linjc16/ctgov huggingface dataset:
A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)

Study Overview
=================
Brief Summary
-----------------
Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. In particular, recognition of a major determinant focused on the ECG or echocardiographic parameters including strain or genetic factor for occurrence of PICM may lead to better identification of patients at high risk. Investigators prospectively enroll a participant with documented high risk of PICM and clinically follow-up to idenify clinical impact of PICM (PICM syndrome) over a long period of time.

Detailed Description
-----------------
Investigators investigate a major determinant focused on the ECG or echocardiogram or genetic factor to predict the PICM after implantation of pacemaker. Not only QRS duration and mechanical strain but also genetic factor could be also investigated to predict the occurrence of PICM before diagnosis fo PICM

Official Title
-----------------
A Major Determinant Focused on the ECG or Echocardiogram for Pacing-induced Cardiomyopathy (PICM) and Its Clinical Outcome (PICM Syndrome) : Prospective, Multi-center, Observational Cohort Study.

Conditions
-----------------
Pacemaker Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mandatory (1 and 2) and optional (3 or 4) Willng to participate in the study and able to sign informed consent Undertaken ECG and echocardiogram including strain before and after device implantation Below preserved left ventricular dysfunction in the echocardiogram Above 15% pacing-rhythm in the device interrogation Exclusion Criteria: Less than 18 years of age Being pregnant or plan to become pregnant Advanced heart failure waiting in heart transplantation Have a life expectancy of less than 1 year

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Heart failure diagnosis and treatment | Occurrence of heart failure symptom, diagnosis and treatment | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality | Occurrence of atrial, ventricular arrhythmia, hear failure admission and all-cause mortality | 5 years |
Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)

Study Overview
=================
Brief Summary
-----------------
Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless telemetry vest in cardiac rehabilitation. Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating the NimbleHeart chest harness system.

Detailed Description
-----------------
20 subjects will be consented to participate at an early cardiac rehabilitation exercise session (typically sessions 1-6). Subjects will wear the NimbleHeart vest concurrently with existing telemetry system during exercise sessions, and thus not replace existing telemetry monitoring. Both staff and subjects will be queried for their (user) experiences during and after each session. Experiences will be documented on surveys after each session. De-identified ECG rhythm strips from the NimbleHeart monitor will be collected to assess quality of tracings. Subjects will be asked to wear the NimbleHeart vest for 2 sessions. Study participation will end after the 2nd session.

Official Title
-----------------
Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)

Conditions
-----------------
Cardiac Rehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participating in the Cardiac Rehabilitation Program. Capable of giving, and willing to sign, informed consent. Exclusion Criteria: Patients with either unstable heart disease or unstable heart failure and for whom exercise is contraindicated. Presence of Ventricular Assist Device (VAD).

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 |
| --- | --- | --- |
| Degree of difficulty in attaching the harness as compared to attaching the standard telemetry system. | How easy or difficult it is to apply the harness system as compared to existing telemetry system. Scores range from 1 to 5 scale where 1 = More difficult and 5 = Much easier | 3 to 4 months | 
| Reported occurrences of subject discomfort | Percentage of subjects with reported harness discomfort and a description of each occurrence of discomfort | 3 to 4 months | 
| Quality of ECG tracings during exercise | Degree of ECG quality to determine heart rate and detect arrhythmia during subject exercise Scores range from 1 to 3 scale where 1 = Poor and 3 = Good | 3 to 4 months |
EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan

Study Overview
=================
Brief Summary
-----------------
The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL). The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline and at the 6 and 12 months after start of EYLEA treatment.

Official Title
-----------------
Special Drug Use Investigation of EYLEA for Quality of Life

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been determined to start EYLEA treatment Patients who are registered to Special drug use investigation of EYLEA for AMD(Trial Number 15858) Patients who have agreed with the patient informed consent Exclusion Criteria: Patients who have already received EYLEA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Patients treated with EYLEA under practical manner for AMD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA |  | From baseline to 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA |  | From baseline to 6 and 12 months | 
| Changes in mean NEI-VFQ-25 overall scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc |  | From baseline to 6 and 12 months | 
| Changes in mean NEI-VFQ-25 subscale scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc |  | From baseline to 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EYLEA, Age-Related Macular Degeneration, QOL
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.

Detailed Description
-----------------
Asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is noticed in children. iGCS are the basic group of drugs in asthma, because of inflammatory character of disease. All iGCS are absorbed to the systemic circulation (small amounts) despite of local exposition in lungs and possess systemic effects. The purpose of trial is to check if iGCS have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.

Official Title
-----------------
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: budesonide
* Drug: D3 vitamin
* Drug: montelukast sodium
* Drug: salbutamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic only to house dust mites Never treated chronically (longer than at least 3 months) with anti-asthmatic drugs Newly-diagnosed or non-treated asthma Must be able to inhale drugs Exclusion Criteria: Other allergic diseases requiring treatment with glucocorticosteroids Other chronic diseases Asthma exacerbation Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>budesonide | Drug: budesonide<br>* budesonide<br>|
| Active Comparator: 2<br>D3 vitamin | Drug: D3 vitamin<br>* D3 vitamin<br>|
| Active Comparator: 3<br>montelukast sodium | Drug: montelukast sodium<br>* montelukast sodium<br>|
| Active Comparator: 4<br>salbutamol | Drug: salbutamol<br>* salbutamol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of bone metabolism (from serum and urine) |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms score (based on PAQLQ), spirometry |  | baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, children, inhaled glucocorticosteroids, bone metabolism
Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height

