linjc16/ctgov huggingface dataset:
Munich Study for Beer Related ECG Change Workup

Study Overview
=================
Brief Summary
-----------------
The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias.

Detailed Description
-----------------
Both regular and acute excessive alcohol intake may deteriorate health. Possible sequelae include cardiac arrhythmias. For acute alcohol intake in particular it is insufficiently understood to what extent cardiac arrhythmias and other ECG changes occur, if the occurence depends on alcohol levels, and if there is a cut off value for occurence. Munich BREW aims to help clarifying these questions. Participants of Munich BREW are identified and invited as visitors of the Munich Octoberfest and similar events. Participants need to be 18 years of age and over and need to declare theri will to participate. Following enrollment, participants will answer astudy questionnaire and will subsequently undergo recording of a 30 sec smart phone based ECG. Ultimately, the alcohol level is determined using a breath alcohol analyzer.

Official Title
-----------------
Munich Study for Beer Related ECG Change Workup

Conditions
-----------------
Arrhythmias, Cardiac

Intervention / Treatment
-----------------
* Other: acute alcohol intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older informed conset signature Exclusion Criteria: Incapability of contracting according to German law (BGB §105, paragraph 2) contraindications against ECG recording or alcohol breath test denial of informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute alcohol intake<br>Visitors of the Munich Octoberfest or similar events who fulfil in- and exclusion criteria | Other: acute alcohol intake<br>* Smart phone based ECG recording<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of cardiac arrhythmias |  | 30 sec | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol related changes in ECG intervals |  | 30 sec | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia, Alcohol, ECG
ARDS Caused by COVID-19

Study Overview
=================
Brief Summary
-----------------
Patients with the acute respiratory distress syndrome (ARDS) have markedly varied clinical presentations. Main characteristics of mechanically ventilated ARDS caused by COVID-19, and adherence to lung-protective ventilation strategies are not well known.

Detailed Description
-----------------
This is a multicenter, prospective, observational study in consecutive, mechanically ventilated patients with ARDS caused by COVID-19 (as defined by the Berlin criteria and confirmed COVID-19 infection in a respiratory tract sample), admitted into a network of 27 Spanish and Andorran intensive care units (ICUs). Clinical features, ventilatory management, and clinical outcomes will be examined

Official Title
-----------------
Main Features and Ventilatory Management of Patients With ARDS Caused by COVID-19

Conditions
-----------------
Acute Respiratory Failure With Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 years or older intubated and mechanically ventilated confirmed COVID-19 infection in a respiratory tract sample acute onset of ARDS, as defined by the Berlin criteria Exclusion Criteria: patients with non-confirmed SARS-CoV-2 infection according to WHO guidance patients with no information on respiratory parameters non- intubated patients

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 |
| --- | --- | --- |
| Discontinuation from mechanical ventilation |  | 28 days |
CardioVascular Disease Progression and Prognosis in COVID-19

Study Overview
=================
Brief Summary
-----------------
The CVP-COVID19 registry is both a retrospective and prospective study design in order to identify predictors of cardiovascular disease progression and mortality for COVID-19. The registry enrolls consecutive patients with positive microbiological tests for SARS-CoV-2 admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms. The study does not test any new diagnostic or therapeutic approach. Patients are treated according to good clinical practice. Patients characteristics, including medical history (with particular attention to cardiovascular and pneumological risk factors), features of physical examination, results laboratory and radiological tests and treatments (pre- and in-hospital) are related with patient outcome. Logistic analysis (univariate, multivariate and propensity) are performed in order to identify factors associated with disease progression. Primary endpoint: mortality.

Detailed Description
-----------------
Members of the Steering Committee: Olivia Manfrini (Università di Bologna, Italy) Raffaele Bugiardini (Università di Bologna, Italy) Stefano Nava (Università di Bologna, Italy) Elisabetta Poluzzi (Università di Bologna, Italy) Maria Carla Re (Università di Bologna, Italy) Caterina Vocale (Policlinico Sant'Orsola) Study Coordinator: Edina Cenko (Università di Bologna, Italy)

Official Title
-----------------
Cardiovascular Clinical Features and Cardiovascular Therapies in the Development, Progression and Outcome of Patients With SARS-Cov-2 Related Pneumonia

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalization for COVID-19 Exclusion Criteria: age <18 years

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 |
| --- | --- | --- |
| Mortality | All causes mortality | 30 days | 
| Mortality | All causes mortality | 6 months | 
| Mortality | All causes mortality | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Diseases, Pneumonia, Viral, SARS-CoV-2, Covid-12, ACE receptor
Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations

Study Overview
=================
Brief Summary
-----------------
Basilea is providing expanded access to derazantinib for patients with locally advanced, inoperable or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR genomic alterations on a patient by patient basis while clinical development of derazantinib is ongoing.

Official Title
-----------------
Expanded Access Use of Derazantinib for Patients With Locally Advanced, Inoperable or Metastatic iCCA Harbouring FGFR Genomic Alterations

Conditions
-----------------
Intrahepatic Cholangiocarcinoma

Intervention / Treatment
-----------------
* Drug: derazantinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all other treatment options have been exhausted patient is ineligible for any ongoing trials or is geographically inaccessible to trials including an ongoing trial with derazantinib there is reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product patient is willing and able to provide written informed consent if applicable, regulatory approval by the appropriate jurisdiction is obtained

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 |
| --- |
|Drug: derazantinib|derazantinib will be administered orally|

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
-----------------
iCCA, intrahepatic cholangiocarcinoma, Metastatic cholangiocarcinoma, FGFR genomic alteration, biliary cancer, bile duct cancer, liver cancer
Metformin Treatment, Renal Function and Lactic Acidosis

Study Overview
=================
Brief Summary
-----------------
From a central registry at the National Board of Health and Welfare in Sweden collect all patients in the city of Malmö prescribed metformin during two years. Glomerular filtration rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU admission were also sought. The study hypothesis is that metformin is prescribed to patients with lower GFR than anticipated with very few cases of lactic acidosis registered.

Official Title
-----------------
Metformin Treatment, Renal Function and Lactic Acidosis. A Population Based

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the city of Malmö prescribed metformin at least three times during two years Available at least one p-creatinine during the two years Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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
-----------------
metformin, type 2 diabetes, e-GFR, creatinine, lactic acidosis
Study of Variables Related to the Discontinuation of Mechanical Ventilation in Patients With Head Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate physiological variables to the decision about the appropriate time to discontinuation of mechanical ventilation in patients with traumatic brain injury. It is expected that these variables are effective in predicting the outcome of weaning from mechanical ventilation.

Detailed Description
-----------------
The aim of this study is to evaluate the effectiveness of integrated pressure index of airway occlusion x index breathing fast and shallow (p 0.1 x f/VT) in predicting success and failure of weaning from mechanical ventilation in patients with traumatic brain injury.

Official Title
-----------------
Evaluation of Integrated Predictive Index of Weaning From Mechanical Ventilation in Patients With Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury, Weaning Failure, Mechanical Ventilation Complication

Intervention / Treatment
-----------------
* Other: Predictive indexes of weaning from mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic Brain Injury (TBI) Patients using artificial airway (intubation and / or tracheostomy) Recovery from the acute phase of the disease underlying Both sexes Ventilation mode pressure support (PSV), pressure support (PS) required to ensure a tidal volume (VT) = 6 to 8 ml / kg Age over 18 years Hemoglobin > 7 g/dL Duration of mechanical ventilation longer than 24 hours Body temperature < 38 degrees pH ≥ 7.30 PaO2 ≥ 60 mmHg with FiO2 ≤ 0.4 and PEEP ≤ 8 cmH2O Glasgow Coma Scale ≥ 8 or tracheostomized Sedative agents minimum dosages to to maintain values of 2 or 3 on the Ramsay Scale Exclusion Criteria: Admitted to the ICU with artificial airways held in other institutions Surgery scheduled for the next 72 hours Withdrawal of consent from parents at any stage of the research

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

| Intervention/Treatment |
| --- |
|Other: Predictive indexes of weaning from mechanical ventilation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result weaning mechanical ventilation in patients with traumatic brain injury,analyzing success and failure of weaning by 0.1 p and f / VT. |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keywords provided by Atlantic Health System:, Rapid Shallow Breathing Index, Mechanical Ventilation, Additional relevant MeSH terms:, Respiration Disorders, Traumatic Brain Injury, Weaning Failure, Mechanical ventilation complication
Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine bleeding. The patients were asked urogenital distress inventory (UDI) (which includes; irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact questionnaire (IIQ) (which includes; physical activity, travel, social/relationships, emotional health)questionnaires in the day of application LNR-IUD and six months later this procedure. Statistical analyse will be performed to evaluate the changes in this time period.

