cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose.
* Previous vaccination against measles, mumps, rubella and/or varicella.
* History of measles, mumps, rubella and/or varicella/zoster diseases.
* Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.
* Rectal temperature ≥ 38°C or axillary temperature ≥ 37.5°C at the time of vaccination.
* Residence in the same household as a high risk person e.g.:
* New-born infants (0-4 weeks of age)
* Pregnant women who have a negative history of chickenpox
* Persons with known immunodeficiency
Adult Spinal Muscular Atrophy (SMA) China Registry

The primary objective of the study is to describe the natural history and utilization of disease modifying therapy (DMT) among adult Chinese participants with SMA linked to chromosome 5q (5q-SMA).


Eligibility Criteria:
Key Inclusion Criteria:

-Genetically confirmed 5q-SMA.

Key Exclusion Criteria:

-Other types of SMA (non 5q-SMA).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Music and Colposcopy in Women With Cervical Dysplasia.

To assess the effect of music during colposcopy on women´s anxiety.


Eligibility Criteria:
Inclusion Criteria:

* women referred for colposcopy due to cervical abnormalities
* We included women if they attended colposcopy for the first time

Exclusion Criteria:

* pregnant women
* presence of a language barrier
* known anxiety disorder or depression
* history of conization or other treatments on the cervix uteri
* known oncological disorder
* auditory defect
* cardiovascular disease
* inadequate colposcopy
Automated Cardiac Arrest Detection and Alerting in Daily Life

Surviving a cardiac arrest that happens outside the hospital depends on quickly recognizing the event and immediately starting CPR. Survival rates have improved when cardiac arrest is witnessed, but when it isn't, help often arrives too late. Wearable biosensors, like special wristbands, could detect cardiac arrest automatically and alert emergency responders, providing faster help.

In the already finished DETECT-1 study, the investigators developed a system that uses wrist-worn sensors to identify cardiac arrest. The goal of the current study is to test how well this system works in people who have an implantable cardioverter defibrillator (ICD). An ICD is a device that monitors and treats dangerous heart rhythms. Study participants will wear a medical wristband with sensors that monitor the heartrate and movement during their daily activities to see if the system accurately detects cardiac arrest.

Survival from out-of-hospital cardiac arrest (OHCA) depends on fast recognition of cardiac arrest and immediate initiation of cardiopulmonary resuscitation (CPR). While survival chances for witnessed OHCA have increased, unwitnessed cases still often receive help too late. Wearable biosensor technology with the functionality of automated cardiac arrest detection and activation of the emergency medical chain would offer a potential solution to provide early help. In the recently published DETECT-1 study, an algorithm for automated cardiac arrest detection using wrist-derived photoplethysmography (PPG) was recently developed.

The current study is a prospective multicenter observational cohort study to validate the sensitivity of the developed cardiac arrest detection algorithm in patients with an implantable cardioverter defibrillator (ICD) during daily life. The study population includes patients with an ICD. Study participants will wear a medical wristband with PPG and accelerometer sensors during daily life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an implantable cardioverter defibrillator (ICD)
* Age 18 years or older
* Fitting the wristband
* In possession of a smartphone that is compatible with the wristband

Exclusion Criteria:

* Known hemodynamically relevant bilateral subclavian artery stenosis
* Medical issues that interfere with wearing of the wristband (e.g. skin disorders)
* Insufficient skills to operate with the device/app
The Safety and Influencing Factors of Liwen Procedure in The Treatment of Hypertrophic Cardiomyopathy

Liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but a small proportion of patients have complications after the operation.

