cyrilzakka/clinical-trials huggingface dataset:
Randomized Prospective Study Comparing the Effectiveness of Massed and Spaced Learning in Microsurgical Procedures

Title: Randomized prospective study comparing the effectiveness of spaced learning to mass learning in microsurgical procedures.

Background:

Spacing phenomenon occurs when learning outcomes are greater with the teaching process spread out over time (spaced learning), as opposed to having the same total duration of teaching carried out over a single session (mass learning). Spaced learning has been shown to improve explicit memory tasks including free recall, recognition, cued -recall and frequency estimation. It has been used in various medical specialties with promising results and has been shown to be at least as good as mass training in learning clinical skills such as cardio-pulmonary resuscitation and laparoscopy skills.

We aim to test the concept of spaced learning in learning delicate and complex skilled procedures like microsurgery. Our hypothesis is that spaced learning is better than mass learning in acquiring microsurgical suturing skills.

Methodology:

Medical students with no prior exposure to microsurgical training were randomized into control (mass-learning) and treatment (spaced learning) groups. The students were all taught to handle microsurgical instruments and to suture a prefabricated 4mm wide elastic strip under the microscope using Digital Surgicals MicroTrainer. The control group was taught continuously over 8hrs while the treatment group was taught in 2-hour sessions held each week over a span of 4 weeks. The learning outcomes that were measured included duration taken as well as the placement of the sutures in relation to each other, with the latter being objectively assessed with the use of a computer program from Digital Surgicals. In addition to being assessed at the beginning of the sessions, all participants completed another test 1 month after the completion of the sessions.


Eligibility Criteria:
Inclusion Criteria:

* Medical students

Exclusion Criteria:

* Anyone who has been exposed to any form of microsurgical training
The Role of Adverse Environment Factors, Family Functioning and Parental Psychopathology in the Response to Treatment With Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder

The purpose of this study is to investigate the association of adverse environmental factors, parental psychopathology, family functioning and genetic factors and the response to methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder.

Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic disorder, with a worldwide estimated prevalence of 5,29%. It is associated with a high risk of functional impairment in many aspects of the patient´s life, such as academic achievements, peers relationships and physical injuries. There are few studies assessing predictive factors of clinical response to treatment. Different patterns of family functioning, such as high family conflict and low family cohesion might be associated with a poor treatment response, possibly mediating the effects of higher severity af the disorder and/or higher prevalence of comorbidity. Parental psychopathology has been associated with a poorer prognosis and is related with family functioning. Adverse social factors have long been studied and are associated with an increased risk for general mental disease, including ADHD, as well as a poorer prognosis. Different genetic factors have been studied and associated with different aspects of the disorder and different clinical responses to treatments. There are no studies evaluating how those factors interact with each other in a Brazilian population.

Eligibility Criteria:
Inclusion Criteria:

* ADHD
* Age: 5 - 18
* Primary Indication of Methylphenidate

Exclusion Criteria:

* IQ \< 70
* Clinical conditions that preclude use of methylphenidate
Evaluation of Providing Coffee to Patients Postoperatively to Decrease Length of Stay in the PACU

The purpose of the study is to determine if providing coffee to patients who self-identify as coffee drinkers postoperatively will decrease the length of stay in the post-anesthesia care unit (PACU).

Decreasing the length of stay in PACU for surgical patient is a pertinent outcome. The shorter length of stay can achieve higher patient engagement scores, while simultaneously increasing the productivity of the unit. This is achieved by making more beds available for new patients coming from the operating room (OR). One thought was that coffee would benefit the investigator's patients experience through a number of pathways. Initially, the stimulant effect of coffee would create a more alert patient. A more alert patient is more likely to comprehend home care instruction and be ready for discharge earlier. Coffee is often used as a remedy for morning sickness. Ideally the act of drinking coffee or even smelling the coffee may decrease the occurrence of Post-Operative Nausea and Vomiting (PONV) in investigator's patient population. Finally, patients frequently state that the inability to drink their morning coffee is often more difficult than not being able to eat prior to surgery. By allowing those to drink coffee in PACU this would make the patient feel that they are being cared for on an emotional level, in addition to a physical level.

