linjc16/ctgov huggingface dataset:
Japanese Lead Extraction Registry

Study Overview
=================
Brief Summary
-----------------
Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The acute success rate at discharge and the complications associated with transvenous lead extraction will be collected. J-LEX registry will provide a reliable information on indications, methods, the success rate, complications and the prognosis at 30 days prognosis.

Detailed Description
-----------------
Japanese Lead Extraction (J-LEX) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system until 30 days after the lead extraction. The investigators will collect the data regarding patient's background and lead characteristic, medical history, details about lead extraction procedure, lead characteristics, and outcomes. The data were anonymized in a linkable manner at each study site before they were sent. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.

Official Title
-----------------
Japanese Lead Extraction Registry

Conditions
-----------------
Arrhythmia, Cardiac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing transvenous lead extraction in Japan. Exclusion Criteria: Patients who receive open-chest surgical extraction alone. Patients who refused to consent.
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 |
| --- | --- | --- |
| Proportion of procedural success | Procedural success was defined as complete or partial and is identified for each lead extracted. | Through discharge from hospital, approximately up to 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of in-hospital deaths | All-cause death, cardiovascular death, and procedure-related death | Through discharge from hospital, approximately up to 2 weeks. | 
| Number of patients with procedure-related complications | Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lead extraction, Pacemaker, Defibrillator, Complication, REDCap
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.

Official Title
-----------------
An Early Feasibility Study to Evaluate Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: AID System
* Drug: Insulin Lispro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months Have a body mass index of 18.5 to 37 kilogram per meter squared Have a hemoglobin A1c level ≥6.0% and ≤9.0% Exclusion Criteria: Have known allergies or history of hypersensitivity to insulin lispro Have had an episode of severe hypoglycemia within the past 6 months Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AID System Containing Insulin Lispro<br>The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. | Device: AID System<br>* AID system<br>* Other names: LY8888AU;Drug: Insulin Lispro<br>* Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.<br>* Other names: LY275585;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) | Number of AEs | In-Patient Period (5 Days) | 
| Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL | CGM measured percentage of time <70 milligrams per deciliter (mg/dL) | In-Patient Period (5 Days) |
DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.

Official Title
-----------------
A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

Conditions
-----------------
Meningeal Neoplasms

Intervention / Treatment
-----------------
* Drug: Intrathecal (injected into the spinal fluid) DepoCyt
* Drug: Intrathecal methotrexate
* Drug: Intrathecal cytarabine (also known as ara-C)


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosed (or previously diagnosed) with lymphoma or a solid tumor (not leukemia) Diagnosed with neoplastic meningitis If female, not pregnant and will not become pregnant while on-study No other experimental therapy within 21 days of participation

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intrathecal (injected into the spinal fluid) DepoCyt|nan|
|Drug: Intrathecal methotrexate|nan|
|Drug: Intrathecal cytarabine (also known as ara-C)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival, defined as the time to neurological progression or death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to neurological progression; |  |  | 
| Survival (all-cause and meningeal disease-specific) |  |  | 
| Frequency of improvement in pre-existing meningeal-disease related neurological deficits |  |  | 
| Karnofsky Performance Scores (KPS) |  |  | 
| Quality of life |  |  | 
| Cytological response rate |  |  | 
| Overall safety profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoplastic, meningitis, cerebrospinal fluid, CSF, meningeal, meninges, CNS, Leptomeningeal Neoplasms
Predicting Poor Outcomes After Primary Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Aim To identify through data analysis key patients, surgeon and operative dependent variables which will improve the performance of knee replacement for primary osteoarthritis Research Question Can the investigators identify association between outcomes and patients characteristics using existing (already collected) datasets What are the characteristics of patients with poor outcome after knee replacement What can be done to improve the outcome of patients at risk of poor results

Detailed Description
-----------------
This is a retrospective analysis of a prospectively collected single centre database.

Official Title
-----------------
Predicting Poor Outcomes After Primary Knee Arthroplasty

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

Intervention / Treatment
-----------------
* Device: Primary knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary knee arthroplasty Osteoarthritis Exclusion Criteria: No consent for joint registry data collection
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary knee arthroplasty<br>Patients with osteoarthritis of the knee undergoing primary knee arthroplasty | Device: Primary knee arthroplasty<br>* Patients undergoing primary knee arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMS |  | 1,2,3 and 5 Years post op |
Effect of Rose-colored Glass on Mood

Study Overview
=================
Brief Summary
-----------------
Decades of psychological research has highlighted the impact of visual perception on mood and happiness. The investigators hypothesized that literally seeing the world through rose colored glasses may have an effect on perception, mood, and happiness. After cataract surgery, which classically increases the vividness of perceived colors, patients report significant satisfaction. The investigators therefore sought to explore whether using pink colored lenses leads to a measurable impact on outcomes.

Detailed Description
-----------------
A randomized controlled clinical trial design will be performed. Subjects will be randomized for either pink lenses (treatment group) or clear lenses (placebo group). Subjects will be asked to wear the assigned glasses throughout the day during the course of the trial. Glasses will not be work while driving at night.

