cyrilzakka/clinical-trials huggingface dataset:
Effects of Methylprednisolone After Total Hip Arthroplasty

The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after hip arthroplasty.

The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.

In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Elective total hip arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria:

* Alcohol or medical abuse
* Allergies to local anesthetics or methylprednisolone
* Age \< 18 years
* Daily use of opioids or glucocorticoids
* Pregnancy or breastfeeding (fertile women)
Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?

This study is being conducted to determine if eszopiclone is as effective as ramelteon when used as a pre-medication (sleeping pill) in sleep studies performed to diagnose and treat sleep apnea.

Many Veterans suffer from sleep disordered breathing with a high prevalence of undiagnosed obstructive sleep apnea. One test that can be effective in the diagnosis of sleep apnea is the polysomnogram (PSG). Split-night PSG consists of a diagnostic phase in the first half of the night and a continuous positive airway pressure titration (CPAP) in the second half of the night. CPAP is the standard, most effective therapy for obstructive sleep apnea. Due to the unfamiliar sleep environment of the laboratory and instrumentation that must be used (application of electroencephalogram leads), patients are frequently not able to sleep adequately. In these cases, the PSG must be repeated. Oral hypnotic agents are often used as a pre-medication to increase the yield of PSG in an attempt to decrease the need for repeat studies.

Numerous data is available on the effects of premedication with oral short-acting hypnotics on PSG quality and efficacy of CPAP titration. In one study, eszopiclone, a nonbenzodiazepine gaba-receptor agonist short-acting hypnotic, has been shown to improve PSG quality and CPAP titration. Another short-acting hypnotic, ramelteon, was recently approved by FDA but the effects of ramelteon in improving PSG quality and efficacy of CPAP titration are unclear. The advantage of ramelteon over eszopiclone is the lack of drug dependency or abuse potential. This study aims to evaluate the efficacy of ramelteon compared to eszopiclone when administered prior to split-night PSG and CPAP titration.

Eligibility Criteria:
Inclusion Criteria:

* Referred by VA Long Beach Sleep Clinic at their initial evaluation during outpatient consultation for suspect obstructive sleep apnea.

Exclusion Criteria:

* Sleep disorders other than obstructive sleep apnea
* No prior PSG
* Uncontrolled medical condition
* Prior known adverse reaction to eszopiclone or ramelteon
* Liver disfunction
* Current alcohol abuser
* Current illicit drug abuser
* Alcohol consumption 12 hours prior to polysomnography
* Decompensated psychiatric disorders
* Severe dementia
* Concomitant use of benzodiazepines, trazodone, narcotics, barbiturates or other medications with sedative or hypnotic effects
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.

This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
* Born after a gestation period of 36 to 42 weeks inclusive.
* Healthy subjects as established by medical history before entering into the study.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose..
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Major congenital defects or serious chronic illness.
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
* Current febrile illness or axillary temperature of ≥ 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked

The aim is to evaluate the performance of Cardioskin and Neuronaute, two connected medical devices CE-marked, manufactured by Bioserenity.

It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.

With this study evulating the performance of two wireless, connected device of electrophysiological signal monitoring. The Cardioskin monitors electrocardiogram signal. The Neuronaute monitors electroencephalogram, electromyogram and electrocardiogram.

This study will permit to optimize the devices performance.

To the study, subjects of at least 18 years old will test Cardioskin and or Neuronaute device, without randomization.

Eligibility Criteria:
Inclusion Criteria:

• man or women of at least 18 years old

Exclusion Criteria:

* Injuries or wounds on the body and scalp
* Participant unable to follow the procedure of use, the judgment of the investigator
* Brain surgery that occurred less than a week ago
* Known allergy to silver, polyamide, silicone, synthetic materials
* Sensory disorders that make the subject insensitive to pain
* behavioral problems that make the subject excessively agitated or aggressive;
* Cardiorespiratory disorders that may be aggravated by mild compression of thorax
* Subject equipped with an electrical stimulation device;
* Inappropriate anthropometric parameters to textile sizes
* Clinically detectable or known pain of the subject;
* Current participation in a clinical trial or participation in a previous clinical study including a period of deficiency not yet completed at the time of this clinical trial
* Predisposition to tension headaches (the compression exerted by the cap may in some cases trigger a headache);
* Use of the Cardioskin device for resuscitation or intensive care.
* Participant with defibrillator, vagus nerve stimulator or other high frequency surgical device
Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure

This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.


