linjc16/ctgov huggingface dataset:
Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.

Detailed Description
-----------------
Patients undergoing percutaneous coronary intervention(PCI) will be randomized to receive subcutaneous local anesthetic (Lidocaine 2% without epinephrine)or no local prior to removal of femoral arterial sheath. They will be assessed for vasovagal reactions and pain intensity during the sheath removal.The incidence of vasovagal reactions and pain intensity scores will be compared between the groups. 200 patients will be enrolled over the course of 2 months.

Official Title
-----------------
Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.

Conditions
-----------------
Syncope, Vasovagal, Pain Intensity

Intervention / Treatment
-----------------
* Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Percutaneous Coronary Intervention Femoral arterial sheath Exclusion Criteria: Less than 18 years old Emergency procedure Transferred out of heart investigation unit prior to sheath removal Radial or brachial sheath Closure devise Venous sheath insitu Intra-aortic balloon pump insitu Tranvenous pacing Mechanical ventilation Cognitive impairment Unable to read English Lidocaine allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine|10 ml subcutaneously|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of vasovagal reaction during femoral sheath removal |  | During sheath removal | 
| Pain intensity during femoral sheath removal |  | During sheath removal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femoral artery sheath, vasovagal reaction, pain, perception
Cardiovascular Treatment

Study Overview
=================
Brief Summary
-----------------
Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals. The aim of this study is to investigate the amount of high-intensity exercise needed to improve aerobic capacity and endothelial function.

Official Title
-----------------
How Little Pain for Cardiac Gain? A Pilot Study

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: 1x4 min interval


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI: 25-30 Males, 35-45 years Healthy

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4x4min<br>4x4minutes interval group | Other: 1x4 min interval<br>* Aerobic interval training<br>|
| Experimental: 1x4min<br> | Other: 1x4 min interval<br>* Aerobic interval training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen consumption and endothelial function |  | baseline and 12 weeks followup | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
slightly overweight, males 35-45 years
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.

Detailed Description
-----------------
The protocol requires all participants to be treated with Avonex and in addition patients will be blindly assigned to either a group who receive Topamax or a placebo control. Repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. The scaled neurologic examinations (EDSS and MSFC) and brain MRI's are done at regular intervals to evaluate possible treatment effects.

Official Title
-----------------
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Avonex and Topamax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing-remitting multiple sclerosis - Exclusion Criteria: Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

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: Avonex and Topamax|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain atrophy on nMRI |  |  | 
| Disease progression on EDSS and MSFC |  |  | 
| Relapse rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing-remitting multiple sclerosis, Brain atrophy, Disease progression
The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures.

Detailed Description
-----------------
To analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures, with the measurements of kyphosis, vertebral collapse and vertebral canal narrowing

Official Title
-----------------
The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures

Conditions
-----------------
Burst Thoracic Spine Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: burst fractures in thoracic spine Exclusion Criteria: fractures that were not burst fractures in thoracic spine

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 79 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 |
| --- | --- |
| burst fractures in vertebrae with true ribs<br>between T1 and T10 | |
| burst fractures in vertebrae with floating ribs<br>between T11 and T12 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual kyphosis | measurement of residual kyphosis by x-ray | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vertebral canal narrowing | vertebral canal narrowing in CT | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal fractures, Thoracic vertebrae, spinal canal, kyphosis
Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment

Study Overview
=================
Brief Summary
-----------------
To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation. To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.

Official Title
-----------------
A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment

Conditions
-----------------
Disseminated Intravascular Coagulation

Intervention / Treatment
-----------------
* Drug: ART-123


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese Association for Acute Medicine-defined DIC criteria score >= 4 Written informed consent from patient or guardian Exclusion Criteria: Patients showing intracranial, pulmonary, gastrointestinal hemorrhage Patients with a history of cerebrovascular disorders within the past 52 week Patients with a history of hypersensitivity to the ingredients of ART-123 preparations Pregnant women, nursing mothers or possibly pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal impairment grade 0<br> | Drug: ART-123<br>* 380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days<br>* Other names: Recomodulin™;|
| Experimental: Renal impairment grade 1<br> | Drug: ART-123<br>* 380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days<br>* Other names: Recomodulin™;|
| Experimental: Renal impairment grade 2<br> | Drug: ART-123<br>* 380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days<br>* Other names: Recomodulin™;|
| Experimental: Renal impairment grade 3<br> | Drug: ART-123<br>* 380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days<br>* Other names: Recomodulin™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Pharmacokinetics | Cmax, Area Under Curve, T1/2,CLtot,CLR | pre-dose, 0,2,4,8,24 hours post-dose | 
| Incidence rate of hemorrhage related adverse events |  | from the start of infusion to 8days after the cessation of infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ART-123, Disseminated Intravascular Coagulation, Pharmacokinetics
Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the investigators can identify early those patients who are admitted to the hospital and have a urinary tract infection (UTI) or those patients that develop a UTI during their hospitalization.

