linjc16/ctgov huggingface dataset:
Human Circadian Sensitivity to Very Short Light Pulses

Study Overview
=================
Brief Summary
-----------------
The mammalian eye serves both visual and non-image-forming functions. New information about the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes, cognitive performance, alertness and sleep. The results of the proposed work can be used to make predictions about the effects of light, to make recommendations involving exposure to or avoidance of light, and to design environmental lighting, resulting in improved health and alertness and decreased errors and accidents.

Official Title
-----------------
Human Circadian Sensitivity to Very Short Light Pulses

Conditions
-----------------
Circadian Rhythm Disorders

Intervention / Treatment
-----------------
* Other: Ocular light or darkness exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: No medications No eye disease No sleep disorders No psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Ocular Light or Dark Exposure<br>Ocular Light or Dark Exposure | Other: Ocular light or darkness exposure<br>* Ocular light or darkness exposure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian Phase (hours) | Circadian phase (hours) measured before and after intervention | Before and after intervention (day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circadian rhythms, Melatonin, Ocular light exposure, Darkness Exposure, Performance, Alertness
WGS of NTM From Sputum of NTM Lung Disease Patients and From Their Environments

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to identify the genetic closeness of NTM derived from patients living together and from their surrounding environment and to trace the temporal relationship between them.

Detailed Description
-----------------
After NTM isolation is done by using culture, from patients' sputum/bronchoscopic samples and their environmental samples, whole genome sequencing (WGS) will be conducted for all NTM isolates. Phylogenetic analysis will be performed based on single nucleotide polymorphism (SNP) on each NTM.

Official Title
-----------------
Whole Genome Sequencing of Nontuberculous Mycobacterium (NTM) Derived From Sputum Specimen of NTM Lung Disease Patients Living Together and From Their Environmental Samples

Conditions
-----------------
Nontuberculous Mycobacterium Infection, Whole Genome Sequencing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The adult over 18 years of age The patient who have respiratory symptoms consistent with NTM, such as a chronic cough, sputum, and hemoptysis, who have NTM-positive findings on CT, and who have NTM identification in two or more sputum cultures or in one or more bronchoscopic/tissue culture. (2007 ATS/IDSA guideline) Pairs of patients living in the same household since diagnosis on NTM lung disease Consent to a collection of environmental samples from the patient's residence. Exclusion Criteria: If the patient does not agree or withdraw.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NTM patient group<br>NTM lung disease patients living together | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic similarity of NTM(Non-Tuberculous Mycobacterium) | Concordance of Single Nucleotide Polymorphisms (SNP) from NTMs derived from patients and their environments | Baseline |
Identification of a Plasma Proteomic Signature for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.

Detailed Description
-----------------
Blood samples are obtained from those patients undergoing procedures to determine if a lung nodule is benign or cancerous. The data from the study will not be used to guide or influence the treatment of the patients enrolled in this study. There is no change from the normal standard of care that patients receive.

Official Title
-----------------
Identification of a Plasma Proteomic Signature for Lung Cancer

Conditions
-----------------
Precancerous Conditions, Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 40 any smoking status, e.g. current, former, or never co-morbid conditions, e.g. COPD Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground glass opacity Pathology: malignant - adenocarcinoma, squamous, or large cell Pathology: benign - inflammatory (e.g. granulomatous, infectious) or non-inflammatory (e.g. hamartoma) Clinical stage, Primary tumor: ≤T2 (e.g. 1A, 1B, 2A and 2B) Clinical stage, Regional lymph nodes: N0 or N1 only Clinical stage, Distant metastasis: M0 only Exclusion Criteria: prior malignancy within 5 years of lung nodule diagnosis No nodule size available No pathology data available for those with Current diagnosis of non-small cell lung cancer Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis: ≥M1

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Incidence rate of Non-Small Cell Lung Cancer | The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test. | 24 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panel of proteins | The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders. | At the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Precancerous Conditions, Carcinoma
Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated intra-abdominal infections. <br />

Official Title
-----------------
A Multicenter, Randomized, Open-Label Comparison of the Safety and Efficacy of Tigecycline> vs Imipenem/Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Chinese Subjects

Conditions
-----------------
Abdominal Abscess

Intervention / Treatment
-----------------
* Drug: tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Hospitalized male or female subjects over 18 years of age Exclusion Criteria: · Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>armDesc1 | Drug: tigecycline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological response at the subject and pathogen level and evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and minimal inhibitory concentration (MIC) values and susceptibility data by isolate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritonitis, Community-Acquired Infections, Cross Infection
A Study of Patients With HER2 Gene Amplified Metastatic Breast Cancer Treated With First Line Herceptin and a Taxane

Study Overview
=================
Brief Summary
-----------------
This study is a Phase IV, prospective, nonrandomized, community-based study of clinical outcomes in patients with metastatic breast cancer treated with Herceptin and a taxane.

