cyrilzakka/clinical-trials huggingface dataset:
Smartwatch and Physician Well-Being

The prevalence of burnout and other forms of distress among physicians is alarmingly high. This clinical trial is being conducted to learn more about if wearing a Smartwatch and having access to its data improves physicians' sense of well-being and if data measured from Smartwatches contain a 'signal' that predicts well-being

We will conduct a randomized controlled trail to evaluate if wearing a Smartwatch improves overall well-being among physicians, and if so, in which dimension of well-being (e.g., fatigue, stress, overall quality of life, burnout). Additionally, we will explore if data from Smartwatches can predict subsequent well-being among physicians.

Study Aims:

1. To determine if wearing a Smartwatch and having access to its physiological data (e.g., sleep, step count, activity, breathing reminders) improves well-being, and if so which well-being dimensions.
2. To determine whether continuous physiological measures (measured from Smartwatches) contain a 'signal' that predicts physician well-being, and if so in which dimensions.

Eligibility Criteria:
Inclusion Criteria:

* Physician

Exclusion Criteria:

* non physicians
Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate

This retrospective observational study will evaluate high-dose methotrexate patterns of use, supportive care measures used during high-dose methotrexate chemotherapy, along with the incidence of delayed elimination of methotrexate, acute kidney injury and any associated impact of delayed elimination of methotrexate on future courses of chemotherapy and disease outcomes in adults and children with cancer.

The study will compare current practice with existing guidelines and best practices to identify potential gaps in the management of high-dose methotrexate administration and delayed elimination of methotrexate. The study will identify variations in practice and outcomes in different study centers, countries, cancer types, patient age groups, by different methotrexate doses and infusion times and different supportive care measures used. The study will also document the proportion of high-dose methotrexate courses in which glucarpidase has been used and any toxicities attributable to the use of glucarpidase.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of any cancer from January 1, 2001 to June 30, 2021.
* Receipt of high-dose methotrexate chemotherapy, defined as a dose of 500 mg/m2 of body surface area or higher.
* Medical records available for review.
* Any age; any cancer type.

Exclusion Criteria:

* None.
Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients

This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypercholesterolaemia who are already in treatment with rosuvastatin according to the approved SPC for no longer than 1 month prior to study entry
* Patients that are able to read, understand and sign the Patient Information \& Consent Form
* Patients that are willing to comply with all study requirements

Exclusion Criteria:

* Patients that are likely not to comply with all study requirements
* Patients that currently participate or have participated in a 3 months period prior to study entry in another clinical trial
* Female of child bearing potential that do not use a reliable method of contraception. Pregnancy or lactation.
* Patients that meet any of the contraindications described in the approved SPC
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of seasonal allergic conjunctivitis

Exclusion Criteria:

* Ocular infection or history of ocular herpes infection
* History of retinal detachment or diabetic retinopathy
* Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
* Ocular surgery within 8 weeks
Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)

The purpose of this study is to learn whether blood flow in the brain is normal in people with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN, may have reduced blood flow. Standard MRI and perfusion scanning techniques will be used to learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other brain regions as well as to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PKAN confirmed by MRI and gene testing
* able to undergo MRI for approximately 1 hour without sedation

Exclusion Criteria:

* deep brain stimulators or other conditions that warrant avoidance of a strong magnetic field
* previous reaction to gadolinium (Gd) contrast agent
* acute or chronic kidney dysfunction
* pregnant and/or nursing at time of study
Effects of Attention Training Interventions on Depression

The purpose of this study is to study the effects of attention training interventions on symptoms and brain function in major depressive disorder.

Attention training programs including mindfulness meditation-based interventions have been shown to be effective for treating depression. Currently the biological and psychological mechanisms of action of attention training for major depression disorder are unknown. The objective of the current study is to improve the investigator's understanding of the mechanisms of attention training interventions for depression.

Research participants will include approximately 165 individuals with major depressive disorder randomized to one of three types of attention training programs. Before and after intervention participants will complete a number of biological assessments including MRI, EEG, behavioral tasks, and questionnaires. The study will be completed across three visits: (1) a screening visit; (2) data collection session 1; and (3) data collection session 2.

