linjc16/ctgov huggingface dataset:
Pain Threshold Measurements in High and Low Altitude Among Healthy Volunteer Adults: A Comparative Study

Study Overview
=================
Brief Summary
-----------------
one measurement of pain threshold in high altitude and in low altitude using pressure algometer and Situational pain scale.

Detailed Description
-----------------
the aim of the study is to compare between pain threshold in high 1.9000 m above sea level and low altitude at sea level in healthy volunteer adults. Assessment performed using: pressure algometer. situational pain scale

Official Title
-----------------
Pain Threshold Measurements in High and Low Altitude Among Healthy Volunteer Adults: A Comparative Study

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: pain threshold measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-52 years old. healthy volunteers Exclusion Criteria: no musculoskeletal problems including muscle spasm no recent injuries or operations. not suffering from any painful condition. not on pain medications or antidepressant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 52 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 |
| --- | --- |
| Group A<br>Pain threshold measurement in high altitude | Other: pain threshold measurement<br>* pressure algometer<br>|
| Group B<br>Pain threshold measurement in low altitude | Other: pain threshold measurement<br>* pressure algometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain threshold assessed with a pressure algometer | pain threshold measurement | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| situational pain scale | measures pain perception in different painful situations | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain scores, pressure algometer, healthy volunteer adults
High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women

Study Overview
=================
Brief Summary
-----------------
Obesity is one of the biggest public health problems of the 21st century as it increases the risk of many co-morbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and puerperium. Obesity is a risk factor for cesarean delivery, failed induction of labor and labor dystocia, and prolonged labor curves especially among women with class III obesity.

Official Title
-----------------
High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women: A Randomized Clinical Trial

Conditions
-----------------
DELAYED LABOUR

Intervention / Treatment
-----------------
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneous onset of labor. Body mass index ≥ 30 kg/m2. Gestational age ≥ 37 weeks. Singleton pregnancy. Cephalic presentation. Reassuring fetal heart rate monitoring. Inefficient uterine contractions during active labor Women who will accept to participate in the study. Exclusion Criteria: Non-reassuring fetal assessment at the time of recruitment. Women received cervical ripening agents. Any patients contraindicated for vaginal delivery. Multiple gestations. Malpresentation. Previous cesarean delivery. Patients with cardiac diseases, pre-eclampsia or any other medical disorders. Fetal demise. Intrauterine growth restriction. Estimated fetal weight ≥ 5000 grams. Pre-labor rupture of membranes > 24 hours.
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: low dose oxytocin<br>patients will receive intravenous infusion of 5 Units of oxytocin/500 mL lactated ringer solution. Starting rate will be 2 mU/min, incrementally increase by 2 mU/min every 30 minutes until achievement of adequate uterine contractions. | Drug: Oxytocin<br>* intravenous infusion<br>|
| Experimental: high dose oxytocin<br>patients will receive intravenous infusion of 5 Units of oxytocin/500 mL lactated ringer solution. Starting rate will be 4 mU/min, incrementally increase by 4 mU/min every 30 minutes until achievement of adequate uterine contractions | Drug: Oxytocin<br>* intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean duration from oxytocin augmentation initiation to delivery | the calculated time between oxytocin infusion till delivery | 12 hours |
A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.

Study Overview
=================
Brief Summary
-----------------
The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal instability) that develop after SCI have value in predicting SCI-associated infections (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in both the time and frequency domains to discriminate between the relative contribution of sympathetic and parasympathetic innervation to changes in HRV. The ability to predict infections will enable novel treatments thereby reducing infection-associated mortality and improving neurological and functional outcomes.

Official Title
-----------------
PROSPECT ADDITION SCI - A PROSPECTive Study of Autonomic Dynamic Dysfunction to Predict infecTIONs After Spinal Cord Injury

Conditions
-----------------
Trauma, Spinal Cord, SPINAL Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute isolated spinal cord injury (AIS A-D) planned for surgical stabilization and decompression, lesion may include more than 1 segment Patients with acute isolated spinal fracture, lesion may include more than 1 segment Legal age of the patient Documented informed consent of the patient Exclusion Criteria: Non-traumatic spinal cord injury Concomitant traumatic brain injury (TBI) (definition: i) patient with severe TBI (Glasgow Coma Scale ≤ 8) and ii) patients with intracranial pressure monitoring sensors) Neoplasia and/or antineoplastic therapy Pregnancy, lactation

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 |
| --- | --- |
| Traumatic Spinal Cord Injury<br>Observational study - monitoring immune response and heart rate variability | |
| Traumatic Spine Fracture, Control Group<br>Observational study - monitoring immune response and heart rate variability acting as a control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sympatho-vagal instability as an identifier for patients at risk for Spinal Cord Injury Associated Infections | Determining whether discrete signs of loss of autonomic control (dysautonomia), not meeting defined criteria of full-autonomic dysreflexia, also renders patients at risk for developing infections. | At all study time-points for a period of 24hours. |
Lyon Uveitis Study

Study Overview
=================
Brief Summary
-----------------
Uveitis or inflammation of the uveal tract results from a heterogeneous collection of disorders of varying etiologies and pathogenic mechanisms. Uveitis is relatively frequent in industrial countries with an estimation of 115 cases for 100 000 persons and is associated with a blindness risk of 10%. Causes of uveitis can be related to different etiologies (infectious, inflammatory or general inflammatory diseases). Therapeutic care is based on ophthalmologic and systemic diagnosis and treatment strategy depends on the severity of inflammation. The main objective of the Lyon uveitis study is to analyze the uveitis ophthalmologic etiology and diagnostic and therapeutic care of the patients. This study is proposed to all patients diagnosed for uveitis and referred to the Department of Internal Medicine of the Croix Rousse hospital, Lyon, france for etiologic diagnosis or treatment. Analysis of i) patients' characteristics, ii) the relevance of complementary exams to determine the uveitis etiology, iii) treatment used. This study will allow a better characterization of the disease on diagnosis practices and therapeutic care.

Official Title
-----------------
Lyon Uveitis Study

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Other: No specific intervention. Collection of clinical data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of uveitis First consultation in the Department of Internal Medicine at the Croix-Rousse hospital, Lyon, France Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No specific intervention. Collection of clinical data|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evolution (persistence or resolution) evaluated by gradation of SEN | Persistence of disease is characterized by persistence of intraocular inflammation evaluated by gradation of SEN. (reference: A Standardization Grading System for Scleritis . Ophthalmology 2011 Apr;118(4):768-71). SEN score ranges from 0 to 5 (resolution = score 0 and persistence = score >0) | At one year after diagnosis |
Acute Subcutaneous Defibrillation

Study Overview
=================
Brief Summary
-----------------
To assess the defibrillation efficacy of a subcutaneous defibrillation system.

Conditions
-----------------
Ventricular Arrhythmias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be undergoing implant of a commercially approved ICD system Subject must be willing to provide Informed Consent Subject must be > 18 years old Exclusion Criteria: Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate < 29 mls/min/1.73m2 (recorded in the last six months) Subject has high risk of infection Subject has EF < 15% Subject at high risk of stroke having a device replacement Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker) Subject is indicated for CRT Subject is pacemaker dependent Subject enrolled in a concurrent study that may confound the results of this study Subject has medical conditions that would limit study participation Subject is pregnant Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. |  | within the first day |
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects

Study Overview
=================
Brief Summary
-----------------
The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. The aim of this study is to measure the effect of different angles of head tilt and soft surface on SVV in healthy subjects with a new automated system.

Detailed Description
-----------------
Two different settings will be used. In the first experiment, healthy subjects will make 15, 30, and 45-degree head tilt to the left and right side while they are standing. In every position, 3 measurements will be done. In the second experiment, 40 health subjects will make the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both head tilt and soft surface. All measurements will be done with a virtual SVV system(Interacoustics).

