linjc16/ctgov huggingface dataset:
Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors for the development of atherosclerotic cardiovascular diseases. The purpose of the study is to assess the efficacy and safety of KB2115 as monotherapy following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115.

Official Title
-----------------
A Placebo Controlled, Double Blind, Randomised, 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Primary Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Eprotirome
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of hypercholesterolemia

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br> <br> |
| Experimental: Eprotirome dose 1<br> | Drug: Eprotirome<br> <br> * Other names: KB2115;|
| Experimental: Eprotirome dose 2<br> | Drug: Eprotirome<br> <br> * Other names: KB2115;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes |  | 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia, dyslipidemia, thyroid, safety
Virtually-integrated Co-management Between Complex Care and Community-based Primary Care Providers

Study Overview
=================
Brief Summary
-----------------
This is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. We will also collect data on a range of patient-centered and utilization outcomes to determine effect compared to usual care.

Official Title
-----------------
Traditional vs Virtually-integrated Co-management of Children With Medical Complexity Between Complex Care and Community-based Primary Care Providers

Conditions
-----------------
Chronic Illness

Intervention / Treatment
-----------------
* Other: videoconferencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregiver of patient seen for co-managed care in Special Care Clinic; caregiver has a smartphone that will accept the technology; PCPs office has wireless internet connection - Exclusion Criteria: Child is in foster care -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>videoconferencing | Other: videoconferencing<br>* Parents/caregivers will use smartphones to videoconference in their SCC provider during PCP visits<br>|
| No Intervention: Control<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of co-managed visits scheduled that are completed through videoconferencing | To determine the feasibility of scheduled visits that are completed through videoconferencing | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Perception of integrated care | Instrument that measures the perception of how well care is integrated. This is a validated, caregiver-reported outcome | Baseline, 3 months and 6 months |
Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C

Study Overview
=================
Brief Summary
-----------------
This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.

Official Title
-----------------
An Open-Label, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: valopicitabine
* Drug: pegylated interferon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical history compatible with genotype-1, chronic hepatitis C infection Treatment-naive (patient has received no previous therapy for hepatitis C viral infection) Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant Patient is co-infected with hepatitis B or HIV Other protocol-defined exclusion criteria may apply.

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

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

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: valopicitabine|nan|
|Drug: pegylated interferon|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
-----------------
Genotype-1, Treatment-Naive
The Lake Nona Life Project

Study Overview
=================
Brief Summary
-----------------
The Lake Nona Life Project aims to examine the health and wellness of participants over the course of multiple years, focusing on the links between health and wellness, longevity, quality of life, and human performance.

Detailed Description
-----------------
The Lake Nona Life Project is a community health and wellness research project of the Lake Nona Institute (LNI), carried out by the Lake Nona Medical City Residents and Partners (the Researchers), and sponsored by Florida Hospital. The project is designed to study patterns, predictors and strategies for improving human health and wellness. Data will be obtained over many years using surveys/interviews, medical tests, and health information from 3rd parties (i.e., health care claims data) obtained with participant permission.

Official Title
-----------------
A Community Epidemiology Study Evaluating the Factors Influencing Overall Health and Wellness

Conditions
-----------------
Health Behavior, Quality of Life, Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Live and/or work in the Lake Nona Community (proper) Able to provide informed consent Able to speak and read English Exclusion Criteria: Unable to speak or communicate in English Living outside of the LNLP study map Cognitive impairment that would not allow survey completion Unable to speak and read English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

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 |
| --- | --- | --- |
| Quality of Life over 10 Years | Participants will self report on an Investigator created questionnaire regarding life satisfaction, stress and life events. Responses will be provided on a five point Likert Scale. | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Participants will self report demographic information consisting of questions related to age, gender and race. | 20 years | 
| Medical History | Participants will self report medical history and chronic conditions. | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health, wellness, life expectancy, quality of life, performance, religion, skin, cardiovascular, joints, bone, respiration, pain, nervous system diseases, oral health, behavior, child, depression, mood, sleep, stress, nutrition, exercise, life change events, personality, employment, social networking, time management, residence characteristics, panic
Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
Seasonal/perennial allergic rhinitis (SAR/PAR) is a common childhood illness. One of the leading therapies for the treatment of SAR/PAR is intranasally inhaled corticosteroids (ICS). One of the major long-term safety concerns is whether ICS interferes with normal growth in allergic rhinitis children. Recent evidence suggests that nasal ICS may cause decreased growth. However, the effect of nasal ICS on long-term growth and the attainment of final adult height is unknown. Another potential systemic adverse effect of ICS use is suppression of the hypothalamic-pituitary-adrenal axis function. The primary hypothesis of this study is that triamcinolone acetonide aqueous nasal spray (TAA) will have no effect on measured adult height in relation to target adult height in children with allergic rhinitis.

