linjc16/ctgov huggingface dataset:
A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of FTY720 on the lung function of patients with moderate asthma

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Parallel, Time-lagged, Ascending, Multi-centre, Multiple-dose Study to Measure the Magnitude and Time Course of the Effect of FTY720 on FEV1 and Other Pulmonary Function Tests (FVC, FEF25-75%, and FEV1/FVC) in Patients With Moderate Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: FTY720
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Forced Expiratory Volume in 1 second of at least 60% History of asthma for at least 6 months Current use of short-acting beta agonists, inhaled long-acting beta agonists and inhaled corticosteroids (up to a specified dose) Exclusion Criteria: History of lung disease other than asthma Smokers Use of inhaled corticosteroid above specified dose Use of oral beta agonists or corticosteroids or other asthma medications Hypersensitivity to the drug Respiratory tract infections within 1 month of the study Other protocol-defined inclusion/exclusion criteria may apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: FTY720<br> <br> |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Pulmonary function tests (particularly Forced Expiratory Volume at 1 sec (FEV1) at Day 10 |  | 10 days | 
| Safety of FTY720 |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of short acting beta agonists during treatment compared to pre-treatment |  | 10 days | 
| Pharmacokinetics of FTY720 and FTY720-P |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, adrenergic beta agonists, multiple sclerosis, pulmonary function tests, forced expiratory volume
Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC

Study Overview
=================
Brief Summary
-----------------
Single Arm-Studies suggest improved remission and survival rates for a Protocol with Mitoxantron 10mg/m2 for 3 days combined with AraC 1g/m2 bid on days 1+3+5+7 compared to a conventional DA 7+3 protocol (45mg/m2 Daunorubicin).

Detailed Description
-----------------
Randomized comparison of the two protocols.

Official Title
-----------------
Therapy of AML in Patients Older Than 60 Years: Randomized Comparison of a Double Induction With Daunorubicin and AraC (as Continuous Infusion) With a Double Induction With Mitoxantrone and Intermittent, Medium High Dose AraC

Conditions
-----------------
Leukemia, Nonlymphocytic, Acute

Intervention / Treatment
-----------------
* Drug: randomization between two established Chemotherapies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of AML age >60 no previous Chemo for AML informed consent Karnofsky >70 Exclusion Criteria: AML M3 uncontrolled Sepsis uncontrolled HYpertension respiratory failure heart-failure NYHA IV, recent myocardial infarction severe organ dysfunction of liver, kidneys, HIV -infection or active Hepatitis B,C

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Daunorubicin + Ara-C<br> | Drug: randomization between two established Chemotherapies<br> <br> |
| Experimental: Mitoxantrone + Ara-C<br> | Drug: randomization between two established Chemotherapies<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate |  |  | 
| Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  |  | 
| Secondary purpose: Is the prognostic evaluation of the treating physician prior to initiation of chemotherapy (prior to randomization) of predictive value? |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy, elderly
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.

Official Title
-----------------
Patisiran-LNP Pregnancy Surveillance Program

Conditions
-----------------
Hereditary Transthyretin-mediated (hATTR) Amyloidosis, Polyneuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy Exclusion Criteria: There are no exclusion criteria for participation in this program.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patisiran<br>Pregnant women exposed to commercial patisiran-LNP (ONPATTRO) during the 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Major Congenital Malformations | Major congenital malformations will be classified according to the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classification systems. | From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Minor Congenital Malformations | Minor congenital malformations will be classified classified according to the EUROCAT and MACDP classification systems. | From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) | 
| Prevalence of Pregnancy Outcomes | Pregnancy outcomes are defined as live birth, spontaneous abortions, stillbirths, elective abortions, molar or pregnancy, ectopic pregnancy, preterm births, and maternal death. | From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) | 
| Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes | Other adverse fetal/neonatal/infant outcomes are defined as low birth weight, failure to thrive, small for gestational age, postnatal growth and development, neonatal, and perinatal, or infant death. | From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hereditary neuropathic amyloidosis, Familial amyloidosis, Amyloidosis, Amyloidosis senile, Cardiac amyloidosis
Impact of Antimicrobial Stewardship Program

Study Overview
=================
Brief Summary
-----------------
Establishing an antibiotic policy based on the local culture sensitivity records to ensure rational use of antibiocs, then measure the clinical and economic impact of this local antibiotic policy.

