linjc16/ctgov huggingface dataset:
OASIS STUDY Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS STUDY)

Study Overview
=================
Brief Summary
-----------------
To survey the health-related quality of life using the SF-36v2 score of patients with chronic brain infarction in Japan Chronic brain infarction in Japan is better than EU/USA

Detailed Description
-----------------
Period:2005-2007 Observation Time:baseline, 8week, 24week matters investigated: QOL determination using SF-36 v2 Age, sex, brain infarction type, stroke severity (modified Rankin scale), side of stroke, complication, smoking, alcohol, dizziness-vertigo-presyncope-light headedness, combination medicine, subjective symptoms, psychic symptoms, rehabilitation, recurrence, evaluation of depression (Japan-Stroke Scale (JSS)-D)

Official Title
-----------------
Outcome Assessment Using SF-36 v2 in Stroke Patient Study(OASIS Study)

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose last attack occurred more than 1 month ago Outpatients (including hospitalization for rehabilitation) Japanese nationality Patients who consented to participate in this study Group I: Patients with dizziness, vertigo, presyncope, and light-headedness which are likely due to secondary chronic cerebral circulation impairment associated with sequelae of brain infarction, and patients for whom KETAS (IBUDILAST) was prescribed Group II: Patients without dizziness, vertigo, presyncope, and light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction Exclusion Criteria: Patients who cannot read, understand and fill in the questionnaire by themselves Patients who idle their time away Patients who are hospitalized Patients who are undergoing treatment for dizziness, vertigo, presyncope, light-headedness which are likely due to chronic cerebral circulation impairment associated with sequelae of brain infarction Patients whose dizziness, vertigo, presyncope, and light-headedness is definitely or likely caused by Meniere disease, vestibular neuronitis, benign paroxysmal positional vertigo, otitis media, or epilepsy6. Patients whom the investigator judges are not suitable to participate in the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OASIS Study Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of SF-36 |  | 0, 8 week, 24 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain infarction, SF-36, HRQOL, Japan, Post-stroke syndrome
Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.

Study Overview
=================
Brief Summary
-----------------
Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways : as Basal/bolus therapy (B/B) in four-five injections per day . as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is achieved, the more likely patient would suffer from hypoglycemic episodes. We propose that the probability of hypoglycemia and its severity has no difference in two main insulin therapy schemes mentioned above. The objective of the study is to compare the incidence of hypoglycemia and its severity in well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style Navigator).

Official Title
-----------------
Comparison of Modern Premixed Insulin and Basal-Bolus Regimens on Blood Glucose Control Using CGMS Device in Optimally-controlled Subjects With DM2.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: Diabetes Mellitus Type 2 diagnosis confirmed by endocrinologist. Diabetes Mellitus Type 2 history of one year at least. HAb1C < 7% and less Age 18-80 yrs Normal Liver function tests Major Exclusion Criteria: History of substance use Pregnancy or breastfeeding mothers Abnormal liver or kidney functional tests Type 1 Diabetes or LADA any active disease ( like viral) at the period of investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
-----------------
continuous glucose monitoring system, hypoglycemia, insulin regimen, basal bolus therapy, modern premixed insulin, diabetes control
Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions

Study Overview
=================
Brief Summary
-----------------
About a half of HER2-negative breast cancer show HER2-low expression that can be targeted by new antibody-drug conjugates. The main aim of this study is to describe the evolution of HER2 expression from primary BC to relapse by including HER2-low category in both primary and recurrent BC samples. Patients with matched primary and relapse BC samples were included. 1299 patients were included.

Official Title
-----------------
Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with available HER2 status of primary breast cancer and relapse/metastases Exclusion Criteria: Patients with other malignancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HER2-0<br> | Other: no intervention<br>* no intervention was needed<br>|
| HER2-LOW<br> | Other: no intervention<br>* no intervention was needed<br>|
| HER2-POSITIVE<br> | Other: no intervention<br>* no intervention was needed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | The overall survival (OS) was defined as time from the date of initial diagnosis of recurrent/metastatic disease to the date of death from any cause | up to 200 months |
Eylea Post Marketing Surveillance(PMS)

Study Overview
=================
Brief Summary
-----------------
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS

Official Title
-----------------
Eylea Post Marketing Surveillance

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients determined to start EYLEA treatment Patients who agree and sign informed consent Patients who receive EYLEA treatment for the first time Patients who meet one of the following Patients diagnosed by physician as having neovascular (wet) age-related macular degeneration wAMD Patients diagnosed by physician as having visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO) Patients diagnosed as having visual impairment due to diabetic macular edema (DME) Patients diagnosed as having visual impairment due to myopic choroidal neovascularization (mCNV) Exclusion Criteria: Patients who have received anti-VEGF therapy within 90 days Patients who are contraindicated based on the approved product label Ocular or periocular infection Active severe intraocular inflammation Known hypersensitivity to any ingredient of this drug
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity] |  | 4 months or 8 months | 
| Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography] |  | 4 months or 8 months | 
| Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography] |  | 4 months or 8 months | 
| IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure] |  | 4 months or 8 months | 
| Measurement of fundus lesion by fundoscopy |  | 4 months or 8 months | 
| Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs) |  | 8 months |
Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the harvest, isolation and culture of cardiac stem cells from endomyocardial biopsies is feasible.

Detailed Description
-----------------
Heart failure is a devastating condition affecting nearly 6 million patients in the United States alone. Ischemic cardiomyopathy, or pump failure secondary to previous heart attack, is considered by many to be the leading cause of heart failure. Stem cell therapy, or regeneration of the lost myocardium, is an intervention that has the potential for reversing the detrimental effects of this disease. Recently published evidence has shown preliminary results indicating the safety and feasibility of utilizing cardiac stem cells for the treatment of ischemic cardiomyopathy. The ability to use a commonly practiced method, such as endomyocardial biopsy, to isolate and expand stem cell cultures could, potentially, make this therapy widely available. The results of this study will be important for the design of future clinical trials.

