linjc16/ctgov huggingface dataset:
Gestational Age Specific Thyroid Function Reference Range

Study Overview
=================
Brief Summary
-----------------
It has been well accepted that maternal thyroid dysfunction has adverse affects on both mothers and fetuses. However, the dramatical changes during pregnancy make the interpretation of thyroid function test (TFT, i.e. free triiodothyronine [FT3], free thyroxine [FT4] and thyrotropin [TSH]) very difficult. Previous studies have shown that the level of thyroid hormones differs from non-pregnant population and varies from gestational ages. Moreover, studies have shown the agreement among different instrument platforms was quite low. This study is aimed to determine gestational age specific TFT reference ranges of the local pregnant population for all available platforms currently used under Hospital Authority and Department of Health.

Official Title
-----------------
Gestational Age Specific Thyroid Function Reference Range in Hong Kong

Conditions
-----------------
Thyroid, Reference Values, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women receiving pregnancy and postnatal care in the Department of Obstetrics & Gynaecology, Prince of Wales Hospital, Hong Kong Exclusion Criteria: 1. Previous history of thyroid dysfunction (hypothyroidism or hyperthyroidism); 2. Autoimmune disease, particularly those receiving corticosteroid or immunosuppressant: e.g. systemic lupus erythematosus; 3. Disease associated with thyroid dysfunction: e.g. molar pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women<br>pregnant women in Hong Kong | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of free triiodothyronine (FT3) during pregnancy | gestational FT3 level | At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly. | 
| Change of free thyroxine (FT4) during pregnancy | gestational FT4 level | At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly. | 
| Change of thyrotropin (TSH) during pregnancy | gestational TSH level | At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid, Reference values, Pregnancy
Physician Preference Study of ShuntCheck - Madsen

Study Overview
=================
Brief Summary
-----------------
ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction. Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)

Official Title
-----------------
Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts

Conditions
-----------------
CSF Flow Through the Shunt of a Hydrocephalus Patient

Intervention / Treatment
-----------------
* Device: ShuntCheck


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle. Subjects must be physically stable as determined by the physician. Exclusion Criteria: Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data. Subjects unable to lie supine with head elevated 30 degrees or less Subjects who have had shunt surgery within two weeks. Inability or unwillingness of subject to endure the test. Other judgments of the investigator.

Ages Eligible for Study
-----------------
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: Diagnostic<br> | Device: ShuntCheck<br>* Thermal dilution test for CSF flow<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ShuntCheck result of Flow Confirmed for asymptomatic shunted patients tested |  | Tested in single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ShuntCheck result of Flow Not Confirmed for symptomatic shunted patients with shunt obstruction |  | Single visit |
Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.

Official Title
-----------------
Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Device: PulseHaler treatment
* Device: CPAP treatment (through a deactivated version of PulsHaler)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD Diagnosis established for at least 1 year; Post-bronchodilator FEV1/FVC < 0.7 Post bronchodilator FEV1 <70% predicted Age: 40 years or older Smoking cigarettes, at least 10PY Patient signed the informed consent form Exclusion Criteria: Bullous Emphysema (ruled out by recent CT) Hospitalization due to exacerbation of COPD within the last 3 months Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks Systemic steroid treatment in the last 4 weeks Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive. Severe cardiac disease, e.g., CHF grade 3 or higher Acute MI within last 3 months CABG within last 3 months Other severe systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PulsHaler first<br> | Device: PulseHaler treatment<br>* treatment is for two weeks, 3 times per day<br>|
| Placebo Comparator: Placebo first<br> | Device: CPAP treatment (through a deactivated version of PulsHaler)<br>* treatment is for two weeks, 3 times per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function tests |  | Within 2 hours from first treatment, and after 2 weeks of treatment | 
| Six minute walk test |  | Within 2 hours from first treatment, and after 2 weeks of treatment | 
| Health related quality of life |  | Within 2 hours from first treatment, and after 2 weeks of treatment |
Mpact Cup Performance After Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.

