cyrilzakka/clinical-trials huggingface dataset:
Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.

The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.

Yearly influenza (flu) epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly. Injectable flu vaccines are generally believed to be effective, but formal studies using modern culture methods to prove this are limited. This study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults (a group at low risk for serious influenza complications) who have received Fluviral (an injectable flu vaccine) with the rate of such illnesses in healthy younger adults who have received an injection of saline (salt water). The rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups, and the immune responses to the vaccine measured.

Eligibility Criteria:
Inclusion Criteria:

* Good health by history and physical exam
* Reliable access to a telephone
* Study comprehension and informed consent

Exclusion Criteria:

* Systolic BP \>/= 140; diastolic BP \>/= 90
* Uncontrolled medical or psychiatric illness (change in last 3 months)
* Cancer, or treatment for cancer within 3 years
* Cardio-pulmonary disease requiring chronic treatment
* Insulin dependent diabetes mellitus
* Renal dysfunction (creatinine \>/= 1.7 mg/dL)
* Hemoglobinopathies
* Clotting disorders that increase the risk of IM injections
* Immunosuppressive illnesses or drugs
* History of demyelinating disease (esp. Guillian-Barre syndrome)
* Employment in professions at high risk for influenza transmission
* Household contact with high-risk individuals
* Receipt of:

  a) Immunosuppressive drugs i) systemic glucocorticoids \>/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 9 months before the study e) Other vaccines within 30 days before, or planned during, the study
* History of:

  1. Severe reactions to other influenza vaccines
  2. Allergy to egg proteins
  3. Sensitivity to mercurials
* Pregnancy/ high risk of pregnancy

  1. Positive urine pregnancy test before treatment
  2. Women of child-bearing potential without credible contraceptive plan
Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.


Eligibility Criteria:
Inclusion Criteria:

* In- and out-patients in need of parenteral nutrition due to inability to sustain an adequate oral/enteral food intake for at least 4 weeks
* Written consent from the subject

Exclusion Criteria:

* Known hypersensitivity to fish-, egg-, soy-, or peanut-protein or to any of the active substances or excipients
* Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia
* Severe liver insufficiency
* Severe blood coagulation disorders
* Subjects with chronic stable renal insufficiency defined as S-creatinine value of \> 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy
* General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration
* Unstable conditions
* Unstable angina pectoris
* Acute shock
* Chemotherapy within 4 weeks before start of the trial
* Chemotherapy during the trial
* Subjects for whom the trial treatment is not appropriate
* Female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum pregnancy test and must agree to maintain adequate birth control practice during the study.
* Participation in another clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during the study
* Prior inclusion in the present study
* Any other feature that in the opinion of the investigator should preclude study participation
REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT

To evaluate if physical exercise intervention leads to an improved asthma control as measured by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can be reduces in asthmatics.

At least 102 asthmatics will be randomized 2:1 (2 to training group; 1 to control) and undergo 6 months of intervention or usual lifestyle.

Subjects must have confirmed asthma diagnosis, on a stable treatment with inhaled corticosteroid, symptomatic and untrained.

At enrollment and during the study asthma medicine is adjusted based on asthma symptoms evaluated by ACQ-5. 6 treatment steps are pre-defined, and if well controlled asthma, subjects are down-titrated one step, if uncontrolled, subjects are uptitrated one step.

Eligibility Criteria:
Inclusion Criteria:

* Asthma (The diagnose of asthma is based on symptoms and at least one positive asthma test the last 5 years (AHR to either mannitol or methacholine, reversibility to beta2-agonist, peak flow variation or positive eucapnic voluntary hyperventilation test))
* ACQ ≥ 1 and ≤ 2.5
* On a daily dose of ICS at a minimum of 400 µg budesonide or equivalent ICS for 3 months and with no changes in asthma medicine 4 weeks prior to enrollment
* Untrained (no participation in vigorous exercise for more than 1 hour per week during the last 2 month)
* Capable of exercising on bike

Exclusion Criteria:

* Unable to speak and understand Danish
* Infection within 4 weeks prior to visit 100\*
* Asthma exacerbation within 4 weeks prior to visit 100\*
* Hospitalized for an asthma attack during the last 2 months
* Treatment with immunotherapy within 5 T½ of the treatment drug prior to visit 100
* Initiation of allergen immunotherapy within 3 months prior to visit 100 or plan to begin therapy during study period
* Treatment with peroral prednisolone
* Respiratory: other chronic pulmonary disease of clinically significance
* Cardiovascular: Unstable ischemic heart disease, myocardial infarction within the last 12 months, symptomatic heart failure (NYHA III-IV or EF \<40%), symptomatic heart arrhythmia (documented with ECG), uncontrolled hypertension (\>155/100)
* Pregnancy or breastfeeding or planned pregnancy within the next 12 months
* Other inflammatory or metabolic diseases with the exception of rhinitis, atopy and well-controlled hypothyroidism treated with or without Eltroxin
* Vaccination less than 2 weeks prior to any visit
* Current or former smokers with \> 20 pack years
* Subjects, who by investigators determination, will not be able to adhere to study protocol

  * If patients are excluded due to a recent infection or exacerbation they can undergo re-screening after a total of 4 weeks after end of exacerbation treatment/clearing the infection.
Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.

Evaluation of safety and pharmacokinetics

Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
* Body mass index in the range of 18 to 30 kg/m2 and body weight\>45 kg.
* Healthy as determined by the investigator on the basis of screening evaluation.

Exclusion Criteria:

* Use of prescription or nonprescription drugs
* Any condition possibly affecting drug absorption
Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol.

A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days.

Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial.

The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects aged \<2 years (term newborn infants to toddlers 23 months of age inclusive)
* Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region

Exclusion Criteria:

* Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after gadobutrol injection
* Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture)
* Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation
* Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection
* Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
* History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
* Subject with renal insufficiency of any intensity, i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula
An Open Trial to Assess the Tolerability of AVANZ Mite Mix Immunotherapy

The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite mix.

The frequency of patients with adverse reactions will be the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18-65 years of age.
* A clinical history of HDM induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
* Positive SPT to Dermatophagoides pteronyssinus (Der pte) or Dermatophagoides farinae (Der far) (wheal diameter ≥ 3 mm).
* A positive specific IgE against Der pte or Der far (≥Class 2; ≥0.70 KU/L) documenting in the last 5 years.

Exclusion Criteria:

* FEV1 \< 70% of predicted value at screening after adequate pharmacologic treatment.
* Uncontrolled or severe asthma.
* A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen, to which the subject is regularly exposed and sensitized.
* History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
* At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
* Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication). Please, see Table 4.
* Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
* Previous treatment by other allergen concomitant IT or immunotherapy with HDM extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted).
* History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
* History of severe and recurrent angioedema.
* Any contraindication according to the Investigator Brochure (IB).
* Use of an investigational drug within 30 days prior to screening.
Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and India

This is a multicenter, prospective, single-arm observational non-interventional study (NIS), which will be conducted in various countries in the Middle East and India.

The study is designed to collect information on the utilization and effectiveness of crizanlizumab treatment in SCD patients under routine clinical practice conditions, to which the physician has made an independent decision to prescribe crizanlizumab.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients with clinical diagnosis of SCD (based on laboratory parameters) of any genotype.
2. Patients newly initiated on treatment with locally approved crizanlizumab.
3. Patients aged 16 years or older at crizanlizumab initiation.

Exclusion Criteria:

1. Patients who did not provide informed consent.
2. Patients who received a stem cell transplant at time of enrollment.
3. Patients who participated in or are participating in a clinical trial at time of enrollment or in the 12 months prior to starting commercial crizanlizumab.
4. According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reasons such as unavailability or severe concomitant illnesses.
Prospective Ultrafast MRI Radiomics for Breast Cancer

The goal of this prospective study is to investigate the performance of ultrafast MRI radiomics in classifying histological factors and subtypes of breast cancer compared with standard MRI among radiologists with varying experience. The written informed consent was obtained from all participant. We extracted 1618 radiomic features from ultrafast and standard contrast-enhanced MRI before treatment. Classification of hormonal receptors, human epidermal growth factor receptor 2, and Ki67 status and subtypes was evaluated using the area under the receiver-operating characteristic curve (AUC) with the DeLong test.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with invasive breast cancer

Exclusion Criteria:

* Diagnosed with other cancer
Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.

