linjc16/ctgov huggingface dataset:
Epidemiology of Venous Thrombosis and Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
To investigate venous thromboembolism in two carefully conducted prospective epidemiologic studies of African American and white adults -- the Atherosclerosis Risk in Communities (ARIC) Study and the Cardiovascular Health Study (CHS).

Detailed Description
-----------------
BACKGROUND: Venous thromboembolism, comprising deep venous thrombosis (DVT) and pulmonary embolism (PE), is a major contributor to morbidity and mortality in the United States. Nevertheless, no comprehensive, prospective, population-based epidemiologic studies have simultaneously examined lifestyle, molecular, and biochemical risk factors for this important disease. DESIGN NARRATIVE: Deep venous thrombosis and pulmonary embolism cases were identified and verified in order to estimate incident rates of hospitalized venous thromboembolism in the combined ARIC and CHS cohorts. The association of venous thromboembolism was determined prospectively with demographic and lifestyle factors, plasma lipids, medical history, and hemostatic components (including fibrinogen, platelet count, factors VIIc and VIIIc) using existing ARIC and CHS data. A nested case control study was conducted using stored pre-diagnosis blood and DNA specimens to determine the prospective associations of venous thromboembolism with the following: levels of procoagulant or anticoagulant factors and related genetic variants (including factor V Leiden), fibrinolytic factors (e.g., plasminogen activator inhibitor-1) and related genetic variants, markers of thrombin activation, and other potentially important biochemical or related genetic factors (e.g., homocysteine). The study was renewed in 2003 to extend event follow-up for four more years and to conduct longitudinal analyses of incidence and potential risk factors not fully explored such as diet, frailty, hormone replace therapy and obesity interactions. It was renewed in 2008 to conduct a genome wide association study. It was again renewed in 2013 and 2017.

Official Title
-----------------
Longitudinal Investigation of Thromboembolism Etiology

Conditions
-----------------
Cardiovascular Diseases, Pulmonary Embolism, Venous Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: in the ARIC or CHS cohorts already Exclusion: not in the ARIC or CHS cohorts

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Venous thrombosis and pulmonary embolism | venous thrombosis and pulmonary embolism | Yearly Follow up |
Validity and Reliability of Indonesian Translated Ages and Stages Questionnaires - Third Edition (ASQ-3) as a Screening Tool for Developmental Delay in 1-12 Months Old Children

Study Overview
=================
Brief Summary
-----------------
This study aimed to provide the validity and reliability of the Indonesian ASQ-3 questionnaires as a screening tool for developmentally delayed children aged less than one year old. This study was divided into 2 phases. The first phase (April-June 2018) included the transcultural adaptation of the ASQ-3 questionnaires for 2 to 12 months age groups from English to Indonesian. The second phase (July- September 2018) included a cross-sectional study of Indonesian ASQ-3 questionnaires for parents/caregivers of children aged 1-12 months, with 35 children in each age group by cluster sampling methods, in 2 district areas in East Jakarta.

Official Title
-----------------
Validity and Reliability of Indonesian Translated Ages and Stages Questionnaires - Third Edition (ASQ-3) as a Screening Tool for Developmental Delay in 1-12 Months Old Children

Conditions
-----------------
Developmental Delay, Child Development, Child Development Disorder, Global Developmental Delay, Infant Development, Motor Delay, Speech Delay, Communication Disorders, Development Delay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents with children aged 1-12 months Parents who finished at least elementary school Exclusion Criteria: Parents with communication difficulties Parents who could not speak Indonesian language

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child development | Measured once with Indonesian Ages and Stages-3 questionnaire (cross sectional study) with maximum score of 60 per domain. | 1 day (Once) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Developmental delay, developmental screening, Indonesian ASQ-3 questionnaire, validity, reliability
Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome

Study Overview
=================
Brief Summary
-----------------
ANCA vasculitis and Sjögren syndrome are two rare diseases, and even more rarely associated. These two conditions have specific organ involvements, and specific follow-up. The Investigators hypothesise that patients with co-occurrence of these two diseases may have a singular clinical course.

Official Title
-----------------
Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome : a Case Series and Systematic Review

Conditions
-----------------
ANCA Associated Vasculitis, Sjogren's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of ANCA vasculitis based on clinical, immunological and histopathological features. Diagnosis of Sjögren syndrom based on ACR/EULAR 2016 criteria. Exclusion criteria: Age < 18 years Insuffisant data during follow-up

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 |
| --- | --- | --- |
| Severity of Sjögren disease | Severity of Sjögren disease | day 1 (Upon diagnosis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sjögren extra-glandular complications | Sjögren extra-glandular complications | day 1 (Upon diagnosis) | 
| severity of ANCA vasculitis | severity of ANCA vasculitis | day 1 (Upon diagnosis) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overlap syndrom
Safety and Tolerability Study of Drug to Treat Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Official Title
-----------------
A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Lurasidone 20 mg
* Drug: Lurasidone 40 mg
* Drug: Lurasidone 80mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Successful completion of participation in protocol #D1050049 Exclusion criteria: Substance abuse Prolactin level of ≥200ng/mL at baseline Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone 20 mg<br>Lurasidone 20 mg oral tablet | Drug: Lurasidone 20 mg<br>* Lurasidone 20mg oral tablet taken once daily for 6-months<br>|
| Experimental: Lurasidione 40 mg<br>Lurasidone 40 mg oral tablet | Drug: Lurasidone 40 mg<br>* Lurasidone 40mg oral tablets taken once daily<br>|
| Experimental: Lurasidone 80mg<br>Lurasidone 80mg oral tablet | Drug: Lurasidone 80mg<br>* Lurasidone 80mg oral tablet taken once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone. | 6-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Latuda, Lurasidone
Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography (TCD) in comatose survivors after cardiac arrest. Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit and cardiac intensive care unit in a university hospital. Patients: all comatose patients older than 18 years successfully resuscitated from an out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic brain injury, no window for TCD measurements, or dead before neurological prognostication are excluded.

Detailed Description
-----------------
The investigators measure the pulsatility index (PI) and diastolic flow velocity (DFV) of the right and left middle cerebral artery during the first 12 h after return of spontaneous circulation (ROSC). The highest value of DFV and the lowest of PI will use for the statistical analysis. Cerebral Performance Category evaluate neurologic outcome at hospital discharge. Data provided by early TCD after ROSC are associated with neurological outcome. The use of these data could lead to the development of therapeutics improving cerebral perfusion in patient resuscitated from an OHCA.

Official Title
-----------------
Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest: the DOTAC Study

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older 18 years out-of-hospital cardiac arrest with recovery of spontaneous cardiac activity Exclusion Criteria: transcranial doppler not done or not interpretable associated cranial trauma died without neurological assessment

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 |
| --- | --- | --- |
| Evaluate the relation between TCD measurements and neurologic outcome at hospital discharge | Good score = CPC 1-2 and bad score = CPC 3-5 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pulsatility index | Evaluate the association between pulsatility index and period of cardiac arrest | 12 hours | 
| Entry of doppler parameters | Identify a doppler parameter than can improve the neurological outcome | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Out-of-hospital cardiac arrest, transcranial Doppler sonography, cerebrovascular circulation, prognosis
300 Antibody Diagnostic Test Kit

Study Overview
=================
Brief Summary
-----------------
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically normal serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.

Official Title
-----------------
Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection

Conditions
-----------------
Acute Bacterial Infections, Acute Viral Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current acute infection age 18-70 male or female any race currently active symptoms

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

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 |
| --- | --- |
| assorted acute infection<br>300 patients diagnosed with assorted acute infection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgM greater than 1xcut off value | Elisa System positive results are greater than 1 times the cutoff. Negative less than 1x cutoff. Prevalence of IGM in general mid-atlantic population is less than 10% of study population. | Antibody value measured within seven days of specimen collection. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytomegalovirus (CMV) IgM &IgG, Lyme, Toxoplasma, Rubella, Rubeola IgM, Rocky mountain Spotted Fever IgM, Ebv IgM, Herpes, Babesia, Measles, Tetanus, Mumps, Mycoplasma, Legionella, Giardia, Syphilis, Bordetella Pertussis, H Pylori, Antibody Titre, Elevated IgG, Abnormal IgM, SLE
What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?