Official Title
-----------------
Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty

Conditions
-----------------
Total Hip Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients requiring a total hip replacement who meets the standard indications for use for Medacta implants patients who accept to participate in the study patients who signed the consent form for the treatment of personal data Exclusion Criteria: patients presenting conditions identified as contraindication for Medacta implants revision surgeries

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 |
| --- | --- | --- |
| implant survival trough Kaplan-Meier curve |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip function with Harris Hip Score |  | preop, 3/6 months, 1, 3, 5, 7, 10 years | 
| record of adverse events |  | intraop, 3/6 months, 1, 3, 5, 7, 10 years | 
| implant stability trough assessment of presence of radiolucencies |  | 3/6 months, 1, 3, 5, 7, 10 years |
An Arrhythmia Risk Predictor Trial

Study Overview
=================
Brief Summary
-----------------
This prospective single-center study is an observational risk stratification trial in about 250 patients with standard indications for ICD treatment. Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current guidelines recommend their use for primary and secondary prevention of sudden cardiac death (SCD). However, a large number of patients never receive an appropriate therapy from their device. In contrast, electrical sorm and multiple ICD shocks occur in other patients. Thus, identification of predictors for survival or ICD shocks is necessary for improved patient selection and optimized therapeutic strategies. Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave alternans (TWA) and Holter ECG including premature ventricular contractions (PVC), non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and deceleration capacity, as well as clinical variables is possible, but not implemented in clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD for primary or secondary prevention of SCD following current guidelines. Patients will be prospectively followed and the predictive value of the risk markers mentioned above to predict all-cause mortality or appropriate ICD shocks will be investigated.

Official Title
-----------------
Clinical-Electrophysiological Risk Marker Trial Goettingen

Conditions
-----------------
Cardiomyopathy, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ischemic or dilated cardiomyopathy sinusrhythm ICD indication strictly following current guidelines (primary and secondary prevention of SCD) Age 18 years or older Exclusion Criteria: no consent atrial fibrillation

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 |
| --- | --- |
| Sinus rhythm, first ICD implantation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality |  | 2008-2013 | 
| First Appropriate ICD Shock | First ICD discharge for malignant ventricular arrhythmia | 2008-2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sudden cardiac death, risk stratification, t-wave alternans, Holter electrocardiography, heart rate turbulence
SeniorWISE: Improving Everyday Memory in At-Risk Elderly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether classes on memory training will help older adults to improve or maintain their daily activities.

Detailed Description
-----------------
Volunteer participants will be randomly assigned to experimental (memory training) and comparison (health promotion) groups. Both groups will learn strategies for successful aging. Participants will be in the study for 27 months and will be interviewed on five occasions for 3 hours per interview. The classroom-based intervention is an 8-session, 1 1/2 hour course designed to teach older adults the use of strategies to improve everyday memory. Strategically-placed booster sessions will be provided to subjects within 3 months following the last class session.

Official Title
-----------------
Improving Everyday Memory in At-Risk Elderly

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Procedure: Memory Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reside in Austin, Texas or Travis County African, Caucasian, or Hispanic heritage Fluent in reading and speaking English Mini Mental Exam scores of 23-30 Pass executive function test Adequate hearing and vision to enable participation in classroom learning Free of Alzheimer's disease or other conditions (e.g., certain cancers) likely to result in mortality before study completion Exclusion Criteria: Under 65 Score less than 23 on MMSE Fail the executive function tests Severe sensory losses, hearing or vision, that would prohibit testing or participation self-report a diagnosis of Alzheimer's disease or other conditions (e.g., certain cancers) likely to result in mortality before study completion

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Memory Training|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
-----------------
Aging, Memory, Mental Recall, Mental Processes
SVT-15652 Otic Solution for the Treatment of Otomycosis.

Study Overview
=================
Brief Summary
-----------------
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.

Official Title
-----------------
A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis).

