linjc16/ctgov huggingface dataset:
Simulation of Consecutive Day Shift Work

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Subjects will complete two consecutive days of simulated structural firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify parasympathetic tone and recovery from work.

Official Title
-----------------
Simulation of Consecutive Day Shift Work

Conditions
-----------------
Hyperthermia, Fatigue; Heat

Intervention / Treatment
-----------------
* Other: 2 days of work heat stress


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-39 y old men and women Self-reported to be healthy Exclusion Criteria: History of any cardiovascular, neurologic, renal, or metabolic disease Current tobacco use or regular use within the last 2 years Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.) History of exertional heat stroke Currently pregnant or breastfeeding, or planning to become pregnant during the study Inability to follow the rules of the protocols or understand the consent form No contraindications for ingestion of the gastrointestinal temperature pill

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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
Interventional Model Description: Repeated measures study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consecutive work<br>Subjects will complete 2 consecutive days of simulated firefighting tasks in the heat. The simulated work consists of 20 minutes of simulated structural work in a hot environment, followed by 20 minutes of seated rest in a temperate room, mimicking a typical recovery period in structural firefighting. Subjects then re-enter the environmental chamber and complete 23 minutes of simulated overhaul work in a temperate environment. | Other: 2 days of work heat stress<br>* 2 consecutive days of identical simulated structural firefighting tasks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature | Gastrointestinal temperature measured with an ingestable pill. | 20 minutes | 
| Heart rate | Heart rate measured with a wearable heart rate strap and monitor | 20 minutes |
Relationship Between Sensory Processing and Motor Development

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants.

Detailed Description
-----------------
The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants. A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study. Test of Sensory Function in Infants was used to evaluate sensory processing, and Alberta Infant Motor Scale was used to evaluate motor development.Spearman correlation test indicated strong positive relation between sensory processing and motor development in preterm infants. Given the relationship between sensory processing and motor development in preterm group, for effective implementation of physiotherapy assessments and interventions, it was thought that it is necessary to evaluate the sensory processing as well as the motor development in preterm infants.

Official Title
-----------------
The Investigation of Relationship Between Sensory Processing and Motor Development in Preterm Infants

Conditions
-----------------
Sensation Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age lower than 37 month corrected age within 10-12 months without congenital anomaly or systemic disease stay in Neonatal Intensive Care Unit (NICU) at least 2 weeks Exclusion Criteria: taken physiotherapy or sensory integration therapy in any rehabilitation center having newborn retinopathy

Ages Eligible for Study
-----------------
Minimum Age: 10 Months
Maximum Age: 12 Months

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 |
| --- | --- |
| preterm<br>infants who born before 37 completed weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigation of sensory processing in preterm infants | Test of Sensory Function in Infants' was used to evaluate sensory processing in preterm infants. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigation of motor development in preterm infants | Alberta Infant Motor Scale' was used to evaluate motor development in preterm infants. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm, Sensory Processing, Motor Development
Holotranscobalamin Remains Unchanged During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues. Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.

Detailed Description
-----------------
Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins and cobalamin analogues. Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo) was measured by in-house ELISA methods.

Official Title
-----------------
Holotranscobalamin Remains Unchanged During Pregnancy. Longitudinal Changes of Cobalamins and Its Binding Proteins During Pregnancy and Postpartum

Conditions
-----------------
Vitamin B12 Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Danish healthy Caucasian women >18 years of age with previous uncomplicated pregnancies and deliveries and presently with a normal pregnancy. Exclusion Criteria: >4 cigarettes smoked per day, Treatment with vitamin B12, folic acid or acetyl salicylic acid, Impaired renal function and clinically significant vaginal haemorrhage before first visit as well as blood haemoglobin <6.4 mmol/L at first visit.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, holotranscobalamin, cobalamin, vitamin B12 analogues, reference interval
Glucagon Like Peptides Receptors Expression in the Stomach of Diabetes Type 2

Study Overview
=================
Brief Summary
-----------------
Glucagon like peptides receptors expression in the stomach of diabetes type 2 Glucagon like peptides (GLP-1, GLP-2), are hormones secreted by L cells located along the gastrointestinal tract. These hormones are secreted after meals and have some roles in regulating the digestion process, absorption, and sending signals to the brain that regulate food consumption. GLP peptides affect peripheral targets and have an important homeostatic role. GLP-1 decreases the circulatory glucose level and GLP-2 has trophic effects which enable adequate intestine growth. We aimed in our study to investigate the GLP-1 and GLP-2 receptor expression in different zones of the stomach in diabetes type 2 patients. If there are differences, it might explain the pathological gastric emptying in these patients. Understanding the function of these peptides may lead to new therapeutic options for diabetic patients with delayed gastric emptying. Methods: 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included in the study and 20 controls aged 18-70 years. Patients with neurological disease will be excluded. During esophagogastroduodenoscopy 3 biopsies will be taken from the antrum, corpus and cardia. The biopsies will be stored in -70. After RNA extraction the GLP receptors expression will established by real time PCR method. Patients with different expression compared to control will undergo isotopic scan for gastric emptying.