Eligibility Criteria:
Inclusion Criteria include:

* DSM-5 criteria for major depressive disorder
* Written informed consent
* Both biological sexes, any ethnicity
* Age 18-55
* Scores exceeding cutoffs on depression questionnaires
* Right-handed
* Normal or corrected-to-normal vision and hearing
* Fluency in written and spoken English
* Absence of psychotropic medication

Exclusion Criteria include:

* Use of substances or prior treatments that may interfere with study procedures or outcomes (e.g., stimulants, blood pressure medication)
* Medical conditions that may interfere with study procedures or outcomes (e.g., thyroid disorder)
* Current therapy and practices overlapping with study interventions
* Select other DSM-5 disorders and symptoms (e.g., psychotic symptoms, suicidal ideation)
* Failure to meet MRI safety requirements or suitability
* Significant inconsistencies in self-report or first-degree relatives with history or current psychotic symptoms
Early Diabetes Intervention Program

This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.

A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by glucose tolerance test criteria but non-diabetic fasting glucose concentrations. Treatment interventions were assessed for their ability to delay worsening of fasting glucose control.

Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose \<140 mg/dL
* 75 g OGTT 2hr glucose \>120 mg/dL
* BMI \> 25 OR history of gestational diabetes mellitus OR family history of type 2 diabetes
* Age at least 25 years

Exclusion Criteria:

* Cancer within 5 years
* Chronic infectious disease (HIV, Hepatitis)
* CVD event within 6 months
* Uncontrolled hypertension or requiring beta blockers or thiazide diuretics for control
* elevated AST or ALT
* Serum creatinine \>1.4 mg/dL (men) or \>1.3 mg/dL (women)
* TG \>600 mg/dL
* Known glucosidase intolerance
* Inability to comply with protocol requirements.
Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...

Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of HCM in children. However, growth of the body and organs, including the heart, is very rapid during childhood. Therefore the long-term effects of DDD pacing in children are unknown.

The purpose of this study is to examine the growth rate and nutrition of children with HCM. Due to this heart condition and the restrictions that are often placed on the child's activity level, children with HCM may grow at a slower rat and may have a greater tendency to be overweight.

Children participating in the study will have their growth rate and nutritional status measured before the study begins and throughout the course of the study.

Findings in this research study will not directly benefit the patients participating in it. However, information gathered as a result of this study may lead to improvements in the management of children with HCM in the future.

Several studies have shown that dual chamber (DDD) pacemaker therapy relieves LV outflow obstruction and improves symptoms in most adult patients with obstructive hypertrophic cardiomyopathy (HCM). It is however, uncertain whether DDD pacing will be efficacious in children with obstructive HCM, because of evolving cardiac morphology and increased LV hypertrophy and outflow obstruction associated with rapid body growth. We propose to monitor clinical progress, and cardiac morphologic and hemodynamic changes over several years following implantation of a DDD pacemaker in children who present with obstructive HCM between the ages of 5 to 15 years. Functional status, myocardial ischemia, arrhythmias, and LV outflow obstruction will be evaluated by exercise tests, echocardiography, thallium scintigraphy, Holter monitoring, electrophysiologic and cardiac catheterization studies. The results of pacemaker therapy will be compared with the findings in a cohort of young patients with obstructive HCM who elect not to be treated with DDD pacemaker.

Eligibility Criteria:
* INCLUSION CRITERIA: DDD Pacemaker Therapy

Children of either gender, aged 5 to 15 years.

Presence of LV hypertrophy and LV outflow obstruction.

EXCLUSION CRITERIA: DDD Pacemaker Therapy

Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.

Chronic atrial fibrillation.

Positive pregnancy test.

INCLUSION CRITERIA: Cohort Study

Children of either gender, 5 to 20 years (children greater than 15 years will be included if there is access to reliable previous catheterization data).

Presence of LV hypertrophy and LV obstruction.

EXCLUSION CRITERIA: Cohort Study

Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.

Chronic atrial fibrillation.