Eligibility Criteria:
Inclusion criteria:

1. 18 years old or older
2. Admitted to Bethesda North Minimally Invasive Surgery Center
3. Reports to consume at least one cup of coffee a day for at least 5 days in a week

Exclusion Criteria

1. History of PONV
2. Pre-existing cardiac arrhythmias
3. History of seizure disorder
4. Pregnant
Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation

The purpose of this trial is to test whether clients of Sun Life are willing to join in a quit smoking program that offers counselling and tobacco cessation products to all participants over a 12-month period. The study team will track the safety and usage of 3 types of cessation products as well as the effectiveness of a virtual pharmacy (i.e. cessation products delivered to participants directly from a pharmacy) over a 12-week treatment period.

The purpose of this study is to look at 3 approved smoking cessation products used in combination with counselling and virtual delivery of the smoking cessation products. The goal is to track product usage, safety, and adherence (how much of the products people use and how many counselling sessions they complete) among people who are already clients of Sun Life

This study will engage people who smoke through an insurance-based outreach program (Sun Life Assurance Company of Canada) to evaluate the efficacy and safety of three pharmacotherapy arms (combination NRT, cytisine, or varenicline) within the OMSC framework, which includes the provision of cost-free virtual counselling, follow-up, and direct-to-consumer delivery of medications.

To our knowledge, there are no prior studies evaluating an entirely virtual smoking cessation intervention which includes virtual counselling/follow-up and direct-to-consumer delivery of pharmacotherapy. This study will also engage the broader community setting, such as clients or employees of industry partners, represents a valuable opportunity to reach a wider population of people who smoke with tailored support. Beyond cost savings associated with smoking cessation, this study may also reduce insurance premiums for patients, thus leading to additional source of cost savings.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years) who are clients of Sun Life Assurance Company of Canada.
* Current cigarette smokers (more than 5 cigarettes per day) who are interested in reducing or quitting in the next 6 months.
* Able to provide informed consent.
* Living in Ontario, Canada

Exclusion Criteria:

* Contraindications to any of the study medications (NRT, cytisine, varenicline).
* Actively using one of the study medications in the past 7 days.
* Actively enrolled in another formal smoking cessation program.
* Pregnant or breastfeeding individuals.
* Unable to engage in follow-up for any reason (for example an acute mental illness, cognitive impairment, unable to speak English or French).
* Other conditions deemed by the study team to interfere with participation or outcomes in the opinion of the study investigator (for example acutely unwell, life expectancy less than 1 year).
Increasing Physical Activity Among Breast Cancer Survivors With Depression

Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.

The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6 month follow up. Intervention components will include print-based education, self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.

Eligibility Criteria:
Inclusion Criteria:

* Positive depression screen (PHQ-9) or current antidepressant treatment
* Report \<150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ
* Physically able to engage in physical activity
* Written and verbal fluency in English

Exclusion Criteria:

* Medical condition contraindicating physical activity participation
* Recurrence of breast cancer
* Ductal carcinoma in situ (DCIS) diagnosis
* Cognitively unable to give informed consent
* Non-English speaking
Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents

Children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) very commonly experience difficulty in initiating and maintaining sleep. Studies have shown that daytime sleepiness resulting from insufficient sleep can affect attention and learning. Therefore, treating insomnia in children with ADHD may not only improve sleep, but it could potentially improve ADHD symptoms as well.

The main purpose of this study is to examine the effects of atomoxetine on ADHD-related insomnia. Atomoxetine (Strattera®) is a non-stimulant drug used to treat ADHD symptoms in both children and adults, and there is evidence that it may also have a positive effect on sleep in children with ADHD. During the study, participants will receive either atomoxetine or placebo for a period of four weeks. We expect that the effects of atomoxetine on sleep will differ from those of placebo, with atomoxetine having a greater effect on improving sleep difficulties.


Eligibility Criteria:
Inclusion Criteria:

* Boy or girl aged 6-17 years, inclusive, and English-speaking
* Meet the DSM-IV criteria for Attention-Deficit/Hyperactivity Disorder
* Have sleep initiation defined by:

  1. difficulty initiating or maintaining sleep that is viewed as a problem by the child or caregiver
  2. sleep onset delay that is not exclusively related to direct or rebound effects of psychostimulant treatment
* Have a parent or legal guardian willing to participate in the study

Exclusion Criteria:

* Have any other primary sleep disorder(s) (e.g. obstructive sleep apnea or periodic limb movement disorder)
* Have a history of significant chronic medical (e.g. diabetes, severe asthma) or psychiatric (e.g. depression) illness
* Have a history of chronic use of sedating (e.g. antihistamines) or alertness enhancing (e.g. caffeine) medications
* Have a history of failure to respond to an adequate (defined as appropriate dose and adequate duration of therapy) previous trial with atomoxetine
Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin

This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects.

This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects. Part 1 consists of 2 arms (cyclosporine and probenecid) and Part 2 consists of 1 arm (rifampin). Twenty (20) unique subjects will be enrolled into each study arm. The PK and safety/tolerability data from Part 1 Arm 1 (cyclosporine) will determine if Part 2 (rifampin) will proceed. Subjects will be on study for up to 72 days, including a 28-day screening period, 6-10 day clinic period, and a 30-day follow-up period post last dose. Blood and/or urine samples for PK analysis will be collected at pre-defined timepoints throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Male or female between 18 and 55 years of age, inclusive, at time of informed consent
* Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive.

Exclusion Criteria:

* Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening; History of latent or active tuberculosis (TB).
* Positive test results for human immunodeficiency virus (HIV) antibody; Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) within 3 months prior to screening , or positive test results for human immunodeficiency virus antibody (HIVab) at Screening.
* Taking any prescription medication or over the counter multi-vitamin supplement, or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to Day -1.
New Daily Persistent Headache Biomarkers Study

New daily persistent headache is a debilitating syndrome which is seldom researched, poorly understood, and without effective treatments. Chronic migraine is a more common but similarly disabling disorder. The goal of this study is to evaluate the blood levels of two proteins involved with pain signaling; calcitonin gene-related peptide (CGRP) and nerve growth factor (NGF).

CGRP levels are known to be elevated in chronic migraine, and recent phase 2 clinical trials suggest that treatments targeting CGRP are safe and effective for treatments for migraine. If CGRP levels are elevated in the blood of people with new daily persistent headache, future studies will be designed to evaluate whether treatments that target CGRP are effective in treating new daily persistent headache. If NGF levels are elevated in the blood of patients with new daily persistent headache and/or chronic migraine, future studies will be designed to evaluate whether treatments that target NGF antibodies (targeted treatments against NGF) are effective in treating NDPH and/or chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

* to add

Exclusion Criteria:

* to add
Change in Choroidal Thickness of Myopic Eyes With a Myopia Control Contact Lens

In this study, the direct effect of the MiSight contact lens (Cooper Vision), a daily disposable contact lens recently approved in Germany for the treatment of myopia, will be investigated. The aim of this study is to demonstrate an increase in choroidal thickness due to the myopic defocus induced by the contact lens. The increase in choroidal thickness after 30 minutes of exposure to the myopic defocus induced by the contact lens will be demonstrated by measuring the subfoveal and macular choroidal thickness.

The increasing incidence of short-sightedness (myopia) worldwide has led to the development of various therapies to control axial length myopia. The latest developments include contact lenses to inhibit the growth of the bulb length, which should influence the growth of the eye in childhood and adolescence by inducing a myopic defocus in the periphery of the retina.

In this study, the direct effect of the MiSight contact lens (Cooper Vision), a daily disposable contact lens recently approved in Germany for the treatment of myopia, will be investigated. The aim of this study is to demonstrate an increase in choroidal thickness due to the myopic defocus induced by the contact lens. The increase in choroidal thickness after 30 minutes of exposure to the myopic defocus induced by the contact lens will be demonstrated by measuring the subfoveal and macular choroidal thickness. In addition, the influence of accommodation will be investigated by measuring the choroidal thickness after 30 minutes of activity at near and far distance. One eye of each of 8 healthy subjects with myopic refraction from -0.5 diopters in the spherical equivalent will be included, with laterality (right/left) being randomized. The choroidal thickness is measured using optical coherence tomography (OCT), which is standard in clinical routine. The examination is non-invasive and is carried out at three points in time: The baseline measurement is carried out before inserting the contact lens, then after 30 minutes of exposure and near focusing. A further measurement is carried out within a week after a further 30 minutes of exposure and distance focusing, so that the results are not distorted by the previous near work. In addition, the axial length is determined at each of the 3 measurement times using optical biometry.

Eligibility Criteria:
Inclusion Criteria:

* myopic refraction
* consent to participate
* minimum age 18 years
* full legal capacity

Exclusion Criteria:

* ocular disease affecting imaging quality including but not limited to cataract, keratoconus
* ocular disease affecting choroidal thickness (pachychoroidal disease)
* astigmatism greater than 1,5 diopters
* best corrected distance visual acuity of 0,1 logMAR or worse
* status post eye surgery
* status post treatment for myopia control
Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies

The goal of this clinical research study is to find the highest dose of Tezacitabine (FMdC) which can be safely given as a continuous infusion by vein to patients with hematologic malignancies. The general safety and effectiveness of this drug will also be studied.

