cyrilzakka/clinical-trials huggingface dataset:
Study of the Physical Activity in Anesthesiologists

This study will measure and compare the physical activity of the anesthesiologists during routine daily work in the operating room as determined by the pedometer-counted steps and to estimate the average daily physical activity by using a seven day exercise recall survey.

This study aims to:

1. Measure and compare the physical activity of the anesthesiology residents and attendings during routine daily work in the main operating room as determined by the pedometer-counted steps walked by every individual
2. Estimate the physical activity outside of work by responding to survey of the past seven day exercise recall

The primary objective of this study is to compare the physical activity of resident and attending anesthesiologists. We hypothesize that the attendings will walk more steps than residents at work, but it is possible that the residents will be more active in their spare time. In addition, we hypothesize that the first year residents, likely associated with inefficiency in work pattern, will have more physical activity at work compared to the third year residents. The final objective of this study is to compare the physical activity of these two groups to the recommended guidelines for healthy lifestyle.

We anticipate that this study will provide us with an idea of the physical activity of the 'average anesthesiologist' in USA and will be useful for determining the need of promoting exercise for healthier lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiology residents and attendings scheduled to work in the main operating room for regular day shift who volunteer for the study

Exclusion Criteria:

* Refusal to be enrolled in the study
* Medical conditions which restrict/prohibit exercise, e.g. recent injury, recent surgical procedure, arthritis
* Pregnancy
* Part-time or on call subjects will be excluded, as well as anyone scheduled to work outside the Main Operating Room, e.g. ICU, endoscopy, obstetrics.
Intraoperative Use of Extracorporeal Cytokine Adsorption During Orthotopic Heart Transplantation

There are several factors initiating cytokine storm and dysregulated systemic inflammatory response during cardiac transplantation. This may lead to serious perioperative complications: circulatory collapse, respiratory insufficiency, acute renal and liver failure, multi-organ dysfunction etc.

On the other hand the high level of cytokines may play an important role in the development of graft rejection which is still a relevant problem in this patient group.

There are some new data showing that the use of extracorporeal cytokine adsorber during long cardiopulmonary bypass time (\>120min) may be beneficial to prevent SIRS (Systemic Inflammatory Response Syndrome) with decreasing the level of cytokines in patients undergoing elective cardiac surgery. However there is lack of data and studies regarding the effect of extracorporeal cytokine adsorption during cardiac transplantation.

The aim of the study is to investigate the effect of extracorporeal cytokine adsorber built in the cardiopulmonary bypass circle during heart transplantation. The hypothesis is that removal of cytokines during heart transplantation prevents the development of extreme systemic inflammatory response, hemodynamic collapse dominated by vasoplegia, and contribute to reduce the incidence of severe perioperative complications and early graft rejection.

Patients undergoing cardiac transplantation will be enrolled in the study after giving a written, signed informed consent.

The participants will be randomized into two groups:

* intervention group (30 patients): a cytokine adsorber (CytoSorb®) will be installed into the cardiopulmonary bypass circle during the operation
* control group (30 patients): no cytokine adsorber will be used during cardiopulmonary bypass

The investigators will collect demographic, clinical and laboratory data about patients before, during and after the operation.

The the use of vasopressors and inotropes in the perioperative period, length of mechanical ventilation, ICU and hospital stay, and incidence of perioperative complications, early cellular or humoral graft rejection, and survival will be documented.

The level of cytokines (IL-1, IL-6, IL-10, IL-17, tumor necrosis factor-alfa) and complements before, during and after the use of cardiopulmonary bypass will be determined if the investigators find relevant difference between the two groups in clinical variables.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing heart transplantation
* no medical or mechanical circulatory support straight before transplantation
* age \> 18 years

Exclusion Criteria:

* age \< 18 years
* septic condition (controlled infection) before transplantation
* prolonged hospital stay straight before transplantation
* use of positive inotropes or vasopressors straight before transplantation
* use of mechanical circulatory support straight before transplantation
* acute liver or kidney failure straight before transplantation
* high urgency transplantation
* retransplantation
* the patient declines participating in the study
Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study

There is poor research supporting the benefits of Early Active Controlled Motion (EACM) protocols post operative scaphoid fixation. Advances in surgical fixation technique for scaphoid fractures should allow for start of earlier mobilization, however there is little evidence in the literature that supports the use of these protocols within the early phases of healing. The study uses a pre-experimental design with purposeful sample population recruitment.


Eligibility Criteria:
Inclusion Criteria:

* Date of injury and diagnosis: scaphoid fracture less than 3 weeks old
* Waist fractures in the middle 1/3 and distal pole 1/3 of scaphoid bone.
* Surgical procedure includes ORIF with screw fixation and/or percutaneous pin with screw fixation.
* To be included in the study the patient needs to have started rehab within the first 10 days after surgery date.

Exclusion Criteria:

* Proximal pole scaphoid fracture
* Past medical history of diabetes and other peripheral vascular disorders.
* History of osteopenia and osteoporosis.
* Previously failed ORIF of scaphoid
* Neurovascular or nerve lesion to the involved upper extremity
* Cognitive deficits related to memory, attention span, judgment as documented in the EMR or need for a legal guardian to be a medical proxy
Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients

The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. The study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.

This will be a single center, randomized, double-blind study consisting of two 2-week treatment periods separated by a 5-7 days washout phase without long-acting bronchodilators. Eligible patients who complete the one week screening phase will be randomized to one of two treatment sequences: 1) Formoterol --\> Formoterol + Tiotropium or 2) Formoterol + Tiotropium --\> Formoterol. During the treatment periods, patients will be allowed to use a short-acting beta2-adrenergic+short-acting anticholinergic as rescue medication (salbutamol+ipratropium via MDI)

Eligibility Criteria:
Inclusion Criteria:

* COPD patients aged ≥ 40 years with stable moderate-to-severe airflow obstruction (FEV1 \< 70% and FEV1/FVC ≤ 70% of predicted normal value) post-bronchodilator
* presenting with a long history of smoking (\> 20 pack-years) and chronic breathlessness (Baseline Dyspnoea Index total score \< 9)

Exclusion Criteria:

* significant cardiovascular disease, hospitalization for COPD exacerbation or presence of a respiratory tract infection within 1 month of screening
* current or childhood asthma
* a history of allergic rhinitis or other atopic disease
* inability to interrupt usual bronchodilator medication
* use of oral steroids within a month before screening
* need for long-term oxygen therapy, arterial oxygen saturation \< 85% at rest anemia, hypo- and hyperthyroidism, hyperadrenergic state
* uncontrolled insulin dependent diabetes mellitus, malignancy, or any disease or condition which limits exercise performance other than COPD
* change in inhaled corticosteroid or theophylline use within 1 month prior to screening
Extreme Lipids Repository

This is a prospective, observational study to establish a repository of samples from patients with extreme lipid phenotypes including but not limited to hyperlipidemia, dyslipidemia, hyperlipoproteinemia, extreme low/high HDL levels and deranged lipoprotein metabolism. The investigators plan to conduct sophisticated composition and functional analyses as well as genetic analysis to better understand the determinants of extreme lipid derangements.

Participants will be recruited from clinical encounters within the University of Texas (UT) Southwestern Medical Center and Parkland Hospital by screening the Electronic Medical Record (EMR) for those with lipid labs and values that satisfy criteria for extreme values. Identified participants will be recruited to provide health information via survey, permission to extract clinical information from the EMR, and blood collection for future analyses. Measurements will span direct measurement of circulating species, genetic analyses, and analysis of circulating cells. The blood specimens will be stored for future studies and collaborations and thus, will constitute a blood-based repository. All study procedures are experimental but do not involve an actual intervention.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (age 18 years or older) diagnosed with any lipid or metabolic disorder including hyperlipidemia, dyslipidemia, hyperlipoproteinemia, low HDL levels and deranged lipoprotein metabolism

Exclusion Criteria:

* Anyone under 18 years of age will be excluded from the study.
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years

The main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography.

The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.

For usual follow-up visit, patients will have a x-ray examination of the spine and the surface topography. The measurement of the angle of scoliosis is achieved by two independent operators for both methods.

