linjc16/ctgov huggingface dataset:
Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure diathermy performance of Sustained Acoustic Medicine Devices with commercially available ultrasound gel coupling patches.

Official Title
-----------------
Verification of Performance of Sustained Acoustic Medicine Device Designs Diathermy

Conditions
-----------------
Measurement of Diathermy on Anatomical Locations of the Body

Intervention / Treatment
-----------------
* Device: Sustained Acoustic Medicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Healthy Volunteer Exclusion Criteria: Is pregnant/nursing. Has an active infection, open sores, or wounds in the treatment area.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sustained Acoustic Medicine Device Group 1<br>Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 for 4 hours. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. | Device: Sustained Acoustic Medicine<br>* The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.<br>* Other names: Long Duration Low-Intensity Device;|
| Active Comparator: Sustained Acoustic Medicine Device Group 2<br>Patients receive treatment from the SAM Ultrasonic Diathermy Device 2 for 4 hours. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity. | Device: Sustained Acoustic Medicine<br>* The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.<br>* Other names: Long Duration Low-Intensity Device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound Diathermy (Degrees Centigrade) | Temperature Measurement On Body (Degrees Centigrade) | 0 - 4 hours |
Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride Tablet under fasted conditions.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Naratriptan Hydrochloride 2.5 mg Tablets Under Fasted Conditions

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: naratriptan hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to naratriptan hydrochloride or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naratriptan hydrochloride|2.5 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 9 days |
The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of slowing heart rate upon both central and peripheral blood pressures using a medication called Ivabradine which slows heart rate without affecting heart contraction, and to compare the effects of ivabradine to a traditional blood pressure lowering medication called metoprolol (which is a beta-blocker).

Official Title
-----------------
The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Drug: ivabradine
* Drug: metoprolol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 - 25 years OR Aged > 60 years Exclusion Criteria Chronic disease Unable to give informed consent Treated or untreated systemic arterial hypertension (SBP > 160 mmHg and/or DBP > 90 mmHg) Resting bradycardia (heart rate < 60 beats/minute) Pregnancy or active lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ivabradine<br> | Drug: ivabradine<br> <br> |
| Experimental: metoprolol<br> | Drug: metoprolol<br> <br> |
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central and peripheral arterial and pulse wave velocity |  | baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central pulse pressure |  | Baseline measurements of central and peripheral arterial and pulse wave velocity will be made at baseline, and 4 hours following the administration of either placebo, metoprolol or ivabradine. |
Ultrasound-Guided Oblique Short-Axis Adductor Canal Block.

Study Overview
=================
Brief Summary
-----------------
The ideal pain management for knee surgery should provide excellent analgesia while minimizing opioid consumption and allowing early mobilization and rehabilitation. The use of the continuous technique in ACB allows the delivery of a larger quantity of local anaesthetic into the adductor canal than in the single-shot technique. The usual approach for ultrasound-guided ACB catheter insertion is through short-axis in-plane approach in which the ultrasound transducer is applied horizontally over the femoral artery and saphenous nerve. In this approach, the catheter is inserted through a 90-degree angulation with the nerve which might make the catheter insertion difficult. In the new oblique position, the catheter will be inserted in a less than 90-degree angulation. This study speculates that decreasing the angle of catheter insertion will make catheter insertion easier and faster.

Official Title
-----------------
Ultrasound-Guided Oblique Short-Axis Adductor Canal Block: Can the Oblique Approach Facilitate Perineural Catheter Insertion: A Randomized Controlled Trial

Conditions
-----------------
Adductor Canal Block

Intervention / Treatment
-----------------
* Other: ultrasound guided adductor canal block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients more than 18 years ASA I-III scheduled for unilateral knee surgery under spinal anesthesia with an adductor canal perineural catheter planned for postoperative pain control Exclusion Criteria: Patient who had an allergy to any drug used in the study Patients with neuropathy of any etiology in the affected extremity, hepatic or renal failure. pregnant females Patients who are unable to communicate with the investigators and hospital staff

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The transverse short-axis group<br> | Other: ultrasound guided adductor canal block<br>* ultrasound-guided adductor canal block using oblique short-axis for catheter insertion<br>|
| Experimental: The oblique short-axis group:<br> | Other: ultrasound guided adductor canal block<br>* ultrasound-guided adductor canal block using oblique short-axis for catheter insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheter placement time (minutes) |  | starting from time of syringe removal from placement needle to time of complete threading of the catheter at 20-cm mark measured in minutes and over 20 minutes |
CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.

Detailed Description
-----------------
The patients will receive infusion of CART cells targeting CD19 to confirm the safety and efficacy of CD19 CART Cells in relapsed or refractory acute myeloid leukemia.

