linjc16/ctgov huggingface dataset:
Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

Study Overview
=================
Brief Summary
-----------------
The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles allograft are comparable to those using Achilles allograft with bone block on its end.

Official Title
-----------------
Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft

Conditions
-----------------
Anterior Cruciate Ligament Rupture

Intervention / Treatment
-----------------
* Procedure: anterior cruciate ligament reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male subjects subjects who had concomitant medial collateral ligament injury which was managed conservatively subjects who had meniscus tear which was managed by partial meniscectomy Exclusion Criteria: subjects who underwent a subtotal or total meniscectomy, meniscal repair, or meniscal transplantation due to meniscus injury subjects who underwent an operation due to any concomitant ipsilateral ligament injuries subjects who underwent microfracture or cartilage transplantation due to full thickness cartilage injury female subjects who were older than 45 subjects who had histories of injuries on either knee

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bone-tendon Achilles allograft group<br>the group which underwent anterior cruciate ligament reconstruction using bone-tendon Achilles allograft | Procedure: anterior cruciate ligament reconstruction<br>* single bundle anterior cruciate ligament reconstruction with Achilles allograft<br>|
| Active Comparator: free tendon Achilles allogarft group<br>the group which underwent anterior cruciate ligament reconstruction using free tendon Achilles allograft | Procedure: anterior cruciate ligament reconstruction<br>* single bundle anterior cruciate ligament reconstruction with Achilles allograft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm score |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side-to-side differences | the differences of anterior displacement of tibia under loading between normal knee and reconstructed knee | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior cruciate ligament, Achilles, free tendon, bone-tendon, free tendon Achilles allograft, Achilles allograft with calcaneal bone block on its end
RNA Sequencing of Individual Versus Wastewater - SARS-CoV2

Study Overview
=================
Brief Summary
-----------------
The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.

Official Title
-----------------
A Comparison Between Individual and Wastewater SARS-CoV2 RNA Sequencing

Conditions
-----------------
Infection Viral

Intervention / Treatment
-----------------
* Other: NO INTERVENTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: whole population tested in Nice during W43 of 2020 Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCR positive<br>samples that are positive for the detection of SARS-CoV2. The SARS-CoV2 sequence of positive samples is provided, together with an indication about patient's neigborhood, corresponding to one of the 21 different spots which wastewater was analyzed | Other: NO INTERVENTION<br>* No INTERVENTION<br>|
| PCR negative<br>samples that are p negative for the detection of SARS-CoV2. T | Other: NO INTERVENTION<br>* No INTERVENTION<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RTqPCR result | positive ou negative result to SAR-Cov2 | 1 month | 
| SARS-CoV2 sequence | analyse of SARS-CoV2 sequence (in the case of positive samples) | 1 month |
The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

Detailed Description
-----------------
The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive. Secondary Objective(s) To assess parent satisfaction and comfort level after circumcision with use of 2-octyl cyanoacrylate skin adhesive and compare to those undergoing circumcision without the use of 2-octyl cyanoacrylate skin adhesive.

Official Title
-----------------
The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision

Conditions
-----------------
Adhesions, Phimosis

Intervention / Treatment
-----------------
* Procedure: stitches and skin adhesive
* Procedure: stitches only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing circumcision Only male patients under the age of 7 years will be eligible Exclusion Criteria: Any patient over 7 years of age Previous circumcision Any parents who are not English language speaking

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stitches only<br>Stitches only closing circumcision wound | Procedure: stitches only<br>* standard of care<br>|
| Experimental: Stitches and skin adhesive<br>application of 2-octyl cyanoacrylate skin adhesive. | Procedure: stitches and skin adhesive<br>* In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.<br>* Other names: skin adhesive;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post circumcision adhesions | Evaluation for adhesions | 3-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent satisfaction and comfort level with circumcision results | Parent survey at follow-up visit. | 3-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circumcision, 2 octyl cyanoacrylate, phimosis
PK Effects of Bifeprunox & Valproate in Bipolar I

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate the effect of bifeprunox on the pharmacokinetics of valproate in subjects with Bipolar I Disorder after multiple dose administration.

