linjc16/ctgov huggingface dataset:
Feasibility of BabyGentleStick- Adult Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.

Conditions
-----------------
Lack of Adverse Events, Reduced Pain Response

Intervention / Treatment
-----------------
* Device: BabyGentleStick™ ON
* Device: BabyGentleStick™ OFF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult volunteers 18-29 years of age. Fluent in written and spoken English Sex: male or female Exclusion Criteria: Pregnant women Cognitive impairment Prisoner Individuals with known hematologic conditions or bleeding disorders Individuals with immune disorders where a finger lance puts them at risk for infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BabyGentleStick™ ON, then BabyGentleStick™ OFF<br>Experimental intervention, then Active Comparator. | Device: BabyGentleStick™ ON<br>* experimental intervention<br>Device: BabyGentleStick™ OFF<br>* active comparator<br>|
| Experimental: BabyGentleStick™ OFF, then BabyGentleStick™ ON<br>Active Comparator, then Experimental intervention. | Device: BabyGentleStick™ ON<br>* experimental intervention<br>Device: BabyGentleStick™ OFF<br>* active comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Subjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events. | 24 hours after the intervention is received for each subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced Pain Response | Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain. | 5 minutes |
Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH

Study Overview
=================
Brief Summary
-----------------
The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension..

Official Title
-----------------
Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy

Conditions
-----------------
Essential Hypertension, Left Ventricular Hypertrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: essential hypertension left ventricular hypertrophy under candesartan treatment Exclusion Criteria:

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patient with essential hypertension and LVH under treatment with candesartan or candesartan HCT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to estimate under naturalistic conditions the impact of the antihypertensive therapy with candesartan or candesartan/HCT on pre-post change from Visit 1 to Visit 2 of Sokolow-Lyon index, Cornell index and Left Ventricular Mass Index. |  | app. 3 monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to estimate the change of the systolic and diastolic blood pressure, separately by the (maximum) prescribed daily dose of candesartan or candesartan/ HCT |  | app. 3 monthly | 
| to gain further insight into the occurrence of unknown, unexpected and/or rarely occurring adverse events (AE) by estimating the incidence under naturalistic conditions. |  | app. 3 monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
essential hypertension, ARB, left ventricular hypertrophy, candesartan
Pilot Study of Physostigmine-Enhanced Opioid Analgesia

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.

Official Title
-----------------
Influence of Physostigmine on Patient-Controlled Analgesia

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Physostigmine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old At least 50 kg Suitable for PCA ASA 1-3 Exclusion Criteria: Bronchial asthma/severe or exacerbated COPD Iritis Stenoses/spasms of intestine, urinary tract, biliary tract Closed traumatic brain injury Severely reduced left ventricular function (EF<30%) Recent myocardial infarction Recent stroke Known allergy or hypersensitivity or contraindications against hydromorphone, physostigmine History of alcohol or drug abuse Patients enrolled in another study Women of childbearing age without a negative pregnancy test

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physostigmine<br> | Drug: Physostigmine<br>* continuous intravenous infusion per syringe pump (13 vials of 2 mg/5 ml --> 26 mg/65 ml; 1 ml = 0.4 mg Physostigmine) at rate of 1 mg/h (2.5ml/h) for 24 hours<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* continuous intravenous infusion of 65 ml NaCl 0.9% with syringe pump at rate of 2.5 ml/h for 24 hours PCA: Patient-controlled analgesia with hydromorphone 0.2 mg/ml, on demand: bolus of 0.2 mg, maximum 5 boli per hour; 4-hour-maximum 4 mg<br>* Other names: hydal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores |  | 24 hours |
Comparison of Ambulatory and Functional Improvement by Morning Walk

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty.

Detailed Description
-----------------
pre-interventional evaluation; within 1 day of initiation of the intervention; 5 days after initiation of the intervention; 10 days after intervention after initiation of the intervention; 42 days after intervention start

Official Title
-----------------
Comparison of Clinical Efficacy and Safety for Ambulatory and Functional Improvement in Patients After Total Knee Arthroplasty With Morning Walk