Official Title
-----------------
Clinical Outcomes in Patients With HER2 Gene-Amplified Metastatic Breast Cancer Treated With First Line Herceptin in Combination With a Taxane: A Phase IV, Prospective, Community Based Study

Conditions
-----------------
Breast Cancer, Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Available tissue for central laboratory evaluation of HER2 status Histologically confirmed, measurable or nonmeasurable but evaluable, HER2 positive metastatic breast cancer (HER2 positive is defined as 3+ staining by IHC or gene amplification by FISH, determined by the local or central laboratory) Life expectancy >6 months Female, age >=18 years ECOG performance status of 0, 1, or 2 Adequate bone marrow function as indicated by the following: *ANC >1500/uL, *Platelet count >=100,000/uL Adequate renal function, as indicated by creatinine <=1.5× upper limit of normal (ULN) Adequate liver function, as indicated by bilirubin <=1.5× ULN and AST or ALT <2× ULN unless related to primary disease Use of an adequate means of birth control (women of childbearing potential) Exclusion Criteria: Initiation of Herceptin >=4 weeks after beginning taxane chemotherapy Prior chemotherapy for metastatic disease Prior cumulative anthracycline dose of >360 mg/m2 History of significant cardiac disease or uncontrolled arrhythmias Ejection fraction of <50% or below the lower limit of normal Active infection Symptomatic or untreated brain metastases Pregnancy or lactation Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest Hypersensitivity to study medications Major organ failure or systemic disease precluding the safe administration of study medications

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
-----------------
Metastatic Breast Cancer
Gustatory Modulators Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy

Study Overview
=================
Brief Summary
-----------------
Identify possible modulators for developing gustatory dysfunction among a sample of depressed Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Detailed Description
-----------------
PECO P Population: depressed Egyptian adults under anti-depressants therapy E1 Exposure 1: commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL) E2 Exposure 2: commonly prescribed Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine) C control (non exposure) : non-pharmacological treatment ( psychotherapy) O Outcome: Identify possible gustatory dysfunction modulators among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Official Title
-----------------
Gustatory Modulators Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy. A Retrospective Cohort Study

Conditions
-----------------
Taste Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Depressed Egyptian adults under antidepressants therapy for at least 3 months/non-pharmacological treatment( psychotherapy) Age from 20 to 50 years old Exclusion Criteria: Antipsychotics Hypnotics Anticonvulsants Ages other than the mentioned • Olfactory dysfunction Chemosensory dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| Exposure 1<br>commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL) administered for at least 3 months | |
| Exposure 2<br>commonly prescribed Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine) administered for at least 3 months | |
| Non exposure<br>Non-pharmacological treatment (psychotherapy) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gustatory dysfunction modulators | -C.M will use an assessment questionnaire (appendix) to assess possible modulators for developing gustatory dysfunction including a number of short-term and long-term factors such as body mass, gender, age, local and systemic diseases, excessive alcohol drinking, drug dependence, smoking, state of oral hygiene, consumption of some foods or drugs | during a period of 7months from February 2020 till August 2020 |
A Study of MG1111 in Healthy Children

Study Overview
=================
Brief Summary
-----------------
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator

Official Title
-----------------
A Phase II/III, Single-blind(Stage 1), Double-blinded(Stage 2), Randomized, Active-controlled, Dose-escalation(Stage 1), Non-inferiority(Stage 2) Study to Evaluate Immunogenicity and Safety of MG1111 in Healthy Children

