linjc16/ctgov huggingface dataset:
A 6-Month Extension Study of OTO-104 in Meniere's Disease

Study Overview
=================
Brief Summary
-----------------
This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to be eligible for this open-label extension study.

Official Title
-----------------
A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Conditions
-----------------
Meniere's Disease

Intervention / Treatment
-----------------
* Drug: OTO-104


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria includes, but is not limited to: Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) clinical study. Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria Exclusion Criteria includes, but is not limited to: Subject is pregnant or lactating. Subject has a history of immunodeficiency disease. Subject has experienced an adverse reaction to intratympanic injection of steroids.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-104<br>12 mg dexamethasone | Drug: OTO-104<br>* Single intratympanic injection of 12 mg OTO-104<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 [Month 6]). | 6 Months |
Attention Training and Its Effects on Body Image Disturbance

Study Overview
=================
Brief Summary
-----------------
Research has consistently found attentional biases towards negative weight-related stimuli in individuals with eating disorders. It has been suggested that these biases may act as a vulnerability factor for the development and maintenance of body dissatisfaction and may therefore be an important target for intervention. Previous studies have demonstrated the capacity to modify the patterns of attention allocation to threatening stimuli in a variety of anxiety disorders, with a subsequent and sustained reduction in anxiety symptoms. Thus, the present study aimed at testing the efficacy of attention training in reducing attentional biases and eating disorder symptoms in individuals with elevated levels of body image disturbance and eating disorder symptomatology of clinical severity. Thirty-two participants were randomly allocated to receive eight sessions of a 10-minute computer task aimed at training their attention away from weight-related stimuli or a control placebo training condition. Results showed that participants in the attention training group had a significantly greater reduction in their attentional bias and body dissatisfaction from pre- to post-training relative to the placebo condition. At follow-up, both groups showed a significant decrease in body dissatisfaction from their pre-training levels. The only significant difference between groups in eating disorder symptoms at follow-up was in terms of the attention training group experiencing a greater reduction in weight and shape concerns.

Conditions
-----------------
Body Dissatisfaction, Eating Disorder Symptoms

Intervention / Treatment
-----------------
* Behavioral: attention training
* Behavioral: placebo training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: If they have a score on the Body Shape Questionnaire of 113 or more AND a score in the EDE-Q of 4 or more in any subscale. Exclusion Criteria: attention bias score of <-10

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

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

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 |
| --- | --- |
| Placebo Comparator: placebo training<br> | Behavioral: placebo training<br> <br> |
| Experimental: attention training<br> | Behavioral: attention training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Interactive Web-Based Program to Improve Food and Activity Choices of Teens

Study Overview
=================
Brief Summary
-----------------
This study will test a website for teens designed to help them improve both diet and physical activity. The website will have several components: educational messages, role model stories, goal setting, self-monitoring forms, problem solving, a monitored discussion forum, and diet and physical activity (PA) assessment questionnaires.

Detailed Description
-----------------
Increasing numbers of youth are at risk for becoming overweight because of poor diets and low physical activity levels. Prevention is key to reducing the obesity problem. Intervention programs must be easily accessible, and include intervention materials in a format that draws attention and interest. This study evaluates an 8-week web-based intervention for teens to promote healthy food and physical activity choices. The web program includes role model stories, nutrition and activity information pieces, goal setting and problem solving, and self-monitoring. Students will complete assessments at baseline, 8-weeks post, and then 6 and 12-months post intervention.

Official Title
-----------------
An Interactive Web-Based Program to Improve Food and Activity Choices of Teens

Conditions
-----------------
Diet, Physical Activity

Intervention / Treatment
-----------------
* Other: teen web


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to speak English 12-17 years old Exclusion Criteria: no special diets

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teen web<br>Main web - with all components | Other: teen web<br>* Min web<br>|
| Active Comparator: Minimal teen web<br>Teen web minus behavioral components | Other: teen web<br>* Min web<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diet (fruit, vegetables, sweetened beverages, fat) |  | baseline, post, 6-and 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | baseline, post, 6- and 12-months | 
| Physical activity:self-report |  | baseline, post, 6-and 12-months |
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.

