >100 mmHg or <84 mmHg Current use or need for blood pressure lowering medication Symptomatic cardiovascular disease, diabetes, renal dysfunction, psychiatric disorder, pregnancy or lactation, history of obesity surgery.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 69 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kiwi fruits<br> | Other: Kiwi fruits<br>* Daily intake of 3 kiwi fruits for 8 weeks<br>|
| Placebo Comparator: Apple<br> | Other: Apple<br>* Daily intake of 1 apple (equivalent in energy) for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kiwi fruits, Blood pressure, Endothelial function, Antioxidant capacity
Influence of Plasma Rich in Growth Factors (PRGF) on Healing of Medial Collateral Ligament (MCL) Tear

Study Overview
=================
Brief Summary
-----------------
To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of medial collateral ligament (MCL) tear.

Detailed Description
-----------------
Autologous platelet-rich matrices may aid in the healing of ligaments & tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Official Title
-----------------
Influence of PRGF on Healing of MCL Tear - Randomized-Double-Blind-Placebo Control Trail

Conditions
-----------------
MCL Tear

Intervention / Treatment
-----------------
* Biological: Plasma Rich in Growth Factors (PRGF)
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-40 years old diagnosed MCL tear grade 2/3 Exclusion Criteria: pregnancy mental or physical disabilities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Placebo Comparator: 2<br>saline | Drug: saline<br>* injection of 6 cc of saline into injured area<br>* Other names: saline 0.9% NaCl;|
| Experimental: 1<br>Plasma Rich in Growth Factors (PRGF) | Biological: Plasma Rich in Growth Factors (PRGF)<br>* injection onto injured area in ligament dose: 3-6mg<br>* Other names: platelet-derived preparation rich in growth factors;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time and efficiency of healing |  | 1 year |