cyrilzakka/clinical-trials huggingface dataset:
Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market study. The Stroke AF study will compare the incidence rate of atrial fibrillation through 12 months between the continuous monitoring arm and the control arm in subjects with a recent ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days
* Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up
* Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke:

  * Congestive heart failure
  * Hypertension (Systolic Blood Pressure \> 140)
  * Diabetes Mellitus
  * Prior Stroke (\>90 days ago, other than study qualifying index event)
  * Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque)

Exclusion Criteria:

* Subject has had a cryptogenic stroke
* Subject has had a cardioembolic stroke
* Subject has untreated hyperthyroidism
* Subject has had a recent myocardial infarction \<1 month of stroke
* Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) \<1 month of stroke
* Subject has a mechanical heart valve
* Subject has valvular disease requiring immediate surgical intervention
* Subject has documented prior history of atrial fibrillation or atrial flutter
* Subject has permanent indication for oral anticoagulation
* Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment
* Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee.
* Subject's life expectancy is less than 1 year
* Subject is pregnant
* Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor
* Subject with a medical condition that precludes the patient from participation in the opinion of the investigator
Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting

This study evaluates the effect of combining non pharmacological anti emetic prophylaxis, namely peppermint essential oil to granisetron and dexamethasone in patient who receive intrathecal morphine for lower segment cesarean section. Half of the patient will receive nasal strip containing peppermint essential oil in addition to granisetron and dexamethasone while the other half will only receive granisetron and dexamethasone.

It is not uncommon to use different group of anti emetic in order to achieve high successful rate in the prevention of opioid induced nausea and vomiting. This study evaluates the effect of combining non pharmacological and pharmacological method to prevent such condition.

Aromatherapy has been used since many years to treat nausea and vomiting. One of the proposed mechanism is by the activation of olfactory receptor when the molecules of essential oil absorb in the mucus lining olfactory epithelium. The signal is then carried by olfactory sensory neuron to the olfactory bulb which filters and send signal to olfactory cortex as well as limbic system to give the feeling of well being.

Granisetron is a serotonin 3 receptor antagonist prevent or treat nausea and vomiting by competitively blocks the action of serotonin at 5-hydroxytryptamine 3 (5HT3) receptors while the mechanism of action of dexamethasone; which is a glucocorticoids is not fully understood.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I and II.
* Non-smoker.
* BMI =\< 40
* Singleton pregnancy

Exclusion Criteria:

* Patient with known allergy to granisetron, dexamethasone, bupivacaine, fentanyl, morphine, paracetamol, celecoxib, ginger oil.
* Patient who has inability to breathe through nose.
* Patient with history of post-operative nausea and vomiting (PONV) or motion sickness
Study Evaluating PSI-697 in Patients With Scleritis

To evaluate the safety of an orally administered single dose of PSI-697 in subjects with scleritis, as a model of inflammatory disease. To evaluate by in vivo confocal microscopy (IVCM) the effect of a single dose of PSI-697 on leukocyte rolling in the scleral blood vessels of subjects with scleritis.


Eligibility Criteria:
Inclusion: Age 18 or higher; A negative urine pregnancy test at screening for female subjects; Female subjects must be postmenopausal or surgically sterile.

Exclusion: Isolated episcleritis; Isolated posterior scleritis; Infectious scleritis.
Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases

The main objective of this trial is to compare feasibility and efficacy of sequential neoadjuvant chemoradiotherapy with 44Gy concomitant boost to neoadjuvant chemotherapy alone. Secondary objectives are to assess the value of position emission tomography (PET）in predicting pathological response and event-free survival（EFS）in stage IIIA non-small cell lung cancer (NSCLC). Further to compare the amount of serum DNA in patients with stage IIIa NSCLC before, during and after chemotherapy, before and after radiotherapy (in arm A) and during follow-up in patients randomized into the trial and to correlate the Deoxyribonucleic acid (DNA) variation with tumor response, remission duration and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven NSCLC with nodal metastases: T1-3N2M0
* Performance status 0-1
* Patient medically fit enough for protocol therapy, including operability
* Age 18-75
* Written informed consent
* No previous chemo- or radiotherapy

Exclusion Criteria:

* Patients with prior or concomitant malignancies Allowed are: non-melanomatous skin cancer, adequately treated in situ cervical cancer or any other neoplastic diseases with disease-free interval ³ 5 years.
* Presence or history of any distant metastasis
* Unstable cardiac disease requiring treatment, congestive heart failure or angina pectoris even if medically controlled, significant arrhythmia, or prior history of myocardial infarction in the last 3 months
* History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
* Active uncontrolled infection
* Uncontrolled diabetes mellitus
* Gastric ulcers
* Preexisting peripheral neuropathy (\> grade 1)
* Other serious underlying medical condition which could impair the ability of the patient to participate in the trial
* Concurrent treatment with other experimental drugs
* Pretreatment with any other cytostatic therapy
* Previous radiotherapy to the chest
* Concurrent treatment with prednisone (or equivalent) except: for the prophylactic medication regimen before treatment, treatment of acute hypersensitivity reactions or chronic treatment (initiated \> 6 months prior to trial entry) at low dose (£ 20 mg methylprednisolone or equivalent)
* Definite contraindications for the use of corticosteroids as premedication
* Treatment within a clinical trial within 30 days prior to trial entry
* Socioeconomic or geographic circumstances that may prohibit proper staging, treatment or follow-up procedures
* Pregnancy, lactation period
Glucose Metabolism and Quality of Life in Healthy Women

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. Women with PCOS often have problems with fertility, unwanted hair growth, and irregular menstrual cycle. PCOS is associated with obesity, changes in glucose metabolism and low quality of life.

In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen levels, cortisol metabolism, anflammatory response, ovarian morphology, body composition, pfysical activity and quality of life is studied in 40 healthy women. The results will be compared with results from studies on women with PCOS in order to investigate any differences in these parametres.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* No medications
* regular menstrual cycle
* no hair growth problems
* BMI 18-35 kg/m2

Exclusion Criteria:

* medication
* diabetes mellitus
* signs of PCOS
* BMI \< 18 or \> 35
Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

The study was carried out in 88 children with severe early childhood caries (dmfs≥age +1) who were referred to the investigators' clinic. Patients who completed dental treatment under general anesthesia in a single session, were included to the study.

Patients were divided randomly into 4 groups and after dental treatment one of the fluoride varnish listed below was applied to each child. The groups were as follows;

1. Duraphat varnish containing 5% Sodium Fluoride (Colgate) (n = 22),
2. Clinpro ™ White Varnish containing 5% of Sodium Fluoride tricalcium phosphate (3M ESPE) (n = 22),
3. Embrace ™ Varnish containing 5% Sodium Fluoride with CXP ™ (Pulpdent) (n = 22),
4. MI Varnish containing 5% Sodium Fluoride casein phosphopeptide amorphous calcium phosphate varnish (GC) (n = 22).

Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples before general anaesthesia; one month after treatment and three months after treatment.

Duraphat (Colgate), which we used as a positive control group in our study, contains only 5% sodium fluoride. It has been reported in studies that Duraphat is effective in remineralization.

Clinpro ™ White Varnish, another topical varnish in this study,was reported to be effective for caries prevention in pre-school children.

One of the varnishes we evaluate in the study, Embrace™ Varnish, contains 5% sodium fluoride with xylitol-coated calcium and phosphate. According to the manufacturer, the xylitol coating prevents the calcium and phosphate salts from reacting until they come in contact with saliva. Saliva dissolves the xylitol and releases the calcium and phosphate ions, which react with the fluoride ions in saliva to form protective fluorapatite on the teeth19 MI Varnish, in the fourth group containing 5% sodium fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP) had a high release of calcium and fluoride ions.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of healthy children with severe early childhood caries,
* younger than 6 years in the primary dentition

Exclusion Criteria:

* history of any chronic disease,
* use of any drugs that reduce salivary flow or antibiotics in the last 4 weeks,
* use of systemic fluoride tablets
Efficacy and Safety of Cranial Electrical Stimulation (CES) for Major Depressive Disorder (MDD)

The purpose of this study is to see if using Cranial Electrical Stimulation (CES) helps improve symptoms of major depressive disorder (MDD). The investigators are studying the device's effectiveness in treating depression, as well as its safety. This is a pilot study.

Eligible participants will be randomly assigned to receive either active CES or sham CES, every weekday for 3 weeks. During the visits, subjects will receive CES or sham CES treatment for 20 minutes.

The primary outcome measure will be change in score on the HAM-D 17. The secondary outcome measure will be change in patient-reported sleep score.

We examined efficacy and safety of one specific cranial electrical stimulator (CES) device at a fixed setting in subjects with treatment-resistant major depressive disorder (MDD). Thirty subjects with MDD and inadequate response to standard antidepressants were randomized to 3 weeks of treatment with CES (15/500/15000 Hz, symmetrical rectangular biphasic current of 1-4 mAmp, 40 Volts) or sham CES (device off) for 20 minutes, 5 days per week. The primary outcome measure was improvement in the 17-item Hamilton Depression Rating Scale (HAM-D-17). Adverse effects (AEs) were assessed using the Patient Related Inventory of Side Effects (PRISE). We hypothesized that subjects who received active as opposed to sham CES would have a significantly greater improvement in their depression symptoms. Due to the small sample, we could not hypothesize an effect size, but would calculate one to determine signal strength to guide the design of a larger, more rigorous study. As an exploratory aim, we also examined whether CES would benefit sleep.

Eligibility Criteria:
Inclusion Criteria

Subjects must meet all of the following criteria to participate in the study:

1. Age 18-65 years old
2. Be in generally good health
3. Meet criteria for Major Depressive Disorder based on the DSM-IV
4. HAM-D-17 score ≥ 15, and ≤ 23

Exclusion Criteria

Subjects meeting any of the following criteria will not be allowed to participate in the study:

1. Taking any antidepressant medications (including natural products such as omega-3, St John's wort, and/or SAMe)
2. Having any unstable health conditions (unstable cardiovascular illness, cardiac arrhythmia, presence of a pacemaker, epilepsy and shock, fever, weakness and hypotension, or presence of a vagal nerve stimulator)
3. Having any electrical stimulation implants - i.e. pacemaker, deep brain stimulators (VNS, DBS), transcutaneous electrical nerve stimulator (TENS)
4. Psychotic or manic symptoms, or other evidence of a psychotic disorder; recent history of substance abuse or dependence
5. Electro Convulsive Therapy (ECT) during the last year
6. Previous course of Cranial Electrical Stimulation
7. Current active suicidal or self-injurious potential necessitating immediate treatment
8. In women, pregnancy, plans to conceive, or unwillingness to comply with birth control requirements
9. Depression-focused psychotherapy initiated within 90 days preceding enrollment or during participation in study
Clinical Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus

Performance evaluation of QIAstat-Dx® ME Panel Plus using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment

The objective of the study is to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment.

The primary objective is to evaluate the performance of QIAstat-Dx® ME Panel Plus in comparison with the results obtained from the reference method.

The secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators.

The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined

Eligibility Criteria:
Inclusion Criteria:

* Specimen must be Cerebrospinal fluid, obtained via lumbar puncture only.
* Specimen must be a de-identified residual leftover specimen.
* Specimen must meet the laboratory testing criteria for individuals with signs and/or symptoms of meningitis and/or encephalitis.
* Specimens must have a minimum 450 µL of residual volume.
* Specimen must be unique (only one sample enrolled per patient).
* Prior to QIAstat-Dx testing, residual CSF specimen must have been stored in accordance with the following:

  * Prospective Fresh:

    * Room temperature (15 °C to 25 °C) for ≤24 hrs
    * Refrigerated (2 °C to 8 °C) for ≤ 7 days
  * Prospective Frozen:

    * -15 ºC to -25 ºC for ≤ 2 months
    * -60 ºC to -90 ºC for ≤ 4 months
  * Retrospective Archived:

    * Frozen
* At the time of QIAstat-Dx testing, specimen must not have undergone more than three (3) freeze/thaw cycles.
* Prospective Samples Only: Specimen must have been collected on or after the date of prospective study activation at the Clinical collection and testing site.
* Retrospective Samples Only: Specimens must have a positive diagnosis as per Standard of Care for any of the following viral targets:

Herpes simplex virus 1 (HSV-1) Herpes simplex virus 2 (HSV-2) Human herpesvirus 6 (HHV-6) Human parechovirus (HPeV) Varicella zoster virus (VZV) Cytomegalovirus (CMV)

Exclusion Criteria:

* Residual CSF specimen has been centrifuged.
* Residual CSF specimen subject identification or label is unclear or missing.
* Residual CSF specimen container has obvious physical damage.
Interferon/Ribavirin-Free Sofosbuvir Based Treatment (AURIC)

Since the availability of interferon free direct acting antivirals (DAA) the centers authorized to prescribed these drugs in Austria submitted their data to a central data base (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (F3/4)