Official Title
-----------------
Effect of Rose-colored Glass on Mood: A Randomized Clinical Trial

Conditions
-----------------
Mood

Intervention / Treatment
-----------------
* Other: Wearing pink glasses
* Other: Wearing clear glasses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over 18 years of age. Exclusion Criteria: Subjects who wear glasses on a regular basis.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pink lenses<br>Pink-colored lenses | Other: Wearing pink glasses<br>* Wearing pink-colored lenses<br>|
| Placebo Comparator: Clear lenses<br>Clear lenses | Other: Wearing clear glasses<br>* Wearing clear glasses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Anxiety Scores on the Visual Analogue Scale at 1 week | Scale range 0-100, higher values represent more anxiety | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Mood Scores on the Visual Analogue Scale | Scale range 0-100, higher values represent more sadness | 1 week | 
| Change from baseline in Happiness Scores on the Visual Analogue Scale | Scale range 0-100, higher values represent more happiness | 1 week | 
| Change from baseline in the Center for Epidemiological Studies Depression Scale score | Scale range 0-60, higher values suggest more depressive symptoms | 1 week |
Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults

Study Overview
=================
Brief Summary
-----------------
To measure the serum bactericidal antibody levels and cell mediated immune responses before and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6 and 12 weeks to healthy UK adults.

Conditions
-----------------
Neisseria Meningitidis

Intervention / Treatment
-----------------
* Biological: Meningococcal outer membrane vesicle vaccine MenBVac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed written consent given for three immunizations with MenBVac and five blood tests Between the ages of 18 and 55 years inclusive at recruitment Exclusion Criteria: Previous history of bacteriologically confirmed meningococcal disease History of clinically significant allergic sensitivity to any vaccine received in the past Immunodeficiency Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol Language difficulties sufficient to preclude adequate comprehension of the study information Possibility of pregnancy Receipt of any other vaccine in the previous 4 weeks Receipt of any group B vaccine in the past Current participation in any other clinical trial Generalized acute systemic illness and/or temp >38C on day of vaccination deferral

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Meningococcal outer membrane vesicle vaccine MenBVac|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and immune response of the rotavirus vaccine in infants who have undergone abdominal surgery.

Official Title
-----------------
Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure

Conditions
-----------------
Intestinal Failure, Rotavirus Vaccines

Intervention / Treatment
-----------------
* Biological: Rotarix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with one of the following diagnoses: necrotizing enterocolitis requiring operation; congenital atresia of the intestine; gastroschisis; midgut volvulus requiring bowel resection; or long-segment intestinal aganglionosis Minimum gestational age of 35 weeks at time of first vaccine dose Exclusion Criteria: immunocompromise secondary to HIV infection or immunodeficiency state active use of corticosteroid or other immunosuppressive agents active infection as defined by fever > 38°C within 24 hours, positive blood culture within 7 days, or positive urine culture within 3 days of enrollment severe malnutrition as defined by serum albumin < 2.0 mg/dL or serum prealbumin < 6 mg/dL.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 14 Weeks

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

| Intervention/Treatment |
| --- |
|Biological: Rotarix|A rotavirus vaccine (Rotarix) will be administered in two doses, 8 weeks apart, in infants between 6 and 14 weeks of age. The standard dosage is 1 mL administered orally or per gastrostomy tube.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable. |  | 1-12 weeks following vaccine administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome measure is the preliminary measurement of the immunogenicity of the rotavirus vaccine in infants with intestinal failure. |  | 1-12 weeks following vaccine administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intestinal failure, Rotavirus vaccine, Infants
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

Study Overview
=================
Brief Summary
-----------------
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.

Official Title
-----------------
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

Conditions
-----------------
Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia

Intervention / Treatment
-----------------
* Device: AMIStem Hip System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System Patient is willing and able to give informed consent to participate in the follow-up program Patient is suitable for surgery and able to participate in the follow-up program. Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use) Exclusion Criteria: Acute systemic or chronic infection Skeletal immaturity Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant. Bone condition that may compromise the stability of the implant. Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.
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 |
| --- | --- |
| Other: AMIStem Hip System<br>Patients who comply with the protocol and received an AMIStem femoral component. | Device: AMIStem Hip System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of implant survivorship using Kaplan Meier curve |  | 10 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the patient's physical level of activity using the Oxford Hip Score |  | pre-op, annually post-op up to 10 years | 
| Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score |  | pre-op, annually post-op up to 10 years | 
| Assessment of implant survivorship as a measure of safety using Kaplan Meier curve |  | 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery | 
| Assessment of the clinical outcome following total hip replacement using the Harris Hip Score |  | pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery |
iCORE: Collaborative Orthopedics Outcomes Registry

Study Overview
=================
Brief Summary
-----------------
The goal of this registry is to review the data collected and research ways to improve patient safety, quality of care, and medical decision-making, reduce medical spending, and help advance orthopedic science and bioengineering.

Official Title
-----------------
iCORE: Collaborative Orthopedics Outcomes Registry

Conditions
-----------------
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Other: Patient Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Patients requested to be seen by an orthopedic surgeon participating in the iCORE Registry. Patient must have the ability to understand the nature of the registry and give written informed consent. Exclusion Criteria: There are no exclusion criteria for this Outcomes Registry.

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 |
| --- |
|Other: Patient Registry|Orthopedic Data Registry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality Improvement |  | 10 years | 
| Treatment Patterns |  | 5 years | 
| Healthcare Utilization |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humanistic Outcomes |  | 10 years | 
| Economic Outcomes |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthopedics, Outcome Assessment