linjc16/ctgov huggingface dataset:
Glucose in Dialysis Water in Non-diabetics

Study Overview
=================
Brief Summary
-----------------
The purposes are to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations of glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and to analysis the relationship between changes in blood pressure on the one hand and changes in vasoactive hormones on the other

Detailed Description
-----------------
Measurement of hormones and blood pressure during dialysis treatment.

Official Title
-----------------
Effect of Glucose in Dialysis Water on Blood Pressure and Vasoactive Hormones in Dialysis Patients

Conditions
-----------------
Renal Failure, Chronic

Intervention / Treatment
-----------------
* Procedure: dialysis with glucose in dialysis water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, Both men and women, Dialysis treatment for at least three months Exclusion Criteria: Heart failure, Chronic liver disease, Diabetes mellitus, Malignant disease, Nephrotic syndrome, Lack of compliance, 7 Unwillingness to participate

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: dialysis with glucose in dialysis water|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of glucose in dialysis water on blood pressure, insulin and vasoactive hormones |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between changes in blood pressure and changes in hormones during treatment |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic renal failure, dialysis, hemodialysis,
A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension

Official Title
-----------------
Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Extended-Release Carvedilol Sulfate
* Drug: Sustained-release Metoprolol Succinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or Females Aged from 18 to 70 years Had a history of essential hypertension Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg Exclusion Criteria: Malignant hypertension Average sitting systolic blood pressure≧180mmHg Type 2 diabetes with hemoglobin A1c≥9% Type 1 diabetes New York Heart Association class Ⅱ-Ⅳ congestive heart-failure Unstable angina Second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place Atrial fibrillation Bradycardia (<60 bpm, seated) Asthma or other obstructive pulmonary disease History of myocardial infarction Stroke in the 6 months before screening Known contraindications to β-adrenergic blocker therapy Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>3 times upper limit of normal Crea>2 times upper limit of normal Pregnancy or lactation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended-Release Carvedilol Sulfate<br>18-72mg/d,po | Drug: Extended-Release Carvedilol Sulfate<br> <br> |
| Active Comparator: Sustained-release Metoprolol Succinate<br>47.5-190mg/d,po | Drug: Sustained-release Metoprolol Succinate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8 |  | Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8 |  | Baseline and Week 8 | 
| Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8 |  | Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Study of Genetic Factors Other Than CYP2C9 and VKORC1 That Influence Warfarin Dose Requirements in a South-east Asian Population

Study Overview
=================
Brief Summary
-----------------
Warfarin is a commonly used anti-coagulant, but has a narrow therapeutic index and wide inter-individual and inter-ethnic variation in dose requirements. Several genetic and non-genetic factors have been identified that could influence warfarin dose requirements. However, current known predictive factors could only explain about 50-60% of warfarin dose variability. Inter-ethnic differences in genetic influences on warfarin dose requirements also exist. We hypothesize that genetic factors other than CYP2C9 and VKORC1 may influence warfarin dosing and serve to further optimize warfarin dosing.

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

Intervention / Treatment
-----------------
* Biological: Blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving maintenance warfarin therapy with a stable therapeutic international normalized ratio (INR) between 2 and 3 for at least 3 months, patients recruited from the anticoagulation clinics at the National University Hospital and Tan Tock Seng Hospital in Singapore between June 2002 and June 2004 for a previous genotyping study (C/00/510, NUH; C/00/535, TTSH, PI-Dr Goh Boon Cher). Exclusion Criteria: patients below 21 years old, or patients with liver disease, malabsorption or chronic diarrheal diseases, or patients taking drugs that may potentially interact with warfarin. Dietary advice to avoid foods that may interfere with warfarin pharmacokinetics will be given to patients during warfarin therapy.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Blood Collection<br> | Biological: Blood collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify genetic variants other than CYP2C9 and VKORC1 that may influence warfarin dose requirements in a multi-ethnic population in Singapore. |  |  |
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.

