linjc16/ctgov huggingface dataset:
Validation of DaTscan for Detection of Parkinson Disease Related Disorders

Study Overview
=================
Brief Summary
-----------------
This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.

Official Title
-----------------
Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue

Conditions
-----------------
Parkinson Disease, Movement Disorders

Intervention / Treatment
-----------------
* Drug: l-123 Ioflupane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 75 or older sporadic late onset Parkinson disease or one of its variants registered in tissue donation program Exclusion Criteria: aged less than 75 years old mental status preventing neuroimaging or transportation to site inability to remain relatively steady during the scanning procedure

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| l-123 Ioflupane<br>Study group includes those clinically diagnosed with Parkinson disease who are aged 75 and older who have agreed to donate brain tissue at time of death and are able to participate in the imaging scan process. | Drug: l-123 Ioflupane<br>* 5 millicuries of Ioflupane<br>* Other names: DaTscan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency Between Diagnostic Procedures | Consistency of diagnosis between: (1) clinical diagnosis, (2) scan results, and (3) pathological results. | Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DaT-SPECT scan, Parkinson's, Diagnostic
Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in New-born Infants

Study Overview
=================
Brief Summary
-----------------
The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).

Official Title
-----------------
Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in Newborns

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Other: RETCAM
* Biological: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature new-born infants born at less than 29 weeks of amenorrhea after informed consent has been obtained from a parent or the legal guardian of the infant Exclusion Criteria: Premature new-born infants presenting a life-threatening condition. Persons without national health insurance cover

Ages Eligible for Study
-----------------
Maximum Age: 4 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RETCAM<br> | Other: RETCAM<br> <br> Biological: Blood samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage of retinopathy of prematurity using a Retcam according to the ICROP classification (International Classification of Retinopathy of Prematurity) revised in 2005. |  | At 4 weeks of life or 31 weeks of amenorrhea | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes. |  | At inclusion |
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: efalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Clinical diagnosis of moderate to severe rheumatoid arthritis. On stable dose of methotrexate. 18 to 80 years of age. Less than 275 lbs. Exclusion criteria: Joint replacement surgery within 60 days of the start of drug dosing. Intra-articular cortisone injections within 28 days of the start of drug dosing. Pregnancy. History of severe allergic or anaphylactic reactions. Active bacterial, viral, fungal, mycobacterium tuberculosis. Positive PPD test. History of any opportunistic infection. Serious persisting local or systemic infection. History of malignancy within the past five years. Received any vaccine within 28 days of the start of study drug dosing. Joint replacement therapy planned within nine months of the start of study drug dosing. Chronic disorders apart from RA affecting the joints. Significant systemic involvement secondary to RA. COPD, asthma, or other pulmonary disease. Received any DMARD other than methotrexate in the 28 days prior to the start of study drug dosing. Approved biologic RA therapy during the 28 days or 7 half-lives of the drug prior to the start of drug dosing. Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing. Liver disease or abnormal hepatic function. Serum creatinine level > 1.5 mg/dL. Platelet count < 125,000 cells/mm3. WBC count < 3,500 cells/mm3. Seropositive for hepatitis B surface antigen. Seropositive for hepatitis C antibody. Known seropositivity for HIV.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Beijing Percutaneous Coronary Intervention Registry

Study Overview
=================
Brief Summary
-----------------
The registry study is to obtain the state of the art of the percutaneous coronary intervention state treatment for coronary heart disease in Beijing area of P.R.China in a real world. The data are collected from 48 hospitals in Beijing area using an uploading system through internet.

Official Title
-----------------
A Registry Study of Percutaneous Coronary Intervention Treatment in Beijing Area of P.R. China

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from selected 48 hospitals of Beijing, P.R.China Patients receiving coronal artery angiography or percutaneous coronary intervention therapy Exclusion Criteria: none
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 |
| --- | --- | --- |
Central Corneal Thickness With SENSIMED Triggerfish

Study Overview
=================
Brief Summary
-----------------
Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.

Official Title
-----------------
Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Device: SENSIMED Triggerfish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma and ocular hypertension scheduled for overnight hospitalisation stable IOP-lowering treatment since at least 4 weeks before study at least 18 years having provided informed consent Exclusion Criteria: contact lens wear within the last 2 years contraindication for silicone lean wear corneal abnormality in either eye ocular infection or inflammation history of ocular surgery within the last 3 months full-frame metal glasses during IOP monitoring with SENSIMED Triggerfish pregnancy and lactation patients not able to understand the nature of the research patients under tutelage patients committed to an institution by virtue of an order issued either by the courts or by an authority simultaneous participation in other clinical research

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 |
| --- | --- |
| SENSIMED Triggerfish<br> | Device: SENSIMED Triggerfish<br>* Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pachymetry (central corneal thickness) |  | after 8 hours nocturnal continuous IOP monitoring |
Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to provide gait parameters as a new objective method to assess total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an ambulatory device with minimal sensor configuration.

