linjc16/ctgov huggingface dataset:
Rilonacept in Diabetes Mellitus Type 1: Safety Study

Study Overview
=================
Brief Summary
-----------------
This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin.

Official Title
-----------------
A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Rilonacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Within 5 years of diagnosis of type 1 diabetes Between the ages of 16 to 45 years Have at least one diabetes-related autoantibody present Have mean C-peptide level > 0.2 nmol/L on a mixed meal tolerance test Be taking insulin Complete written informed consent Exclusion Criteria: Taking inhaled or oral steroids (for example Advair, Orapred) Have an active infection Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis Have ongoing use of medications known to affect glucose tolerance Have a live vaccine 90 days prior to, or during this study Taking any other experimental medication within the past 28 days Have prior treatment with rilonacept Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies Pregnant or lactating females Males and females unwilling to use an acceptable method of contraception for the duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 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: Rilonacept<br> | Drug: Rilonacept<br>* Rilonacept given subcutaneously, dose per package labeling, once weekly.<br>* Other names: Arcalyst, IL-1 Trap;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of infection in study participants |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of other adverse effects in study participants |  | 7 months | 
| Changes in participants' sex steroids (testosterone/estradiol) |  | 7 months | 
| Changes in participants' HbA1c levels, insulin doses, and beta cell preservation |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interleukin 1, Type 1 diabetes mellitus, Rilonacept, Arcalyst
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.

Detailed Description
-----------------
This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: SPARC0913


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged ≥18 years Willing to participate and giving written informed consent Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma Exclusion Criteria: History of allergic hypersensitivity or poor tolerance to latanoprost History of Substance abuse or addiction (alcohol drugs) in the past 3 years History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication Any abnormality preventing IOP measurement

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: SPARC0913<br> | Drug: SPARC0913<br>* One drop of SPARC0913 in affected eye once daily for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With AEs | Subjects with treatment emergent adverse events | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit) | From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Ocular hypertension
1 Year Post Discharge Prognostic Model From the National Heart Failure Audit (NHFA)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in England and Wales.

Detailed Description
-----------------
There is a need for a prognostic model for 1 year survival of patients discharged alive after an unscheduled hospital admission for heart failure. This study aims to develop and validate a prognostic model that will enable management planning and facilitate the identification of therapeutic needs or targets. Also, it will assist care providers to predict or quantify patients' survival based on their baseline characteristics. The National Heart Failure Audit (NHFA) held by National Institute for Cardiovascular Outcomes Research (NICOR) is one of the largest available national heart failure registry. It includes data from unscheduled heart failure admissions in England and Wales. In the audit, heart failure diagnosis is defined as a diagnosis that has been confirmed by imaging or brain natriuretic peptide (BNP) measurement. This study will use NHFA data to develop and validate the proposed model.

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

Intervention / Treatment
-----------------
* Other: Heart Failure Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 and above survived to discharge have mortality status at 1 year post-discharge Exclusion Criteria: Non-index heart failure admissions during the study period will be excluded from the study sample.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure<br>All patients in the audit that meets the eligibility criteria | Other: Heart Failure Management<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 1 year |
Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.

Official Title
-----------------
Atorvastatin and Prevention of Contrast Induced Nephropathy Following Coronary Angiography

Conditions
-----------------
Contrast Induced Nephropathy

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having chronic stable angina who were referred for coronary angiography non-pregnant female subjects no history of diabetes mellitus no history of renal failure no history of single kidney no history of cardiogenic shock no history of unstable angina no history of myocardial infarction no history of hypersensitivity to statins no history of previous intravascular contrast injection during one month before admission Exclusion Criteria: glomerular filtration rate (GFR) <60 cardiogenic shock
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>taking atorvastatin like placebo 12 hours before the procedure | |
| No Intervention: long term statin group<br>taking atorvastatin for a long time before entering the study (their routine treatment) | |
| Experimental: preoperation statin group<br>taking atorvastatin 12 hours before the procedure | Drug: Atorvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast induced nephropathy (CIN) incidence | CIN is determined as an increase in post-procedural serum creatinine of > 0.5 mg/dl or > 25% from baseline in the absence of any other causes | 48 hours after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine (Cr) level |  | 48 hours after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary angiography, chronic stable angina, CIN
Phase II Study of Neoadjuvant Chemotherapy With Doxorubicin Followed by Docetaxel-Cisplatin in Locally Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Phase II study of neoadjuvant chemotherapy with Doxorubicin followed by Docetaxel-Cisplatin in locally advanced breast cancer

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

Intervention / Treatment
-----------------
* Drug: Doxorubicin, Docetaxel, Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with locally advanced breast cancer Exclusion Criteria: Patients with metastatic breast cancer
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 |
| --- | --- |
| Active Comparator: Arm 1<br>Doxorubicin, Docetaxel, Cisplatin | Drug: Doxorubicin, Docetaxel, Cisplatin<br>* Doxorubicin, Docetaxel, Cisplatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness |  | overall |
One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab

Study Overview
=================
Brief Summary
-----------------
Purpose: The aim of this study is to evaluate the functional and anatomical effects of switching from Bevacizumab to Aflibercept in patients with persistent DME resistant to Bevacizumab. Methods: Patients with DME refractory to Bevacizumab (1.25 mg/ 0.05 mL) were subsequently switched to Aflibercept (2.0 mg/0.05 ml). The included patients received 5 loading doses of intravitreal Aflibercept (2.0 mg/0.05 mL) (Eylea; Bayer, Berlin, Germany) given monthly. After the loading dose, Aflibercept was injected every 2 months. The follow up duration was one year.

Official Title
-----------------
One Year Results of Switching to Aflibercept for Persistent Diabetic Macular Edema Resistant to Bevacizumab

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Aflibercept Injection [Eylea]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic patients, older than 18years, center-involving DME, central macular thickness (CMT) >300 μm by spectral domain optical coherence tomography (SD-OCT) 1 month after the last Bevacizumab injection. The best corrected visual acuity must be better than 0.05 decimal visual acuity (1.3 log MAR). Only one eye from each patient was included in the study. If both eyes met the inclusion criteria, the eye with worse visual acuity was included. Exclusion Criteria: Patients were excluded if they had dense media opacity, pregnancy, previous intravitreal steroid therapy. uncontrolled diabetes mellitus (HbA1c ≥ 10%) and prior intraocular surgery (with the exception of uneventful cataract surgery >6 months prior to conversion). Other exclusion criteria included active proliferative diabetic retinopathy, tractional maculopathy, macular ischemia and other ocular diseases: age-related macular degeneration, central/branch retinal vein occlusion, and glaucoma.

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 |
| --- | --- |
| Other: Diabetic macular edema resistant to Bevacizumab<br>Patients resistant to 6 monthly Bevacizumab injection were switched to Aflibercept. | Drug: Aflibercept Injection [Eylea]<br>* intravitreal injection of Aflibercept in resistant DME.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central macular thickness after one year | Optical Coherence Tomography changes after 12 months. | 12 months |
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools

Study Overview
=================
Brief Summary
-----------------
Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination. Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders. Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken. The results of the study will be regularly monitored by the supervisors who will have full access to these results.

Official Title
-----------------
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools: A Cross Sectional Study

Conditions
-----------------
Molar Incisor Hypomineralization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acceptance for participation in the study. Eruption of four first permanent molars. Eruption of four permanent maxillary and mandibular incisors. Both genders. Exclusion Criteria: Uncooperative children. Children with orthodontic appliances. Children with systemic diseases which may affect teeth development. Children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Molar Incisor Hypomineralization | Prevalence of Molar Incisor Hypomineralization done via clinical examination using a disposable diagnostic set in the school laboratory or an empty class, in day light. | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MIH
Pharmacogenetics in Primary Care Psychotropics

Study Overview
=================
Brief Summary
-----------------
Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real time intervention improve patient outcomes?

Official Title
-----------------
Pharmacogenetics in Primary Care Psychotropics

Conditions
-----------------
Depression, Obsessive-Compulsive Disorder, Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Pharmacogenetic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 Prescribed a drug of interest for the first time Exclusion Criteria: Previous pharmacogenetic testing available

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Intervention<br> | Diagnostic Test: Pharmacogenetic testing<br>* Basic pharmacogenetic panel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient oriented outcome1- Clinical Improvement | Clinically significant improvement as noted by physician (Subjective and PHQ-9) | 6 months | 
| Patient oriented outcome2- Adverse effects | Number of patients with specific, common side effects (from medical chart) | 6 months | 
| Patient oriented outcome3- Time to Improvement | Days to clinical improvement (from medical chart) | Up to 6 months | 
| Patient oriented outcome5- Visits | Total number of visits to clinic with medication titration required (from medical chart) | 6 months |
HKT-500-US12 In Adult Patients With OA Knee Pain

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee

Detailed Description
-----------------
A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Official Title
-----------------
Protocol HKT-500-US12: A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee

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

Intervention / Treatment
-----------------
* Drug: HKT-500 Topical Patch
* Other: Placebo Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female 45 years of age or older with osteoarthritis of the knee Exclusion Criteria: subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, 2, II, HKT-500 Topical Patch<br>A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee | Drug: HKT-500 Topical Patch<br>* Treatment with Ketoprofen Topical Patch<br>* Other names: Ketoprofen;|
| Placebo Comparator: Placebo Patch<br>Treatment with placebo patch | Other: Placebo Patch<br>* Treatment with placebo patch<br>* Other names: Sham tratment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Onset and Duration |  | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Time Frame |  | 36 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis,Knee,Ketoprofen,Pain,Patch,Analgesic