linjc16/ctgov huggingface dataset:
Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The proposed research project will retrospectively review the anesthetic records over the past 5 years and identify patients who present with a history of penicillin allergy or allergy to an antibiotic in the penicillin family. The reason for that history and the facts on which that allergy are noted will be determined. Additionally, the choice of antibiotic prophylaxis will be recorded and any adverse effect to that antibiotic noted. We will also note whether appropriate timing of the antibiotic is achieved.

Conditions
-----------------
Penicillin Allergy

Intervention / Treatment
-----------------
* Drug: Antibiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are labeled as penicillin or penicillin family allergic. Exclusion Criteria: As neurosurgical patients routinely receive vancomycin at NCH for surgical prophylaxis, they will be excluded from the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Penicillin allergy<br> | Drug: Antibiotic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Antibiotic Related Adverse Event |  | 24 hours |
Valved Graft PMCF Study

Study Overview
=================
Brief Summary
-----------------
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

Official Title
-----------------
Valved Graft Post-Market Clinical Follow-up Study

Conditions
-----------------
Aortic Valve Disease, Ascending Aorta Abnormality, Aortic Dissection

Intervention / Treatment
-----------------
* Device: VAVGJ
* Device: CAVGJ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement Exclusion Criteria: anticoagulation therapy intolerant active endocarditis anatomical or medical, surgical, psychological or social contraindications

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 |
| --- | --- |
| Group 1<br>VAVGJ | Device: VAVGJ<br>* Replacement of the aortic valve and ascending aorta<br>|
| Group 2<br>CAVGJ | Device: CAVGJ<br>* Replacement of the aortic valve and ascending aorta<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annualized event rate of all-cause mortality | Primary Safety Endpoint | 5 Years | 
| annualized event rate of reintervention | Primary Effectiveness Endpoint | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Root Replacement, Ascending Aorta Replacement, Valved Graft, CAVGJ, VAVGJ
Genetic Analysis of Familial Hypertrophic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
To map the genetic defect responsible for familial hypertrophic cardiomyopathy.

Detailed Description
-----------------
BACKGROUND: Familial hypertrophic cardiomyopathy is a disease of heart muscle that is genetically transmitted as an autosomal dominant trait, with a high degree of penetrance. Affected individuals typically have asymmetric thickening of the interventricular septum often involving the adjacent left ventricular free wall. Histologically, myocardial cells are enlarged and muscle bundles are grossly disorganized, producing a whorled pattern. The physiologic consequence of this cardiomyopathy is diastolic dysfunction with impaired ventricular relaxation and elevated diastolic pressures in the heart and pulmonary vasculature. Patients can experience dyspnea, angina, palpitations, and syncope. Complications of the disease include atrial fibrillation, congestive heart failure, thromboembolism, and most importantly, sudden death. DESIGN NARRATIVE: The three kindreds studied included one in Iceland, one in the St. Lawrence region in Canada, and one in the Pittsburgh, Pennsylvania area. Pedigrees were established for the three kindreds. All family members were clinically evaluated by physical exam, electrocardiogram, and comprehensive M-mode and two-dimensional echocardiography. Lymphoblastoid cell lines were derived from all members of the three pedigrees. Restriction fragment length polymorphism analyses were used to identify a DNA probe that was linked to familial hypertrophic cardiomyopathy. Studies were conducted to determine if the familial hypertrophic cardiomyopathy locus was the same in all three kindreds and to identify the gene responsible. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Myocardial Diseases, Cardiomyopathy, Hypertrophic

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Treatment of Patients With Anxiety Disorder (0777-022)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the safety and efficacy of MK0777 during treatment for Generalized Anxiety Disorder.

Official Title
-----------------
A Double-Blind, Mulitcenter, Placebo-Controlled, Flexible-Dose Replicate Study of MK0777 Gel Extrusion Module (GEM) 3 mg B.I.D. to 8 mg B.I.D. in the Treatment of Outpatients With Generalized Anxiety Disorder

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: MK0777
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female patients ages 18 to 70 Exclusion Criteria: Women who are breastfeeding or pregnant Positive result at prestudy on urine drug screen for illicit drugs History of alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0777|Duration of Treatment: 4 weeks|
|Drug: Comparator: placebo (unspecified)|Duration of Treatment: 4 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Biomarkers for Prediction of Hand Function After Stroke - The ProHand Study

Study Overview
=================
Brief Summary
-----------------
The overall aim is to identify key determinants for recovery of hand function after stroke by applying newly developed hand function measures together with MRI measurements of the lesioned cerebral structures.

