linjc16/ctgov huggingface dataset:
A Clinical Investigation of the M2a-Magnum™ Hip System

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip System

Detailed Description
-----------------
This is a 10 year prospective data collection documenting the function and survivorship of the M2a-Magnum™ Hip System. Patients are required to come in for preoperative, operative, one year follow-up, three year follow-up, five year follow-up, and ten year follow-up exams. This product was FDA cleared in 2004.

Official Title
-----------------
A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System

Conditions
-----------------
Arthritis, Osteoarthritis, Hip, Rheumatoid Arthritis, Joint Disease, Bone Disease

Intervention / Treatment
-----------------
* Device: M2a-Magnum™ Hip System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-inflammatory degenerative joint disease including: Avascular Necrosis, Diastrophic Variant, Fracture of the Pelvis, Fused Hip, Leg Perthes, Osteoarthritis, Slipped Capital Epiphysis, Subcapital Fractures, Traumatic Arthritis Rheumatoid Arthritis Correction of Functional Deformity Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques Revision of previously failed total hip arthroplasty Exclusion Criteria: Absolute contraindications include: Infection, Sepsis, and Osteomyelitis Relative contraindications include: Uncooperative patient or patient with neurologic disorders that are incapable of following directions Osteoporosis Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy, or neuromuscular disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| M2a-Magnum™ Hip System<br>Patients who received the M2a-Magnum™ Hip System | Device: M2a-Magnum™ Hip System<br> <br> * Other names: Magnum Hip;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of revisions, removals, and/or complications |  | Any time | 
| X-Rays |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Knee Replacement, Total Knee Arthroplasty, Hip Arthritis
Myocardial Blood Flow by 15O Water PET

Study Overview
=================
Brief Summary
-----------------
Coronary heart disease is a very common condition caused by narrowings in the blood vessel supplying the heart. the investigators are studying new tests to diagnose heart disease. In this study the investigators plan to investigate a special scan called a PET/CT (Positron emission tomography/computed tomography) and a new type of CT (Computed tomography) scan to tell us about the flow of blood to the heart muscle.

Detailed Description
-----------------
Participants will undergo PET/CT with oxygen-15 labelled water and computed tomography myocardial perfusion imaging.

Official Title
-----------------
Validation of Computed Tomography Myocardial Perfusion Imaging Using Quantification of Myocardial Blood Flow by Positron Emission Tomography With 15O-water

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

Intervention / Treatment
-----------------
* Other: Computed tomography myocardial perfusion imaging
* Other: Oxygen 15 labelled water positron emission tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected coronary artery disease Exclusion Criteria: inability or unwillingness to undergo CT or PET imaging renal failure (serum creatinine >200 um/L or eGFR <30 ml/min) hepatic failure allergy to iodinated contrast pregnancy contraindication to adenosine inability to give informed consent atrial fibrillation with a fast ventricular rate (>70 beats per minute)

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 |
| --- | --- |
| Suspected coronary heart disease<br> | Other: Computed tomography myocardial perfusion imaging<br> <br> Other: Oxygen 15 labelled water positron emission tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial blood flow | Myocardial blood flow ( ml/g/min) measured by oxygen-15 water positron emission tomography | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional flow reserve | Fractional flow reserve measured during invasive coronary angiography | 1 month | 
| Myocardial perfusion | Myocardial perfusion measured as hypoperfusion on adenosine computed tomography myocardial perfusion imaging | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary heart disease, computed tomography myocardial perfusion, positron emission tomography, oxygen 15 labelled water, myocardial perfusion, myocardial blood flow
18613 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment - Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coppertone (BAY987517)<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number - R84-087)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Child Behavior After Local Anesthetic Injection Using Needless Systems

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique

Official Title
-----------------
Assessment of Child Behavior and Soft Tissue Reaction After Local Anesthetic Injection Using Needle Versus Needless Systems

Conditions
-----------------
Child Behavior

Intervention / Treatment
-----------------
* Procedure: Local anesthesia injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative. Children who are medically fit. Children who are capable of interacting on a mental level. Children between the ages of 6 to 8. First dental visit. Exclusion Criteria: Children who struggle with behavioral control (uncooperative). Children who have a history of allergic reaction to local anesthetic drugs. Parental rejection for participation.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local anesthesia injection with the comfort in jet (Needless system)<br>A needle-less injection approach will be used to administer the local anesthetic solution | Procedure: Local anesthesia injection<br>* Local anesthesia administration<br>|
| Active Comparator: Local anesthesia injection with needle injection (conventional technique).<br>A conventional aspirating syringe fitted with 27-gauge long needles will be used to administer the local anesthetic solution. | Procedure: Local anesthesia injection<br>* Local anesthesia administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child behavior (Feeling pain during injection) (Binary Yes/No) | Pain perception during LA injection | During injection (Immediate) (No follow up) |
Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Study Overview
=================
Brief Summary
-----------------
To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy

Detailed Description
-----------------
This study will focus on subjects with documented zinc deficiency (levels <75 µg/dl) as group most likely to benefit from the zinc supplementation. The investigators also acknowledge that zinc may be beneficial in all HIV subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.