Official Title
-----------------
Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis

Conditions
-----------------
Allergic Rhinitis, Allergy, Growth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/Female aged 6-13 years of age Diagnosis of SAR/PAR, with symptoms within the past 3 months Positive skin test to inhalant allergen with negative saline control No previous use of intranasal inhaled, oral, IV or topical steroid use within past 6 months. If the subject has asthma, only mild intermittent (per NAPP) guidelines treated with PRN bronchodilator Exclusion Criteria: screening height outside the 5th and 95th percentiles History of abnormal growth Any other chronic condition beside allergic rhinitis or mild intermittent asthma Subject who has insufficient allergic rhinitis symptoms to require daily therapy during the trial. Subject with a known hypersensitivity to any active ingredients or excipents in the study medications Subject with nasal candidiasis, acute or chronic sinusitis, significant nasal polyposis (impairs nasal breathing), or other gross anatomical deformity of the nose sufficient to impair nasal breathing (e.g., deviated septum) Subjects with a history of substance abuse, mental illness or retardation Subjects with a history or presence of glaucoma or posterior subcapsular cataract Subjects with nocturnal enuresis. Use of Theophylline, Intal/Tilade or leukotriene modifiers.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis, Allergy, Growth
Back School for Non-specific Low Back Pain (LBP) in an Urban Setting

Study Overview
=================
Brief Summary
-----------------
This study will be a comparative design between 2 groups of subjects attending classes on back education in an urban setting. Participants will be randomized to either an individual one-on-one back school session or to the 8 group sessions.

Official Title
-----------------
The Effect of an 8-session Back School Versus a Single, Abbreviated Session When Looking at Non-specific Low Back Pain in an Urban Setting

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Back school


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants 18 years of age or older who have been suffering from non-specific LBP for at least 3 months Exclusion Criteria: Additional impairments contraindicating their safe participation in the back school program, such as evidence of spinal cord pathology, cauda equina, progressive neurological damage, infection, inflammation, malignancy, fracture or a progressive, neurodegenerative disease as well as back surgery within the past year

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One individual back school session<br>The 1 individual session will consist of a 60 min 1-on-1 education/exercise session with an athletic trainer. Information will be an abbreviated version of the 8-session school and fill focus on the strengthening, stretching, pain control and movement re-education most needed for the individual. | Other: Back school<br> <br> |
| Active Comparator: 8 group session of back school<br>All sessions last 45-60 minutes. There will be up to 8 participants in each session which will be led by an athletic trainer or rehabilitation trainer. Pain management, prevention strategies, and active treatment will be covered in the 8 sessions. Active treatment includes strengthening, stretching, pain control, movement re-education, and walking. | Other: Back school<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Modified Oswestry Disability Index |  | At 4 weeks, 10 weeks, 4 months, and 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion |  | At 4 weeks, 10 weeks, 4 months, and 7 months | 
| Change in the Numeric pain rating scale |  | At 4 weeks, 10 weeks, 4 months, and 7 months | 
| Change in the International Physical Activity Questionnaire |  | At 4 weeks, 10 weeks, 4 months, and 7 months |
Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

Official Title
-----------------
Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

Conditions
-----------------
Pain, Inflammation

Intervention / Treatment
-----------------
* Drug: bromfenac ophthalmic solution
* Drug: placebo comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery Agree to return for all required visits Agree to avoid disallowed medications Exclusion Criteria: Known hypersensitivity to bromfenac and salicylates

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-bromfenac ophthalmic solution<br>sterile ophthalmic solution | Drug: bromfenac ophthalmic solution<br> <br> |
| Placebo Comparator: 2-placebo comparator<br>sterile ophthalmic solution | Drug: placebo comparator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of ocular inflammation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal
Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the toxicity of amifostine in patients with bone marrow failure related to Fanconi's anemia. II. Determine the efficacy of this treatment regimen in this patient population. III. Evaluate the effect of this treatment regimen on bone marrow progenitor cell proliferation and peripheral blood mononuclear cell apoptosis in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a dose escalation study. Patients receive amifostine IV over 3-5 minutes three times a week for three weeks. Cohorts of 3 patients receive one of three dose levels of amifostine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed weekly for 3 weeks.

Conditions
-----------------
Fanconi's Anemia

Intervention / Treatment
-----------------
* Drug: amifostine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of Fanconi's anemia by conventional diepoxybutane or mitomycin sensitivity assays, or molecular testing Bone marrow failure verified on at least 3 occasions in the preceding 3 months by any one of the following: hemoglobin less than 8 g/dL; absolute neutrophil count less than 1,000/mm3; platelet count less than 30,000/mm3; symptomatic bone marrow failure (e.g., exercise limitation from anemia or spontaneous bleeding from thrombocytopenia) Evidence consistent with myelodysplastic syndrome allowed if less than 5% blasts on bone marrow aspiration; clonality on bone marrow cytogenetic analysis OR morphological changes on bone marrow aspirate Refusal of or unsuccessful with prior conventional therapies --Prior/Concurrent Therapy-- Biologic therapy: No prior bone marrow transplantation; no concurrent hematopoietic growth factors Endocrine therapy: No concurrent androgens --Patient Characteristics-- Hepatic: Bilirubin no greater than 2 times normal AST no greater than 3 times normal ALT no greater than 6 times normal Renal: Creatinine no greater than 2 times normal Other: No prior malignancy; no active bacterial, viral, or fungal infection requiring therapy other than prophylaxis; not pregnant; negative pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 2 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: amifostine|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
-----------------
Fanconi's anemia, aplastic anemia, hematologic disorders, rare disease