Official Title
-----------------
Genitourinary Symptoms in Women Using Levonorgestrel Releasing Intrauterine Systems

Conditions
-----------------
Lower Urinary Tract Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women using levonorgestrel releasing intrauterine device for the treatment of menorrhagia or adenomyosis Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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 |
| --- | --- | --- |
| Urinary frequency | We think that the urinary frequency will be lesser after 6 months of the therapy. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| social activity | We think that social activity will be better after reducing urinary symptoms | 6 months |
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin

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

Intervention / Treatment
-----------------
* Drug: DPP-IV Inhibitor
* Drug: Metformin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients 18-75 years of age; type 2 diabetes; stable metformin therapy for >=3 months before screening. Exclusion Criteria: women who are pregnant, breast-feeding, or not using an adequate contraceptive method; type 1 diabetes; any anti-hyperglycemic medication other than metformin in the last 3 months.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DPP-IV Inhibitor<br>* Escalating doses po bid<br>Drug: Metformin<br>* As prescribed<br>|
| Experimental: 2<br> | Drug: DPP-IV Inhibitor<br>* Escalating doses po bid<br>Drug: Metformin<br>* As prescribed<br>|
| Experimental: 3<br> | Drug: DPP-IV Inhibitor<br>* Escalating doses po bid<br>Drug: Metformin<br>* As prescribed<br>|
| Placebo Comparator: 4<br> | Drug: Metformin<br>* As prescribed<br>Drug: Placebo<br>* po bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in HbAlc\n |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n |  | Week 16 | 
| AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n |  | Throughout study |
Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

Study Overview
=================
Brief Summary
-----------------
To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C

Official Title
-----------------
A Randomized, Double-blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin.

Conditions
-----------------
Dyslipidemia/Glucose Metabolism Disorder

Intervention / Treatment
-----------------
* Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patient with Type 2 Diabetes treated with stable dose of metformin and with dyslipidemia not appropriately controlled with a statin treatment. Exclusion Criteria Type 1 diabetes.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: fenofibrate (F) + metformin (M) hydrochloride fixed combination<br>* F80mg/M500mg - per os - twice a day during 24 weeks / or / F80mg/M850mg - per os - twice a day during 24 weeks /or / F54mg/M850mg - per os - three times a day during 24 weeks<br>|
| Active Comparator: 2<br> | Drug: Metformin<br>* 500mg - per os - twice a day during 24 weeks /or / 850mg - per os - twice a day during 24 weeks /or / 850mg - per os - three times a day during 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TG / HDL-C ratio |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid and glycemic parameters |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Periodontitis and Upper gi Post-operative Complications

Study Overview
=================
Brief Summary
-----------------
Periodontitis is a infection of mouth gingival mucosa and connecting tissue. It has been shown in previous studies to have a effect on the risk of heart diseases getting worse and elevate risk in heart surgery. The investigators are studying periodontitis and how it affects upper gastrointestinal tract patients complication rates and the quality of complications.

Detailed Description
-----------------
Before patricipating patients go to preop, the investigators have them take a mouth rinsing quick-test, periosafe(c), that tells specifically about periodontitis. Participants go to surgery (upper gi) and have a normal operation following our clinics standards and normal follow up. After the investigators analyze the patient data concerning possible complications and do they have relations between the positive periodontitis results. Participants are also given advice about seeing a dentist if positive results are seen, but the operating surgeons do not get to know the mouth rinsing test results.

Official Title
-----------------
Meaning of Periodontitis in Post-operative Complications After Upper Gastrointestinal Tract Surgery

Conditions
-----------------
Periodontitis, Surgery--Complications

Intervention / Treatment
-----------------
* Diagnostic Test: periosafe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need for a upper gi surgery Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All the patients that have upper-gi surgery in our time frame are asked to join in the study
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: periosafe|mouth rinsing quick-test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| meaning of periodontitis in post operative complications | Periodontitis is being tested by Periosafe (c) quick-test. Participants with positive results on the test have periodontitis. Participants patient data is being analyzed after surgery and is compared to periodontitis results. The correlation between periodontitis and surgical complications is subject to analysis. | 1 month after surgery |