Official Title
-----------------
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects

Conditions
-----------------
Vestibular Nerve Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Subjective Visual Vertical with Virtual SVV instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No ear disease No neurologic disease No surgery for ear, brain or musculoskeletal system Exclusion Criteria: Diabetes mellitus Drug use effective on central nervous system

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual SVV<br>The subjects will be tested by virtual SVV. The deviation angle will be measured at 15, 30 and 45-degree head tilt to the left and right side while they are standing | Diagnostic Test: Subjective Visual Vertical with Virtual SVV instrument<br>* The deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Visual Vertical | The measurement of deviation angle with 15, 30 and 45-degree head tilt to the left and right side while they are standing | 1 month |
Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status

Study Overview
=================
Brief Summary
-----------------
Lower limb apophysitis cause long-term pain, decrease in function, and can reduce or completely hinder participation in sports and physical activity, yet there is little knowledge on the long-term consequences for health. Our objective with this investigation is to capture self-reported health-status for all adults having been diagnosed with lower limb apophysitis in the period of 1977 to 2020 and compared these data with normative values for the background population. We are therefore conducting a national cross-sectional study based on data from the Danish National Patient Registry. In this protocol we describe, as detailed as possible, the planned methods.

Official Title
-----------------
Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status

Conditions
-----------------
Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged 18-55 having received diagnostics codes pertaining to lower limb apophysitis (Severs, Sinding-Larsen Johansson, Osgood Schlatter) in the years 1977-2020 in Denmark will be eligible to participate. Exclusion Criteria: Diseased participants will be censored

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical and mental health | SF-12 (Short-form 12 item) health survey | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep: problems and duration |  | Baseline | 
| Self-reported level of satisfaction with participation in physical activity and sports | Tegner activity scale (0-10, 10 being no physical activity) and individual specific specific questions | Baseline | 
| Knee pain | Evaluated on at 0-100 numerical pain rating scale pertaining (0 being no pain) to the knee or other body parts, and worst pain last week or the last month | Baseline | 
| KOOS subscales | Knee injury and Osteoarthritis Outcome Score (KOOS) and its 5 subscale each scoring 0-100, with 100 being the no problems. | Baseline | 
| Number of Comorbidities from National Health Survey. and musculoskeletal diagnoses from knee or heel |  | Baseline | 
| PAS-2 | Physical activtiy scale | Baseline |
Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.

Official Title
-----------------
Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis

Conditions
-----------------
Severe Sepsis or Septic Shock

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 Severe sepsis or septic shock Central venous catheter (for blood drawing) Exclusion Criteria: Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses >1,000 I.U. per day or activated vitamin D at any dose History of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis Expected to die or leave the ICU within 48 hours History of hypersensitivity or any allergic reaction to calcitriol End stage renal disease Acute Kidney Injury receiving intermittent renal replacement therapy Enrolled in a competing study 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcitriol<br>Calcitriol 2mcg IV x 1 | Drug: Calcitriol<br> <br> |
| Placebo Comparator: Placebo<br>Normal saline 2cc IV x 1 | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Interleukin-6 (IL-6) Levels at 48 Hours |  | 48 hours | 
| Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours | NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations. | 48 hours |
The Effect of Punctal Plugs on Tear Volume and Osmolality

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.

Detailed Description
-----------------
50% of contact lens wearers have dryness/discomfort during contact lens wear. Significant decreases in lipid layer and tear film break up time during contact lens wear have been reported, leading to excessive evaporation, reduced tear volume and an increase in osmolality. Similar tear film changes occur with Dry Eye Disease. A commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms. Punctal plugs block the tear drainage system, and often increase tear stability, and improve ocular surface health. This study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. Collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days) occlusion of the ocular drainage system, are easily removed if necessary and are inserted with minimal risk.

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Device: Temporary Collagen Inserts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Exclusion Criteria: Corneal refractive surgery Contraindications to contact lens wear Latex allergy Corneal hypoesthesia Active corneal infection Acute or sub-acute inflammation or infection of the anterior chamber of the eye

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Temporary Collagen Inserts|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular comfort after 6 hours of contact lens wear |  |  | 
| Dryness sensation after 6 hours of contact lens wear |  |  | 
| Tear film volume before and after 6 hours of contact lens wear |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective ocular sensitivity after 6 hours of contact lens wear |  |  | 
| Tear film and contact lens osmolality after 6 hours of contact lens wear |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lenses, intolerance, punctal plugs, tear volume, Intolerance to contact lens wear due to dryness symptoms