Kornimate/medical-research-clean huggingface dataset:
3-5 fraction stereotactic body radiation therapy for palliation of head and neck squamous cell carcinoma: the fast phase ii randomized trial

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: to learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "sbrt") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.

objectives: * to compare local progression-free survival following palliation with sbrt versus traditional fractionations in patients with hn scc deemed ineligible for curative-intent treatment. * to compare pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between the treatment modalities.

Eligibility criteria:
inclusion criteria: * age 18 or older * willing to provide informed consent * histologically confirmed squamous cell carcinoma * primary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site) * ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization) * prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physician * metastatic disease is permitted exclusion criteria: * contraindications to radiotherapy * pregnant or lactating women 5.0 pre-treatment evaluation * history and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization. o clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment * documentation of smoking history * staging imaging within 12 weeks prior to randomization: * contrast-enhanced ct of the neck and chest or * mri of the neck with ct of the chest or * whole body pet/ct * histological confirmation of squamous cell carcinoma * pregnancy test for women of child-bearing age, within 2 weeks prior to randomization * assessment of all baseline symptoms, using ctcae version 5.0 within 2 weeks prior to randomization. * assessment of baseline pain score (nrs) and analgesic use (non-opioid and opioid) * completion of qol scoring within 2 weeks of randomization * informed consents must be obtained prior to any study specific activities
possible therapy by phone for caregivers

Conditions: Anxiety; Anxiety Disorders and Symptoms; Caregiver Burnout

Summary: caregivers of adults with dementia report higher stress, including anxiety and depressive symptoms, burden, and existential suffering, than caregivers of people with other chronic diseases.

acceptance and commitment therapy (act) is a behavioral intervention designed to increase psychological flexibility in the face of challenges. the investigators are trying to determine proof of concept that suggests that act is effective in reducing anxiety and associated psychological distress in dementia caregivers. this study will recruit n=20 dementia caregivers to receive 6 weekly 1-hour telephone-based act sessions

Eligibility criteria:
inclusion criteria: * 21 years or older * able to communicate in english * able to provide informed consent * listed as primary caregiver in the chart of a patient with alzheimer's disease or related dementia (dard) * intends to continue caregiving form adrd patient for at least 12 months or greater * clinically elevated anxiety score (score of 10 or higher on gad-7) exclusion criteria: * non-family member of the adrd patient * has adrd or other serious mental illness diagnosis such as bipolar or schizophrenia as determined by icd-10 code

Keywords: alzheimer's disease dementia caregiving caregiver anxiety acceptance and commitment therapy telehealth
investigation of the response relationship of nn5401 in type 1 diabetics

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial was conducted in europe. the aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of nn5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes. the trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of nn5401 and biphasic insulin aspart, respectively.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmhg for systolic or 50-90 mmhg for diastolic * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
carotid ultrasound under pulsed-wave doppler mode to check the pulse in cardiopulmonary arrest patients.

Conditions: Cardiac Arrest

Summary: it's crucial to determine whether a pulse is present or not in patient with cardiac arrest. but more and more studies have shown that manual palpation is unreliable for detecting pulse 1-4. failure to detect pulselessness may cause delay of chest compression and directly affect the patient's outcome. likewise, failure to rapidly detect return of spontaneous circulation may cause prolonged chest compression and increase associated injury during resuscitation. more and more studies have demonstrated that echo guided pulse detection is feasible 5-7. the aim of our study is to check carotid pulse via ultrasound. this is a prospective study and the patient selection is in-hospital or out of hospital cardiac arrest. a curvilinear ultrasonography transducer is used and placed transversely on either right/left carotid artery under pulsed-wave doppler mode to check whether the pulse is present or not. the result of ultrasonography will be compared with manual palpation and to determine the accuracy and effectiveness of clinical usage.


Eligibility criteria:
inclusion criteria: * any patient presenting at er with cardiac arrest older than 20 years-old exclusion criteria: * younger than 20 years-old * patient who is pregnant
assessing a novel virtual environment that assists with activities of daily living

Conditions: Dementia; Alzheimer Disease; Neurodegenerative Diseases

Summary: this phase 1 study looks at how a new videogame-based program can help residents and care partners prepare for adls in a fun way with minimal risk, potentially reducing escalating problems associated with adl completions.

central themes in person-centered care are dignity/respect/choice for the care recipient. this phase l clinical study is a minimal risk study that focuses on how the new technology can support and amplify these principles, while assisting care staff. the investigators will use a novel digital health device developed with user-centered design principles, mirroring a range of evidence-based non-pharmacological interventions for people living with alzheimer's disease and its related dementias (ad/adrd). this is a purpose-built virtual world depicting activities of daily living (adls). it contains interactive engagement stimuli, including customized digital artifacts that hold meaning to the person. the investigators hypothesize that undertaking adl-related virtual activities will support completions of actual adls, thereby increasing effectiveness and improving care outcomes. aim 1: feasibility successful outcomes are \>55% participation rate and a statistically significant difference between assessments of participation and non-participation, indicating tolerability and acceptability of routine interventions. aim 2: effectiveness successful outcomes are: * a reduction in adl-related care challenges compared to baseline * reduced time spent on the evening adls compared to baseline * a reduction in negative response behaviors associated with the adl * greater interest in the adl * a positive shift in care staff attitudes

Eligibility criteria:
inclusion criteria: the subject will have a diagnosis of ad/adrd, or symptoms of an undiagnosed ad/adrd as observed by professional care staff and confirmed by the head of clinical care. the investigators will neither include nor exclude participation based on cognitive test scores. the subject will have had challenge(s) completing one or more adls in the previous month, as discussed at staff meetings, referenced in care plans, or observed/experienced by direct care staff. other specifications: * understand english or russian. * can sit comfortably for at least 15 minutes in a chair/wheelchair at a table or propped up in bed or princess chair with a tray table * are not known to be in pain * have good vision, or good corrected vision (i.e., glasses) * have good hearing, or good corrected hearing (i.e., aids) * may sometimes have anxiety or agitation when undertaking adls. exclusion criteria: ineligible subjects are those with significant non-ad/adrd neurological, psychiatric, or physical impairment or those who are totally dependent upon others for adls.

Keywords: technology dementia alzheimer's disease virtual behavioral cognitive immersive caregiver digital health videogame memory non-pharmacological
comparison of robot-assisted laparoscopic myomectomy with traditional laparoscopic myomectomy

Conditions: Uterine Myoma

Summary: this study is to reveal any potential advantage of robot-assisted laparoscopic myomectomy (rlam) over traditional laparoscopic myomectomy (tlm) by comparing the perioperative variables and short-term outcome of ralm and tlm patients.

all patients with symptomatic uterine myomas who underwent traditional laparoscopic myomectomy or robotic laparoscopic myomectomy were enrolled.

Eligibility criteria:
inclusion criteria: * cases with uterine myoma
endovascular management of pediatric intracranial arteriovenous shunts

Conditions: Arteriovenous Malformations; Arteriovenous Fistula

Summary: * review the outcomes of the endovascular management of pediatric intracranial arteriovenous shunts. * give an effective treatment for pediatric intracranial arteriovenous shunts and can detect the best method could be used and assess safety and efficacy of different endovascular techniques in treatment of different av shunts. * improve the outcome of these patients and decease rate of recurrence and complications.

intracranial arteriovenous shunts (icavs) in young children are characterized by frequent high-flow fistulas. in association with high-flow fistulas and the physiological condition of the developing brain and heart, each icavs type tends to present at a certain age with unique symptoms. vein of galen aneurysmal malformation (vgam) and dural sinus malformation with arteriovenous (av) shunt tend to present in the neonate with high output cardiac failure. in infancy, vgam, pial arteriovenous fistula (avf) and infantile dural avf (davf) tend to present with hydrodynamic disorder such as macrocephaly, ventriculomegaly, prominent facial veins, and developmental delay. pial avf, av malformation, and infantile davf can present with focal neurological signs such as seizure or hemorrhage at older ages they are in the subpial space, as opposed to vgam or davf, which are extrapial in location and tend to present with systemic symptoms . endovascular treatment is currently the first choice of treatment for most pediatric icavs. the treatment goal should be defined on a patient-by-patient basis, according to the unique physiological condition of the child.