Official Title
-----------------
Pilot Study of the Efficacy and Safety of CD19 Targeted Chimeric Antigen Receptor Engineered T Cell in the Treatment of Relapsed or Refractory CD19 Positive Acute Myeloid Leukemia (AML)

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Biological: CART-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia Age 6-65 years. Left ventricular ejection fractions≥ 0.5 by echocardiography. Creatinine < 1.6 mg/dL. Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal. Bilirubin <2.0 mg/dL. Karnofsky performance status ≥ 60 Expected survival time ≥ 3 months (according to investigator's judgement) Exclusion Criteria: Pregnant or lactating women. Uncontrolled active infection. Active hepatitis B or hepatitis C infection. Class III/IV cardiovascular disability according to the New York Heart Association Classification. HIV infection. Patients with history of seizure Active central nervous system leukemia

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD19 positive relapsed or refractory acute myeloid leukemia<br>MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia | Biological: CART-19<br>* CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19 cells/kg).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events are evaluated with CTCAE V4.03 | 12 months |
Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients

Study Overview
=================
Brief Summary
-----------------
To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative delirium in liver transplant patients in the ICU. Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery. Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.

Official Title
-----------------
Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Drug: Precedex
* Drug: placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation Exclusion Criteria: Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at baseline, who have neurologic deficits at baseline, or who are allergic to dexmedetomidine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline<br>same infusion rate as experimental group (dexmedetomidine) | Drug: placebo control<br>* placebo<br>* Other names: 0.9% saline;|
| Experimental: dexmedetomidine<br>0.1mcg/kg/hr of dexmedetomidine infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery. | Drug: Precedex<br>* infusion of 0.1mcg/kg/hr of precedex<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysis of the incidence of postoperative delirium in liver transplant patients in the ICU. | after August 25, 2014 | 1 week or transfer to ward, whichever comes first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU. | after August 26, 2014 | 1 week or transfer to ward, whichever comes first. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
delirium, incidence, dexmedetomidine
Safety of Nintedanib in Real World in China

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the incidence rates of adverse drug reactions (ADRs) and fatal adverse events (AEs) among idiopathic pulmonary fibrosis (IPF) patients in China who initiate nintedanib during the study period.

Official Title
-----------------
Safety of Nintedanib in Real World in China: a Non-interventional Study Based on Idiopathic Pulmonary (Interstitial) Fibrosis Registry China Study (PORTRAY) Data

Conditions
-----------------
Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: nintedanib
* Drug: pirfenidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who initiate nintedanib during the study period Patients who initiate pirfenidone during the study period Patients who use neither nintedanib nor pirfenidone Patients who were diagnosed with IPF according to the 2011 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines in the past 3 months before recruitment Patients who are 40 years old and above when enrolled Patients who are willing to participate in the study and sign the informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Nintedanib new users<br> | Drug: nintedanib<br>* nintedanib<br>|
| Pirfenidone new users<br> | Drug: pirfenidone<br>* pirfenidone<br>|
| no drug-treated users<br>subjects who did not receive nintedanib, pirfenidone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse drug reactions (ADRs) during entire follow-up period |  | During entire follow-up period, up to 1 year | 
| Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date |  | During follow-up period after index date, up to 1 year | 
| Incidence rate of fatal adverse events (AEs) during entire follow-up period |  | During entire follow-up period, up to 1 year | 
| Incidence rate of fatal adverse events (AEs) during the 1-year follow-up period after the index date |  | During follow-up period after index date, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean age at baseline of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug |  | At baseline | 
| Percentage of each gender of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug |  | At baseline |
A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).

Study Overview
=================
Brief Summary
-----------------
The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.

Official Title
-----------------
Study to Evaluate Clinical Consistency of the Liquid Formulation of GSK Biologicals' HRV Vaccine and to Evaluate Liquid Formulation Compared to Lyophilised Formulation of the HRV Vaccine Administered as a Two-dose Primary Vaccination.

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants birth weigh >2000 g, 11 -17 weeks old at Dose 1 with written informed consent. Exclusion Criteria: Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.

Ages Eligible for Study
-----------------
Minimum Age: 11 Weeks
Maximum Age: 17 Weeks

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRV vaccine, Diarrhoea, Rotavirus
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Mesh repair for open incisional hernia repair with fibrin sealant or with drainage

Official Title
-----------------
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Drug: Tisseel®
* Procedure: Drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with a large incisional hernia >5cm diameter that needs elective repair with mesh augmentation Exclusion Criteria: no written informed consent 'hostile' abdomen emergency surgery (incarcerated hernia) parastomal hernia incisional hernia outside the midline recurrent incisional hernia

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Study group (Tisseel®) | Drug: Tisseel®<br>* Mesh repair for open incisional hernia repair with fibrin sealant<br>|
| Other: 2<br>Control group | Procedure: Drainage<br>* Mesh repair for open incisional hernia repair with drainage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay |  | At time of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative drainage volume |  | Day 0,1, 2, 3 ? and at day of removal | 
| Perioperative morbidity rate |  | At time of discharge | 
| Pain measured using VAS |  | Daily till discharge and after 3 weeks post-surgery | 
| Quality of life by SF-36 questionnaire |  | Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery | 
| Recurrence |  | At one year |