Detailed Description
-----------------
Almost half of surviving stroke patients are left with impaired function of the hand but individual profiles of weakness, spasticity, sensory and bimanual function vary widely. Improved prediction of recovery after stroke has broad implications for clinical decisions on the type, duration and goals of rehabilitation. 100 consecutive patients with 1st ever stroke and upper limb hemi-paresis will be subject to imaging, at 4 weeks and 6 months, and behavioral assessments at 4 weeks, 3 months and 6 months after stroke. The imaging protocol includes anatomical sequences for lesion mapping, diffusion tensor imaging and resting-state functional MRI for structural and functional connectivity analyses, respectively. Clinical hand function measures will be combined with novel validated methods to quantify spasticity,grip force control, sensory and bimanual function. ProHand will provide insights into neural mechanisms related to recovery of hand function after stroke and enable enhanced prediction and development of targeted treatment trials.

Official Title
-----------------
Recovery of Hand Function After Stroke- a Longitudinal Study Using Novel Methods to Quantify Hand Function and Connectivity in Brain Networks

Conditions
-----------------
Stroke, Hemiparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first ever stroke and clinically diagnosed arm paresis Exclusion Criteria: incapability to give informed concent and/or understand and comply with instructions, other disorders that may affect hand function (e.g. other neurological conditions, arthritis), cerebellar lesions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Change in Fugl-Meyer Assessment for Upper Extremity |  | From 4 weeks to 3 and six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognosis, Hand function, Rehabilitation, Spasticity, MRI
The Serum Tissue Factor Level in Lung Cancer Patients as a Prognostic Factor

Study Overview
=================
Brief Summary
-----------------
This study uses serum tissue factor and tissue factor inhibitor and factor VII to monitor the pre-coagulation status in lung cancer patients and to correlate the pre-coagulation status with clinical staging and prognosis.

Detailed Description
-----------------
The staging of lung cancer was according to tumor size, involvement of lymph node and metastatic status. But there is a different prognosis in cancer patients of the same stage. The coagulation status of cancer patients was considered as an important possible prognostic factor. So in this study, we want to evaluate patients' coagulation status and find the relation of coagulation status and cancer status. We thus propose a prospective study using coagulation factors in order to search for the relationship between cancer stage and pre-coagulation status in Taiwanese lung cancer patients. We will also evaluate the potential use of tissue factor as a prognosis predictor in lung cancer patients.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly-diagnosed lung cancer Serum from cancer-free healthy volunteers Exclusion Criteria: Chronic renal failure or end-stage renal disease [ESRD] (creatinine [Cr] > 2 ) Hyperlipidemia on statin therapy Acute myocardial infarction Tapal or Plavix use Active thromboembolic event Severe liver disease (> child B)

Ages Eligible for Study
-----------------
Minimum Age: 16 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
-----------------
Tissue factor, Lung cancer, Tissue factor protein inhibitor, Factor VII, Factor X
Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Detailed Description
-----------------
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Official Title
-----------------
A Randomized, Open Label, Single Dose, 2X2 Cross-over Study to Compare Pharmacokinetics Between Rosuvastatin 10mg and Omega-3 1g Co-administration and HCP1007 in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HCP1007 / omarco and crestor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers, age between 20 and 45 Informed of the investigational nature of this study and voluntarily agree to participate in this study BMI of >20kg/m2 and <26kg/m2 subject Exclusion Criteria: Use of any prescription medication within 14 days prior to Day 1 Use of any medication within 7 days prior to Day 1 Participation in another clinical study within 60 days prior to start of study drug administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCP1007<br>HCP1007 | Drug: HCP1007 / omarco and crestor<br>* HCP1007 / Rosuvastatin plus Omega-3<br>|
| Active Comparator: omarco and crestor<br>Rosuvastatin plus Omega-3 | Drug: HCP1007 / omarco and crestor<br>* HCP1007 / Rosuvastatin plus Omega-3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve(AUC) last |  | 0,0.5,1,1.5,2,2.5,3,4,5,6,9,12,24,48hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCP1007, Rosuvastatin, Omega-3
A Study of Neurofeedback for the Treatment of Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to reveal relationship between brain activities and the symptoms of Parkinson disease when a neurofeedback training was applied for them.