Official Title
-----------------
Placebo-controlled Study on the Pharmacokinetics,Pharmacodynamics, Safety and Tolerability of Concurrent Valproate and Bifeprunox Administration in Subjects With Bipolar I Disorder

Conditions
-----------------
Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 18-65 years old meeting DSM-IV criteria for Bipolar I Disorder, either manic or mixed episodes, with or without psychotic features Exclusion Criteria: subjects who are acutely manic, acutely depressed, psychotic or subjects with a current Axis I primary psychiatric diagnosis other than Bipolar I Disorder based on DSM-IV TR criteria.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bifeprunox|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
-----------------
bipolar, drug interaction, pharmacokinetics, valproate
Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.

Detailed Description
-----------------
Currently there is no prospective study in hemangioma patients answering critical questions such as: which type of steroid should be used,how much should we use and for how long. This study is an investigator blinded study with two arms:one arm is receiving standard treatment with daily oral corticosteroids and the other is receiving intravenous pulse corticosteroids daily for 3 days, monthly for 3 months. The main outcome of the study is assess the efficacy of each treament modality as the percentage improvement in the hemangioma's appearance. The secondary outcomes are the safety profiles of the two drugs and the changes in the angiogenesis markers as a result of treatment intervention.

Official Title
-----------------
The Efficacy and Safety of Intravenous Pulse Steroids Compared to Standard Oral Steroids in the Treatment of Problematic Hemangiomas in Infants: A Randomized Controlled Trial

Conditions
-----------------
Hemangiomas

Intervention / Treatment
-----------------
* Drug: prednisolone
* Drug: methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual obstruction, large/dysfiguring hemangiomas) 1-4 months of age signed consent form Exclusion Criteria: refusal to participate age > 4 months complicated nonvisible hemangiomas congenital heart disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 4 Months

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: prednisolone|nan|
|Drug: methylprednisolone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent improvement in the appearance of hemangioma |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of side-effects experienced by the patients |  |  | 
| Changes in the angiogenesis markers |  |  |
A Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by Magnetic Resonance Imaging (MRI)(0812-003)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test MK0812 on disease activity in patients with relapsing-remitting MS. Disease modifying activity will be assessed by measurement of brain lesions via MRI brain scans and an open label extension is offered.

Official Title
-----------------
A Randomized, Double-Blind Placebo Controlled, Parallel Groups Study to Assess the Effects of MK0812 on Disease Activity in Patients With Relapsing-Remitting Multiple Sclerosis as Measured by MRI

Conditions
-----------------
Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: MK0812


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have clinically definite relapsing-remitting MS onset within last 10 years and have had at least 1 objective clinical exacerbation in the last year OR a recent clinically isolated syndrome suggestive of MS occurring 3-12 months before screening Patients must be relatively healthy Exclusion Criteria: Patient has primary progressive MS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Intervention/Treatment |
| --- |
|Drug: MK0812|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual rate of new GD-enhancing lesions as assessed by MRI |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume and cumulative number of new persistent Gd-enhancing lesions |  | 3 Months |
Expanded Access Protocol to Provide Patisiran to Patients With Transthyretin-mediated Amyloidosis With Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the long-term safety of patisiran in patients with ATTR amyloidosis with cardiomyopathy as assessed by a review of adverse events (AEs).

Detailed Description
-----------------
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided.

Official Title
-----------------
Expanded Access Protocol to Provide Patisiran to Patients With Transthyretin-mediated Amyloidosis (ATTR Amyloidosis) With Cardiomyopathy

Conditions
-----------------
Transthyretin-mediated Amyloidosis With Cardiomyopathy, ATTR Amyloidosis With Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: Patisiran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy; AND Had an inadequate response to or could not tolerate standard of care, in the opinion of the investigator. Is not eligible for on-label use of commercial patisiran in the opinion of the investigator. Exclusion Criteria: New York Heart Association (NYHA) Class IV NYHA Class III AND ATTR amyloidosis disease Stage 3 (defined as both N-terminal prohormone B-type natriuretic peptide (NT-proBNP) >3000 ng/L and estimated glomerular filtration rate [eGFR] <45 ml/min/1.73 m^2). [Gillmore 2018] Current or future participation in another investigational device or drug study, scheduled to occur during this study, or has received an investigational agent or device within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing (Day 1). Patients who have previously participated in a gene therapy trial for hATTR amyloidosis. Patients currently enrolled in, eligible for inclusion in, or who have dropped out of an ongoing interventional (therapeutic) clinical trial related to ATTR amyloidosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Patisiran|Patisiran administered by intravenous (IV) infusion|

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
-----------------
RNAi therapeutic, Amyloidosis, Cardiomyopathy, TTR, Transthyretin
Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2)

Study Overview
=================
Brief Summary
-----------------
The IPOD-B2 Study aims to understand the pathogenesis of postoperative delirium in patients undergoing major surgery. The investigators will identify then correlate soluble biomarkers in blood and cerebral spinal fluid with changes in High Density-Electroencephalogram.

Official Title
-----------------
Interventions for Postoperative Delirium: Biomarker-2 (IPOD-B2) Pilot Study

Conditions
-----------------
Delirium

Intervention / Treatment
-----------------
* Procedure: High Density-Electroencephalogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>21 years old) Patients scheduled for an elective open thoracoabdominal aortic aneurysm or TEVAR (thoracic endovascular aortic/aneurysm repair) Requiring spinal drain for surgery that is predicted to stay in two or more days Willing and able to provide informed consent Exclusion Criteria: Contraindication for spinal drain Documented history of dementia Unable to communicate with the research staff due to language barriers Individuals who the PI determines are not appropriate for the study such as a history of appointment cancellations. Pregnant or Nursing Prisoners

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: High Density-Electroencephalogram|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline and correlation between biomarker levels in CSF and HD-EEG changes |  | Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute changes in biomarkers in CSF and plasma in delirious and non-delirious patients between baseline and post-operative period |  | Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9 | 
| Correlation between biomarkers in CSF and plasma in delirious and non-delirious patients |  | Post-operative measure: Up to postoperative day (POD) 9 | 
| Absolute changes in activity and connectivity in HD-EEG from baseline to postoperative |  | Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9 | 
| Correlation of biomarkers with the incidence of spinal cord ischemia |  | Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Up to postoperative day (POD) 9 |
Prevalence & Progression of Subclinical Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
To evaluate subclinical atherosclerotic disease in menopausal women.

Detailed Description
-----------------
BACKGROUND: Decreased ovarian function and premenopausal obesity are likely the primary determinants of early coronary atherosclerosis as measured by calcification on EBCT. Aortic calcification occurs earlier than coronary calcification, may predict coronary calcification, and is expected to be the best marker of risk associated with traditional factors in these younger women. Preliminary data indicate that changes in coronary and aortic calcification can be observed over short periods of time in these women. A period of diminishing estrogen levels is the optimum time to observe changes in endothelial function which likely precede measurable atherosclerosis and thus may be the earliest markers for disease potential. Vascular stiffness, a marker for the biologic aging of the vascular system, is highly correlated with measures of insulin sensitivity which is altered in women at mid-life in conjunction with increases in central adiposity. Racial differences in disease prevalence and the relative importance of certain risk factors are likely. DESIGN NARRATIVE: Subclinical atherosclerosis will be evaluated in 728 women (305 African American, 423 Caucasian) enrolled in the Pittsburgh and Chicago sites of the Study of Women's Health Across the Nation (SWAN), a multicenter study characterizing the biological and psychosocial antecedents and sequellae of menopause. The extent to which diminishing ovarian function affects vascular function and accelerates the development of atherosclerosis in the coronary arteries, aorta and carotid arteries will be evaluated. Serial measures of coronary and aortic calcification (by electron beam computed tomography [EBCT] ), carotid atherosclerosis, endothelial function and aortic stiffening will be performed two years apart. The prevalence and progression of subclinical atherosclerosis will be evaluated in relation to serial measures of ovarian function, psychosocial and behavioral factors, markers of clotting and inflammation as well as traditional cardiovascular risk factors, all collected in SWAN. The study is conducted jointly by Dr. Lynda Powell (R01HL65581) at Rush-Presbyterian-St. Luke's Medical Center in Chicago and Dr. Kim Tyrrell (R01HL65591) at the University of Pittsburgh.

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Coronary Arteriosclerosis, Carotid Artery Diseases, Menopause

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |