linjc16/ctgov huggingface dataset:
Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the clinical status of patients who participated in the original pivotal Betaseron study at 20 years after randomized treatment initiationStudy end-points include: Mortality - All-cause mortality - Cause specific mortality - Multiple sclerosis-related mortality EDSS (Expanded Disability Status Scale) Cognition Resource use SPMS (Secondary Progressive Multiple Sclerosis) status Employment history

Official Title
-----------------
An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Betaseron (Interferon beta-1b, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously enrolled in the Betaseron pivotal study protocols TB01-35686 in the US and TB01-35886 in Canada (total, N=372) Patient, caregiver, or legal guardian must provide written informed consent Patient must confirm her/his ability and agreement to participate in the study at the beginning of the phone call

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 |
| --- | --- |
| Group 1<br> | Drug: Betaseron (Interferon beta-1b, BAY86-5046)<br>* Telephone survey of all patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive exploration of mortality, EDSS, cognition, resource use, SPMS status and employment history by length of exposure to Betaseron and stratified by the original clinical trial group assignment (1.6 MIU, 8 MIU, placebo) |  | 20 years |
Caffeine Consumption and Mortality in Diabetes

Study Overview
=================
Brief Summary
-----------------
Previous studies suggested an inverse relationship between coffee consumption and mortality in the general population. Furthermore, an inverse association between coffee consumption and serum biomarkers of inflammation and insulin resistance has been described. Prospective studies showed that coffee consumption might be associated with reduction in the incidence of type 2 diabetes. Although caffeine consumption appears to be associated with a decreased risk of developing type 2 diabetes, the relationship between caffeine consumption and mortality in patients with diabetes remains uncertain. The current analysis aimed to assess the effects of caffeine consumption and caffeine source on all-cause, cardiovascular and cancer mortality among patients with diabetes.

Official Title
-----------------
Caffeine Consumption and Mortality in Diabetes: an Analysis of National Health and Nutrition Examination Survey (NHANES) 1999-2010

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NHANES participants from 1999 to 2010 above 18-year old, with diagnosis of diabetes Exclusion Criteria: Implausible alimentary reports (defined as consumption of less than 500 kcal/day or more than 3500 kcal/day) Missing information on caffeine consumption Missing information on mortality

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality as assessed by NHANES linked National Death Index public-access | From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality | Cardiovascular mortality as assessed by NHANES linked National Death Index public-access | From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years | 
| Cancer mortality | Cancer mortality as assessed by NHANES linked National Death Index public-access | From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to 12 years |
Selenium Supplementation of Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients with liver cirrhosis can improve their selenium nutritional status by taking supplemental selenium.

Detailed Description
-----------------
Selenium is an essential nutrient. Selenium carries out its biological functions through selenoproteins. The liver converts dietary selenium to a form that can be used to make selenoproteins. Patients with cirrhosis have much lower selenium levels than healthy individuals. We hypothesize that patients with cirrhosis are unable to utilize dietary selenium for selenoprotein synthesis. These patients may benefit from another form of selenium: selenate. We will compare the effects of two supplemental forms of selenium on plasma selenium levels in patients with cirrhosis. Patients will be randomized to receive either a placebo, 200 µg selenomethionine, 200 µg selenate or 400 µg selenate, daily, for 8 weeks. We will measure selenium levels in the blood at baseline, week 4 and week 8. We will determine which forms of selenium, if any, increased plasma selenium levels of the cirrhosis patients.

Official Title
-----------------
Selenium Supplementation of Patients With Cirrhosis

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Dietary Supplement: 200 µg selenium as selenate
* Dietary Supplement: 400 µg selenium as selenate
* Dietary Supplement: 200 µg selenium as selenomethionine
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver disease aged 18 or above Exclusion Criteria: substance abuse renal failure

