linjc16/ctgov huggingface dataset:
Maturational Changes in Cardiac Structures -- Blood Pressure Relationship -- SCOR in Hypertension

Study Overview
=================
Brief Summary
-----------------
To examine a school-based population of children for maturational changes in blood pressure and cardiac structures.

Detailed Description
-----------------
BACKGROUND: Although excessive left ventricular mass has been viewed as an adaptation to increased blood pressure, it can precede the rise in blood pressure in hypertensive models. Excessive growth of the heart may reflect additional factors contributing to eventual level of blood pressure. In children, rapid heart growth may be predictive of subsequent high childhood blood pressure level and greater incidence of cardiovascular disease in adult relatives. These studies had the potential of defining maturational changes in known risk factors which might help predict future hypertensive disease. The study was a subproject within a Specialized Center of Research (SCOR) in Hypertension. The Request for Applications for the SCOR was released in October, 1988. DESIGN NARRATIVE: A total of 124 prepubertal males and females were followed longitudinally for five years. Yearly examinations defined the stages of sexual maturation. On four occasions each year, subjects were studied for resting and ambulatory blood pressure, echocardiography, anthropometry and activity assessment. Once yearly, each subject had blood drawn for hormone analyses and whole blood viscosity estimate. From these data, growth velocities of the heart and rate of change of blood pressure were determined. These parameters were analyzed to determine if rapid growth of the heart preceded or followed the rise in blood pressure observed during puberty and body size and composition, sexual maturation and hormone changes, and sympathetic activity. The study was a subproject within a SCOR in Hypertension. Approximately 7 percent of total dollars were awarded for this subproject. 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
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

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

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

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

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 |
| --- | --- | --- |
Intensive Monitoring Scheme of Lidocaine Cataplasms

Study Overview
=================
Brief Summary
-----------------
In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of Lidocaine Cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).

Official Title
-----------------
Intensive Monitoring Scheme of Lidocaine Cataplasms

Conditions
-----------------
Adverse Reaction to Drug

Intervention / Treatment
-----------------
* Drug: Lidocaine Cataplasms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients receiving Lidocaine Cataplasms from January 1, 2021 to April 1, 2022. Exclusion Criteria: Unable to obtain complete medication information.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients using Lidocaine Cataplasms<br> | Drug: Lidocaine Cataplasms<br>* The main ingredient of this product is lidocaine, the cream surface is white or almost white, the cream is evenly spread on the back, and the cream surface is covered with film.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Past medical history and other diseases that the researcher thinks have clinical significance. Collect the frequency, type, years, etc. of drinking and/or smoking, as well as the family history of diseases. Including white blood cell, red blood cell, hemoglobin, platelet count, etc. Including white blood cells, red blood cells, urine protein, urine sugar, etc. Including ALT, AST, ALP, TBil, GGT, BUN, Cr, etc. The researcher issued a prescription of lidocaine gel plaster according to the drug instructions, and recorded the indications, medication time, dose, frequency, drug batch number, etc. It includes all kinds of reactions unrelated to the treatment purpose during the study period, including symptoms, signs, laboratory abnormalities with clinical significance or special examinations.administration or discharge. | January 1, 2021 - April 1, 2022 |
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
In this randomised controlled cross-over study we will investigate whether intrathoracic pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature supraventricular and ventricular contractions as well as atrial fibrillation in patients with paroxysmal atrial fibrillation.

Official Title
-----------------
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

Conditions
-----------------
Patients With Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Mueller manoeuvre
* Other: Inspiratory threshold
* Other: Expiratory apnoea
* Other: Steady state normal breathing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age 18-75 years History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm Informed consent Exclusion criteria: Mental or physical disability precluding informed consent or compliance with the protocol Amiodarone or Dronedarone medication Previous radiofrequency ablation for atrial fibrillation Severe structural heart disease

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mueller manoeuvre<br>Mueller manoeuvre lasting for 20 seconds | Other: Mueller manoeuvre<br> <br> |
| Active Comparator: Inspiratory threshold<br>One continuous inspiration through an inspiratory threshold load for 20 seconds | Other: Inspiratory threshold<br> <br> |
| Active Comparator: Expiratory apnoea<br>Expiratory apnoea (without respiratory effort) lasting for 20 seconds | Other: Expiratory apnoea<br> <br> |
| Sham Comparator: Steady state normal breathing<br>Steady state normal breathing for 20 seconds | Other: Steady state normal breathing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with premature myocardial contractions and/or atrial fibrillation |  | 20 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG-derived myocardial de- and repolarization times |  | 20 seconds |
Multiple Dose Healthy Volunteer Study of PF-03715455.

Study Overview
=================
Brief Summary
-----------------
Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Detailed Description
-----------------
Healthy volunteer PK study

Official Title
-----------------
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03715455 In Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: PF-03715455
* Drug: PF-03715455
* Drug: PF-03715455
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Standard healthy volunteer criteria

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PF-03715455 1.6mg BID<br> | Drug: PF-03715455<br>* PF-03715455 1.6 mg BID<br>|
| Active Comparator: PF-03715455 4 mg BID<br> | Drug: PF-03715455<br>* PF-03715455 4mg BID<br>|
| Active Comparator: PF-03715455 10 mg BID<br> | Drug: PF-03715455<br>* PF-03715455 10 mg BID<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax). |  | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. |  | 28 Days |
Inpatient Alcohol Detox & Psychotherapy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate effectiveness of inpatient detoxification and psycho-therapeutic support, measured in terms of readiness to change and abstinence maintenance. The study participants will be the patients admitted for alcohol use disorder (age: 18 years above) at a tertiary level hospital in Kathmandu. Baseline assessments on readiness to change will be done during admission, and compared prior to and after discharge. Percentage of participants maintaining abstinence in 3 months after discharge will be another outcome to be analysed.