Conditions
-----------------
Healthy Children

Intervention / Treatment
-----------------
* Drug: Varicella Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children aged 12 months to 12 years. Subjects or parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures Negative history of Varicella and varicella vaccine Subject in good health, based on medical history and physical examination Exclusion Criteria: Subjects who have a history of Varicella or administration of varicella vaccine Subjects who have ahd an acute febrile episode at some time during the 72 hours before administration of investigational product or those who had any symptom suspected to be allergy including systemic rash.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MG1111(Varicella vaccine)<br>A single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1 | Drug: Varicella Vaccine<br>* The subject will receive investigational product or comparator.<br>* Other names: vaccination;|
| Active Comparator: Comparator(Varicella vaccine)<br>A single injection of 0.5ml comparator will be administered subcutaneously at Visit 1 | Drug: Varicella Vaccine<br>* The subject will receive investigational product or comparator.<br>* Other names: vaccination;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieved seroconversion |  | 42 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titer(GMT) measured by the FAMA assay |  | At day 0 and Day 42 post-vaccination | 
| Geometric mean titer(GMT) measured by gpELISA |  | At day 0 and Day 42 post-vaccination |
Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.

Detailed Description
-----------------
It describes the long-term quality of life (QoL) after ultrasound guided foam sclerotherapy (UGFS) and surgical stripping, outcomes with regard to clinical, and ultrasound recurrence, progression of venous disease, predictive value of the presence of central / deep venous obstruction for recurrence of varicose veins and the long term cost analysis. Recurrence of varicose veins was defined as the presence of one or more venous symptoms such as pain, cramps, restless legs and a tired/heavy feeling in the treated leg, in combination with the presence of reflux longer than 0·5 s. The initial definition of recurrent reflux, which is defined as reflux for more than 2 cm in length in the treated vein segment (proximal great saphenous vein (GSV) ) as measured by colour flow duplex ultrasound (DUS). DUS findings of the treated proximal GSV were categorized as: 1, absence of reflux; 2, reflux; 3, occlusion; 4, partial occlusion with reflux; 5, absence of vein, is being used. Patients in categories 2 and 4 are considered to have reflux.

Official Title
-----------------
Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study

Conditions
-----------------
Varicose Veins

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients included in previous FOAM study Exclusion Criteria: no received informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High ligation and stripping (surgery)<br>6-10 years post classical stripping of the great saphenous vein. | |
| Foam sclerotherapy<br>6-10 years post post ultrasound guided foam sclerotherapy of the great saphenous vein. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term QoL follow-up of patients after UGFS and surgical stripping |  | 6-10 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical recurrence |  | 6-10 years follow-up | 
| Technical recurrence | Vein closure rates | 6-10 years follow-up | 
| Number of retreatments |  | 6-10 years follow-up | 
| Venous Clinical Severity Score change |  | 6-10 years follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Foam, UGFS, Stripping, Incompetence
Recirculation, Oxygenator Blood Volume and Cardiac Output Measurements During Extracorporeal Membrane Oxygenation

Study Overview
=================
Brief Summary
-----------------
This study is to test the usefulness of ultrasound dilution measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). At the present time there are no devices available to perform these functions.

Detailed Description
-----------------
At the present time there are no devices available to measure recirculation, oxygenator blood volume and cardiac output in patients on extracorporeal membrane oxygenation. The study uses an external monitor, laptop computer, clamp on flowsensors and ultrasound dilution technology to measure blood flow. Measurements are made by injecting 0.5 - 1 ml/kg of sterile isotonic saline into the patient's extracorporeal circuit. The subject will be monitored throughout the measurements. The measurements will be coordinated with the regular care of the extracorporeal circuit.

Official Title
-----------------
Measurement of Recirculation, Oxygenator Blood Volume and Cardiac Output in ECMO Using a Modified Transonic Systems (tm) HD02 Monitoring System

Conditions
-----------------
Recirculation, Oxygenator Blood Volume, Cardiac Output, Venoarterial Extracorporeal Membrane Oxygenation, Venovenous Extracorporeal Membrane Oxygenation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonatal, pediatric or adult patients receiving venoarterial or venovenous extracorporeal membrane oxygenation. Exclusion Criteria: Patients not receiving venoarterial or venovenous extracorporeal membrane oxygenation.
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 |
| --- | --- | --- |
| Cardiac output, recirculation or oxygenator blood volume measurements made in patients receiving extracorporeal membrane oxygenation. |  | Duration of extracorporeal membrane oxygenation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac output, recirculation, oxygenator blood volume, venoarterial extracorporeal membrane oxygenation, venovenous extracorporeal membrane oxygenation