Eligibility Criteria:
Inclusion Criteria:

• Mechanically ventilated via an endotracheal tube or mask

Exclusion Criteria:

* Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
* Cognitive impairment prior to acute ICU illness (non-verbal)
* Preadmit immunocompromised (\>prednisone 20 mg/d for 2 wks)
* Acute stroke
* Body mass index (BMI) \>45
* Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
* Hip fracture, unstable cervical spine or pathological fracture
* Mech vent \>48 hours prior to transfer from an outside facility
* Current hospitalization or transferring hospital stay \>72 hours
* CPR on admission, DNR on admission
* Hospitalization within 30 days prior to admission
* Cancer therapy within last 6 months
* Re-admission to ICU within current hospitalization
Comparison of Procalcitonin Level in Normal Population and in Chronic Kidney Disease Patients Who Don't Have Infection

Chronic kidney disease (CKD) is a life threatening condition with high risk of pre-term death and need for dialysis. It is defined as kidney damage that has continued for more than 3 months as characterized by structural or functional abnormalities of the kidney, with or without decreased glomerular filtration rate (GFR). It is also defined as GFR \< 60mL/min/1.73 m2 for more than 3 months, with or without structural kidney damage.

The PCT level in healthy individual without infection is below the limit of detection (0.01 ng/mL), and it is significantly elevated under the stimulation of pathogens. However, due to the pre-existing endogenous inflammation that occurs in CKD patients and the impaired kidney clearance, the reference range that applies to the general population may not be appropriate for diagnosing infections in CKD patients. More recently, debate has continued regarding whether the PCT level is increased in CKD patients without infection, and the optimal reference for CKD patients remains undetermined


Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease patients.
* ESRD patients

Exclusion Criteria:

Any condition of infection or sepsis such as :

* Fever
* Increased TLC above normal
* Tachycardia
* Tachypnea
* Disturbed conscious level
Systematic Administration of Calcium and Vitamin D After Thyroidectomy

Transient hypocalcaemia consist the most common postoperative complication after thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and may lead to longer hospital stay as well as in discomfort of the patients. For the management oral or intravenous calcium with or without vitamin D administration can be used based on the blood calcium levels and on the symptomatology. The investigators intent to study a new protocol with oral calcium and vitamin D given systematically from the day of operation to assess if this practice can minimize the rate of transient hypocalcaemia and as a consequence minimize the length of stay in the hospital.

Transient hypocalcaemia consist the most common postoperative complication after thyroidectomy (10-45%). It may be mild and subclinical or cause mild or severe symptoms and may lead to longer hospital stay as well as in discomfort of the patients. For the management oral or intravenous calcium with or without vitamin D administration can be used based on the blood calcium levels and on the symptomatology.

Group A = control group will be managed as usual. Oral or IV supplements of Calcium will be giver on demand and recorded according to the clinical picture or the biochemical hypocalcaemia.

Group B= study group will be given systematically from the day of operation a scheme with oral calcium in the form of 1000ca++mg/tab and oral alfacalcidol in the form of 0.5 micrograms/tb The patients will receive one tablet three times a day oral calcium (3g/d) and 2 tablets , two times a day alfacalcidiol (2 micrograms/d) for the first 5 days. Afterwards they will be taking 2 tablets a day of oral calcium ( 2g) and 2 tablets a day alfacalcidiol (1micrograms/d) for another 10 days ( total 15 days) The investigators intent to minimize the immediate transient hypocalcaemia rate and give time to the parathyroids which may have been bruised or have compromised function initially to recover by day 15.

The 1st and 2nd postoperative day the invastigators are going to take blood samples and assess the 25 hydroxy vit D, the parathyroid hormone (PTH) and the Ca++. The investigators will also assess the calcium levels after the first week and if necessary ( in cases with longstanding hypocalcaemia ) in later day.

The patients will be discharged from the hospital the day after the operation provided the calcium levels are within normal range and they are completely asymptomatic.

In case of symptoms after the discharge the patients will be managed accordingly and this will be recorded in the records of each patient

Eligibility Criteria:
Inclusion Criteria:

* Thyroid pathology only
* No calcium metabolism problems
* Total / near total thyroidectomy

Exclusion Criteria:

* Renal failure,
* Secondary hyperparathyroidism,
* Primary hyperparathyroidism,
* thyroid lobectomy,
* Thyroid reoperation
Inflammation as a Predictor in Cardioversion of Atrial Fibrillation

The laboratory test, C-Reactive Protein (CRP), has become well established as a marker of inflammation. Recently a high CRP level (indicating an increase in inflammation) was identified as a risk factor for atrial fibrillation. We are conducting this study with patients such as yourself with atrial fibrillation who are planning to undergo cardioversion to determine what sort of relationship exists between CRP levels and atrial fibrillation. We will then look at success rates of converting atrial fibrillation to normal sinus rhythm, compared to patients' CRP levels.


Eligibility Criteria:
Inclusion Criteria

* Atrial fibrillation patients referred for DC cardioversion
* On stable medical therapy

Exclusion Criteria

* Known chronic inflammatory states such as infections, rheumatoid arthritis or known vasculitides.
* Patients having undergone recent surgery or who are on steroid therapy for any reason will be excluded.
The Factors Affecting the Achievement of Glucose Monitor in the Patients on Diabetes

To assess the effect of glucose monitors on glucose control and cardiovascular risks.

The investigators will enroll patients with diabetes. The answered questionnaire and blood samples will be collected at baseline. After change the methods or frequency of glucose monitor, the blood samples will be collected again. The investigators will analyze the factors which may affect the glucose control after changes in methods of glucose monitor.

Eligibility Criteria:
Inclusion Criteria:

* Adults with diabetes

Exclusion Criteria:

* Incooperative patients
Inflammation Genomics and Atherosclerosis - Ancillary to CARDIA

To examine the associations of common variation in inflammation/thrombosis genes with intermediate quantitative phenotypes and subclinical coronary atherosclerosis in the Coronary Artery Risk Factor Development in Young Adults (CARDIA) Study, a large, bi-racial cohort study.

BACKGROUND:

Atherosclerosis is a major determinant of coronary heart disease and is determined by the interplay of genetic and environmental risk factors. Although atherosclerosis tends to aggregate in families, it does not exhibit classical Mendelian segregation. Thus, the genes that determine an individual's risk of atherosclerosis likely involve multiple sites within genes and interactions between genes, all of which define a genetic risk that is modified by the host environment.

DESIGN NARRATIVE:

The genetic epidemiology study examines the associations of common variation in inflammation/thrombosis genes with intermediate quantitative phenotypes and subclinical coronary atherosclerosis in the Coronary Artery Risk Factor Development in Young Adults (CARDIA) Study, a large, bi-racial cohort study. The set of 25 candidate genes involve pathways (cytokines, chemokines, and their receptors; cellular adhesion molecules; and, coagulation proteins) and include several receptor-ligand pairs. Using cladistic analysis and the resources of the Program in Genomic Applications (PGA), the investigators will identify a limited set of single nucleotide polymorphisms (range 3-10 SNPs per gene) that characterize common haplotypes in these candidate genes within persons of African descent and European descent. DNA from the CARDIA Year 10 examination (n = 3,950 subjects) will be genotyped for the selected variants that characterize the common haplotypes. Data on the presence of common variants and haplotypes will be incorporated into the CARDIA Study database. Levels of two important intermediate phenotypes, fibrinogen and C-reactive protein (CRP) were previously determined. Non-invasive assessment of coronary atherosclerosis, defined as the presence of coronary artery calcification (CAC), was obtained on CARDIA participants at the Year 15 exam. Analyses will be stratified by race/ethnicity and focus on the associations of the common haplotypes with fibrinogen, CRP, and CAC measured in early adult life. Secondarily, the investigators will explore possible gene-gene and gene-environment interactions. The proposed multi-disciplinary collaboration should enhance the sensitivity and specificity of efforts to assess the associations of common variation in sets of inflammation/thrombosis candidate genes and cardiovascular risk in young adults.

Eligibility Criteria:
Cardiac cohort participants with DNA
Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

For patients undergoing a psychiatric crisis, hospitalisation is required. In developing countries specially in sub-urban or rural areas, most patients don't access intensive care. In India, AYUSH system of medical care is widely used, including crisis resolution and community treatment have been widely implemented in various mental health systems. However, evidence to support their effectiveness has remained very low.

Present study is designed as community based participatory research, where Ayurveda treatment , a short-term, specialised, crisis intervention is provided by community outreach team.


Eligibility Criteria:
Inclusion Criteria:

* Presenting with a psychiatric complaint.
* Male or female patients at least 18 years of age.
* Each patient, or a patient's legal representative (as allowed by local law), must understand the nature of the study and must agree to study enrollment.

Exclusion Criteria:

* Patients who have delirium or dementia
* Prisoners
* Pediatric patients
* Elderly patients
* Pregnancy or breastfeeding
Guelph Family Health Study: Full Study

The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The investigators primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study will also assess the cost-effectiveness of the intervention from a societal perspective.

The overall objective of this research is to test, among families with children age 2-5 years, the immediate and longer-term impacts of a home-based intervention to improve household routines associated with reduced obesity risk. The primary hypothesis is that, compared to control, children in the intervention group will have lower BMI following the 6-month intervention period and 18-month follow-up period. The secondary outcomes are change in children's % body fat, waist circumference and obesity-related behaviours: sleep, activity, sedentary behaviour, family meals, and dietary intake. Although child outcomes are the focus of this evaluation, changing household routines may also improve parent behaviour; thus, the investigators will assess change in parent behaviours and weight outcomes. This study also assess the cost-effectiveness of the intervention from a societal perspective.

The investigators will randomly allocate 356 socio-economically diverse Ontario families to receive either: 1) 4 motivational coaching home visits, bi-weekly emails, and mailed behaviour supports (intervention group), or 2) Monthly emails with general health information (control group). Primary and secondary outcomes will be assessed at baseline, post-intervention (6-months), and 18-month follow-up, and data will be analyzed by intention to treat.

This study tests a novel and promising approach to obesity prevention - an approach that engages families at home, where they eat, play, and sleep. The interdisciplinary investigator team has partnered with parents and key knowledge users in public health and primary care to develop this intervention. As a result, this research could provide a sustainable model for early life obesity prevention, leading to long-term improvements in health and reduction in costs to the health system and society as a whole.

Eligibility Criteria:
Inclusion Criteria:

* families who have at least 1 child age 18 months - 5 years
* families who live in the Guelph area
* families who can respond to English surveys

Exclusion Criteria:

* plan to move away within the next year
* have children with severe health conditions (e.g., cerebral palsy) that prevent participation in study activities.
Association Between S-LAAO and Adverse Cardiovascular Events Among Patients Undergoing Coronary Artery Bypass Grafting.

This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.


Eligibility Criteria:
Inclusion Criteria:

1. Subject undergoing coronary artery bypass grafting according to clinical indications;
2. Age is more than 18 and less than 80 years old;
3. Male and non pregnancy female;
4. Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.

Exclusion Criteria:

1. Pregnancy female;
2. Participate in other clinical trial in the last 1 month.
3. Subject doesn't agree to sign an informed consent from prior to study procedures.
4. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
5. New York Heart Association (NYHA) Class IV heart failure.