People spend almost a third of their life sleeping and understanding how the spine can adapt to a mattress is essential for promoting people's health. The general objective of this study is to study and evaluate the adaptation of the spine to a mattress. The primary objective is the assessment of the variation in the lumbar lordosis angle (sagittal plane) in the supine position, on a mattress, compared to the value measured in the supine position on a rigid surface.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 45 years old
* Female or Male sex
* Cognitive integrity
* Absence of usual contraindications to MRI

Exclusion Criteria:

* Clinical condition diagnosed by a doctor
* Spinal pathologies
* Pregnant woman
* Claustrophobia
Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients

The purpose of this study is to identify the effects of different doses of dexmedetomidine on postoperative cognitive dysfunction in elderly hypertensive patients


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Elective gastrointestinal surgery
* American Society of Anesthesiologists class II to III
* Aged between 65 and 80 years old
* Weight between 45 and 75 kilogram,Body Mass Index between 19 and 24 kg.m-2
* With primary hypertension reaching or more than 1 year
* Normal cognitive function,mini-mental state examination more than 27

Exclusion Criteria:

* Severe arrhythmia,atrioventricular block and secondary hypertension
* Liver and kidney dysfunction,pulmonary disease,endocrine disease
* Suspected or confirmed difficult airway
* Any disease or pathologic change will interfere study result
* Inability to exchange with serious visual and hearing impairment
* Long term use of sedative-hypnotic drugs and antidepressant drug
* Addicted to alcohol, tobacco or drug
* Neuromuscular disease
* Suspected of malignant hyperthermia
* Allergic to investigational products or with other contraindication
* Participated in other study within 30 days
Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka

This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.

The participating physicians (investigators) will be asked to enrol only those subjects to whom they administer Synflorix™ in the course of their normal clinical practice according to the locally approved Prescribing Information.

Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
* Infants aged 6 weeks and above and children.
* Written, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.

Note: Consent for this PMS study is solely for collection of safety and reactogenicity data and not for vaccination that is per routine practice. Data for demography, medical history and previous vaccination history, and concomitant medication/vaccination will also be collected.

Exclusion Criteria:

* Subjects with contraindications according to the locally approved PI.
* Child in care.
* Previous administration of three doses of Synflorix™.
* Previous vaccination with a pneumococcal vaccine other than Synflorix™.
* Planned administration of another pneumococcal vaccine other than Synflorix™ during the PMS study.
Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor

The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.

A novel continuous noninvasive blood pressure monitor is compared to invasive arterial measurement at postoperative care unit after a planned operation. Monitor captures also saturation and ECG, which are compared to traditional monitoring.

Eligibility Criteria:
Inclusion Criteria:

* subjected to operative treatment with the need for invasive blood pressure measurement
* spontaneous ventilation
* able to give informed consent

Exclusion Criteria:

* denial by patient
* pacemaker
Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Without Cystocele

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). The treatment strategies are different between DU and BOO. In general, urodynamic/videourodynamic studies are important for differential diagnosis. However, urodynamic/videourodynamic studies are invasive. The investigators are interested in whether there were specific symptoms or measurements that can be used for initial differential diagnosis between DU and BOO. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the clinical and urodynamic differences between the DU, BOO and non-DU/BOO groups.

Between April 1996 and September 2018, all women with symptoms of voiding dysfunction who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of maximum flow rate (Qmax), voided volume, post-void residual volume (PVR) and detrusor pressure at a maximum flow rate (PdetQmax) were excluded from this study. Besides, women with cystocele were also excluded. The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%. Those women without DU or BOO were allocated to the non-DU/BOO group.

STATA software was used for statistical analysis. ANOVA test with Bonferroni correction or chi-square test was used for statistical analysis as appropriate. Linear regression analysis with age adjustment was used to assess the adjusted effect of variables. P \< 0.05 was considered as statistical significant.

Eligibility Criteria:
Inclusion Criteria:

* Women with symptoms of voiding dysfunction.

Exclusion Criteria:

* Cystocele
* Those women who have no complete data of maximum flow rate (Qmax), voided volume, post void residual volume (PVR) and detrusor pressure at maximum flow rate (PdetQmax) were excluded from this study.
Non-specific Response to H1N1 Vaccine

This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of H1N1 influenza vaccine.
* Healthy individuals with no signs of influenza or other infectious disease.

Exclusion Criteria:

* Signs of influenza or other infectious disease in 1 month before study participation.