linjc16/ctgov huggingface dataset:
Ocular Effects of Carotid Endarterectomy

Study Overview
=================
Brief Summary
-----------------
All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about 1 year, will be offered to participate. Retinal and choroidal structural changes will be assessed using swept-source OCT technology

Official Title
-----------------
Ocular Effects of Carotid Endarterectomy A Cohort Longitudinal Study

Conditions
-----------------
Choroid, Carotid Stenosis, Carotid Endarterectomy

Intervention / Treatment
-----------------
* Device: OCT swept source DRI-Atlantis, Topcon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Carotid stenosis requiring surgical management Exclusion Criteria: Ocular conditions: media opacities precluding fundus visualization, bilateral no-light perception Ocular surgery within 6 months prior to endarterectomy

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient undergoing carotid endarterectomy<br>All patients undergoing carotid endarterectomy in Shaare Zedek Medical Center Visual acuity measurement (Snellen) SS-OCT (DRI-Atlantis, Topcon) 3-dimensional scanning protocol with 3 μm axial resolution and a speed of 100,000 A-scans per second. 256 B-scans to be taken on an area of 12 × 9 μm. On pre-op visit (Monday) Day 1 post-surgery Discharge day Week 1 post-surgery Month 1 post-surgery | Device: OCT swept source DRI-Atlantis, Topcon<br>* 3-dimensional scanning protocol with 3 μm axial resolution and a speed of 100,000 A-scans per second. 256 B-scans to be taken on an area of 12 × 9 μm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in choroidal thickness | Change in choroidal thickness (microns) on OCT pictures | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Visual acuity as assessed by Snellen chart | One year | 
| Retinal changes | Analysis of OCT pictures | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCT
Vascular Inflammation in Adolescents With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control.

Detailed Description
-----------------
Many published studies reveal that adult patients with T1DM can have early, silent and more advanced vessel wall thickness than normal subjects. This is influenced by the degree of their blood sugar control. If this is happening in adolescents, we want to know what proportion of adolescent children with type 1 diabetes show signs of early blood vessel damage. We also want to learn if these signs of damage are linked to other factors such as how long someone has had diabetes, blood sugar control or individual differences because of a difference in genetic make-up.

Official Title
-----------------
Prevalence of Oxidative Stress, Endothelial Dysfunction, Increased Carotid Artery Intima-media Thickness (cIMT) and Biomarkers of Vascular Inflammation in Adolescents With Type-1 Diabetes Mellitus (T1DM)

Conditions
-----------------
Type 1 Diabetes Mellitus, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents ages 12-18 years Tanner stage III-V T1DM > 2 years HgbA1c <8 or >10 for previous 2 years Exclusion Criteria: Subjects with known history of hypercholesterolemia or family history of hypercholesterolemia Family history of premature cardiovascular disease Hypertension defined as subjects with blood pressure greater than the 90th percentile for age Anemia defined as Hgb <11.0 g/dl ADHD Congenital heart disease Pituitary tumor Known allergy to ultrasound gel Recent head injury Chromosomal abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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 |
| --- | --- |
| HgbA1c <8<br>Adolescents with HgbA1c < or equal to 8% for the previous 12 months | |
| HgbA1c >10<br>Adolescents with HgbA1c > or equal to 10% for previous 12 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM |  | 1 year |
Epidemiologic Patterns of Bacteremia After Trauma

Study Overview
=================
Brief Summary
-----------------
Presence of pelvic and liver injury on arrival in ED, gastrointestinal tract perforation and massive transfusion within the first 24 hours after trauma appear a significant risk factor for bacteremia. Scoring with the ISS, intra-abdominal and pelvic injury and presence of transfusion and shock at admission to ED appears a useful tool for identifying trauma patients at increased risk of bacteremia.