Conditions
-----------------
Arthroplasty, Replacement, Knee, Robotics

Intervention / Treatment
-----------------
* Device: Morning walk
* Other: no Morning walk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent Unilateral or both Total Knee Arthroplasty Exclusion Criteria: brain disease, spinal cord injury, peripheral neuropathy, myopathy Inability to ambulate fully due to muscukoskeletal disorders MMSE<23 history of arthroplasty surgery on either of legs Cardiac pacemaker Refusal of participation
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morning walk<br>200 steps of gait rehabilitation using an end-effector typed gait robot with 5 minute break, 3 times a day for 10 weekdays: the end-effector type gait robot (Morning Walk®, Hyundai Heavy Industry, Republic of Korea) | Device: Morning walk<br>* a end-effector typed gait robot with a saddle<br>|
| Active Comparator: No Morning walk<br>200 steps by themselves or with a help of a walker on a even floor at a comfortable pace with 5 minute break, three times a day for 10 weekdays | Other: no Morning walk<br>* ambulation voluntary or with a help of walker<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of WOMAC index | Western Ontario and McMaster Universities Osteoarthritis Index | 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS | visual analogue scale | 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention |
Cardiac Biomarkers After Marathon Running and Coronary Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
This study evaluates cardiac biomarkers and their association to coronary artery disease in marathon runners.

Detailed Description
-----------------
The MaraCat study is an observational prospective study evaluating the association between cardiac biomarkers and coronary artery disease in 43 runners participating in the 2018 Paavo Nurmi Marathon. The study participants were recruited according to two age criteria - under 35 years and over 44 years of age. Comprehensive laboratory samples were collected immediately after the run, while the control workup was done in a separate visit with no significant physical excercise in the preceding two weeks. In the under 35 years -group, the control workup included an echocardiography, ecg and blood samples. In the over 44 years group, the control studies included coronary CT, echocardiography, ecg and laboratory tests.

Official Title
-----------------
Association of Cardiac Biomarker Elevation After Marathon Running and Coronary Atherosclerosis - the MaraCat Study

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age under 35 years or over 44 years Participant of Paavo Nurmi Marathon 2018 Informed consent signed Exclusion Criteria: No informed consent existing coronary artery disease

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Under 35 years<br> | |
| Over 44 years<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Troponin-T level after marathon | Cardiac troponin-T levels (ng/L), [electrochemiluminescence (ECLIA) method] | 0-30minutes after finishing the Paavo Nurmi Marathon | 
| Association Cardiac troponin-T level and coronary CT findings | Cardiac troponin-T levels (ng/L), [electrochemiluminescence (ECLIA) method] | Cardiac Troponin-T 0-30 minutes after finishing the Paavo Nurmi Marathon. Control Troponin-T levels and coronary CT angiography at control visit (>30days after marathon). |
NIRS Measurement After SCP Block

Study Overview
=================
Brief Summary
-----------------
Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes causing increased arterial blood flow and venodilatation . Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing oxygen saturation by detecting the absorption and reflection of near-infrared light . The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula revision has not yet been examined. We postulate an increase in tissue oxygenation by sympathicolysis caused by peripheral regional anesthesia that might be the reason for beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular plexus block in this group of patients.

Official Title
-----------------
Near-infrared Spectroscopy to Assess Changes in Tissue Oxygenation Following Supraclavicular Plexus Block in Patients Undergoing Vascular Surgery

Conditions
-----------------
Arterio-venous Fistula

Intervention / Treatment
-----------------
* Drug: Supraclavicular nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing surgery under regional anaesthesia Exclusion Criteria: patients refusal

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supraclavicular Nerve Block<br>Patients undergoing vascular surgery for creation or revision of an arterio-venous fistula. Intervention: supraclavicular plexus block for anaesthesia. NIRS measurement before and after brachial plexus block. | Drug: Supraclavicular nerve block<br>* Supraclavicular nerve block using ultrasound and 10ml ropivacaine 0.5% with 20ml mepivacaine 1%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIRS after block | Absolute change from baseline value in tissue oxygenation | 5 minutes before block until 30 minutes after block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between both arms | Absolute difference in tissue oxygenation between blocked arm and contralateral arm | 5 minutes before block until 30 minutes after block | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIR Spectroscopy, Nerve Blockade, Surgical Arteriovenous Shunt
Echocardiographic Assessment of Intrapulmonary Vasodilatation: Agitated Saline Versus Polygeline

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate agitated saline versus polygeline for detection of intrapulmonary vasodilatation in patients with cirrhosis.

Detailed Description
-----------------
Intrapulmonary vasodilatation is a frequent finding in patients with cirrhosis. Its diagnosis is established via contrast enhanced echocardiography. One used method is the contrast agent agitated saline and another frequently used method is the contrast agent polygeline. The purpose of this study is to compare these two echocardiographic contrast agents with respect to their ability to detect intrapulmonary vasodilatation.