Official Title
-----------------
Effectiveness of Inpatient Alcohol Detoxification and Psychotherapeutic Support Program

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Detoxification & psychotherapeutic support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as ADS according to ICD 10 Exclusion Criteria: Major Psychiatric or medical comorbidity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral, detoxificaiton & psychotherapy<br>Providing treatment as usual (detoxificaion) & psychotherapy | Behavioral: Detoxification & psychotherapeutic support<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form | The questionnaire is 19 item self-report questionnaire assessing client readiness for change. There are three sub scales: Recognition, Ambivalence, and Taking Steps. Higher scores indicate greater recognition, ambivalence and taking steps. Scores range from 7 to 35, 4 to 20, and 8-40, respectively. | Change from baseline at discharge, an average of 2 weeks | 
| Percentage of participants staying abstinent | Percentage of participants not taking single drink or staying complete abstinent | Three month follow up |
Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

Study Overview
=================
Brief Summary
-----------------
Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).

Official Title
-----------------
A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily

Conditions
-----------------
Colitis, Ulcerative

Intervention / Treatment
-----------------
* Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis general medical assessment satisfactory and no clinically significant and relevant abnormalities Exclusion Criteria: severe ulcerative colitis subject in relapse for > 6 weeks use of systemic or rectal steroids within last 4 weeks prior to baseline subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease subjects hypersensitive to salicylates/aspirin subjects with moderate or severe renal impairment

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

| Intervention/Treatment |
| --- |
|Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of subjects in remission (UC-DAI score) |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology |  | 8 weeks | 
| Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA |  | 8 weeks | 
| Safety and tolerability |  | 8 weeks |
Effects of Tai Chi on Frailty in Elderly Adults

Study Overview
=================
Brief Summary
-----------------
The aim of this study is determine the effects of Tai Chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. We hypothesize that long-term Tai Chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.

Official Title
-----------------
The Effects of Tai Chi on the Nonlinear Dynamics of Frailty in Elderly Adults

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Other: Tai Chi
* Other: Education-Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women over age 70 will be included if they are able to stand and walk unassisted, are free of any acute or unstable medical conditions, and are able to understand directions and participate in the protocol. Exclusion Criteria: Potential subjects will be excluded 1) if they cannot stand and ambulate unassisted, 2) are experiencing any symptomatic cardiovascular or respiratory disease, or have 3) a myocardial infarction or stroke within 6 months, 4) painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility, 5) systolic BP above 160 or diastolic BP above 100 mm Hg, 6) a cardiac pacemaker, 7) Parkinson's Disease or other neuromuscular disorder, 8) metastatic cancer or immunosuppressive therapy, or 9) have significant visual impairment.

Ages Eligible for Study
-----------------
Minimum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi group<br> | Other: Tai Chi<br>* The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).<br>|
| Active Comparator: Educational Control group<br> | Other: Education-Control<br>* The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty Index | Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. | post-intervention |
A Bedside Portable Endoscopy for the Esophageal Foreign Body

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a bedside portable endoscopy is effective in identifying the esophageal foreign body in the emergency room.

Official Title
-----------------
Efficacy of a Bedside Portable Endoscopy on Identifying the Esophageal Foreign Body

Conditions
-----------------
Esophageal Foreign Body

Intervention / Treatment
-----------------
* Device: A bedside portable endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who visit the emergency room due to apparent foreign body in esophagus Exclusion Criteria: Patients unable to insert a portable endoscopy through the nasal cavity Patients unable to undergo conventional esophagogastroduodenoscopy for a gold standard examination

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A bedside portable endoscopy<br> | Device: A bedside portable endoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive predictive value and negative predictive value of the bedside portable endoscopy to identify esophageal foreign body defined by comparison with conventional esophagogastroduodenoscopy as a gold standard method |  | Within 1 hr after procedure |
Clinical Outcomes of Patients With COVID19

Study Overview
=================
Brief Summary
-----------------
As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

Official Title
-----------------
Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019

Conditions
-----------------
Coronavirus Disease 2019

Intervention / Treatment
-----------------
* Other: retrospective analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with COVID19 Exclusion Criteria: Suspected patients with COVID19, not confirmed by the laboratory Patients who are refused to receive medical treatments
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 patients<br>Hospitalized patients with COVID-19 | Other: retrospective analysis<br>* The investigators retrospectively analyzed the hospitalized patients with COVID-19.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to negative conversion of severe acute respiratory syndrome coronavirus 2 | The primary outcome is the time to negative conversion of coronavirus | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital | The time of hospitalization. | 1 month | 
| Survival | The rate of survival within hospitalization of these patients will be tracked. | 1 month | 
| Intubation | The rate of intubation within hospitalization of these patients will be tracked. | 1 month |