linjc16/ctgov huggingface dataset:
Performance Evaluation Study

Study Overview
=================
Brief Summary
-----------------
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points

Detailed Description
-----------------
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points. The evaluation will include two studies: A matrix study will compare a capillary sample collected via finger prick with a venous sample collected into a blood tube, both scanned on OLO. A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.

Official Title
-----------------
Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center

Conditions
-----------------
Hematology

Intervention / Treatment
-----------------
* Diagnostic Test: Fingerstick blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood samples will be collected from oncologic patients older than 18 years old arriving at the oncologic daily care center of Ichilov hospital, with predefined normal and abnormal blood counts Exclusion Criteria: Patient younger than 18 years old Visibly hemolyzed specimens (sample plasma should be checked for hemolysis by technician while selection of specimen from tube racks). Visibly clotted specimens (Reasonable to assume that samples processed with clinical reported results are not clotted). A sample that is not successfully scanned on OLO within 3 attempts (e.g. rejected due to irregular cell morphology, or microscopically visible hemolysis).

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 |
| --- | --- |
| Adult Oncology Patients<br>Adult oncology patients | Diagnostic Test: Fingerstick blood draw<br>* Each participant shall be pricked twice in order to perform CBC test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBC Comparison | Comparison between CBC results obtained from the Sight OLO and the reference device in venous and capillary samples covering medical decision points relevant to onclology patient | Immediately after sample collection is completed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematology
Cost of Adverse Events Related to How Often Follow-Up Occurs Among Patients With Cancer That Has Spread

Study Overview
=================
Brief Summary
-----------------
This study is a real-world retrospective claims analysis to assess and compare AE-related HCRU and medical costs among patients with different follow-up frequency after initiating a melanoma therapy.

Official Title
-----------------
Economic Burden of Adverse Events Associated With Follow-Up Frequency Among Patients With Metastatic Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Biological: Nivolumab
* Biological: Ipilimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with metastatic melanoma Initiated at least 1 treatment for metastatic melanoma after 2011 Continuous enrollment in their healthcare plan for at least 6 months before and at least 6 weeks after the index date Patients who received at least 1 dose of study drug in CA209-067

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

| Intervention/Treatment |
| --- |
|Biological: Nivolumab|Melanoma intervention|
|Biological: Ipilimumab|Melanoma intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with less frequent general outpatient visits |  | Approximately 5 years | 
| Composite monthly incidence rate of adverse events (AEs), AE-related healthcare resource utilization, and medical costs among the metastatic melanoma patients with more frequent general outpatient visits |  | Approximately 5 years | 
| Treatment-related and all-cause AE costs for nivolumab/ipilimumab combination therapy for metastatic melanoma |  | Approximately 5 years | 
| Treatment-related and all-cause AE costs for nivolumab monotherapy for metastatic melanoma |  | Approximately 5 years | 
| Treatment-related and all-cause AE costs for ipilimumab monotherapy for metastatic melanoma |  | Approximately 5 years |
Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).

Official Title
-----------------
Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study

Conditions
-----------------
Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)

Intervention / Treatment
-----------------
* Drug: Rubus occidentalis extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years of age or older prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl) Exclusion Criteria: pregnant women taking anti-hyperglycemic agents within 3 months at the time of enrollment history of heart failure, myocardial infarction, cerebral infarction uncontrolled hypertension (systolic BP > 160mmHg, or diastolic BP > 100mmHg) serum triglyceride level > 500mg/dl kidney dysfunction (serum Creatinine > 30% of upper normal limits) hepatic dysfunction (AST, ALT > 3 times of upper normal limits) taking systemic glucocorticoids within 1 month

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br> | |
| Active Comparator: Rubus occidentalis extract 900mg<br>taking Rubus occidentalis extract 900mg/day for 12weeks | Drug: Rubus occidentalis extract<br> <br> |
| Active Comparator: Rubus occidentalis extract 1800mg<br>taking Rubus occidentalis extract 1800mg/day for 12weeks | Drug: Rubus occidentalis extract<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum glucose (fasting and post 75g oral glucose tolerance test) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum insulin |  | 12 weeks |
Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease

Study Overview
=================
Brief Summary
-----------------
Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.

Detailed Description
-----------------
oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1 PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be repeated except PON1 phenotyping.

Official Title
-----------------
Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease

Conditions
-----------------
Hashimoto Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 years Exclusion Criteria: inability to give a written consent other conditions and drug usage affect oxidative stress

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy<br> | |
| euthyroid hashimoto<br> | |
| hypothyroid hashimoto<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poxidative stress markers |  | After levotren therapy |
Hemofiltration for Contrast-Induced Nephropathy

Study Overview
=================
Brief Summary
-----------------
Contrast-induced acute renal failure can be prevented with hemofiltration which is performed during cardiac catheterization

Official Title
-----------------
Prevention of Contrast-Induced Nephropathy by Real-Time Hemofiltration

Conditions
-----------------
Chronic Kidney Disease, Cardiac Catheterization

Intervention / Treatment
-----------------
* Procedure: hemofiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with serum creatinine>2.0mg/dl and/or GFR<50ml/min Exclusion Criteria: Emergent cardiac catheterization Patients on chronic dialysis Patients with HYHA>III heart failure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hemofiltration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of contrast-induced acute renal failure, Elevation of serum creatinine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for hemodialysis |  |  |
Evaluation of the Cerebral Edema in Children Having Diabetic Ketoacidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath.

Detailed Description
-----------------
The purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath. For that, If patients have Fluid treatment shall be started in 4 hours in our or other Emergency Care, they will be included our study. If not, they will be out of our study. How we measure; First measurement shall be taken in 4 hours. Second measurement shall be taken at 12 hours in mild and 12-18 hours measurement shall be taken for severe diabetic ketoacidosis, Third measurement shall be taken after fluid treatment. Fourth measurement shall be taken at polyclinic control. So, after all measurements will be hand and all data will be analyzed with statistical program. After that all outcome will be discussed and compared with patient at normal conditions at their polyclinic visit.

Official Title
-----------------
Evaluation of the Cerebral Edema With Measurement of Optic Nerve Sheath in Children Having Diabetic Ketoacidosis

Conditions
-----------------
Cerebral Edema

Intervention / Treatment
-----------------
* Other: Ultrasonic Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluid treatment shall be started in 4 hours in our or other Emergency Care Exclusion Criteria: Fluid treatment was started over four hours in other Emergency Care

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ultrasonic Measurement|How we measure; First measurement shall be taken in 4 hours. Second measurement shall be taken at 12 hours in mild and 12-18 hours measurement shall be taken for severe diabetic ketoacidosis, Third measurement shall be taken after fluid treatment. Fourth measurement shall be taken at patients polyclinic control.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic Nerve Sheath diameters will be measured from 3 mm back of globe. | Optic Nerve Sheath diameters will be measured in Children Having Diabetic Ketoacidosis and compared with normal conditions at polyclinic. | March 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C10.228.140.187
The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on the the pulmonary function of adult asthmatic Egyptian patients

Detailed Description
-----------------
Asthmatic patients are recruited and divided into two groups. One receives Alfacalcidol beside their normal medications while the other acts as a control group receiving the normal asthma medication. Both groups are followed up for four months.

Official Title
-----------------
The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients

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

Intervention / Treatment
-----------------
* Dietary Supplement: Alfacalcidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with asthma Non-smokers Exclusion Criteria: Liver impairment Kidney impairment Patients receiving digoxin Known hypersensitivity to 1α-hydroxyvitamin D3, vitamin D or any of its analogues and derivatives Hypercalcaemia Hyperphosphatemia Pregnancy and breast-feeding Patients on nutritional supplements with a potential effect on 25(OH)D serum concentrations Had a History of stones in the urinary tract or diseases of calcium or bone metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>receive Alfacalcidol 1 mcg daily for 4 months beside the conventional asthma medications | Dietary Supplement: Alfacalcidol<br>* 1-alpha hydroxy cholecalciferol 1 mcg<br>* Other names: One alpha;|
| No Intervention: control<br>Asthmatic patients receiving conventional asthma medications | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forced expiratory volume % predicted values |  | 4 months |
Rituximab-induced Pulmonary Function Changes

Study Overview
=================
Brief Summary
-----------------
Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatory myositis.

Detailed Description
-----------------
The objective of this study is to investigate whether rituximab (RTX), a drug commonly prescribed in patients with rheumatoid arthritis (RA) or inflammatory myositis, is associated with subclinical interstitial lung disease (ILD). Surrogate markers for interstitial lung diseases are a decrease of the forced vital capacity (FVC) and/or the diffusing capacity of the lung for carbon monoxide (DLCO). However, the measurement of these lung function parameters is indicated as regular follow-up examinations during the treatment with RTX according to the principles of good clinical practice. We will perform pulmonary function testing (spirometry) including measurement of the DLCO in patients with RA, who are going to be treated with RTX. A baseline lung function measurement will be performed immediately before RTX therapy is started. Follow-up measurements will be performed at 2 weeks, 4 weeks, 8 weeks and 6 months after initiation of RTX therapy. A reduction in forced vital capacity (FVC) of >10% or a fall of >15% in DLCO will be defined as indicative for ILD.

Official Title
-----------------
Rituximab-induced Pulmonary Function Changes - an Observational Study in Patients With Rheumatoid Arthritis and Inflammatory Myositis

Conditions
-----------------
Rheumatoid Arthritis, Inflammatory Myositis

Intervention / Treatment
-----------------
* Other: Lung function measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients with established diagnosis of RA or inflammatory myositis, in whom a de novo RTX treatment is indicated Age >18 y Informed consent of patient Exclusion criteria: - Acute infection Pre-existing interstitial pulmonary disease Patients with impaired forced vital capacity (FVC) on spirometry (<80% predicted) or with impaired DLCO (<75% predicted). 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

| Intervention/Treatment |
| --- |
|Other: Lung function measurement|Spirometry and measurement of diffusing capacity for carbon monoxide|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Intravitreal Bevacizumab on Non -Age-Related Macular Degeneration (AMD) Related Choroidal Neovascularization (CNV)

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of bevacizumab for treatment of non-AMD choroidal neovascularization (CNV); eg:angioid streaks, ocular histoplasmosis, high myopia, idiopathic,etc

Conditions
-----------------
Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases with subfoveal or juxtafoveal CNV due to a non-AMD related cause. Exclusion Criteria: Evidence of AMD
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: bevacizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central macular thickness |  | 6 months | 
| leakage in fluorescein angiography |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Choroidal neovascularization (CNV), Bevacizumab, Non AMD, High myopia, angioid streaks, Ocular histoplasmosis, Idiopathic
Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms

Study Overview
=================
Brief Summary
-----------------
Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or intractable pain. The aim of this approach is to improve pain management, and also to improve patient comfort. This study will assess patient discomfort symptoms before and after setting up intrathecal analgesia.

Detailed Description
-----------------
Descriptive multicenter study including patients with refractory cancer pain (unmanageable drug sides effects or intractable pain) who will receive intrathecal analgesia Patient discomfort symptoms will be evaluated before and after the beginning of intrathecal analgesia at 15, 30, 60 and 90 days. Moreover, the impact on patient close relatives and on return home will be assessed.

Official Title
-----------------
Evaluation of Discomfort Symptoms in Patients With Refractory Cancer Pain and Intrathecal Analgesia Management

Conditions
-----------------
Refractory Cancer Pain, Intrathecal Analgesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients aged 18 and older obligation of affiliation or beneficiary of a social security scheme patients with cancer and refractory localized cancer pain because of drug side effects or intractable pain localized pain in topography accessible to intrathecal analgesia (legs, abdomen and pelvis, pancoast-tobias symdrom) patient's informed consent for the study patient able to complete the evaluation questionnaires estimed vital prognosis more than three month patient with all conditions for intrathecal anagelsia Exclusion criteria: patient with intracranial hypertension refusal of patient to be included in the study refusal of patient to receive intrathecal analgesia patient with many refractory pain localizations not accessible to intrathecal analgesia

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 |
| --- | --- | --- |
| Number Evaluation of Edmonton symptoms | Edmonton symptom assessment system | up to 90 days after patient inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomy assessment score for activities of daily living | Autonomy assessment score for activities of daily living | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory cancer pain, intrathecal analgesia, pain management, discomfort symptoms management