linjc16/ctgov huggingface dataset:
Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

Study Overview
=================
Brief Summary
-----------------
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although we can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.

Official Title
-----------------
Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease

Conditions
-----------------
Kawasaki Disease

Intervention / Treatment
-----------------
* Drug: Atorvastatin and anakinra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Kawasaki disease with a Z score of 3 or larger of the LAD or RCA Exclusion Criteria: Taking a CYP3A4 metabolized drug (such as cyclosporine)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin and anakinra<br>Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day | Drug: Atorvastatin and anakinra<br>* Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day in children with acute KD at least 1 year old with CAA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | The number of participants with adverse events related to study drugs will be assessed and reported | 6 weeks |
Clinical Investigation of the SelectSecure Pacing Lead

Study Overview
=================
Brief Summary
-----------------
People who have a slow heart beat, or whose heart does not beat on its own, may be in need of an electronic device called a pacemaker. A pacemaker is implanted surgically just under the skin in the upper chest area. This device helps the heart beat at a regular rhythm by sending electrical signals (pacing) directly to the heart tissue through flexible wires called leads. The purpose of this study is to demonstrate that the SelectSecure (Model 3830) lead is safe and effective for both sensing the heart's natural rhythm and pacing the heart when it does not beat on its own. This lead will be studied in both the right atrium and right ventricle. A previously market approved Medtronic lead model will serve as a comparison to prove the safety and effectiveness of the SelectSecure Model.

Official Title
-----------------
Clinical Investigation of the SelectSecure Pacing Lead

Conditions
-----------------
Bradycardia

Intervention / Treatment
-----------------
* Device: Pacing Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are in need of a pacemaker that paces in both the right atrium and ventricle. Exclusion Criteria: Subjects who are in need of an implantable cardioverter defibrillator (ICD). Subjects who have a mechanical or diseased tricuspid valve (a structure in the heart, located between the right atrium and right ventricle, which allows blood to flow from the atrium to the ventricle). Steroid contraindication

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pacing Lead|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month safety (complications and all lead-related adverse events) and efficacy ( pacing and sensing) objectives |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead and catheter handling characteristics, and lead impedance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bradycardia
A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC.

Official Title
-----------------
A Pilot, Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Disseminated Mycobacterium Avium Complex Disease (MAC) in AIDS Patients Who Are Receiving Standard Acute Treatment for This Opportunistic Infection

Conditions
-----------------
Mycobacterium Avium-Intracellulare Infection, HIV Infections

Intervention / Treatment
-----------------
* Drug: Nelfinavir mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection New diagnosis of MAC bacteremia and < 7 days of therapy. Prior Medication: Allowed: Patients no more than 7 days of therapy for MAC disease. Exclusion Criteria Prior Medication: Excluded: Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir mesylate|nan|

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
-----------------
AIDS-Related Opportunistic Infections, Placebos, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, Nelfinavir, Anti-Infective Agents, Anti-HIV Agents
Low Cylinder Toric

Study Overview
=================
Brief Summary
-----------------
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).

Official Title
-----------------
Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: Toric IOL (SN60T3)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Cataracts Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D) Exclusion Criteria: Preoperative ocular pathology Planned monovision

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcrySof Toric T3<br>Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL) | Device: Toric IOL (SN60T3)<br>* Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Distance Visual Acuity | Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA). | 6 months | 
| Best Corrected Distance Visual Acuity | Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the logarithm of the minimum angle of resolution. It is a unit of measure for visual acuity (VA). | 6 Months | 
| Residual Refractive Cylinder | Residual Refractive Cylinder at month 6 measured in diopters (D). | 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Survey | Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toric IOL
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment

Study Overview
=================
Brief Summary
-----------------
PANGEA is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease.

Official Title
-----------------
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment

Conditions
-----------------
Stroke, Cardiac Arrest, Traumatic Brain Injury, Brain Mass, Status Epilepticus, Spinal Cord Disease, Hydrocephalus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 7 days to 17 years inclusively and admitted to an ICU (ICU can be classified as general, cardiac, trauma, etc). Children with acute or acute on chronic neurologic disease that occurred just prior to hospital admission or occurred during the hospital admission. Acute neurologic disease is secondary to TBI, stroke, brain mass, hydrocephalus, cardiac arrest, status epilepticus, CNS infection/inflammation, or spinal cord injury. Exclusion Criteria: Children with acute perinatal neurologic disease. Children with isolated chronic brain injury and no acute neurologic disease.