Official Title
-----------------
Evaluation of Two Methods for the Echocardiographic Assessment of Intrapulmonary Vasodilatation in Patients With Liver Cirrhosis: Agitated Saline Versus Polygelatine

Conditions
-----------------
Liver, Cirrhosis

Intervention / Treatment
-----------------
* Procedure: echocardiography for intrapulmonary vasodilatation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years presence of liver cirrhosis evaluation for liver transplantation or transjugular intrahepatic portosystemic shunt Exclusion Criteria: inadequate echocardiographic image quality allergies to echocardiographic contrast agents pulmonary valve stenosis pulmonary embolism relevant tricuspid regurgitation cardiomyopathy

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: echocardiography for intrapulmonary vasodilatation|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver, cirrhosis, hepatopulmonary syndrome
The Effect of Palonosetron on the QTc Interval During Perioperative Period

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.

Official Title
-----------------
The Effect of Palonosetron on the QTc Interval During Perioperative Period

Conditions
-----------------
Anesthesia, General, Palonosetron

Intervention / Treatment
-----------------
* Drug: Palonosetron
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective abdominal surgery under general anesthesia Exclusion Criteria: Cardiac valvular disease Clinically significant arrhythmias including atrial fibrillation Anti-emetics within 24 hours before surgery Steroids within 1 week before surgery Cancer chemotherapy or radiotherapy within 4 weeks before surgery Diabetes mellitus Pregnancy Patients receives a QT-prolonging drug

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palonosetron<br>Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia | Drug: Palonosetron<br>* 0.075 mg IV as bolus before induction of general anesthesia<br>* Other names: Aloxi;|
| Placebo Comparator: Control<br>Intravenous administration of normal saline before the induction of general anesthesia | Drug: Normal saline<br>* 2 ml normal saline as bolus before induction of general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corrected QT interval (QTc interval) | at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation | up to 90 minutes after induction of general anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female |  | up to 2 hours after induction of general anesthesia | 
| corrected QT interval (QTc interval) at Postanesthetic care unit |  | up to 1 hour after arrival on postanesthetic care unit | 
| Incidence of postoperative nausea and vomiting |  | for 24 hours after surgery | 
| proportion of patients who have more than 500 ms of corrected QT interval (QTc interval) |  | up to 2 hours after induction of general anesthesia |
Development of a NIPTT for Detecting Copy Number Variations

Study Overview
=================
Brief Summary
-----------------
To collect whole blood samples from pregnant women for the purpose of developing, optimizing and evaluating laboratory-developed noninvasive prenatal test (NIPT) for the detection of fetal chromosomal abnormalities of interest defined as microinsertions, microdeletions and other copy number variations (CNVs). The NIPT result will be compared to the test results obtained by microarray analysis of fetal cellular material obtained by amniocentesis or chorionic villus sampling.

Detailed Description
-----------------
This is a single center specimen collection study. Eligible subjects from across the USA will be referred to the single center for participation. This study will evaluate whether the test methods being developed for the detection of fetal chromosomal abnormalities of interest in maternal whole blood samples can be used in clinical practice. Enrollment of study subjects will be done in two phases - an initial pilot study phase to collect samples for research and development activities, followed by a larger single-blinded sample collection phase for NIPT evaluation. For both phases, study subjects will be enrolled in a prospective manner until the predetermined sample size is attained. Each study subject will be asked to provide one 20mL blood sample.

Official Title
-----------------
Noninvasive In Vitro Diagnostic Test For Fetal Chromosomal Abnormality: Assay Development and Optimization in Affected Pregnancies With Abnormal Microarray Findings

Conditions
-----------------
Copy Number Variations

Intervention / Treatment
-----------------
* Device: MaterniT GENOME


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female Subject is 18 years of age or older Subject is pregnant at no less than 10 weeks and no more than 36 weeks gestation Subject provides a signed and dated informed consent Subject has a current pregnancy in which the fetus is determined to have a chormosomal abnormality of interest (microinsertions, microdeletions and other CNVs) as determined by microarray analysis of fetal cellular material obtained by IP Exclusion Criteria: Subject has experienced fetal demise in the current pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MaterniT GENOME|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of non-invasive pregnancy test (NIPT) | NIPT results will be compared to test results obtain by microarray analysis of fetal cellular material obtained by amniocentesis or chorionic villus sampling | 5 years |