Eligibility criteria:
inclusion criteria: * 1- clinical manifestation of av shunt according to the pathology with radiological diagnosis by ct angiography or mra 2- patient must be under 18 years old exclusion criteria: 1. any patient above 18 years old 2. asymptomatic patients
pharmacokinetic study comparing budesonide/formoterol easyhaler and symbicort turbuhaler forte

Conditions: Asthma

Summary: the purpose of this study is to compare the test product budesonide/formoterol easyhaler with the marketed product symbicort turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility criteria:
inclusion criteria: 1. written informed consent (ic) obtained. 2. males and females, 18-60 (inclusive) years of age. exclusion criteria: 1. evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gi, pulmonary, metabolic-endocrine, neurological or psychiatric disease. 2. any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. 3. any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. 4. known hypersensitivity to the active substance(s) or the excipient of the drug. 5. pregnant or lactating females.
the effects of metformin on morbidity and mortality in elderly patients

Conditions: Burns

Summary: elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.glucose metabolism with insulin resistance is a hypermetabolic response pathway that profoundly affects post-burn outcomes. the aim if this study is to determine whether metformin can improve morbidity and mortality in elderly burn patients. the investigators hypothesize that metformin will improve clinical outcomes and mortality of elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burn.


Eligibility criteria:
inclusion criteria: 1. aged 60 - 99 years of age. 2. ≥5% total body surface area (tbsa) burn. 3. admitted to burn center ≤ 120 hours post-burn injury. 4. at least one surgical intervention likely required. 5. provide written informed consent. exclusion criteria: 1. death upon admission. 2. decision not to treat due to burn injury severity. 3. presence of anoxic brain injury that is not expected to result in complete recovery. 4. pre-existing renal failure (egfr is \< 30 ml/min). 5. severe liver disease (child-pugh c). 6. pre-existing insulin-dependent type ii diabetes. 7. clinical contraindication to give metformin. 8. allergy to metformin or insulin. 9. history of lactic acidosis while receiving metformin treatment.
the effect of occupational therapy on anxiety, depression, and psychological well-being symptoms in the elderly: a single-blind randomized-controlled study

Conditions: The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly

Summary: participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. all participants were first informed about the study and their informed consent was obtained. participant information form, geriatric anxiety scale, psychological well-being scale, and geriatric depression scale were filled out by all participants. the elderly in the intervention group were divided into 5 groups of 10 and a time was determined for the session in cooperation with the participants in each subgroup. a 60-minute therapy session was administered by the occupational expert. the applications were carried out in a total of 7 sessions as a daily session. the control group was not subjected to any application. geriatric anxiety scale, psychological well-being scale, and geriatric depression scale were refilled for the second time in all elderly on the 7th day after the application.

participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. all participants were first informed about the study and their informed consent was obtained. participant information form, geriatric anxiety scale, psychological well-being scale, and geriatric depression scale were filled out by all participants. the elderly in the intervention group were divided into 5 groups of 10 and a time was determined for the session in cooperation with the participants in each subgroup. a 60-minute therapy session was administered by the occupational expert. the applications were carried out in a total of 7 sessions as a daily session. the control group was not subjected to any application. geriatric anxiety scale, psychological well-being scale, and geriatric depression scale were refilled for the second time in all elderly on the 7th day after the application.

Eligibility criteria:
inclusion criteria: * the elderly, who agreed to participate in the study, * were aged 60 and over, were cooperative, * had no communication problems, * and did not receive any training, course, or practice on coping with anxiety, tension, and stress were included in the sample. exclusion criteria:
epigenomic and machine learning models to predict pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the goal of the multicentric and interdisciplinary imagene project is to pursue early diagnosis for pancreatic cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (crpa) as a clinical support tool to calculate a personalized risk profile. the study is a longitudinal, non-randomized exploratory clinical study. a total of 170 asymptomatic first-degree relatives of pc patients.

the study is a longitudinal, non-randomized exploratory clinical study. a total of 170 asymptomatic first-degree relatives of pc patients. the study population consists of 170 first (1st) degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer, where the patient satisfies one or more of the following conditions: * was diagnosed with pancreatobiliary cancer \<50 years of age; * was diagnosed with pancreatobiliary cancer \>50 years of age and personal history of any solid cancers. the crpa will be assessed in 170 first degree relatives of pc patients, in whom the development of pancreatic cysts will be assessed by wb-mri at baseline and at one year.

