linjc16/ctgov huggingface dataset:
Study of the Metabolism of Two Magnesium Supplements in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease. The aim of this part of the project is to study the pharmacokinetics of the following two magnesium supplements: Mablet (dietary supplement) Magnesium Sulfate (solution for infusion)

Official Title
-----------------
Pharmacokinetic Study of Mablet as Oral Supplement and Magnesium Sulfate as Infusion

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Mablet (Magnesium-supplement)
* Drug: Magnesium Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers. Exclusion Criteria: Smokers, Using pharmaceuticals/supplements, Vegans/vegetarians, Major changes in eating habits within one week prior to study start.

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline<br> | |
| Active Comparator: Mablet<br> | Dietary Supplement: Mablet (Magnesium-supplement)<br>* Mablet: Magnesium hydroxide/ -oxide (360 mg/tablet) 3 tablets as a single dose Produced by: Gunnar Kjems APS<br>* Other names: Mablet;|
| Active Comparator: Magnesium sulfate<br> | Drug: Magnesium Sulfate<br>* Solution for a single bolus-infusion, containing 2 grams of magnesium sulfate.<br>* Other names: Magnesiumsulfat 'SAD';|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters | Clearance, half-life & absorption fraction | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clearance, Half-life, Absorption fraction, Pharmacokinetics
Effective Management of Calcific Aortic Stenosis in the Elderly

Study Overview
=================
Brief Summary
-----------------
Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities. Transcatheter Aortic Valve Implantation (TAVI) has recently extended the therapeutic indications in patients at high risk of surgery. However, the proportion of different treatments is not known in a contemporary population that can be treated according to the different resources currently available. The scientific goal of this observational research is to evaluate intra-hospital therapeutic decision in elderly patients referred because of symptomatic severe aortic stenosis. The one-year survival will be analyzed according to the therapeutic decision and the characteristics of the patients.

Official Title
-----------------
Effective Management of Calcific Aortic Stenosis in the Elderly

Conditions
-----------------
Calcific Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized due to symptomatic tight aortic stenosis (NYHA >= II, dyspnea, angina or syncope); Having given his consent to participate in the study. Exclusion Criteria: Non-severe aortic stenosis; Asymptomatic aortic stenosis; Patient under the age of 75; Patient refusing to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| Hospitalized patients due to a severe, symptomatic aortic sten<br>Patients who agreed to participate in the study, aged ≥75 years, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical and surgical centers participating in the study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collate the therapeutic decision (medical treatment, TAVI [Transcatheter Aortic Valve Implantation] or surgical aortic valve replacement) comprehensively for all hospitalized patients because of a severe, symptomatic RAC. | The primary endpoint is the therapeutic indication retained by the medical-surgical team in charge of the patient during hospitalization: medical treatment, TAVI or surgical aortic valve replacement. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year-survival | Survival at one year will be analyzed. The analysis of the relationship between therapeutic decision and survival will be studied by taking surgical aortic valve replacement as a reference class. | 1 year |
Systematic Assessment of Vascular Risk

Study Overview
=================
Brief Summary
-----------------
It is hypothesized that patients with vascular disease are undertreated for modifiable risk factors, leading to increased morbidity and mortality in this population. The objective of this study is to develop a comprehensive database that will demonstrate the current adequacy of risk factor management in this high risk population, and that will provide needed guidance for future treatment options.

Official Title
-----------------
Toronto Vascular Disease Risk Factor Assessment Program: Systematic Assessment of Vascular Risk

Conditions
-----------------
Peripheral Vascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who attend the Vascular Surgery Clinic at Toronto General Hospital, St. Michael's Hospital, and St. Joseph's Health Centre who have PAD, cerebrovascular disease (CBVD), or aneurysms will be eligible for this study. Patients who are currently enrolled in other clinical studies are eligible for this study; however proper adherence to the other study will take precedence over of the current proposal.

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the SUPRAtube Device

Study Overview
=================
Brief Summary
-----------------
Purpose of the trial: Evaluate the efficacy and safety of the device of self-invention of continuous oropharyngeal aspiration denominated SUPRAtube in patients with orotracheal intubation and mechanical ventilation.

Official Title
-----------------
Evaluation of the Effectiveness and Safety of an Own-invention System for Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the SUPRAtube Device

Conditions
-----------------
Aspiration Pneumonias

Intervention / Treatment
-----------------
* Device: Supratube
* Other: Reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Endotracheal intubation and invasive mechanical ventilation, Exclusion Criteria: Immediate postoperative oral cavity. Traumatic oral cavity injury. Platelet count less than 50000.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Supratube<br>Patient with orotracheal intubation and supratube device | Device: Supratube<br>* Aspiration of orotracheal secretions with supratube device<br>Other: Reference<br>* Usual aspiration with any other device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aspirated secretions | volume of aspirated secretions | 24 hours after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events related to supratube device use | 24 hours after intubation |
User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)

Study Overview
=================
Brief Summary
-----------------
Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.

Official Title
-----------------
User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: blood glucose measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with type 1 or type 2 diabetes or healthy Subjects who are able to complete informed consent form (by him/herself or by his/her guardian); 18 years old and above; Exclusion Criteria: Does not meet inclusion criteria; Subjects with any other severe disease in the discretion of the investigator Not capable to read English user instructions at the discretion of the patient Pregnancy or Nursing mothers Any condition that may prevent participants from successful participation in the trial (in discretion of the investigator) Illiteracy

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood glucose measurement|After the patient has performed the manual reading, the investigator or staff member will obtain another capillary blood sample and a reference reading by means of the YSI 2300 Stat plus analyzer will be performed and recorded. If patients need more than one attempt to get a successful blood glucose reading, the number of attempts will be documented. A questionnaire needs to filled by the participant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement performance | invasive CoG (study device) blood glucose measurement in comparison to blood glucose measurment of a comparator device (YSI 2300 STAT Plus). | up to 1 day |
Claudication Evaluation During Rowing ExerciseS

Study Overview
=================
Brief Summary
-----------------
Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort.

