linjc16/ctgov huggingface dataset:
Antiarrythmic Drugs - Long-term Follow-up in the Modern Era

Study Overview
=================
Brief Summary
-----------------
Antiarrhythmic drugs are associated with significant side effect profiles. Amiodarone has primarily class III action and whilst it has unrivalled efficacy in management of certain arrhythmias, it has a formidable side effect profile. Complications of continued therapy include, thyroiditis, hepatitis, cholestasis, increased skin sensitivity and pulmonary fibrosis. Current prescribing guidelines recommend frequent blood tests to monitor kidney, liver and thyroid function, in addition to frequent pulmonary function tests. Sotalol is a betablocker which possesses class III action in high doses and may predispose to QT prolongation Other class I agents such as flecainide and propafenone can be associated with sudden cardiac death in certain populations, and may predispose to other arrhythmias. This study will examine the incidence of discontinuation of AAD therapy and adverse events.

Official Title
-----------------
Retrospective Record Linkage Study to Investigate the Incidence of Complications and Follow-up Associated With Anti-arrythmic Drug Therapy

Conditions
-----------------
Cardiac Dysrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one prescription for antiarrythmic drug
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Currently receiving antiarrythmic drugs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac, Dysrhythmia, Safety
Placental Transfusion Project for Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the World Health Organization have recently published recommendations related to placental transfusions in preterm infants. This project will review outcomes of preterm infants following a quality improvement implementation process in several delivery centers in Indiana. Centers involved in this project are also part of the Indiana Vermont Oxford Network (IRB#1003-84). Data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the Vermont Oxford Network collection. This project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the ACOG recommendations.

Detailed Description
-----------------
Centers involved in this project are also part of the Indiana Vermont Oxford Network. Data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the Vermont Oxford Network collection. This project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the ACOG recommendations.

Official Title
-----------------
Placental Transfusion in Preterm Infants Born at Less Than 34 Weeks of Gestation … Role of Delayed Cord Clamping and Umbilical Cord Milking

Conditions
-----------------
Intraventricular Hemorrhage, Sepsis, Necrotizing Enterocolitis

Intervention / Treatment
-----------------
* Other: <30 wks gestation or 1500 grams


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants born at participating hospital who are less than 30 weeks gestation or less than 1500 grams and/or preterm infants 30 weeks to less than 34 weeks gestation Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| <30 wks gestation or 1500 grams<br>Preterm infants born at participating hospitals | Other: <30 wks gestation or 1500 grams<br>* Outcomes of preterm infants recorded<br>|
| 30 wks to <34 wks gestation<br>Preterm infants born at participating hospitals | Other: <30 wks gestation or 1500 grams<br>* Outcomes of preterm infants recorded<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in common complications of preterm birth |  | 3 years |
Prospective Study of Sinonasal and Skull-base Tumours Management

Study Overview
=================
Brief Summary
-----------------
This observational prospective clinical study aims to describe the epidemiology, management and outcome of patients with sinonasal and skull-base pathology (tumours and diseases with malignant clinical characteristics) in a tertiary otorhinolaryngology referral centre. The main questions it aims to answer are: what is the caseload of patients with the included pathology in our centre what are the results of management of these cases what are the epidemiological characteristics of included patients what is the quality of life of included patients.

Official Title
-----------------
Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service

Conditions
-----------------
Nasal Neoplasm, Nasal Neoplasm Benign, Skull Base Neoplasms, Skull Base Osteomyelitis, Sinonasal Disorder, Sinus Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sinonasal and/or skull-base cancer sinonasal disease expanding through the skull-base the patient's written informed consent Exclusion Criteria: lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement
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 |
| --- | --- | --- |
| Absence of the disease | Absence of the disease after the treatment has been completed | twelve months after the treatment completion | 
| Overall survival | Survival after the treatment has been completed | twelve months after the treatment completion |
Predictors of Neuro-cognitive Decline and Survival in HIV-infected Subjects

