Kornimate/medical-research-clean huggingface dataset:
mindfulness-based stress reduction for adults with low-risk chest pain associated with anxiety

Conditions: Chest Pain; Anxiety; Mindfulness

Summary: this emergency department based study investigates the feasibility and effectiveness of a mindfulness based stress reduction (mbsr) training program referral for patients with chest pain at low risk for acute coronary syndrome but associated with anxiety. outcomes assessed for eligible patients randomized to mbsr vs. usual care include mental health (longitudinal generalized anxiety disorder - 7 (gad-7) scores), quality of life (promis global short form), and ed resource utilization (return emergency department (ed) visits).

to determine the effect of an mbsr training program for patients with low-risk chest pain associated with anxiety on mental health (longitudinal gad-7 scores, quality of life (promis global short form), and ed resource utilization (return ed visits). the working hypothesis is that early referral to mbsr will help patients better regulate their thoughts, feelings, and bodily sensations related to their anxiety symptoms and have a significant positive effect on patient-centered outcomes such as mental health, quality of life as well as decreased ed resource utilization. to this end the investigators will randomize patients identified via a two step process (heart score \ 9 to usual care referrals versus mbsr. the investigators will then follow these participants for outcomes including change in gad-7 scores, promis global short form, ed utilization among other outcomes at 6 weeks, 3 months, 6 months, and 1 year.

Eligibility criteria:
inclusion criteria: * chief complaint of chest pain * heart score of 0-3 indicating major adverse cardiac events (mace) risk equivalent to ≤2% * gad-7 score \> or = 10 exclusion criteria: * age \<18 or ≥ 71 * chief complaint of anxiety, panic, or similar * prior personal acute coronary syndrome (acs) history (known at time of provider interview) * previous enrollment in the study * traumatic injury to the chest * suicidal ideation or active psychosis or behavioral issues requiring psychiatric monitoring * hemodynamic instability * non-english speaking * potential issues affecting follow up: prisoners, homeless patients, out-of-town residences

Keywords: chest pain anxiety mindfulness emergency service, hospital
alvimopan use in polytraumatized patients

Conditions: Post Operative Ileus

Summary: to evaluate the efficacy and safety of alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.


Eligibility criteria:
inclusion criteria: * ages 18 to 80 * poly-traumatized patients * extubated patients after abdominal exploration * underwent abdominal exploration, had colon resection with primary anastomosis with closure of abdomen exclusion criteria: * mechanically ventilated patients * patient not expected to survive glasgow coma scale = 3 * pregnant patients * apache score \> 40 (observed mortality 100%) saas ahmed naved et al 2011 * vasopressor therapy * septic patients * thoracotomy * bogota bag * intravenous drug abuser (ivda) as evidenced by urine toxicology upon admission to the trauma unit * patients with prior history of gastric surgery and/or colonic surgery * medical history: of severe cardiovascular disease, renal diseases, hepatitis c or hepatic failure, autoimmune disease, crohn and ulcerative colitis (in view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction * prior pancreatic anastomosis or gastric anastomosis; ostomy formation * chronic use of nonsteroidal anti-inflammatory drugs
nutritional status assessment of pediatric cystic fibrosis patients and effect of nutrition education on nutritional status

Conditions: Cystic Fibrosis in Children

Summary: the goal of this clinical trial is to to assess the nutritional status of children diagnosed with cystic fibrosis between the ages of 2-14, to determine the changes in the nutrition education given to the mothers of the patients on the nutritional status of the children and the nutritional knowledge of the mothers, and to compare them with the control group.. the main questions it aims to answer are: 1. will be better the nutritional status of children of mothers in the education group will be better compared to the control group? 2. will the macro and micronutrient recommended dietary allowance (rda) and diet quality of children with cystic fibrosis in education group increase after nutrition education? 3. will the nutrition knowledge test scores of mothers of children with cystic fibrosis in education group on "nutrition in cystic fibrosis" increase after nutrition education? mothers of children diagnosed with cystic fibrosis will participate in the study as a result of the call of the cystic fibrosis association in turkey. mothers participating in the study will be divided into 2 groups. while the mothers in the first group will be given nutrition education 3 times a week, 1 hour a day, no education session will be given to the mothers in the control group. the nutritional status and nutrient consumption of children in the training group and the control group will be compared.


Eligibility criteria:
inclusion criteria: * mothers included in the research must have responded to the kifder (cystic fibrosis association in turkey) call. * children of mothers included in the research must have been officially diagnosed with cystic fibrosis. * mothers included in the research mustn't receive any nutrition education beforehand. * children of mothers included in the research mustn't be regularly followed by a dietitian. exclusion criteria: * children of mothers included in the research mustn't have a feeding tube. * children of mothers included in the research mustn't be diagnosed with any other disease known to affect growth.

