linjc16/ctgov huggingface dataset:
Airway Pressure During Nasal High Flow and CPAP in Neonates

Study Overview
=================
Brief Summary
-----------------
Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. The aim of the study was to investigate airway pressure during NHF and CPAP in neonates.

Detailed Description
-----------------
Methods: A physiological study which measured pressure intra-nasally with micro (750 µm) pressure probes (Millar, USA) in 10 (5M / 5F) healthy newborns with mean gestation age 37.18 (SD 1.29) wk and mean birth weight of 2414 (SD 503.13) g. NHF was applied at 8 L/min (AIRVO 2) through smaller (OPT 314) and larger (OPT 316) Optiflow nasal cannula; CPAP 5 cmH20 was produced by a Bubble CPAP system and nasal mask interface at constant flow 8 L/min (Fisher & Paykel Healthcare, NZ). Values are expressed in cmH20 as means and standard deviations (SD).

Official Title
-----------------
Airway Pressure During Nasal High Flow and CPAP in Neonates

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Device: NHF small cannula
* Device: NHF big cannula
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy term newborns Exclusion Criteria: Newborns with any medical problems after birth Absent of parents consents

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NHF small cannula<br>NHF 8 L/min (Airvo2) , Smaller cannula (neonatal, yellow) | Device: NHF small cannula<br>* NHF 8 l/min by Airvo 2 by small cannula<br>* Other names: Optiflow, HFNC;|
| Experimental: NHF big cannula<br>NHF 8 L/min (Airvo2) , Bigger cannula (neonatal, purple) | Device: NHF big cannula<br>* NHF 8 l/min by Airvo 2 by large cannula<br>* Other names: Optiflow, HFNC;|
| Experimental: Mask CPAP<br>CPAP 5cm H2O | Device: CPAP<br>* Nsal CPAP 5cm H2o by face mask<br>|
| No Intervention: no intervention<br>control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper airway pressure generated by NHF compared to CPAP | Pressure in upper airways | Up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal High Flow, CPAP, airway pressure, newborn
The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

Detailed Description
-----------------
150 patients will be included for the prospective cohort study. Patients will be recruited from the Region of Southern Denmark and Capital Region. Participants will undergo MRI scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two clinical tests. An 8-week follow-up will be made with patients completing a questionnaire. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

Official Title
-----------------
The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients

Conditions
-----------------
Pain, Lumbar Disc Herniation, Back Pain, Spinal Diseases, Surgery

Intervention / Treatment
-----------------
* Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and radiologically diagnosed lumbar disc herniation. Low back pain with pain below the knee or anterior thigh pain in one or both legs. Dermatomal leg pain. Average pain intensity of 3 or more on a Numerical Rating Scale (0-10 NRS). Exclusion Criteria: History of previous lumbar spine surgery. Surgery in general in the past 4 months. Current use of anticoagulants. Diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local muscle trauma, cancer metastases, fibromyalgia, neuropathy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with lumbar disc herniation<br> | Diagnostic Test: Paraspinal Mapping and Quantitative Sensory Pain Test<br>* Participants will be tested at baseline.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing |  | 8 week follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electromyography, Paraspinal Mapping, Quantitative clinical tests, Conditioned pain modulation, Temporal pain summation, Pain threshold, Pain tolerance
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter

Study Overview
=================
Brief Summary
-----------------
Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.

Official Title
-----------------
Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: Acutus Medical System Mapping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years One documented occurrence of typical AFL within the past 6 months Be able and willing to sign informed consent Exclusion Criteria: Contraindication to a non-emergent interventional EP procedure Require treatment in or access to left atrium Had a myocardial infarction within the prior two months Had cardiac surgery within the prior three months Intracardiac thrombus Permanent pacemaker/ICD leads in/through right atrium Clinically significant tricuspid valve regurgitation or stenosis Cerebral ischemic event (including TIA) in the prior six months Pregnant Currently enrolled in any other clinical investigation Any other significant uncontrolled or unstable medical condition

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acutus Medical System<br> | Device: Acutus Medical System Mapping<br>* Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients in which offline construction of pre- and post-treatment activation maps can be completed | Proprietary software algorithms will be used generate electrical activation maps based dipole density data acquired by the Acutus Medical Catheter during the procedures. These activation maps will then be applied to a 3D model of the endocardial surface to create a 3D activation map. | 3 months post-procedure | 
| The number of patients that experience a device-related adverse events as a measure of safety and tolerability |  | 7 days post-procedure |
Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada

Study Overview
=================
Brief Summary
-----------------
Active metropolitan area surveillance for hospital admissions related to invasive infection with Neisseria meningitidis will be conducted at the 12 centers in the IMPACT network in collaboration with Public Health officials, local infection specialists and infection control practitioners during the interval from January 1, 2016 to December 31, 2022.

Detailed Description
-----------------
The objectives are 3-fold, including: description of affected children and adults and the nature and outcome of the infection episodes incidence rate determination in defined populations, by age, serogroup and study year detailed study of the organisms recovered from cases

Official Title
-----------------
IMPACT Project Protocol: Enhanced Population-based Core Surveillance of Meningococcal Invasive Infections at Participating Centers Across Canada

Conditions
-----------------
Invasive Meningococcal Disease

Intervention / Treatment
-----------------
* Other: surveillance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Neisseria meningitidis isolated or detected by PCR from a normally sterile body site or fluid, such as blood, CSF, joint fluid, pleural, peritoneal, pericardial fluid or tissue biopsy - Exclusion Criteria:patients diagnosed based only on clinical signs, gram stain, or antigen test meningococci isolated only from respiratory tract, including conjunctiva, sinuses, middle ear/mastoid, throat, peritonsillar abscess, cervical lymph node, tracheal aspirate, bronchial lavage etc -

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons of all ages<br>Persons of all ages admitted between January 1, 2016 and December 31, 2022 with a positive result of Neisseria meningitidis isolated or detected by PCR from a normal sterile site, such as blood, CSF, joint fluid, pleural, peritoneal, pericardial fluid or tissue biopsy | Other: surveillance<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory confirmed invasive meningococcal cases. | Laboratory confirmed invasive meningococcal cases. | End of 2021 |
Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed.

Official Title
-----------------
Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany)
* Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schizophrenic patients with a negative syndrome. PANSS > 40. Exclusion Criteria: other psychiatric or neurologic diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham<br>patients receive sham tDCS stimulation | Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany)<br>* daily tDCS treatment over left DLPFC, 20 min, 2 mA<br>|
| Active Comparator: active<br>active transcranial direct current stimulation | Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany)<br>* same as sham stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SANS reduction | decrease by 30% | 4 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropsychological tests | increase in SOPT by 30% increase in TMT by 30% | 4 weeks after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, negative syndrome, PANSS
A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).

Official Title
-----------------
A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: artesunate sachets
* Drug: Arsuamoon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs). An informed consent document signed and dated by the subject or a legally acceptable representative. Exclusion Criteria: Any condition possibly affecting drug absorption. A positive urine drug screen. Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to artesunate or its derivatives.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0<br> | Drug: artesunate sachets<br>* single dose 50 mg (2 X 25 mg) artesunate sachets<br>|
| Active Comparator: 2.0<br> | Drug: Arsuamoon<br>* single dose 50 mg arsuamoon tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUCinf and AUClast, for DHA |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate. |  | 1 year | 
| Safety laboratory tests, vital signs, and adverse events. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioequivalence study-artesunate sachets-arsuamoon tablet
Body-fluid Balance and Drinking Habits in Patients With Retinal Vascular Occlusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the body-fluid balance in patients with retinal vascular occlusion and the influence of drinking habits and hemodilution on the degree of body hydration.

Detailed Description
-----------------
Patients with retinal vascular occlusion who are hospitalized for hemodilution and cardiovascular risk assessment are asked to report their drinking habits. Hydration status before and during hemodilution is assessed with a body-fluid analyzing scale.

Official Title
-----------------
Examination of the Body-fluid Balance in Patients With Retinal Vascular Occlusion Before and During Hemodilution and the Influence of Drinking Habits on the Degree of Body Hydration

Conditions
-----------------
Dehydration, Retinal Vascular Occlusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age over 18 years Exclusion Criteria: age under 18 years hypertensive urgency myocardial infarction < 4 weeks ago, chest pain heart rhythm disorders, high degree valvular defects pacemaker, defibrillator peripheral arterial occlusive disease end stage renal disease acute hepatitis, chronic inflammatory intestinal disease pregnancy

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 |
| --- | --- |
| retinal vascular occlusion<br>Patients with retinal vascular occlusion undergo a hematocrit dependent 5 day hemodilution | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in body-fluid balance | The influence of hemodilution on body-fluid balance in patients with retinal vascular occlusion is examined | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with dehydration | All patients are asked to fill in a questionnaire concerning their drinking habits (thirst, fluid intake). Patients body-fluid balance during hemodilution is measured with bioimpedance spectroscopy (Body Composition Monitor, Fresenius) | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal vascular occlusion, drinking habits, body hydration, body-fluid balance
A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma

Study Overview
=================
Brief Summary
-----------------
To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.

Official Title
-----------------
A 12-Week Randomized, Evaluator-Masked, Parallel-Group, Multinational, Multi-Center Study Comparing The Efficacy And Safety Of The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt) In Patients With Open-Angle Glaucoma Or Ocular Hypertension.

Conditions
-----------------
Glaucoma, Open Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Xalacom
* Drug: Cosopt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xalacom|nan|
|Drug: Cosopt|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean IOP measurements obtained in the study eye at each time point |  |  |
Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow

Study Overview
=================
Brief Summary
-----------------
Purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, optic nerve fibers thickness and choroidal thickness.

Detailed Description
-----------------
Purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, Retinal Nerve Fiber Layer (RNFL) thickness, optic nerve fibers thickness and choroidal thickness. Adult patients with no ocular pathology that are being treated in the neurology or pain clinics with medical cannabis for different indications, were examined in the eye clinic. First examination took place after the patient was not smoking for 5 hours. Three more examinations took place 1 hour 3 hours and 5 hours after smoking cannabis. The following parameters were checked: blood pressure, pulse, visual acuity, intra ocular pressure, corneal thickness, axial length, slit lamp examination of anterior segment, fundoscopy and Optical Coherence Tomography (OCT) of the retina, and optic nerve.

Official Title
-----------------
Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow

Conditions
-----------------
Intra Ocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Treated with medical cannabis for approved medical indications Exclusion Criteria: Known ocular pathology Topical or systemic treatment for intra ocular pressure Previous topical, intra ocular or systemic steroid treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra ocular pressure |  | 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cannabis, Intra ocular pressure, Ocular perfusion, Blood pressure