Official Title
-----------------
Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Conditions
-----------------
Inflammation, Cardiovascular Diseases, Zinc Deficiency

Intervention / Treatment
-----------------
* Drug: Zinc Gluconate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 infection Documentation of an HIV-1 RNA level of ≤400 copies/mL in the last 4 months prior to study entry Male or Female age ≥18 years Zinc level ≤0.75 mg/L in the last 60 days Exclusion Criteria: Pregnancy/lactation Known cardiovascular disease Uncontrolled diabetes

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double-blind randomized placebo-controlled trial 2:1 Patients will be given zinc gluconate capsules at a dose of 90 mg elemental zinc daily or matching placebo for 24 weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc gluconate<br>Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. | Drug: Zinc Gluconate<br>* Two 45 mg capsules once daily<br>|
| Placebo Comparator: Placebo<br>Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. | Drug: Placebo<br>* Two placebo capsules once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of zinc supplementation in HIV-infected subjects | Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency | baseline and 24 weeks | 
| Effect of zinc supplementation in HIV-infected subjects | Changes in markers of inflammation and immune activation by measuring momonocyte activation soluble markers CD14 (sCD14), high sensitivity C reactive protein (hsCRP), and soluble tumor necrosis alpha receptor I and II (sTNFR-I and II) | baseline and 24 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zinc, inflammation, Cardiovascular Diseases risk
Biofeedback for Adolescent Cannabis Use Disorder

Study Overview
=================
Brief Summary
-----------------
The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome: number of days used cannabis in the past 30 days).

Official Title
-----------------
Biofeedback for Adolescent Cannabis Use Disorder

Conditions
-----------------
Adolescent Cannabis Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Heart rate variability biofeedback
* Behavioral: CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be between the ages of 13 and 19 years, with a parent or legal guardian available to complete parental assessments, if the participant is a minor meet Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V) criteria for cannabis use disorder by clinical interview; be medically healthy; be willing to participate in the study intervention and assessments; plan to live locally for at least 4 months; be able to read English well enough to complete study questionnaires; have self-reported cannabis use in the past 28 days; have a Perceived Stress Scale score > 20. Exclusion Criteria: current or past psychosis; bipolar I or II disorder; the need to take psychotropic medications at any time during the study; pregnancy; psychiatric or substance use disorder that cannot be managed with outpatient care (e.g. alcohol withdrawal, severe major depressive disorder, significant suicidal ideation); and medications known to affect HRV (e.g. albuterol, pseudoephedrine, beta adrenergic blockers).

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 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: Cognitive behavioral therapy (CBT) alone<br> | Behavioral: CBT<br> <br> |
| Experimental: Cognitive behavioral therapy plus HRV biofeedback<br> | Behavioral: Heart rate variability biofeedback<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Stress Scale |  | baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of days used marijuana in the past 28 days |  | baseline and 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescent, cannabis, biofeedback
Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage.

Official Title
-----------------
Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation for Long-term Use in Pediatrics

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Pulmicort Respules for the first time due to bronchial asthma Children of >= 6 months and < 5 years old age at the start of study treatment

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 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 |
| --- | --- |
| Pulmicort Respules<br>Those with an exposure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | Range of 3 years | 
| Effects on growth rate | Variation of the height/weight from the baseline. | Range of 3 years | 
| Effects on the adrenal cortical function. | Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort. | Range of 3 years | 
| Effects on development of infections. | Existence and type of infections. | Range of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical course under Pulmicort long-term use | Validation of the frequency of asthmatic attack, level of the asthmatic attack, daily life, night sleep from baseline |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial asthma, Pulmicort Respules, long term use, pediatrics
New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if there is a connection between a higher level of peptide alpha defensin in blood serum with the metabolic profile of adolescents aged 13-17.

Official Title
-----------------
New Insights Into the Metabolic Syndrome: the Role of Alpha Defensin

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Serum blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Youths with metabolic syndrome (BMI above 95%) Youths with BMI below 3% Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adolescents aged 13-17 will be divided into two groups according to BMI (body mass index)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMI above 95%<br>Serum blood will be taken from obese youths with suspected metabolic syndrome | Diagnostic Test: Serum blood<br>* Serum blood test for laboratory analysis to determine level of alpha defensin<br>|
| Active Comparator: BMI below 3%<br>Serum blood will be taken from slim youths | Diagnostic Test: Serum blood<br>* Serum blood test for laboratory analysis to determine level of alpha defensin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alpha defensin level | Alpha defensin level above 12ng/microliter | 2 hours |