linjc16/ctgov huggingface dataset:
Turkish Validation and Reliability of LURN SI-29 Questionnaire in Patients With Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
Lower urinary tract symptoms is quite frequent in men and women. To better understand the the symptoms that characterize lower urinary tract, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN). In this study we aim to validate the LURN-29 score to Turkish language

Official Title
-----------------
Turkish Validity and Reliability of LURN SI-29 Questionnaire Form in Patients With Lower Urinary Tract Symptoms

Conditions
-----------------
Lower Urinary Tract Symptoms, Urinary Incontinence

Intervention / Treatment
-----------------
* Other: Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)
* Other: IPSS
* Other: UDI-6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lower urinary tract symptoms, Over 18 years old,Patient with the cognitive ability to read Exclusion Criteria: Patients above 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Lower urinary tract sypmtoms<br>Patients with Lower urinary tract sypmtoms over 18 years old will be included to this study | Other: Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)<br>* LURN SI-29<br>Other: IPSS<br>* International Prostate Symptom Score<br>Other: UDI-6<br>* Urogenital Distress Inventory<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LURN SI-29 Questionnaire | The subscale and total scores for the LURN SI-29 are normalized to a scale from 0 - 100 | 3 months | 
| International Prostate Symptom Score-IPSS | The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | 3 months | 
| UROGENITAL DISTRESS INVENTORY- 6 | UDI-6 a six item symptom inventory, specific to symptoms associated with lower urinary tract dysfunction,and combines information on irritative, stress and obstructive/discomfort symptoms | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower urinary tract symptoms, Patient reported outcomes, Questionnaire
Genetic Epidemiology of Blood Pressure Intervention

Study Overview
=================
Brief Summary
-----------------
To localize and identify new genes related to variation in blood pressure (BP) responses to a low dietary sodium intake, a high dietary sodium intake, oral potassium supplementation, and the cold pressor test.

Detailed Description
-----------------
BACKGROUND: Systemic hypertension is a complex disease determined by both genetic and environmental factors and is of significant public health interest. In addition, identifying genes that interact significantly with dietary sodium and potassium intake, or even the cold pressure test may enable clinicians to target life style modification for prevention and treatment of hypertension. The study is conducted in response to a Request for Applications issued in October, 2001 on the Interaction of Genes and the Environment in Shaping Risk Factors for Heart, Lung, Blood, and Sleep Disorders. DESIGN NARRATIVE: The study uses a family intervention study design. The investigators will recruit 750 sibships (n=1750 siblings) and their parents (n=1250) from 500 families, each family ascertained through a proband who has untreated high normal BP or stage-1 hypertension (systolic BP 130-160 mm Hg and diastolic BP 85-100 mm Hg) from rural China. They will collect baseline information on medical history, lifestyle risk factors, anthropometric measures, BP, and blood measures (renin activity, ACE, angiotensin II, natriuretic peptide, glucose, insulin, and lipids) in all participants, and dietary nutrient intake (three 24-hour recalls) and urinary sodium and potassium excretion (three 24-hour) in the siblings. They will conduct the following interventions in the siblings: a cold pressor test at baseline (day 2 or 3), a 1-week low sodium-feeding study (40 mmol sodium/day on days 4-10), a 1-week high sodium-feeding study (280 mmol sodium/day on days 11-17), and a 1-week oral potassium supplementation (90 mmol potassium/day on days 18-24). They will measure BP and 24-hour urinary sodium and potassium excretion during the last 3 days of each intervention period. They will also perform genotyping for genomewide linkage scans and for candidate genes in all siblings and their parents. BP responses to the interventions will be analyzed primarily as quantitative traits. The primary analyses include linkage analysis, transmission/disequilibrium test, and association analysis between genetic markers and BP responses to the interventions.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias

Study Overview
=================
Brief Summary
-----------------
People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia are routinely offered a defibrillator (ICD). An ICD is an implanted device which can recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF, can only be treated with a shock. Patients find shocks painful and this study is intended to find out whether it is possible to pace the heart at very high rates during VF. It is hoped that if this is possible, further research could lead to effective treatment of VF with pacing rather than shocks, and therefore better outcomes for patients.