Official Title
-----------------
Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Total knee arthroplasty: mobile bearing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement Informed consent
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TKA mobile<br>TKA mobile | Device: Total knee arthroplasty: mobile bearing<br>* Total knee arthroplasty: mobile bearing<br>|
| No Intervention: TKA<br>TKA fix | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Stride Length | distance in meters of gait stride lenght measured by a data logger with five inertial sensors | 5years | 
| EuroQoL Quality of Life Scale (EQ-5D) | The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time. | 5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures | Scoring system to clinically rate the knee abefore and after TK, scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. | 5years | 
| Number of Participants With Dislocation | count of numbers of dislocated implants. | 5years |
Validation of the GoCheck Kids® Eye Screeningtest in Infants in Flanders

Study Overview
=================
Brief Summary
-----------------
The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study.

Detailed Description
-----------------
Comparison of the results of the GoCheck Kids application on iPhone with a complete eye examination (gold standard) including cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

Official Title
-----------------
Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.

Conditions
-----------------
Amblyopia, Infant

Intervention / Treatment
-----------------
* Diagnostic Test: Complete Eye Examination by Ophthalmologist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GoCheck Kids (GCK) evaluation at Child and Family Agency at the age between 11-16 months. Exclusion Criteria: Allergy for the used cycloplegia cyclopentolate 0.5%. Any history of ocular surgery The time window between GCK measurement and the complete eye examination may not exceed 2 months. The parents or legal representatives of the child do not understand or speak Dutch, French or English.

Ages Eligible for Study
-----------------
Minimum Age: 11 Months
Maximum Age: 16 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GoCheckKids screening<br>GoCheckKids screening at the Child And Family Agency at the age of 12-15 months (+- 1 month) are invited to undergo a complete eye examination by an ophthalmologist for evaluation of amblyopia risk factors. | Diagnostic Test: Complete Eye Examination by Ophthalmologist<br>* complete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity of GCK eye screener | Day 1 | 
| Specificity | Specificity of GCK eye screener | Day 1 | 
| Positive predictive value | Positive predictive value of GCK eye screener | Day 1 | 
| Negative predictive value | Negative predictive value of GCK eye screener | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eye screening
Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence rates of infection among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications

Official Title
-----------------
Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of rheumatoid arthritis Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM Age 18 years or older at the time of drug initiation Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation Exclusion Criteria: Below 18 years of age at the time of BDM or DMARD initiation Lacking six months of continuous enrollment prior to the initiation of one of the study drugs
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients initiating abatacept<br> | |
| Patients initiating other biologic disease-modifying drugs<br> | |
| Pts initiate non-biologic disease-modify anti-rheumatic drugs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection |  | Every four months throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaphylactic reactions |  | Every four months throughout the study | 
| Multiple sclerosis, lupus, and psoriasis |  | Every four months throughout the study | 
| Concomitant biologic use |  | Every four months throughout the study |
Frozen Blastocyst Transfer in Natural Cycle

Study Overview
=================
Brief Summary
-----------------
The rational of the study is to assess the pregnancy rate after the transfer of frozen blastocyst in natural cycle controlled by external administration of hCG.

Official Title
-----------------
Cryopreserved Thawed Blastocyst Transfer in Natural Cycle With or Without hCG Administration

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: hCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age < 40 BMI:18-29 kg/m2 day 5 frozen embryo previously IVF/ICSI Exclusion Criteria: OOCYTE DONATION CYCLES

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hCG group<br> | Drug: hCG<br>* 5000IU<br>|
| No Intervention: LH pic<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FET, Spontaneous LH pic, Blastocyst, natural cycle, hCG
Professional Quality of Life in German Psychologists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess professional quality of life in German psychologists working with patients with mental disorders.

Detailed Description
-----------------
The purpose of this study is to assess professional quality of life, which includes compassion satisfaction, burnout and secondary traumatization in clinical psychologists, working with patients with mental disorders, in Germany.

Official Title
-----------------
Professional Quality of Life in German Psychologists Working With Patients With Mental Disorders

Conditions
-----------------
Mental Disorder, Burnout, Caregiver, Burnout, Professional

Intervention / Treatment
-----------------
* Diagnostic Test: Online questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical psychologist Currently working with patients with mental disorders At least 18 years old Sufficient German skills for answering the questionnaire Exclusion Criteria: None

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

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 |
| --- | --- |
| Clinical psychologists in Germany<br>Clinical psychologists in Germany currently working with patients with mental disorders | Diagnostic Test: Online questionnaire<br>* Online questionnaire via SoSciSurvey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compassion Satisfaction | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Compassion Satisfaction (Minimum: 10 - Maximum: 50 - Higher scores mean a higher compassion satisfaction. | 1 day | 
| Burnout | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Burnout (Minimum: 10 - Maximum: 50 - Higher scores mean a higher level of burnout. | 1 day | 
| Secondary Traumatization | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Secondary Traumatization (Minimum: 10 - Maximum: 50 - Higher scores mean a higher level of secondary traumatization. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Professional quality of life, Compassion satisfaction, Burnout, Psychologists, Mental disorders, Mental health