Patients then have a follow-up visit at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient with idiopathic scoliosis,
* Body mass index BMI below or equal to 25,
* Cobb angle measured on radiographs between 10 and 25 degrees,
* Parental authorization.

Exclusion Criteria:

* Patient with secondary scoliosis (neurological, Prader Willi syndrome...)
Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

This study evaluates the prognostic value and potential therapeutic impact of combined pressure and flow measurements in the evaluation of epicardial coronary stenosis and microvascular function.

ILIAS registry is a global effort to gather lesion-level data on the diagnostic and prognostic value of combined coronary pressure and flow measurements in clinical practice. Data is gathered from 7 nations (The Netherlands, Korea, Japan, Spain, Italy, Denmark, USA), using either coronary Doppler velocity measurements or coronary thermodilution measurements to obtain invasive coronary flow assessment. Patient treatment was governed by the local clinical practice guidelines at the time of the invasive procedure, but was at the operator's discretion. A standardized data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel evaluation was used.

Eligibility Criteria:
Inclusion Criteria:

* underwent combined measurements of coronary pressure and flow for at least 1native coronary artery

Exclusion Criteria:

* hemodynamic instability
* culprit vessel of acute coronary syndrome
Social-LEAF Life Enhancing Activities for Caregivers

This study examines a behavioral intervention to improve social connection and reduce loneliness for caregivers of a loved one with Dementia with Lewy Bodies (DLB).

The objective of the Social-LEAF study is to examine psychological mechanisms whereby Social LEAF delivered in a group and via video call reduces loneliness and improves positive emotions for older caregivers of loved ones with DLB. This is an 18-month Stage 2 study examining Social LEAF, which is strengths-based and teaches positive coping skills focused on improving social relationships and is delivered remotely in a group format. These two adaptations to the original LEAF intervention are included to provide a more potent means of improving social connection. A pilot phase with up to 20 caregivers (Aim 1) will address these adaptations regarding feasibility, acceptability, and signal for reducing loneliness, with refinements as needed. A second phase (Aims 2 and 3) will involve a randomized trial comparing Social LEAF to control (30 caregivers in each arm) on loneliness (primary outcome), positive affect (mechanism), and social engagement (mechanism). Data will also be collected on acceptability and perceived benefits using mixed methods.

Aim 1 is to refine the LEAF intervention to target social relationships and loneliness.

Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers.

Aim 3 is to examine efficacy of Social LEAF in reducing loneliness, increasing positive affect, and increasing social engagement.

Eligibility Criteria:
Inclusion criteria:

* Must be a primary care partner of a person that has been clinically diagnosed with Dementia with Lewy Bodies (DLB) or Parkinson's Disease Dementia, and has access to high-speed internet connection at home or in a location where they can speak privately with a facilitator. iPads and a hotspot will be given to those who lack internet and a sufficient mobile device but show willingness to participate. The iPads and hotspot will be returned to the study team once study procedures have concluded. Must be willing and ready to begin the intervention either immediately or in 6 weeks depending on which group they are randomly selected to be in.
* Must begin LEAF procedures as soon as consented to the study. Has not taken part in Aim 1 of the study.
* Will have waited the 6-week period before starting LEAF procedures after consenting and has not taken part in Aim 1 of the study.

Exclusion Criteria:

* Not a primary care partner of a person with DLB. Is a primary care partner of someone who has not been clinically diagnosed with DLB. Cannot speak English or provide clear and concise consent to the project.
* Has not started LEAF procedures at the beginning and has taken part in Aim 1 of the study.
* Has started/taken part in the LEAF procedures at the beginning and also has taken part in Aim 1 of the study.
A Double-blind Evaluation of Adverse Effects of Bath With Wipes Impregnated With 2% Chlorhexidine Versus Placebo

Traditional bed bathing have been related to cross-infection. In order to avoid this complication, single-use products such as wipes impregnated with chlorhexidine use is increasing. Nevertheless among nursery staff concern about its side effects prevents its widespread use. The investigators want to know if there are any differences between the use of 2% chlorhexidine wipes and a placebo concerning side effects.

Hygiene is part of health recovery in patients, nevertheless in unconscious or sedated patients this procedure becomes a task for the nursing staff. Traditional soap and water bed bath is becoming obsolete as soap could induce skin injuries due to changes in the pH of the skin and furthermore, almost every items used for this procedure could be a reservoir for pathogens, and therefore could lead to infection. Nowadays single-use products are a new option for prevent cross-infections. Nevertheless, traditional bed bathing is a tightly established practice among nursing staff. New evidence about side effects and comfort by wipe bed bathing is needed.

Chlorhexidine impregnated wipes have been used to perform the bed bathing in severe ill patients, as it can protect them from infections. The aim of this study is to determinate if bed bathing with 2% chlorhexidine impregnated wipes has a similar effect that a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteer

Exclusion Criteria:

* History of skin allergies or atopy, as well as reactions to soaps or chlorine compounds.
Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury

Acquired brain injury can result in impaired everyday functioning as well as psychosocial problems, including depressive symptoms, irritability, or negative self-concept. The purpose of this study is to determine whether a combination of neuropsychological and cognitive behavioral therapy is effective in the treatment of these sequelae.

Acquired brain injury (ABI) commonly results in persistent cognitive, emotional and motivational problems. About 50% of patients involved develop psychiatric illness, most likely in the first year following ABI, which is associated with reduced psychosocial functioning and less favorable rehabilitation outcome. Treatment of these complex conditions requires a combination of neuropsychological and psychotherapeutic intervention techniques.

This study aims at evaluating a combination of neuropsychological intervention methods, which include developing and using compensation strategies for cognitive impairments (attention, memory and executive functions), and psychotherapeutic intervention focusing on emotion regulation, developing positive self-concepts and adjustment of life-goals. These therapeutic interventions are modularized and patients are assigned to intervention modules according to results of objective neuropsychological testing and interviews.

Eligibility Criteria:
Inclusion Criteria:

* Having suffered an acquired brain injury after the age of 14, such as traumatic brain injury, neoplasm (after surgery), toxic brain damage, or brain damages through inflammatory diseases
* Being at least 3 months post injury
* Being German-speaking
* Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

* Suffering from recurrent, degenerative, or progressive neurological diseases (e.g. multiple sclerosis, dementia, Chorea Huntington)
* Current or past psychosis or bipolar disorder
* Current or past diagnosis of substance dependency
* History of mental retardation
* Currently in psychotherapy
* Severe lateralized disorder (e.g. aphasia, neglect)
* Lacking minimum basic skills for attending therapy (e.g. not orientated to person, place, time, and events; unable to sustain attention for an hour-long session; cannot state cognitive strengths and weaknesses; cannot state areas in everyday functioning that are impaired due to the acquired brain injury)
Evaluation of Efficacy and Safety of AGP on Immune Enhancement

The researchers investigated the immune enhancing effects of AGP for Korean participants.

The aim of the study is to investigate the effects of AGP on immune enhancement based on 8 week, randomized, double-blind, placebo-controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* The levels of white blood cells within range 3x10\^3/μL\~8x10\^3/μL
* have had at least two cold in the last 12 months.

Exclusion Criteria:

* subjects with BMI\<18.5 kg/m\^2
* subjects taking medications such as immune related drug or functional foods
* history of disease that could interfere with the test products or impede their absorption
* pregnant or lactating women and heavy smokers.
* being judged by the responsible physician of the local study center as unfit to participate in the study
Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.

This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory effects of QAX028 compared to tiotropium and placebo in mild-to-moderate COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 40-75 years with diagnosis of mild or moderate COPD
* Current or X-smokers with a smoking history of \>10 pack-years.
* Screening ipratropium post-bronchodilation FEV1 at 1 h post-dose will be greater than 50% of the normal predicted FEV1 value.

Exclusion Criteria:

* Patients who can not comply with the following washout periods for standard

COPD treatments as follows should be excluded:

* Short-acting bronchodilators
* Long-acting bronchodilators
* Inhaled steroids

Other protocol-defined inclusion/exclusion criteria may apply.