linjc16/ctgov huggingface dataset:
Web-Mediated Risk Assessment for Endoscopic Screening of Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Gastric cancer is one of the most common malignancies in China. Early detection is critical for gastric cancer management. However, the diagnosis rate of patients with early gastric cancer is still low. Therefore, the investigator design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve early gastric cancer diagnosis rate.

Official Title
-----------------
Randomized Trial Comparing Gastroscopy Following Web-Mediated Risk Assessment With Routine Endoscopy for Gastric Cancer Screening

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: pre-endoscopic screening risk assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Age 18-60. 2.Signed informed consent Exclusion Criteria: 1.Severe back ground disease including malignancy. 2.State after gastric surgery. 3.COPD, CHF, CRF and any disease with respiratory disturbances. 4.Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre-endoscopic screening risk assessment<br> | Diagnostic Test: pre-endoscopic screening risk assessment<br>* pre-endoscopic screening risk assessment<br>|
| No Intervention: routine screening<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic rate of patients with early gastric cancer | Diagnostic rate of patients with early gastric cancer | 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the high-rik individual for gastric cancer | Diagnostic rate of patients with early gastric cancer | 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer, Screening, Risk assessment
Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients

Study Overview
=================
Brief Summary
-----------------
The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.

Official Title
-----------------
Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Diagnostic Test: HPV genotyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Stable HIV disease (i.e. receiving ART for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures) Referred for high-resolution anoscopy Exclusion criteria Documented AIN (treated or untreated) Local anal inflammation (proctitis) and/or acute fissure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV genotyping<br> | Diagnostic Test: HPV genotyping<br>* Quantitative HPV genotyping on anal swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HPV subtypes in HIV-positive patients | Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between high-resolution anoscopy findings and quantitative HPV genotyping | Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days | 30 minutes up to 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Papilloma Virus, Anal Intraepithelial Neoplasia
A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.

Official Title
-----------------
Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability and Pharmacokinetics of RO6811135, Following Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Subjects.

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO6811135
* Drug: RO6811135


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male healthy volunteers, 18-45 years of age inclusive Healthy as determined by screening assessments Body mass index (BMI) between 18-30 kg/m2 Exclusion Criteria: Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases History of anaphylaxis or severe systemic hypersensitivity or allergic reactions Any history of alcohol and/or drug of abuse addiction during the past 5 years Smoking more than 5 cigarettes a day or the equivalent amount of tobacco Any clinically relevant abnormal test results prior to first dosing Positive for hepatitis B, hepatitis C or HIV infection Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: RO6811135 s.c.<br> | Drug: RO6811135<br>* Single subcutaneous dose<br>|
| Active Comparator: B: RO6811135 i.v.<br> | Drug: RO6811135<br>* Single intravenous dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC) |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 5 weeks | 
| Pharmacodynamics: Fasting serum glucose/serum insulin |  | 48 hours | 
| Nausea scale: Visual analogue scale |  | 48 hours |
Water Intervention for Thinking in Kids (WITiKids ) Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the influence of changes in water intake on changes in cognitive function among preadolescent children. Further, the proposed work will determine the relationship between urinary markers of hydration process and cognitive function. We hypothesize that an increase in water intake will result in greater cognitive performance. In addition, improvements in hydration demonstrated by lower urine concentration will be correlated with greater cognitive performance.

Official Title
-----------------
The Effects of Hydration on Brain, Cognition, Memory & Achievement in Childhood

Conditions
-----------------
Low Fluid Intake, Chronic

Intervention / Treatment
-----------------
* Behavioral: Water Intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parental/guardian consent Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision). Exclusion Criteria: Participants younger than 9 years and older than 10 years at the time of testing age. Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid). Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications). Participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the Tanner Staging System IQ below 85 Use of medications that alter urinary excretion and water metabolism Use of internal electronic device, such as a pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIGH<br>Increase water intake to 2.5 liters per day for 4 days | Behavioral: Water Intake<br> <br> |
| Experimental: LOW<br>Decrease water intake to 0.5 liter per day for 4 days | Behavioral: Water Intake<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flanker Task Accuracy |  | 2 Hours on the morning of Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Osmolality |  | 24 hours during final day of fluid intake modulation (Day 4) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Water, Children, Cognition, Hydration
Compensatory Brain Mechanisms for Amygdala-associated Cognitive Dysfunction: Potential Role of the Cortical Mirror Neuron System

Study Overview
=================
Brief Summary
-----------------
Identify if the mirror neuron system, or other networks, can compensate for amygdala dysfunction, using behavior and structural/functional MRI.

