linjc16/ctgov huggingface dataset:
A Pilot Study of Topical Antiflammin-2 for Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

Detailed Description
-----------------
This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

Official Title
-----------------
A Pilot Study of Topical Antiflammin-2 for Psoriasis

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must be age 18 or older. Patients male or female must use contraception if of childbearing age. No men and women actively attempting to conceive a child during the time of drug testing. No pregnant or nursing women. Patients must be otherwise healthy, immunocompetent, ambulatory patients with psoriasis who have more than 5 percent of their body surface area involved with the disease or who have localized disabling psoriasis. Have failed one prior topical treatment regimen including topical cortiscosteroids, coat tar preparations, or ultraviolet light. An ambulatory performance status of 0,1,2 (ECOG Scale). Ability to participate in an out -patient study and to provide informed consent. Creatinine less than 2.0 mg/100ml. Bilirubin less than or equal to 1.5 mg/100ml; prothrombin time less than or equal to 1.3 times control. WBC greater than 3000/mm(3), granulocytes greater than 1500/mm(3), platelets greater than 100,000/mm(3). No clinically significant cardiac disease. No patients with previously documented serious infectious diseases such as pneumocystis pneumonia, mycobacterium avium infection, etc. which would suggest clinically evident immunodeficiency. No systemic treatment for psoriasis (methotrexate, PUVA, UVB, cyclosporine, etc.) and topical treatments (corticosteroids, tar, anthralin, etc.) during the four weeks prior to study entry, and topical treatment during the two weeks prior to study entry.
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
-----------------
Inflammation, Lipocortin, Phospholipase A-2, Skin, Uteroglobin, Psoriasis
A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis

Study Overview
=================
Brief Summary
-----------------
This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.

Official Title
-----------------
Efficacy of C.E.R.A for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV , Not on Dialysis , Treated According to Routine Clinical Practice

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Other: Cohort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18 to 65 years of age inclusive Patients with chronic kidney disease Stage III-IV not on dialysis Hb < 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels) Adequate iron status as judged by the treating physician Exclusion Criteria: Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication Significant acute or chronic bleeding Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) Active malignant disease during the last five years (except non-melanoma skin cancer) Uncontrolled or symptomatic secondary hyperparathyroidism Epileptic seizure during the last 6 months Poorly controlled hypertension (sitting blood pressure > 170/100 mmHG) Myocardial infarction or stroke, or severe or unstable CAD Severe liver disease during the previous 6 months Congestive heart failure NYHA Class III-IV Diagnosis or suspicion of pure red cell aplasia (PRCA) Planned elective surgery during the study period (except cataract surgery and vascular access surgery) Transfusion of red blood cells during the previous 2 months Pregnant women Any contra-indications to Mircera

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cohort|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the value of novel non-invasive medical imaging methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes in the neck by comparing their results to findings at the time of surgery.

Official Title
-----------------
Cervical Nodal Metastasis in Squamous Cell Carcinoma of the Head and Neck - Novel MRI, FDG-PET, and Histopathologic Correlation

Conditions
-----------------
Head and Neck Cancer, Carcinoma, Squamous Cell, Head and Neck Cancers

Intervention / Treatment
-----------------
* Radiation: PET scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Adult patients with newly diagnosed (biopsy-proven), untreated squamous cell carcinoma (SCC) of the head and neck who will undergo neck dissection as part of primary surgical therapy. Exclusion Criteria:- A prior adverse reaction to the contrast/tracer agents being used in the imaging methods being studied. - Pregnancy.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: PET scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the performance of novel imaging methods for detecting cervical nodal metastasis. |  | pre and post surgery |
EC95 of Remifentanil for Preventing Cough

Study Overview
=================
Brief Summary
-----------------
The investigator designed this study to investigate remifentanil effect-site concentration in 95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol anesthesia.

Detailed Description
-----------------
At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). Extubation was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.

Official Title
-----------------
Predicted EC95 of Effect-site Concentration of Remifentanil for Preventing Cough After Laryngomicrosurgery From Propofol Anesthesia

Conditions
-----------------
Drug Usage

Intervention / Treatment
-----------------
* Drug: Remifentanil
* Drug: Propofol anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II patients undergoing general anesthesia for laryngomicrosurgery Exclusion Criteria: Anticipated difficult airway COPD, Asthma Recent URI (< 2 weeks) Severe cardiac, hepatic renal disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil<br>Extubation was performed when remifentanil was maintained a predetermined concentration throughout the emergence periods. | Drug: Remifentanil<br>* The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)<br>* Other names: Ultiva;Drug: Propofol anesthesia<br>* Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.<br>* Other names: Fresofol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cough | Number of cough or a strong and sudden contraction of the abdomen during periextubation periods | from end of surgery to 5 min after tracheal extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extubation, Remifentanil, Laryngomicrosurgery
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by pubertal status. There is a 7- to 14-day washout with a placebo prior to treatment for all patients. The first group receives oral guanfacine 3 times a day for 8 weeks. The dose is gradually increased to minimize sedation; by day 14, most patients are stabilized and the dose is then increased as clinically indicated and tolerated. The second group receives a placebo 3 times a day for 8 weeks. Patients in either group may be treated with guanfacine for an additional 8 weeks.

