linjc16/ctgov huggingface dataset:
Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether RX-10100 are effective in the treatment of Major Depressive Disorder (MDD).

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study of RX-10100 in Subjects With Major Depressive Disorder.

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: RX-10100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Moderate to severe MDD as determined by the DSM-IV-TR Axis 1 Disorders and by the Montgomery Asberg Depression Rating Scale (MADRS). Exclusion Criteria: Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not willing to practice a reliable method of birth control Depressive episode duration of less than 1 month Lifetime history of any psychotic disorders Anxiety disorders Significant suicidality Clinically significant medical conditions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RX-10100 high dose<br>RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks | Drug: RX-10100<br>* Extended-release tablet, taken twice daily for 8 weeks<br>* Other names: Serdaxin®;|
| Experimental: RX-10100 low dose<br>RX-10100 Study drug is to be given orally, in tablet form, twice daily, for 8 weeks | Drug: RX-10100<br>* Extended-release tablet, taken twice daily for 8 weeks<br>* Other names: Serdaxin®;|
| Placebo Comparator: Placebo<br>Matching placebo is to be given orally, in tablet form, twice daily, for 8 weeks | Drug: RX-10100<br>* Extended-release tablet, taken twice daily for 8 weeks<br>* Other names: Serdaxin®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)at week 9 |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at weeks 3, 5, and 7 |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, Depression, Major Depression
The Correlation Between Sevoflurane and qNOX

Study Overview
=================
Brief Summary
-----------------
This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the correlation between the sevoflurane and NOX index.

Detailed Description
-----------------
This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the analgesia effect of the sevoflurane. And test the correlation between the sevoflurane and NOX index.

Official Title
-----------------
The Prospective Observational Research of the Analgesic Effect of Sevoflurane and the Correlation Between Sevoflurane and qNOX

Conditions
-----------------
Analgesic Adverse Reaction, Nociceptive Pain, Inhalation; Vapor

Intervention / Treatment
-----------------
* Device: nociception index qNOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective thoracoscope surgery patients Age ranging from 25 to 85 years American Society of Anesthesiologists (ASA) Physical Status score of 2 to 4 a body mass index (BMI) ranging from 18.5 to 40 kg/m2. Exclusion Criteria: Clinical diagnosis of Alzheimer's Disease implanted pacemaker Clinical diagnosis of psychiatric diseases Clinical diagnosis of epilepsy Clinical diagnosis of autonomic nervous system disorders which might affect the EEG

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: nociception index qNOX|non-invasive, real time, monitoring for nociception stimulation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sevoflurane application correlated with the qNOX index | The sevoflurane application correlated with the qNOX index, meanwhile reflect the analgesia effect of sevoflurane application | through study completion, an average of 1 year |
In-Hospital Comprehensive Geriatric Assessment in Aged Acute Medical Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare acute ill elderly medical patients in a geriatric department with general medical departments, and to examine the effects of comprehensive geriatric assessment in the geriatric setting compared with general medical care.

Detailed Description
-----------------
Design: 1) a cross-sectional study followed by 2) a subgroup study by retrospective follow-up

Conditions
-----------------
Acute Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted to the departments of medicine at Aarhus University Hospital either through the emergency medical ward or directly to the medical wards in the period from January 1, 2009 to December 31, 2010. Exclusion Criteria: patients admitted to the neurology-, cardiology-, nephrology- or haematology departments, and patients discharged directly to their homes from the emergency medical ward.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Patients admitted to Geriatric Department<br>The patients receive comprehensive geriatric assessment | |
| Patients admitted to general medical departments<br>This group do not receive comprehensive geriatric assessment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidity | By Charlsons Comorbidity Index | At hospital admission (day 1) | 
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 8 days. | Number of days of hospitalization an expected average of 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute readmission | The number of acute readmissions in the participants within 30 days and 90 days after the discharge, respectively. | 30 days and 90 days | 
| Mortality | The number of short-term mortality in the participants within 30 days after hospital admission. | Within 30 days after hospital admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Services for the Aged, acute medical care, comprehensive geriatric assessment, Geriatric Assessment, Geriatrics, Aged
Thyroid Uptake Quantification on a New Generation of Gamma Camera

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the potential of a new large field CZT gamma camera to estimate the thyroid uptake (TU) on Single photon emission computed tomography (SPECT) and SPECT/CT images in comparison with standard planar scintigraphy. The secondary objective is to analyze the diagnostic contribution of SPECT/CT imaging.

