cyrilzakka/clinical-trials huggingface dataset:
Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.

In the present study, we have trained 10 patients in subcutaneous self-administration of Velcade. After their training, patients will alternately receive their treatment in the hospital and at home by self-administration. In keeping with common practice, a nurse contacts the patients by telephone before 9.00 am on the day of treatment to ensure that the patient is physically "fit" to receive the medication and to discuss any side effects. To highlight the advantages and disadvantages of the changed treatment practice from the perspectives of both patients and healthcare professionals, data is collected from two consecutive semi-structured interviews with n = 10 patients and n = 1 focus group interview of the healthcare professionals involved. Moreover, time registration of medication administration both at the hospital and in the patients' home is done. The qualitative data will be analyzed via the method of condensation and continual quantitative data will form the basis of a cost-benefit analysis.


Eligibility Criteria:
Inclusion criteria

* Patients must have Multiple Myeloma
* Patients (or their relatives) must be deemed physically and cognitively suitable and willing for self-administration of subcutaneous Velcade
* Patients must be able to understand and speak Danish
* Patients must have received a minimum of 1 treatment cycle in the outpatient clinic

Exclusion criteria

* Lack of willingness to participate in scheduled interviews
* Patients who are cognitively affected
* Must not be receiving trial treatment
To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan

The objective of the projects is to Develop and implement a Package of interventions that will comprise of an augmented communication and counseling strategy coupled with private sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach during the Polio campaigns followed by the evaluation of this project for acceptability, feasibility and effectiveness of the intervention Package.

This particular project has been designed to address the bottlenecks through innovations to address community mobilization and demand creation on one hand and assess the synergistic immune enhancement potential of combining Inject able Polio Vaccine (IPV) and Oral Polio Vaccine (OPV) in at-risk children. This project will be implemented in high risk union councils of Karachi, district Kashmore in Sindh and Bajaur Agency in Federally administered Tribal areas (FATA)

This will be a three cell cluster randomized trial to achieve the objectives of the study. The first cell of the study will receive all the routine activities being carried out by the polio program, the second cell will receive an expanded intervention with community support groups, enhanced communication package, education and counseling and involvement of private sector. While the third cell will receive all of the interventions of second cell with a combined OPV IPV approach during the polio immunization campaign through child health camps.

We have calculated a total sample size of 120 clusters, 40 clusters per group for each study area i-e 120 for Karachi, 120 for Kashmore and 120 for Bajaur. Polio program in Pakistan has well established and demarcated vaccination areas assigned to a vaccination team, each vaccination area usually covers about 200 children therefore the area of vaccination team will be considered as one cluster in the proposed study.

The implementation of the project will be followed by impact assessment activities that will include post vaccination coverage surveys and Immunity assessment activities and Environmental sample collection. A total sample size of 5310 children has been calculated for the immunity studies for seroprevalance and 5130 for stool virus shedding

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 1 month to 5 years that reside within the study sites, and do not plan to travel away during entire the study period.

Exclusion Criteria:

* Children with known thrombocytopenia or bleeding disorders; children acutely ill or with signs of acute infection (e.g. fever ≥ 101 F) at the time of NID and a diagnosis or suspicion of immunodeficiency disorder.
The Natural History of Geographic Atrophy Progression (GAP) Study

The objective of the 18-month trial is to evaluate the natural history of geographic atrophy by assessing the rate of progression of the geographic atrophic lesion over time.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration with no CNV lesion.

Exclusion Criteria:

* Age related
High Intensity Interval Training in Chronic Heart Failure

The aim of this study is to investigate the effect of high-intensity interval training and moderate intensity continuous training on cardiopulmonary functions in chronic heart failure.

enroll chronic heart failure patients into 3 randomized controlled group

* high intensity interval training
* moderate intensity continous training
* control

perform cardica rehab for 12 weeks, compare primary and secondary endpoints between baseline and 12 weeks results

Eligibility Criteria:
Inclusion Criteria:

* medically stable chronic heart failure
* NYHA II-III
* can perform cardiopulmonary exercise test
* after 3months with proper medication
* age 30 to 70
* ejection fraction\< 40%

Exclusion Criteria:

* contraindication to cardiopulmonary exercise test
* musculoskeletal problem who cannot perform cardiopulmonary exercise test
* cognition deficit who cannot understand directions
* severe medial illness
Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour

The aim of this observational study is to assess the effect of early labour analgesia on obstetric and neonatal outcomes in induced labour in primiparous women with a full-term pregnancy whose labour was induced with a Cook balloon or prostaglandins.