Detailed Description
-----------------
In the present study, investigators aim to investigate amygdala dysfunction & potential compensation in individuals with high and low traits (e.g. Autism, Anxiety, Depression traits, Alexithymia), high and low stress or protective factors in the environment (social network, early life stress) and different molecular genetic make-up. On the neural level, functional and structural connectivity as well as task-related BOLD activation will be assessed.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: screen high and low triat subjects


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: history of head injury claustrophobia; medical or psychiatric illness female subjects were pregnant or taking oral contraceptives. taking any form of medication and drunk any caffeine-containing beverages on the day of the experiment.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: screen high and low triat subjects|use a range of questionniares to screen screen high and low triat subjects (eg. Autism, Anxiety, Depression traits and social network size)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain activity and connectivity during social and cognitive tasks | brain activity and connectivity was measured by the fMRI scanner | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amygdala, mirror neuron system, brain network
APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)

Study Overview
=================
Brief Summary
-----------------
To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in the postmenopausal, early breast cancer as seen under current practice

Official Title
-----------------
A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Patients with early breast cancer who are scheduled to receive first-line adjuvant endocrine therapy with aromatase inhibitor under the routine clinical practice Histologically or cytologically proven to be HR+(ER or PR +) Postmenopausal woman, defined as a woman fulfilling any of the following criteria(by the local guideline): Age >= 50 years Age < 50 years with amenorrhoea > 12 months and an intact uterus FSH levels within postmenopausal range (over 30-40 IU/ml), or Having undergone a bilateral oophorectomy. No other concomitant endocrine therapy such as estrogen therapy or selective estrogen receptor modulators Exclusion Criteria: Recurrence of breast cancer Known hypersensitivity to aromatase inhibitor or to any of the excipients Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol Previous inclusion in the present study Participation in a clinical study during the last 30 days

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aromatase Inhibitor, Breast Cancer, compliance, Naturalistic, Observational
Randomized Controlled Trial to Evaluate of Dexmedetomidine for the Effect on Operative Visibility in Patients Undergoing Endoscopic Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
Various maneuvers are commonly used to achieve the ideal operative field necessary for successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during intranasal operation. The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to remifentanil , an ultrashort-acting opioid.

Conditions
-----------------
Chronic Sinusitis

Intervention / Treatment
-----------------
* Drug: Propofol and dexmedetomidine
* Drug: propofol and remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Ⅰ-Ⅱ Aged between 20 and 70 year General anesthesia for endoscopic sinus surgery Exclusion Criteria: Body mass index >30 Congestive heart failure, Sinus Bradycardia(<50 BPM), Uncontrolled hypertension, Coagulopathy Drug addiction Pregnancy Allergic fungal infection

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: remifentanil<br> | Drug: propofol and remifentanil<br>* Both group : propofol effect site TCI 2-4 mcg/ml, Remifentanil group : remifentanil effect site-TCI 2-4ng/ml Dexmedetomidine group: dexmedetomidine 0.5mcg/kg loading and 0.5mcg/kg/hr infusion<br>|
| Experimental: dexmedetomidine<br> | Drug: Propofol and dexmedetomidine<br>* Both group : propofol effect site TCI 2-4 mcg/ml, Remifentanil group : remifentanil effect site-TCI 2-4ng/ml Dexmedetomidine group: dexmedetomidine 0.5mcg/kg loading and 0.5mcg/kg/hr infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical satisfaction about visibility of operative field | subjective satisfaction about visibility of operative field by surgeon/ numerous rating scale / 0: worst - 10:best | Within 1 day of endoscopic sinus surgery finish including dressing of surgical wound |
Mobile App for Mood in Pregnancy (Ginger iO)

Study Overview
=================
Brief Summary
-----------------
The Mobile Mood Tracking App study is a small randomized trial of acceptability and usability of a mobile phone mood tracking application (mobile app) among women with depressed mood in pregnancy. The study will be assessing the perceived value and usability of this tool in pregnancy over eight weeks to test whether women using this app are more likely to receive assessments and treatments of depressed mood than women not using it.

Conditions
-----------------
Mood Disorders, Depression

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive screening for elevated depression symptomatology (PHQ-9 score must be greater than or equal to 5.) Exclusion Criteria: Women with pregnancies of less than 33 weeks gestation.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MyPennMedicine (MPM)<br>Participants assigned to this arm downloaded only the MyPennMedicine mobile app. | Other: No Intervention<br> <br> |
| MPM and Ginger iO<br>Participants assigned to this arm downloaded both the MyPennMedicine mobile app and Ginger iO mood tracking app. | Other: No Intervention<br> <br> |
| Lottery<br>Participants assigned to this arm downloaded both the MyPennMedicine mobile app and Ginger iO mood tracking app. They were also given a lottery incentive if they completed 70% of the daily mood ratings. | Other: No Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of increased provider intervention for the treatment of worsening depressive symptoms confirmed by the mobile mood tracking application. |  | 8 weeks |
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

Study Overview
=================
Brief Summary
-----------------
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.

Official Title
-----------------
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft in Patients With Thoracic Aortic Pathologies

Conditions
-----------------
Thoracic Aortic Aneurysm, Penetrating Ulcers

Intervention / Treatment
-----------------
* Device: Relay Thoracic Stent-Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diagnosed descending thoracic aneurysm or penetrating ulcer Subjects whose anatomy can accommodate the Relay device Subjects who consent to participate Subjects who agree to a follow-up schedule Exclusion Criteria: Subjects with lesions other than thoracic aneurysm and penetrating ulcer Subjects with less than 1 year life expectancy Subjects who are pregnant Subjects with medical conditions that wold complicate the endovascular procedure or confound results (e.g., Marfan's syndrome, morbid obesity, severe coronary artery disease) Subjects participating in another investigational study

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Relay Thoracic Stent-Graft|Device implant|

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
-----------------
Relay, Thoracic, Aneurysm