linjc16/ctgov huggingface dataset:
Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.

Official Title
-----------------
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: SBI-087
* Drug: SBI-087
* Drug: SBI-087
* Drug: SBI-087


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III. Rheumatoid arthritis disease onset at >16 years of age and duration of disease at least 6 months. Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit. Exclusion Criteria: Any significant health problems other than rheumatoid arthritis. Treatment of greater than 10 mg of prednisone per day. Therapy with immunosuppressants within 6 months before study day 1

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBI-087 0.15 mg IV<br> | Drug: SBI-087<br>* IV, Single dose<br>|
| Experimental: SBI-087 0.5 mg IV<br> | Drug: SBI-087<br>* IV, Single dose<br>|
| Experimental: SBI-087 100 mg SC<br> | Drug: SBI-087<br>* SC, Single dose<br>|
| Experimental: SBI-087 200 mg SC<br> | Drug: SBI-087<br>* SC, Single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as determined by the number and severity of adverse events at the different dose levels |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA |  | 12 months | 
| To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087 |  | 12 month | 
| To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087 |  | 12 month |
Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in real life settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice

Official Title
-----------------
Secotex ®: Prescription Event Monitoring in Patients With Benign Prostatic Hyperplasia (BPH)

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Tamsulosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information Exclusion Criteria: Patients with known hypersensitivity to Tamsulosin, or any other component of the product Patients with a history of orthostatic hypotension or severe liver failure
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with benign prostatic hyperplasia (BPH)<br> | Drug: Tamsulosin<br> <br> * Other names: Secotex ®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 6 months |
Remote Ischemic Preconditioning During Lower Limb Revascularization

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the role of remote ischemic preconditioning (RIPC) in preventing acute kidney injury after lower limb revascularization. Remote ischemic preconditioning(RIPC) is a simple, cost-free and non invasive procedure (transient upper limb ischemia/reperfusion) that could provide organ protection (Heart, Brain and Kidney) following ischemia injuries.

Official Title
-----------------
Effects of Remote Ischemic Preconditioning on Renal Outcomes Following Lower Limb Revascularization

Conditions
-----------------
Ischemic Preconditioning, Acute Kidney Injury, Limb Ischemia

Intervention / Treatment
-----------------
* Procedure: RIPC
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for open limb revascularization Exclusion Criteria: Peripheral vascular disease affecting upper limbs Chronic kidney disease in stage 4 or 5 (eGFR<30 ml/min/1,73m2) Patients underwent contrast-enhanced radiological exams in the previous 7 days Treatment with glibencamide or prostaglandins

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients were randomly assigned in 1:1 ratio to either control group or RIPC using computerized randomization table
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC Group<br>Remote ischemic preconditioning | Procedure: RIPC<br>* 4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff<br>|
| Sham Comparator: Control Group<br>Sham remote ischemic preconditioning | Procedure: Control<br>* deflated cuff placed on the left arm for 40 min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI | the incidence of Acute Kidney Injury, defined as absolute rise of ≥ 0.3 mg/dL and/or a relative increase of 25% in serum creatinine compared to preoperative | 72 Hours | 
| AKI | the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative. | 72 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI Risk Score | the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 * IGFBP-7) | 24 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remote ischemic preconditioning, lower limb revascularization, TIMP-2, IGFBP-7
Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross over study of 12 months duration. Patients are stratified by type of juvenile rheumatoid arthritis (systemic onset vs pauciarticular disease vs polyarticular disease). Patients are randomized to receive either gammalinolenic acid (GLA) or placebo (safflower seed oil) orally. Parents are asked to maintain the child's usual diet over the course of study. Patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.

Conditions
-----------------
Juvenile Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: gamma-Linolenic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Juvenile rheumatoid arthritis (systemic onset, pauciarticular disease, and polyarticular disease) Active synovitis --Prior/Concurrent Therapy-- No more than 2 concurrent nonsteroidal antiinflammatory drugs No more than 2 concurrent second line agents (e.g., D-penicillamine, oral or injectable gold, antimalarials, methotrexate, sulfasalazine) Must have started second line agent at least 3 months prior to study Must be on stable doses of all medications for at least 1 month prior to study Prior prednisone allowed if started at least 3 months prior to study

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gamma-Linolenic acid|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
-----------------
arthritis & connective tissue diseases, juvenile rheumatoid arthritis, rare disease
Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Detailed Description
-----------------
Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. Nevertheless, there are about 10% of patients having intraretinal cystoid changes after surgery with potential for disturbance of visual acuity. The aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.

Official Title
-----------------
Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

Conditions
-----------------
Macular Edema, Cystoid

Intervention / Treatment
-----------------
* Device: optical coherence tomography (OCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of an ERM indication for membrane peeling defined as significant loss of vision and/or metamorphopsia due to the ERM application of periocular triamcinolone acetonide at the end of surgery at least one follow-up examination present in the patient's history Exclusion Criteria: macular edema caused by conditions other than ERM (such as choroidal neovascularization, diabetic macular edema, etc.)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Studygroup<br>Retrospective analysis of OCT, IOP and distance corrected visual acuity from the patients history. | Device: optical coherence tomography (OCT)<br>* OCT visualizes the retinal layers by backreflection of light<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraretinal cystoid changes | presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure (IOP) | intraocular pressure is examined during the time period of 3 months after surgery | 3 months | 
| distance corrected visual acuity | distance corrected visual acuity is measured at baseline and 3 months after surgery | 3 months |
Diabetes Knowledge Assessment

Study Overview
=================
Brief Summary
-----------------
To assess the knowledge of both type 2 diabetics and non-diabetics on diabetes, nutrition, and exercise. Although type 2 diabetics should know more about their disease and its needs, it is not expected they will know significantly more than the lay public.

Detailed Description
-----------------
A validated survey about diabetes, nutrition, obesity, and exercise will be dispersed to type 2 diabetics and non-diabetics, and then analyzed.

Official Title
-----------------
Use of Modified Foods in the Dietary Treatment of Type II Diabetes Mellitus: Knowledge Assessment

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: survey of information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetic or non-diabetic, age 18 and over Exclusion Criteria: type 1 diabetic

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

| Intervention/Treatment |
| --- |
|Behavioral: survey of information|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Aspirin Resistance Reversibility in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is assessing the prevalence of aspirin resistance in a cohort of diabetic patients. Those found resistant has been undergone pharmacological tests using different drug formulations to investigate the reversibility of aspirin resistance.

Official Title
-----------------
Impact of Different Pharmacological Formulations on Aspirin Resistance Reversibility in Diabetics Patients

Conditions
-----------------
Aspirin Resistance

Intervention / Treatment
-----------------
* Drug: lysine acetylsalicylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabete mellitus type 2 asa since 30 days at least plts >150000 and <450000 Exclusion Criteria: recent ACS (within 30 days) anticoagulant therapy haemorragic diathesis

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: asa resistant<br>asa resistant patients receive endovenous infusion of lysine acetylsalicylate 288 mg and if asa resistance has been reversed they have been prescribed oral soluble salt of lysine acetylsalicylate. | Drug: lysine acetylsalicylate<br> <br> * Other names: Cardirene;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelets aggregation assessed by two tests (PFA100 and VerifyNow) | diabetic patients found aspirin resistant receive and infusion of 288 mg of lysine acetylsalicylate and they are tested again 24 h after the infusion to investigate if aspirin resistance have been reversed. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stability of aggregation state after the reversion of aspirin resistance using oral formulation of lysine acetylsalicylate |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelets aggregation, asa resistance
Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt

Study Overview
=================
Brief Summary
-----------------
Decrease mortality rate resulting from pneumonia

Detailed Description
-----------------
Recruiting patients with pneumonia admitted at Assiut University hospital . Then assessment of their condition and severity of pneumonia by examination and X-ray chest . After that, we aim at assessment their nutrition status and it's effect on severity of pneumonia. So we aim to investigate them by CBC, Albumin, CRP and CXR and correlate these parameters with the severity of pneumonia to assess the impact of nutrition on outcome of chest infections

Official Title
-----------------
Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt

Conditions
-----------------
Hypoalbuminemia, Stunted Growth, Anemia, Iron Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Measurement of nutritional parameters in children with pneumonia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of pneumonia on day 1 of hospital admission. Exclusion Criteria: patients with cardiac diseases patients with immune deficiency disorders

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 60 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Measurement of nutritional parameters in children with pneumonia|measurement of Body Mass Index, head circumference, weight, length|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of body mass index in patients with pneumonia | we calculate height of patients in metres and weight in Kg then we divide the weight over the height square to get the body mass index | Day 1 assessment on hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Albumin in patients with pneumonia in g/dl | blood samlpe will be taken for measuring Albumin level | Day 1 assessment on hospital admission | 
| Hemoglobin level in patients with pnemonia in g/dl | blood samlpe will be taken for measuring hemoglobin level | Day 1 assessment on hospital admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, nutrition, blood tests, body mass index
Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Study Overview
=================
Brief Summary
-----------------
Rationale: The diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. Hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently decrease the tension that can be developed and the amount of transdiaphragmatic pressure that can be produced. Reducing the lung hyperinflation could improve the diaphragm function mechanically. One of the treatments to reduces lung hyperinflation is the bronchoscopic treatment using endobronchial valves. To our knowledge the change in diaphragm function after bronchoscopic endobronchial valve treatment was never investigated. Objective: To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV). Study design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves. Main study parameters: Change in diaphragm function 6 week after EBV treatment measured by ultrasound. The main outcome will be diaphragm motion (difference between maximum in- and expiration).

Official Title
-----------------
Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Diagnostic Test: Echography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves Patient read, understood and signed the Informed Consent Form Exclusion Criteria: There are no exclusion criteria for this study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EBV-patients<br>Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves | Diagnostic Test: Echography<br>* Echography of diaphragma and other respiratory muscles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diaphragm motion measured by ultrasound | Change in diaphragm motion 6 week after EBV treatment measured by ultrasound. | 6 weeks |