Official Title
-----------------
High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias

Conditions
-----------------
Arrhythmias

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronisation Defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is older than 18 years of age; Any patient with a Medtronic cardiac implantable defibrillator undergoing defibrillation testing; No contra indication to defibrillation testing Patient is able to give informed consent. Exclusion Criteria: Patient is younger than 18 years; Patient is not able to give informed consent or is unwilling to participate in the study; Patient has a contraindication to defibrillation testing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac Resynchronisation Defibrillator|Defibrillation testing of cardiac defibrilator|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid pacing of the heart | The primary outcome measure is to determine whether it is possible to obtain ventricular capture of the heart by repetitive pacing at very high rates during ventricular fibrillation. | 10 seconds |
Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film

Study Overview
=================
Brief Summary
-----------------
This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. this record will modify the first formulation by addition certain concentration of steroid.

Official Title
-----------------
Steroid Loaded Intranasal Films as a Local Treatment of Anosmia

Conditions
-----------------
Smell Loss

Intervention / Treatment
-----------------
* Drug: Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients' adults aged from 18 years to 50 will included in the study. A confirmed case (positive PCR), recovered/discharged (2 negative PCR), suffering from sudden recent anosmia or hyposmia with or without loss of taste. Exclusion Criteria: Patients with chronic sinusitis. Patients with acute allergic rhinitis. Patients' nasal polyposis Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell. Patient poly morbidities or poly pharmacy. Elder, pregnant, or nursing woman. Patients with chronic diseases. Autoimmune diseases. Patient suffering end organ problems.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br> | Drug: Prednisolone<br>* intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone<br>|
| Experimental: steroid based intranasal film<br> | Drug: Prednisolone<br>* intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smell restoring | Discrmination test; to recogonize the odd odor three times trial | three week | 
| Smell restoring | Sniffs test; to recogonize the first concentration he could identify | three week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammation | to measure the extent of inflammation the reddness and size | three weeks |
COVID-19 Infection in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Dialysis patients have a higher risk of infectious complications including complications from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19. There have been several reports describing the effect of CO¬VID-19 in the dialysis population.

Detailed Description
-----------------
A report of hospitalized COVID-19 patients from Wuhan, China, showed that hemodialysis patients had worse outcomes compared to controls without kidney failure. In addition, the hemodialysis COVID-19 patients developed serious complications such as shock, acute respiratory distress syndrome (ARDS), arrhythmias, and acute cardiac injury at a higher rate. In a population of hospitalized dialysis patients in New York City, there was a 31% mortality rate and 75% of those who required mechanical ventilation died. These complications are due to some of their underlying comorbidities and difficulties of keeping adequate social distancing as recommended by CDC guidelines. We aim to identify all hemodialysis patients who will be admitted from October 1, 2021 to Septemper 30, 2022. Patients who tested positive for COVID-19 by a polymerase chain reaction (PCR) or highly suspected (CORAD 4-5) according to radiological finding, will be selected and followed until discharge from hospital to determine who will develop complications and who will need ventilatory support. Also, the rate of death will be monitored. Therefore, the current study is aiming to better understand the hemodialysis patients' characteristics profile that makes them susceptible for complications and death.

Official Title
-----------------
Incidence of COVID-19 Infection in Hemodialysis Patients and Predictors of Disease Complications and Mortality in Assiut University Hospital Hemodialysis Unit: A Cross-Sectional Study

Conditions
-----------------
COVID-19 Infection in Hemodialysis Patients

Intervention / Treatment
-----------------
* Radiation: MSCT chest
* Diagnostic Test: PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All hemodialysis patients who defined as patient receiving maintenance dialysis prior to admission and diagnosed with COVID-19 infection either highly suspicious radiological findings (CORAD 4-5) or proved by PCR for COVID-19. Exclusion Criteria: ALL Patients diagnosed COVID-19 other than hemodialysis patients. Hemodialysis patients with chest infection other than COVID-19.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: MSCT chest|CORAD 4-5 MSCT chest|
|Diagnostic Test: PCR|PCR positive for COVID-19|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 infection in hemodialysis patients. | radiological and laboratory findings on MSCT chest & PCR respectively. | 1 year |
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.

