linjc16/ctgov huggingface dataset:
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).

Official Title
-----------------
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: Gammaplex® (Human Normal Immunoglobulin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion criteria. Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill. Postmenopausal or surgically sterile female volunteers could be enrolled. Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vigam® Liquid infused at up to 3mL/min<br>Gammaplex® (Human Normal Immunoglobulin) | Biological: Gammaplex® (Human Normal Immunoglobulin)<br> <br> |
| Experimental: Gammaplex® infused at up to 3mL/min<br>Gammaplex® (Human Normal Immunoglobulin) | Biological: Gammaplex® (Human Normal Immunoglobulin)<br> <br> |
| Experimental: Gammaplex® infused at up to 6mL/min<br>Gammaplex® (Human Normal Immunoglobulin) | Biological: Gammaplex® (Human Normal Immunoglobulin)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters for serum immunoglobulin G (IgG) |  | Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subjects
Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Study Overview
=================
Brief Summary
-----------------
Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Detailed Description
-----------------
Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area. Measurements are made with subjects fully clothed and seated. Measurements are made in triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete. Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish normal ranges of these parameters for subsequent use as comparisons to evaluate and track changes in patients with head and neck lymphedema.

Official Title
-----------------
Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Conditions
-----------------
Lymphedema, Secondary

Intervention / Treatment
-----------------
* Diagnostic Test: TDC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy with no current or past skin conditions affecting neck or arms Exclusion Criteria: Known to have diabetes of any type. Having facial or neck hair that prohibits accurate measurements

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Adults<br>Healthy | Diagnostic Test: TDC<br>* measurements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck-to-Arm TDC ratio | Neck-to-Arm TDC ratio | one year | 
| Sub-Mental-to-Arm TDC ratio | Sub-Mental-to-Arm TDC ratio | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilateral values and Variability in TDC values | Bilateral values and Variability in TDC values | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tissue dielectric constant, head and neck lymphedema, lymphedema, reference values
Remote Ischemic Conditioning in STEMI to Decrease Infarct Size

Study Overview
=================
Brief Summary
-----------------
Following acute STEMI patients may have significant myocardial damage and subsequent heart failure. There is currently conflicting data regarding the benefit of remote ischemic conditioning to decrease the magnitude of infarction. Remote ischemic condition is a process where by repetitive intermittent limb ischemia is used to decrease the magnitude of myocardial damage caused by coronary artery occlusion and the subsequent reperfusion injury in STEMI patients. RemCon-STEMI is a multicenter randomized trial to test the impact of remote ischemic conditioning in acute STEMI.

Official Title
-----------------
A Multi-center Randomized Trial of Remote Ischemic Conditioning to Reduce Infarct Size in Patients With an ST-Elevation Myocardial Infarction

Conditions
-----------------
STEMI, CAD

Intervention / Treatment
-----------------
* Procedure: Remote Ischemic conditioning
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with STEMI within 6 hours of symptom onset and: Are expected to receive reperfusion therapy with either fibrinolysis or primary PCI. Documented informed consent (verbal) Exclusion Criteria: Cardiogenic shock History of anatomical deformity or vascular complication that limit ability to conduct remote ischemic preconditioning

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
Interventional Model Description: Remote ischemic condition versus standard of care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard of care<br>no intervention will occur in the standard of care arm | Other: Standard of care<br>* Standard of care<br>|
| Active Comparator: Remote Ischemic Conditioning<br>Remote ischemic conditioning using BP cuff on left arm | Procedure: Remote Ischemic conditioning<br>* BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all cause death | all cause death, cardiogenic shock or chf through 90 days | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long term survival | survival | up to 1 year | 
| myocardial infarction size | mi size using peak elevation of cardiac biomarkers | within 72 hours of hospital admission | 
| ECG infarct size | QRS score on baseline and discharge ECGS | with 10 days or hospital discharge whichever occurs first | 
| Reperfusion | ST segment resolution 30 minutes post PCI | within 24 hours of admission to hospital |
Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending multiple doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ONO-2952
* Drug: ONO-2952 Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking male or female subjects (18-55 inclusive) Body mass index (BMI) of 19-35 kg/m2 (inclusive) For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception Exclusion Criteria: History or presence of clinically significant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Arm 1: Experimental<br> | Drug: ONO-2952<br>* 30 mg to 100 mg QD at a multiple dose, and 21 days duration<br>|
| Placebo Comparator: Arm 2: Placebo Comparator<br> | Drug: ONO-2952 Matching Placebo<br>* 30 mg to 100 mg QD at a multiple dose, and 21 days duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events |  | 36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of PK of ONO-2952 in plasma samples |  | 36 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, ONO-2952, Healthy adult subjects, Multiple dose, Tolerability, Pharmacokinetics
Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyse blood pressure during rate control therapy in patients with tachycardic atrial fibrillation in a real-world emergency cohort.

Detailed Description
-----------------
Atrial fibrillation (AF) is the primary clinical problem in 3.3% to 10.0 % emergency department (ED) admissions. Rate control is an integral part of the management of symptomatic tachycardic AF patients. According to the recent guidelines beta-blockers, digoxin, the calcium channel blockers diltiazem and verapamil, amiodarone or combination therapy should be considered for rate control. Haemodynamic side-effects in particular hypotension may occur. Heart rate and blood pressure behavior in an ED population during rate control therapy in patients with tachycardic atrial fibrillation will be analysed.