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Procedure: GLP receptors expression
* Procedure: ESOPHAGOGASTRODUODENOSCOPY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included in the study and 20 controls aged 18-70 years Exclusion Criteria: Patients with neurological disease will be excluded

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: GLP receptors expression|nan|
|Procedure: ESOPHAGOGASTRODUODENOSCOPY|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
-----------------
PATIENTS WITH DIABETES MELLITUS TYPE 2, UNDERGO UPPER ENDOSCOPY, BIOPSIES FOR GLP RECEPTORS EXPRESSION, PCR ANALYSIS
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.

Official Title
-----------------
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Atazanvir/ritonavir + efavirenz
* Drug: Atazanvir/ritonavir + efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3 Antiretroviral (ARV) naive prior to enrollment Normal plasma triglycerides ≤ 200 mg/dL Women of child-bearing age must use effective barrier contraception Exclusion Criteria: Pregnancy or breast feeding Evidence of resistance to antiretroviral drugs History of elevated blood cholesterol or triglycerides History of diabetes Hypersensitivity to any component of the study drugs Any cholesterol or triglyceride lowering medications in the past six months Use of growth hormone, megestrol acetate, or anabolic steroids in the past six months Imprisonment or involuntary incarceration for medical treatment

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Atazanvir/ritonavir + efavirenz<br>* Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.<br>* Other names: Reyataz & Sustiva;|
| Experimental: B<br> | Drug: Atazanvir/ritonavir + efavirenz<br>* Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.<br>* Other names: Reyataz & Sustiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change from baseline in fasting plasma triglycerides at Week 8 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48 |  |  | 
| The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV/AIDS
Predictors of Occult Atrial Fibrillation in 171 Patients With Cryptogenic TIA and Minor Stroke

Study Overview
=================
Brief Summary
-----------------
Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke. This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.

Conditions
-----------------
Cryptogenic Transient Ischemic Attack and Minor Stroke

Intervention / Treatment
-----------------
* Procedure: Holter 21 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cryptogenic TIA/Minor stroke Age > 18 years Medical care in Neuro Vascular Unit of CH Versailles Holter 21 days performed Exclusion Criteria: ACFA history ECG or telemetry who showed ACFA before the Holter initializing Carotid Stenosis / symptomatic vertebral Arterial dissection Prothrombotic state demonstrated by laboratory tests Infective endocarditis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients taken care in neurovascular unit<br> | Procedure: Holter 21 days<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring | Atrial fibrillation >= 30 secondes | Day 21 |
Percutaneous Transluminal Angioplasty Registry

Study Overview
=================
Brief Summary
-----------------
Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating blood vessels in the treatment of peripheral artery disease. The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PTA. This registry is an open-end observational study to assess the characteristics and outcomes in patients with undergoing PTA.

Official Title
-----------------
PTA Registry - an Observational Study of Percutaneous Transluminal Angioplasty

Conditions
-----------------
Percutaneous Transluminal Angioplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing PTA Exclusion Criteria: < 18 years

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 |
| --- | --- | --- |
| Patency rate |  | 6 months | 
| Creatinine level |  | 2 Days after PTA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days | 
| Days of Hospitalization | Days of Hospitalization at 12 months | 12 months | 
| Ankle-Brachial Index | Clinical Improvement measured by Ankle-Brachial Index | 6 months and 12 months | 
| walking distance | Clinical Improvement measured by walking distance | 6 months and 12 months | 
| Restenosis rate | Percentage of patients with restenosis at 12 months | 12 months |
Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials

Study Overview
=================
Brief Summary
-----------------
This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.

Official Title
-----------------
An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.

Conditions
-----------------
Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: TGR-1202
* Drug: TGR-1202 + Ublituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol. Subjects must have completed at least 6 cycles of therapy on their current protocol. Exclusion Criteria: Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TGR-1202<br>Oral TGR-1202 Daily | Drug: TGR-1202<br>* Oral Daily TGR-1202<br>|
| Experimental: TGR-1202 + Ublituximab<br>Oral TGR-1202 in combination with Ublituximab intravenous administration | Drug: TGR-1202 + Ublituximab<br>* Oral Daily TGR-1202 + Ublituximab IV Administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities | Toxicity according to the investigator (Adverse events with NCI-CTC 4.0) | Evaluated at each planned visit through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment | Date of progression reported for each patient | Evaluated at each planned visit through study completion, an average of 2 years |
Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment

Study Overview
=================
Brief Summary
-----------------
Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD. This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).

Conditions
-----------------
Polypoidal Choroidal Vasculopathy

Intervention / Treatment
-----------------
* Drug: Intravitreal aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active polypoidal choroidal vasculopathy, Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32) Age above 45 No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability Intravitreal injection of aflibercept is indicated by current clinical recommendations Exclusion Criteria: Simultaneous treatment with another anti-VEGM agent Diabetic retinopathy Personal history of vitrectomy or uveitis Personal history laser photocoagulation and/or verteporphin phototherapy Tear in the pigmentary epithelium Chorioretinitis scar Macular atrophy in the pigmentary epithelium Treatment with corticosteroids Eye surgery less than 3 months before inclusion

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aflibercept<br> | Drug: Intravitreal aflibercept<br>* Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection |  | 28 weeks |