linjc16/ctgov huggingface dataset:
COVID-19 Nasal Swab Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare 2 types of nasonasopharyngeal swabs (a new design to a conventional nylon-flocked nasopharyngeal swab) for effectiveness.

Detailed Description
-----------------
Compare the Precision ADM CanSwab nasopharyngeal swab to a conventional nylon-flocked nasopharyngeal swab on the basis of: The amount of SARS-CoV2 virus (COVID-19) collected by swabs, measured in CT (thermal cycles) Clinical concordance rate Patient comfort during nasopharyngeal sampling procedure

Official Title
-----------------
Comparative Evaluation of Nasopharyngeal Swabs for Sampling and Detection of SARS-CoV2

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Device: CanSwab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Ability to provide informed consent COVID-19 positive cohort only: a previous, positive COVID-19 test in the last 5 days and patient remains symptomatic Exclusion criteria: Malformation of the base of the known skull Active nosebleed before the start of the sample

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CanSwab - 1st<br>CanSwab will be swabbed first | Device: CanSwab<br>* New nasopharyngeal swab design.<br>|
| Experimental: CanSwab - 2nd<br>CanSwab will be swabbed second. | Device: CanSwab<br>* New nasopharyngeal swab design.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of SARS-CoV2 virus (COVID-19) collected | amount of SARS-CoV2 virus (COVID-19) collected measured in CT (thermal cycles). | Baseline | 
| Clinical concordance rate | Calculate approximate sensitivity and specificity of the CanSwab to the Flocked swab control. | Baseline | 
| Patient comfort | Patient description of comfort level between the 2 swabs experience measured by Worse, Identical or Better | Baseline |
Verification Study of Ciclosporin for Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of oral OL27-400MEPC 3 mg/kg/day (2-5 mg/kg/day) in 2 divided doses daily for 8 weeks to patients with severe adult atopic dermatitis. THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Official Title
-----------------
Verification Study of Ciclosporin for Atopic Dermatitis

Conditions
-----------------
Severe Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: ciclosporin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Appropriate the definition/diagnosis criteria of atopic dermatitis of the Japanese Dermatological Association Patients with severest atopic dermatitis [according to the Guidelines for Treatment of Atopic Dermatitis 2002, the severity of atopic dermatitis will be classified as severest when an eruption associated with severe inflammation (a lesion associated with erythema, papule, erosion, infiltration, lichenification, etc.) is noted on at least 30% of body surface on the day of subject enrollment]. Exclusion Criteria: - Patients who received oral preparations, injections, inhaled preparations and suppositories of steroids or immunosuppressants other than tacrolimus hydrate ointments within 14 days of subject enrollment Patients who might receive the oral/injection drugs which are known to enhance nephrotoxicity, increase serum potassium levels, HMG-CoA reductase inhibitors or theophylline during the treatment period. Patients who received or are receiving an ultraviolet therapy (PUVA therapy, etc.) Patients with hypertension, active infectional disease, gout etc. Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ciclosporin|nan|

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
-----------------
Atopic Dermatitis, Ciclosporin,
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.

Official Title
-----------------
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

Conditions
-----------------
Peripheral Arterial Diseases

Intervention / Treatment
-----------------
* Device: EverFlex™ stent with Entrust™ delivery system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts), or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting. Exclusion Criteria: Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.

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 |
| --- | --- |
| Experimental: EverFlex™ stent with Entrust™ delivery system<br> | Device: EverFlex™ stent with Entrust™ delivery system<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Stent Elongation | Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length | Intra operative | 
| Successful Stent Deployment | Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment. | Procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Superficial Femoral Artery, Proximal Popliteal Artery, Everflex, Entrust, stent
Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

Detailed Description
-----------------
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

Official Title
-----------------
Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Tarceva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically confirmed adenocarcinoma of the pancreas resectable disease tumor </= 6cm diameter ECOG performance 0-1 Organ system fxn: granulocytes (>/=1800/uL); plt ct >/=100K; bili</=2mg; liver enzymes <2.5ULN; crt </=1.5; Normal CXR Negative pregnancy test Exclusion Criteria: metastatic disease or peritoneal seeding based on cross-sectional imaging previous irradiation to the planned field prior chemotherapy or immunotherapy active infection active PUD