Positive pregnancy test.
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US)

The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary study objectives were:

* To evaluate the effects of rimonabant on craving and weight;
* To evaluate the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period
* To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in the population of smokers);
* To observe the percentage of abstinent patients during a 40-week follow-up post treatment period;
* To evaluate quality of life (QOL) and pharmacoeconomics.


Eligibility Criteria:
Inclusion Criteria:

* Smokers smoking at least 10 cigarettes/day (on average) in the 2 months preceding screening visit;
* Motivated to quit smoking (Motivation Scale Score above or equal to 6 on a 10-point scale).

Exclusion Criteria:

* Smoked or consumed more than 3 times within the 3 months immediately preceding the screening visit: non tobacco cigarettes or related products or any form of tobacco product other than cigarettes;
* Current and regular consumption of marijuana (hashish).
* Met current criteria on the MINI International Neuropsychiatric Interview (MINI) for any of the following psychiatric disorders/states: major depressive episode, dysthymia, suicidality, manic episode or hypomanic episode, panic disorder, agoraphobia, social phobia (social anxiety disorder), obsessive compulsive disorder, posttraumatic stress disorder, alcohol dependence or abuse, substance dependence or abuse (excluding nicotine or caffeine), anorexia nervosa, bulimia nervosa, or generalized anxiety disorder;
* Met lifetime criteria on the MINI for manic episode or hypomanic episode, or psychotic disorders;
* Carried a diagnosis of, or suspicion of any cognitive disorder (eg, delirium, dementia, amnestic disorder) or any other psychiatric or developmental disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) that may interfere with his/her ability to understand or complete study related procedures;
* Had a history of severe depression, ie, those who have required hospitalization, or patients with 2 or more recurrent episodes of depression, or a history of multiple suicide attempts;
* Had used, within 3 months before the screening visit:

  * Nicotine replacement of any type for more than 3 days at the maximum prescribed dose, or
  * Behavioral and/or motivational counseling, therapy, support group, or other procedure intended to assist smoking cessation on more than 3 days, or
  * Bupropion (amphebutamone), or
  * Systemic long acting corticosteroids, or
  * Any therapy intended to treat or alleviate depressive symptoms (pharmacologic, somatic, or psychological) for more than 1 week.
Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes

The purpose of the study is to look at the effect of replacing the physician only visit by a transmission of information on the participant's current diabetes management and blood glucose monitoring results followed by a phone contact by the diabetes nurse educator. The study will also measure the effect on diabetes control (HbA1c), satisfaction with care, resource utilisation, and costs to the health care system and to the participant.

We hypothesize that replacement of the physician-only visit by a virtual visit will not result in worsening of the medical outcomes and that it will result in a reduction in medical resources utilization and costs for families while increasing the satisfaction with care.

Improved metabolic control reduces both the onset and progression of diabetes-related complications in adults and adolescents with type 1 diabetes. Frequency of contact with the medical care team has been associated with better control. Both the American Diabetes Association and Canadian Diabetes Association recommend regular quarterly visits. However, the increase in case loads and the limited manpower available forces us to look at alternative models of care. A model of care in which medical visits alternate between a face to face multidisciplinary visits and a virtual visit done via fax or e-mail communication and a phone call may be advantageous to both the patient and the medical care team. For the patient and his family, this model would decrease time away from school and work, travel inconveniences and costs. For the medical care team it may decrease time per patient and therefore increase the number of patients served with the same resources.

Eligibility Criteria:
Inclusion Criteria:

* Children: 17 years of age or less
* Diagnosis of Type 1 Diabetes for at least 12 months
* Currently being followed at the Alberta Children's Hospital Diabetes Clinic.