Ages Eligible for Study
-----------------
Minimum Age: 7 Days
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of acute brain insult |  | 4 days over a 1 year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Hospital discharge or 3 months |
Tuberculosis Research Blood Bank

Study Overview
=================
Brief Summary
-----------------
To create a Tuberculosis Research Blood Bank for future molecular genetics and serological studies

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Procedure: Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TB suspect with positive sputum smear

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum 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 |
| --- | --- |
| TB diagnosis<br> | Procedure: Develop a bank of blood samples from patients infected with TB for future molecular genetics studies and serological studies<br>* Blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop TB Blood Bank | To develop a bank of blood samples (serum, plasma, buffy coat DNA) and urine from patients infected with TB. This blood and urine will be used for future molecular genetics studies. Demographic data will be collected and samples will be stored by number. The banked specimens will be evaluated in an attempt to identify susceptibility genes in TB disease. Specifically, expression of the human Bcg gene that codes for resistance to M. tuberculosis will be evaluated and its expression correlated expression with gender, race, clinical TB characteristics. Each patient will have a unique identifier and therefore data generated from this analysis will not be linkable to the patient. | Long-Term |
Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.

Official Title
-----------------
Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients

Conditions
-----------------
Pancreaticobiliary Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Routine care + Nutritional product
* Other: Routine care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (age more than 19) Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer Exclusion Criteria: Patient who denied clinical trial Diabetes Mellitus(DM) patient with DM complication Hyperlipidemia patient with vascular co-morbidity Impaired renal function or renal failure (GFP<70%) Poor nutritional status (PG-SGA grade C)

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br> | Dietary Supplement: Routine care + Nutritional product<br>* Routine post-op care + Nutritional supplement by specific product<br>|
| Active Comparator: control group<br> | Other: Routine care<br>* Routine post-op care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Intake Rate(%) for postoperative diet | Diet Intake Rate(%) | Pre-operation | 
| Food Intake Rate(%) for postoperative diet | Diet Intake Rate(%) | 1 day before discharging | 
| Food Intake Rate(%) for postoperative diet | Diet Intake Rate(%) | 1 week after discharging (first outpatient follow up) |
Swiss Autoimmune Hepatitis Cohort Study

Study Overview
=================
Brief Summary
-----------------
Research project in which biological material is sampled and health-related personal data is further used and collected. Coded data are used.

Detailed Description
-----------------
To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, a biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on AIH. In addition, the cohort will allow collaborations with reference networks on AIH abroad. Measurements and procedures: Enrolment visit and one follow-up visit at least once a year are planned. An additional follow-up visit at 6 months postdiagnosis is planned for newly diagnosed patients. Whole blood is collected for biobanking once a year Optionally, if available and collected during normal clinical procedures, liver fragments are obtained. Number of subjects projected for the entire study (all sites combined): 500 (corresponding to 1/3 of the estimated global AIH population residing in Switzerland, assuming a disease prevalence of 20:100,000)

Official Title
-----------------
Swiss Autoimmune Hepatitis Cohort Study

Conditions
-----------------
Hepatitis, Autoimmune

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of AIH, either type I or type II Only patients living in Switzerland Exclusion Criteria: N/A
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 |
| --- | --- | --- |
| Disease course | Observing disease course | 3 years | 
| Disease features | Observing disease features in Swiss population and see if they are similar to other countries' | 3 years | 
| Response to treatment | Observing response to treatment | 3 years | 
| Overall survival | Observing overall survival | 3 years | 
| Transplantation-free survival rate | Observing transplantation-free survival rate | 3 years |
Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens

Study Overview
=================
Brief Summary
-----------------
This is a pilot randomized controlled trial to assess the effects of advanced supply of emergency contraception versus routine care in a teen postpartum population. The goals are to assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.

Official Title
-----------------
A Pilot Randomized Control Trial of Advanced Supply of Levonorgestrel Emergency Contraception vs. Routine Postpartum Contraceptive Care in the Teenage Population

Conditions
-----------------
Post Partum

Intervention / Treatment
-----------------
* Drug: Plan B (Levonorgestrel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female English speaking Aged 14-19 at enrollment Immediately postpartum of a live infant Planning to parent the baby Desiring to delay another pregnancy for at least one year General good health Willing and able to follow the study protocol Exclusion Criteria Allergy to levonorgestrel Current substance abuse Plans for relocation outside of Philadelphia

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>No advance supply of emergency contraception | |
| Active Comparator: 2<br>Advance supply of emergency contraception is given | Drug: Plan B (Levonorgestrel)<br>* PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. |  | 1 year | 
| PREGNANCY RATES |  | 1 year | 
| PLAN B USE |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Teen, Plan B, Post Partum, Emergency Contraception