It aims to answer whether early labour analgesia (\< 4 centimetres of cervical dilation) prolongs the duration of labour. Secondary outcomes will be Incidence of caesarean section, use of oxytocin, onset of fetal heart rate abnormalities within 30 minutes of augmentation, incidence of episiotomy, amount of blood loss, need for epidural catheter repositioning due to inadequate analgesia, onset of breakthrough pain defined as need for "rescue" top-ups within 60 minutes of previous top-ups, Apgar score (at 1 and 5 minutes), neonatal umbilical pH and neonatal intensive care unit admission. Patients who received early partoanalgesia were compared for the proposed outcomes with patients who received partoanalgesia in active labour (cervical dilation \> 4 centimetres).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Primipara;
* Single pregnancy;
* Gestational age \> 36 weeks;
* Induced labour with Bishop Score \< 6;
* Cervical dilatation at start of analgesia ≤ 6 cm;
* ASA Class 2.

Exclusion Criteria:

* Endouterine fetal death;
* Anhydramnios:
* Trial labour after caesarean section;
* Cardiotocogram class ≥2 before start of analgesia;
* Third trimester bleeding;
* Patient refusal;
* Inability to understand informed consent.
Response to Donepezil, Drug Plasma Concentration and the CYP2D6 and APOE Genetic Polymorphisms

Pharmacological treatment of AD is currently based on cholinesterase inhibitors (ChEI) and memantine, which have been shown to lead to modest, although effective, clinical benefits. Donepezil is a ChEI metabolized through the cytochrome P (CYP) 450, primarily by the 3A4 and 2D6 isoforms. The CYP2D6 gene presents polymorphisms that can alter its expression. The plasma therapeutic level ranges from 30 to 75 ng/mL, and 50% of acetylcholinesterase inhibition is achieved when the concentration reaches 15.6 ng/mL. An optimal plasma level is greater than 50 ng/mL.

These polymorphisms may influence the individual's response to treatment with donepezil and the concentration of the drug in AD patients, without achieving the desired effect. However, most of the individuals are EM, i.e., the metabolism of the drug occurs according to the expected kinetics and is associated with the presence of one or two wild-type alleles.

Objective: investigate the pattern of clinical response to donepezil in a group of patients with AD and AD with cerebrovascular disease (CVD) in relation to the plasmatic concentration of donepezil and polymorphisms of the CYP2D6 and apolipoprotein E (APOE) genes.

Patients taking donepezil were seen four times (from June 2009 to March 2013) and were submitted to the MMSE test, the Consortium to Establish a Registry for Alzheimer'sDisease battery (CERAD), and the Pfeffer Functional Activities Questionnaire. CERAD memory evaluation was further divided into five components: incidental recall (CERAD151 INC), immediate recall 1 and 2 (CERAD-RM1, CERAD-RM2, respectively) and delayed recall after five minutes (CERAD-R). Each aspect was analyzed individually and compared between groups at baseline and after 12 months of treatment with donepezil. All patients had blood samples (10mL) collected to obtain donepezil plasmatic concentration (DPC) measurements and for APOE and CYP2D6 genotyping.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the National Institute on Aging and the Alzheimer's Association diagnostic criteria of probable AD dementia or the NINDS-AIREN (National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences) diagnostic criteria of AD with cerebrovascular disease (AD + CVD)
* Patients presenting mild or moderate dementia according to the Clinical Dementia Rating (CDR), i.e., CDR 1 or 2, respectively

Exclusion Criteria:

* Patients treated with ChEI or memantine before study entry
* Patients diagnosed with frontotemporal dementia, dementia with Lewy bodies or vascular dementia,
* Patients classified as CDR 3 or with Mild Cognitive Impairment
* Illiterate patients
* Disagreement between the first investigator and the treating physician regarding the diagnosis
Non-Invasive Measurement of Hemoglobin (Using Pulse Co-Oximetry) in Patients Undergoing Elective Cesarean Delivery

We aim to assess a new pulse oximeter which measures continuous hemoglobin concentration (SpHb) in healthy patients undergoing elective Cesarean delivery (CS). This patient population often experiences significant blood loss during surgery, and measurements of surgical blood loss are often inaccurate. We will compare measurements of SpHb with estimated blood loss during the perioperative period, and laboratory measurements of hemoglobin at set time intervals during the perioperative and postoperative periods (to evaluate the accuracy of this device's ability to measure continuous SpHb).

We hope that this pulse oximeter will provide important new information (SpHb) about hemoglobin measurement in patients undergoing elective CS, who may often experience significant blood loss and postpartum anemia in the perioperative period. The measurement of perioperative blood loss is often inaccurate, and formal measurements of hemoglobin levels are often associated with time delays, especially in the setting of ongoing acute blood loss. We hope that this device will provide accurate continuous data of hemoglobin in this patient population, which may prove to be a significant advance in patient monitoring in this patient population. Probes for SpHb measurement will be provided by Masimo Corporation.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy term (\> 37 weeks gestation)
2. ASA 1 and 2 pregnant patients undergoing elective uncomplicated Cesarean delivery under neuraxial anesthesia
3. Age 18-40 yrs

Exclusion Criteria:

1. Patients with abnormal Hemoglobin disorders.
2. Patients with hyperbilirubinemia.
3. Patients who are smokers.
4. Patients with peripheral vascular disease or conditions affecting vascularity of the digits.
SPI-1005 Treatment in Severe COVID-19 Patients

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Positive nCoV2 PCR test by nasopharyngeal, oral, saliva, or respiratory sample
* Clinical signs, symptoms, and respiratory status consistent with severe COVID-19
* Score of 5-7 on the WHO Ordinal Scale
* Onset of severe COVID-19 symptoms ≤7 days of study enrollment
* Subject is in-patient at time of randomization to study treatment
* Subject or legally authorized representative is willing and able to provide informed consent, and agrees for subject to comply with planned study procedures including reproductive requirements

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding.
* Participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent.
* Patients with impaired hepatic or renal function.
* Subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.
The Effectiveness of Kinesio Taping in Patients With Knee Osteoarthritis

Knee osteoarthritis is the most common kind of arthritis that occurs due to degeneration of the joint articular cartilage, producing pain, stiffness, and impaired movement. Kinesio taping is a simple and inexpensive therapeutic procedure that can help with knee osteoarthritis symptoms. Kinesio taping is a high-stretch elastic adhesive material that allows the treated area to have free mobility. This technique was preferred by physical therapists for knee osteoarthritis rehabilitation because of its positive effects, such as decreased pain and increased mobility and muscular performance.


Eligibility Criteria:
Inclusion Criteria:

* Complaining of knee pain but no serious knee injuries
* No Physical therapy treatment taken for the past 3 months
* Painful range of motion (ROM)
* Significant decrease in active and passive ROM.

Exclusion Criteria:

* Knee surgery within the last three months
* Neural, articular, or muscular conditions affecting lower limb function
* Systemic arthritic diseases
Fat Biology, Sleep Disorders, and Cardiovascular Disease

Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to be a key process in the development of cardiovascular disease. Endothelial dysfunction appears to be caused by both sleep disordered breathing and obesity. As endothelial dysfunction is among the first clinical marker that predicts future cardiovascular events, understanding molecular mechanisms leading to impairment of endothelial function is very important. Endothelial function requires the proper functioning of endothelial nitric oxide synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal nitric oxide synthesis in endothelial cells as caveolin-1 helps to spatially organize eNOS in close proximity to signaling proteins that are important for eNOS activation. In certain diseases however, the balance of caveolin-1 and eNOS can be disrupted resulting in impaired nitric oxide synthesis and leading to endothelial dysfunction.

The investigators therefore seek to characterize levels of caveolin-1, and correlate this with the presence or absence of sleep disordered breathing, obesity, and cardiovascular disease. The current IRB protocol covers the performance of fat biopsies on subjects who have recently completed a sleep study either in the Center for Sleep Medicine or in our sleep laboratory and were found to have sleep disordered breathing or no sleep disordered breathing, subject with sleep disordered breathing who have been treated successfully with continuous positive airway pressure for 3-6 months, and subjects undergoing other studies in our lab who are obese or non-obese and subjects who have known cardiovascular disease and subjects without known cardiovascular disease.


Eligibility Criteria:
Lac of contraindication for fat biopsy, inability to provide informed consent.
Ultrasound Elasticity Imaging of Venous Thrombi

The purpose of this study is to see if the investigators can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Deep vein thrombosis (DVT) is a blood clot and is a common illness that can result in pain and death if not recognized and treated well. Death can occur when the venous clots break off and form pulmonary emboli (PE), which can block the arteries of the lungs. DVT and PE most often complicate the course of sick patients but may also affect healthy persons. DVT can also be a chronic disease. In those instances in which DVT and PE develop, in addition to the death risk, hospitalization is drawn out and healthcare costs are increased. Therefore, the purpose of this study is to see if we can use ultrasound imaging to determine the type of clots in patients to help better manage their care.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who have a diagnosis of chronic DVT that is at least 2 weeks old and are free from an acute DVT on top of your chronic DVT.
* Male and female patients who have been diagnosed with an acute blood clot by the Diagnostic Vascular Lab and w/symptoms occurring within the previous 2 weeks.
* Patients under the age of 18 who give assent (permission) and whose parents give consent.
* Adult patients who give consent.