Conditions
-----------------
Tourette Syndrome

Intervention / Treatment
-----------------
* Drug: guanfacine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Tourette syndrome or other chronic tic disorder meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) Clinician's Global Impression for ADHD greater than 4 Hyperactivity Index of Conners Parent or Teacher Questionnaire standard score 65 or higher (1.5 standard deviation units) --Prior/Concurrent Therapy-- At least 2 weeks since medication for tics, ADHD, or obsessive compulsive disorder (4 weeks since neuroleptics or fluoxetine) No failure on prior guanfacine --Patient Characteristics-- Hepatic: No liver failure Renal: No renal failure Cardiovascular: No hypertension No other heart disease Pulmonary: No pulmonary disease Other: No Intelligence Quotient below 80 No current DSM-IV diagnosis of the following: Major depression Bipolar disorder Pervasive developmental disorder Psychotic disorder No seizure disorder No other significant medical condition No pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: guanfacine|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
-----------------
Tourette syndrome, neurologic and psychiatric disorders, rare disease
The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A

Study Overview
=================
Brief Summary
-----------------
Influenza continues to inflict an important burden on health-care systems. The 2009 H1N1 influenza virus first appeared in Mexico and the United States in March and April 2009 and has swept the globe with unprecedented speed. The aim of this study is to evaluate effect of supplement vitamin on the clinical course of patients with acute respiratory illness suspected novel H1N1 infection.

Detailed Description
-----------------
Patients with acute respiratory illness randomized to control or vitamin groups. The patients completed questionnaire about their initial symptom scores. After 5 days of vitamin trial, patients were asked about their symptom by telephone survey.

Official Title
-----------------
The Impact of Vitamin on the Clinical Course in Cases Infected by Novel H1N1 Influenza Virus A: a Randomized-controlled Trial

Conditions
-----------------
H1N1 Influenza

Intervention / Treatment
-----------------
* Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)
* Drug: Placebo (digestive tablet)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 20 years Acute respiratory illness suspected H1N1 infection Acute febrile respiratory illness(BT > 37.8) and throat pain or cough or nasal congestion Exclusion Criteria: Pregnancy Hypersensitivity to vitamin A History of liver disease or renal disease Urinary stone 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin<br>Vitamin(vitamin A 15mg,C 500mg,E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics | Drug: Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)<br>* Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics<br>|
| Placebo Comparator: Control<br>Placebo(digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics | Drug: Placebo (digestive tablet)<br>* Placebo (digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of symptom score |  | 1 week after initial visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, vitamin, improvement of symptom
Automated Telephone System to Improve Treatment Adherence in People With Depression

Study Overview
=================
Brief Summary
-----------------
This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression.

Detailed Description
-----------------
The purpose of this study is to test the efficacy of a computerized telephone system called TLC (Telephone-Linked Care) in helping subjects adhere to their antidepressant medication regimens.

Official Title
-----------------
Telecom System to Improve Adherence to Antidepressants

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Computer Assisted Education for Behavior Change


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three Prescribed at least one antidepressant medication Access to a telephone with touch-tone service Speak and understand conversational English Exclusion Criteria: Current significant alcohol or drug abuse Clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), or other neurodegenerative diseases Alzheimer's disease and other dementia Cancer, undergoing radiation therapy or chemotherapy Suffering from Renal disease or on dialysis Immunologic disorder (rheumatoid arthritis, systemic lupus erythematosus [SLE], etc.) HIV Terminal illness Homeless Legally blind Planning to leave the geographic area during the study period

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

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Computer Assisted Education for Behavior Change|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antidepressant medication adherence |  | Measured monthly for 4 months | 
| Adherence to scheduled psychiatry clinic visits |  | Measured monthly for 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression status, measured by self-administered depression inventory scale |  | Measured at baseline and at 4 month follow-up | 
| General health status, measured by self-rating health survey |  | Measured at baseline and at 4 month follow-up |
Cryo Balloon for Residual Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.

Official Title
-----------------
CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Device: CryoBalloon Focal Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age > 18 years old Able to provide informed consent Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection, Exclusion criteria: Age younger than 18 years old Presence of esophageal varices Esophageal stricture precluding passage of an endoscope Inability to provide informed consent Esophageal cancer (T2 and above) Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000 Pregnancy (if required a pregnancy test would be performed as part of routine clinical care)

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: focal cryo ablation<br>Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment | Device: CryoBalloon Focal Ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of Barrett's Esophagus | Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation | 3 months post Cryoballon Focal Ablation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's, high grade dysplasia, ablation, cyrotherapy
Venous Thrombectomy/Thrombolysis Outcome Registry

Study Overview
=================
Brief Summary
-----------------
Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The Registry will track patient outcome and quality of life over 60 months for treatment with anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in accordance with current treatment guidelines .

Official Title
-----------------
A Patient Outcome Study After Pharmacomechanical Catheter-directed Thrombolysis and Standard Treatment for Venous Thrombosis

Conditions
-----------------
Deep Venous Thrombosis, Post Thrombotic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Data obtained in line with good clinical practice, applicable laws and regulation Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Quality of Life, |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Post-Thrombotic Syndrome |  | 60 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDT, PCDT, DVT, PTS, Quality of Life