Study Overview
=================
Brief Summary
-----------------
Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.

Official Title
-----------------
A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Device: 0.6 mm tread pitch implant
* Device: 0.1 mm tread pitch implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Periodontally-healthy or periodontally-treated patients Smokers are included All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw. Exclusion Criteria: All other contra indications for implant surgery Guided bone regeneration or use of any substitutes No implantation in regenerated or augmented bone No immediate loading cases

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: 0.6 mm tread pitch implant<br> | Device: 0.6 mm tread pitch implant<br>* 0.6 mm tread pitch implant will be used<br>|
| Experimental: 0.1 mm tread pitch implant<br> | Device: 0.1 mm tread pitch implant<br>* 0.1 mm tread pitch implant will be used<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document the outcome of bone remodeling around IBT implants |  | 3 years after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To clinically and radiographically document the placement of both IBT implant thread types in the same patient |  | over 2 years | 
| 3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation |  | over 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implants, different tread pitch design
Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Official Title
-----------------
Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Device: T2762
* Device: Vismed®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent Male or female aged from ≥ 18 years old. Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection. Exclusion Criteria: Best far corrected visual acuity < 1/10 Severe blepharitis Severe Dry Eye

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: T2762<br> | Device: T2762<br>* 1 drop in each eye 3 to 6 times daily during 84 days<br>|
| Active Comparator: Vismed®<br> | Device: Vismed®<br>* 1 drop in each eye 3 to 6 times daily during 84 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Ocular Staining (With Oxford Scale - Ranges : 0-15) | Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed). | Baseline and Day 35 |
Treatment With Crizotinib Single Patient Expanded Access IND 134375

Study Overview
=================
Brief Summary
-----------------
Two year old male with a new diagnosis of Inflammatory Myofibroblastic Tumour. The patient presented with 2 months of intermittent fever and 1-2 weeks of abdominal distention and constipation. An abdominal mass was palpable on exam and US concerning was for neoplasm of abdomen. Treatment with Crizotinib will be utilized to reduce the size of the lesion and create more optimal tissue plains between vital structures prior to attempted surgical resection would greatly reduce potential morbidity for this patient.

Official Title
-----------------
Treatment With Crizotinib Single Patient Expanded Access IND 134375

Conditions
-----------------
Inflammatory Myofibroblastic Tumour

Intervention / Treatment
-----------------
* Drug: Crizotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This treatment plan is intended for the use of Crizotinib in the treatment of a single patient with Inflammatory Myofibroblastic Tumour Exclusion Criteria: Not applicable as Expanded Access only includes one patient

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 2 Years

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.

Study Overview
=================
Brief Summary
-----------------
Dental implant supported screwed prosthetic rehabilitations are associated to several advantages, as a minimal occlusal spaced and easier hygiene and maintenance. In this sense, screwed rehabilitations have been associated with lower frequency of biological and technical complications. Nevertheless, the screwing process results in the formation of a prosthetic chimney that requieres an appropriate sealing protocol. This protocol needs to include a material for the protection of the screw head. Nowadays, there is a lack of materials for this intended use with marketing authorisation. Several materials have been tested in the bibliography including PTFE, although there are not high quality studies. In this context, this clinical investigation aims to evaluate the efficacy and safety os a PTFE-based product (MAFILL) for the sealing of prosthetic chimneys and the protection of the screw head.

Official Title
-----------------
Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.

Conditions
-----------------
Edentulous Alveolar Ridge

Intervention / Treatment
-----------------
* Device: MATFILL (PTFE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Clinical need for the placement of a implant-supported dental prosthesis Clinical need for the filling of the prosthetic chimney Signing informed consent Exclusion Criteria: Inability of follow-up

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MATFILL<br>Prosthetic chimney filling with MATFILL prior to other sealing materials to protect the screww head. | Device: MATFILL (PTFE)<br>* Filling of the prosthetic chimney with the compressed material<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integrity of screw head | Integrity of the screw head observed in photographs | 6 weeks | 
| Integrity of screw head | Retightening after screw after unscrew | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of prosthetic complications | Occurrence of prosthetic complications during follow-up | 6 weeks | 
| Occurrence of biological complications | Occurrence of biological complications | 6 weeks |