linjc16/ctgov huggingface dataset:
Study to Safety, Tolerability and Immunogenicity of EG-COVII in Healthy Adult

Study Overview
=================
Brief Summary
-----------------
This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers

Detailed Description
-----------------
Subjects will undergo a Screening period beginning up to 2 weeks prior to enrollment, the vaccinations will be administered on week 0 and week 3, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).

Official Title
-----------------
A Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: EG-COVII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure; Healthy volunteers aged above 18 years at the time of screening; Have had at least authorised primary COVID-19 vaccination(s) regardless of numbers of booster; The last authorised COVID-19 vaccination, the participants received, should be more than 16 weeks prior to the first IP vaccination; Exclusion Criteria: Participant with the evidence of COVID-19 infection at screening (Positive for COVID-19 with RT-PCR test with nasal mid-turbinate specimen); Participant who has the history of COVID-19 infection within 6 months from the first IP vaccination; Close contact with a person infected with COVID-19 within 2 weeks prior to the first IP vaccination;

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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EG-COVII<br> | Biological: EG-COVII<br>* EG-COVII is a bivalent vaccine to prevent SARS-CoV-2 infection against wild type and Omicron variants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of EG-COVII in healthy adult volunteers | Number of participants with adverse events (AEs) Number of participants with abnormal clinical laboratory results (hematology /chemistry /urinalysis) Number of participants with abnormal vital sign Number of participants with abnormal physical examination results | 7 weeks follow up |
Clinical Outcomes of Patients With a Light Adjustable Lens (LAL) in at Least One Eye

Study Overview
=================
Brief Summary
-----------------
To collect data on bilateral pseudophakic patients implanted with the RxSight Light Adjustable Lens (LAL) in at least one eye

Official Title
-----------------
Clinial Outcomes of Bilateral Pseudophakic Patients With a Light Adjustable Lens (LAL) Implanted in at Least One Eye

Conditions
-----------------
IOL

Intervention / Treatment
-----------------
* Device: Light Adjustable Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with bilateral pseudophakia who have been implanted with the LAL in at least one eye and who have completed LDD light treatments Exclusion Criteria: Visually significant eye disease

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 |
| --- | --- |
| LAL in at least one eye<br> | Device: Light Adjustable Lens<br>* The Light Adjustable Lens (LAL) is a posterior chamber, UV absorbing, three-piece, foldable, photoreactive silicone intraocular lens with a squared posterior optic edge intended to be implanted in the capsular bag following phacoemulsification. Selective exposure of the implanted RxSight LAL using the Light Delivery Device (LDD) to deliver a spatially profiled UV light produces modifications in the lens curvature resulting in a spherical or spherocylindrical power change post-operatively. A subsequent lock-in exposure is delivered to the implanted LAL to stabilize the lens power.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction - subjective questionnaire | Subjective questionnaire explores the frequency/need for glasses for various visual functions at distance/intermediate/near, experience with dysphotopsias, and overall satisfaction of visual function without glasses. | 3-18 months after cataract surgery |
Factors Associated With Survival in Patients Having Pneumocystis Jirovecii

Study Overview
=================
Brief Summary
-----------------
Pneumocystis jirovecii is a fungus that can colonize the airways of some patients and be responsible for a disease called pneumocystosis in other patients and mainly in immunocompromised patients. Pneumocystosis was mainly linked to HIV in the 1990s, but with the advent of new immunosuppressive molecules used in cancers or autoimmune diseases and with the increase in the number of transplants, the epidemiology has changed in recent years. Studies on P. jirovecii-related mortality are only based on patients with pneumocystosis. As a result, patients who are simply colonized or patients who are sick but not treated are not taken into account in these studies. The investigators therefore wish to study the overall mortality at six weeks and at three months in all patients with a positive sample for P. jirovecii

Official Title
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Factors Associated With Survival in Patients With a Positive Sample for Pneumocystis Jirovecii at the Strasbourg University Hospital: a Retrospective Study From 2016 to 2018

Conditions
-----------------
Pneumocystis Jirovecii Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patients with a positive respiratory sample for P. jirovecii cared for in Strasbourg University Hospitals between 01/01/2016 and 31/12/2018. Positive samples are defined as a direct examination finding cysts or trophozoites after staining with May-Grunewald-Giemsa and/or Gomori-Grocott, a positive P. jirovecii PCR on sputum, tracheal aspirates or bronchial fluid -alveolar Subject not objecting to the reuse of their data for scientific research purposes. Exclusion criteria: - Subject having expressed its opposition to the reuse of its data for scientific research purposes.

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 |
| --- | --- | --- |
| Survival at six weeks and three months after infection |  | six weeks after infection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumocystis jirovecii Infection, P jirovecii Infection, Pneumocystis Infections, Pneumocystis jirovecii, Pneumonia, Pneumocystis
Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.

Official Title
-----------------
Efficacy and Safety of Capecitabine and Cyclophosphamide (XC) Versus Physician's Choice as Maintenance Therapy for Advanced Breast Cancer: a Randomized, Controlled, Open-label Clinical Trial

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

Intervention / Treatment
-----------------
* Drug: XC
* Drug: TPC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, age≥18 years old ECOG≤2 Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions HR+/HER2+ or HR-/HER2+ or HR-/HER2- At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1 Disease control (complete response + partial response + stable disease) after salvage treatment Expected survival ≥6 months Adequate organ function Exclusion Criteria: during pregnancy and lactation Patients with central nervous system metastasis

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Experimental: capecitabine and cyclophosphamide (XC)<br>capecitabine and cyclophosphamide as maintenance therapy every 3 weeks | Drug: XC<br>* Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days<br>|
| Active Comparator: physician's choice<br>Any physician's choice as maintenance therapy (except for XC regimen). | Drug: TPC<br>* Any physician's choice as maintenance therapy (except for XC regimen)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first. | From the date of starting maintenance therapy to the date of first documentation of disease progression or death from any cause (up to approximately 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0. | From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)] |
Electronic Medical Record Alerts to Optimize Medical Therapy in Heart Failure and Reduced Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
OPTIMAL-HF is a pragmatic, cluster randomized, single-blind intervention trial that will be conducted at an outpatient clinic in Argentina. The trial will assess the effectiveness of an individualized-based alert system compared to usual care in improving GDMT optimization at 90 days in patients with HFrEF.

Official Title
-----------------
Electronic Medical Record Alerts to Optimize Medical Therapy in Heart Failure and Reduced Ejection Fraction in a Low-middle Income Country

Conditions
-----------------
HFrEF - Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
-----------------
* Other: EMR alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients Inclusion Criteria: Eligible patients will include those with an EF ≤ 40% on their most recent echocardiogram, age > 18, and an outpatient cardiology encounter during the study period. Age 18 or over Exclusion Criteria: under optimal medical treatment palliative care, or undergoing hemodialysis will be excluded Cardiologist Inclusion criteria: Cardiologists from an outpatient clinic at a cardiovascular center in Buenos Aires will be selected for potential participation in the study. Exclusion criteria Cardiologists belonging to the heart failure service

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: EMR Alert<br> | Other: EMR alert<br>* EMR alert for medication optimization<br>|
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint will be the GDMT optimize score in HfrEF patients 90 days after randomization. |  | 90 days |
To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.

Detailed Description
-----------------
To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects

Official Title
-----------------
To Evaluate the Safety and Tolerability of GS3-007a Oral Solution in a Multi-dose, Randomized, Open, Single-center Study in Healthy Chinese Adult Subjects.

Conditions
-----------------
Healthy Subject

Intervention / Treatment
-----------------
* Drug: GS3-007 oral liquid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult subjects aged 18-45 years (including boundary values), male or female; Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg; Exclusion Criteria: (Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation; (screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment; ALT and AST exceed the upper limit of the normal range;

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS3-007 oral liquid<br>36 subjects，12 subjects in each dose group. Two dose groups were planned: 0.8 mg/kg and 1.6 mg/kg once a day for 4 weeks. According to the research progress of 1.6mg/kg QD, it was decided whether to add 0.8 mg/kg twice a day for 4 weeks. | Drug: GS3-007 oral liquid<br>* The dosage was calculated according to body weight, once a day or twice a day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEAEs |  | 35 Days |
The Effect of Using Walking Aid On TUG Test

Study Overview
=================
Brief Summary
-----------------
The Timed Up and Go Test is a measurement tool that allows the participant to use assistive devices and walking aids during the test that evaluates functional mobility. This study was conducted to determine the effect of using walking aids on the Timed Up and Go test and it's correlation with balance in stroke patients.

Detailed Description
-----------------
Cross-sectional, observational study

Official Title
-----------------
The Effect of The Use of Walking Aid On Timed Up and Go Test In Patients With Stroke

Conditions
-----------------
Stroke, Locomotion Disorder, Neurologic

Intervention / Treatment
-----------------
* Diagnostic Test: evaluation af mobility and balance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mini Mental State Test >24 Stroke patients who can walk 10 meters with or without walking aid Exclusion Criteria: Individuals dependent on bed or wheelchair Individuals with musculoskeletal disease that may adversely affect mobility and balance. Individuals who have had any operation in the last 6 months

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: evaluation af mobility and balance|evaluation af mobility and balance Timed Up and Go Test Berg Balance Scale|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go Test | Mobility | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Balance | up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
balance, stroke, Timed Up and Go Test, locomotion
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring

Study Overview
=================
Brief Summary
-----------------
From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation [SD] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose & Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).

Official Title
-----------------
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose

Conditions
-----------------
Type 1 or Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥18 years, male or female; Clinically diagnosed with diabetes; Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring; Consent to participate in this clinical study, and sign the Informed Consent Form (ICF). Exclusion Criteria: Disagree to wear the investigational device continuously according to the requirements of the trial; Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial; Plan to undergo magnetic resonance imaging (MRI) during the clinical trial; With diffuse subcutaneous nodules at the wearing site of the investigational device; Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening; With mental disorders, lack of self-control and inability to express clearly; Have participated in any other clinical trial within the past 1 month; Where the investigator thinks not suitable for being enrolled.

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 |
| --- | --- |
| In pateint<br> | |
| Out pateint<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall mean absolute relative difference (MARD) |  | 8 or 15 days |
Australian University of California San Francisco (UCSF) Concussion in Athletes (AUSSIE-2)

Study Overview
=================
Brief Summary
-----------------
Analysis of cardiac induced brain forces using cranial accelerometry has been shown to diagnose concussion in high school athletes. This trial expands on this observation by recording headpulse signals in a recently concussed athletes playing Australian rules football.

Detailed Description
-----------------
Recently concussed athletes will have headpulse measurements obtained as soon after the clinically identified concussion as is feasible and at 1-3 day intervals over the course of a month. These recordings will pair with a self administered neurological symptom inventory (NSI) to track the athletes subjective concussion symptoms. Data from the prior study (AUSSIE-1) will be used to confirm the predictive value of the established algorithm

Official Title
-----------------
Australian UCSF Concussion in Athletes Studied With Cranial Accelerometry Part 2

Conditions
-----------------
Concussion, Mild

Intervention / Treatment
-----------------
* Device: Headpulse measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Concussion Subjects: Inclusion Criteria: Diagnosed with sport related concussion first recording obtained within one week willingness to have multiple recordings in the month following concussion Exclusions: - head laceration Control subjects: Inclusion Criteria athletes without concussion over the last year willingness to have single or multiple recordings Exclusion Criteria: head laceration

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Concussed<br>Diagnosis of concussion | Device: Headpulse measurements<br>* Placement of headset on subject<br>* Other names: Wrist accelerometer;|
| Controls<br>Athletes with no concussion with the preceding year | Device: Headpulse measurements<br>* Placement of headset on subject<br>* Other names: Wrist accelerometer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of model for the detection of concussion | Sensitivity of headpulse measurements confirming concussion | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery of headpulse following concussion | Time (hours) when the headpulse biometric returns to within 1 SD of normal values | 1 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
headpulse, mTBI