linjc16/ctgov huggingface dataset:
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?

Detailed Description
-----------------
Periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the longevity of implants used for treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA man prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis loosening. We perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss around a uncemented femoral stem.

Official Title
-----------------
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Conditions
-----------------
Bone Loss

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on the waiting list for a total hip arthroplasty Primary osteoarthritis Osteoarthritis secondary to congenital dislocation of the hip Exclusion Criteria: Rheumatoid arthritis Bisphosphonate treatment Osteomalacia Hypocalcemia Previous surgery of the affected hip

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Risedronate<br> | Drug: Risedronate<br>* 35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can risedronate reduce migration of a uncemented femoral stem |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periprosthetic bone loss risedronate bisphosphonates
Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

Study Overview
=================
Brief Summary
-----------------
The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.

Official Title
-----------------
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study

Conditions
-----------------
Bacteremia

Intervention / Treatment
-----------------
* Drug: Daptomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female of 18 years or older females: negative pregnancy test Hospitalisation in the medical ICU High suspicion or evidence of Gram-positive infections requiring antibiotic therapy Subjects receiving standard antibiotic treatment for Gram-positive infection Evidence of renal failure Clinical necessity for continuous renal replacement therapy Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign. Exclusion Criteria: Skeletal muscle disorders or CPK levels of > 2 x ULN History of hypersensitivity to the drug Participation in another study Subjects with a history of muscle disease Patients with severe liver function impairment (Child C) Life expectancy of less than 5 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daptomycin|once daily over 5 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing. | 15 patients are devided in 3 cohorts of 5 patients each. PK data(measured on day 1, 3 and 5) of the first 5 patients receiving daptomycin 6mg/kg/day during 5 consecutive days additionally to standard antibiotic treatment are compared with PK data of daptomycin 6mg/kg/day in healthy volunteers and dose is adapted in the next 5 patients based on these results. The same is done for the last 5 patients. | PK on days 1, 3, and 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics
Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.

Official Title
-----------------
Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

Conditions
-----------------
Connective Tissue Disease, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consent form men and women> 18 years fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR) Exclusion Criteria: all contraindications for exercise testing significant restriction of the left ventricle, unstable coronary artery disease and myocardial infarction in the last 6 months patients with other lung diseases (as the pulmonary infestations as part of systemic disease) or related musculoskeletal disorders influencing baseline exercise capacity pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients | Correlate Spiroergometric, lung functional Magnetic Resonance Imaging (MRI) and echocardiographic parameters with invasive hemodynamic findings collected by right heart catheterization: which other non-invasive parameters can be found to detect pulmonary hypertension? Can pulmonary hypertension be detected at rest in the echocardiography? In which patients can only stress-Doppler echocardiography confirm manifest or latent pulmonary hypertension? Is stress-Doppler echocardiography a suitable for early detection of pulmonary hypertension in patients with collagen vascular disease? | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subdivision of patients with connective tissue disease in different degrees of severity | Can spiroergometric findings help to subdivide patients with connective tissue diseases into groups according to degrees of severity, and differ the patients based on spiroergometric findings? To what extent is this distinction comparable with the classifications for the functional classes (application for PH according to the New York Heart Association (NYHA) classification) | 3 years |
Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)

Study Overview
=================
Brief Summary
-----------------
This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia.

Official Title
-----------------
Local Registry for Data Collection of Patients With Achondroplasia / Hypochondroplasia for Epidemiological, Care and Research Studies

Conditions
-----------------
Achondroplasia, Hypochondroplasia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of achondroplasia/hypochondroplasia Patients (and/or Parents legal guardian when required) able to provide informed consent Exclusion Criteria: Absence of diagnosis of achondroplasia/hypochondroplasia Patients (and/or Parents legal guardian when required) not able to provide informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Achondroplasia<br> | Other: Registry<br>* observational, data collection<br>|
| Hypochondroplasia<br> | Other: Registry<br>* observational, data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registry of Achondroplasia and Hypochondroplasia Patients | Collection of medical information of achondroplasia and hypochndroplasia patients intended for use in future research studies. | 10 years |
HSV Oral Reactivation in Children

Study Overview
=================
Brief Summary
-----------------
In the proposed study, the investigators will carry out novel research to evaluate both symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy number in children with and without HIV. Study Objectives: To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children Secondary Objectives: To determine the acceptability of performing daily oral swabs in children age 3-12

Official Title
-----------------
Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania

Conditions
-----------------
HSV-1, HIV

Intervention / Treatment
-----------------
* Other: Underlying medical illness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 3 and ≤12 years old parental/guardian consent and children's assent must be obtained and participants and parent/guardian must be able to comply with study procedures For HIV-infected group: Positive HIV serology by either ELISA x 2, ELISA + WB or PCR testing Exclusion Criteria: age <3 and > 12 years old Acute illness which by opinion of the investigator makes enrollment in the trial unfeasible (including active tuberculosis, malaria or other opportunistic infection requiring treatment) co-enrollment in other therapeutic/intervention trials (observational trial enrollment is permitted). Stable co-administration of other medications is permitted (e.g. bactrim) For HIV-infected children; receiving or eligible for antiretroviral (ART) therapy by local standards

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

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 |
| --- | --- |
| HIV negative<br> | |
| HIV positive<br>HIV positive children in care | Other: Underlying medical illness<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HSV detection rate |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HSV copy number |  | 14 days |
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment outcome from biologic therapy.

