Kornimate/medical-research-clean huggingface dataset:
study of the combination of acalabrutinib (acp-196) and pembrolizumab in advanced head and neck squamous cell carcinoma

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: study of the combination of acalabrutinib (acp-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * histologically or cytologically confirmed recurrent, metastatic or unresectable hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy * presence of radiographically measurable disease as defined by recist 1.1 * ecog performance status of 0 or 1 exclusion criteria: * prior malignancy (other than hnscc), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years * known central nervous system metastases and/or carcinomatous meningitis * a life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug
healthcare worker resilience as measured by physiologic feedback

Conditions: Burnout, Professional

Summary: reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. decreased sleep and recovery has physiologic consequences which can be measured using biometric data. the goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors including mindfulness training and diet can maximize recovery and performance. the goal of this study is to quantify the impact if modifiable daily behaviors including sleep, nutrition, in order to understand the factors that contribute to high level performance, burnout, and physician wellbeing in surgical trainees and attendings.

informed consent will be obtained prior to participation in the research study. a member of the research team will provide the participant with the consent form and allow them adequate time to read and ask questions prior to giving consent. if consent is not obtained, the participant will not be allowed to participate in the research study. participants will be asked to wear a biometric sensor for six months. the biometric sensor (the whoop strap) collects heart rate, heart rate variability, activity, and sleep metrics. half of the participants will complete coaching to improve resilience with arena strive and half will be a control group instructed that sleep is important. in the latter 3 months of the study, the control group will have the opportunity to wear a continuous glucose monitor. at the completion of the study period all participants will have access to arena strive coaching. other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, glucose levels using continuous glucose monitoring, exercise and mindfulness.

Eligibility criteria:
inclusion criteria: * study participants will include full time clinically active healthcare workers exclusion criteria: * exclusion criteria will be anyone who is not a full-time clinical healthcare worker
influence of kinesiology taping application on severity of signs and symptoms in breast engorgement.

Conditions: Lactation Disorders

Summary: the aim of the research is to asses the efficacy of kinesiology taping application in breast engorgement in early postpartum stage. kinesiology application will be performed by women's health physiotherapist. patient's perceived improvement and milk outflow following application will be assessed.


Eligibility criteria:
inclusion criteria: * cesarian section or vaginal delivery * delivery between 37 and 41 gestational week * signs and symptoms of breast engorgement (significant increase of breast between 2nd and 10th day postpartum, pain, obstructed milk outflow) * vas 4 and more * volume of milk outflow less than 20ml * 6 point self-rated engorgement scale between 3 and 6 exclusion criteria: * age less than 18 and more than 45 * patients after extensive surgical breast intervention or having breast implants * allergy to kinesiology taping
relationship between the risk of falls and frailty, and the effect of a physical exercise program on these conditions in the elderly: a randomized crossover clinical trial.

Conditions: Frail Elderly Syndrome; Fall

Summary: the goal of this randomized crossover clinical trial is to examine the effectiveness of a new therapeutic exercise program in elderly patients with risk of falls and physical fragility. the main questions it aims to answer are: * if the therapeutic exercise program proposed is a successful treatment for this kind of patients * if patients at risk of falls also suffer from pre-frailty or frailty, and if they can be treated together with the proposed therapy. participants will follow a program consisting of exercises to correct posture, gain strength and contribute to greater balance. researchers will compare the therapy and control groups to see if the program increases the percentage of muscle mass of participants, their mobility, balance, quality of life and if they reduce their fried´s frailty criteria, fear of falling and falls compared to their usual physical activity.


Eligibility criteria:
inclusion criteria: * community dwelling older adults. * independent for ambulation. * with a cognitive state that do not prevent understand the researcher indications. * not performing regular physical exercise (only basic activities of daily living, but no other type of intervention). exclusion criteria: * contraindication of physical exercise. * evident impaired cognitive state. * vestibular or central nervous system affection. * can´t speak and understand spanish correctly.
smilda - symbicort®turbuhaler® allergan challenge study in allergic patients with mild asthma

Conditions: Asthma

Summary: to compare the effects of formoterol alone (oxis® turbuhalerò) and the fixed combination of formoterol and budesonide (symbicort® turbuhalerò) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma


Eligibility criteria:
inclusion criteria: * a diagnosed history of asthma for at least 6 months * mild and stable asthma, only using β2-agonists as needed for the last 4 weeks. * fev1 \>70% of predicted normal value (post-bronchodilator value). * skin prick test positive to pollen, animal dander or house dust mite. exclusion criteria: * any significant respiratory disease, other than asthma. * upper or lower respiratory tract infection within 4 weeks before inclusion. * use of: 1. inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma. 2. inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening. 3. regular nsaids

Keywords: asthma allergen challenge airway responsiveness airway inflammation symbicort®
gore propaten vascular graft vs. disadvantaged autologous vein graft

Conditions: Peripheral Arterial Occlusive Disease

Summary: the primary patency of the gore propaten vascular graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.

primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. a disadvantaged autologous vein is defined as meeting at least one of the two following criteria: (1) any autologous vein(s) other than greater saphenous vein deemed usable by the investigator; (2) usable ipsilateral or contralateral autologous greater saphenous vein that meets any of the following criteria: (a) diameter of less than or equal to 3.0 mm; (b) inadequate length requiring splicing; (c) poor quality vein that is either sclerotic or phlebitic.

Eligibility criteria:
inclusion criteria: 1. patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease. 2. patient meets the disadvantaged autologous vein criteria described in section 4.1. 3. patient has a post-operative life expectancy greater than one year. 4. patient is at least 21 years of age. 5. patient is able to comply with all study requirements and be available for follow-up visits at 1, 6, 12, 24 and 36-months post-procedure. 6. patient is willing and able to provide written, informed consent. exclusion criteria: 1. patient has had a previous instance of heparin induced thrombocytopenia type 2 (hit-2) or has known hypersensitivity to heparin. 2. patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease. 3. patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts. 4. patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. however, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure. 5. patient has been previously randomized for this study. 6. patient has active infection in the region of graft placement.
exercise to improve balance in older adults with hearing impairment - a proof-of-concept study

Conditions: Hearing Loss; Gait, Unsteady; Balance; Distorted; Old Age; Debility

Summary: hearing impairment is common in older adults, and recent research points to associations between hearing impairment and balance/mobility. the association may be due to more attentional resources being used to compensate for the sensory loss, with less resources available for maintaining balance. the aim of this projects is therefore to investigate whether an exercise program with focus on motor-cognitive tasks is feasible for older adults with hearing impairment. the study is meant as a proof-of-concept study, where trialling will be evaluated, and results will be used to inform the design of a larger and adequately powered study.

study design: this is an experimental (exercise) study with follow-ups three and twelve months after exercise completion. participants: participants will be recruited from two instances: * "praksisnett", which is a collaboration between gps and researchers in bergen, norway, where gps recruit potential participants to research projects. * the ear, nose, throat department at haukeland university hospital (bergen), who provide service to older adults with hearing impairment. the aim is to include 60 patients into three intervention arms: i) virtual reality exercises, ii) vestibular rehabilitation exercises and usual care intervention arms: * virtual reality exercises: participants will exercise in virtual environments twice weekly. the choice of environments/tasks will be individualized, and progress from sitting/standing exercises, to doing exercises while walking on a treadmill. the aim is to perform cognitive and motor tasks simultanously. * vestibular rehabilitation exercises: this is an exercise approach that has been used in clinical groups, such as patients with vestibular disorders and traumatic brain injury. the aim is to perform movements/exercises where the participant is exposed gradually to movements that may be provocative for the vestibular system. the exercises will be done in a movement lab at western norway university of applied sciences. participants will be randomised to either of the three intervention arms using a computerized procedure. neither participants, testers or deliverers of the intervention will be blinded. testers and intervention deliverers will be physiotherapists, students enrolled in a master program in clinical physiotherapy and bachelor students in physiotherapy.

Eligibility criteria:
inclusion criteria: * hearing threshold above 30 db exclusion criteria: * inability to give informed consent, * inability to speak scandinavian languages or english * diseases with severe motor impairments (such as mb parkinsons)
sym004 in subjects with stage iv non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a multi-center, open-label, phase 1b, dose escalation trial of sym004 administered in combination with 1 of 3 platinum-doublets in subjects with stage iv non-small cell lung cancer (nsclc). the sponsor decided to discontinue the development of sym004. also the decision was made to discontinue the development of sym004 in nsclc indication. the decision to discontinue sym004 in nsclc was not related to any safety or efficacy findings regarding sym004. as a result of the early discontinuation of the trial during the dose escalation part, the expansion cohort will no longer be performed hence the pre-specified secondary endpoints are not analyzed and were removed from the protocol based on protocol amendment 2 dated 31 march 2015.


