linjc16/ctgov huggingface dataset:
Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
This Phase 3 trial will investigate the efficacy, tolerability and safety of fesoterodine fumarate (SR) (fesoterodine; SPM 907) in adult male and female subjects with overactive bladder syndrome. The trial is a randomized, double-blind placebo controlled multicenter trial. The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg, fesoterodine fumarate 8mg, or placebo during the double-blind Treatment period. Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment. The following safety variables were observed and assessed: adverse events, change in residual urinary volume (mL), change in laboratory parameters, change in vital signs, change in electrocardiogram (ECG), change in physical examination and change in urological/urogynecological examination.

Official Title
-----------------
A Phase 3, Parallel Group, Randomized, Double-Blind, Placebo Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: SPM 907


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overactive bladder syndrome Exclusion Criteria: Less than 8 micturitions in 24 hours

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 907|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.

Official Title
-----------------
An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia.

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

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate
* Drug: conventional treatment for schizophrenia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years. Clinically stable and in an outpatient setting before entering the study (visit 1). Exclusion Criteria: Use of clozapine and quetiapine within two months prior to visit 1. If total points are ≤ 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: 1<br>quetiapine fumarate | Drug: Quetiapine fumarate<br>* oral<br>* Other names: Seroquel;|
| Active Comparator: 2<br>Conventional treatment for schizophrenia | Drug: conventional treatment for schizophrenia<br>* various standard therapies<br>|
| Experimental: 3<br>quetiapine fumarate + Cognitive Remediation Therapy | Drug: Quetiapine fumarate<br>* oral<br>* Other names: Seroquel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social outcome measured by Strauss-Carpenter scale |  | change from baseline to last visit and end of CRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PANSS total score |  | change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit | 
| Change in PANSS positive, negative and general psychopathology symptom subscales |  | change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit | 
| Change in cognition as measured by a Cognitive Battery of Tests |  | change from baseline to end of CRT and from baseline to last visit |
Prognostic Score in Covid-19

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to define the clinical and biochemical parameters that characterize COVID-19 patients with a negative prognostic evolution. Our clinical score will be capable to recognize patient with favorable prognosis or patient with poor prognosis by statistical data analysis.

Official Title
-----------------
Identification of a Clinical Score to Support the Clinician in Phase 2 of Covid-19

Conditions
-----------------
Covid19 Prognostic Parameters

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 and symptomatic and positive for COVID-19 by polymerase chain reaction assay for rhino-pharingeal swab Exclusion Criteria: Under 18

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 |
| --- | --- |
| Development cohort<br> | Other: data collection<br>* clinical data collection<br>|
| Validation cohort<br> | Other: data collection<br>* clinical data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection of clinical and demographical parameters of patients affected by COVID-19 | Data about sex, age, symptom start date, vital parameters, comorbidity, symptoms, hematochemicals blood tests, therapy, oxygen support, radiology, condition evaluation will be manual collected. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Application of statistical analysis on data of patients affected by COVID-19 | The collected data will be analyzed through descriptive statistics analysis, ROC curves, regression analysis, and Machine Learning techniques to predict the prognosis of patients affected by COVID-19. | 2 months |
A Study With RO4917523 in Patients With Fragile X Syndrome

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is 6 weeks. The target sample size is <100 patients.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Safety and Tolerability, and Exploratory Efficacy and Pharmacodynamic Effects Study of RO4917523 in Adult Patients With Fragile X Syndrome.

Conditions
-----------------
Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: Placebo (for RO4917523 ascending doses)
* Drug: Placebo (for RO4917523 fixed dose)
* Drug: RO4917523
* Drug: RO4917523


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18 to 50 years of age Fragile X Syndrome IQ less than 75 Reliable caregiver Exclusion Criteria: Current psychosis or presumption of psychosis History of suicidal behavior or considered a high suicidal risk Severe self-injurious behavior Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension, diabetes) Current seizure disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Placebo Comparator: Placebo (for RO4917523 ascending doses)<br> | Drug: Placebo (for RO4917523 ascending doses)<br>* Placebo daily po<br>Drug: Placebo (for RO4917523 fixed dose)<br>* Placebo daily po<br>|
| Placebo Comparator: Placebo (for RO4917523 fixed dose)<br> | Drug: Placebo (for RO4917523 ascending doses)<br>* Placebo daily po<br>Drug: Placebo (for RO4917523 fixed dose)<br>* Placebo daily po<br>|
| Experimental: RO4917523 ascending doses<br> | Drug: RO4917523<br>* RO4917523 ascending doses daily po<br>|
| Experimental: RO4917523 fixed dose<br> | Drug: RO4917523<br>* RO4917523 fixed dose daily po<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters |  | AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Behavior and cognition assessments |  | Every 2 weeks throughout study |
Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.

Detailed Description
-----------------
Postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count, biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°C pending analysis. The primary endpoint was numbers of infective complications.Secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.