Detailed Description
-----------------
Study Objective The Ultimate aims of antimicrobial stewardship program are to improve antimicrobials efficacy, minimize their adverse effects and limit antimicrobial resistance. The aim of this study is to measure the clinical & economic impact of antimicrobial stewardship program interventions. Methodology Study Design: • Prospective-audit with feedback program strategy (Single-center, prospective, pre- and post-intervention study). Setting: • This study will be conducted in Neonatal Intensive Care Unit of Assiut University Children's Hospital, Assiut University, Assiut, Egypt. Timing: • 12- 18 months. Ethical Approval: • This study approved by the University Ethics Medical Committee. Informed consent is unnecessary since antimicrobial stewardship program interventions represent a part of routine clinical practice. Patients records will be identified by coded numbers to maintain privacy.

Official Title
-----------------
Impact of Antimicrobial Stewardship Program on Antibiotics Use in Neonatal Intensive Care Unit at Assiut University Children's Hospital

Conditions
-----------------
Blood Stream Infections

Intervention / Treatment
-----------------
* Other: Clinical pharmacists recommendations to optimize antibiotics use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the Neonatal intensive care unit (NICU) during study period and administered any antibiotic were included in the study. Exclusion Criteria: Patients Who have no antibiotics during their length of stay

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre- interventions group<br>Without clinical pharmacists recommendations to optimize antibiotics use | |
| Post - interventions group<br>interventions include clinical pharmacists recommendations to optimize antibiotics use | Other: Clinical pharmacists recommendations to optimize antibiotics use<br>* Optimal dosing, drug bug mismatch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate in each group | Number of deaths | 18 month | 
| Average Length of hospital stay in each group | In days | 18 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Antibiotics consumption | in the form of defined daily doses | 18 month |
Adverse Reactions and Efficacy of Fixed-dose Combination Anti-tuberculosis (TB) Drugs

Study Overview
=================
Brief Summary
-----------------
The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or tablet are available to prevent the development of drug resistance. However, the fixed-dose combination regimen is not consistent with the dosages that are usually given. The present available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and adverse reactions when using fixed-dose combinations regimen should be considered. The aim of the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The investigators also evaluate the efficacy of two regimens and determine the incidence of discontinuation of TB drugs and the predisposed factors between two regimens.

Official Title
-----------------
Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed pulmonary TB and extrapulmonary TB patients No previous anti-TB drugs treatment Age≥18years old Exclusion Criteria: Expected life < 6months Baseline AST/ALT > 3x upper limit of normal (ULN) Age <18years old

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Separate anti-TB drugs<br> | |
| Fix-dosed combination anti-TB drugs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment |  | two year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of anti-TB treatment between using FDC and single drugs |  | two year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fix-dose combination anti-TB drug, adverse effect, efficiency
Interleukin 4 and Interferon Gamma Predictors of Human Papillomavirus Immunotherapy in Warts

Study Overview
=================
Brief Summary
-----------------
In the present study the investigators assessed the invitro role of IL-4 and IFN-γ in predicting the response to bivalent HPV vaccine after whole blood stimulation

Detailed Description
-----------------
40 Patients and 40 controls are enrolled in the study. Participants suffer from chronic recurrent cutaneous and genital warts. Blood samples were withdrawn then whole blood cultures are prepared. Cultures are stimulated with bivalent HPVvaccine. IL-4 and IFN-γ measurement in culture supernatants by ELISA. IL-4 and IFN-γ are investigated to predict the therapeutic response to bivalent HPV vaccine immunotherapy in warts.