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: 1<br>200 µg selenium as selenate | Dietary Supplement: 200 µg selenium as selenate<br>* 200 µg selenium as selenate<br>|
| Experimental: 2<br>400 µg selenium as selenate | Dietary Supplement: 400 µg selenium as selenate<br>* 400 µg selenium as selenate<br>|
| Experimental: 3<br>200 µg selenium as selenomethionine | Dietary Supplement: 200 µg selenium as selenomethionine<br>* 200 µg selenium as selenomethionine<br>|
| Placebo Comparator: 4<br>placebo | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma selenoprotein P, Plasma GPX-3 activity, Total plasma selenium |  | 8 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cirrhosis, liver disease, selenium, selenoproteins, selenoprotein P, biomarkers
Effect of TEAS on Rocuronium Injection Pain

Study Overview
=================
Brief Summary
-----------------
Pain from the injection of rocuronium is a common side effect during anesthetic practice, occurring in 50%-80% of patients. Several methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing the rocuronium injection pain.

Official Title
-----------------
Efficacy of TEAS On Prevention of Rocuronium Injection Pain

Conditions
-----------------
Injection Pain

Intervention / Treatment
-----------------
* Device: TEAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 year aged ASA I-III Who was to undergo various elective operations. Exclusion Criteria: Cardiovascular surgery Patients with pacemakers Patients requiring rapid sequential induction

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP TEAS<br>Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6). | Device: TEAS<br>* Transcutaneous electrical acupuncture stimulation<br>|
| Placebo Comparator: Control Sham Group<br>Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation. | Device: TEAS<br>* Transcutaneous electrical acupuncture stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain with rocuronium injection | pain will be graded as no pain; mild pain; moderate pain; severe pain following administration of a priming dose of rocuronium | 5 minutes |
Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

Study Overview
=================
Brief Summary
-----------------
This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.

Official Title
-----------------
A Pilot, Open-label, Multicenter Intra-individual Comparison of Multihance and Vasovist for Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) of Renal Arteries

Conditions
-----------------
Steno-occlusive Disease

Intervention / Treatment
-----------------
* Drug: Multihance
* Drug: vasovist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known or suspected renovascular disease based on one of the following criteria: severe hypertension hypertension refractory to standard therapy abrupt onset of moderate to severe hypertension at age < 35 years normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension unexplained by stable elevation of serum creatinine > 2Mg/dL positive findings for stenosis from another imaging modality

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Multihance<br>* 0.5 Molar, single injection at 0.2 mL/kg<br>|
| Active Comparator: 2<br> | Drug: vasovist<br>* 0.25 molar single injection 0.03 ml/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity compared to DSA |  | post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy and predictive values; inter-reader agreement for diagnostic performance |  | post dose |
Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.

Official Title
-----------------
The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic schizophrenia Serum 25(OH)D level below 30 ng/ml Deficit in cognitive functions Exclusion Criteria: Hypercalcemia Hepatic or renal failure Obese Metabolic syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Oral placebo daily for 8 weeks | Drug: Placebo<br>* Oral placebo daily for 8 weeks<br>|
| Active Comparator: Vitamin D<br>Vitamin D Cholecalciferol 2000 IU oral daily for 8 weeks | Drug: Cholecalciferol<br>* cholecalciferol 2000 IU oral daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function | cognitive function as measured with standard cognitive battery | At the end of week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDNF serum level | BDNF serum level as measured with ELISA method | At the end of week 8 |
Aniseikonia in Epiretinal Membrane Patients

Study Overview
=================
Brief Summary
-----------------
Examination of aniseikonia in epiretinal membranes patients before and after surgery

Detailed Description
-----------------
Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.

Official Title
-----------------
Aniseikonia in Epiretinal Membranes

Conditions
-----------------
Epiretinal Membrane

Intervention / Treatment
-----------------
* Other: Cataract guideline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epiretinal membrane Phakic on both eyes Exclusion Criteria: no previous eye surgeries refractive status +/- 2 seq

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cataract guideline<br>In this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery | Other: Cataract guideline<br>* The patients gets an IOL according to cataract guideline correcting the ametropia<br>|
| No Intervention: Standard refraction<br>The patients gets an IOL ensuring his preoperatively refraction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aniseikonia | Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test | 1 year |
COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector

Study Overview
=================
Brief Summary
-----------------
Hospital staff, on the front line in the COVID-19 crisis, have many questions about the risk that they have been infected with this potentially fatal virus. These questions of course primarily concern caregivers working in sectors dedicated to COVID-19 patients, whether they are resuscitating or not, but also those in non-COVID-19 sectors, or even staff without direct contact with patients. In addition, depending on the suddenness and intensity of this COVID-19 wave, these personnel have been more or less trained and sometimes exposed due to the dire lack of protective equipment. In some countries such as Great Britain, this has resulted in significant absenteeism, a source of deepening the shortage of caregivers. This proportion of contaminated caregivers has not been evaluated on the whole of French territory. Studies from other countries suggest figures ranging from 1.5% in China to 20% in Italy. It is therefore impossible to rely on such variable data to have a reliable estimate. Since june 2020, all staff in French health establishments could benefit a serological test. Thus, in this epidemiological study, we propose to rely on this institutional serological screening to describe the link between seroconversion of hospital staff, regional intensity of the epidemic, and sectors of activity (COVID-19 sectors, non-COVID-19 caregivers , non-COVID-19 non-caregivers.

Official Title
-----------------
Study of the COVID-19 Serological Status of Hospital Staff Working or Not in the COVID-19 Sector in 3 French Regions Facing the COVID-19 Epidemic With Varying Degrees of Intensity

Conditions
-----------------
Infection Viral

Intervention / Treatment
-----------------
* Other: Health Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital staff from Argenteuil, Belfort, Dijon and Limoges hospitals. Age ≥ 18 years old Participation agreement Exclusion Criteria: Protected persons Refusal of participation

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 |
| --- |
|Other: Health Questionnaire|Completion of a short questionnaire noting the result of the serology and looking for elements in favor of exposure to the virus, whether professional or extra-professional.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with a COVID-19 seroconversion | Number of subjects with a COVID-19 seroconversion fixed by the presence of IgG + in serology according to the service (COVID19 +, COVID19- caregiver, COVID- non-caregiver). | through study completion, an average of 5 month |
Blood Pressure Monitor Clinical Test (Cuff Range: 13.5 Cm-22cm)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 13.5 cm-22 cm.

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cuff circumference: 13.5cm-22cm

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 28 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 |
| --- | --- |
| blood pressure monitor<br>Cuff circumference:13.5cm-22cm | |
| stethoscopy<br>Cuff circumference: 13.5cm-22cm | |

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
-----------------
BP
A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Compare the Effectiveness and Safety of DIuretics Add-On Strategy in Acute Decompensated Heart Failure Patients (DIOS II)

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients

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

Intervention / Treatment
-----------------
* Drug: Furosemide
* Drug: metolazone
* Drug: furosemid/spironolactone
* Drug: metolazone/spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dyspnea at rest or minimal activity tachypnea (respiratory rate > 20/min) or rales or pulmonary edema on chest X-ray Exclusion Criteria: hospitalization for acute heart failure decompensation cardiogenic shock (Systolic Blood Pressure < 80mmHg) Need or plan for renal replacement therapy (dialysis, kidney transplant) serum creatine level > 2.5mg/dl serum potassium (K+) > 5.5mg/dl Age > 80 years old or poor compliance patients allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics life expectancy < 6 months (e.g. metastatic malignancy, liver cirrhosis) pregnancy or women at age of childbearing potential

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Add furosemide/no spironolactone<br> | Drug: Furosemide<br>* furosemide (doubling previous furosemide dose)<br>|
| Experimental: Add metolazone/no spironolactone<br> | Drug: metolazone<br>* metolazone (add 2.5mg qod)<br>|
| Experimental: Add furosemid/spironolactone<br> | Drug: furosemid/spironolactone<br>* spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)<br>|
| Experimental: Add metolazone/spironolactone<br> | Drug: metolazone/spironolactone<br>* no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine output change | efficacy of diuretics add-on therapy, urine output change | from admission to Hospital Day (HOD)#4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine change | safety of diuretics add-on therapy, serum creatinine change | from admission to HOD#4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, diuretics, kidney, glomerular filtration rate