Eligibility criteria:
inclusion criteria: * male or female outpatients (except where inpatient stay is required for medical need at the investigator's discretion) at least 18 years of age at the time of informed consent * histologically-confirmed nsclc stage iv disease (according to the seventh edition of the lung cancer staging system) * eligibility for platinum-based chemotherapy * tumor tissue available for epidermal growth factor receptor (egfr) expression analysis * measurable disease defined as 1 or more target lesions according to response evaluation criteria in solid tumors version 1.1 (recist 1.1) * life expectancy of at least 3 months * eastern cooperative oncology group (ecog) performance status less than or equal to 1 * other protocol defined inclusion criteria could apply exclusion criteria: * previous therapy for stage iv nsclc, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months * previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment * in countries where anaplastic lymphoma kinase (alk) inhibitors are available for the treatment of nsclc, subjects need to have been screened for alk fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (tki) therapy * in countries where egfr tkis are available for the treatment of nsclc, subjects need to have been screened for egfr mutations and excluded if positive, unless previously treated and progressed on an appropriate tki therapy * concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement) * known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology * history of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix) * other protocol defined exclusion criteria could apply

Keywords: carcinoma, non-small-cell lung sym004
3d echocardiography managing infantile pompe's disease

Conditions: Congenital Disorders

Summary: pompe's disease, also known as glycogen storage disease type ii, is a genetic disorder due to deficiency of acid glucosidase (gaa), which results in lysosomal glycogen storage in various tissues. very low levels of gaa usually present in infancy, lead to a progressive cardiac and skeletal muscle disorder and death before age 1 year. most infants develop massive hypertrophic cardiomyopathy which progresses to dilated cardiomyopathy and cardiorespiratory arrest. 3d echocardiography can be a simple, non-invasive method of following cardiac disease progression in infantile pompe's disease.

we report the utilization of real-time 3d echocardiography and new in-line software to calculate cardiac mass, volume and function in two cases of infantile pompe's disease. furthermore, the multi-dimension cine loop showed the severity of cavity obliteration during the cardiac cycle. we present 2 cases seen at our institution between january - february, 2005 in infants ages 1 and 5 months, both with cardiac signs as initial presentation. the younger infant had cardiomegaly since birth and was hospitalized briefly for respiratory distress at 1 month. the older infant, diagnosed at 4 months with hypertrophic cardiomyopathy, was hospitalized after cardiac arrest one month later. both children had various tests done during the course of diagnosis and treatment, including gaa enzyme assay, cardiac catheterization, endomyocardial biopsy, developmental assessment, genetic evaluation, ekg, cxr and echocardiography.

Eligibility criteria:
inclusion criteria: * infant seen at children's healthcare of atlanta, egleston january - february, 2005 infantile pompe's disease exclusion criteria: * those who do not meet inclusion criteria

Keywords: pediatric cardiac infantile pompe's disease 3d echocardiography
evaluation of sbrt for patients with locally advanced unresectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the aim of this phase ii study is to assess the efficacy and safety of sequentially integrated treatment of folfirinox or gemcitabine-abraxane and sbrt in patients with unresectable pancreatic cancer.

the aim of this prospective mono-institutional phase ii study is to assess the efficacy and safety of sequentially integrated treatment of folfirinox or gemcitabine-abraxane and sbrt with a total dose of 54 gy in 6 fractions of 9 gy /fractions in patients with locally unresectable pancreatic cancer. primary endpoint is to evaluate overall survival (os); the overall survival time will be calculated from the start of chemotherapy to death. secondary end points are to evaluate acute and late toxicities, freedom from local progression (fflp) and progression free-survival (pfs). acute and late toxicities will be scored according to the nci common terminology criteria for adverse events (ctcae) v3.0. local progression will be defined according to recist criteria. time to toxicity and time to local or distant progression will be defined from the start of chemotherapy. technical success will be defined as the ability to implant at least 2 fiducials in the tumor area. migration will be defined as a change in inter-fiducial distance. clinical success will be defined as the ability to guide the application of sbrt by using the fiducials. any adverse event will be recorded (acute pancreatitis, clinically relevant upper gi bleeding requiring blood transfusion, abscesses in the area of the fiducials, sepsis).

