cyrilzakka/clinical-trials huggingface dataset:
Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients

Parallel, randomized and controlled clinical trial to evaluate the effect of 12 months of noninvasive mechanical ventilation versus conventional treatment in hypercapnic patients with stable COPD.

Main objective: To evaluate the effect of 12 months of noninvasive ventilation on c-reactive protein concentration and daily physical activity in hypercapnic patients with stable COPD.

Secondary objectives: To compare the plasmatic concentration of other inflammatory biomarkers between COPD patients with conventional treatment and wich noninvasive ventilation. To determine the response of breathlessness, health-related quality of life and lung function to noninvasive ventilation. To identify the COPD patients with a higher gasometric and clinic response to noninvasive ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age: 45-75 yrs.
* COPD diagnosis (postbronchodilator FEV1/FVC \< 0.7) for at least 6 months.
* FEV1 \< 45% predicted
* Baseline pH 7.35-7.45
* Baseline PaCO2\>45 mmHg breathing current air
* Smoking history (\>15 pack-year)
* Clinically stable for at least the last three months
* Pharmacological treatment optimized in the last two years.

Exclusion Criteria:

* Previous diagnosis of asthma, other airway obstructive disease, sleep apnea syndrome, interstitial lung disease, chest wall disease or neuromuscular disease.
* Apnea-hypopnea index \> 10/h
* Morbid obesity (BMI \> 45 Kg/m2)
* Previous diagnosis of ischaemic heart disease, cardiac failure, cirrhosis, chronic renal failure, rheumatoid arthritis or other inflammatory disease.
Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol

Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has a form that is increased in the morning and decreased in the evening. The investigators expected to be influenced by circadian rhythm according to the time of operation, and compared morning and afternoon surgery.

44 patients to undergo hip hemiarthroplasty or total hip replacement were divided to morning surgery group(Group A) and afternoon surgery group(Group P). All surgery was done by the same orthopedic surgeon. Anesthesia of Group A was started at 8 a.m. and Group P was at 12\~2 p.m. Blood sampling was performed at 7:30 a.m., after induction of anesthesia, 6, 12, 24 and 48 hours after surgery in all patients of both groups. Cortisol, IL-6, and IL-8 was measured immediately after blood sampling. Visual analogue scale(VAS) was used to assess the degree of pain at before start of anesthesia, 6, 12, 24 and 48 hours after surgery. The postoperative hospital stay was calculated. Postoperative management was done by the same management team. Surgical wounds were treated at the same 24 hour intervals.

A sample size was calculated to differentiate between groups. Because difference of cortisol according to groups in ANOVA based on pilot study, the sample size was 20 patients per group. (Effect size f(v)= 0.5297047, α=0.05, 1-β=0.90) The investigators recruited total 44 patients to cover dropout 10%.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for hip hemiarthroplasty
* Patients scheduled for total hip replacement

Exclusion Criteria:

* Sleep disorder
* Mental disorder
* Psychiatric medication
Effects of Energy Drinks on Sleep and Cardiovascular Health

The purpose of this study is to learn about the change in quality of sleep, structural organization of sleep, and cardiovascular responses after consuming an energy drink compared to a placebo drink with no caffeine or stimulants.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and older.
* Healthy subjects without known cardiovascular disease and thyroid disease.
* Subjects who are on no medications (except oral contraceptive pill).
* Nonsmokers.
* No prior history of caffeine sensitivity or allergy.

Exclusion Criteria:

* Subjects with known cardiovascular or thyroid disease.
* Subjects currently taking medications other than oral contraceptive pill.
* Smokers.
* Prior history of caffeine sensitivity or allergy.
* Pregnancy.
* Subjects who regularly consume energy drinks.
* Subjects who typically go to sleep after midnight.
* Subjects who traveled across 2 time zones in the last 7 days.
* Shift workers.
* Subjects who have or are suspected to have sleep apnea.
* Subjects who have a body mass index \> 35kg/m\^2.
Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA)

This prospective study will examine whether transient maternal hyperoxygenation is useful as a diagnostic test to more accurately detect TGA patients with poor vs. good neonatal intra-cardiac mixing of blood, based on the in-utero response to oxygen exposure. This study is Health Canada regulated

This is a prospective pilot study to examine whether transient maternal hyperoxygenation is useful as a diagnostic test to more accurately detect TGA patients with poor vs. good neonatal intracardiac mixing of blood, based on the in-utero response to oxygen exposure. Acute maternal oxygen administration will transiently increase the fetal oxygen levels to those reached at birth with spontaneous breathing, thus simulating conditions that will naturally occur at the time of birth. Echocardiogram and MRI will be used to examine the effects on the fetal circulation. The prenatal findings will then be compared to the neonatal presentation.

The investigators postulate that conditions that predispose newborns to acute neonatal compromise will be detectable and distinguishable prior to birth by echocardiography, MRI, or by combining the findings of both exams.

Eligibility Criteria:
Inclusion Criteria:

* Fetus with simple TGA +/- small VSD
* Intention of active postnatal management after birth

Exclusion Criteria:

* Fetus with complex form of TGA
* Significant fetal arrhythmia
* Major non-cardiac lesions
* Maternal contraindications for fetal MRI
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections

Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA.

We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older with \>3 unformed stools/24 hours with positive stool test for C. difficile.
* Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment.

  * High risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations
  * Medium risk: 1st generation cephalosporin, macrolides\*, and aztreonam

    * \*The macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection

Exclusion Criteria:

* Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon).
* Patients with an allergy to oral vancomycin or fidaxomicin.
* Patients anticipated to receive metronidazole after enrollment.
* Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for \> 24 hours within the preceding 72 hours at the time of enrollment.
* Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment.
* Patients who are on laxatives before they are enrolled into the study, such as lactulose, if:

  * Patients have had a recent dose adjustment;
  * Baseline number of bowel movement while on laxatives is unknown.
  * Number of bowel movements and/or consistency has not changed from baseline.
* Patients who have had colostomy or ileostomy
* Patients who will have colostomy or ileostomy after enrollment and before study ends
* Patients who are or will be on long-term (\>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment
Viral Load Analysis of the SARS-CoV-2 Virus in Nose Versus Mouth Sites

It is a single-center, non-profit experimental study, intended to evaluate the viral load of SARS COV 2 in nasal and oral samples of positive subjects to evaluate any variation and understand which is the most suitable site for carrying out the swab.

Experimental study on de-identified, biological samples (nasal and buccal swab).

The study will be performed on patients admitted to IRCCS Sacro Cuore Don Calabria Hospital or health care workers or their family members, who tested positive for SARS-CoV-2 by either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics.

Among the family members, also children \>4 years old will be included. The reason for including children and young subjects is based on data indicating that they seems to be highly sensitive to Omicron infection and that their vaccination status could influence viral load. The nose and mouth swab are poor invasive and they could be well tolerated also by children.

Whinin 7 days from diagnosis, the subjects will be requested to sample another two specimens i.e. nasal swab and mouth swab, that will be tested for the presence of SARS-CoV-2 RNA. Results, expressed as cycle threshold will be then compared to analyze viral loads from the two different sites.

Moreover, an aliquot will be retro-transcribed into cDNA and sequenced by Next Generation Sequencing (NGS) to obtain the virus entire genome sequence or evaluated by RT-PCR for variant determination.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to IRCCS Sacro Cuore Don Calabria Hospital or health care workers or their family members. Among the family members, also children \>4 years old will be included.
* Subjects verified as positive to SARS-CoV-2 according to either a molecular or antigen test, performed on nasopharyngeal swab, according to current diagnostics.
* Subjects who will accept to participate to the study and will sign the informed consent.

Exclusion Criteria:

* lack of any needed data or inform consent
Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course

The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female subject between 8 and 15 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Born after a normal gestation period between 36 and 42 weeks.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease.
* Planned administration of a vaccine not foreseen by the study protocol since birth and during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose of the three-dose primary vaccination course, with the exception of licensed Neisseria meningitides conjugate vaccines or Bacillus Calmette-Guérin (BCG) vaccine that can be given in between study visits or after the third visit, provided they are given preferably with a 4 weeks interval but not less than 3 weeks apart from the study vaccine doses.
* Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs since birth.
* Planned administration of immunoglobulins and/or any blood products since birth or planned administration during the period up to 30 days after the third dose of the primary vaccination course.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of seizures, progressive neurological disease or intra-cerebral haemorrhage.
* Major congenital defects or serious chronic illness.
* Acute febrile illness at the time of planned vaccination
* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
EuroPainClinics® Study V (Prospective Observational Study)

In this prospective observational trial the effect of the Endoscopic discectomy microinvasive therapy should be examined in (approximately 500) adult patients with low back pain.


Eligibility Criteria:
Inclusion Criteria:

* lumbar disc prolapse with unilateral radiculopathy, on clinical evaluation, positive straight leg raise or femoral stretch test, and identification of a single nerve root lesion on MRI

Exclusion Criteria:

* The exlusion criteria: bilateral root symptoms, double root involvement, cauda equina syndrome and negative MRI Picture for disc herniation, unsigned infomed consent
Comparison of Pre-hospital and In-hospital Iv-tPA Stroke Treatment

This is a comparison of clinical outcomes between a pre-hospital and an in-hospital thrombolysis patient registry.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke diagnosis with thrombolytic treatment
* Admission via EMS
* Known premorbid status of need of assistance
* NIHSS before treatment available
* Time of onset (or last well seen) between 4:00am and 10:30pm

Exclusion Criteria:

* Unknown time of onset
* In-hospital thrombolysis despite decision against treatment because of contraindications in STEMO
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.


Eligibility Criteria:
Inclusion Criteria:

* Subject implanted or upgraded with a NG3 or NG4 CRT-D device connected with any manufacturer quadripolar LV lead based on BSC labeling for devices in specific geographies.
* Subjects must be enrolled between 1 and 21 calendar days post CRT-D implantation procedure.
* Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
* Subject is willing and capable of complying with follow-up visits and procedures as defined by this protocol

Exclusion Criteria:

* Subject with documented life expectancy of less than 12 months
* Subject currently on the active heart transplant list or has a current Left Ventricular Assist Device or other assist device (mechanical circulatory support device).
* Subject who have had a pre-existing CRT device
* Subject enrolled in any other concurrent clinical trial without prior written approval from BSC Clinical Trial Manager
* Women of childbearing potential who are or might be pregnant at time of study enrolment
* Any contra-indication to receive a CRT-D device per local guidelines
Oculomotor Markers and Attachment in Adolescents

The study aims to identify specific visual scanning patterns of attachment pictures in adolescent with different attachment style.

Oculomotor parameters will be assessed during visualization of 2 sets of pictures. The first set presents a distress picture and is followed by a slide composed of 3 pictures (one representing comfort, one representing complicity and the last representing a neutral scene).

Psychophysiological parameters (skin conductance reactivity-SCR) is also assess during this visualization.

Eligibility Criteria:
Inclusion Criteria:

* non hospitalized child who is going to school

Exclusion Criteria:

* not french-speaker vision problem more than 20 cigarettes/day
Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)

Congenital heart defects (CHD) are the most common major human birth malformation, affecting \~8 per 1,000 live births. CHD are associated with significant morbidity and mortality, and are second only to infectious diseases in contributing to the infant mortality rate. Current understanding of the etiology of pediatric cardiovascular disorders is limited.

The Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) is a multi-center, prospective observational cohort study. Participants will be recruited from the Pediatric Cardiac Genomics Consortium's (PCGC) centers of the NHLBI-sponsored Bench to Bassinet (B2B) Program. Biological specimens will be obtained for genetic analyses, and phenotype data will be collected by interview and from medical records. State-of-the-art genomic technologies will be used to identify common genetic causes of CHD and genetic modifiers of clinical outcome.

To accomplish this, the PCGC will develop and maintain a biorepository of specimens (DNA) and genetic data, along with detailed, phenotypic and clinical outcomes data in order to investigate relationships between genetic factors and phenotypic and clinical outcomes in congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

• Signed consent form

Exclusion Criteria:

* Isolated patent foramen ovale
* Isolated prematurity-associated patent ductus arteriosus
Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo

Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation.

The effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality.

The investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A adenosine receptors modulation.


Eligibility Criteria:
Inclusion Criteria:

* Age = 18 years
* Surgery valvular settled(adjusted) (plasties or aortic replacement, mitral, tricuspid or mixed), under CEC
* Period of weaning in caffeine: limitation of the consumption of coffee(café), tea, chocolate, in a cup the day before the intervention
* Consent of the patients after information

Exclusion Criteria:

* Pregnant or breast-feeding women
* Women taking an oral contraception (half-life of the caffeine increased until 3 times)
* Minors(miners) or adults under guardianship
* Persons staying in a sanitary or social establishment
* Not profitable persons of a national insurance scheme
* Private persons of freedom
* Persons requiring a surgery of replacement valvular as a matter of urgency
* Patients having been treated(handled) by papaverine, dipyridamole, corticoids, immunosuppressors or antibiotics during six weeks preceding the date of inclusion
* Weighty patient lower than 50 kg or upper to 100 kg or having a body mass index upper to 29 Kg / m2
* Presence of an active infection, a chronic inflammatory pathology, a lung arterial high blood pressure
Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors

To assess the effect of single pill therapy on the management of hypertension and other cardiovascular risk factors (e.g., dyslipidemia) in Indian patients in whom the treating doctor has already considered that the administration of the amlodipine/atorvastatin single pill to be appropriate

Patients who have been prescribed single pill Caduet are eligible to participate in this study. The treating physician will obtain written informed consent from each subject or the subject's legally acceptable representative before any study-specific activity is performed.

The study terminated on May 5, 2008. The decision to terminate was due to inability to achieve study timelines and undue delay in obtaining IEC/IRB permission at some sites. No safety or efficacy issues caused the decision to terminate.

Eligibility Criteria:
Inclusion Criteria:

Patients who have been prescribed single pill Caduet are eligible to participate in this study. Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.

Exclusion Criteria:

* Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin, or any component of this medication,
* Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal,
* Or who are pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures. Amlodipine/atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus.
Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support

Invasive mechanical ventilation is one of the most important and life-saving therapies in the intensive care unit (ICU). In most severe cases, extracorporeal lung support is initiated when mechanical ventilation is insufficient. However, mechanical ventilation is recognised as potentially harmful, because inappropriate mechanical ventilation settings in ICU patients are associated with organ damage, contributing to disease burden. Studies revealed that mechanical ventilation is often not provided adequately despite clear evidence and guidelines. Variables at the ventilator and extracorporeal lung support device can be set automatically using optimization functions and clinical recommendations, but the handling of experts may still deviate from those settings depending upon the clinical characteristics of individual patients. Artificial intelligence can be used to learn from those deviations as well as the patient's condition in an attempt to improve the combination of settings and accomplish lung support with reduced risk of damage.


Eligibility Criteria:
Inclusion Criteria:

• Subjects who are 18 years or older and receive invasive mechanical ventilation for \> 4 hours

Exclusion Criteria:

• Patients receiving one-lung ventilation