Exclusion Criteria:

* None
Influence of Regular Exercise and Detraining on Metabolic and Emotional Parameters in Diabetic Individuals

This quasi-experimental study aim to evaluate the effect of moderate aerobic exercise on glucose and lipid metabolism as well as the scales of anxiety and depression and levels of salivary cortisol in women with type 2 diabetes.

This quasi-experimental study aim to performed a 12-week training program (3 times/week, 60 minutes per session) which consisted of a supervised moderate aerobic exercise previously determined (50% to 70% of maximal Heart Rate) in women with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* having normal physical examinations,
* no participation in regular, moderate or intensive exercise for at least 6 months before the study and
* not be following a diet

Exclusion Criteria:

* the use of insulin and beta-blocker medications and
* the functional inability to perform exercise
The Effect of Informative Letters on the Prescription and Receipt of Opioids

Inappropriate prescribing exposes patients to health risks and results in wasteful public expenditures. This study will evaluate an approach to fighting abusive prescription: sending letters to suspected potentially inappropriate prescribers warning them that they are outliers compared to their peers and have been flagged for review. The study will target high prescribers of opioids in the Schedule II controlled substances class. Two types of letters will be tested: one focusing on the health consequences of inappropriate prescribing for patients, and the other focusing on the consequences for prescribers including e.g. potential administrative actions. Using claims data, the investigators will assess the effect of the letters on prescribing of opioids, receipt of opioids by patients, substitution behavior by prescribers and patients, and health outcomes of patients.


Eligibility Criteria:
Inclusion Criteria:

* Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in prescription drug events (PDE), in 2014Q3-2015Q2 and 2015Q3-2016Q2
* Outlier with respect to prescribing of Schedule II opioids relative to peers, measured in 30-day equivalents, in 2014Q3-2015Q2 and 2015Q3-2016Q2

Exclusion Criteria:

* Deceased
* Fewer than 75 Schedule II Opioid PDE in 2015Q3-2016Q2
* Specialty listed as "Student in an Organized Health Care Education/Training Program"
Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections

This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis.

Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly used for treatment of knee osteoarthritis. Even though there are many studies investigating the effectiveness of these treatments, the results are mostly qualitative. Also there are a few studies comparing these two treatment modalities. In this study the investigators aim to compare these modalities both for self-reported data (pain, physical function) and objective measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be controls for each group.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to consent
* Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee osteoarthritis
* Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis
* Unilateral osteoarthritis/complaint

Exclusion Criteria:

* Past or actual knee infection
* History of surgery, fracture on knee
* Collagen tissue disease
* Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.)
* Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure, liver failure)
* Knee injection in past 6 months
* Immunodeficiency
* Pregnant/breastfeeding
* Malignancy
Outcome of Children Post Mechanical Ventilation

Mechanical ventilation is a life-saving therapy widely used in PICU, but not without adverse effects. The mid-term outcome of mechanically ventilated children who survive critical illness is still poorly defined, in terms of respiratory status, functionality, and quality of life. This lack of knowledge can lead to delays in management and thus hinder the recovery of children.

The aim of this study is to determine the impact on the functional and respiratory outcome of pediatric patients after a stay a PICU of the province of Quebec.

This is a prospective longitudinal cohort study of pediatric patients requiring mechanical ventilation for at least 48 hours, in all 4 PICUs in the province of Quebec (Canada).

In follow-up PICU clinics, children and family outcomes will be evaluated 2, 6 and 12 months post PICU discharge.Children and their families will be enrolled locally from each PICU, their baseline data will be collected by local research staff and their post-discharge outcomes will be followed centrally from the Centre Hospitalier Universitaire Sainte-Justine.

The specific aims are to determine the functional, respiratory and neurocognitive function of PICU survivors and Health related Quality of life. Psychosocial status of the child and parents will also be determined.

The primary goal is to describe the impact of a critical illness and mechanical ventilation on PICU survivors and their families in order to improve the health and well-being of PICU survivors and their families, and ultimately to improve the care of children after a PICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients \< 18 years of age;
* Admission to a PICU at the Centre Hospitalier Universitaire Sainte-Justine (CHUSJ), Montreal Children's Hospital (MCH), Centre Hospitalier Universitaire de Québec - Université Laval (CHUL) or Centre Hospitalier Universitaire de Sherbrooke (CHUS);
* Patients with invasive mechanical ventilation for ≥48 hours.

Exclusion Criteria:

* Patients admitted for congenital heart surgery