linjc16/ctgov huggingface dataset:
A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ED) about risks, benefits, and alternatives to receiving procedural sedation for their children.

Official Title
-----------------
A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department

Conditions
-----------------
Informed Consent Process

Intervention / Treatment
-----------------
* Other: computed-assisted information program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents with patients under 18 years of age patients receive the procedural sedation and anesthesia in the emergency department Exclusion Criteria: clinically unstable refuse to participate unable to understand the consent process for this study

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>No computed-assisted information program will be administered. | |
| Experimental: intervention<br>computed-assisted information program will be administered. | Other: computed-assisted information program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| structured questionnaire | a structured questionnaire with knowledge measure and satisfaction will be delivered to the participants for data collection. | before and immediately after the intervention when participants are in the emergency department, it is expected to take an expected average time of one hour |
Novel Device for Screening Patients With Symptoms of OSA

Study Overview
=================
Brief Summary
-----------------
An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate it's accuracy and usefulness as a screening device for patients with symptoms of OSA

Official Title
-----------------
Validation of a Novel Device for Screening Patients With Symptoms of OSA

Conditions
-----------------
Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Diagnostic Test: Ring oxymetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above 18 years old and below 70 years old, both men and women Exclusion Criteria: Patients requiring oxygen therapy or noninvasive ventilation; Patients with a diagnosis of chronic obstructive pulmonary disease, chronic heart failure, neuromuscular disease, insomnia, clinical symptoms of parasomnia, periodic limb movement, or narcolepsy. Patients on medication known to interfere with heart rate, such as beta-blockers, digoxin or calcium receptor antagonists.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ring oxymetry|a new type oxymetry wear on index finger like a ring|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the concordance of the ring oximetry with PSG as the gold standard |  | 1 year |
Clinical Performance Evaluation of DxN HBV Assay

Study Overview
=================
Brief Summary
-----------------
The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.

Detailed Description
-----------------
Same as brief summary.

Official Title
-----------------
Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Diagnostic Test: DxN HBV Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years of age or older Subject has serological evidence of chronic HBV infection, and measurable HBV-DNA and ALT at baseline Subject will undergo treatment with tenofovir or entecavir for a minimum of 48 weeks Exclusion Criteria: Co-infection with HIV or HCV at enrollment Subject has decompensated liver disease or liver cancer Prior participation in study Current or planned participation in an investigational drug or device study

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HBV Infected patients<br>chronic HBV patients who will undergo standard of care FDA approved antiviral therapy to treat HBV infections. Will have blood drawn to be tested using the DxN HBV Assay. Study is observational and results will not be used to manage patient care. | Diagnostic Test: DxN HBV Assay<br>* Molecular diagnostic test to detect Hepatitis B<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response (SVR) | Defined as unquantifiable HBV Viral load at 48 weeks of treatment. | Up to 48 weeks |
Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.

Official Title
-----------------
Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter : Inclusion Criteria: Patients with advanced prostate cancer, without previous chemotherapy, progressing on hormonal treatment, performance status 1 to 2 Exclusion Criteria: Other cytostatic treatment, other malignity, severe comorbidity

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single group<br> | Drug: docetaxel<br>* Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA decline |  | after each docetaxel administration and after the end of treatment | 
| pain response |  | after each docetaxel administration and after the end of treatment | 
| side effects occurrence |  | Throughout the study |
Molecular Hydrogen for Cognitive Function and Performance in Elderly

Study Overview
=================
Brief Summary
-----------------
A variety of non-pharmacological interventions have been used in the management of Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic modality has demonstrated conclusive positive results in terms of effectiveness. Although it is still unknown what triggers AD, recent studies have shown that AD is associated with brain energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis to be evaluated in this project is that administration of H2 will positively affect patient-reported outcomes and clinical biomarkers in men and women suffering from AD.

Conditions
-----------------
Cognitive Impairments, Aging

Intervention / Treatment
-----------------
* Other: Molecular Hydrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 65 No psychiatric comorbidities Exclusion Criteria: Use of dietary supplements 4 weeks before study commence

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Molecular Hydrogen<br>Molecular hydrogen: 20 min per day of 3% H2 during 4 weeks | Other: Molecular Hydrogen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-Cog score for cognitive function | ADAS-Cog total score and scores for 4 separate cognitive domains (memory, orientation, praxis, and language) will be evaluated. | Change from Baseline ADAS-Cog Score at 4 weeks |
Right-sided Colon Tumor, Laparoscopic Versus Open Surgery, in an ERAS Protocol

Study Overview
=================
Brief Summary
-----------------
Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol. Hypothesis: Operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.

