linjc16/ctgov huggingface dataset:
The Impact of CRT on Renal Function

Study Overview
=================
Brief Summary
-----------------
The study is observational, prospective, including patients undergoing CRT-D / CRT-P implantation in the department of cardiology. In the current project, the researchers assumed that the improvement in cardiac function obtained in patients qualified according to the ESC / PTK guidelines for resynchronization therapy may improve renal function in a prospective 12-month follow-up. In addition, it is planned to take into account the possibility of temporary deterioration of kidney function, which may occur immediately after implantation of the resynchronization device due to the nephrotoxic effect of the contrast agent.

Official Title
-----------------
Assessment of the Impact of Resynchronization Therapy on Renal Function

Conditions
-----------------
Chronic Kidney Diseases, Chronic Heart Failure

Intervention / Treatment
-----------------
* Device: cardiac resynchronisation therapy (CRT) implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with heart failure who had met the criteria for CRT implantation according to European Society of Cardiology guidelines for the treatment of heart failure Exclusion Criteria: no written consent to participate in the study no indications for CR implantation current infection children pregnant women

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 |
| --- |
|Device: cardiac resynchronisation therapy (CRT) implantation|In a group of 100 patients with chronic cardio-renal syndrome, the blood and urine biomarkers are tested before CRT implantation and after 48 hours, 3 months and 1 year of follow-up.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of changes renal function: 48 hours, one month and one year after cardiac resynchronization therapy device implantation procedure. | Assessment of the number of patients with with chronic type 2 cardio-renal syndrome with improvement or deterioration renal function assessed by blood and urine biomarkers within the first 48 hours, one month and one year after CRT implantation. | 1 year for each patient in the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic cardio-renal syndrome biomarkers
Treatment of Hypertension With Two Exercise Intensities

Study Overview
=================
Brief Summary
-----------------
To determine whether exercise training could significantly replace medication as a treatment for mild essential hypertension.

Detailed Description
-----------------
BACKGROUND: Arterial hypertension affects over 50 million Americans. While drug treatment is effective, exercise would be safer, might be cheaper, and would bring added health benefits if it could replace drugs in controlling hypertension. DESIGN NARRATIVE: Randomized, controlled trial. Known hypertensives (n=162) whose diastolic blood pressures rose to between 90 and 104 within four months of discontinuing medication under careful observation had their pressures controlled with enalapril. Oxygen consumption (V02) peak was measured during cycle ergometry. Eligible subjects were randomly assigned to 18 months participation in one of three groups: 1) high intensity endurance training (35 minutes three times/week at heart rate at 70-85 percent of V02 peak), 2) moderate intensity endurance training (35 minutes three times/week at heart rate of 50-70 of V02 peak), and 3) contact control. Enalapril was forward or back titrated or discontinued to maintain a normal blood pressure. After 12 months participation, medication was withdrawn under careful supervision from all subjects still taking it. The trial tested the hypotheses that: 1) a greater number of subjects undergoing either or both of the two 18 month exercise training programs would be able to stop anti-hypertensive medication than non-exercising controls, 2) moderate and high intensity endurance training were equally effective in replacing drugs in the treatment of mild essential hypertension, and 3) subjects that were successful at withdrawing anti-hypertensive medication would have: greater improvements in V02 peak, better initial psychological status or greater improvements in psychological status, and greater compliance with the exercise training program. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: exercise


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

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Liverpool Care Pathway for the Dying at Residential Care Homes

Study Overview
=================
Brief Summary
-----------------
Liverpool Care Pathway for the dying patient (LCP) was developed to transfer the care practice from the hospice setting to the hospital setting in UK. LCP is a pathway with standardized registration method to monitor the care and its results. The primary aim is to study the effects of LCP on dying patients symptom burden and communication with close relatives and health care professionals.

Detailed Description
-----------------
All residential care homes in Skellefteå municipality are included in the study and randomized either to control or intervention group. During the baseline period the care is provided as usual. During the intervention period the LCP is used for patients for whom the dying phase is diagnosed in the intervention group. Usual care is performed for the control group. After death of a patient a close relative fill in a questionnaire.

