linjc16/ctgov huggingface dataset:
A Study of Disposable Transnasal Esophagoscope

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety and tolerance.

Detailed Description
-----------------
A disposable, transnasal esophagoscope, E.G. ScanTM was developed by IntroMedic Co. Ltd. (Seoul, Korea). This device was designed to allow patient to undergo endoscopy with minimum pain without sedation. This endoscopy system consists of thin probe with a CMOS camera, controller and simple display system. This system is light enough to carry and does occupy much space, and thus, it can be used at patient bed sides in intensive care units, in emergency rooms, and even in doctor's offices.

Official Title
-----------------
A Novel Disposable Transnasal Esophagoscope: a Prospective Pilot Trial of Feasibility, Safety and Tolerance

Conditions
-----------------
Gastroesophageal Reflux, Esophageal Varices, Esophageal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 20 years or older endoscopy indicated for reflux symptoms (heartburn, epigastric soreness and/or regurgitation), dyspepsia (epigastric discomfort, bloating, early satiety), or non-cardiogenic chest pain, or known or suspected to have esophageal varices, infectious esophagitis, or other esophageal disease based on their medical history a written informed consent form Exclusion Criteria: history or symptoms of severe rhinitis and sinusitis symptoms of acute respiratory inflammation at the time of examination abnormal anatomy of the nasal cavity or nasopharynx due to nasal tumors or previous nasopharyngeal surgery taking anticoagulants such as coumadin patients for whom a EGD could not be performed

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophagoscope, esophageal disease, gastroesophageal reflux, esophageal varices
Naxitamab and GM-CSF in People With Neuroblastoma

Study Overview
=================
Brief Summary
-----------------
This is an Expanded Access Program (EAP) that will give the participants access to the drug naxitamab before it is approved by the FDA. Naxitamab will be combined with granulocyte-macrophage colony stimulating factor (GM-CSF). Participants in this study will have high-risk neuroblastoma that either went away completely after treatment (complete remission) or has come back (relapsed/refractory). Researchers think the combination of naxitamab and GM-CSF will be effective because naxitamab and GM-CSF strengthen the immune system's response to cancer cells in different ways. Naxitamab is an antibody, like the proteins made by the immune system to protect the body from harm. Naxitamab helps the cells of the immune system to find and attack cancer cells. GM-CSF is a protein that strengthens the immune system by increasing the number of immune cells called granulocytes. Granulocytes are white blood cells that fight off cancer cells. The combination of naxitamab and GM-CSF is a type of immunotherapy.

Official Title
-----------------
Expanded Access Use of Naxitamab/GM-CSF Immunotherapy for Consolidation of Complete Remission or Relapsed/Refractory High-Risk Neuroblastoma

Conditions
-----------------
High-Risk Neuroblastoma

Intervention / Treatment
-----------------
* Biological: Naxitamab/GM-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are ineligible to participate in study NCT03363373 (IRB# 18-375), will be considered for treatment under this expanded access protocol. Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels Patients must have HR-NB (MYCN-amplified stage 2/3/4/4S of any age and MYCNnonamplified stage 4 in patients greater than 18 months of age). Patients must be in first or greater CR or have refractory or relapsed disease If previously treated with any anti-GD2 mAb, human anti-hu3F8 antibody (HAHA) titer must be negative. Exclusion Criteria: Active life-threatening infection Pregnant women or women who are breastfeeding HAHA titer positive History of anaphylaxis CTCAE grade 4 to naxitamab

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Naxitamab/GM-CSF|naxitamab/GM-CSF for 5 Cycles|

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
-----------------
Remission High-Risk Neuroblastoma, Relapsed/Refractory High-Risk Neuroblastoma, Naxitamab, GM-CSF, 20-227
102 Annual Pap Smear Screening Database Maintenance Project

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the subsequent cancer risks, including gynecological cancers and malignancies at other sites, after the detection of screening positives and the diagnosis for primary cervical cancer.

Official Title
-----------------
102 Annual Pap Smear Screening Database Maintenance Project

Conditions
-----------------
Cancer, Human Papillomavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Citizens in Taiwan Women who attended screening, or who were diagnosed as cervical cancer Women who did not attend screening for at least 6 years Exclusion Criteria: Women died before the follow-up initiation Women who had received hysterectomy before the follow-up initiation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 130 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Entire Taiwan women<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the cancer diagnosis or the recurrence, the death, or the last date of follow-up, whichever came first |  | up to 25 years |
Spiration Valves Against Standard Therapy

Study Overview
=================
Brief Summary
-----------------
VAST is a multicenter, prospective, randomized, controlled study designed to evaluate treatment of persistent air leak with the SVS as compared to standard chest tube drainage management and other standard-of-care interventions in the control group. Eligible subjects will be randomized to receive either Spiration Valves (investigational arm) or continue standard-of-care treatment (control arm). Once the air leak has resolved, Spiration Valves should be removed.

Official Title
-----------------
Safety and Effectiveness of the Spiration Valve System (SVS) in Air Leaks

Conditions
-----------------
Pulmonary Air Leaks

Intervention / Treatment
-----------------
* Device: Spiration Valve System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has an air leak ≥ 100 mL/min, as measured by a digital thoracic drainage system (DTDS) Subject has air leak present on at least the 5th day following origination. Exclusion Criteria: Subject has air leak only on forced exhalation or cough Subject has sepsis Subject has pneumonia Subject has Acute Respiratory Distress Syndrome (ARDS) Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures Subject has undergone a bone marrow transplant Subject has a primary pneumothorax Subject has undergone a prior intervention (including pleurodesis, surgery, blood patch, and pneumoperitoneum) or valve placement.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spiration Valve System<br>The treatment group will have valves deployed to achieve leak isolation. | Device: Spiration Valve System<br> <br> |
| No Intervention: Medical Management<br>The control group for this study will receive standard chest tube drainage management and standard-of-care interventions. This group will be evaluated and followed in the same manner as the treatment group, but without having valves placed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Air Leak Cessation |  | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endobronchial Valve, Minimally Invasive, Intrabronchial Valves, Digital Thoracic Drainage System, Spiration Valve System, Prolonged Air Leak, Persistent Air Leak
Plasma Marine n-3 Polyunsaturated Fatty Acids and Patient and Graft Survival

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the association between n-3 polyunsaturated fatty acids and patient and graft survival. The association between other fatty acids and mortality and graft loss endpoints will also be evaluated.

Detailed Description
-----------------
This observational study focuses on the effects of marine n-3 polyunsaturated fatty acids (PUFAs) intake, measured as fatty acid levels in plasma phospholipids, and mortality and graft loss endpoints in renal transplant recipients. Data on morbidity, mortality and graft loss in The Norwegian Renal Registry is matched against data on fatty acid composition in a large renal transplantation cohort of approximately 2000 patients with a median follow up time of about 5 years. It is a follow up study, although retrospectively evaluated. It will evaluate the role of marine n-3 PUFAs as a prognostic marker in renal transplantation by investigating the association between the levels (weight percentage of total fatty acids) of marine n-3 PUFAs in plasma phospholipids and events, including mortality and graft loss.

Official Title
-----------------
The Levels of Marine n-3 Polyunsaturated Fatty Acids in Plasma Phospholipids as a Prognostic Marker of Mortality and Graft Loss Endpoints in Renal Transplant Recipients.

Conditions
-----------------
Disorder of Transplanted Kidney

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received a renal transplant. Signed informed consent. Exclusion Criteria: Under the age of 16 years.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Renal transplant recipients<br>No intervention. Measurements of plasma marine n-3 polyunsaturated fatty acids levels, indicating intake of fish and seafood. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | First patient recruited October 1999 and all remaining patients were censored at August 2012. | Up to 12 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of function in the renal transplant. | As for primary endpoint. | Up to 12 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplantation, n-3 polyunsaturated fatty acids, Mortality, Graft loss, Rejection
Standard Operating Procedures in Daily Clinical Routine

