Kornimate/medical-research-clean huggingface dataset:
sweat evaporimeter measurement

Conditions: Cystic Fibrosis

Summary: the investigators hypothesize that measurement of beta adrenergic induced sweat rate using an evaporimeter can accurately and reliably determine different levels of cftr dysfunction within a spectrum of patients expressing various degrees of cystic fibrosis disease. the investigators overall goal is to determine whether the evaporimeter technique of measuring beta-adrenergic induced sweat rate is capable of accurately and reliably identifying different levels of cftr dysfunction, as a prerequisite before advancing this technique as biomarker assay into clinical trials.

preliminary data show that following β-adrenergic stimulation, evaporimetry can reliably measure sweat secretion that is: highly reproducible in healthy controls; reduced by 50% in cf obligate heterozygotes; and absent in cf patients carrying severe mutations on both alleles. further, test- retest experiments suggest good intra-individual reliability. all these features satisfy the required criteria for a biomarker assay that is capable of assessing small increments in cftr function in vivo in clinical trials designed to assess the effectiveness of correctors and potentiators of cftr channel activity. therefore, to provide additional evidence of the value of this novel technique the investigators will determine the accuracy and reliability of evaporimetry to measure beta-adrenergic induced sweating in subjects with a range of cftr channel activity.

Eligibility criteria:
inclusion criteria: 1. male or female ages 18 years and older. 2. subject with or without confirmed diagnosis of cf. 3. written informed consent obtained from subject. exclusion criteria: 1. patients who are participating in clinical trials evaluating the safety, efficacy or clinical outcome of drugs that may alter the cftr cl channel function will be excluded. 2. any subject with a known hypersensitivity to any agonist used in the study or subjects receiving any drug (e.g. theophylline, antihypertensive agent) that might interfere with the investigations. 3. subjects with active dermatitis or other chronic skin condition such as psoriasis or a strong allergic history. 4. patients with a history of cardiac disease (including arrhythmias or hypertrophic obstructive cardiomyopathy). 5. cf patients with severe malnutrition (bmi\<18 kg/m2). 6. cf patients with severe lung disease (fev1\<25%). 7. subject who has been treated for pulmonary exacerbation or other acute illness within one week of the study procedure. 8. any medical condition that, in the opinion of the investigator, will interfere with accurate conduct of the study. 9. subjects who are pregnant or lactating. 10. subject who is not able to stop inhalation therapy of β -adrenergic drugs 12 hrs before starting each test.

Keywords: cystic fibrosis sweat evaporimeter
the role of prolonged nightly fasting to improve sleep and cognition in breast cancer survivors

Conditions: Breast Cancer Survivor; Cancer Related Cognitive Difficulties; Sleep; Quality of Life

Summary: the investigators are interested in finding out how prolonged nightly fasting (pnf) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.

the purpose of this innovative, remotely-delivered pilot randomized controlled trial (rct) is to explore the use of an 8-week prolonged nightly fasting (pnf) intervention, as compared to a health education-only (hed-only) control condition, among ethnically and racially diverse (≥50% black, hispanic, and/or native american) breast cancer survivors (bcss) with cancer-related cognitive impairment (crci) to examine changes in cognitive function, sleep, insomnia and health-related quality of life (i.e., mental and physical). additionally, intervention feasibility will be assessed among the pnf participants. all participants will receive health education (hed) throughout. bcss living with crci (n=60) will be recruited nationwide and randomized 1:1 into the pnf or hed-only groups. linear mixed models will be used to compare outcome changes in the pnf group compared to hed-only group (aims 1-3); descriptive and qualitative analyses will be used in the exploratory aim.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old 2. diagnosed with breast cancer (all stages included) 3. ≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included) 4. score ≤30 or lower on the patient reported outcome measurement information system cognitive function short form 8a (sr-crci) 5. able to speak/understand english 6. have access to a computer and wi-fi 7. live within the united states 8. identifies as female 9. willing and able to fully participate in the study exclusion criteria: 1. type 1 diabetes 2. actively enrolled in formal diet/weight loss program 3. previous bariatric surgery 4. eating disorder history 5. night shift work 6. pregnant, breast feeding, or trying to get pregnant 7. dementia, psychological, psychiatric, or neurological diagnoses 8. active brain or central nervous system disease 9. prior or current use of memory enhancing medications 10. history or current brain radiation 11. frequently fasting for 12+ hours every night 13) history of hypoglycemia 14) depression screening on phq9 with a score of 20 or greater across all 9 questions or anything other than 0 on question 9

Keywords: breast cancer breast cancer survivor brain fog prolonged nightly fasting nationwide remote non-invasive health education sleep quality of life
re-deem dose finding study for dabigatran etexilate in patients with acute coronary syndrome

Conditions: Coronary Disease

Summary: the purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (mi) at high risk for new ischaemic cardiovascular events.


Eligibility criteria:
inclusion criteria patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications. exclusion criteria 1. long term treatment with any other oral anticoagulant 2. severe/disabling stroke within last 6 months 3. conditions associated with increased bleeding risk 4. anaemia or thrombocytopenia 5. severe renal impairment 6. liver disease 7. positive pregnancy test
efficacy study of cognitive intervention in amnestic mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: * there will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group. * there will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.

the change of modified adas-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.

Eligibility criteria:
inclusion criteria: * 50 to 85 years of age * memory complaint corroborated by a participant and an informant * delayed recall score on the seoul verbal learning test (svlt) below 1.0 standard deviations from the mean of the age and education-normative values among the korean population * global cdr score is 0.5, memory cdr score is 0.5 or 1. * above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the korean mini-mental state examination * normal functional activities * not diagnosed with dementia * modified hachinski ischemic score (his): 0-4 * brain magnetic resonance imaging or ct showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment. * subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information. * he/she can read and write * written informed consent exclusion criteria: * any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks * any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease) * any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin b12 or folate, or positive venereal disease research laboratory test * any patients with any primary neurodegenerative disorder or psychiatric disorder other than ad (i.e., parkinson's disease, schizophrenia, or major depressive disorder) * any patients with any history of drug or alcohol addiction during the past 10 years * any hearing or visual impairment that can disturb the efficient evaluation of the patient

Keywords: mild cognitive impairment cognitive therapy prevention
wise cortical strip for intraoperative neurophysiological monitoring

Conditions: Brain Tumor Adult; Epilepsy

Summary: the win study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the wise cortical strip (wcs) for ce certification purposes. participants with documented diagnosis of epilepsy or brain tumor requiring intracranial surgery, who meet all eligibility criteria, will undergo intraoperative neurophysiological monitoring (ionm) during a neurosurgical intervention with the wcs and a comparator device.

the ionm is the use of electrophysiological methods to identify important neural structures in the operative field, including eloquent areas, in order to monitor their functional integrity during the neurosurgical lesion resection. the benefit of performing functional monitoring of the areas surrounding the lesion is to minimize neurological damages during surgical lesions resection and thus to avoid and/or limit significant post-operative impairments. during the therapeutic resection of brain tumors or epileptogenic lesions, the use of the ionm is associated to other intraoperative techniques (e.g. brain mapping techniques) that, together to combined efforts of a multidisciplinary team of neurosurgeons, neuroradiologists, neuropsychologists, and neurophysiologists, contribute to the definition of location, extension, and extent of functional involvement that a lesion causes in an individual participant. the principal electrophysiological methods to perform the ionm are the recording of brain's electrical activities (somatosensory evoked potentials, seps and electrocorticography, ecog) and electrical stimulation of motor regions (to elicit motor evoked potentials, meps) using cortical strips placed on surface of the brain. thus, the wcs is intended to be used intraoperatively on the brain surface, to perform brain monitoring.

Eligibility criteria:

Keywords: cortical strip electrode
high dose rate brachytherapy for treatment of keloids

Conditions: Keloid

Summary: this prospective study evaluates the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids. main outcomes are recurrence rate, scar quality and physical complaints.

this prospective evaluation describes the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids in a large mixed fitzpatrick skin type patient population. after intralesional excision, a unique low dose radiation scheme of 2x6gray (gy) was administered in 2 fractions: the first within 4 hours, the second within 24 hours. keloids were evaluated pre- and postoperative (1 week, 3, 6, 12 months, 5years). scars were measured and recurrence was judged. an evaluation of the outcome of the scars was obtained using the patient and observer scar assessment scale. statistical analyses were conducted using spss version 20.0 (spss, inc, chicago, iii)

Eligibility criteria:
inclusion criteria: * keloid defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion. keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (\>1yr) * the keloid had been proven insensitive to at least one other treatment * patients had to be older than 10 years of age. exclusion criteria: * keloids not suitable for excision with primary closure due to its size or anatomical location * pregnancy or diabetes

Keywords: brachytherapy radiotherapy scar treatment
increasing the yield of blood cultures in neonates

Conditions: Bacteremia

Summary: the purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.


Eligibility criteria:
inclusion criteria: * all blood cultures taken in the nicu during the study period. exclusion criteria: * bacteria that are normal flora of the skin such as coagulase negative staphylococci or streptococci viridans are considered, except if grown in two sets of cultures or in the presence of laboratory and clinical indices of infection.

Keywords: bacteremia blood cultures sepsis
effects of occlusal splint and therapeutic home exercises

Conditions: Quality of Life; Neuropathic Pain; Somatic Pain

Summary: in this randomized controlled study, investigators planned to investigate the efficacy of oral occlusive splint and therapeutic home exercises in increasing the quality of life and reducing somatic and neuropathic pain in patients with temporomandibular joint dysfunction, determine their effects on other clinical data, and report long-term outcomes

the aim of the present study to compare the efficacy of oral occlusive splint and therapeutic home exercises in increasing the quality of life and reducing somatic and neuropathic pain in patients with temporomandibular joint dysfunction and report long-term outcomes. one hundred and one patients with temporomandibular joint dysfunction were included in the study. the patients were randomly divided into two groups: the first group received a mandibular oral occlusal splint and the second group was given a home exercise program for the temporomandibular joint. the patients were evaluated based on their maximum mouth opening, visual analog scale, short-form mcgill pain questionnaire, paindetect, oral health-related quality of health and hospital anxiety and depression scale scores at the beginning of treatment and at the end of the first and sixth months.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of temporomandibular joint disorders for more than one month * being aged 18 to 60 years exclusion criteria: * history of trauma to temporomandibular joint or face * history of an inflammatory joint disease * chronic analgesic use lasting more than six months * previous treatment for temporomandibular joint disorders * history of a major psychiatric, neurological or neuromuscular disease (lambert-eaton syndrome, orofacial or tardive dyskinesia, myasthenia gravis) * migraine diagnosis * chronic headache or neck pain * chronic pain syndrome * pregnancy * disc displacement with or without reduction

Keywords: temporomandibular joint disorders exercise therapy occlusal splint neuropathic pain
early postoperative pain and 30-day complications following major abdominal surgery: an observational study

Conditions: Infectious Complications; Postoperative Pain; Acute Pain; Postoperative Complications; Surgery--Complications

Summary: in this retrospective cohort study, we assess the relationship between the intensity of early postoperative pain and the risk of infectious- and non-infectious complications within 30 days after major abdominal surgery.


Eligibility criteria:
inclusion criteria: * major abdominal surgery under general anesthesia exclusion criteria: * younger than 18 years of age * procedures outside the operation room * procedures solely under regional anesthesia, i.e. no general anesthesia

Keywords: early postoperative pain infectious complications
study of venetoclax and azacitidine in advanced bcr-abl negative myeloproliferative neoplasms

Conditions: Myeloproliferative Neoplasm

Summary: the purpose of this research study is to look at how safe and useful a drug called azacitidine in combination with a drug called venetoclax, is in people with accelerated or blast phase brc-abl negative myeloproliferative neoplasms.

all participants in this study will receive azacitidine and venetoclax. this study will be done in multiple stages: safety run-in period - 7 participants will receive the study drugs to ensure that the combination is safe and tolerable. stage 1 - about 15 participants will receive the study drugs and will be evaluated to see whether they respond to the study drugs. stage 2 - if enough participants in stage 1 respond to the study drugs, then stage 2 will begin. during this stage, an additional 25 participants will take part in the study to further see if participants respond to the study drugs.

Eligibility criteria:
inclusion criteria: * ability to voluntarily provide written informed consent. * documented diagnosis per world health organization (who) 2016 criteria of bcr-abl negative myeloproliferative neoplasms (mpn). * documented mpn transformation to accelerated phase (ap) or blast phase (bp) without prior blast reduction therapy for their ap/bp disease. * eastern cooperative oncology group (ecog) performance status 0-2. * adequate organ function. * must practice at least one reliable method of birth-control starting at least on cycle 1 day 1 until at least 90 days after the last dose of study drug. * female participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1. exclusion criteria: * history of allogeneic stem cell transplant for mpn. * previous treatment with venetoclax, navitoclax, azacytidine or other hypomethylating agents (hma). * white blood cell count \>25 x 10\^9/l. * current enrollment in another interventional study. * presence of any active uncontrolled infection such as bacterial or fungal infections progressing despite adequate antimicrobial treatment. * myocardial infarction in the preceding 3 months. * active human immunodeficiency virus (hiv), hepatitis b (hbv), hepatitis c (hcv) infection. * history of active malignancy in the previous 2 years. * any psychiatric illness or social circumstances or significant co-morbid conditions that may compromise study participation. * pregnant or breastfeeding women. * patients with known central nervous system (cns) involvement with acute myeloid leukemia (aml) or cns extramedullary hematopoiesis. * patients with t (15;17) * patients who have received strong and/or moderate cyp3a inducers within 7 days prior to the initiation of study treatment. * active covid-19 infection. * history of prior blast-reduction therapy for ap/bp-mpn. * preceding history mds, chronic myelomonocytic leukemia (cmml), and other myelodysplastic syndromes (mds)/mpn overlap syndromes.
efficacy of adding topiramate to current treatment in treatment-resistant generalized social phobia (gsp)

Conditions: Social Phobia

Summary: ssri's are considered first-line treatments for gsp, however many patients continue to have significant symptoms despite an adequate trial of an ssri. topiramate, a drug, which targets the glutamate system in the brain, has been shown to improve symptoms of social phobia when used on its own and has also been used as an additive treatment in other anxiety disorders. this study will test the efficacy of adding topiramate to a subject's current ssri in cases of gsp which are considered to be treatment-resistant.


Eligibility criteria:
inclusion criteria: * outpatient with primary dsm-iv gsp * completion of an adequate trial (14 wks) of open, flexible dose ssri treatment (fluoxetine 80mg/day, paroxetine 60mg/day, fluvoxamine 300 mg/day, sertraline 200mg/day, citalopram 60mg/day, escitalopram 30mg/day) * non or partial response to ssri treatment (cgi-s \> 4, lsas \> 40) exclusion criteria: * any other dsm-iv axis i primary diagnosis * meeting dsm-iv criteria for body dysmorphic disorder, eating disorder or current alcohol/substance abuse * a lifetime history of bipolar affective disorder * a hx of schizophrenia/psychotic disorders, delirium, dementia, or amnestic/other cognitive disorders * borderline/antisocial personality disorder * a comorbid axis ii cluster a personality disorder * hx of \> 3 adequate trials with an ssri * score of \> 4 on madrs q.10 * current increased risk of suicide * prior use of or an allergy to topiramate * participation in any clinical trial 30 days prior to entering the study * unable to tolerate being free of or shows signs of withdrawal benzodiazepines for 4 weeks * hx of seizures, kidney stones or thyroid problems * bmi \< 20

Keywords: treatment refractory generalized social phobia
fibre and appetite regulation trial (fart)

Conditions: Obesity; Diabetes

Summary: high intake of cereal fibre has been shown to be associated with reduced weight gain and improved insulin sensitivity. we hypothesize these effects are due to the short chain fatty acids derived from the bacterial fermentation (breakdown) of fibre in the colon (large intestine). insulin resistant subjects will be randomized to receive 2 servings of a low-fibre cereal (eg. puffed rice) or 2 servings of a high-fibre cereal (wheat bran cereal) per day for one year. the effects of the diets on body weight, appetite, abdominal fat, blood short chain fatty acids, glucose, insulin, lipids and hormones will be measured


Eligibility criteria:
inclusion criteria: * non-diabetic male or non-pregnant females * aged 18-60 * bmi\<36 * fasting insulin \>40pmol/l (70%ile) exclusion criteria: * intention to lose \>5kg in weight * presence of diabetes (fasting glucose \>6.9mmol/l) * use of diuretics, beta-blockers or weight reducing drugs * use of antibiotics in last 3 months and use of antibiotics more than once annually for the last 2 years * significant gastrointestinal, liver or kidney disease * use of lipid-lowering drug * major medical or surgical event in last 6 mo. * fibre intake \>30g/d * inability to eat low or high fibre breakfast cereals * unwilling or unable to give consent or comply with protocol

Keywords: human nutrition dietary fibre insulin resistance obesity glucose colonic fermentation short chain fatty acids glp-1 appetite abdominal fat