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tarceva|Tarceva: 100mg/day x 2 weeks (Days 1-14) +|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy |  | Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Cancer, Resectable Pancreatic Cancer, adenocarcinoma of the pancreas
IgA-positive Versus IgA-negative Immune Complex Vasculitis

Study Overview
=================
Brief Summary
-----------------
Cutaneous vasculitis due to vascular deposition of large circulating immune complexes is a disease frequently seen by general practitioners and dermatologists. The clinical symptom is palpable purpura with predilection for the lower legs. In some cases vasculitis also affects systemic organs, such as the kidneys and the intestine. When the immune complexes contain immunoglobulin class A (IgA) and when there is systemic involvement, the disease has been referred to as Henoch Schönlein purpura. When there are no signs of systemic involvement, the disease has been referred to as cutaneous leukocytoclastic angiitis. The investigators hypothesize that palpable purpura with predilection for lower legs is a pathognomonic clinical sign for immune complex vasculitis in both IgA vasculitis and IgA-negative vasculitis, but that only the presence of IgA in immune complexes is likely to be associated with systemic involvement and therefore warrants more extensive diagnostic procedures Vice versa the investigators postulate that the presence of IgG or IgM without IgA in immune complexes excludes systemic involvement The investigators also want to investigate to which of the 2 groups patients with palpable purpura and negative immunofluorescence should be assigned.

Official Title
-----------------
Retrospective Analysis of Frequency of Systemic Involvement in IgA-positive Cutaneous Immune Complex Vasculitis Versus IgA-negative Cutaneous Immune Complex Vasculitis

Conditions
-----------------
Cutaneous Vasculitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven leukocytoclastic vasculitis clinically palpable purpura Exclusion Criteria: no histological confirmation relevant data missing in file

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 |
| --- | --- |
| IgA-positive vasculitis<br>Patients with immune complex vasculitis who show perivascular deposits of IgA | |
| IgA-negative vasculitis<br>Patients with immune complex vasculitis who show no perivascular deposits of IgA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of systemic involvement in patients with IgA-positive versus patients with non-IgA-positive immune complex vasculitis |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immune complex vasculitis, cutaneous vasculitis, IgA vasculitis, IgA nephropathy
This is a Study to Get More Information About Non Ambulatory Boys & Men With Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
Many therapeutic trials in DMD exclude non-ambulatory boys and men. Rate of progression in these non-ambulatory patients has been studied but consensus has not been reached for what measures are most reliable and reproducible. Furthermore, any treatment trial would be expected to demonstrate improved function and improvement in quality of life. Therefore, function, strength, and quality of life must be understood and standardized. While the goal of this proposal is to standardize clinical outcomes for therapeutic trials, careful understanding of the progression of DMD in non ambulatory boys may also lead to better medical treatment.

Detailed Description
-----------------
For Non-ambulatory study, boys must be unable to walk without assistive devices for greater than or equal to one year. Age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years through age 22 years. Genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of DMD with biopsy/genetic confirmation in a primary relative.

Official Title
-----------------
Clinical Outcomes Validation in Non Ambulatory and Young Boys/Men With Duchenne Muscular Dystrophy (DMD)

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Non-ambulatory study, boys must be unable to walk without assistive devices for greater than or equal to one year. Age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years through age 22 years. Genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of DMD with biopsy/genetic confirmation in a primary relative. Exclusion Criteria: 1. For Non-ambulatory study, the inability to understand and cooperate with the testing would exclude a subject. -

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 22 Years

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

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 |
| --- | --- | --- |
| Dystrophin gene mutations that predispose to early onset cardiomyopathy |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DMD, non ambulatory
Smoking Cessation Program: A Quality Improvement Trial in a Resident-Based Outpatient Clinic

Study Overview
=================
Brief Summary
-----------------
The researchers hypothesize that smoking cessation counseling improves with the implementation of a smoking status assessment data sheet in routine consults. This is a quality improvement study design to evaluate the impact of the implementation of a more formal smoking status evaluation in a resident/faculty driven outpatient clinic.