Official Title
-----------------
Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients

Conditions
-----------------
Urinary Tract Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years old or older admitted as a result of trauma to Saint Marys Hospital at Mayo Clinic Exclusion Criteria: Prisoners Pregnancy Active urinary tract stones Less than 65 years of age

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Geriatric Traumatic Injury<br>Geriatric trauma pateints being admitted to Saint Marys Hosptial. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify of bacteria, genes and proteins that are highly predictive of UTI development | To identify which bacteria, genes and proteins will be highly predictive of UTI development in geriatric trauma patients. We hypothesize that the combination of 16S rDNA and metaproteomics will identify the most informative biosignatures (species/genes/proteins) discerning UTI from asymptomatic bacteriuria. | Nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker candidates for UTIs recalcitrant to antibiotic treatment. |  | Nine months | 
| Morbidity |  | 9 months | 
| Mortality |  | 9 months |
Safety and Performance of the TFCC FastFix in the Wrist

Study Overview
=================
Brief Summary
-----------------
Assess safety and performance post-market of the TFCC FastFix in the wrist.

Official Title
-----------------
Safety and Performance of the TFCC FastFix in the Wrist

Conditions
-----------------
Suture Retention Device to Facilitate Triangular Fibrocartilage Complex (TFCC) Repair

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone TFCC repair using the TFCC FastFix Device Patients aged 18 years and older Patients that are > 12 months post-operative. Exclusion Criteria: Subjects who are < 12 months post-operative Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate (%) of clinical success of six months post-operative. Clinical success is defined as wrists without signs of device failure and/or re-intervention after assessment by surgeon |  | 6 months |
Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the hypothesis that dietary n-3 PUFA will have a beneficial effect on systemic and local markers of inflammation when combined with traditional, non-surgical periodontal therapy.

Official Title
-----------------
Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.

Conditions
-----------------
Periodontal Attachment Loss

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age, male or female At least 20 natural teeth present at the time of periodontal examination Be diagnosed with severe, chronic periodontitis; Be willing to participate in the study Exclusion Criteria: <18 years of age Less than 20 natural teeth present at time of periodontal examination Unable or unwilling to provide informed consent or follow study protocol Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment Use of systemic antibiotics within the last 3 months Pregnancy as diagnosed by administered pregnancy test. You are nursing a baby. Are allergic to fish or fish products. You are taking any other medications, such as dietary supplements, that could affect the outcome of the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish oil<br> | Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)<br>* 1000mg capsules three times daily, duration 28 weeks.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* corn/soybean oil capsules 1g/three times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical attachment loss |  | baseline, 8, 16, 28 weeks |
Middle Ear Implant: Assessment of Satisfaction in the Medium Term

Study Overview
=================
Brief Summary
-----------------
Currently, the data from the literature do not evaluate the use of the middle ear implant in implanted patients in the medium term (10 years and over) but only in the short term (1-5 years). Based on the observation of the absence of these data, we considered it necessary to evaluate in the medium term the satisfaction of the patients carrying a middle ear implant and their rate of abandonment with a horizon of 10 to 20 years of apparatus.

Official Title
-----------------
Middle Ear Implant: Assessment of Satisfaction in the Medium Term

Conditions
-----------------
Deafness

Intervention / Treatment
-----------------
* Other: Interview patient


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patient accepting to participate to this study Patient having a middle ear implant since 10 - 20 years at time of inclusion Exclusion Criteria: patient not dead

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

| Intervention/Treatment |
| --- |
|Other: Interview patient|Interview patient without scoring about the reasons for the implant, the complications, the reasons for abandonment, the evaluation of the satisfaction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the abandonment rate | calculate the rate of patient having abandonment the Use of Middle Ear Implant | at inclusion |
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.

Detailed Description
-----------------
Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic

Official Title
-----------------
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2)

Conditions
-----------------
Heroin Dependence, Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Heroin Dependence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 62 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Heroin Dependence|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Compliance |  |  | 
| Dosing schedule preferences |  |  | 
| Analog rating scale for dosing schedule effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug dependence