Official Title
-----------------
Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery

Conditions
-----------------
Gastric Tumor, Pancreatic Tumor, Liver Tumor

Intervention / Treatment
-----------------
* Drug: MCT/LCT and fish oil
* Drug: MCT/LCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition Exclusion Criteria: Metabolic disease Chronic kidney or liver failure Shock Contraindications for lipid administration PN during the 15 days before hospitalisation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 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: MCT/LCT<br>Structural Fat Emulsion Injection 250ml per day, for 7 days | Drug: MCT/LCT<br> <br> * Other names: Structural Fat Emulsion Injection (Fresenius-Kabi, Germany);|
| Experimental: MCT/LCT and fish oil<br>Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days. | Drug: MCT/LCT and fish oil<br> <br> * Other names: Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) and fish oil (Omegaven,Fresenius-Kabi, Germany);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infective complications |  | within the first 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  | average of 2 weeks | 
| plasma immunological markers |  | from 1 day before surgery to 7 days after surgery |
Evaluation of Thermal-Aided Muscle Stimulation

Study Overview
=================
Brief Summary
-----------------
An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps

Conditions
-----------------
Weakness, Atrophy

Intervention / Treatment
-----------------
* Device: Thermal-aided muscle stimulation
* Device: Body Temperature Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject does not meet any exclusion criteria Exclusion Criteria: Age < 18 years Subject is pregnant Subject has an implanted pacemaker/defibrillator Subject diagnosed with epilepsy Subject has implanted metallic femoral rods Subject is chair- or bed-bound Subject has neuromuscular disease or abnormalities Subject BMI > 45 Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Device: Thermal-aided muscle stimulation<br>* Thermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110<br>|
| Active Comparator: Body Temperature Control<br>Stimulation performed with body temperature control | Device: Body Temperature Stimulation<br>* Body temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Contraction Force | Measured in Newtons | At 30 s intervals for 20 minutes |
PROTECT-TIMI 30 Trial

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.

Detailed Description
-----------------
Platelet inhibitor drugs

Official Title
-----------------
A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents

Conditions
-----------------
Unstable Angina

Intervention / Treatment
-----------------
* Procedure: Percutaneous Coronary Intervention (PCI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features: diabetes elevated cardiac proteins in the blood (indicating acute coronary syndrome) Be willing and able to give informed consent Exclusion Criteria: uncontrolled hypertension cardiac episode (heart attack) within the previous 24 hours before randomization into the trial prior heart surgery (PCI) within the previous 2 weeks before randomizing in the trial any electorcardogram (ECG) finding that make the Holter monitor for ischemia unable to read

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous Coronary Intervention (PCI)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Improved Coronary Flow Reserve |  |  | 
| Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ischemia on continuous EKG monigoring through 24 hours after surgery. |  |  | 
| Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GP IIb/IIIa inhibitors, eptifibatide, Anti-thrombotic agents
Prevalence and Risk Factors for Common Diseases

Study Overview
=================
Brief Summary
-----------------
By using national databases in Sweden the aim of the present project is to: Investigate if the incidence of our most common diseases, such as fracture and cardiovascular disease, has changed from 1970-2017 To investigate whether the risk of death for our most common diseases have changed from 1970-2017. To investigate the risk of a new episode after suffering from our most common diseases from 1970-2017 To investigate the risk factors for our most common diseases, and whether these have changed from 1970. To investigate how severe disease or death affects the health of a close relative.

Detailed Description
-----------------
Please see above on the summary.

Official Title
-----------------
Prevalence and Risk Factors for Common Diseases in Sweden: A Nationwide Cohort Study

Conditions
-----------------
Cardiovascular Diseases, Fracture, Cancer

Intervention / Treatment
-----------------
* Other: To describe the incidence of disease and evaluate risk factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All people living in Sweden that is diagnosed with our most common diseases between 1970-2017. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: To describe the incidence of disease and evaluate risk factors|Se above|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of disease | To investigate the incidence of the most common diseases, and whether the incidence has changed. | 1970-2017 | 
| Age at diagnosis of disease | To investigate age at diagnosis of our most common diseases, and whether this has changed. | 1970-2017 | 
| Risk of death or disease in relative | Risk of death or disease in close relative to those diagnosed with severe disease or died. | 1970-2017 | 
| Risk factors for disease or death | Risk factors for our most common diseases or death | 1970-2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk for readmission | To investigate the risk of readmission for our most common diseases, and whether this risk has changed, | 1970-2017 |
ECigs, Inflammation and Oxidative Stress

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress and inflammation.

Detailed Description
-----------------
Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for biomarkers of inflammation and oxidative stress.

Official Title
-----------------
E-Cigarettes and Monocytes

Conditions
-----------------
E-cigarettes, Oxidative Stress, Inflammation

Intervention / Treatment
-----------------
* Other: e-cigarette
* Other: empty (-cigarette sham control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Cardiac disease Respiratory disease Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover with 2 week washout
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cig<br>One time exposure to e-cig | Other: e-cigarette<br>* use e-cig for 30 minutes<br>* Other names: e-cig;|
| Experimental: sham<br>One time exposure to empty e-cig | Other: empty (-cigarette sham control)<br>* use empty e-cig (sham control)<br>* Other names: empty e-cig;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular Reactive Oxygen Species, units = % fluorescence | cellular oxidative stress, including cytoplasmic and mitochondrial oxidative stress, in viable cells | within 4 hours of E-cig use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD 14+ Monocyte, units = % of total cells | CD 14+ Monocyte, % of total cells will be measured with antibodies and stable dye | within 4 hours of e-cig use |