Official Title
-----------------
Right-sided Colon Tumor, Laparoscopic and Open Surgery, in an ERAS Protocol

Conditions
-----------------
Colon Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: right-sided colon tumor or large benign adenoids 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological Anatomic diagnosis (PAD) on a tumor biopsy | After PAD result, malign or benign tumor, type of malign tumor,tumor growth, stage, lymphatic recharge. Right selection of patients to laparoscopic versus open surgery in relation to PAD result? | day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay, days | Compare laparoscopic versus open surgery | 30 days after surgery | 
| C - reactive protein | Inflammation answer laparoscopic versus open surgery | 1-7 days after surgery |
Safety and Efficacy of APD356 in the Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity. The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy. Subjects who are on concomitant medications for control of hypertension or blood lipids may qualify.

Detailed Description
-----------------
This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 12 weeks, to obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Official Title
-----------------
A 12-Week, Dose-Ranging, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of APD356 in Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: APD356


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or nonpregnant, nonlactating females aged 18-65 years (inclusive) Body mass index (BMI) of 30-45 kg/m2 Non-smoker No concomitant medications other than hypertension medications (stable > 90 days) and/or statins (stable > 90 days) No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency No more than mild mitral valve regurgitation and absence of aortic valve regurgitation upon screening echocardiogram

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: APD356|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Changes in waist circumference, hip circumference, and waist/hip ratio |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Loss, Serotonin, 5-HT2c, Satiety, Obesity, Appetite suppressant, Overweight
Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using pCLE With AI

Study Overview
=================
Brief Summary
-----------------
Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes. Probe-based confocal laser endomicroscopy (pCLE) can diagnose ESN accurately.However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.

Official Title
-----------------
Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using Probe-based Confocal Laser Endomicroscopy With Artificial Intelligence

Conditions
-----------------
Esophageal Neoplasms, Artificial Intelligence, Confocal Laser Endomicroscopy

Intervention / Treatment
-----------------
* Diagnostic Test: The diagnosis of Artificial Intelligence and endoscopist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18 and 80; agree to give written informed consent； suspected esophageal mucosal lesion was found by white light endoscopy. Exclusion Criteria: Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| esophageal mucosal lesions observed by pCLE<br>pCLE is used to distinguish the suspected lesions detected by white light endoscopy. | Diagnostic Test: The diagnosis of Artificial Intelligence and endoscopist<br>* When suspected esophageal mucosal lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnosis efficiency of Artificial Intelligence | The primary outcome is to test the diagnostic accuracy, sensitivity, specificity, PPV, NPV of the Artificial Intelligence for diagnosing esophageal mucosal disease on real-time pCLE examination. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists | The secondary outcome is to compare the diagnosis efficiency (including diagnostic accuracy, sensitivity, specificity, PPV, NPV for diagnosing esophageal mucosal disease on real-time pCLE examination) between Artificial Intelligence and endoscopists. | 1 month |
Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis

Official Title
-----------------
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship

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

Intervention / Treatment
-----------------
* Drug: GW856553


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology. Must have 3 or more swollen or 3 or more tender/painful joints at screening. Must be on stable weekly methotrexate (2.5mg-25mg) for at least eight weeks prior to screening. Exclusion criteria: Must not be morbidly obese.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW856553|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein (CRP) levels 72 hours post-dose. |  | 72 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein (CRP) levels 24 and 48 hours post-dose |  | 24 and 48 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW856553, biomarkers, CRP, rheumatoid arthritis
Biomarker Discovery and Application in Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators' long-term objective is to research and develop innovative new tests which diagnostic laboratories can use to 1) detect methylated DNA targets, 2) tumor specific antigens, and 3) markers of Bacillus Calmette-Guerin (BCG) treatment in patient urine samples. The investigators plan to detect methylated DNA targets and control targets by methylation-specific polymerase chain reaction (msPCR) on DNA isolated from urine samples from bladder cancer positive and negative patients to determine its sensitivity and specificity in detecting bladder cancer. The investigators plan to use patient sera as a tool to detect tumor specific antigens expressed by bladder cancer cell lines. Once a bladder tumor specific protein is identified, the investigators will assess its presence in the urine of bladder cancer patients and absence in healthy patients by enzyme-linked immunosorbent assay (ELISA). The investigators plan to use both in vitro models and patient clinical samples to elucidate the role of bladder epithelial cells in mediating BCG immunotherapy and identify biomarkers of treatment effectiveness. Once a biomarker is identified, the investigators will assess its presence in the urine of bladder cancer and absence in healthy patients. Once the investigators determine the feasibility of these tests, the investigators will further perform an extensive clinical study, comparing the tests to existing diagnostic methods. This study will provide the foundation for FDA approval, which is required for tests to become widely accepted tools for clinicians to use in bladder cancer diagnosis. The investigators' tests will improve early detection of bladder cancer, thereby improving patient health and decrease cancer deaths, a key mission of the National Institutes of Health.

Official Title
-----------------
Biomarker Discovery and Application in Bladder Cancer: Identification and Detection of Gene Methylation, Tumor Specific Antigenes Markers of BCG Treatment.

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Exclusion Criteria: No exclusion criteria

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |