cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis

The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.


Eligibility Criteria:
Inclusion Criteria:

* Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age
* Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.

Exclusion Criteria:

* A BMD T score ≤ -3.50 at the hip,
* History of hip fracture
* Severe metabolic bone diseases
* Significant laboratory abnormalities
* Recent treatment with agents affecting bone metabolism
A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema

To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years old;
2. Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
3. Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
4. 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
5. 6MWD \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
6. mMRC score≥2;
7. Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2\>50 mmHg on room air;
8. Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.

Exclusion Criteria:

1. Contraindications to bronchoscopy, such as:

   Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc;
2. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency;
3. Use of morphine derivatives within 4 weeks prior to screening;
4. Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
5. Recent COPD exacerbation in preceding 6 weeks;
6. Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung lobe volume \> 40%;
7. Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;
8. Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);
9. History of heart and/or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils, stents, etc.);
10. Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;
11. Pregnant or breastfeeding;
12. Current enrollment in any other investigational study which has not completed requisite follow-up;
13. Any conditions assessed by investigator that make patients inappropriate for enrolment.
A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS

To evaluate whether immune globulin and ganciclovir (DHPG) results in faster initial response as compared to DHPG alone. To evaluate whether immune globulin and DHPG gives longer duration of remission than DHPG alone (i.e. 16 weeks). To evaluate the toxicities of the combination of DHPG and immune globulin as compared to those of DHPG alone. To evaluate if there is a difference between the two groups in regard to survival, immune functions, and CMV viremia and viruria.


Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

* First episode of sight-threatening CMV retinitis.
* At least one pending culture for CMV from the blood or urine prior to entry.
* Life expectancy \> 6 months.
* Karnofsky performance = or \> 60.
* Ability to understand the nature of the study, to comply with study requirements, and to sign informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Known selective IGA deficiency or antibodies against IgA.
* History of previous episodes of sight-threatening CMV retinitis.

Patients with the following are excluded:

* Previous episode of sight-threatening CMV retinitis.
* Concomitant treatment with other investigational agents except ddI or ddC.
* Life expectancy \< 6 months.
* Continued alcohol or drug abuse.
* Known selective IgA deficiency and known to have antibodies against IgA.
* Karnofsky performance \<60.

Other investigational agents except ddI or ddC.

ddI ddC
Evaluation of the Safety and Performance of Magneto Microcatheter

A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical signs consistent with acute ischemic stroke
2. Patient with Acute Ischemic Stroke within 24 hours from symptoms o
3. Age 18-85 years old
4. Consent process is completed per international and local regulations

Exclusion Criteria:

1. Known use of cocaine or other vasoactive substance
2. Known bleeding diathesis
3. Any known hemorrhagic or coagulation deficiency.
4. Current use of oral anticoagulants with International Normalized Ratio (INR) \> 3;
5. PTT (Partial Thromboplastin Time)\>2 at screening
6. Uncontrolled hypertension (Systolic blood pressure\>185 or Diastolic blood pressure\>110) refractory to pharmacological management
7. Pregnant or lactating female
8. CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score\<6, mass effect and/or intracranial tumor
9. Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion.
Protectivity and Safety Following Recombinant Hepatitis B Vaccine

Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population

Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population.

Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy individu as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.
2. Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
3. Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. Subjects with known history of Hepatitis B contained vaccination in the last 10 years
3. Evolving severe illness and/or chronic disease and fever (axillary temperature more than37.5oC) within the 48 hours preceding enrollment.
4. Known history of allergy to any component of the vaccines (based on anamnesis)
5. HBsAg positive
6. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
8. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant.
9. Pregnancy \& Lactation (Adult)
10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

Cataract extraction is one of the most common operative procedures performed throughout the world. Conventionally, patients are discharged with postoperative drops of steroids and antibiotics or a combination of both. These drops are to be administered for 2-6 weeks depending on individual eye unit protocol. Many patients find the postoperative drops arduous and non-compliance can cause prolonged inflammation and discomfort. Patients with cognitive, physical and visual impairments require assistance from family or community nurses to administer drops. A single perioperative injection of Triamcinolone has been shown to be an effective replacement for drops postoperatively in two previous studies 1, 2.

Aims \& objectives

The aim of this study is to see if a single orbital floor injection of Triamcinolone is equivalent to conventional steroid and antibiotic drops used post operatively in uneventful phacoemulsification surgery in treating postoperative inflammation.

This is a prospective randomized control trial of 80 patients undergoing routine phacoemulsification cataract extraction. The patients were randomly assigned to receive the triamcinolone injection or post operative topical treatment of G Maxitriol QDS 1/52 tapering over one month. Forty mg of triamcinolone was injected inferior temporally immediately post operatively prior to undraping the patient in theatre in those randomized to this group. The patients were reviewed at week one and at one month.