Study Overview
=================
Brief Summary
-----------------
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.

Detailed Description
-----------------
Subjects are reclaimed to finish several turning task under different turning angle. The wearable system is patched on both subjects' legs and waist, to assess turning characteristics under different turning angle.

Official Title
-----------------
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.

Conditions
-----------------
Ambulation Difficulty

Intervention / Treatment
-----------------
* Other: Turning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to walk 10 m independently without any device. Exclusion Criteria: Dizzy causing by eye disorders or vestibular disease. Any disease which involved in gait performance. Can't follow the order by investigator during task.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal subjects<br> | Other: Turning<br>* start to walk with normal speed, and then turn to approach the terminal under different angle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turning step count | record numbers of step during turning | pre-test and post-test within a week | 
| Turing time | record second which subject spend during turning | pre-test and post-test within a week | 
| Stride length during turning | record the distance of bipedal stride length respectively | pre-test and post-test within a week | 
| Walking speed approached turning | record the velocity and change of velocity before start turning | pre-test and post-test within a week | 
| Turning angle | record the total turning angle and bipedal turning angle each step | pre-test and post-test within a week |
Vegetative Monitoring During Brainstem-associated Surgery

Study Overview
=================
Brief Summary
-----------------
Intraoperative Monitoring of Heart rate variability, Blood pressure variability, Baroreceptorsensivity etc.

Official Title
-----------------
Vegetative Monitoring During Brainstem-associated Surgery

Conditions
-----------------
Brain Tumor, Recurrent, Vestibular Schwannoma, Brainstem Neoplasm, Brainstem Glioma

Intervention / Treatment
-----------------
* Procedure: Intraoperative Monitoring during resection of brain tumor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 0-99 brain tumor Exclusion Criteria: no consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brain stem associated tumors<br>Brain stem associated tumors | Procedure: Intraoperative Monitoring during resection of brain tumor<br>* Intraoperative Monitoring during resection of brain tumor<br>|
| Tumors without brain stem assocation<br>Tumors without brain stem assocation | Procedure: Intraoperative Monitoring during resection of brain tumor<br>* Intraoperative Monitoring during resection of brain tumor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (HRV) | Comparison of HRV in the 2 groups (brain stem-associated vs. non associated surgery) | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cardiovascular complications | Comparison of no. of cardiovascular complications (cardiac arrest, sudden tachy/bradyarryhthmia, hyper/hypotension, trigeminocardiac reflex) in the 2 groups | intraoperatively |
Effects of Xanthophylls on Optical Density

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to investigate the influence of a intervention with lutein und zeaxanthin from crucifers on the optical density of the macular pigment of patients with non exudative age-related maculopathy. It is hypothesized that the applied study beverage elevates plasma concentrations of the administered xanthophylls and the optical density after 4 weeks of intervention.

Official Title
-----------------
Alteration of Optical Density and Plasma Xanthophylls After Short Term Supplementation With Macular Carotenoids in Patients With AMD

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Dietary Supplement: Verum
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with non exudative age-related maculopathy Exclusion Criteria: intake of dietary supplements containing lutein and zeaxanthin
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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lutein and zeaxanthin<br> | Dietary Supplement: Verum<br>* 10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day<br>|
| Experimental: Placebo<br> | Dietary Supplement: Placebo<br>* 10 subjects consume for 4 weeks a placebo beverage without any lutein and zeaxanthin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical density of macular pigment in AMD patients |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of xanthophylls in plasma of AMD patients |  | 10 weeks | 
| blood lipids |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human study, AMD, lutein, zeaxanthin, optical density
Host DNA Methylation for Endometrial Cancer Screening

Study Overview
=================
Brief Summary
-----------------
Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening in a multi-center cohort. Thirteen hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 10,000 patients.

