linjc16/ctgov huggingface dataset:
US Post-Market Surveillance Study of the Surfacer System

Study Overview
=================
Brief Summary
-----------------
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.

Detailed Description
-----------------
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. A minimum of 30 patients will be enrolled in the study, all cases to be performed un-proctored at up to 12 sites in the United States, with no site enrolling more than 6 subjects. All patients enrolled will sign an informed consent form for use of their data. Investigators will invite patients who will be treated with the device in accordance with the approved labeling and who met enrollment criteria to join the study.

Official Title
-----------------
US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)

Conditions
-----------------
Venous Disease

Intervention / Treatment
-----------------
* Device: Central Venous Access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc. Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods Subjects are willing and able to give written informed consent Exclusion Criteria: Occlusion of the right femoral vein, right iliac vein or inferior vena cava Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian) Occlusion within the arterial system Occlusion within the coronary or cerebral vasculature

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 |
| --- |
|Device: Central Venous Access|The Surfacer® Inside-Out® Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Venous Access operational | safe insertion of the device to facilitate central venous access | 24 hours | 
| Incidence of adverse events through 24 hours | no procedural adverse events or peri procedural adverse events | 24 hours |
Global Registry for Endovascular Aortic Treatment (GREAT)

Study Overview
=================
Brief Summary
-----------------
Prospective, observational Registry to obtain data on device performance and clinical outcomes.

Detailed Description
-----------------
This is a prospective observational cohort Registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore Endovascular Aortic products.

Official Title
-----------------
'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation

Conditions
-----------------
Multiple Pathologies

Intervention / Treatment
-----------------
* Device: Endovascular aortic repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age required by state regulations Indication for aortic endovascular stent graft repair Signed informed consent Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular aortic repair<br>Patients treated with Gore Endovascular Aortic Products. | Device: Endovascular aortic repair<br>* Treatment with Gore Endovascular Aortic Products.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect real world data on the incidence of serious device events. |  | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aorta
Doctor-Patient Communication in Spanish

Study Overview
=================
Brief Summary
-----------------
Does use of a translator or use of less than perfect Spanish diminish provider-patient communication compared to a native speaker.

Detailed Description
-----------------
Spanish speaking drop-in patients will be consented then randomized to receive care by a native Spanish speaker, an English speaker using a translator, or an English speaker with intermediate Spanish skills using Spanish. After the visit, the researcher will enquire about patient satisfaction, when the next appointment is, whether medication has been changed, and what instructions their provider gave them. Each provider will do a similar questionnaire. A blinded researcher will score a concordance of plans between provider and patient to see if there is a significant difference in retained information between the groups.

Official Title
-----------------
Doctor-Patient Communication in Spanish

Conditions
-----------------
Upper Respiratory Infection, Hypertension, Diabetes

Intervention / Treatment
-----------------
* Behavioral: Spanish speaker level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spanish speaker Exclusion Criteria: -

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: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Spanish speaker level|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention of medical information |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hispanic, communication
Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure

Study Overview
=================
Brief Summary
-----------------
Observational study is to demonstrate a clinically significant reduction of ionizing radiation exposure during transcatheter ablation of supraventricular tachycardias using the EnSite precision mapping system in a real-world clinical setting without compromising efficacy and safety.

Official Title
-----------------
Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure (AALARA)

Conditions
-----------------
Tachycardia, Supraventricular

Intervention / Treatment
-----------------
* Procedure: Electrophysiology Study and Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients ≥ 18 years of age Patient indicated for supraventricular arrhythmias ablation according to the current guidelines Patient is willing to provide written informed consent. Exclusion Criteria: Patient is pregnant. Contraindications to ionizing radiation exposure Patient's life expectancy is less than 1 year Associated complex congenital heart disease Cardiac implantable electric devices Known pathological venous access to the heart

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 |
| --- |
|Procedure: Electrophysiology Study and Ablation|Electrophysiology Study and Ablation of Supraventricular Arrhythmias|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation exposure dose | The dose of ionizing radiation exposure in patients undergoing Supraventricular Tachycardia catheter ablation utilizing a non-fluoroscopic EnSite Precision 3D mapping system | The day of performing the procedure | 
| Incidence of procedure related cardiac Adverse Events (Safety) | Cardiac related serious adverse events frequency during and after ablation procedure of supraventricular arrhythmias | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy time | Fluoroscopy time during the procedure | The day of performing the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Supraventricular tachycardia, Radiation exposure
Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet

Study Overview
=================
Brief Summary
-----------------
Video intubating stylet can be safely and effectively used for nasotracheal intubation, but the optimal bending angle is still unknown. In this study, the optimal bending angle will be determined by comparing the intubation time and success rate of nasotracheal intubation with video intubating stylet at two different bending angles.

Detailed Description
-----------------
intubation will be accomplished at 70 bending angle and 90 degrees bending angle in each group. intubation time, success rate, additional manoeuvres and epistaxis will be recorded and compared.