The goal of this observational study is to explore the incidence of postoperative complications of the Liwen procedure in hypertrophic cardiomyopathy patients underwent Liwen procedure in Xijing Hospital. The main question it aims to answer are:

* What is the incidence of complications in HCM patients underwent Liwen Procedure during postoperative hospitalization and a short-term follow-up period?
* What is the relevant factors of complications in HCM patients who underwent Liwen Procedure during postoperative hospitalization and short-term follow-up period? Can the complications of surgical patients during postoperative hospitalization be predicted? Participants have been evaluated using a variety of medical examinations before they underwent Liwen Procedure. Variants collected from medical examination and case history were used to analyze the association with each postoperative complication.


Eligibility Criteria:
Inclusion Criteria:

1. Subject with symptoms that limit daily activities (New York Heart Association functional class \>II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
2. Subject with a peak LVOT gradient≥50 mm Hg
3. Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.

Exclusion Criteria:

1. Subject with a peak instantaneous Doppler LVOT gradient of \<50 mm Hg
2. Subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
3. Subject has end-stage heart failure
The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )

This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline

Systemic sclerosis is a disease with a high burden caused by morbidity and increased mortality. To date a cure for SSc is not available. In this trial, patients are treated very early in the disease which could change the long term outcome of SSc in these patients.

In daily practice, patients so early in the disease course are not treated although they might be at risk for early escalation and internal organ involvement, reducing their prognosis. A trial to investigate the efficacy of a relative save, inexpensive and easy accessible treatment will provide us with the opportunity to change the disease course and reducing the disease burden of a portion of the SSc patients

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age over 18 years
* Fulfilling VEDOSS criteria (9):

  * Raynauds' Phenomenon and
  * Positive for disease specific auto antibodies (anti-centromere or anti-topoisomerase antibodies) and
  * typical nail fold capillaroscopic findings
* Puffy fingers \< 3 years
* Modified Rodnan skin score = 0

Exclusion Criteria:

* Presence of acroosclerosis, acrosteolysis and digital ulcers
* Presence of anti-RNA polymerase III auto antibodies

Previous systemic treatment for SSc, namely:

* methotrexate,
* prednisone (\> 14 days in previous 6 months),
* mofetil mycophenolate
* cyclophosphamide.

Clinically significant internal organ involvement:

* diffusion capacity of lung for carbon monoxide (DLCO) \< 80% predicted,
* vital capacity (VC) \< 70% predicted
* renal dysfunction with glomerular filtration rate (GFR) \< 60 ml/min
* diastolic dysfunction \> grade 1 on echocardiography
* pulmonary hypertension
* weight loss \>10% in the last 6 months with unknown cause

Contra-indications for methylprednisolone, such as:

* pregnancy, lactation
* psychotic or depressive disorder
* ulcus duodeni or ventriculi
* untreated hypertension (\> 160-90 mmHg)
* acute infections
Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway

The addition of an inhaled long-acting beta-adrenergic agonist to an inhaled glucocorticosteroid improves disease control in persistent asthma. This observation has supported the use of long-acting beta-adrenergic agonist/glucocorticosteroid combination preparations for the management of asthma. Currently, salmeterol/fluticasone and formoterol/budesonide are available for clinical use. The long-term beneficial clinical effects of the two drug classes seem to be synergistic, and several mechanisms of glucocorticoid-beta-adrenergic agonist interactions involving gene transcription have been invoked to explain this phenomenon.This study, wish to address the question whether glucocorticoids can acutely potentiate the bronchodilator response to a long-acting beta-adrenergic agonist.We expect that in patients with asthma, the short-term bronchodilator effect of salmeterol is enhanced by the addition of fluticasone, which by itself has no short-term bronchodilator effect. To test this premise, we will assess the respective short-term effects of salmeterol (50 µg), fluticasone (250 µg), salmeterol/fluticasone (50/250 µg), and placebo/placebo on spirometric parameters. Airway Blood flow will also be measured to ensure that vasoconstriction does not occur.

Fourteen lifetime nonsmokers with a physician diagnosis of asthma will be recruited for the study. All subjects will be allowed to use short-acting beta-adrenergic agonists as rescue medication.

Inclusion criteria:

1. Males and females, 18 to 65 years of age.
2. FEV1 60-85% of predicted on the screening day.

Exclusion criteria:

1. Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women.
2. Cardiovascular disease and/or use of cardiovascular medications

2. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18 to 65 years of age.
2. FEV1 60-85% of predicted on the screening day. -

Exclusion Criteria:

1. Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. 2. Cardiovascular disease and/or use of cardiovascular medications 3. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above

-
Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis

This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population

This study was prematurely discontinued after approximately 5 years. The decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in MS on a different population.

Eligibility Criteria:
Inclusion Criteria:

* Patients completed the core study BAF312A2201
* Written informed consent provided before any assessment of the extension study
* Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception

Exclusion Criteria:

* Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
* Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
* Active infections
A Study in Participants With First-Line Nivolumab Plus Ipilimumb Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer

The purpose of the study is to collect real-life data during the early post-market authorization approval period in Germany.

The study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus ipilimumab in combination with two cycles of chemo therapy in participants with confirmed stage IV Non-Small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage IV Non-Small Cell Lung Cancer (NSCLC) (histologically or cytologically confirmed stage), without known Epidermal Growth Factor Receptor (EGFR)- or Anaplastic Lymphoma Kinase (ALK)-alterations (according to label approved by EU)
* Decision to initiate a first-line treatment with nivolumab plus ipilimumab combined with two cycles of chemotherapy for the treatment of NSCLC according to the German label has been made independently of the study

Exclusion Criteria:

* Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
* Participants with known EGFR- or ALK-alterations

Other protocol-defined inclusion/exclusion criteria apply
Jafron Haemoadsorption During Cardiopulmonary Bypass

Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. Jafron is a device designed to remove cytokine from the blood using haemoadsorption (HA). This preliminary report aims to evaluate the potential of Jafron to decrease peri-operative cytokine levels in cardiac surgery.

In this context the investigators introduce the study design for multi-centre pilot randomized report in 40 patients undergoing elective CPB procedures with an expected time \>120 minutes for each extracorporeal procedure. Patients will be randomly allocated to either standard of care (n = 20) or Jafron HA(n = 20) during cardiopulmonary bypass (CPB). The primary outcome will be the difference between the two groups in cytokines levels (IL-2, IL-6,TNF-α, IFN gamma) and secondary parameters (Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Lymphocytes, Monocytes, Eosinophils, Basophils) will measured at anaesthesia induction, at the endof CPB , Primary outcomes: hemodynamics with or without vasoconstrictors use, the mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours). This prospectivemulti-centre randomized controlled report will take place in two Centres: Anthea Hospital, GVMCare \& Research, Bari, Italy; Virgen de la Arrixaca University Hospital, Murcia, Spain; between May 2022 and September 2022. The target population per centre will include (n=20) patients; will beallocate for each center to either standard of care (n = 10) or Jafron HA (n = 10) planned for elective cardiac surgery with increased risk of cytokine release.

Eligibility Criteria:
Inclusion Criteria :

* elective cardiac surgery under CPB
* double valve replacement or a complex surgery with an expected CPB duration \> 120 min
* redo cardiac surgery

Exclusion criteria:

* end-stage renal disease (dialysis dependence)
* active infectious endocarditis
* emergency or off-pump procedure
* prescription of non-steroidal antiinflammatory medication (except for low-dose aspirin) or corticosteroids within 7 days
* enrolment in another conflicting study
* administration of human albumin during CPB
A Study of Cranial Electrotherapy Stimulation as an Add-on Treatment for Tic Disorders (SCATT)

Tic disorders is recognized as a neuropsychiatric disease. The treatments of tic disorders include drug therapy, psychotherapy and physical therapy. As a non-invasive therapy, cranial electrotherapy stimulation(CES) is approved to have few side effects and applied in various areas, especially in psychiatric diseases. However, up to now there have been no results about the effects of CES in the treatment of tic disorders.The investigators hope CES could offer a useful approach for treating tic disorders.

The investigators will conduct a randomized, double-blind, sham-controlled trial to determine the efficacy of CES as an add-on treatment for tic disorders (SCATT). The study will be conducted at an outpatient, single-center academic setting. A total of 100 patients aged 6 to 17 years with tic disorders and lack of clinical response to 4 weeks' pharmacotherapy will be enrolled. Patients will be randomly into 2 groups and given 4 weeks' treatment, including 40 daily 30-minute sessions of active CES(500μA\~2mA) or sham CES(lower than 100μA) on weekdays. Change in Yale Global Tic Severity Scale (YGTSS) is considered to be the primary outcome. The secondary outcome is the changes in Clinical Global Impression (CGI) and Hamilton Anxiety Scale (HAMA). Assessments will be performed at baseline, week 2, week 4 and week 8. Adverse events(AE) will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Aged 6-17 years old
* Diagnosed with TD, according to Intentional Classification of Diseases (ICD-10) criteria, currently in a phase of exacerbation.
* Presented to be lack of response to medication after 4 weeks of treatment

Exclusion Criteria:

* Physical illnesses, such as cholera, hepatolenticular degeneration, myoclonic epilepsy, drug-induced extrapyramidal symptoms and organic diseases
* Substance dependence and abuse
* Severe psychiatric disease, such as depression, bipolar disorder, schizophrenic disease,
* Risk for suicide or attempted suicide
* Researchers think that the patient is not suitable for the study
Oral Cyanocobalamin (Eligen B12) Bioavailability Study

The purpose of this study is to assess and compare the pharmacokinetics (PK) of cyanocobalamin after the oral administration of Eligen® B12 (cyanocobalamin/SNAC), oral cyanocobalamin alone (commercially-available formulation) and cyanocobalamin administered intravenously (IV) (also a commercially-available formulation) to healthy male subjects under fasting conditions. The safety and tolerability of oral Eligen® B12 (cyanocobalamin/SNAC) versus oral cyanocobalamin alone and versus IV cyanocobalamin are also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years.
* Signed ICF prior to any study-related procedures.
* Normal organ function including renal and hepatic function.
* Normal hematological function.
* Body weight between 60 and 100 kg and within 18 - 30 kg/m2 for body mass index (BMI).
* Normal ranges in vital signs, ECG, and laboratory tests.
* Normal ranges of serum B12, methylmalonic acid (MMA), and homocysteine.

Exclusion Criteria:

* Current use (within 14 days) of acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) (i.e., aspirin or ibuprofen)
* Current use (within 14 days) of antibiotics, antacids, multivitamins, or nutritional supplements.
* Absolute platelet count below 100 x 109/L
* History or current diagnosis of any clinically significant disease of the liver, kidneys or GI system, or any abnormal condition that compromises the function of these systems and could result in the possibility of altered absorption, excess accumulation, or impairment of metabolism or excretion of the study product.
* History or current diagnosis of any clinically significant hematological, immunological, metabolic, cardiovascular, neurological, or GI abnormalities which that should, in the opinion of the Investigator exclude the subject from this study.
* Any other clinically significant laboratory value at Screening, which, in the opinion of the Investigator, suggested a condition that could have precluded the subject from entering this study.
* At risk of transmitting infection via blood samples e.g., producing a positive HIV test at screening or having participated in a high-risk activity for contracting HIV; producing a positive HBsAg test at screening; producing a positive hepatitis C antibody test at screening.
* Participation in a clinical research study involving a new chemical entity within 30 days of study entry.
* Significant loss or donation of blood within 56 days or plasma within 30 days prior to the initial dose in this study.
* Unsuitable for any reason to receive study product in the opinion of the Investigator.
* Alcohol consumption within the last 48 hours prior to study entry or anytime during the study.
* Positive urine alcohol test.