Detailed Description
-----------------
Obtaining curve values of tcpO2 interpretable when recording the effort by rowing on rowing. Show the occurrence of ischemia in the lower limbs during recording effort by rowing on rowing

Official Title
-----------------
Claudication Evaluation During Rowing ExerciseS. Rehabilitation Arteritis of Lower Limbs by Rowing

Conditions
-----------------
Peripheral Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referred for an oximetry exercise test Patient able to walk on a treadmill Patient covered by the French health insurance Patient able to understand the protocol Patient agrees to be involve in the protocol and sign the consent form Exclusion Criteria: any heart issues during the last 3 months pregnancy

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 |
| --- | --- | --- |
| Changes in transcutaneous oxygen pressure (tcpo2) value in the calf for different rowing intensities | during exercise on rowing ergoùmeter, we collect reliable measurements of TcPO2 on chest and limb and calculate the DROP index (Limb changes minus chest changes) | up to 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral artery disease, transcutaneous oxygen pressure, claudication, rowing ergometer
Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery

Study Overview
=================
Brief Summary
-----------------
Post-operative wound infections can prolong hospital stays, increase rates of readmission to the intensive care unit, and increase the costs of treatment significantly. This study will conduct a prospective chart review of all patients undergoing elective spinal surgery on both the neurosurgery and orthopedic spine services at two facilities on an academic campus. The investigators will collect the data of those patients who develop post-surgical infections. This data will then be analyzed and compared to published data from other studies. The aim of this investigation is to passively collect this infection data, which may ultimately provide needed baseline incidence rates using current and standard protocols.

Detailed Description
-----------------
This is a chart review study.

Official Title
-----------------
Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery - a Prospective Study

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Procedure: Spinal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Patients undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services Patients who develop post-operative wound infections within 90 days of surgery Exclusion Criteria: Patients younger than 18 years of age Patients who are not undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services Patients who do not develop post-operative wound infections within 90 days of surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Incidence of surgical site infection<br>The number of spinal surgery patients with surgical site infections. | Procedure: Spinal surgery<br>* Elective spinal surgery performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who develop a surgical site infection (SSI) | Spinal reoperation at the same surgical location for incision, debridement and irrigation | 90 days following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal surgery, surgical site infection
Carotid Ultrasound in the Evaluation of Heart Failure

Study Overview
=================
Brief Summary
-----------------
Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

Detailed Description
-----------------
Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

Official Title
-----------------
Carotid Ultrasound in the Evaluation of Heart Failure

Conditions
-----------------
Coronary Artery Disease, Cardiomyopathy, Heart Failure

Intervention / Treatment
-----------------
* Other: Carotid ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LVEF 40% or less Exclusion Criteria: Prior diagnosis of coronary or carotid obstructive atherosclerosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LV systolic dysfunction<br>Diagnostic Testing | Other: Carotid ultrasound<br>* Measurement of intima-media thickness<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy for severe CAD |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy for significant CAD |  | 1 Day |
Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of multiple doses of intravenous DT-216 in adult patients with Friedrich Ataxia.

Official Title
-----------------
A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose and Multi-Dose Study of DT-216 in Adult Patients With Friedreich Ataxia

Conditions
-----------------
Friedreich Ataxia

Intervention / Treatment
-----------------
* Drug: DT-216
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetically confirmed diagnosis of Friedreich Ataxia with homozygous GAA repeat expansions. Able and willing to sign informed consent form prior to study enrollment. Stage 5.5 or less on the Functional Staging for Ataxia (FSA) at screening. Exclusion Criteria: Has any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study. Has clinically significant abnormal laboratory results. Has significant cardiac disease. Received an investigational drug within 3 months of screening.

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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple Dose: DT-216<br>Participants will be administered multiple doses of DT-216 | Drug: DT-216<br>* DT-216 will be administered by intravenous (IV) injection<br>|
| Placebo Comparator: Multiple Dose: DT-216 matching placebo<br>Participants will be administered multiple doses of placebo | Drug: Placebo<br>* Matching Placebo will be administered by intravenous (IV) injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Measure | Frequency of treatment emergent adverse events (TEAEs) | Up to approximately 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters | Maximum Plasma Concentration (Cmax) of DT-216 | Up to approximately 60 days | 
| Pharmacokinetic parameters | Time to Maximum Plasma Concentration (Tmax) of DT-216 | Up to approximately 60 days | 
| Pharmacokinetic parameters | Area Under the Concentration-time Curve (AUC) of DT-216 | Up to approximately 60 days |
Combined RF Surgery of the Tongue Base and Uvulopalatopharyngoplasty (UPPP) for Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Introduction: The aim of the study was to investigate the effectiveness of combined bipolar radiofrequency surgery of the tongue base (RFBT) and uvulopalatopharyngoplasty (UPPP) in a single session for obstructive sleep apnea (OSA) and to determine whether this combination is safe and well tolerated.

Official Title
-----------------
Combined Bipolar Radiofrequency Surgery of the Tongue Base and Uvulopalatopharyngoplasty for Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstructive sleep apnea not treated by CPAP Exclusion Criteria: a history of previous surgery for OSA and only one level of airway obstruction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RFITT+UPPP<br> | |
| UPPP<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |