linjc16/ctgov huggingface dataset:
Consistency of PD-L1 Detecting Method Between E1L3N and 22C3 Monoclonal Antibodies in NSCLC Patients

Study Overview
=================
Brief Summary
-----------------
Evaluated the correlation between the qualitative test results of Xiamen Aide PD-L1 antibody reagent (immunohistochemistry) and the efficacy of Keytruda single-agent therapy, and the research data is used to support the registration and marketing of the assessment reagent

Official Title
-----------------
Consistency of Immunohistochemical Detecting Assays Using E1L3N and 22C3 Monoclonal Antibodies for Detection of PD-L1 Expression in NSCLC Patients: A Prospective CONFIDENCE Study

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18，advanced non-small cell lung cancer confirmed by histopathology, and have received K-drug mono-therapy in the past, the return visit information is complete, with traceable information such as tumor imaging examinations before and after treatment, and the curative effect can be judged; Able to provide FFPE samples with a storage life of 4 years: 6 slices of continuous slices with a thickness of 3-5μm Exclusion Criteria: Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells <100); K-drug mono-therapy is neoadjuvant therapy or adjuvant therapy; Other situations that the investigator thinks are not suitable for participating in this clinical study

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency | the consistency of PD-L1 expression between monoclonal antibodies of E1L3N and 22C3 | August 2018- September 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival time | August 2018- September 2021 | 
| ORR | Objective response rate | August 2018- September 2021 |
Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Objective of study is to assess the costs of care, objective and subjective caregiver burden and quality of life in relation to disease severity measured by cognitive function, ADL capabilities and presence of behavioral disturbances in Alzheimer's disease

Official Title
-----------------
Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of possible or probable Alzheimer's disease, with or without vascular elements The primary caregiver can be identified The patient and his/her primary caregiver are both willing and able to participate in the study Exclusion Criteria: Patient or caregiver affected by alcohol or narcotics to the extent that it interferes with the completion of the study Patient or caregiver does not understand English Patient and/ or caregiver is the physician or physician's staff Patient and/ or caregiver is a family member of the physician or physician's staff
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<br>1200 adults with mild to severe Alzheimer's disease | |
| Caregivers<br>1200 informal caregivers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q) |  | Collected one time only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resource Utilization in Dementia (RUD) |  | collected one time only | 
| Short Form - 12 domains instrument (SF-12) |  | collected one time only | 
| World Health Organization Quality of Life instrument (WHO-QoL) |  | collected one time only | 
| Zarit Caregiver Burden Interview (ZBI) |  | collected one time only | 
| 15 domains Quality of Life Index instrument (15D) |  | collected one time only |
Pain Control After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Patients are randomized to receive pain control after Total Knee Arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. Pain, analgetic use and mobility is asessed.

Official Title
-----------------
Pain After Total Knee Arthroplasty With Either Regional or Local Pain Katheter

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Regional pain control
* Procedure: Local pain control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication to Total Knee Arthroplasty Signed informed consent Exclusion Criteria: Chronic pain Allergy against local anaesthetics Not understanding study or questionnaires

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 |
| --- | --- |
| Active Comparator: Regional pain control<br>Regional pain catheter | Procedure: Regional pain control<br>* Regional pain catheter<br>|
| Experimental: Local pain control<br>Local intraarticular pain catheter | Procedure: Local pain control<br>* Local intraarticular pain catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Pain on Visual Analog Scale | daily until day 7 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgetics | Use of additional analgetics | daily until day 7 after surgery | 
| Mobility | grade of mobility | daily until day 7 after surgery | 
| Function | Knee Society Score | preoperative, 3 month, 1 year | 
| Patient reported outcome | Oxford Knee Score | preoperative, 3 month, 1 year | 
| Quality of Life | EQ 5D | preoperative, 3 month, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Knee Arthroplasty, Total Knee Replacement, Outcome, Results, Pain
Frequency and Clinical Evolution of Olfactory and Taste Disorders in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
A novel coronavirus SARS-CoV-2 HAS arose in 2019 in Wuhan, China. Beside the classical semiology of this infection, numerous patients described olfactory and teste disorders. These symptoms are not described in this coronavirus, neurotropism of coronaviridae has been documented before. The aim of the study is to evaluate prevalence of anosmia and dysgeusia (olfactory and taste disorders) in coronavirus diagnosed patients and compare with different clinical conditions. The second endpoint is to evaluate the duration of these symptoms in order to better understand the semiology of this infection.

Official Title
-----------------
Prevalence and Clinical Evolution of Olfactory and Taste Disorders in Patients Infected by SARS-CoV-2

Conditions
-----------------
COVID-19 by SARS-CoV-2 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 diagnosed
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals diagnosed for COVID-19<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anosmia | Prevalence for anosmia in the COVID-19 + patients | 45 days | 
| Ageusia | Prevalence for ageusia in the COVID-19 + patients | 45 days | 
| Duration of the loss of anosmia ageusia | Duration measured in days | 45 days |
Sodium Management in Acute and Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time) and a moderate Na restriction in the long term on readmissions and mortality in patients in III NYHA class.

Official Title
-----------------
Sodium Management in Acute and Chronic Phases in Patients With New York Heart Association Class III (Class C) Heart Failure. Short and Long Term Findings.

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Decompensated HF due to ischemic or nonischemic cardiomyopathy, >18 years of age, HF according to Framingham criteria NYHA functional class III EF <40%, Serum creatinine <2,5 mg/dL BUN <60 mg/dL, Exclusion criteria: NYHA class > III or < III, Cerebral vascular disease, Dementia, Cancer, Uncompensated diabetes, Severe hepatic disease Patients requiring pacemaker Previous RCT implantation Alcoholic habit

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 |
| --- | --- |
| low sodium diet 80 mmol/day<br> | |
| moderate sodium intake 120 mmol/day<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| readmission for HF worsening |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure III NYHA class, Furosemide, Sodium, water restriction, decompensated heart failure, Hypertonic saline solution, Moderate sodium restriction
Time-Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals

Study Overview
=================
Brief Summary
-----------------
Only few data are available on the influence of strenuous exercise on the content of circulating progenitor cells and especially the timeframe of their release. The aim of the present study was to investigate the potential influence of 4 hours of cycling on the time-dependent release of progenitor cells.

Detailed Description
-----------------
What is the response of hematopoietic and endothelial progenitor cells after a standardized prolonged endurance exercise? What is the kinetic of cell mobilization during this standardized exercise?

Official Title
-----------------
Time Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals.

Conditions
-----------------
Healthy Men

Intervention / Treatment
-----------------
* Procedure: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

| Intervention/Treatment |
| --- |
|Procedure: Exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial progenitor cells (EPC) release on |  | 4 hours |
Evaluation of Biological Markers of Mesenteric Ischemia During an Ultra-trail

Study Overview
=================
Brief Summary
-----------------
To assess the evolution of biological markers of mesenteric ischemia during ultratrail.

Detailed Description
-----------------
During physical exercise, increased sympathetic nervous system activity redistributes blood flow from splanchnic organs to working muscles. With prolonged duration and / or intensity, the splanchnic blood flow can be reduced by 80% or more. A severely reduced of splanchnic blood flow can frequently cause gastrointestinal ischemia. This ischemia associated with reduced vagal activity probably results in changes in motility and absorption. High symptoms are reported in 40% of runners with reflux and heartburn in 15-20% of runners. The low symptoms have an incidence of about 70% in the long runs type ultra-trail. Biological markers such as I-FABP have been shown to be useful in the diagnosis of mesenteric ischemia.