Exclusion Criteria:

* Compromised metabolic control (HbA1c \> 10%)
* Uncontrolled hypo or hyperthyroidism
* Uncontrolled celiac disease
* Language or psychosocial barrier preventing the family from completing the study
* Diabetes duration of less than 1 year
* Participation in other clinical trials with specified clinic visits.
Positive Effects of Haematococcus Astaxanthin on Oxidative Stress and Lipid Profile in Overweight and Obese Adults

The purpose of this study is to determine whether astaxanthin (ASX) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with BMI over 25.0 kg/m2
* Non-smoker

Exclusion Criteria:

* Excessive alcohol consumption
* Pregnant or lactating women
* Dyslipidemia, hyperglycemia, or other chronic diseases.
* Subjects who were taking vitamin supplements
Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France

The objective of this study is to review the results of annual radiation doses received by interventional cardiologists and radiologists in France. The results of this study will allow the improvement of classification of interventional cardiology and radiology activities and procedures to help define radiation dose constraints for occupational exposure, according to the number and types of procedures performed.

The study is based on the hypothesis that some specialties in interventional cardiology (cardiology or rythmology procedures) and in interventional radiology (vascular, neuroradiology, osteoarticular) and some types of procedures present greater exposure risks for interventional cardiologists and radiologists. It is expected that the annual radiation dose limits for workers can be exceeded if good practices for both patient and worker radiation protection are not applied. Also, dosimetry equipment used to detect radiation dose although provided to the workers are not systematically worn by the physician during the procedure . The study is likely to show that for an equivalent speciality and number of procedures per type of act, the correct use of collective and personal radiation protection equipment (préciser) will lower occupational radiation exposure of physician . Similarly, for an equivalent activity and number of procedures per type of act , a trained physician would have a lower occupational exposure than an untrained physician. The physician's radiation exposure should therefore increase with a greater number of procedures per type of procedure performed and as the radiation dose delivered to the patient increase. Finally, there would be a different correlation between patient's radiation dose and physician's exposure depending on specialty, procedures, modality, experience and availability and use of collective and personal radiation protection equipment.


Eligibility Criteria:
Inclusion Criteria:

* Physician performing interventional cardiology or radiology procedures with a fixed C-arm system
* Physician systematically wearing at least one of the following personal dosimeters: whole body, extremities, lens.

Exclusion Criteria:

* Physician who did not perform an interventional procedure during the observation period (2019-2021)
* For the primary endpoint by year, physician with more than 3 months of missing data (more than one 3-month period or more than 3 1-month periods)
Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years

This study aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems.

The hydroxyapatite has a local effect which can improve cortical index.


Eligibility Criteria:
Inclusion Criteria:

* 80 years
* 1 year follow-up
* femoral neck fracture

Exclusion Criteria:

* bad-realized radiographs
NAS-NRC Twin Registry

To continue a registry of World War II veteran twins maintained by the National Academy of Sciences-National Research Council (NAS-NRC).

BACKGROUND:

The registry of World War II veteran twins came into existence in the late 1960's through a search and link effort of state vital statistics records and Veterans Administration files through the Medical Follow-up Agency of NAS-NRC. Since that time, the registry has served as a data resource for investigators in a variety of scientific fields who want to study genetic and environmental aspects of various human characteristics. Because of the size and geographic coverage throughout the United States, the registry offers a method of recruiting sizeable numbers of twins for study even under geographic restrictions. Of special value to medical researchers is the built-in medical follow-up for morbidity and mortality through Veterans Administration insurance and benefits records. This allows researchers to gather baseline data which may be related prospectively to morbidity and mortality events.

The NHLBI has made extensive use of the World War II veteran twin registry beginning in 1969, when the NHLBI Twin Study was initiated. At that time, NHLBI used the World War II veteran twin registry to recruit a group of 514 pairs of twins in five geographic areas to participate in a study which included a battery of questionnaires and a physical examination. Since that time, a second examination and third examination of the cohort have been completed and the registry has been used to maintain contact with the twins and provide surveillance for morbidity and mortality events of the participants in the study.

DESIGN NARRATIVE:

Maintenance of the existing registry continued as addresses of all members were updated annually as well as morbidity and mortality data through surveillance of Veterans Administration insurance and death benefit records or through the National Death Index. All morbid events and deaths were coded by ICD codes. Support activities were provided for the NHLBI Twin Study including providing death certificates for events occurring among the 1,028 twins participating in the study and mailed questionnaire follow-up.

Although contract support ended in September, 1988, analyses of the survey and mortality data are continuing.

Eligibility Criteria:
No eligibility criteria