Eligibility criteria:
inclusion criteria: * 1st degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer, where the patient satisfies one or more of the following conditions: * was diagnosed with pancreatobiliary cancer \<50 years of age; * was diagnosed with pancreatobiliary cancer \>50 years of age and personal history of any of the following cancers: breast cancer, ovarian, fallopian tube or primary peritoneal cancer, melanoma, colorectal cancer, endometrial cancer, prostate cancer, oesophagogastric cancer, urinary tract cancer, small bowel cancer, brain tumour, sebaceous skin tumour; * was confirmed diagnosis of any of the following conditions in the family: hereditary breast and ovarian cancer, peutz-jeghers syndrome, hereditary pancreatitis, lynch syndrome, familial atypical multiple mole melanoma syndrome; * significant family history in first degree relatives for cancer (e.g. two or more cancers in one individual or the same cancer in more individuals; * a single 1st degree relative with pancreatic cancer; * being a patient alive after 5 years from diagnosis (cancer free or currently treated). * cancer free at the time of enrollment; exclusion criteria: * individuals with comorbidities that adversely influence their ability to tolerate the screening procedures or the screen-detected findings, or tolerate treatment of an early- stage screen-detected cancer, or that limit their life expectancy. * subjects already diagnosed with cancer currently in treatment; * subjects who are already in the process of clinical assessment or included in a screening program for a suspected tumour. * contraindications for the whole-body magnetic resonance imaging (wb-mri) radiological exam
feasibility of a behavioral activation trial

Conditions: Major Depressive Disorder

Summary: the goal of this project is to train community mental health therapists in behavioral activation (ba) treatment for major depressive disorder and then to conduct a study examining the feasibility of evaluating the effectiveness of ba in this setting.

after finalizing a 9-session ba treatment model for major depressive disorder in the community mental health center (cmhc) setting, the final treatment manual will be used to train clinicians in ba at the cmhc through workshops and training cases. upon completion of training and certification of adequate implementation of ba, a total of 80 patients with mdd will be randomly assigned in a 3:1 ratio to 9 sessions of ba or treatment-as-usual (tau) at the cmhc. feasibility will be assessed in terms of (1) percent of eligible patients who refuse randomization, (2) percent of patients who complete 9 sessions of ba treatment, (3) percent of ba homework assignments that are completed, (4) percent of monthly assessments obtained, and (5) patient ratings of credibility and alliance in ba treatment. the ability of cmhc therapists to adequately implement ba will be assessed by rating taped sessions on ba adherence and competence scales. in addition to feasibility/acceptability of ba and tau, this study is designed to test whether theoretically important targets of ba change over the course of ba treatment, and whether such changes are associated with changes in depressive symptoms. the target measures will be assessed at baseline, month 1, month 2, and month 3. to support the potential role of these targets as the mechanisms of change in ba, change in the target variables will be examined in relation to change in depression symptoms. the investigators will also pilot a potential moderator of treatment effects (trait reward processing, as measured at baseline using the effort-expenditure for rewards task) to include this potential moderator in a subsequent fully-powered study with the long-term goal of identifying the types of patients most responsive to ba.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of mdd based on the scid for dsm-iv (or dsm-v, if available), 2. ability to read at least at the 4th grade level, 3. willingness to participate in research, 4. willingness to be audio recorded (for both therapists and patient- participants) exclusion criteria: 1. current or past psychotic disorder, seizure disorder, or clinically significant organic pathology 2. acute medical problem requiring immediate inpatient treatment, 3. current substance abuse or dependence requiring primary referral to substance abuse program, 4. significant suicidal risk/ideation requiring immediate referral or suicidal gesture within the last 3 months