Detailed Description
-----------------
Planar and SPECT/CT scintigraphy will be performed on a new generation large field CZT gamma camera and thyroid uptake (TU) value will be calculated on planar acquisition for 23 consecutive patients referred in our department for hyperthyroidism. With a quantitative approach using attenuation, scatter correction and iterative algorithm with resolution recovery we will have the possibility to calculate the TU value with SPECT or SPECT/CT acquisitions. Our primary objective will be to evaluate the potential of a new large field CZT gamma camera to estimate the thyroid uptake on SPECT (Tomography without attenuation correction) and SPECT/CT (tomography with attenuation correction) acquisitions compared with standard planar scintigraphy as a gold standard. The secondary objective will be to analyze the diagnostic contribution of SPECT/CT images. To established this study it will be necessary to introduce cross-calibration factors performed from a thyroid phantom, for planar and SPECT acquisitions, to estimate the thyroid uptake values.

Official Title
-----------------
Quantitative Analysis of 99mTc-Pertechnetate Thyroid Uptake With a Large Field CZT Gamma Camera: Feasibility and Comparison Between SPECT/CT and Planar Acquisitions

Conditions
-----------------
Hyperthyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hyperthyroidism confirmed by blood test (TSH) and thyroid ultrasound Exclusion Criteria: Pregnant women

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 |
| --- | --- | --- |
| Thyroid uptake | Quantification of thyroid uptake | Inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPECT/CT | Diagnostic contribution of SPECT/CT | Inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid, uptake, quantification, CZT, Planar, SPECT/CT
Perioperative Pediatric Blood Transfusion Therapy

Study Overview
=================
Brief Summary
-----------------
The present retrospective study analyses perioperative haemotherapy in children and adolescents at the University Hospital Frankfurt.

Detailed Description
-----------------
In the center of the analyses are the perioperative consumption of transfused red cell concentrates, platelet concentrates and frozen fresh plasma in children and adolescents. The distribution by subject area is also examined, demographic distribution and indicators on transfusion. With the introduction of the Patient Blood Management for adults at the University Hospital in 2013 have become potentially also result in changes in transfusion practice in children, which should also be investigated.

Official Title
-----------------
Analysis of Perioperative Pediatric Blood Transfusion Therapy

Conditions
-----------------
Transfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents <18 years Hospital admission Operation Exclusion Criteria: - none

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfused red cell concentrates | Quantity of transfused red cell concentrates | 01.01.2010 - 31.12.2019 | 
| Platelet concentrates transfused | Quantity of Platelet concentrates transfused | 01.01.2010 - 31.12.2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transfusion, Pediatric, Patient Blood Management
A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics. Subjects are dosed for 14 days.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

Conditions
-----------------
Safety and PK in Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: MS-553
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In good general health with BMI 18 to 32 kg/m2. Females must be nonpregnant, nonlactating, postmenopausal at least 2 years or surgically sterilized at least 6 months prior Exclusion Criteria: History of skin rash, migraine, or clinically significant ocular diseases, conditions predisposing to QT prolongation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MS-553<br>MS-553 oral tablet BID x 14 days | Drug: MS-553<br>* Study Drug<br>|
| Placebo Comparator: Placebo<br>Placebo oral tablet BID x 14 days | Drug: Placebo<br>* Matching placebo to MS-553<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Adverse Events as a Measure of Safety and Tolerability |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | 14 days | 
| Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve |  | 14 days |
Faith-Based Initiative to Promote Health in Appalachia

Study Overview
=================
Brief Summary
-----------------
The project will target two behavioral causes of obesity: a sedentary lifestyle and an unhealthy diet. The goal is to test a faith-based intervention among men and women who are members of participating Appalachian churches. The primary hypothesis being tested in this project is: The change in body mass index from baseline to one year follow-up in intervention churches will be greater than among comparison churches, such that the differential change will be negative on average.