Detailed Description
-----------------
We hypothesize that smoking cessation counseling improves with the implementation of a smoking status assessment data sheet in routine consults. This is a quality improvement study design to evaluate the impact of the implementation of a more formal smoking status evaluation in a resident/faculty driven outpatient clinic. This will be an observational study in which differences in quality measures will be compared between baseline and re-measurement periods. Population target: 900 patients screened before and after the implementation of the QI intervention. Primary outcome: smoking status evaluation. Secondary Outcome: number of patients advised to quit, plan implementation for smoking cessation, smoking cessation program referrals, number of NRT and bupropion prescription.

Official Title
-----------------
Smoking Cessation Program: A Quality Improvement Trial in a Resident Based Outpatient Clinic

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: nicotine replacement therapy and bupropion
* Behavioral: smoking cessation counseling and referrals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21 years or older Seen at MMH family health center Current smoker

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| A<br>Smokers | Drug: nicotine replacement therapy and bupropion<br>* 3-6 months<br>Behavioral: smoking cessation counseling and referrals<br>* Organizational counseling and referrals<br>|

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
-----------------
smoking cessation, nicotine replacement therapy, bupropion, smoking
Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis(RA) with a high incidence and high morbidity, the pathogenesis has not been fully elucidated. Fibroblast-like synovial cells excessive proliferation and synovial angiogenesis is the most important cause of RA synovitis and joint destruction. Our study was to find the role of Sonic Hedgehog(SHH) pathway in regulating proliferation of fibroblast-like synovial cells and modulating excess angiogenesis of synovial tissue.

Detailed Description
-----------------
4ml blood from active RA patients(n=35) and healthy volunteers (n=35) will be collected peripheral blood mononuclear cells will be detached messenger ribonucleic acid expression of Sonic Hedgehog pathway associated factors in both groups will be detected Synovial tissues from 4 RA patients and 4 patients with traumatic or meniscal injury who need to carry out knee joint replacement operation will be collected inflammatory feature of synovial tissue will be observed the expression of Shh, Ptch1, Gli1 and Smo in synovial tissue will be detected by immunohistochemistry assay fibroblast-like synoviocytes will be cultured from synovial tissue of RA patients

Official Title
-----------------
Preliminary Study of Sonic Hedgehog Signaling Pathway in the Pathogenesis of Rheumatoid Arthritis

Conditions
-----------------
Arthritis, Rheumatoid, Neovascularization, Pathologic, Synovitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: definitely diagnosed the disease is active (DAS28>3.2) Exclusion Criteria: combined with severe organ dysfunction combined with other rheumatic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| RA group<br>expression of Shh pathway associated factors from peripheral blood mononuclear cells or synovial tissues will be detected | |
| control group<br>expression of Shh pathway associated factors from peripheral blood mononuclear cells or synovial tissues will be detected | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRNA expression |  | 1 day (December 15, 2012) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Rheumatoid, Sonic hedgehog protein, human, Neovascularization, Pathologic, Synovitis
Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET

Study Overview
=================
Brief Summary
-----------------
18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches. We propose to conduct a prospective study to evaluate early therapeutic response using 18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients. Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy. The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and non-responder patients.

Detailed Description
-----------------
Further study details as provided by Centre Oscar Lambret

Official Title
-----------------
Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET

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

Intervention / Treatment
-----------------
* Other: FDG-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Breast cancer treated by neo-adjuvant chemotherapy (T>2cm) Measurable lesions ,assessed clinically and by ultrasound Delay minimum between biopsy and PET: 15 days PS-WHO: 0 Exclusion Criteria: T<2cm Inflammatory breast cancer (T4d) Diabetic patients unbalanced (glycemia>1.40) Pregnant or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: FDG-PET<br>* 370 MBq of FDG one hour before imaging acquisition PET just before neo-adjuvant chemotherapy and just before the second cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation rate of SUV(BSA max)before and after the 1st cycle of neoadjuvant chemotherapy |  | before and 3 weeks after 1st cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison to clinical and ultrasound assessment after the 3rd cycle of chemotherapy |  | 3 weeks after the 3rd cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma, breast