linjc16/ctgov huggingface dataset:
A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine

Conditions
-----------------
Migraine Headaches

Intervention / Treatment
-----------------
* Drug: RWJ-333369


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established history of migraines for at least 1 year; Have between 3 and 12 migraine attacks per month, and no more than 15 headache days in total per month; Migraines must have first started before age 50. Exclusion Criteria: Most frequent headache type is not migraine; Failed 3 or more studies of effective migraine-preventing medications; Overuse of pain medications to treat migraines; Not willing to stop use of migraine-preventing medications; Significant serious concomitant diseases.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: RWJ-333369|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Headaches, Migraine headaches, Head pain
Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

Official Title
-----------------
A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Dose 1 gevokizumab
* Drug: Dose 2 gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye Controlled uveitic disease in both eyes Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy Effective contraceptive measures Exclusion Criteria: Infectious uveitis and masquerade syndromes Isolated anterior uveitis Contraindication to mydriatics Active tuberculosis disease History of allergic or anaphylactic reactions to monoclonal antibodies History of recurrent infection or predisposition to infection; active ocular infection Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Solution for subcutaneous injection<br>|
| Experimental: Dose 1 gevokizumab<br> | Drug: Dose 1 gevokizumab<br>* Solution for subcutaneous injection<br>|
| Experimental: Dose 2 gevokizumab<br> | Drug: Dose 2 gevokizumab<br>* Solution for subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with an occurrence of uveitic disease through Day 168 |  | Day 0 through Day 168 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of uveitic disease |  | Day 0 through Day 168 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis
Prednisone for Heart Failure Patients With Hyperuricemia

Study Overview
=================
Brief Summary
-----------------
Hyperuricemia is a very common finding in patients with heart failure. It is usually related to diuretic use and deteriorated renal function. The recently evidence showed that uric acid (UA) lowering therapy may improve clinical status in symptomatic heart failure patients with hyperuricemia. In their clinical practice, the investigators found that glucocorticoids could dramatically lower UA while improving renal function. Thus the investigators design this randomized head to head study to test our hypothesis that prednisone have the same efficacy to allopurinol on lowering UA and could improve renal function at the same time.

Official Title
-----------------
Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia

Conditions
-----------------
Heart Failure, Hyperuricemia

Intervention / Treatment
-----------------
* Drug: prednisone
* Drug: allopurinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old NYHA Class III-IV EF =< 40% Uric acid => 9.5 mg/dL Exclusion Criteria: Acute gouty arthritis Any condition (other than CHF) that could limit the use of prednisone or allopurinol Any concurrent disease likely to limit life expectancy. Active myocarditis, or an obstructive or restrictive cardiomyopathy Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prednisone<br> | Drug: prednisone<br>* 1 mg/kg/day with a maximum dose of 60 mg/day given orally<br>|
| Active Comparator: allopurinol<br> | Drug: allopurinol<br>* allopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in uric acid level |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in creatinine clearance rate |  | 4 weeks | 
| Daily urine volume |  | 4 weeks | 
| Body weight |  | 4 weeks | 
| patient assessed dyspnea and physician assessed global clinical status |  | 4 weeks | 
| 6-minute walking distance |  | 4 weeks | 
| NYHA functional class |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prednisone, allopurinol, heart failure, hyperuricemia
Stem Cell Transplant and Zoledronic Acid Improve Outcome in Previously Untreated Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.

Detailed Description
-----------------
Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.

Official Title
-----------------
Results of Phase III Study to Assess if Zoledronic Acid Have Antumor Activity in Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of multiple myeloma No previous treatment Symptomatic High risk (ISS) or stage III ( Durie-Salmon) No severe comorbidities - Exclusion Criteria: Pregnancy HIV + Refuse treatment -

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| zoledronic acid or not zoledronic acid<br>patients with multiple myeloma will be treated with cytoreductive therapy following by zoledronic acid or not. | Drug: zoledronic acid<br>* zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years<br>|
| zoledronic acid or not zoledronic acid<br>patients with multiple myeloma will be treated with cytoreductive therapy following by stem cell transplant and did not received zoledronic acid | |
| zoledronic acid<br>Patients with multiple treated with cytoreductive therapy following by stem cell transplant will be planned to received zoledronic acid | Drug: zoledronic acid<br>* zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free disease and overall toxicity in myeloma multiple | In patients treated with cytoreductive therapy following by stem cell transplant and that received zoledronic acid by 2 years,they were evaluable for assess antitumor effect of zoledronic acid | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skeletal event | evaluate the number of skeletal events in patients with multiple myeloma that received zoledronic acid | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple myeloma, stem cell transplant, zoledronic acid
The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis?

Detailed Description
-----------------
The aim of the present study was to monitor the clinical outcomes and the metabolic response of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled type 2 diabetes. Regarding clinical and metabolic parameters at baseline, no differences were displayed between two groups. However, at 3-months follow-up period the patients within a test group were demonstrated better clinical outcomes than patients in a control group

Official Title
-----------------
The Effects of Non -Surgical Periodontal Therapy on Glycemic Control and Periodontal Health in Diabetic Patients With Periodontitis (Randomized Controlled Clinical Trial)

Conditions
-----------------
Chronic Periodontitis, Generalized

Intervention / Treatment
-----------------
* Combination Product: amoxicillin 500mg and metronidazole 400mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis Exclusion Criteria: Pregnancy Alcoholism and smoking Presence of any systemic disorders other than hypertension and diabetes Diabetic major complications

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>Metronidazole 400mg,three times daily for two weeks Amoxicillin 500mg,three times daily for two weeks. | Combination Product: amoxicillin 500mg and metronidazole 400mg<br>* metronidazole 400mg and amoxicillin 500mg three times daily for two weeks<br>* Other names: Amoxil and Flagyl;|
| No Intervention: control group<br>no intervention during study period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycosylated haemoglobin (HbA1c) | Blood was taken from a peripheral vein to monitor HbA1c using high-performance liquid chromatography | 3 months |
Aranesp® Monthly Preference Study - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).

Official Title
-----------------
Aranesp® Monthly Preference Study - 2

Conditions
-----------------
Kidney Disease

Intervention / Treatment
-----------------
* Drug: Aranesp®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 8 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Self-injecting at home with Procrit® - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

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: Aranesp®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject preference |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney disease, Renal, CKD (Chronic Kidney Disease), CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen, Aranesp®, Darbepoetin alfa, QW dosing, Q2W dosing, Q4W dosing, Patient preference, Subject preference
Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

Detailed Description
-----------------
Non small cell lung cancer patients.

Official Title
-----------------
Retrospective Analysis Evaluating Molecular Factors of Primary Resistance to Tyrosine Kinase Inhibitors in Metastatic Non Small Cell Lung Cancer Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis Metastatic disease treated with gefitinib or erlotinib Presence of at least one measurable lesion according to RECIST criteria Exclusion Criteria: No tumor tissue available No clinical data available

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the incidence of EGFR (Epidermal growth factor ) and KRAS (Kirsten ras sarcoma viral oncogene homolog ) mutations in 300 NSCLC (non small cell lung cancer) patients treated with gefitinib or erlotinib |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations. |  | 1 year |
Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

Study Overview
=================
Brief Summary
-----------------
The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.

Detailed Description
-----------------
Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula. Patients will be followed periodically until their 12-month follow-up.

Official Title
-----------------
A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Device: Anal Fistula Plug (SurgiSIS AFP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older Primary, persistent, or recurrent fistula tract that is either transsphincteric, suprasphincteric, or extrasphincteric Signed informed consent Willing to return for follow-up visits Exclusion Criteria: Crohn's Disease Ulcerative Colitis HIV Positive Immune System Disorder Collagen Disorder Tuberculosis History of radiation to anorectal region Allergies to pig tissue Religious or cultural objection to use of pig tissue in this surgical application J-pouch fistulas Previous Surgisis AFP Plug placement in target fistula tract Tracts with acute abscess, infection or inflammation Superficial fistula tracts conventionally treated with fistulotomy/fistulectomy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Anal Fistula Plug | Device: Anal Fistula Plug (SurgiSIS AFP)<br>* Anal Fistula Plug<br>* Other names: SurgiSIS Biodesign;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing Success |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Measures |  | 3, 6, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fistula, anal fistula
Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether reducing inflammation of the surface of the eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase patient comfort.

Detailed Description
-----------------
Continued use of glaucoma drops can alter the outer surface of the eye and result in swelling and irritation, changing the structure of the eye. This structural change has been found to be a significant risk factor for the failure of glaucoma surgery. A comparison of how well patients do after glaucoma surgery depending on whether they use Restasis (the only prescription medication approved by the FDA for treating dry eye) or artificial tears (which can be purchased without a prescription) for 6 months following their surgery.

Official Title
-----------------
Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Restasis
* Drug: Endura (artificial tears)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with uncontrolled glaucoma scheduled for filtering surgery Exclusion Criteria: Under 18 years of age Unable to understand informed consent

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients received restasis eyedrops during 6 month post-operative period | Drug: Restasis<br>* 1 drop in study eye twice a day X 6 months<br>|
| Placebo Comparator: 2<br>Patients receive artificial tears (Endura) during 6 month post-operative period | Drug: Endura (artificial tears)<br>* 1 drop in study eye twice a day X 6 months<br>* Other names: Endura;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocular inflammation |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma filtering surgery, restasis, conjunctival inflammation