Detailed Description
-----------------
Purpose: Bacteremia is a major nosocomial infection problem in view of its high mortality. Bacteremia occurs in trauma patients frequently and increases a morbidity and mortality. The aim of this study was to identify risk factors and to describe epidemiological patterns for early onset (EOB) and late onset (LOB) bacteremia after trauma. Methods: All trauma patients admitted to surgical intensive care unit (SICU) and general ward (GW) from January 2011 to December 2015 were retrospectively enrolled. The following information was collected for each patient and recorded in a computer database: demography, severity of trauma according to the Injury Severity Score (ISS) and each abbreviated injury score (AIS), severity of coma according to the Glasgow Coma Scale (GCS), presence of shock and transfusion. Early onset bacteremia was defined as EOB when onset occurred within 7 days after trauma, and late onset bacteremia was defined as LOB when appearing after 7 days from trauma.

Official Title
-----------------
Epidemiological Patterns for Early Onset and Late Onset Bacteremia After Trauma

Conditions
-----------------
Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who admitted to intensive care unit (ICU) or general ward (GW) through the emergency department after trauma were studied Exclusion Criteria: Patients who arrived on dead-on arrival

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 |
| --- | --- |
| 1<br>Patients with Bacteremia after trauma | |
| 2<br>Patients with non-bacteremia after trauma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factor for bacteremia after trauma | finding fisk factor for bacteremia in traumatic patients | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etiology of bacteremia after trauma | distinguishing G(+) cocci, G(-) rod, and candida spp. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma, CLABSI
A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis

Study Overview
=================
Brief Summary
-----------------
A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis

Detailed Description
-----------------
A long-term, open label, non-comparative, multi-center study to evaluate the safety of tacrolimus cream-B 0.1% in treating the signs and symptoms of psoriasis.

Official Title
-----------------
A Phase 3, Long-Term, Open Label Study to Evaluate the Safety of Twice Daily Tacrolimus Cream-B 0.1% in the Treatment of Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Tacrolimus Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of plaque psoriasis Exclusion Criteria: Skin disorder other than plaque psoriasis in the areas to be treated. Disease on only scalp

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus Cream|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Outcome, Tacrolimus, Safety, Psoriasis
Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.

Official Title
-----------------
A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

Conditions
-----------------
Peripheral T-Cell Lymphoma, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin's Lymphoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory to or relapsed after at least 1 prior treatment regimen; Eastern Cooperative Oncology Group (ECOG) score of 0 to 2; At least 18 years of age. Exclusion Criteria: Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks); Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months; Known hepatitis B virus, hepatitis C virus or HIV infection; Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TGR-1202<br>TGR-1202 Daily Oral Dose | Drug: TGR-1202<br>* TGR-1202 Daily Oral Dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose acceptable for participants | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities. | 28 days (1 cycle of therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202 | Up to 1 year |
In-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate

Study Overview
=================
Brief Summary
-----------------
Prospective randomized clinical trial to assess the effect of in-hospital intensive counseling and follow-up vs. usual care, on re-admission rates of patients with Asthma. The study population will include asthma patients admitted to internal Medicine departments and medical ICU at Soroka University Medical Center, due to asthma exacerbation.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Intensive counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ≥ 18 years old. Admitted to Internal Medicine at Soroka University Medical Center due to asthma exacerbation. Exclusion Criteria: Substance abuse (except for tobacco). Handicapped or bed ridden patients. Patients who don't speak Hebrew, English, Russian or Arabic. Other significant respiratory disease such as COPD, interstitial lung disease (as decided by the PI).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive counseling by a pulmonologist<br>Counselor visit during hospitalization, telephone follow up for 4 weeks and a follow up visits. | Behavioral: Intensive counseling<br> <br> |
| No Intervention: Usual care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-admission rate |  | Within 6 months after discharge |
Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS) Damage

Study Overview
=================
Brief Summary
-----------------
The goal of the present study is to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, and typically developed controls.