Official Title
-----------------
A Phase 1 Double-Blind Crossover Comparative Study of Neurofeedback for the Treatment of Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Training with Neurofeedback
* Other: The other Training with Neurofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with age more than 20 Subjects obtained the consent Subjects with Parkinson disease and healthy subjects Exclusion Criteria: The subjects who can not conduct the tasks Subjects with severe illness Subjects whom the experimenter think as in appropriate Subjects with implantable devices such as pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training with Neurofeedback<br> | Other: Training with Neurofeedback<br>* Neurofeedback the brain activities by Magnetoencephalography<br>|
| Experimental: The other Training with Neurofeedback<br> | Other: The other Training with Neurofeedback<br>* Neurofeedback the brain activities by Magnetoencephalography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration of Brain Activities | measured by magnetoencephalography | At the time Immediately following the training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The raw score change from baseline in the Movement disorder society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part Ⅲ scores | MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total score is the sum of the subscale scores for Part III and ranges from 0 (no disability) to 132 (total dependence). | At the time Immediately following the training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, Magnetoencephalography, Neurofeedback
Pain After Intravitreal Therapy

Study Overview
=================
Brief Summary
-----------------
This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT.

Detailed Description
-----------------
Purpose: To evaluate the influence of the type of the needle on pain scores after intravitreal therapy (IVT). Design: Randomized clinical trial Methods: A total of 200 patients, treated with an IVT for exudative age-related macular degeneration (AMD) or a vascular retinal disease, will be included and randomly assigned to be treated with either a 27-gauge needle (group 1) or a 30-gauge needle (group 2). After IVt the patient has to fill out a standardized questionnaire including pain scores on the visual analog scale after the surgical procedure. Regression analysis of the scaled questionnaires should allow for a standard recommendation regarding the optimal needle size for minimal subjective pain during IVT.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: 27-gauge
* Procedure: 30-gauge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vitrearetinal disease including age-related macular degeneration, clinical significant macular edema due to diabetic retinopathy or other vascular disorders treatment with intravitreal therapy Exclusion Criteria: missing informed consent age under 50 years

Ages Eligible for Study
-----------------
Minimum Age: 51 Years

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

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

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: Group 1<br>27-gauge needle | Procedure: 27-gauge<br>* 27-gauge needle for IVT<br>|
| Active Comparator: Group 2<br>30-gauge needle | Procedure: 30-gauge<br>* 30-gauge needle for IVT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analoge Scale | pain scores on the visual analog scale after the IVT | 1 day, after the intravitreal therapy (IVT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients demographic data | age, gender, number of IVT, surgeon, prior surgical procedures | 1 day, record of patients data before or after intravitreal therapy (IVT) | 
| Baker scale | pain scores on the baker scale after the IVT | 1 day, after the intravitreal therapy (IVT) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intravitreal therapy, pain scales, gauge, Pain Scores, Visual Analog Scale
Mayo Clinic Phage Program Biobank

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to help scientists and clinicians discover answers to research questions related to antibiotic-resistant bacterial infections, and the role that phage therapy plays as a possible treatment.

Official Title
-----------------
Mayo Clinic Phage Program Biobank

Conditions
-----------------
Bacteriophage Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age. Able to provide informed consent. Individual must have a future treatment plan to receive or has historically received phage therapy. Exclusion Criteria: Individuals , 18 years of age. Unwilling/unable to provide informed consent.

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 |
| --- | --- | --- |
| Enrollment of study participants | To recruit and enroll participants up to 100 participants who have received or will receive phage therapy treatment | 5 years | 
| Collection of biospecimens | Total number of biospecimens collected which may include blood samples and synovial fluid | 5 years | 
| Medical record review | Review the medical record of enrolled participants to ascertain any new health outcomes. | 5 years | 
| Increase treatment options and level of care for patients with bacterial infections | Total number of collaborations with clinical investigators and researchers at both Mayo Clinic and across the globe. | 5 years |