Patients with leukemias that have relapsed from previous therapies have a low cure rate. Hence the need to discover new antileukemic agents. Tezacitabine is a nucleoside analogue with equivalent or even superior activity when compared with ara-C in leukemic cell lines. It has shown significant antitumor activity in vitro and in vivo tumor models. Several phase I studies with various dosing schedules have been conducted in solid tumors where the dose-limiting toxicity (DLT) is mainly myelosuppression, usually a favorable feature for development of leukemia. In a phase I study in hematological malignancies, we used Tezacitabine as a bolus infusion daily x 5. The DLT consisted of grade 3 CNS toxicities and mucositis in 3/6 patients. The study is ongoing and we are currently evaluating a dose level of 7.5 mg/m2 as possible Maximum Tolerated Dose (MTD). However, in view of the fact that tezacitabine is a cell cycle specific agent with a short terminal plasma half-life of 2 to 6 hours, a continuous infusion dosing schedule may enhance the activity and reduce the incidence of adverse effects of tezacitabine.

Eligibility Criteria:
* Patient with relapsed/refractory acute leukemias (AML, ALL, high-grade myelodysplastic syndromes, CMML in transformation with \>/= 10% peripheral blood/bone marrow blasts, CML in blast crisis), or patients with relapsed/refractory CLL and an absolute neutrophil count of \>/= 1,000/ml and platelet count of \>/= 75,000/ml.
* Signed informed consent indicating that patients are aware of the investigational nature of this study, and in keeping with the policies of this hospital. The only acceptable consent form is attached at the end of this protocol.
* Age \>/= 15 years.
* ECOG performance status \</= 2.
* No severe, concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for study entry.
* Pregnant and/or lactating females are not eligible.
* Normal organ function (serum bilirubin £ 2 mg/dL, serum creatinine £ 2 mg/dL). Patients with renal or liver dysfunction due to organ leukemic involvement may be eligible after discussion with the principle investigator.
* Patients must be off of all previous chemotherapy, immunotherapy, or radiotherapy for at least 2 weeks prior to entering this study, and must have recovered from all toxic effects, unless life-threatening increases in tumor burden occur.
Effectiveness of Routine Sterile Gloving in Blood Culture

The purpose of this study is to determine whether routine sterile gloving can lower contamination rates in blood culture.

Because contamination during sampling for blood culture may interfere in interpreting the results of blood culture, lowering the contamination rates in blood culture is very important. According to current guideline, routine sterile gloving is not recommended. We hypothesized that routine sterile gloving can lower contamination rates in blood culture.

Eligibility Criteria:
Inclusion Criteria:

* The patients in whom Blood culture is medically needed

Exclusion Criteria:

* Blood sample is obtained through central venous catheter or arterial line
* No consent to this study
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes for at least 1 year
* Nonsmokers for prior 6 months
* BMI less than or equal to 35kg/m2
* HbA1c \> or = 7% and \< or = 11%
* Serum creatinine \< or = 1.8 mg/dL in female subjects and \< or = 2.0 mg/dL in male subjects
* FEV1 \> or = 70% of predicted, DLco \> or = 70% , TLC \> or = 80% predicted
* Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
* Urine cotinine \< or = 100 ng/mL

Exclusion Criteria:

* History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
* Evidence of severe complications of diabetes
* Aminotransferase and/or alanine aminotransferase \> than 3 times the upper limit of normal
DePuy Revision TKA Implant 5yr Survivorship

This will be a retrospective chart review of 200 charts of adult patients who have undergone a revision TKA at New England Baptist Hospital and who received implant component(s) manufactured by DePuy Orthopedics. The data will be collected retrospectively after patients are seen clinically for a minimum of five years after surgery to answer:

1. What is the five-year survivorship of revision a knee prosthesis containing components manufactured by DePuy Orthopedics among adult revision TKA patients?
2. What patient factors are associated with the need for re-operation after revision TKA among patients receiving DePuy implant components? How do clinical outcomes change from baseline over the five-year follow-up after revision TKA surgery?

Data collection will include patient-reported and clinician-reported measures.


Eligibility Criteria:
Inclusion Criteria:

* Received a Revision TKA (must have been initial revision)

  --Received J\&J/DePuy implant components for initial revision
* Procedure performed at New England Baptist Hospital

Exclusion Criteria:

* 2nd Revision TKA on knee
* Received femoral or tibial components not of DePuy manufacture