Official Title
-----------------
Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of diabetes for at least 12 months Basal/bolus treatment with human insulin for at least 2 months preceding trial start Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2 HbA1c lesser than or equal to 12.0% Exclusion Criteria: Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months Any condition that the investigator and/or sponsor feel would interfere with trial participation Known or suspected allergy against trial product or related products

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: human insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of human insulin antibodies |  | after 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of human insulin antibodies |  |  | 
| Frequency of adverse events |  |  |
COVID-19 in Patients With Anosmia in Egypt

Study Overview
=================
Brief Summary
-----------------
The study aims to test the frequency of severe acute respiratory syndrome new corona virus SARS-CoV-2 or other respiratory viruses in patients presenting with anosmia or dysgeusia to Ain Shams University Hospitals, Cairo, Egypt.

Detailed Description
-----------------
Fifty Patients presenting to Triage and/or Ear, Nose and Throat (ENT) clinics in Ain Shams University Hospitals with the chief complaint of Anosmia/ dysgeusia in the period July- September 2020; will undergo thorough history taking, clinical assessment and polymers chain reaction rt-PCR to SARS-COV2; and if proven negative to COVID 19, PCR to other respiratory pathogens will be tested. COVID-19 patients will be managed according to the standard protocol of Ain Shams University Hospitals. Follow up after 3 weeks for the outcome of recovery of the smell sense and seroconversion by rapid test for immunoglobulins IgM/ IgG of COVID 19, for the probability of a false negative PCR at initial visit. Ethical committee approval for the current study protocol was obtained. Patients will be invited to participate and the informed consent will be signed.

Official Title
-----------------
Detection of SARS-CoV-2 in Patients Presenting With Anosmia During COVID-19 Pandemic Era in Egypt

Conditions
-----------------
Anosmia, Covid19, Dysgeusia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult (>18 years) patients presented with acute-onset anosmia. Exclusion Criteria: patients with anosmia or gustatory dysfunctions before the epidemic; patients with previous history of chronic sinusitis or previous sinus surgery.

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 |
| --- | --- | --- |
| Recovery from Anosmia | subjective questionnaire about smell and taste | 3 weeks | 
| Seroconversion | developing IgM/ IgG antibodies by rapid test | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID 19 | developing other symptoms of COVID 19 | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corona virus, SARS-CoV-2, Olfactory Disturbance, Taste Disturbance
Comparison of Psychometric Properties of Three Depression Measures in Patients With Stroke

Study Overview
=================
Brief Summary
-----------------
This study is going to comprehensively examine the psychometric properties of the three depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years.

Detailed Description
-----------------
This study is going to comprehensively examine the psychometric properties of the three depression scales (Hamilton depression scale (HAMD), Hospital anxiety and depression scale (HADS), and Beck Depression Inventory (BDI)) in stroke patients over a period of three years. This study will be divided into two parts. In the first part, we will spend 3 years in recruiting 200 consecutive patients with a diagnosis of first stroke onset to compare the validity, responsiveness, and acceptability of the HAMD, HADS, and BDI. All patients will be assessed using the three depression scales and other functional measures at 14, 30, 90, 180, and 365 days after stroke. In the second part, the inter-rater reliability of the three depression scales will be examined in the first year. Sixty chronic stroke patients will be recruited in the study. Furthermore, the other 60 chronic stroke patients will be recruited in the second year for examining the test-retest reliability and measurement error of the three depression scales. This study would be the first one to systematically compare the psychometric properties of the three depression scales in a long-term follow up study. The results of the study will be able to help clinicians and researchers select the most suitable depression scales for stroke patients. The results will also provide us references to develop a new depression scale, if needed, for stroke patients.

Official Title
-----------------
Comparison of Psychometric Properties of Three Depression Measures in Patients With Stroke

Conditions
-----------------
Cerebrovascular Accidents

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a diagnosis stroke ability to complete questionnaires Exclusion Criteria: patients with other major diseases (e.g., cancer)

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
depression, psychometrics
Spectral Domain OCT Imaging in Patients With Optic Nerve Head Drusen (Tuebingen SD-OCT IN OPTIC NERVE HEAD DRUSEN STUDY)

Study Overview
=================
Brief Summary
-----------------
Optic nerve head Drusen are a mostly bilateral change of the optic nerve, eventually causing a slow, but progression loss of the visual fields. Characteristic are the crystalline deposits at the entrance of the optic nerve, the so called optic disc. The material consists of calcium, calcium phosphate, iron, but also amino acids and polysaccharides. The diagnose is made or confirmed by different imaging modalities like ultrasound and auto-fluorescence imaging. By using the high-resolution imaging with spectral-domain optical coherence imaging (SD-OCT) the volume and deposits at the optic disc can be measured and quantified. The purpose of this study whether and how defects in the visual fields are related to the deposits. Multimodal imaging of the optic nerve head is planned within the cross-sectional study, at two different time intervals (2 years). Changes in retinal fibre layer (RNFL) thickness and disc parameters are analyzed. Presence and extent of auto-fluorescent changes are evaluated. The prospective trial wants to clarify whether certain parameters at baseline indicate the further outcome and development.

Official Title
-----------------
Spectral Domain Optic Cohaerence Tomography Imaging in Patients With Optic Nerve Head Drusen

Conditions
-----------------
Optic Disc Drusen

Intervention / Treatment
-----------------
* Device: Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Drusen of the optic disc (as proven by ultrasound and clinical appearance) Exclusion Criteria: mental disability loss of fixation other eye diseases potentially leading to a loss of visual fields
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in RNFL thickness |  | baseline and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of Visual Fields |  | baseline and 2 years | 
| Change in auto-fluorescent areas |  | baseline and 2 years | 
| Change in Drusen material |  | baseline and 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drusen, SD-OCT
Maternal Perception of Fetal Movements Evaluation Using and Analyzing the Variables of Antepartum Computerized Cardiotocography: An Exploratory Study.

Study Overview
=================
Brief Summary
-----------------
Several studies analysed the association of fetal movement counting with perinatal mortality and fetal outcomes. However, no one examined the relationship of the maternal perception of fetal movement with the fetal wellbeing quantifies through computerised cardiotocography. Our study evaluates the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.

Official Title
-----------------
Maternal Perception of Fetal Movements Evaluation Using and Analyzing the Variables of Antepartum Computerized Cardiotocography: An Exploratory Study.

Conditions
-----------------
Fetal Movement

Intervention / Treatment
-----------------
* Diagnostic Test: ; Computerized cardiotocography (cCTG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nonlaboring term singleton pregnancies (37 0/7 - 41 6/7 weeks of gestation) Exclusion Criteria: fetal malformations, stillbirths, preterm deliveries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ; Computerized cardiotocography (cCTG)|To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters. |  | External cCTG was completed at least 20 minutes (maximum 60 minutes), two transducers were placed on the maternal abdomen: one over the fetal heart level and the other one at the uterine fundus. For each cCTG, the following data were evaluated: Basal FHR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fetal movement, Fetal activity, fetal assessment, fetal well-being, Computerized cardiotocography (cCTG), Fetal heart rate (FHR)
Double-blind, Randomised Study of A3384 in BAM/BAD

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).

Official Title
-----------------
A Phase II, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of A3384 in Patients With Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)

Conditions
-----------------
Bile Acid Malabsorption

Intervention / Treatment
-----------------
* Drug: A3384


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests as applicable Exclusion Criteria: Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study Patient needs medications prohibited as specified in the protocol

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A3384 Low dose<br>Administered twice daily for the duration of the study | Drug: A3384<br> <br> |
| Experimental: A3384 High dose<br>Administered twice daily for the duration of the study | Drug: A3384<br> <br> |
| Placebo Comparator: Placebo<br>Administered twice daily for the duration of the study | Drug: A3384<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs). |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms | Change from Baseline in average severity of diarrhoea during the second treatment week (last 7 days of reporting). Change from Baseline in average severity of abdominal discomfort during the second treatment week (last 7 days of reporting). Change from Baseline in average severity of abdominal bloating during the second treatment week (last 7 days of reporting). Change from Baseline in average BSFS during the second treatment week (last 7 days of reporting) | Baseline and 2 weeks |