Official Title
-----------------
Comparison of Two Bending Angles for Nasotracheal Intubation With a Malleable Vedio Stylet

Conditions
-----------------
Intubation;Difficult

Intervention / Treatment
-----------------
* Device: bending angle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients require nasotracheal intubation Exclusion Criteria: fixed, or limited, neck movement, obstructive sleep apnoea, bilateral nasal obstruction or patients with an abnormal coagulation status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 70-degree bending angle group<br>intubation with a 70-degree bending angle | Device: bending angle<br>* patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle<br>|
| Experimental: 90-degree bending angle group<br>intubation with a 90-degree bending angle | Device: bending angle<br>* patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of nasotracheal intubation | The percentage of successful nasotracheal intubation | Procedure (From the beginning of intubation to the end of intubation) |
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

Study Overview
=================
Brief Summary
-----------------
To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases

Detailed Description
-----------------
Primary Endpoints: Engraftment of donor cells Regimen related toxicities Secondary Endpoints: Disease-free survival Overall survival

Official Title
-----------------
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

Conditions
-----------------
Hematological Neoplasms, Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: Busulfex, Fludarabine, ALemtuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Performance status 0-2 Ejection fraction > 30% AST/ALT and bilirubin not > 4 times normal Creatinine clearance greater than 70 ml/min. FEV1 greater than 1.0 and diffusion capacity greater than 40% Age 18-75 years Patients must be at high risk for conventional regimen related toxicity Malignant hematologic disease that would otherwise be considered treatable with ASCT Exclusion Criteria: Does not meet the above Inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1 | Drug: Busulfex, Fludarabine, ALemtuzumab<br>* Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Transplant Related Mortality (TRM) |  | At Day 100 post trans-plant | 
| Number of Participants Experiencing Engraftment Donor Chimerism (EDC) |  | At time of study termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Relapse-Free |  | 100 days post-transplant | 
| Number of Participants Overall Survival as a Function of Time. |  | 100 days post transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allogenic stem cell transplant, Hematologic diseases
Topical Capsaicin for Cyclical Vomiting

Study Overview
=================
Brief Summary
-----------------
This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.

Official Title
-----------------
Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes

Conditions
-----------------
Cyclical Vomiting

Intervention / Treatment
-----------------
* Drug: Capsaicin 0.1% Cream
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected cyclical vomiting syndrome / cannabinoid hyperemesis active severe nausea or vomiting in the emergency department Exclusion Criteria: pregnant women, children < 18 years, no prior history of similar symptoms, suspected surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsaicin<br>0.1% capsaicin cream, one application | Drug: Capsaicin 0.1% Cream<br>* Topical application<br>|
| Placebo Comparator: Placebo<br>Topical cream with no active drug | Drug: Placebos<br>* placebo cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea Visual Analog Scale | Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea | 30 minutes |
Amitriptyline vs GON and SON Blocks in Migraine

Study Overview
=================
Brief Summary
-----------------
Comparison of efficacy and safety of amitriptyline and nerve blocks

Detailed Description
-----------------
This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater occipital nerve and supraorbital nerve)

Official Title
-----------------
Comparison of Amitriptyline and Nerve Blocks (GON and SON) in Patients With Migraine

Conditions
-----------------
Migraine, Headache

Intervention / Treatment
-----------------
* Drug: Lidocaine 1% Injectable Solution
* Drug: Amitriptyline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with migraine according to ICHD-3 Exclusion Criteria: Being over 50 years or under 18 years Malignancy and other systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- |
| Experimental: Active<br>Greater occipital nerve and supraorbital nerve block with 1% lidocaine once a week for first four weeks then once a month for 5 months | Drug: Lidocaine 1% Injectable Solution<br>* Repeated injections of lidocaine to greater occipital nerve and supraorbital nerve once a week for first four weeks then once a month for five months<br>|
| Active Comparator: Control<br>Amitriptyline 25 mg daily for 6 months | Drug: Amitriptyline<br>* Amitriptyline 25 mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with 50% Reduction of Headache Frequency | Monthly headache frequency will be followed | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Major and minor side effects will be followed | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
greater occipital nerve, supraorbital nerve, nerve blocks
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify differences in satisfaction, pain and length of stay between patients undergoing hip replacement who are discharged from the hospital on the day of surgery compared to patients who stay one night in the hospital.

Official Title
-----------------
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach

Conditions
-----------------
Osteoarthritis of the Hip

Intervention / Treatment
-----------------
* Procedure: Same day discharge
* Procedure: Next day discharge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary THA without acute hip fracture or prior hardware that would need to be removed at the time of surgery Unilateral THA Pre-operative Body Mass Index (BMI) < 40 kg/m2 Age < 75 years at time of surgery Pre-operative hemoglobin > 10 g/dL if pre-operative hemoglobin data is available No history of cardiopulmonary disease that would necessitate inpatient monitoring after surgery Pre-operative ambulatory status does not require the use of a walker or wheelchair No chronic pre-operative opioid medication use or opioid addiction Assistance available at home after discharge from hospital No other condition or circumstance that would preclude rapid discharge from the hospital after surgery Subject's English proficiency allows understanding of study and Informed Consent Subject consented to participate in this study Exclusion Criteria: Revision THA Bilateral THA Pre-operative BMI ≥ 40 kg/m2 Age ≥ 75 at time of surgery Pre-operative hemoglobin ≤ 10 g/dL if pre-operative hemoglobin data is available History of cardiopulmonary disease requiring acute inpatient monitoring Pre-operative ambulatory status requiring the use of a walker or wheelchair Chronic pre-operative opioid medication use or opioid addiction Limited or no assistance available at home after discharge from hospital Any other condition or circumstance that would preclude rapid discharge from the hospital Subject not proficient in English Subject did not consent to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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 |
| --- | --- |
| Active Comparator: Same day Discharge<br> | Procedure: Same day discharge<br> <br> |
| Active Comparator: Next day discharge<br> | Procedure: Next day discharge<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction |  | Discharge through 30 days post-op |