Official Title
-----------------
Harvest, Isolation and Culture of Cardiac Stem Cells From Endomyocardial Biopsies

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any heart failure patient scheduled for RHC without contraindication for biopsy. Any patient undergoing biopsy for diagnostic purposes may also be included in the study. Exclusion Criteria: Severe comorbidities (AST, ALT, serum creatinine > 3 times the upper limit of normal). Pregnancy or women of childbearing potential. Anticoagulation which cannot be stopped for 5-7 days. Hepatitis B, C or HIV. Inability to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart failure<br>Patients with heart failure from any cause will be considered as potential participants given their clinical background meets eligibility criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of using endomyocardial biopsy samples to isolate and expand cardiac stem cell cultures. |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem cell therapy
Open Prospective Study for Determination of Predictive Measures for Pain During Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy

Detailed Description
-----------------
The aim of the work is to determine prdictive pre-endoscopic factors for pain during colonoscpy. These factors may be demographic, antrophometric, socio-ecomomic, related to previous medical staus or to anxiety levels. We will try to find an objective parameter for prdiction of pain during colonoscopy, so pre-procedural intervantion will be applied in order to reduce the pain.

Official Title
-----------------
Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy Using Moderate Sedation: A Prospective Randomized Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-70 screening colonoscopy Exclusion Criteria: Failed prior colonoscopy pain as a main referral indication complications during previous exam Inpatients Excision of more than 3 polyps Diagnosis ofCancer, IBD Incomplete exam

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-endoscopic Rectal balloon volumes | Volume for first sensation, desire to deficate and maximal tolerance volume | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | Demographic data related to excessive pain | 1 year | 
| Pre-endocopic levels of anxiety | Relation of Pre-endoscopic levels of anxiety to pain during colonoscopy | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, pain, rectal balloon
Sevoflurane In Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Ischemic postconditioning can reduce myocardial injury following myocardial infarction. A potential pharmacological agent is the anesthetic Sevoflurane. The investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will reduce infarct size.

Detailed Description
-----------------
Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation with Sevoflurane during the procedure or to usual care.

Official Title
-----------------
Sevoflurane Sedation During Primary Percutaneous Coronary Intervention.

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Oxygen + Sevoflurane
* Drug: Oxygen (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First STEMI, presenting within 6 hours after the onset of chest pain Symptoms lasting > 30 minutes Persistent ST-segment elevation > 0.1 mV in 2 or more contiguous leads Exclusion Criteria: Hypersensitivity to sevoflurane or other halogenated agents Malignant hyperthermia Cardiac arrest Cardiogenic shock Previous myocardial infarction or coronary bypass surgery Pre-infarction angina Heart failure (NYHA III/IV) Chronic inflammatory disease Severe renal impairment Hepatic dysfunction Use of Glyburide

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Sevoflurane | Drug: Oxygen + Sevoflurane<br>* Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.<br>|
| Placebo Comparator: 2<br>Oxygen | Drug: Oxygen (placebo)<br>* Control will receive oxygen only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size by area under the curve of cardiac markers. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular function. |  | Six month | 
| ST segment elevation resolution |  | 90 minutes | 
| TIMI flow |  | 60 minutes | 
| Renal function |  | 48 hours | 
| CRP |  | 24 hours | 
| Patient satisfaction |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, Postconditioning, Sevoflurane
Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives

Study Overview
=================
Brief Summary
-----------------
In order to gain a greater understanding of the full experience of children with life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years olds in active treatment for cancer, and instruct them to make video illness narratives over the course of 1-3 months. The narratives will be studied as an intervention; each of the participants will be administered a measure of physical symptoms (the Memorial Symptom Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words. Our hypothesis is that these narratives will provide insight into the lives of children with cancer, increase their self-esteem, and decrease symptom distress, and improve communication between patients and their doctors.

Detailed Description
-----------------
In addition to the above outcome measures: The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words.

Official Title
-----------------
Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Video Illness Narrative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with cancer Age 10-18 In active treatment for cancer Followed at the Strong Memorial Hospital/Golisano Children's Hospital Exclusion Criteria: Non-English Speaker Cognitively impaired so as to make data collection difficult

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video Illness Narrative<br>single arm pilot study | Behavioral: Video Illness Narrative<br>* video<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memorial Symptom Assessment Scale |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rosenberg Self Esteem Scale |  | 3 mopnths |
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

Study Overview
=================
Brief Summary
-----------------
Cutaneous leishmaniasis is typically treated with the parenteral product pentavalent antimony. Miltefosine is an oral agent shown to be active for mucosal leishmaniasis due to L braziliensis in Bolivia and cutaneous leishmaniasis due to L panamensis in Colombia. This trial is intended to evaluate miltefosine for cutaneous leishmaniasis due to L braziliensis in Bolivia. Patients will be randomly assigned to miltefosine or pentavalent antimony. Standard dose regimens will be used for both drugs.

Official Title
-----------------
Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia

Conditions
-----------------
Cutaneous Leishmaniasis

Intervention / Treatment
-----------------
* Drug: miltefosine
* Drug: antimony


Participation Criteria
=================
Eligibility Criteria
-----------------
Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion. Previous RX: No specific or putatively specific therapy for leishmaniasis (Sb, pentamidine, amphotericin B, imidazoles, allopurinol) Other diseases: No concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT) and kidney function tests (creatinine).

Ages Eligible for Study
-----------------
Minimum Age: 3 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: miltefosine|nan|
|Drug: antimony|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cutaneous, leishmaniasis, drug, miltefosine