Official Title
-----------------
IL-4 and IFN-γ as Immunologic Predictors of Response to HPV Immunotherapy in Warts

Conditions
-----------------
Warts Hand, Wart, Genital

Intervention / Treatment
-----------------
* Biological: IL-4 and IFN-γ measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recurrent and recalcitrant cutaneous and anogenital warts. Exclusion Criteria: History of allergy to the HPV vaccine Active viral, fungal, or bacterial infections Immunosuppressive diseases or drugs. Autoimmune diseases, or other systemic diseases, e.g., hepatic, or renal disorders, diabetes, meningitis or convulsions Skin allergies Pregnancy and lactation Earlier wart treatment at least one month before enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 36 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients having multiple recurrent and recalcitrant cutaneous and genital warts | Biological: IL-4 and IFN-γ measurements<br>* Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants<br>|
| Controls<br>Healthy volunteers matched for age and sex | Biological: IL-4 and IFN-γ measurements<br>* Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of IFN-γ and IL-4 levels | Quantitative measurement of IFN-γ and IL-4 in culture supernatants | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the size of warts | Clinical observation and photographing of wart size | 6 months |
PMCFU of an Annular Closure System

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.

Detailed Description
-----------------
Retrospective chart review of patients treated with lumbar discectomy and annular closure. Review of patient charts through 3 month post op, for analysis of symptomatic lumbar reherniation at the index level.

Official Title
-----------------
Post-Marketing Clinical Follow-up of an Annular Closure System

Conditions
-----------------
Lumbar Disc Herniation

Intervention / Treatment
-----------------
* Device: Annular closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Records for any subject treated with a Barricaid annular closure device will be considered for inclusion into the study Exclusion Criteria: Records for any subject treated without a Barricaid annular closure device will be considered for exclusion
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Discectomy + annular closure<br>All patients treated with lumbar discectomy and implantation of an annular closure device | Device: Annular closure<br>* Lumbar discectomy patients treated with Annular Closure Device BARRICAID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic reherniation | Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain) | 3 months post op |
Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate reverse total shoulder arthroplasty patients preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Official Title
-----------------
Reverse Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing Reverse Total Shoulder Arthroplasty

Conditions
-----------------
Osteo Arthritis Shoulders, Proximal Humeral Fracture, Rotator Cuff Tear, Rotator Cuff Tear Arthropathy

Intervention / Treatment
-----------------
* Other: reverse total shoulder arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking >18 years of age Reverse TSA performed by principal investigator Exclusion Criteria: Non-English speaking <18 years of age

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 |
| --- |
|Other: reverse total shoulder arthroplasty|reverse total shoulder arthroplasty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total operative time | minutes | preoperative to up to 8 years postoperative | 
| amount of blood loss | mls | preoperative to up to 8 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Outcomes | American Shoulder and Elbow Surgeon score to measure shoulder function and pain. Scale of 0-100, 100 being the best possible score | preoperative to up to 8 years postoperative | 
| Patient Outcomes | Simple Shoulder Test score to measure shoulder function. Scale from 0-12, 12 being the most functional. | preoperative to up to 8 years postoperative |
Efficacy Observational Study of Candesartan Cilexetil on Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe treatment with candesartan cilexetil 16mg for 8 weeks, in uncontrolled hypertensive patients, in improvement of achieving of treatment goals and impact on blood pressure level in patients with uncontrolled hypertension treated with candesartan cilexetil.

Official Title
-----------------
Non-interventional Study on Uncontrolled Hypertensive Patients for Evaluating Efficacy of Candesartan Cilexetil as Monotherapy or add-on Therapy.

Conditions
-----------------
Primary Hypertension

Intervention / Treatment
-----------------
* Drug: Candesartan Cilexeotil 16mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of essential hypertension (mild or moderate as defined in European Guidelines of Hypertension, 2003), that are treated already with candesartan cilexetil 16mg o.d. within last 2 weeks or more, according to Romanian approved Atacand SPC. Written informed consent to allow access and use(analysis) of data collected Exclusion Criteria: Patients not to be included in the programme: patients who have any contraindication to the product as detailed in Romanian approved Atacand SPC. Use of specific concomitant medication known to present a potential safety concern according to Romanian approved SPC

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

| Intervention/Treatment |
| --- |
|Drug: Candesartan Cilexeotil 16mg|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
-----------------
hypertension