Study Overview
=================
Brief Summary
-----------------
This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age

Official Title
-----------------
Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium

Conditions
-----------------
Growth Disorder

Intervention / Treatment
-----------------
* Drug: Treatment with Genotropin in different dosages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the 90-080 study Exclusion Criteria: Any severe, acute or chronic disease Any other identifiable reason for short stature
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Treatment with Genotropin in different dosages|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final height, compared to the expected familial target height |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry |  |  |
ATP Level and Cough Sensitivity to ATP in Subjects With Refractory Chronic Cough

Study Overview
=================
Brief Summary
-----------------
This is a prospective case - control study to investigate ATP level in induced sputum and cough sensitivity to ATP in subjects with refractory chronic cough. 60 refractory chronic cough and 30 matched healthy controls were recruited. Medical history records, cough severity assessment, induced sputum for ATP measurement, ATP evoked cough and capsaicin evoked cough were completed. The difference of sputum ATP level between patients and control and the correlation between sputum ATP level and cough sensitivity to ATP were analyzed.

Official Title
-----------------
ATP Level in Induced Sputum and Cough Sensitivity to ATP in Subjects With Refractory Chronic Cough

Conditions
-----------------
Refractory Chronic Cough

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic cough as sole symptom lasting ≥6 months; No potential causes were identified after full investigations or cough persisted after treatment trials directed to potential causes; Cough Visual Analogue Score ≥30mm. Exclusion Criteria: Current or recent smokers (<6 months abstinence) , those with >20 pack-year smoking history; With a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <60%; With a history of upper respiratory tract infection or significant change in pulmonary status within 4 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Refractory chronic cough<br>Subjects would be performed induced sputum test, ATP and capsaicin cough provocation test. | |
| Healthy control<br>Subjects would be performed induced sputum test, ATP and capsaicin cough provocation test. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ATP level in sputum | ATP level in induced sputum in subjects with refractory chronic cough and healthy control | 2022/04/01-2023/04/02 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ATP cough sensitivity | cough sensitivity for ATP in subjects with refractory chronic cough and healthy control | 2022/04/01-2023/04/02 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractory chronic cough, unexplained chronic cough
Institutional Registry of Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The Institutional Registry of Liver Transplantation is a system for data collection related to patients with liver disease who are possible candidates for liver transplantion. This tool was designed by a multidisciplinary team that includes hepatologists, surgeons, informatics and biostatisticians. It intends to collect the information from the clinical evaluation, physical examination, complementary diagnostic methods and laboratory data. The information is captured sistematically, following structured, standardized and monitored processess to ensure the quality of the data obtained. The aim is to use the available technology to generate a complete database that can be used to answer research questions.

Official Title
-----------------
Institutional Registry of Liver Transplantation

Conditions
-----------------
Liver Transplantation, Clinical Registry

Intervention / Treatment
-----------------
* Procedure: orthotopic liver transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with indication for liver transplantation Patients who are followed by the Liver Transplantation Unit of Hospital El Cruce Exclusion Criteria: Patients who deny to participate after the informed consent process.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: orthotopic liver transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to mortality | All patients are followed from the date of the inclusion to the registry, by periodic controls by the hepatologists and through telephones calls by the coordinator nurse, both before and after the transplantation. Every patient who dies during the 5 years of follow up will count as an event. Patients who are lost to follow up will be censored, in this case we will use the date of the last control or telephone call where he or she was alive. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to retransplantation | We will considerate retransplantation as a competitive risk for death, calculating the time since the date of the transplant until the date of retransplantantion or not during the 5 years of follow up. | 5 years |
A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.

Official Title
-----------------
A Single-dose, Double-Blind, Placebo-Controlled, Parallel Group Safety, Tolerability and Pharmacodynamic Study of Subcutaneous REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

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

Intervention / Treatment
-----------------
* Drug: REGN88
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years of age Subjects must weigh >50 and <100 kg Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III Exclusion Criteria: A history of Listeriosis or active tuberculosis (TB) Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit History of prior articular or prosthetic joint infection History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>Active dose | Drug: REGN88<br>* Single dose of REGN88 and 43 day follow up.<br>|
| Experimental: Dose 2<br>Active dose | Drug: REGN88<br>* Single dose of REGN88 and 43 day follow up.<br>|
| Experimental: Dose 3<br>Active 3 | Drug: REGN88<br>* Single dose of REGN88 and 43 day follow up.<br>|
| Placebo Comparator: Dose 4<br>Placebo dose | Other: Placebo<br>* Placebo to match REGN88 administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hs-C reactive protein (hs-CRP) |  | 43 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Assessment of Pain and Subject's Global Assessment of Disease activity |  | 43 Days |
Chloroprocaine for Continuous Epidural Analgesia in Neonates and Infants

Study Overview
=================
Brief Summary
-----------------
This a study to retrospectively review our experience with the use of chloroprocaine for postoperative epidural infusions in neonates and infants. Pain scores and the need for intravenous analgesic agents will be recorded from the records to demonstrate the efficacy of the technique.

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Chloroprocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates and infants who have received chloroprocaine for epidural anesthesia. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- |
| Chloroprocaine<br>Neonates and infants who have received chloroprocaine for epidural anesthesia. | Drug: Chloroprocaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | Every 6 hours for 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain medicine consumption |  | Every 6 hours for 72 hours |