cyrilzakka/clinical-trials huggingface dataset:
Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients

To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A).

To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).


Eligibility Criteria:
Inclusion Criteria:

* All types of locally advanced and metastatic malignancy
* Male/female participants
* Age\>18 y.o.
* Signed informed consent for participation in the study
* No restriction on Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) Performance Status
* Subject should not have received a prior systemic anti-viral treatment for Covid19 disease.

Exclusion Criteria:

* Patients with known hypersensitivity to hydroxychloroquine or chloroquine, azithromycin, erythromycin, or any other macrolide, ketolide or any of the excipients of the hydroxychloroquine and/or azithromycin-based specialty used.
* Severe hepatic impairment and patients with severe cholestasis.
* Patients with renal insufficiency with creatinine clearance \< 40 mL/min.
* Combinations of drugs contraindicated in accordance with the approvals of the specialties used.
* Patients currently treated with Tamoxifen
* Patients already treated by hydroxychloroquine or azithromycin for Covid19 disease or currently treated with other antiviral drugs against coronavirus.
* Patients with known contra-indication to treatment with the study drug, including retinopathy, G6PD deficiency, QT prolongation and severe hepato-cellular insufficiency.
* Patients post allogeneic hematopoietic stem cell transplantation are eligible to the Part B treatments but the potential toxic effects of hydroxychloroquin and azithromycin on hematopoietic stem cells should be taken into consideration by prescribers.
* Pregnant or breastfeeding women. Women of childbearing potential (WOCBP, as defined in appendix 2) should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response

The objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration.

We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, \>10 mmHg respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will previously have been excluded.

Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening (7AM).

Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment groups:

* Oxygen therapy group
* Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will be performed with a bilevel pressure ventilator. Functional respiratory variables as well as quality of life and sleep at onset and after 6 months treatment will be compared.

The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients \< 80 years old.
* COPD (ERS/ATS (FEV1 \< 80%, FEV1/FVC \< 70%, TLC \> 80%)).
* Oxygen therapy indication (PaO2 \< 55 mmHg or 55-59 associated to pulmonary arterial hypertension, chronic Cor Pulmonale, Chronic Heart failure, arrhythmias or polyglobulia).
* PaCO2 \> 50 mm Hg.
* Clinically stable at least prior to one month.
* Hypercapnic response: increasing PaCO2 \> 10 mmHg at 7 a.m after all night with oxygen compared with PaCO2 when awake and without oxygen therapy.

Exclusion Criteria:

* Active smoker.
* Bronchiectasis or tuberculous after-effects.
* Chronic respiratory failure secondary to thorax cage or neuromuscular diseases.
* BMI \> 35 kg/m2
* OSAS.
* Locomotor system problems that disable 6 minutes walking test execution.
* Patients with tracheostomy.
* Other serious comorbidity (i.e chronic heart failure functional class \> II NYHA, cancer or chronic renal failure that requires dialysis.
Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of COVID-19

Oslo University Hospital has initiated an observational study on hospitalised patients with confirmed COVID-19, the infection caused by Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2).

Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS-CoV-2, require investigation to understand pathogen biology and pathogenesis in the host. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host directed therapies, the transmission dynamics, and factors underlying individual susceptibility.

At Oslo University Hospital, an observational study on the newly discovered emerging SARS- CoV-2, the coronavirus that causes COVID-19 infection has started. The study has been approved by the Regional Ethics Committee, so that inclusion of confirmed COVID-19 cases admitted at the hospital can start immediately including the first patients needing hospitalisation. The plan is to include more hospitals in other parts of Norway, starting with inclusion of Akershus University Hospital, Vestre Viken Drammen Hospital and Østfold Hospital. The study is anticipated to provide much needed data on the course of the COVID-19 infection, as well as generating knowledge about the virus and its transmission.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 by screening of SARS-CoV-2 E-gene

Exclusion Criteria:

* Refusal of consent by patient or closest relative
A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension

This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous system's (SNS) activity in subjects with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 25-65 years
* Subjects with essential hypertension (EH)
* Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
* Subjects with normal sinus rhythm
* Subjects with resting heart rate (RHR) greater than 70 bpm
* Subjects who give written informed consent

Exclusion Criteria:

* Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
* Subjects with bradyarrhythmia/hypotension
* Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association \[NYHA\] Class III - IV)
* Subjects with uncontrolled diabetes mellitus (DM)
* Subjects with bronchial asthma
* Subjects with gastro-intestinal ulcer or skin ulcer
* Subjects with liver dysfunction/renal impairment
* Subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers.
* Subjects with glaucoma
* Subjects with known allergic/intolerance to beta-blocker
* Pregnant or lactating women
* Subjects who had participated in another clinical study within the last 3 months
* Subjects who have legal incapacity or limited legal capacity
Use of the Avulux® Lenses as an Aid in Reducing the Impact of Migraine Headaches

The purpose of this research is to assess how well the Avulux® migraine lenses work in reducing the impact of migraine headaches as measured by improvement in an 11-point pain scale after two and four hours of device application, when compared to a control device.

Avulux® is intended to reduce the severity of headache pain in adult patients diagnosed with episodic migraine headaches. In this study, the investigative Avulux® device shall consist of a pair of optical filters in the form of spectacle lenses, provided in a standard spectacle frame; the lenses contain a dye that effectively blocks light at specified wavelength ranges while minimizing distortion of the visible spectrum. The optical filters block a portion of the optical spectrum that is suspected to stimulate photophobic responses that trigger some, and exacerbate most, migraines.

The control/sham device for this study shall be a pair of plastic lenses provided in a standard spectacle frame, which will have negligible light-blocking properties at the optical wavelengths which are blocked by the Avulux® device.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older
* Subject is willing and able to provide written informed consent
* Diagnosis of migraine, based on a history of at least 5 attacks per month with the following primary headache characteristics:

  * Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
  * Headache has at least two of the following characteristics:

    * unilateral location
    * pulsating quality
    * moderate or severe pain intensity
    * aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs)
  * Headache occurs with at least one of the following symptoms:

    * nausea and/or vomiting
    * photophobia and phonophobia
* Subject has experienced at least 4 migraine attacks in the last month, with at least two migraine attacks resulting in severe pain prior to the use of any abortive medications
* Migraines are not attributed to another disorder

Exclusion Criteria:

* Subjects participating in another prospective, interventional clinical study
* Subjects with other light sensitive conditions, such as iritis
* Subjects who have less than 4 headache days per month with the above characteristics
* Chronic migraine subjects (defined as subjects who experience a minimum of 15 headache days per month)
* Subjects with headaches due to medication overuse (defined as regular use of headache medication for a minimum of 10 days per month, for a minimum period of 3 months)
* Subjects who have had any change in their migraine treatment within 4 weeks prior to study enrollment
* Subjects whose family members are currently participating in this study, or are employees of the study site, Avulux, or the coordinating CRO
Impact of Elimination or Reduction of Dietary Animal Proteins on Cancer Progression and Survival - A Pilot Study

The purposes of this study are

* to test the hypothesis that elimination or reduction of dietary animal proteins leads to an improved prognosis in tumor patients
* to estimate the effect size and thus to enable sample size calculations for further studies
* to test the feasibility and tolerance of different diets, especially a vegan diet, in cancer patients and to proof that a vegan diet does not lead to a deterioration of health, tumor progression or to malnutrition
* to test the online platform as a study platform
* to test validity of self reported and online generated data

Participating cancer patients select one of 3 defined diets (omnivor/lacto-ovo-vegetarian/vegan) at baseline and will continue their prescribed oncological therapy at their attending physician/clinic.

Participants provide data (cancer history, tumor behavior, food frequency questionnaires, questionnaires referring to quality-of-life) at baseline and at 3 and 6 months with optional data entry points at 12 and 124 months and a follow up questionnaire at 12 and 24 months. Data is entered online via the study platforms www.essenundkrebs.net and www.foodandcancer.net in German and English language (no additional clinical visits are required).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer
* Inclusion in a tumor treatment or follow-up program
* Age \>18 years

Exclusion Criteria:

* Psychiatric treatment during the last 3 months
* Pregnancy
* Breast feeding
* BMI \< 18,5 kg/m2
* Major difficulties with food intake (swallowing, lack of appetite) limiting food intake
* Participation in other studies requiring the attendance to a particular diet
Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis

Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by recurrent airway infections, affecting many systems including lung, pancreas and sweat glands. Cough is an important defense mechanism for clearing the secretions that increase in respiratory diseases. There have been studies investigating the effect of expiratory muscle training on disease groups such as chronic obstructive pulmonary disease, multiple sclerosis, parkinson's disease, and the elderly and healthy individuals. Studies that evaluating effects of expiratory muscle training in cystic fibrosis are limited in the literature. The aim of this study was to evaluate the effect of cough strength in children and adolescents with CF and the effect of expiratory muscle training program on cough strength, exercise capacity, respiratory muscle strength and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cystic fibrosis
* 8-18 years
* Clinically stable during last six weeks

Exclusion Criteria:

* hemoptysis
* low saturation (SpO2\<90%)
* acute lower respiratory tract infection
* cardiac problems (heart failure, arrhythmia, cardiomyopathy, etc.)
* cognitive problems
* pneumothorax
Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering.

Veneers will be randomly allocated to study crowns. Study crowns will be evaluated over three years. The test porcelain veneer is CAD/CAM milled as a veneer shell that is then fused to the CAD/CAM milled Lava crown to make the final crown to be cemented in the patient's mouth. This may be a more predictable technique in the fabrication of Lava crowns than current conventional methods.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Have at least one decayed back tooth in need of a crown
* Study tooth to be an upper or lower premolar or molar tooth/ teeth
* Study tooth to be vital and asymptomatic at start of study

Exclusion Criteria:

* Teeth which are non vital, have had root canal treatment
* Teeth which are pulp capped
* Sensitive teeth
* Significant untreated dental disease including periodontitis and rampant decay
* Pregnant or lactating women
* Patients with allergies to any of the materials to be used in the study
* Unable to attend the recall appointments
T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy

Data on the impact of biological therapies, especially of IL6-blocker treatment, on the T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve short-term follow-up.

Here, the investigator prospectively measure the percentages of 15 circulating T-cell subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43 IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological therapy. These are then compared with results obtained in early, untreated RA patients and gender-and-age matched healthy controls.


Eligibility Criteria:
Inclusion Criteria for patients:

* Diagnosis of rheumatoid arthritis classified according to the 2010 ACR/EULAR classification criteria for RA
* Biological treatment with anti-TNF therapy (adalimumab or certolizumab pegol or etanercept or infliximab or golimumab) or anti-IL-6R agent (tocilizumab)

Inclusion Criteria for healthy controls:

* negative history of RA symptoms
* negative status upon detailed physical and laboratory examination including normal CRP and ESR values

Exclusion Criteria:

* other autoimmune comorbidity
* lack of informed consent
Registry of Preterm Newborns With Severe Pulmonary Hypertension

The purpose of this prospective research registry is to collect data on treatment strategies and outcomes for premature newborns with severe pulmonary hypertension (PH).

There is a lack of consensus on the role of inhaled nitric oxide (iNO) therapy and other pulmonary vasodilators for the treatment of severe pulmonary hypertension (PH) in premature newborns (\<34 weeks gestation). However, a proper randomized, controlled trial of iNO in premature newborns with severe PH has not been completed. Some practices embrace the American Academy of Pediatrics (AAP) statement that there is no condition for which iNO should be used in the premature newborn, and others selectively treat premature infants with inhaled nitric oxide (iNO) who suffer life threatening hypoxemia due to suprasystemic PH and right-to-left veno-arterial admixture across the arterial duct and/or oval foramen. The number of neonatal intensive care units (NICUs) adopting each of these approaches is currently unknown, but it is possible that the former group is increasing due to administrative pressure to reduce uncompensated off-label iNO use. A prospective registry collection of treatment strategies and outcomes for this subset of premature newborns will help define current treatment strategies and yield important information about safety and efficacy of the different approaches to management, and would inform the debate more effectively than a series of iNO treated infants alone. Data collected includes maternal age, race/ethnicity, pregnancy and delivery complications, prenatal medications, infant characteristics such as Apgar scores, birthweight, congenital anomalies, respiratory status, pharmacologic therapy used for PH and its side effects, and blood gas data. Up to 100 sites in North America will be invited to monitor for appropriate cases.

Eligibility Criteria:
Inclusion Criteria:

* Premature newborns 23-34 weeks gestation
* Echocardiographic evidence showing systemic or suprasystemic levels of PH, or \> 5% difference in pre-post ductal saturation if echo is not available.
* Fraction of inspired oxygen (FiO2) \>0.60 in the first 72 hours after birth

Exclusion Criteria:

* None
Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, treated with five different types of antipsoriatic treatment, and 20 healthy patients. All 100 subjects will be subjected to anthropometric measurements, blood will be collected for laboratory tests, and an imaging test will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.

Research design: A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, without other chronic diseases, treated with five different types of treatment (local therapy, methotrexate, inhibitor of tumor necrosis factor α, inhibitor of interleukin 17 and inhibitor of interleukin 23), and 20 healthy patients aged 30-45 years. All 100 subjects will be subjected to anthropometric measurements (measurement of weight, height, systolic and diastolic blood pressure, heart rate, waist circumference), blood will be collected for laboratory tests (full blood count with differential, CRP, serum electrolytes, lipid panel, fasting glucose, HbA1c, alanine aminotransferase, aspartate aminotransferase, creatinine, urea, TNF-alpha, IL-6, IL-12, IL-17, IL-23, hsCRP, IFN-gamma, TRANCE, TRAIL, GDF-15, D-dimer, fibrinogen, overall haemostasis potential, overall coagulation potential, VCAM-1, ECAMs), and an imaging test (flow-mediated dilation and measurement of pulse wave velocity) will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.

Aim of the study: The impact of chronic systemic inflammation in psoriasis on subclinical defects in the cardiovascular system (endothelial dysfunction, arterial stiffness, insulin resistance, platelet activation, and coagulation activation) and their effects on each other will be studied. In addition, the effect of the five main types of psoriasis treatment on all listed subclinical defects of the cardiovascular system will be investigated. Moreover, it will be investigated whether the type of treatment affects systemic inflammation in psoriasis in the same manner.

Expected results: It is expected that all five groups of patients will differ from each other in terms of the degree of subclinical impairment of the cardiovascular system, depending on the expression of psoriasis and the type of treatment they receive. This will form the basis for establishing preventive measures against cardiovascular diseases in patients with psoriasis.

Eligibility Criteria:
Inclusion Criteria:

- patients with psoriasis aged 30 to 45 years in stable phase of the disease for at least last 6 months

Exclusion Criteria:

* any treatment besides treatment of psoriasis
* carotid disease
* heart failure
* atrial fibrillation
* diabetes type 1 or 2
* cardiovascular event in the past
* chronic kidney disease stage 3, 4, 5 or end-stage kidney disease
* psoriatic arthritis or any other rheumatic disease
* malignancy
* menopause in women
* other chronic inflammatory diseases
Clinical Trial to Evaluate the Efficacy and Safety of CKD-495 Tablet

To Evaluate the Efficacy and Safety of CKD-495

A Phase 2, Multi-center, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-495 in Patients with Acute and Chronic Gastritis

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female subjects aged ≥ 19
2. Acute or Chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the Investigator's Product taken date
3. Patients who have more than 1 subjective symptom

Exclusion Criteria:

1. Patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine
2. Patients who have been taken any gastritis medicine that could affect the treatment: H2 receptor antagonist, PPI(Proton Pump Inhibitor), antacid, improvement of movement in digestive system, Prostaglandin, and protective agent for gastritis
3. Patients who have to take medicine that could cause gastritis