Study Overview
=================
Brief Summary
-----------------
Patients will be followed every 6 months for a total of 5 visits (Month 0, 6, 12, 18 and 24). The first visit is the screening and entry visit which can occur at any time after the subject finishes SEARCH 001 study but preferably it should occur approximately 6 months after SEARCH 001 study completion. At each visit, patients will undergo the following Assessment of function including activity of daily living questionnaire History of medical illnesses, medication history Neurological examination: All patients will have a neurological evaluation and neuropsychological evaluation to characterize neurocognitive and neurological status. (It is possible that patients within the non-dementia group will meet criteria for dementia after close testing is completed). Neuropsychological assessment: Thai Depression Inventory. HIV viral load and storage of blood for proviral DNA level Final outcome assessment based on all available data. If possible, it is intended that these diagnoses will be determined through monthly VTC conference calls with UH investigators. This consensus conference will include the Thai investigators, the UH neurologist, the UH neuropsychologist and the UH principal investigators.

Conditions
-----------------
AIDS, Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have completed the SEARCH 001 study are eligible to enroll in this SEARCH 001.1 study provided that they understand and voluntarily sign the informed consent form. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected, no dementia<br>Patients with HIV-infection but no dementia | |
| HIV-infected, dementia<br>Patients with HIV-infection and dementia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, multi-regional observational,24 month study. Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

Detailed Description
-----------------
This is a multi-center, multi-regional observational,24 month study. Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

Official Title
-----------------
A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has any form of MS (confirmed by McDonald and/or Poser criteria) Patient is 18 years old or more (inclusive, at time of informed consent). Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent) Patient can be with or without treatment Patient has read, understood, signed and dated informed consent form Patient is able to fill in the questionnaire by him/herself Exclusion Criteria: CIS Patient (MS not confirmed by Mc Donald and /or Poser criteria) Patient receives or is planned to receive during the course of this study any investigational drug or experimental procedure Patient suffers from dementia in the opinion of the investigator Patient suffers of major medical or psychiatric illness in the opinion of the investigator

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 |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score |  | Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis Quality of life
Prevention of Postoperative Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to determine the safest and most effective therapeutic strategy to decrease the incidence of postoperative atrial fibrillation following cardiac surgery in an era with shorter ICU and hospital length of stay. A secondary goal is to evaluate the length of hospital stay associated with each treatment strategy.

Official Title
-----------------
A New Therapeutic Strategy to Reduce the Incidence of Postoperative Atrial Fibrillation

Conditions
-----------------
Postoperative Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > or = to 18 years sinus rhythm undergoing either coronary artery bypass graft surgery (CABG), valvular heart surgery or a combined procedure Exclusion Criteria: received a class-I or class-III antiarrhythmic agent in the past six months had second or third degree heart block had a resting heart rate of less than 50 beats per minute had a systolic blood pressure less than 100 mmHg had severe asthma or severe chronic obstructive pulmonary disease had uncontrolled heart failure had a serum aspartate aminotransferase or alanine aminotransferase concentration greater than four times the upper limit of normal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| b-blocker<br> | |
| amiodarone<br> | |
| atrial pacing<br> | |
| amiodarone plus atrial pacing<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of atrial fibrillation | The primary endpoint of this study was also the occurrence of atrial fibrillation for any length of time requiring treatment as a result of symptoms or hemodynamic compromise. | postoperative day 0-day of discharge (an average of 5 days) | 
| occurrence of atrial fibrillation | The primary endpoint of this study was the occurrence of atrial fibrillation lasting longer than five minutes | postoperative day 0-day of discharge (an average of 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay | The secondary endpoint was the length of hospital stay after surgery. | participants will be followed for the duration of hospital stay, an expected average of 5 days |
Acute Kidney Injury in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) in critically ill trauma patients has been shown to significantly increase mortality, length of stay, and costs, however detection has proven difficult as markers like elevated creatinine and decreased urine output may take days to manifest and are late indicators of AKI. The combination of two urinary biomarkers, Tissue Inhibitor of Metalloproteinase 2 (TIMP-2) and Insulin-like Growth Factor Binding Protein 7 (IGFBP-7), has been shown to increase within 12 hours following renal insult, allowing assessment of risk for developing acute kidney injury. Therefore, the investigators plan to assess if acute kidney injury in critically ill trauma patients can be determined earlier using urinary TIMP-2 and IGFBP-7 via the NephroCheck testing system. These markers have not been specifically evaluated in trauma patients at risk of AKI.

Official Title
-----------------
Predicting Acute Kidney Injury in Critically Ill Trauma Patients Using Metalloproteinase 2 (TIMP2) and Insulin-like Growth Factor Binding Protein7 (IGFBP 7)

Conditions
-----------------
Acute Renal Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: trauma patients with multiple injuries; abdominal injuries; crush injuries; those who present in shock (systolic blood pressure <90 or mean arterial pressure <65); require blood transfusions, vasopressors or mechanical ventilation Exclusion Criteria: known pregnancy; patients under 21 years of age; known moderate to severe AKI prior to enrollment and end stage renal disease. known moderate to severe AKI prior to enrollment and end stage renal disease

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Measurement of u rinary metalloproteinase 2 (TIMP-2) and Insulin-like growth factor binding protein 7 (IGFBP-7) biomarker elevation that corresponds to acute kidney injury by creatinine and urine output |  | one year |
Effect of Consumption of Dairy Product on Upper Gastric Discomfort

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the consumption of test dairy products is effective in reducing upper gastric discomfort after 2 weeks of product consumption.

Official Title
-----------------
Effect of Consumption of Dairy Product on Upper Gastric Discomfort

Conditions
-----------------
Upper Gastric Discomfort

Intervention / Treatment
-----------------
* Other: 1- Test dairy product containing specific ingredients
* Other: 2- Control dairy product without specific ingredients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 21 - 60 years old Experiencing upper gastric discomfort Exclusion Criteria: Participants with alarm symptoms (dysphagia, bleeding, involuntary weight loss clinically significant >10% of it habitual weight during the last 6 months). Participants with diagnosed severe organic esophageal medical history (endoscopic eosophagitis A, B, C or D of Los Angeles classification, peptic stenosis, Barrett oesophagus, huge hiatus hernia or para-esophageal) gastric or duodenal ulcer or high digestive haemorrhage clinical history.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 = Test product<br>Arm 1 - intervention 1 (test product) | Other: 1- Test dairy product containing specific ingredients<br> <br> |
| Placebo Comparator: 2 = Control product<br>Arm 2 - intervention 2 (control product) | Other: 2- Control dairy product without specific ingredients<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastro-oesophageal symptoms as assessed by RDQ questionnaire |  | Two timepoints are considered in the assessment of the change outcome measures: from Baseline (before product consumption) to Endpoint (i.e. final evaluation visit after 2 weeks of product consumption) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dairy product, upper gastric discomfort, adult
Stapes Footplate Thickness Measured With UHR-CT

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients.

Detailed Description
-----------------
Stapes footplate thickness will be measured under its anterior crus, its posterior crus and at its midpoint, in both the stapes axial plane and the laletral semi-circular canal planes.

Official Title
-----------------
Stapes Footplate Thickness Measured With UHR-CT

Conditions
-----------------
Otosclerosis, Otitis Media

Intervention / Treatment
-----------------
* Diagnostic Test: ultra-high resolution CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ultra high resolution CT of the temporal bone available Exclusion Criteria: previous 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| otosclerosis<br>otosclerosis patients | Diagnostic Test: ultra-high resolution CT<br>* stapes footplate thickness measurement<br>|
| chronic otitis media<br>otitis media with middle ear opacities | Diagnostic Test: ultra-high resolution CT<br>* stapes footplate thickness measurement<br>|
| controls<br>sudden ear loss, pre-implantatory imaging, vertigo, tympanic perforation | Diagnostic Test: ultra-high resolution CT<br>* stapes footplate thickness measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stapes footplate thickness in mm in the stapes axial plane | stapes footplate thickness measured with a digital caliper on our PACS system with the accuracy of a tenth of a millimetre, under the anterior crus of the stapes, under the posterior crus of the stapes, and at its midpoint, in the stapes axial plane and in the lateral semi circular canal plane, to compare both values and find out wich one is the most pertinent | october 2020-october 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interobserver variability | interobserver variability | october 2020-october 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultra high resolution, ct, stapes, footplate, otosclerosis, otitis media