Study Overview
=================
Brief Summary
-----------------
Primary study endpoint: blood sugar values Patients: Patients admitted to an ICU 5 steps: Routine treatment, Implementation of SOP for blood sugar monitoring and intervention, Education of intensive care nurses, 6 months free interval without further education or check-up of SOP implementation, Check of SOP implementation and clinical outcome concerning range of blood sugar

Detailed Description
-----------------
SOP for blood glucose monitoring and treatment was implemented on an intensive care unit. Staff was trained. After a free interval patient's outcome was monitored in terms of daily blood sugar profile prior implementation of SOP and after implementation+free interval of SOP.

Official Title
-----------------
Does Implementation of a Standard Operating Procedure for Blood Sugar Control Into Daily Clinical Routine Improve Care of Patients

Conditions
-----------------
Blood Glucose

Intervention / Treatment
-----------------
* Behavioral: Implementation of SOP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to an ICU Exclusion Criteria: Patient's or close relative's refusal

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Blood sugar monitoring and intervention as clinical routine, no SOP defined and implemented | |
| Experimental: 2<br>Blood sugar monitoring after implementation of SOP | Behavioral: Implementation of SOP<br>* SOP for blood sugar monitoring and intervention will be defined and ICU nurses will be educated to use this SOP in clinical routine<br>* Other names: Insulin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood sugar range |  | 4 times a day for total ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay |  | After discharge from ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood glucose, Clinical pathways
Validation of Low Dose CT for Diagnosis of Urolithiasis

Study Overview
=================
Brief Summary
-----------------
The investigators have developed an extremely low dose renal computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. The investigators plan to test this exam in patients with known or suspected urolithiasis undergoing clinically indicated CT.

Official Title
-----------------
Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Urolithiasis in Children and Young Adults

Conditions
-----------------
Nephrolithiasis, Ureterolithiases

Intervention / Treatment
-----------------
* Diagnostic Test: Extremely low dose CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric and young adult patients (ages 4 to <21 years) Known or suspected urolithiasis Undergoing clinically indicated CT of the abdomen/pelvis Exclusion Criteria: Pregnancy Prior enrollment in the same study (no patient will be enrolled more than once)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Patients will receive both the clinically indicated and extremely low dose CT exams | Diagnostic Test: Extremely low dose CT<br>* Patients undergoing clinically indicated CT will also receive the extremely low dose CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of extremely low dose CT | Sensitivity | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Stone, Renal, Renal Stone
Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context : Impact on Therapeutical Managment

Study Overview
=================
Brief Summary
-----------------
The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.

Official Title
-----------------
Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context

Conditions
-----------------
Juvenile Idiopathic Arthritis, COVID 19, Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Juvenile Idiopathic Arthritis satisfying Edmonton criteria Ongoing DMARD therapy or AINS for 3 months Exclusion Criteria: Inhability to consent

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- | --- |
| Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis | Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD | 1 Day |
Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever)

Study Overview
=================
Brief Summary
-----------------
This study is aimed at validating key therapeutic targets and biomarkers associated with allergic rhinitis. The therapeutic target expression will be investigated after a 7 day course of corticosteroid treatment followed by allergen challenge.

Official Title
-----------------
A Study to Validate Key Therapeutic Targets and Biomarkers During Allergen Exposure in Subjects With Allergic Rhinitis

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Fluticasone Propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: No signs or symptoms of rhinitis outside of the relevant airborne allergen season. Exclusion criteria: History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments. Symptoms of rhinitis at inclusion indicated by total VAS score of >40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score >20. Subjects not showing a nasal response to allergen concentration =< 10,000 BU/ml. Subjects with positive skin prick test for Dust House Mite.

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluticasone Propionate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in expression of key allergy targets in the nose following exposure to allergen. Assessment of protein expression measured by western blotting and immunohistochemistry in nasal biopsy tissue. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of corticosteroids treatment on the change in target expression following allergen challenge. Nasal lavage fluid and nasal secretions will be measured by ELISA and chemiluminescent assay. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hay fever, biomarkers