Official Title
-----------------
Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS)

Conditions
-----------------
Walking Performance

Intervention / Treatment
-----------------
* Other: gait evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post-severe closed head injury (Glasgow Coma Scale [GCS] score at admission to emergency room of ≤8) [Kathryn 2008]. at least one year post trauma. ages 7 to 13 years. independent ambulation (foot orthoses permitted). Exclusion Criteria: had received botulinum toxin for spasticity management or had undergone orthopedic surgery in the past six months. unable to follow simple instructions.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 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 |
| --- | --- |
| children<br> | Other: gait evaluation<br>* The children will asked to walk under different conditions: (1) walking at a self-selected speed faster and slower on the GAITRite® system and on a treadmill and while listening and to a metronomeQuoting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prevention of Falls and Injurious Falls Among Elderly People

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe and analyse the effects of multifactorial trial on the incidence of falls and injurious falls and on different risk factors of falling among the home-dwelling aged.

Detailed Description
-----------------
The aims of the study: To implement a program for the prevention of falls and injurious falls. To describe the structure and activities of the fall prevention program implemented among the aged who are living in their own home, have at least moderate cognitive abilities, have fallen during previous 12 months and are 65 years of age or older. A further aim is to describe the frequency of participation according to age, gender, residence, health and physical condition. To describe the effects of prevention on primary risk factors of falling such as muscle strength, balance, eye sight, medications, depression and home hazards in relation to age, gender, health and physical condition. To describe and assess the effects of prevention on the incidence of falls and injurious falls. To assess the effects of prevention on physical, cognitive and psychosocial functional abilities, quality of life and use of health and social services and deaths.

Conditions
-----------------
Falls, Accidental Falls

Intervention / Treatment
-----------------
* Behavioral: Multifactorial prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years of age or older home-dweller having fallen at least once during the previous 12 months at least moderate cognitive abilities (MMSE over 17) able to walk 10 metres independently Exclusion Criteria: MMSE under 17

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Multifactorial prevention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of falls and injurious falls |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of falling |  |  | 
| Functional abilities |  |  | 
| Quality of life |  |  | 
| Use of health and social services |  |  | 
| Deaths |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Falls, Accidental falls, Prevention, Aged, Multifactorial trial
Acoustic Pharyngometry in Obstructive Sleep Apnea Syndrome Patients, With Indication of Continuous Positive Air Pressure

Study Overview
=================
Brief Summary
-----------------
Acoustic Pharyngometry (AP) is a method of measurement of Transversal Sectional Areas (TSA) and Volumes of oral cavity and pharynx, based on acoustic waves. The aim of this study is to describe changes on oropharynx dimensions caused by CPAP (Continuous Positive Air Pressure) in patients with severe Obstructive Sleep Apnea Syndrome when compared with patients with Primary Snore, using AP. The exam will be made during the use of CPAP, at various pressures. The investigators also intend to determine if pressure determined by Polysomnography in OSAS patients cause some type of different change in AP graphic.

Detailed Description
-----------------
The investigators are performing AP exams in severe apneics (cases) and primary snorers (control group),first basal, and then at the same time of using CPAP with a nasal mask, at progressive pressures (from 4 to 10 cmH20 in snorers, and until 2 pressures above the polysomnography determined pressure in apneics). The wave tube of pharyngometer is connected to the patient´s mouth by a mouthpiece, and to the computer. It makes a graphic of area x distance for each measurement. Then the investigators compare the changes in area, distance and volume of oral cavity and pharynx, determined by CPAP pressures, in both groups, and compare the measurements inside each group and between the two groups. Finally, the investigators analyse the CPAP pressure that most modifies the AP graphic, observing if it has some relationship with the polysomnography determined CPAP pressure. The investigators intend this way to show the kind of modifies determined by CPAP in oral cavity and oropharynx and, secondarily, observe some relationship of AP and polysomnography in determine the CPAP ideal pressure for severe apneic patients.

Official Title
-----------------
Evaluation of Effect of Continuous Positive Air Pressure (CPAP) on Upper Airway Dimensions, by Acoustic Pharyngometry (AP), in Severe Obstructive Sleep Apnea Syndrome (OSAS) and Primary Snore Patients

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 - 65 years old Female and male Exclusion Criteria: Cardiopathies Chronic nasal obstruction Using neurologic or psychiatric drugs

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?
-----------------
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
-----------------
Acoustic Pharyngometry, CPAP, Obstructive Sleep Apnea Syndrome