Eligibility Criteria:
Inclusion Criteria:

* uncomplicated cataract surgery, ability to attend follow appointments at one week and one month

Exclusion Criteria:

* included premorbid ocular pathology including previous ocular inflammation and glaucoma, previous ocular surgery, history of CMO, diabetes, concurrent use of systemic anti-inflammatories including inhaled or topical therapy, history of systemic inflammation, inability to attend follow up appointments at one week and one month, complicated cataract surgery
Effects of Core Stabilization and Strengthening Exercise on Quality of Life in Clinical Lumbar Instability

This study will compare the effects of 2 exercise programs including core stabilization exercise and general trunk strengthening exercise programs on trunk muscle activity, physical dysfunction, quality of life and lumbar motion in low back pain patient with clinical lumbar instability.

Clinical lumbar instability is the one of causes of chronic low back pain, that affects to pain intensity and quality of life. For clinical studies using core stabilization exercise (CSE) as treatment have revealed conflicting findings on pain, functional disability and muscle responses in chronic low back pain. The CSE promotes local muscle system that to provide lumbar stability. However, the stability of spine related to global muscle system, that using in this study.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain due to clinical lumbar instability

Exclusion Criteria:

* Specific low back pain
* Cuada equine syndrome
* Neurological deficit
Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics and efficacy of CFZ533 as an add-on therapy to standard of care in patients with moderate to severe myasthenia gravis (MG).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MG class IIa to IVa inclusive (Myasthenia Gravis Foundation of America Clinical Classification).
2. Quantitative Myasthenia Gravis (QMG) score of 10 or greater. If the QMG score is \< 15 no more than 4 points may be derived from items 1 or 2 (ocular motility disturbance and ptosis).
3. Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive.
4. Only one immunosuppressant or immunomodulatory drug at a stable dose is allowed during the study (i) azathioprine and mycophenolate mofetil must be stable for at least 4 months prior to randomization (ii) cyclosporine must be stable for at least 3 months prior to randomization.
5. If the patient is on oral corticosteroids, methotrexate or tacrolimus at screening, the dose must be stable for at least 1 month prior to randomization.
6. If the patient is on cholinesterase inhibitors at screening, the dose must be stable for at least 2 weeks prior to randomization.
7. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, may be included in the study if they are using highly effective methods of contraception during the study and for 12 weeks after study treatment.

Exclusion Criteria:

1. MGFA grade I, IVb, or V disease.
2. Documented presence of unresected thymoma.
3. Patients having undergone thymectomy or thymo thymectomy (resection of thymoma) within 6 months of screening.
4. Patients having received any of the following treatments prior to randomization:

   1. IVIg or plasma exchange within 8 weeks;
   2. oral or IV cyclosphosphamide treatment within 3 months;
   3. IV corticosteroid bolus (dose higher than 1 mg/kg) within 3 months;
   4. belimumab within 6 months. For patients who received belimumab earlier, B cell count should be within normal range;
   5. rituximab within 12 months. For patients who received rituximab earlier, B cell count should be within normal range;
   6. any other biologic or an investigational drug within 1 month or five times thehalf-life, whichever is longer.
   7. Live vaccines within 4 weeks of study drug infusion.
5. Patients who are at significant risk for TE as judged by the investigator or have any one of the following:

   1. History of either thrombosis or 3 or more spontaneous abortions with or without the presence of anti-cardiolipin autoantibodies;
   2. Presence of prolonged partial thromboplastin time (PTT).
Physiotherapy and Reaction Time in Hemophilia

This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions.

Introduction: The positive effects of physiotherapy and exercise on joint health, frequency of hemartrosis (FoH) in patient with hemophilic arhropathy (PwHA) are well explained in the literature. However, adaptation problems to physiotherapy sessions (usually 3 times a week) may cause PwHA to ignore the need for therapy. It may be more beneficial for PwHA to adapt physiotherapy and exercise into daily live.

Aim: To investigate the effect of a once-a-week physiotherapy combined with home exercises on joint health, FoH, muscle strength, pain, reaction time and dynamic balance.

Methods: 20 patients have hemophilic arthropathy in knee and/or ankle were randomly divided into 2 groups, named home exercise (HE) and comprehensive physiotherapy combined with home exercise (CPcwHE). In the clinical assessment, HJHS, manuel muscle tester, Fitlight® system for reaction time, functional reach test for dynamic balance were used and questioned the number of bleedings in the last 6 weeks for FoH. The CP group received comprehensive physiotherapy (manual therapy, neuromuscular electrical stimulation and exercises) 1 day a week, and did the exercises at home the other 2 days a week. The HE group performed the exercises given to CP at home 3 times a week. Evaluations were repeated at the end of 6 weeks.