Detailed Description
-----------------
The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.

Official Title
-----------------
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: BG00012
* Drug: BG00012
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be taking methotrexate inadequate response to at least one conventional DMARD swollen and tender joint count Exclusion Criteria: previous treatment with TNF or any other biologic or prosorba column Other criteria also apply.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>BG00012 480 mg/day | Drug: BG00012<br>* oral<br>|
| Active Comparator: 2<br>BG00012 720 mg/day | Drug: BG00012<br>* Oral<br>|
| Placebo Comparator: 3<br> | Drug: placebo<br>* oral placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of BG00012 with methotrexate in this population. |  | 12 weeks |
Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05

Study Overview
=================
Brief Summary
-----------------
This study will evaluate longitudinal change of tau deposition as measured by flortaucipir F 18 uptake over time.

Official Title
-----------------
An Open Label, Multicenter Study Evaluating the Imaging Characteristics of a Follow up 18F-AV-1451 Scan in Subjects That Participated in the Confirmatory Cohort of 18F-AV-1451-A05

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Flortaucipir F18
* Procedure: PET Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmatory cohort subjects who completed the 18F-AV-1451-A05 (NCT02016560) study Exclusion Criteria: Current clinically significant cardiovascular disease, ECG abnormalities, risk factors for Torsades de Pointes (TdP), or are taking drugs known to cause QT prolongation Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session Have received or participated in a trial with investigational medications in the past 30 days

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follow-up Flortaucipir PET Scan<br> | Drug: Flortaucipir F18<br>* 370 megabecquerel (MBq) IV single-dose<br>* Other names: 18F-AV-1451;Procedure: PET Scan<br>* positron emission tomography (PET) scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tau Deposition Over Time by Diagnostic Group and Amyloid Status | Change in flortaucipir standardized uptake value ratio (SUVr) over 18 months. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. A positive change in SUVr represents an increase in tau deposition in the brain. Change = 18 month SUVr - baseline SUVr obtained in Study A05. | 18 months |
Bariatric Surgeries in Elderly

Study Overview
=================
Brief Summary
-----------------
an examination of the different aspects of bariatric surgery in elderly in comparison with non-elderly patients.

Detailed Description
-----------------
the study examines the success rate, complications, revisions, days of hospitalization and co-morbidities in elderly and in non-elderly patients that underwent bariatric surgery in our medical center

Official Title
-----------------
Bariatric Surgeries in Elderly

Conditions
-----------------
Bariatric Surgery

Intervention / Treatment
-----------------
* Other: clinical measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bariatric surgery Exclusion Criteria: below 18 years old

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| elderly<br>patients underwent bariatric surgery and are above 65 years old | Other: clinical measurements<br>* follow up on the number of complications, revisions, hospitalization and co-morbidities<br>|
| non-elderly<br>patients underwent bariatric surgery and are below 65 years old | Other: clinical measurements<br>* follow up on the number of complications, revisions, hospitalization and co-morbidities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications. | data collection and analysis will be ended in six months. data will be collected from the medical records. | six months | 
| Number of revisions | data collection and analysis will be ended in six months. data will be collected from the medical records. | six months | 
| Number of days of hospitalization | data collection and analysis will be ended in six months. data will be collected from the medical records. | six months | 
| Incidence of co-morbidities | data collection and analysis will be ended in six months. data will be collected from the medical records. | six months |
Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Study Overview
=================
Brief Summary
-----------------
Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Drug: Antihistamine
* Drug: Corticosteroid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had two documented prior episodes of acute otitis media. Have no current middle ear effusion (fluid). Exclusion Criteria: Have chronic otitis media. Have acute otitis media in addition to chronic otitis media.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Antihistamine|nan|
|Drug: Corticosteroid|nan|

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
-----------------
Antibiotics, Adrenal Cortex Hormones, Histamine H1 Antagonists, Infant, Otitis Media