Eligibility criteria:
inclusion criteria: * histologically and/or radiologically (ct scan and/or mri scan and/or fdg-pet) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board. * eighteen years of age or older, * minimum karnofsky performance status of 70. * lesions cannot exceed 5 cm in maximum diameter. * absence of lymph-nodal metastases * patients received 4-6 months of folfirinox or gemcitabine-abraxane before sbrt was administered. * baseline total body ct scan performed no more than 2 months before treatment. * placing fiducial markers through endoscopes is permitted (eus-guided fiducials placement before the treatment). * acceptable organ and bone marrow function. * ability to maintain the set-up position during rt. * all patients give informed consent and sign a study-specific informed consent form. exclusion criteria: * metastatic disease * prior abdominal radiotherapy * other malignancies diagnosed within 5 years * gastric or duodenal obstruction. * concurrent chemotherapy.
effectiveness of a cbt-based mhealth intervention targeting moud retention, adherence, and opioid use

Conditions: Opioid-use Disorder

Summary: the focus of this study is to examine the effectiveness of imfree relative to mhealth ed in facilitating treatment retention and adherence and reducing opioid use among adults with oud initiating bup treatment. there are two specific aims: (1) to test the effectiveness of imfree, delivered in conjunction with medical management with buprenorphine (imfree + mm), relative to mhealth ed + mm, in facilitating buprenorphine treatment retention and adherence in a population of individuals with oud initiating mm (n=200). (2) to evaluate the cost-effectiveness of imfree.


Eligibility criteria:
inclusion criteria: * age \> 18 * dsm-5 diagnosis of oud * no more than 2 weeks from the date of bup induction * able to read and comprehend english at the 6th grade level (determined by realm) * able to provide informed consent * presently owns a mobile phone that can send and receive text messages exclusion criteria participants must not have: 1. life threatening or unstable medical illness requiring treatment or making participation difficult 2. dependence on alcohol or other illicit substances for which medical detoxification is imminently needed 3. presence of acute psychiatric symptoms warranting intensive treatment or hospitalization (e.g., acute suicidality or mania).
dce-mri and dwi for detection and diagnosis of breast cancer

Conditions: Breast Cancer; BIRADS 3; BIRADS 4; BIRADS 5

Summary: a type of magnetic resonance imaging called diffusion weighted imaging (dwi) will be tested to define cancerous from non-cancerous lesions in the breast.

for this study, the investigators plan to evaluate dwi scans performed in women with breast lesions identified by conventional breast mri. the investigators will determine whether an adc threshold can be defined for distinguishing benign and malignant lesions on dwi, assess the difference in adc cutoffs for mass and non-mass lesions, and investigate the potential improvement in accuracy using techniques such as nonzero minimum b-value (to remove perfusion effects in the adc measures) and normalized adc measures (to account for variations in water content and other factors).

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent; * 18 years of age or older; * successful completion of breast mr examination with dwi required by protocol; * undiagnosed breast lesion (bi-rads 3, 4, or 5) identified on mri. the bi-rads assessment must refer to a focal finding within the breast (i.e. mass, non-mass, or focus) as opposed to diffuse processes (e.g. background parenchymal enhancement, skin thickening) or lesions outside the subcutaneous breast (e.g. axillary lymph nodes, focal skin lesions, osseous lesions, etc.). exclusion criteria: * participants with current or recent history (within 6 months prior to the mri) of chemotherapy for cancer; * neoadjuvant chemotherapy between mri and confirmation of lesion outcome (study lesions must be biopsied prior to undergoing any chemotherapy); * pregnant (if a female is of childbearing potential - defined as a pre-menopausal female capable of becoming pregnant - confirmation of pregnancy status per the site's standard of practice should be done prior to mri); * unwilling or not suitable to undergo mri or use the contrast agent gadolinium.

Keywords: breast cancer diagnosis malignant benign biopsy