Eligibility Criteria:
Inclusion Criteria: -Clinical diagnosis of hemophilia

-Clinical diagnosis of hemophilic arthropathy in ankle and/or

Exclusion Criteria:

* Clinical diagnosis of any neurological disease
Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)

Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.

Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC).

Eligibility Criteria:
Inclusion Criteria:

* survived cardiac arrest
* voluntary consent

Exclusion Criteria:

* no voluntary consent
E-nose and Inflammatory Asthma Phenotypes

Patients with persistent asthma have different inflammatory phenotypes. The electronic nose is a new technology capable of distinguishing volatile organic compound breath-prints in exhaled breath among different pulmonary diseases.

Question of the study. Is the electronic nose breath-print analysis able to discriminate among different inflammatory asthma phenotypes?

Materials/patients and methods. Fifty-two consecutively enrolled patients with persistent asthma were included in a cross-sectional proof of concept study. Inflammatory asthma phenotypes were recognized by inflammatory cell counts in induced sputum. Breath-prints were analyzed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values. Receiver Operating Characteristics (ROC) was calculated.

Legal and ethical aspects The study was conducted in accordance with the Declaration of Helsinki principles (18th Word Medical Assembly, 1964) and was approved by the Clinical Research Ethics Committee (approval number: IIBSP/10/122/1161) of our institution. The participants provided their written informed consent to participate in this study and personal identification data were anonymized.

Eligibility Criteria:
Inclusion Criteria:

Adults with persistent asthma, defined as per the Global INitiative for Asthma Management (GINA) criteria, and specifically with positive bronchodilator test, or a daily peak expiratory flow (PEF) variability greater than 20%, or a positive methacholine challenge test documented in case history. Subjects were consecutively enrolled from the outpatient visits of a specialized Asthma Unit located in a tertiary University Hospital.

Exclusion Criteria:

Subjects were excluded if they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion or were receiving oral steroids or immunosuppressive treatments.
Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease

The purpose of this study is to see the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in patients with Parkinson's disease.

This study is a randomized 1:1 placebo-controlled 12-week study of Mirabegron in 144 Parkinson's subjects the age of 40 to 80 with overactive bladder. Active drug will be Mirabegron 50mg daily. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 1. Enrolled subjects will have 3 study visits to the clinic as well as 1 phone visit.

Eligibility Criteria:
Inclusion Criteria:

* Subject who signed a consent form approved from IRB(Institutional Review Board) or IEC(Independent Ethics Committee)
* Diagnosis of Parkinson's disease by a neurologist
* taking a Parkinson's medications stably during 4 weeks preceding screening
* 40 Years to 80 Years, Male and Female
* Patient has overactive bladder symptoms more than 4 weeks preceding screening.
* OABSS questionnaires total score≥ 3 and entries of urinary urgency score≥ 2
* The expanded disability status scale ≤ 7

Exclusion Criteria:

* Subjects who have any intervention and operation which can influence on study such as bladder augmentation, vesical sphincter, artificial sphincter, intravesical botulinum toxin treatment etc.
* Use of indwelling catheter or self-catheterization
* acute urinary tract infection or urolithiasis at screening
* History of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
* total volume urine \> 3L a day
* Screening post-void residual \> 200ml
* Nonpharmacological therapy within the previous 4 weeks of screening
* screening blood pressure \>180 systolic or 110 diastolic
* subjects who have orthostatic hypotension, syncope, hypokalemia, or angle-closure glaucoma
* Clinically Significant ECG in recent year
* Screening estimated glomerular filtration rate (eGFR) \< 29, AST ( aspartate aminotransferase ) or ALT ( alanine aminotransferase ) \> 2x upper limit of normal, γ-GT(gamma-glutamyl transferase) \> 3xULN
* take following medication additionally or change the dose: previous 4weeks of screening to end of the study (tamsulosin/silodosin/terazosin, baclofen, diazepam, amitriptyline, DDAVP/desmopressin) previous 12weeks of screening to end of the study (finasteride, dutasteride)
* Use β2- adrenoreceptor agonist, loop diuretic, CYP 3A4 inducer, CYP 2D6 narrow therapeutic index, CYP 3A4 inhibitor, antifungal agent, antiarrhythmic agent
* History of allergy to Mirabegron and beta-adrenergic receptor
* Use of one of the anti-cholinergic bladder medications such as Propiverine / tolterodine / trospium / darifenacin / solifenacin / fesoterodine and mirabegron within 14 days of the screening visit. Subjects who have used one of these medications in the past but discontinued it at least 14 days prior to the screening visit can be enrolled.
* women who have potential to become pregnant during the course of the study