Official Title
-----------------
The Accuracy of Host DNA CDO1 and CELF4 Methylation for Endometrial Cancer Screening: a Multi-center Cohort Study

Conditions
-----------------
Cancer Screening, Endometrial Cancer, DNA Methylation, Cervical Cytology, Liquid Biopsy, Cohort Study

Intervention / Treatment
-----------------
* Diagnostic Test: DNA methylation testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With uterine and uterine cervix intact Aged 18 years or older With accessible histological results of endometrium Signed an approved informed consents With accessible cervical cytology before harvesting endometrial histology Exclusion Criteria: Not meeting all of the inclusion criteria

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: DNA methylation testing|DNA CDO1 and CELF4 methylation testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of methylation testing | Sensitivity of methylation testing of cervical cytology compared with histology | One week | 
| Specificity of methylation testing | Specificity of methylation testing of cervical cytology compared with histology | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of methylation testing | Positive predictive value of methylation testing of cervical cytology compared with histology | One week | 
| Negative predictive value of methylation testing | Negative predictive value of methylation testing of cervical cytology compared with histology | One week |
Intravascular Ultrasound for Hepatocellular Carcinoma Staging

Study Overview
=================
Brief Summary
-----------------
To diagnose hepatocellular carcinoma (HCC) and to determine the extent of the disease, a triphasic CT scan or a magnetic resonance imaging are required. The characterization of hepatic nodules is more difficult when the HCC lesions have a diameter of less than 2 cm. Since accuracy in the assessment of the number and the size of HCC nodules, as well as of the invasion of blood vessels is crucial to determine outcome after liver transplantation due to tumour recurrence, there is a need for techniques with a higher definition potential. As a consequence, to improve outcome and to optimize organ allocation, patients on the liver transplantation waiting list might benefit from intravascular ultrasound as an additional examination to complete the pre-transplant tumour staging process.

Official Title
-----------------
Intravascular Ultrasound for the Staging of Hepatocellular Carcinoma: a Pilot Study

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Device: Intravascular ultrasound of the liver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatocellular carcinoma nodules patient on liver transplantation waiting list written informed consent Exclusion Criteria: thrombosis of hepatic veins or vena cava

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intravascular ultrasound of the liver|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
-----------------
staging, hepatocellular carcinoma, liver transplantation, intravascular ultrasound
Sixteen Years Trends in Reported Undernutrition in Switzerland

Study Overview
=================
Brief Summary
-----------------
To assess 16-year trends in undernutrition reporting and management in Switzerland

Detailed Description
-----------------
Analysis of data from the Swiss hospital discharge databases between 1998 and 2014. The database was provided by the Swiss federal office of statistics (http://www.bfs.admin.ch); it covers 98% of public and private hospitals within Switzerland and includes all stays for each hospital.

Official Title
-----------------
Sixteen Years Trends in Reported Undernutrition in Switzerland

Conditions
-----------------
Malnutrition, Epidemiology

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (aged ≥20 years), length of hospital stay >1 day, not having any ICD-10 codes related to pregnancy, childbirth and puerperium (i.e. ICD-10 codes beginning with letter O) as main diagnosis, and having complete demographic data and information on main diagnosis and mortality Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|Observational study using official data from the Federal Office of Statistics|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| undernutrition reporting | ICD-10 codes E12 (undernutrition-related diabetes mellitus), E40 (kwashiorkor), E41 (nutritional marasmus), E42 (marasmic kwashiorkor), E43 (unspecified severe protein-energy undernutrition), E44 (protein-energy undernutrition of moderate and mild degree), E46 (unspecified protein-energy undernutrition), R63 (R63.0: Anorexia, R63.3: feeding difficulties and mismanagement; R63.4: abnormal weight loss and R63.6: Insufficient intake of food and water due to self-neglect), and R64 (cachexia). | 1998-2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional management | CHOP codes related to enteral nutrition (96.6 and 96.35), parenteral nutrition (99.15), nutritional advice and therapy (89.0A.30, 89.0A.31 or 89.0A.32, depending on year) and multimodal nutritional therapy (89.0A.4*, where *=any number). | 1998-2014 |