linjc16/ctgov huggingface dataset:
Prevalence of Glaucoma in the Israeli Arab Population

Study Overview
=================
Brief Summary
-----------------
there is a variety of glaucoma prevalence within different populations. this study examine the prevalence of glaucoma in the Arab population in Israel' as well as the demographic variables and the compliance to treatment in the population.

Detailed Description
-----------------
from Medical records of primary care clinic in the city of Tira. the patients are recruited, all glaucoma patients are above age of 20 years. they must suffer from CDR >= 0.5 with/without asymmetry with the other eye. or they suffer from glaucomatous damage to the visual fields.

Official Title
-----------------
Glaucoma Prevalence in the Israeli Arab Population

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cup-to-disk ratio (CDR) > 0.5 with asymmetry between the eyes Intraocular pressure (IOP) > 23 mm Hg Damage to the field of vision Age- above 20 Yrs. old Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Glaucoma patients<br>all the ,medical records of patients who were diagnosed with primary open angle glaucoma, closed angle , pseudoexfoliative and neovascular glaucoma. | |

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
-----------------
Glaucoma, Compliance, Prevalence
Human Milk Fortifiers and Acid-Base Status

Study Overview
=================
Brief Summary
-----------------
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants. Two different compositions are tested, main difference is in electrolyte composiiton.

Detailed Description
-----------------
Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE < -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.

Official Title
-----------------
Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Drug: changing of fortifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: growing premature infants with a birth weight < 2000g Exclusion Criteria: congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation

Ages Eligible for Study
-----------------
Minimum Age: 10 Days
Maximum Age: 3 Months

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: changing of fortifier|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of metabolic acidosis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for oral bicarbonate administartion |  |  | 
| longitudinal growth |  |  | 
| weight gain |  |  | 
| amino acid levels in plasma an urine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth, oral feeding, nutrition
Carotid Ultrasound Under Pulsed-wave Doppler Mode to Check the Pulse in Cardiopulmonary Arrest Patients.

Study Overview
=================
Brief Summary
-----------------
It's crucial to determine whether a pulse is present or not in patient with cardiac arrest. But more and more studies have shown that manual palpation is unreliable for detecting pulse 1-4. Failure to detect pulselessness may cause delay of chest compression and directly affect the patient's outcome. Likewise, failure to rapidly detect return of spontaneous circulation may cause prolonged chest compression and increase associated injury during resuscitation. More and more studies have demonstrated that echo guided pulse detection is feasible 5-7. The aim of our study is to check carotid pulse via ultrasound. This is a prospective study and the patient selection is in-hospital or out of hospital cardiac arrest. A curvilinear ultrasonography transducer is used and placed transversely on either right/left carotid artery under pulsed-wave doppler mode to check whether the pulse is present or not. The result of ultrasonography will be compared with manual palpation and to determine the accuracy and effectiveness of clinical usage.

Official Title
-----------------
Carotid Ultrasound Under Pulsed-wave Doppler Mode to Check the Pulse in Cardiopulmonary Arrest Patients.

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Carotid ultrasound under pulsed-wave doppler mode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient presenting at ER with cardiac arrest older than 20 years-old Exclusion Criteria: younger than 20 years-old patient who is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Patient presenting at emergent department with cardiac arrest<br> | Device: Carotid ultrasound under pulsed-wave doppler mode<br>* Carotid ultrasound under pulsed-wave doppler mode to check whether carotid pulse is present<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid ultrasound under pulsed-wave doppler compared with manual palpation | The result of ultrasonography will be compared with manual palpation and to determine the accuracy（e.g., no pulse under manual palpation but positive pulse-wave finding）of clinical usage. | 5 seconds during pulse check period of resuscitation | 
| Carotid ultrasound under pulsed-wave doppler compared with manual palpation | The result of ultrasonography will be compared with manual palpation and to determine the effectiveness (e.g., the time need to confirm whether pulse is present or not under manual palpation and ultrasound) of clinical usage. | 5 seconds during pulse check period of resuscitation |
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1