Official Title
-----------------
A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy

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

Intervention / Treatment
-----------------
* Biological: KB003
* Other: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 6 swollen and at least 6 tender joints C-reactive Protein (CRP) > Upper Limit Normal (ULN) Prior inadequate response from biologic therapy Stable regimens of concomitant RA therapies Exclusion Criteria: Unstable medical conditions

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KB003 70 mg<br> | Biological: KB003<br>* KB003 IV x5 doses<br>* Other names: Recombinant anti-GM-CSF IgG1K monoclonal antibody;|
| Experimental: KB003 200 mg<br> | Biological: KB003<br>* KB003 IV x5 doses<br>* Other names: Recombinant anti-GM-CSF IgG1K monoclonal antibody;|
| Experimental: KB003 600 mg<br> | Biological: KB003<br>* KB003 IV x5 doses<br>* Other names: Recombinant anti-GM-CSF IgG1K monoclonal antibody;|
| Placebo Comparator: Placebo<br> | Other: Placebo Comparator<br>* Placebo IV x5 doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. | KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods) | Weeks 14 & 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
KB003, Rheumatoid Arthritis, Biologics-Inadequate, GM-CSF
Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.

Detailed Description
-----------------
Advances in surgical and clinical management of patients with congenital heart disease has made survival to adulthood an expectation. Today there are more than 1 million adult survivors of congenital heart disease, but increasing age brings additional concerns for this patient population. Although the literature remains scarce, existing evidence suggests that inactivity, obesity, diabetes, cancer, and acquired cardiovascular disease may be at least as prevalent in patients with congenital heart disease, if not more so, than in an age-matched general population. Acquired cardiovascular disease is likely to impact substantially on long-term survival and quality of life in these patients with palliated and already fragile hearts. This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.

Official Title
-----------------
Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female over 18 years of age Moderate or Complex Congenital Heart Disease Willingness to Consent Exclusion Criteria: Pregnancy Surgery within 6 months Unrepaired cyanotic heart disease Patients with Eisenmenger Syndrome physiology

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 |
| --- | --- |
| Adult Congenital Heart Disease<br>18 years and older with congenital heart disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for acquired cardiovascular disease in adults with congenital heart disease |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital Heart Disease, Acquired Cardiovascular Disease
Edema and Fibrosis CMR Imaging in Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
7 Tesla MRI is a new magnetic field strength that has become available at Penn for cardiovascular MRI. This new scanner has potential to improve assessment of cardiovascular disease due to its increased signal-to-noise ratio, higher spatial resolution, and response to magnetic properties of tissue at high field. The purpose of this study is to assess the feasibility of 7 T CMR. Secondly, we wish to investigate its use, to improve clinical and research MRI. Altogether, 7 T may permit better clinical diagnosis of cardiomyopathy.

Official Title
-----------------
Edema and Fibrosis Cardiac Magnetic Resonance Imaging in Cardiomyopathy

Conditions
-----------------
Cardiomyopathies

Intervention / Treatment
-----------------
* Device: 7 T CMR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between the ages of 20-70 years old Exclusion Criteria: Advanced renal disease (estimated GFR rate < 30 mL/min) or hypersensitivity to gadolinium contrast agent. Presence of cardiac pacemaker or implanted cardioverter defibrillator Pregnancy Inability to provide informed consent Other contraindications to MRI (such as claustrophobia)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with cardiomyopathy | Device: 7 T CMR<br>* 7 tesla MRI device<br>|
| Normal subjects<br>No prior history of heart disease. | Device: 7 T CMR<br>* 7 tesla MRI device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ejection fraction |  | 5 years |
A Pre-Enrollment Protocol for HIV-Infected Adolescents

Study Overview
=================
Brief Summary
-----------------
PRIMARY: To identify, characterize, and co-enroll HIV-infected adolescents into existing and future ACTG (or other NIH-sponsored) HIV treatment protocols through the systematic and recurrent assessment of eligibility. To assess the ability of adolescents enrolled in ACTG 220 to adhere to ACTG (or other NIH-sponsored) HIV treatment protocols; and to define factors that influence the adolescent's ability to enter or adhere to study protocols. SECONDARY: To describe the nature, stage, and progression of HIV infection in adolescents. Little is known about HIV-infected adolescents as a group and, as a result, small numbers of them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely.

Detailed Description
-----------------
Little is known about HIV-infected adolescents as a group and, as a result, small numbers of them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely. At entry and at every subsequent visit, participants are systematically evaluated for eligibility and willingness to enter ACTG (or other NIH-sponsored) HIV treatment protocols from a menu developed and updated by the Pediatric Adolescent Working Group of the ACTG. A survey of participant attitudes, behaviors, and beliefs is administered and updated semiannually. Participants attend clinic visits every 3 months and are followed for a minimum of 6 months, until the end of the study. They receive periodic physical exams, STD and gynecologic or genitourinary evaluations, HIV symptom assessment and related diagnoses, TB evaluation, and laboratory tests (hematology and immunology).

Official Title
-----------------
A Pre-Enrollment Protocol for HIV-Infected Adolescents

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Participants must meet the following criteria: HIV infection. NOT currently enrolled in an ACTG treatment protocol. Exclusion Criteria Co-existing Condition: Participants with the following condition are excluded: No legal provision for consent to participate in clinical research can be determined.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 20 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
-----------------
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Adolescent Behavior