Official Title
-----------------
Evaluation of Biological Markers of Mesenteric Ischemia During an Ultra-trail

Conditions
-----------------
Ultra-trail Participation

Intervention / Treatment
-----------------
* Biological: Blood analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Voluntary Subject Age > 18 years Written consent Subject affiliated to Social Security Medical certificate (mandatory to take part in the ultra-trail) Exclusion Criteria: Refusal to participate Subject with legal protection (guardianship, trusteeship)

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 |
| --- | --- |
| Runners<br>To assess the evolution of biological markers of mesenteric ischemia during ultratrail. | Biological: Blood analysis<br>* Blood test of biological markers of mesenteric ischemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess biological markers of mesenteric ischemia (IFABP) | during ultratrail. | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between digestive symptoms and biological markers (IFABP). |  | at day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biological markers, mesenteric ischemia, ultratrail
Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Study Overview
=================
Brief Summary
-----------------
This study was designed to check the efficacy of a new oral medical drug treatment, namely Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma. Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to have the D2 receptor in in vitro studies.

Official Title
-----------------
Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Conditions
-----------------
Cushing's Disease, Corticotroph Adenoma

Intervention / Treatment
-----------------
* Drug: Cabergoline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Cushing's disease uncured biochemically after pituitary surgery with adenoma on histopathology Exclusion Criteria: Patient's intolerance to drug or known sensitivity to ergot derivatives Pregnancy, lactation or female wishing to be pregnant Any serious medical illness Patient on any drugs known to have an interaction with cabergoline including antihypertensives like reserpine and methyl dopa, neuroleptics, metoclopramide, etc

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cabergoline<br> | Drug: Cabergoline<br>* Dose 1 mg/week in divided doses, increased by 1 mg/week every month, to the maximum of 5 mg/week. If response is seen than the dose at which response is seen is continued until the end of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cabergoline
Clinical Test for Armed-used Blood Pressure Monitor With Preformed Cuff(Monitor When Being Inflated)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the blood pressure level of the patient using a blood pressure monitor which test the blood pressure level in inflating state . The cuff range in the study is 22cm-48cm

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cuff circumference:22cm-48cm Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| monitor method<br>blood pressure monitor Cuff circumference:22cm-48cm stethoscopy Cuff circumference: 22cm-48cm | |

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
-----------------
BP
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

Official Title
-----------------
A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression

Conditions
-----------------
Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: existing diagnosis of ADPKD by modified-Ravine criteria Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI Exclusion Criteria: Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 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 |
| --- | --- |
| No treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of change in total kidney volume with ADPKD-related outcomes |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported pain |  | every 6 months | 
| SF-12 Scores |  | every 6 months | 
| ADPKD-Impact Scale Score |  | every 6 months | 
| Cost of care |  | every 6 months | 
| EQ-5D Scores |  | Every 6 months |
Genotype Influence on Recovery After Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Genetic differences in response to brain injury may reasonably be expected to play a role in the initial consequences of traumatic brain injury and in the rate of recovery from such injury.

Detailed Description
-----------------
Polymorphisms in the Apolipoprotein E gene encode functional variants which differentially determine the rate at which neuronal repair can occur, and are associated with differences in expression of neurodegenerative processes, including traumatic brain injury. It is proposed that the accuracy of prediction of outcome after head injury will be significantly increased by inclusion of APOE genotype alone, or in combination with other variables such as severity of head injury, cognitive, electroencephalographic or neuroradiologic measures, or treatment strategies.

Official Title
-----------------
The Influence of APOE Genotype on Recovery After Traumatic Brain Injury

Conditions
-----------------
Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients enrolled in the DVHIP are subject to the following recruitment criteria: Mild, moderate or severe closed head injury, where the cut off between mild and moderate is defined by GCS<12. PTA>24 hrs or - foca cerebral contusion on CT/MRI or Loss of Consciousness (LOC) > 12 hours. Note: the definition of mild, moderate or severe head injury differs widely between centers and is absolutely not critical for the work proposed as we will use continuous measures of severity throughout. Within three months of first assessment. (In practice, patients may be recruited after 3 months. We will deal with this issue by covarying the time from injury to first assessment in our analyses). Rancho Los Amigos cognitive level of 5-7 at first assessment. Volunteer informed consent signed by patient of family. Military or veterans health care beneficiary. Age 17-55 Exclusion Criteria: Unwillingness to participate in rehabilitation program or cooperate with investigators. History of prior severe traumatic brain injury of other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 55 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic Brain Injury