Conditions
-----------------
Otomycosis

Intervention / Treatment
-----------------
* Drug: SVT-15652
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: At least 18 years of age Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated. Signs/symptoms of pruritus, otalgia and ear fullness. Debris or drainage clinically consistent with fungal infection. Main Exclusion Criteria: Known bacterial otitis externa or malignant otitis externa. Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery. Structural ear anomalies which may difficult the evaluation of the therapeutic response. Uncontrolled diabetes mellitus. Any infection requiring systemic antimicrobial or systemic antifungal therapy. Concomitant medicines that may interfere with the study evaluations.

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: SVT-15652<br>1 vial twice daily | Drug: SVT-15652<br>* 1 vial twice daily<br>* Other names: SVT-15652 Otic Solution;|
| Placebo Comparator: Placebo<br>1 vial twice daily | Drug: Placebo<br>* 1 vial twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Cure (Clinical and Mycological Cure) | Percentage of subjects with therapeutic cure | Test of cure on day 24 |
A Test of the Investigational SEM Scanner

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. This will help with clinical interpretation of the numbers and readings this device will provide.

Official Title
-----------------
An Investigational, Non-significant Risk Study to Collect Data Needed to Analyze Readings Given by the SEM Scanner Point of Care 200 Series (SEM POC 200) and Its Ability to Detect Sub Epidermal Moisture.

Conditions
-----------------
Pressure Ulcers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are 18 years of age or older. Subject or health care proxy is willing and able to provide informed consent for enrollment. Subject is agreeable to having skin assessments, blanchability tests, and SEM Scanner readings performed daily at all anatomical sites for a duration of five (5) days, with photography as needed. Subject is admitted to an intensive Care Unit (ICU) and has an anticipated ICU course of 48 hours or greater. Subject is not Comfort Measures Only (CMO). Subject is anticipated to be bedridden for ore than 6 hours per day. All four (4) of the subject's anatomical sites in question (sternum, sacrum, left heel and right heel) are accessible for scanning (e.g., no cast or medical device present such that heels are not accessible). Exclusion Criteria: Subject has broken skin or scar tissue at the sternum, sacrum, left heel or right heel. Subjects for whom the physical act of performing the inspections and measurements required in this study are contra-indicated, as determined by the principal investigator or attending physician. Subjects or legal representatives who are unable to understand the aims and objectives of the trial. Presence of any condition(s) which seriously compromise(s) the subject's ability to complete this study, or has a known history of poor adherence with medical treatment. Subject is pregnant. Subject is incarcerated.

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 |
| --- | --- | --- |
| Descriptive statistic measurements | The endpoint for this study is the establishment of descriptive statistics around readings given by the SEM Scanner. | 5 day study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sub-epidermal moisture, Pressure Ulcers
Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
Existing records will be reviewed to evaluate the predictors of complications including stricture formation, bleeding or perforation associated with endoscopic mucosal resection

Detailed Description
-----------------
Barrett's esophagus (BE) is a complication of gastroesophageal reflux disease in which the normal squamous lining of the esophagus is replaced by specialized columnar epithelium.1 Approximately 5%-10% of patients diagnosed with BE are thought to be at risk of developing esophageal adenocarcinoma.2 Patients with high-grade dysplasia (HGD) on biopsy are at the greatest cancer risk³. EMR is being performed clinically in our Barrett's Esophagus Unit on a regular basis during endoscopy for patients with Barrett's Esophagus and/or early esophageal adenocarcinoma. There are two predominant endoscopic mucosal resection (EMR) techniques exist using FDA approved devices - the EMR cap method using a transparent cap/snare combination and the endoscopic variceal ligation method using a band ligator/snare combination to resect tissue.

Official Title
-----------------
Endoscopic Mucosal Resection in Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus, Early Esophageal Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Barrett's Esophagus Early Esophageal Adenocarcinoma History of Endoscopic Mucosal Resection Exclusion Criteria: NA

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with barretts esophagus and/or early esophageal adenocarcinoma who have undergone endoscopic mucosal resection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and types of adverse events in participants who have undergone endoscopic mucosal resection with documented adverse events will be evaluated for predictors of complications | analysis | 3 months after EMR procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic Mucosal Resection