From end of 2013 303 HCV-monoinfected patients with advanced liver disease (F3/4) were treated with interferon (IFN)-free and RBV-free SOF-based regimens. During this period only 7 patients received additional RBV. These patients were not included in this analysis. Only patients who completed 12 weeks of treatment-free follow up until July 2015 were included in this analysis. In Austria, prescription of DAAs is restricted to specialized treatment centers. Data are obtained by 6 participating centers and submitted to the central database forming for of the Austrian Ribavirin- and Interferon-free cohort (AURIC). Incoming data are reviewed by the staff of the hepatitis study group of the Dept. of Medicine III, Medical university of Vienna.The treatment regimens consisted of SOF/DCV, SOF/SMV, and SOF/LDV. The duration of treatment was based on a response guided approach at the discretion of the treating physician (12 or 24 weeks).

Sixty six patients who had started therapy before August 2014 received SMV or DCV as part of a named patient program, SOF was prescribed. For the remaining patients all drugs were prescribed and paid for by the Austrian social insurance.

This study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis C:

Sustained virologic response (SVR) defined as undetectable HCV-RNA after 12 weeks of treatment free follow up

Virological breakthrough/relapse defined as reappearance of HCV on treatment/during follow up

Impact of viral kinetics on prediction of treatment efficacy: Viral load measured repeatedly (at baseline, on days 2,7,14,21,28,and than every 4 weeks until end of treatment) allows to study the rapidity of viral clearance. This parameter was used to assess whether length of treatment can be modified. Plasma HCV RNA levels were quantified by One Signal Amplification (Versant HCV RNA 3.0),

Adverse Event Recording (using standard GCP criteria)

Longterm outcome after SVR based on examining patients with SVR in six monh intervals. Examination will include liver sonography, elastography, routine blood chemistry including alpha1-fetoprotein

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens

Exclusion Criteria:

* other disease with poor prognosis (ie. metastatic cancer, heart failure)
* participation in a clinical trial
Effect of Preliminary Administration of Cyclosporine (Sandimmun ®) on Different Markers of Cardiac Ischaemia Induced by Cardiopulmonary Bypass

Observe the effect of preliminary cyclosporine administration on different markers of cardiac ischaemia led by the aortic cross-clamp during coronary artery bypass surgery with Cardiopulmonary bypass.

The coronary artery bypass surgery, in spite of substantial improvements during the last years, is still associated to a post-operative mortality and morbidity: myocardial infarction, heart failure, cardiac arrhythmia, renal failure, Stroke.

These complications are often due to ischaemia - reperfusion injury event. Recent studies showed that in case of cellular stress (in particular during the reperfusion after ischaemia) a not specific pore, called Mitochondrial permeability transition Pore (MPTP), could be opened. That caused the loss of ion homeostasis, then cell death as well as by apoptosis as by necrosis.

Prevent the opening of this MPTP during the myocardial reperfusion after coronary bypass, for example, is an important objective to improve the cardioprotection.

The Cyclosporin A, prevents the MPTP from opening. Several studies have shown an cytoprotection led by cyclosporin A, after ischaemia reperfusion in several models as isolated rats heart, in vivo rats heart and ex vivo myocardial ( atrial ) human tissues.

Recently, a multicentric study performed in humans, during the acute phase of myocardial infarction, showed a reduction of infarct size by approximately 40% in the cyclosporine group compared to control group.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized for a coronary artery bypass surgery
* Not urgent surgery
* Left ventricular ejection fraction (LVEF)\> 40 %
* 18 years and older
* patient who have sign the informed consent form
* Affiliation to the French Social Security.

Exclusion Criteria:

* Beating heart surgery with or without Cardiopulmonary Bypass
* Patient receiving another surgical gesture combined to the CABG
* Myocardial infarction or vascular cerebral attack less than 30 days
* Previous History of cardiac surgery;
* Renal failure (creatinine \> 200 µmol/l)
* Uncontrolled hypertension
* hyperkaliemy;
* hyperuricemy;
* Acute Coronary Syndrome
* Malignant tumor
* Unchecked infection
* Previous intravenous administration of Sandimmun ®;
* allergy to ciclosporin, ethyl alcohol, castor oil or nitrogen
* Pregnant Woman, parturient without contraception, or breast-feeding
* Age \< 18 years
* Patient who have not signed the form of consent;
* Patient Under guardianship or being the object of a legal protective measure