linjc16/ctgov huggingface dataset:
A Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.

Official Title
-----------------
Randomized, Open-labeled, Single Dosing Study to Assess Food Effect on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Fimasartan
* Drug: Fimasartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20 - 45 years sex: male body weight: greater than 55 kg written informed consent Exclusion Criteria: known allergy to Fimasartan existing cardiac or hematological diseases existing hepatic and renal diseases existing gastrointestinal diseases acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder abnormal diet which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day participation in a clinical trial during the last 60 days prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group B<br>Period 1: fed control → Period 2: fasted control | Drug: Fimasartan<br>* Period 1: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast Period 2: administration of fimasartan 240mg at 9:00am, without the breakfast<br>|
| Active Comparator: Group A<br>Period 1: fasted control → Period 2: fed control | Drug: Fimasartan<br>* Period 1: administration of fimasartan 240mg at 9:00am, without the breakfast Period 2: administration of fimasartan 240mg at 9:00am, 30 minutes after the breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, Tmax, AUC, T1/2, CL/F etc. |  | 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers
Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value

Study Overview
=================
Brief Summary
-----------------
Ultraslow full-power SWL versus slow power-ramping SWL in Renal stones with high attenuation value

Detailed Description
-----------------
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones

Official Title
-----------------
Ultraslow Full-power SWL Versus Slow SWL in Renal Stones With High Attenuation Value

Conditions
-----------------
Renal Stones

Intervention / Treatment
-----------------
* Procedure: SWL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single Renal stone less than or equal to 3 cm (2 cm for lower calyceal stones) radio-opaque stone high attenuation value (≥ 1000 HU) stone Exclusion Criteria: Abnormal renal anatomy renal insufficiency solitary kidney coagulopathies uncontrolled hypertension renal artery or aortic aneurysm active urinary tract infection pregnancy severe skeletal malformations (spinal deformity) precluding proper stone localization skin to stone distance (SSD) > 11 cm BMI > 30 Kgm/m2

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultraslow shock wave lithotripsy (SWL)<br>SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power). | Procedure: SWL<br>* Shock wave lithotripsy<br>* Other names: ESWL;|
| Active Comparator: Slow power-ramping SWL<br>SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW. | Procedure: SWL<br>* Shock wave lithotripsy<br>* Other names: ESWL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | Complete clearance of stones in addition to clinically insignificant residual fragments | 3 months following last session of SWL | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications rate | Comparison of rate of complications in both groups | 3 months following last session of SWL | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal stones, SWL, High density stones, Ultraslow SWL, Slow SWL, Ramping, Pause
Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil

Study Overview
=================
Brief Summary
-----------------
Besides the specific response to vaccine antigens, the investigators will analyze the anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess the range of the count with the highest possibility of vaccine response. Thus, knowledge of vaccine response in HIV-infected patients, indicate which patients would have greater potential for vaccine response in vivo.

Detailed Description
-----------------
The study will be divided into three groups. Patients with HIV-1 infection will be subdivided into groups according to T CD4 + lymphocytes at the time of vaccination: Over 500 CD4 T cells count and bellow 500 CD4 T cells count. A healthy control group will be also studied.

Official Title
-----------------
Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Biological: HPV vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV Men with age between 35 and 45 years of age. Exclusion Criteria: Current or previous infection with human papillomavirus (HPV)

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 45 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine<br>one group with HPV vaccine | Biological: HPV vaccine<br>* HPV vaccine<br>* Other names: cerverix;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Anti-HPV antibody titers | The anti-HPV titers will be compared from baseline to the date of sample collection | 0, 30 and 180 days of vaccination anti-HPV | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, HPV, Clinical trial, outcome
A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.

Official Title
-----------------
An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Aliskiren/HCTZ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients 18 years old or older. Patients with a diagnosis of hypertension. Patients who are eligible and consent to participate in the study Exclusion Criteria: Severe hypertension Previous or current diagnosis of heart failure. History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aliskiren/HCTZ|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting Diastolic Blood Pressure lowering effect at baseline, and week 8. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8 |  |  | 
| Safety and tolerability |  |  | 
| Proportion of patients achieving a blood pressure control target at week 8 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diastolic, systolic, hypertension, aliskiren, blood pressure, hydrochlorothiazide, HCTZ
A Study of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Hypothesis: 25-hydroxy vitamin D levels in non-itching hemodialysis (HD) patients will be higher than those in HD patients with itching 25-hydroxy vitamin D levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin D levels of patients complaining of itching.

Detailed Description
-----------------
25-hydroxy vitamin D levels from non-itching HD patients in this study will be compared to 25-hydroxy vitamin D levels from our ongoing study in HD patients with itching. The primary endpoints for both studies are continuous variables. Student's t test will be used to test for statistical significance. Multiple regression analysis will be used for controlling covariates and testing the interaction among covariates.

Official Title
-----------------
A Cross-sectional Analysis of 25-hydroxy Vitamin d Levels in Non-itching Hemodialysis Patients

Conditions
-----------------
Vitamin D Deficiency, End Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis treatment for > 3 months No complaints of itching within 1 month prior to study enrollment Exclusion Criteria: Age < 18 years Failure to provide informed consent Intact PTH < 70 pg/ml or > 1,000 pg/ml Serum phosphorus > 7.0 Serum calcium (adjusted for albumin)> 11 Active malignancy Likelihood of imminent renal transplantation Current ergocalciferol treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| 25 hydroxy vitamin D level | Pt will have blood sample taken and fill out 1) Pruritis Survey 2) Phosphorus Restriction Compliance Survey | up to 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pruritis in hemodialysis patients, 25-Vitamin D in chronic kidney disease
Clinical Curative Effect Evaluation Study of Treatment of Oral Deferiprone Tablets in Aceruloplasminaemia Patients

Study Overview
=================
Brief Summary
-----------------
Aceruloplasminemia is an autosomal recessive disorder characterized by iron deposition in the brain and visceral organs. Deferiprone was used to treat aceruloplasminemia in previous study. In this study, we will assess the clinical curative effect evaluation of oral deferiprone in Chinese aceruloplasminemia patients.

Detailed Description
-----------------
Diabetes is one of the most severe symptom in aceruloplasminemia. In this study, we use R2* of pancreas MRI to evaluate the effect of deferiprone treatment.

Official Title
-----------------
Clinical Curative Effect Evaluation Study of Treatment of Oral Deferiprone Tablets in Aceruloplasminaemia Patients

Conditions
-----------------
Aceruloplasminemia

Intervention / Treatment
-----------------
* Drug: Deferiprone treated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years Diagnosed with aceruloplasminaemia Genetically confirmed diagnosis of aceruloplasminaemia Exclusion Criteria: Contraindications to deferiprone therapy Pregnancy was excluded in women of childbearing age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: Patients who was diagnosed as aceruloplasminiaemia
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deferiprone treated<br>Deferiprone (25 mg/kg/day) was given to the enrolled patient. | Drug: Deferiprone treated<br>* Deferiprone (25 mg/kg/day) was given to the enrolled patients.<br>* Other names: Clinical Curative Effect Evaluation Study of Treatment of Oral Deferiprone Tablets in Aceruloplasminaemia Patients;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pancreas MRI | Pancreas MRI is related to iron accumulation of pancreas | Up to 3 months | 
| Change of glycated hemoglobin (HbA1c) | HbA1c is a measure of long-term blood sugar control | Up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aceruloplasminemia, Deferiprone, Pancreas MRI
Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.

Official Title
-----------------
Optimum Frequency and Timing of Oral Iron Administration for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

Conditions
-----------------
Sleep Disorder, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder, Iron-deficiency

Intervention / Treatment
-----------------
* Drug: Ferrous sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days. Age 2 to 8 years. Diagnosis of restless leg syndrome, periodic limb movement disorder, or sleep disturbance. Exclusion Criteria: Currently taking oral formulation of iron other than a multivitamin. Untreated obstructive sleep apnea. Gastrointestinal disorder, including gastroesophageal refluex disease and celiac disease. Prior gastrointestinal surgery; e.g., gastrectomy, duodenal bypass, and presence of G-tube. Use of H2 blocker, antacid, or proton pump inhibitor. Inflammatory disorders, including juvenile idiopathic arthritis or inflammatory bowel disease.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 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 |
| --- | --- |
| Active Comparator: Ferrous sulfate daily<br>Subject will take 3 mg/kg oral iron in the morning | Drug: Ferrous sulfate<br>* Guideline-recommended 3 mg/kg/day dosing<br>|
| Active Comparator: Ferrous sulfate twice daily<br>Subjects will take 1.5 mg/kg oral iron twice daily | Drug: Ferrous sulfate<br>* Guideline-recommended 3 mg/kg/day dosing<br>|
| Active Comparator: Ferrous sulfate every other day<br>6 mg/kg oral iron every other day in the morning | Drug: Ferrous sulfate<br>* Guideline-recommended 3 mg/kg/day dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ferritin level | Ferritin level in blood measured in micrograms per liter | Baseline, 2 months | 
| Side effects | Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining) | 2 months |
Prague Registry of Electric Cardioversion

Study Overview
=================
Brief Summary
-----------------
This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.

Official Title
-----------------
Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias

Conditions
-----------------
Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia, Atrial Tachycardia

Intervention / Treatment
-----------------
* Procedure: Electric cardioversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive out-patients undergoing electric cardioversion for atrial fibrillation, atrial tachycardia, or typical atrial flutter Exclusion Criteria: Unstable patients with acute conditions requiring unplanned hospitalization

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 |
| --- | --- |
| Electric cardioversion<br>Patients who underwent elective cardioversion for atrial arrhythmia | Procedure: Electric cardioversion<br>* Electric cardioversion in short sedation according to established clinical practice and indications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute major complications | Major thromboembolic events or events related to cardioversion requiring unplanned hospitalisation (bleeding, severe bradycardia, anesthesia-related complications, heart failure etc) | Within 24 hours from the procedure | 
| Subacute major complications | Major thromboembolic events or events related to cardioversion requiring unplanned hospitalisation (bleeding, severe bradycardia, anesthesia-related complications, acute heart failure etc), evaluated by structured phone call. | 24 hours to 30 days after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute minor complications | Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms) | Within 24 hours from the procedure | 
| Acute efficacy | Presence of sinus rhythm on continous ECG (5-lead) monitoring | Within 2 hours from the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anticoagulants, Anticoagulation, Cardioversion, NOAC, DOAC
Invasive Infections in Children With Hemoglobinopathies

Study Overview
=================
Brief Summary
-----------------
Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. Since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause of invasive infections. The purpose of this study is to analyse in a retrospective study the incidence of those infections in a group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.

Official Title
-----------------
Invasive Infections in Children With Hemoglobinopathies. A Clinical Descriptive Retrospective Study.

Conditions
-----------------
Thalassemia, Sickle Cell Anemia

Intervention / Treatment
-----------------
* Procedure: Historical records


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated in the Pediatric Hematology Unit.

Ages Eligible for Study
-----------------
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Historical records|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
-----------------
Thalassemia, Sickle cell anemia, Splenectomy, Infections, Streptococcal Pneumonia