Official Title
-----------------
Liverpool Care Pathway for the Dying at Residential Care Homes

Conditions
-----------------
End-of-life Care

Intervention / Treatment
-----------------
* Other: Liverpool care pathway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nursing homes in Skellefteå municipality, Sweden Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Liverpool care pathway<br>Liverpool care pathway for dying at nursing homes | Other: Liverpool care pathway<br>* Liverpool care pathway is started tha last day in life for elderly at nursing homes<br>* Other names: palliative care;|
| No Intervention: control<br>Usual care is performed for the control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of care | changes between the groups about values of symptom scores on the Edmonton assessment scale (ESAS) and the views of informal carers-evaluation of services (VOICES)assessed by close relative | one month to six months after the relatives death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| place of death | changes between the groups | the time of death | 
| drug consumption |  | the last three days before death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
palliative care, nursing homes, Liverpool care pathway
Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients

Study Overview
=================
Brief Summary
-----------------
Chronic inflammation that comprises the exocrine glands' function leads to xerophthalmia and xerostomia in Sjögren's syndrome. The oral consequences range widely and they are related to decreased salivary output. Hydroxychloroquine may inhibit cholinesterase activity in salivary glands via interference with antigen processing mechanism, and thus, the investigators' hypothesis was that salivary gland function may be improved if treated with hydroxychloroquine. The effects of hydroxychloroquine on the salivary flow rate, subjective and objective parameters of the patients were also assessed.

Official Title
-----------------
Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.

Conditions
-----------------
Sjögren's Syndrome, Xerostomia

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were recently diagnosed with primary SS according to American-European criteria and who were scheduled for HCQ treatment in Ege University Faculty of Medicine, Department of Rheumatology Exclusion Criteria: Sjögren patients consuming alcohol or tobacco
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sjögren<br>Pre and post treatment establishment of salivary flow rate, objective and subjective clinical oral complications' severity of the patients using hydroxychloroquine | Drug: Hydroxychloroquine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary flow rate, objective and subjective clinical oral complaints |  | 2005 Jan-2009 Jan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sjögren's Syndrome, hyposalivation, mouth dryness, complications
A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.

Official Title
-----------------
A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: DE-114 ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provided signed, written informed consent. Has a positive result from a Type I allergy test. If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. Exclusion Criteria: Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DE-114 ophthalmic solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular Itching Score by Visit | Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. | From baseline to 8-week |
Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is an unsatisfactory screening test.In this prospective clinical study,we will enroll patients with cirrhosis of various causes, all of whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including liver elastography (LSM) and spleen elastography (SSM). Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis of cirrhosis.At the same time, based on SSM and serum differential protein, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found.

Official Title
-----------------
Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis: a Prospective, Single-center Trial

Conditions
-----------------
Gastroesophageal Varices, Portal Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age ranged from 18 to 75 years. Clinical or pathological diagnosis of cirrhosis; Electronic gastroscopy is planned; To agree and sign the informed consent; Exclusion Criteria: Hepatocellular carcinoma or other malignant tumors have been or are currently diagnosed; Orthotopic liver transplantation patients; Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt; Pregnant women; Neurological or psychiatric disorders;

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high-risk esophageal varices | Incidence of high-risk esophageal varices | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding event happen | Incidence of hemorrhagic events | 1 year | 
| bleeding event happen | Incidence of hemorrhagic events | 2 years |
Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

Study Overview
=================
Brief Summary
-----------------
There is an increase in the prevalence of obstructive apnea-hypopnea syndrome (OSA) in children for which the pathophysiological explanation is unknown. The main objective is to compare pharyngeal collapsibility in asthmatic children with SHS score > 2.75 or ≤ 2.75 (OSA prediction score validated in French). Secondary objectives: Compare pharyngeal size, tracheal size, loop gain and its components (controller, plant), lung volumes and expired and nasal NO in asthmatic children with SHS score > 2.75 or ≤ 2.75. The bias due to the possible existence of an alveolar hyperventilation syndrome associated with asthma will be taken into account.