Official Title
-----------------
Appalachia Community Cancer Network II Centers for Reducing Cancer Disparities: Faith-Based Initiative to Promote Health in Appalachia

Conditions
-----------------
Cancer, Obesity

Intervention / Treatment
-----------------
* Behavioral: Walk by Faith


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Member of the participating church who has attended services at least 4 times in the past 2 months resident of an Appalachia county Able bodied (no contraindications to physical activity and no dietary restrictions that are part of a medically prescribed diet for weight loss or formal weight loss program) Able to read and write in English Have a BMI indicating that they are overweight (BMI > or = 25.0, assessed during biometric measurement) Under 400 pounds (per self-report and confirmed during biometric measurement) Not planning to move out of the area within the next year Does not reside in nursing facility or residential home If female, is not pregnant, breastfeeding or less than 9 months post-partum and does not intend to become pregnant during the study Able to provide informed consent. Exclusion Criteria: Does not meet Inclusion 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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walk by Faith<br>Intervention arm | Behavioral: Walk by Faith<br>* The Walk by Faith program is aimed at increasing physical activity and improving healthy eating to reduce or maintain healthy BMI among members of the churches.<br>|
| No Intervention: Comparison<br>Non-intervention arm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index from baseline to one year follow-up |  | Baseline, month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Mass Index, Cancer, Obesity
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

Study Overview
=================
Brief Summary
-----------------
To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).

Official Title
-----------------
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

Conditions
-----------------
Uterine Leiomyoma

Intervention / Treatment
-----------------
* Device: Uterine Embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients from 18 to 50 years old; symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural; patient agrees with study procedures; patient signs the informed consent form. Exclusion Criteria: asymptomatic women; isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma; leiomyoma diameter higher than 10 cm; leiomyoma above the umbilical scar; endometrial neoplasia or hyperplasia or presence of any malignancy pregnant or breast feeding women; active vasculitis; pelvic irradiation history; uncontrolled coagulopathies; renal insufficiency; contrast allergy; concomitant use of GnRH analogues.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single-arm, open label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization<br>Uterine Embolization with PVA Microspheres | Device: Uterine Embolization<br>* Uterine Embolization with PVA Microspheres<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Volume Reduction | Uterine Volume Reduction measured by MRI | 6 months | 
| Fibroid Reduction | Fibroid Reduction measured by MRI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Improvement | Quality of Life Improvement measured by UFS-QOL | 6 months | 
| Ovarian Function | Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embolization, Uterine Leiomyoma, Embospheres, Microspheres
Observation of the Natural Course of Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
This research will study natural course of dry AMD in Chinese population, screen fundus imaging indicators for patients with Chinese dry AMD, describe the clinical features of Chinese patients with dry AMD, and obtain a biological sample library of dry AMD mainly in China.

Official Title
-----------------
Observation of the Natural Course of Dry Age-related Macular Degeneration

Conditions
-----------------
Macular Degeneration, Dry, Dry Age-related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50-85 yrs male or female AMD patients Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations. Exclusion Criteria: Any eye with disease that would interfere with the retinal examinations Research eye with CNV or high myopia Surgeries that may interfere with AMD evaluation Long-term uses of medications that are associated with retinal or neural toxicities. IOP more than 26 mmHg Received cataract surgery in 3 months. Other conditions: diseases that causes less than 5 years survival; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer. Other conditions not suitable for the current study

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Visual acuity | A typical ETDRS chart that if frequently used for visual acuity testing | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drusen density and shape | Drusen Measurement on OCT or Fundus photography | 60 months | 
| The rate of 5-year progression | The evaluation criteria for progression: progress to intermediate (only for patients with early phase AMD at baseline) or intermediate-to-late, or late stage AMD. | 60 months | 
| GA growth rate |  | 60 months |