Study Overview
=================
Brief Summary
-----------------
The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients. The KBS Systems 1.0(b) device avoids the common practice of accessing the vein to draw blood for conventional laboratory analysis. Instead, the KBS Systems 1.0(b) device uses Raman Spectroscopy to acheive the measurement of various blood analytes through the use of only approximately 40µl of blood. Such a small volume of blood can be sampled via a finger prick procedure rather than needing a larger volume of blood sampled via a venipuncture. The spectra contain information of all the molecules present in the blood (RBCs, hemoglobin, glucose, sodium, potassium, etc.). From these spectra, the system is able to analyze the blood and provide results in a matter of minutes, rather than hours or even, in some cases, days.

Official Title
-----------------
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1

Conditions
-----------------
Calibration and Validation of Analyte Testing System

Intervention / Treatment
-----------------
* Diagnostic Test: Minimally invasive and non-invasive blood analyte measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults > 18 yrs of age. Willingness and ability to provide informed consent Hospital patients with a physician-prescribed laboratory blood test Exclusion Criteria: People with clotting factor disorders and/or currently taking anticoagulation medication. Has any other medical condition that, in the opinion of the Investigator, would interfere with the person's participation in this study (i.e. double arm amputee). Any skin abnormalities or tattoos located on the palm(s) of the hand(s). The left palm is preferred for this study; however, the right palm can be used if the left palm is excluded. Parkinson's disease, dyskinesia, tremors, or similar that may make it challenging for said person to hold their hand on the device in a still and stable manner.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Minimally invasive and non-invasive blood analyte measurement|Rapid point-of-care minimally invasive blood analyzer consisting of a spectrometer and a computer loaded with Kaligia software that controls the data acquisition and signal processing to interpret blood analyte measurement.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyte validation | CLIA laboratory analyte values will be compared to device analyte readings and inform machine learning of device software learning to achieve device calibration and validation of readings. | 6 months |
Long-Term Follow-up Study for Multiple Myeloma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3102 Study (NCT00103662).

Study Overview
=================
Brief Summary
-----------------
This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).

Detailed Description
-----------------
This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled study to evaluate AMD3100 plus granulocyte colony stimulating factor (GCSF) versus G-CSF plus placebo to mobilize and transplant Multiple Myeloma (MM) patients (protocol AMD31003102LTF [NCT00103662]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662).

Official Title
-----------------
Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 6X 10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation

Conditions
-----------------
Multiple Myeloma, Autologous Transplantation

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: plerixafor
* Drug: granulocyte colony-stimulating factor (G-CSF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662) Exclusion Criteria: No Exclusion Criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G-CSF plus plerixafor<br>Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received plerixafor prior to undergoing apheresis. | Drug: plerixafor<br> <br> * Other names: AMD3100;Drug: granulocyte colony-stimulating factor (G-CSF)<br> <br> |
| G-CSF plus placebo<br>Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received placebo prior to undergoing apheresis. | Drug: Placebo<br> <br> Drug: granulocyte colony-stimulating factor (G-CSF)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662) |  | 5 years |
ABX464 First in Man Study

Study Overview
=================
Brief Summary
-----------------
This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).

Detailed Description
-----------------
This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France). Six subjects per dose group were enrolled into 1 of 4 groups with escalating doses of ABX464 (50, 100, 150 and 200 mg). For each dose group, a first subject was treated, if no adverse event (AE) occurred, a second subject was dosed one hour later. The four last subjects were dosed the day after if no clinically significant AE occurred. Escalation to the following dose level was decided after review of PK and safety data (laboratory results, ECG, vital signs and AEs)

Official Title
-----------------
ABX464 First in Man, Open Label, Parallel Group, Single Ascending Dose Study

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: ABX464


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Subject in good health on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG) and routine laboratory safety tests Subject with a BMI of 18 27kg/m² Non smokers or light smokers of less than 10 cigarettes per day Having given their written informed consent Exclusion Criteria: Subject with any on-going infection or disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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: ABX464<br>50, 100, 150 or 200 mg once a day / Single Administration | Drug: ABX464<br>* Single Administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients experiencing at least one Adverse Event |  | Up to 45 days post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentrations (Cmax) of ABX464 and metabolite |  | Up to 45 days post dosing | 
| Area Under the Curve (AUC) of Plasma Concentrations of ABX464 and metabolite |  | Up to 45 days post dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features.

Detailed Description
-----------------
The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine, or any combination of the three, in patients experiencing a manic episode with depressive or irritable symptoms. To assess the back ground and baseline features associated with response/non-response to risperidone plus mood stabilizer in patients with mania with depressive or irritable features. To assess the symptomatic dimensions of response of risperidone added to mood stabilizers in patients with mania with depressive or irritable features.

Official Title
-----------------
Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic YMRS score>/= 16 One or more of following: 3 MADRS depression items scoring >/=3 3 BISS depression items scoring >/=3 YMRS irritability and aggressive items sum score>/=4 Taking lithium, valproate or lamotrigine at stable dose for 4 wks or longer, with adequate serum level age 18 and over Male or female Inpatient or outpatient Exclusion Criteria: -

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: Risperidone<br>patients will receive risperidone for up to 20 weeks | Drug: Risperidone<br>* risperidone will be administered 1-3mg pills, each night, for up to 20 weeks<br>* Other names: risperdal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forty percent reduction in YMRS |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| twenty percent reduction in MADRS |  | 20 weeks | 
| Remission rate, defined as final score of plus or minus eight on YMRS and MADRS |  | 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mixed mania, depression, irritability
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis .

Official Title
-----------------
A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.

Conditions
-----------------
Non-infectious Anterior Uveitis

Intervention / Treatment
-----------------
* Drug: TRS01 eye drops
* Drug: TRS01 eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study. Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation. An eligible subject must have: Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol. Must have vision ≥ 20/40 in the non-study eye. Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol. Exclusion Criteria: Any form of infectious uveitis Active retinitis Cancer or melanoma that is actively treated with immunotherapy Pregnancy / lactation Receiving specific medication/interventions as specified per protocol

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRS01 low dose<br> | Drug: TRS01 eye drops<br>* Dosed four times a day (QID)<br>|
| Experimental: TRS01 high dose<br> | Drug: TRS01 eye drops<br>* Dosed four times a day (QID)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Both Systemic and Ocular Adverse Events | Number of patients experiencing Adverse Events during the study | 10 weeks |
The Prevalence of Helicobacter Pylori in Shanghai, 2013 to 2019

Study Overview
=================
Brief Summary
-----------------
The study was a cross-sectional single-center study, conducted at Renji Hospital, Shanghai Jiaotong university school of medicine. We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy from January 1, 2013 through December 31, 2019. The medical records were analyzed for the prevalence of H. pylori infection in patients with peptic ulcers.

Official Title
-----------------
The Prevalence of Helicobacter Pylori Infection in Patients With Peptic Ulcer Disease in Shanghai, 2013 to 2019

Conditions
-----------------
Peptic Ulcer, Helicobacter Pylori Infection

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who had undergone upper gastrointestinal endoscopy in Renji Hospital because of uninvestigated dyspepsia during 2013 and 2019 were analyzed. Exclusion Criteria: Patients that underwent upper endoscopy for reasons other than uninvestigated dyspepsia such as cirrhosis follow-up, major systemic diseases or other indications were excluded. Exclusions also included absence of biopsies, unknown H. pylori status and acute ulcer bleeding.

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| Gastric ulcer<br> | Other: NO intervention<br>* NO intervention<br>|
| Duodenal ulcer<br> | Other: NO intervention<br>* NO intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence of Helicobacter pylori and peptic ulcer | the trends change from 2013 to 2019 | 2013.1.1-2019.12.31 | 
| the ration of Helicobacter pylori positive peptic ulcers | the trends change from 2013 to 2019 | 2013.1.1-2019.12.31 |