Detailed Description
-----------------
Detailed measurements and questionnaires: Measurement of pharyngeal volume by acoustic pharyngometry in sitting and lying position with calculation of pharyngeal compliance. Measurement of ventilation (15 minutes) and transcutaneous PCO2 measurement, three apnea tests at the end of the test, hyperventilation test. PFT with spirometry and static volume measurement. Multiple flow measurement of exhaled NO with calculation of bronchial flow and alveolar fraction of NO. Nasal NO measurement. Questionnaires for OSA: the Pediatric Sleep Questionnaire (PSQ) and the SCR (Sleep Clinical Record). Questionnaires for functional respiratory disorder: French hyperventilation questionnaire SHAPE and the Nijmegen score

Official Title
-----------------
Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children

Conditions
-----------------
Asthma, Obstructive Sleep Apnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed asthma established on the notion of typical respiratory functional signs and the notion of reversibility of a bronchial obstruction on previous PFT and/or asthma exacerbation diagnosed by the physician in an emergency room. Ongoing asthma treatment (including SABA on demand) Exclusion Criteria: not asthmatic children

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal collapsibility pharyngeal collapsibility pharyngeal collapsibility | Pharyngeal compliance will be measured using acoustic pharyngometry | 1 year |
Modification of the Local Abnormal Ventricular Activity Only

Study Overview
=================
Brief Summary
-----------------
Local abnormal ventricular activity (LAVA) is composed of high-frequency, mainly low voltage signals that represent near-field signals from slow-conducting tissue and thus potential VT isthmuses. The identification of LAVA potentials and their modification have usually been a complimentary component of the substrate-based modification of scar related ventricular arrhtyhmias. With better identification through technical solutions and improved algorithms, LAVA modification may be feasible for treatment in therapy refractory VT.

Detailed Description
-----------------
As of 2019 we started LAVA modification only in a subset of patients with therapy refractory ventricular tachycardia. The cohort icludes 55% patient with ischemic cardiomyopathy and 45% with dilated cardiomyopathy. 80% are ICD recipients. These patients were now retrospectively analysed in depth. The endpoint is time to relapse of ventricular tachycardia or ICD shock or death due to malignant arrhythmia. We evaluated all patients we treated accordingly from March 2019 through October 2020. No patient was excluded.

Official Title
-----------------
Substrate Based Modification in Ventricular Tachycardia: Ablation of the Local Abnormal Ventricular Activity Only

Conditions
-----------------
Ventricular Tachycardia

Intervention / Treatment
-----------------
* Procedure: Cardiac ablation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: therapy refractory ventricular arrhythmia Exclusion Criteria: none

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 |
| --- |
|Procedure: Cardiac ablation therapy|In a subset of patients with known therapy refractory arrhythmia sole LAVA modification is fashioned|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VT | occurrence/documentation of ventricular arrhythmia in participant after substrate modification during follow-up period (either Holter ECG or defibrillator interogation or ILR/ICM or electrophysiology study) | 12 months | 
| appropriate therapy delivered by defibrillator (ICD) | appropriate therapy (shock, ATP) delivered by ICD in participants during follow-up period | 12 months | 
| death | patient succumbed due to malignant ventricular arrhythmia or therapy | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death any cause | death any cause during observation period | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
local abnormal ventricular activity, substrate modification, electrophysiology, LAVA, decremental
The Role of NEWS on Intensive Care Discharges

Study Overview
=================
Brief Summary
-----------------
To determine the ability of the NEWS at tertiary intensive care unit discharges to predict the development of clinical deterioration. To determine a cut-off value for NEWS score for early readmission

Detailed Description
-----------------
The Nationaly Early Warning Score (NEWS) is a single score based on the measurement of vital signs and inspired gases by the patient. A higher NEWS indicates severity of illness and risk of adverse outcomes. The use of NEWS values to select the appropriate patients for tertiary ICU discharges has not been tested. Our aim is to test the value of NEWS on discharges tertiary ICU.

Official Title
-----------------
The Role of NEWS on Tertiary Intensive Care Discharges

Conditions
-----------------
Intensive Care

Intervention / Treatment
-----------------
* Other: readmission
* Other: discharge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years old Stay higher than 48 hours Exclusion Criteria: Under 18 years old Stay lower than 48 hours Intoxication Exitus

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 |
| --- | --- |
| discharge<br>patients discharged from icu | Other: readmission<br>* Readmission after 48 hours<br>Other: discharge<br>* Discharge<br>|
| readmission<br>patients readmitted icu in 48 hours after icu discharge | Other: readmission<br>* Readmission after 48 hours<br>Other: discharge<br>* Discharge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate | Clinical deterioration within 48 hours after ICU transfer | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NEWS