Official Title
-----------------
Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Rate control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Atrial fibrillation or atrial flutter and heart rate ≥ 110 bpm Indication for rate control Informed consent Exclusion Criteria: • Inclusion criteria not met

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Rate control|Rate control according to the Atrial fibrillation - ESC Guidelines 2016|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and maximum blood pressure difference between before (baseline) and during/after medication. |  | 20th July 2019 to 20th July 2021 |
Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

Study Overview
=================
Brief Summary
-----------------
To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA.

Official Title
-----------------
Hemodynamically Important PDA in Newborns Under 32 Weeks: Clinical and Echocardiographic Findings and Outcomes

Conditions
-----------------
Patent Ductus Arteriosus After Premature Birth

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born at less than 32 weeks newborns Exclusion Criteria: Congenital heart disease Syndromic and/or major congenital anomaly

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 7 Days

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated<br> | Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy<br>* Ecocardiography at 1st, 3rd and 7th day of life Doppler US (cranial and renal) at 1st, 3rd and 7th day of life Near-infrared spectroscopy monitoring after birth during first 3-days of life<br>|
| Untreated<br> | Diagnostic Test: Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy<br>* Ecocardiography at 1st, 3rd and 7th day of life Doppler US (cranial and renal) at 1st, 3rd and 7th day of life Near-infrared spectroscopy monitoring after birth during first 3-days of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter of PDA | Measurement the diameter of ductus in mm/weight using echocardiography | 1 year | 
| Velosity of PDA | Measurement the velosity of ductus using CW doppler on ecocardiyograpy | 1 year | 
| Left ventricule expansion | Measurement left ventricule end diastolic and end systolic diameter, left atrium/aort ratio on ecocardiography | 1 year | 
| Velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries | Measurement velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries using doppler ultrasonography | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiology, Newborn, Diseases, Congenital Heart Defects, Patent Ductus Arteriosus
Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study

Study Overview
=================
Brief Summary
-----------------
This project tend to investigate the affection of ketone bodies on brain metabolism. This will be done by measuring human cerebral uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in healthy subjects by ketone infusion. Hypotheses Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow. Altered oxygen consumption during hyperketonemia in healthy subjects.

Official Title
-----------------
Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study

Conditions
-----------------
Ketone Body Metabolism, Brain Metabolism

Intervention / Treatment
-----------------
* Drug: ketone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy BMI 20-30 kg/m2 Exclusion Criteria: smoking alcohol abuse severe comorbidity blood donation 6 month prior claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Saline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy | Drug: placebo<br>* Saline infusion.<br>|
| Experimental: Hyperketonaemia<br>Ketone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy | Drug: ketone<br>* 3-OHB is infused intravenously.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism in brain, CMR | cerebral glucose metabolism measured by PET tracer during the above time frame | t=240-360 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress metabolism | growth hormone, cortisol, glucagon, adrenalin, ghrelin. | 0-360 minutes | 
| Oxygen use | cerebral oxygen consumption measured by PET tracer during the above time frame | T=150-200 minutes | 
| cerebral blood flow | cerebral blood flow measured by PET tracer during the above time frame | t=180-250 minutes | 
| Intramuscular signaling | protein and insulin signaling in muscle | t= 260 minutes |
Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to develop and evaluate the effects of a computer-tailored intervention targeting pain barriers and catastrophizing in adults having cardiac surgery. The hypotheses are that in the experimental group, in comparison to the control group, participants will show lower levels of pain, less pain interference in their activities, less attitudinal barriers, and less pain catastrophizing. A pilot-RCT is privileged to assess the preliminary effects of the intervention on the following outcomes: pain intensity, analgesic consumption, pain interference, barriers and pain catastrophizing.

Official Title
-----------------
Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery-SOULAGETAVIE

Conditions
-----------------
Cardiac Surgery, Pain, Adult, Pain Management

Intervention / Treatment
-----------------
* Behavioral: soulageTAVIE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first intention cardiac surgery 18 years old or more able to fill up questionnaires in french Exclusion Criteria: participation to another psychosocial intervention cognitive or psychiatric disorder

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: soulageTAVIE|VITaPaCS consists in a 30 minute-computer-tailored preoperative session, which is animated by a virtual nurse who guides the participant through a learning process about analgesic medication intake, pain communication, and cognitive restructuring. The information and the strategies provided are specifically tailored to the participants' profile, determined by a screening questionnaire, but also by their responses in real-time during the computer session. Two postoperative clinical reinforcements of ten minutes are also provided by the treating nurse based on the flags identified through the preoperative session.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity |  | 24, 48, 72 hrs, 7 days, 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute postoperative pain, nursing intervention
Management of Uterine Leiomyomata and Adenomyosis

Study Overview
=================
Brief Summary
-----------------
to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Detailed Description
-----------------
The aim of the present study is: to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Official Title
-----------------
Management of Uterine Leiomyomata and Adenomyosis : Role of Hysteroscopy in Diagnosis and Norethisterone in the Treatment

Conditions
-----------------
Abnormal Uterine Bleeding

Intervention / Treatment
-----------------
* Drug: Norethisterone acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia. (3) regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients; Exclusion Criteria: (1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fibroid cases<br>Norethisterone acetate for 5 months | Drug: Norethisterone acetate<br>* Norethisterone acetate for 5 months<br>|
| adenomyosis<br>Norethisterone acetate for 5 months | Drug: Norethisterone acetate<br>* Norethisterone acetate for 5 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis | Symptomatic improvement | 6 months |