Keywords: cystic fibrosis nutrition education nutritional status
a study evaluating safety, tolerability, and clinical activity of forimtamig-based treatment combinations in participants with relapsed or refractory multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r mm). the study consists of two phases: a dose exploration phase and a dose-expansion phase.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy of at least 12 weeks * documented diagnosis of mm according to the imwg diagnostic criteria * evidence of progressive disease based on investigator's determination of response by imwg criteria on or after last dosing regimen * measurable disease * aes from prior anti-cancer therapy resolved to grade ≤ 1, * adequate organ functions exclusion criteria: * pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the last dose of study drug * plasma cell leukemia with circulating plasma cell count ≥ 5% or \>500/microliter (µl) * participants with known amyloidosis * participants with myelodysplastic syndrome * prior treatment with monoclonal antibody (mab) and antibody-drug conjugate within 4 weeks or 5 half-lives of the drug, whichever is shorter * prior anti-cancer therapy (chemotherapy, small molecule/tyrosine kinase inhibitors, radiotherapy) within 14 days prior to first forimtamig administration * prior solid organ transplantation * active auto-immune disease or flare within 6 months prior to start of study treatment * known or suspected chronic active epstein-barr virus (ebv) infection * hepatitis b virus (hbv) infection * acute or chronic hepatitis c virus (hcv) infection * known history of hiv seropositivity * live vaccine(s) within one month prior to start of the treatment * participants not fully vaccinated for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) as per local recommendations * previous refractoriness to carfilzomib * participants who discontinued prior carfilzomib treatment due to treatment-related toxicity * participants with known liver cirrhosis * participants eligible for allogeneic stem cell transplantation (sct) or autologous sct at the time of enrollment for study bp43437 are excluded
outpatient laparoscopic radical prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of the study is to evaluate the incidence of surgery-related complications between day 0 and day 30.

this is an observational, prospective, open, non-comparative (single arm), bicentric study. this study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting. the possibility of performing this procedure on an outpatient basis is left to the surgeon's discretion, according to well-defined medical procedure criteria. this cohort is part of the usual care. the study will observe the incidence and describe the type, number, severity, duration and frequency of procedure-related complications that may arise in the first month post-op of ambulatory laparoscopic radical prostatectomy. for this reason, patient follow-up will stop at 1 month after surgery, during a routine follow-up visit.

Eligibility criteria:
inclusion criteria: * male, age ≥ 18 years; * localized prostate cancer; * validation in a multidisciplinary consultation meeting of curative treatment; * scheduled laparoscopic radical prostatectomy; * patient able to understand the information related to the study, to read the information leaflet and to signify his/her non-opposition or opposition to participating in the study; * membership of a social security scheme; * patient having been informed and having given oral non-opposition. exclusion criteria: * surgical emergency; * patient not eligible for ambulatory care; * long-term curative anti-coagulant treatment; * resident more than 100km from the clinic; * home alone the first night; * patient under guardianship, curatorship or deprivation of liberty.
choosing options for insomnia in cancer effectively (choice): a comparative effectiveness trial of acupuncture and cognitive behavior therapy

Conditions: Insomnia; Cancer

Summary: the aim of this study is to determine which of two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in cancer survivors. the investigator also wants to study the factors that might impact why someone might prefer or do better in one treatment over the other. group 1 will get acupuncture - acupuncture is an ancient chinese technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing. group 2 will get cognitive behavioral therapy for insomnia (cbt-i) - cbt-i is a treatment to address behaviors and thoughts that are known to effect problems with sleep.


Eligibility criteria:
inclusion criteria: * english-speaking, age ≥ 18 years old * a diagnosis of cancer with no restrictions placed on type of cancer or stage. eligibility criteria are not be restricted to msk confirmed biopsy/diagnosis. participating institution's testing is sufficient for other study sites. * completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded). * a score \>7 on our primary outcome (the insomnia severity index) * a diagnosis of insomnia disorder as defined by the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5), per the diagnostic interview. according to this nosology, insomnia is defined as dissatisfaction with sleep quality or quantity characterized by difficulty initiating sleep, maintaining sleep, or early morning awakenings that cause significant distress or impairment in daytime functioning and occur at least three nights per week for at least three months despite adequate opportunity for sleep. * patients using psychotropic medication (e.g. antidepressants) will remain eligible for study participation provided that the dose was not recently altered (stable over the previous 6-weeks). * patients using hypnotics or sedatives will be eligible for study participation. considering the high use of benzodiazepines within the oncology population, past research has included participants who met diagnostic criteria for insomnia, despite the use of benzodiazepines, and included monitoring of medication use. exclusion criteria: * another sleep disorder, other than sleep apnea, that is not adequately treated. * previous experience with cbt or acupuncture to treat insomnia * currently participating in another acupuncture trial or a trial to treat insomnia * the presence of another axis i disorder not in remission * employment in a job requiring shift work that would impair the ability to establish a regular sleep schedule * patients who are currently taking oral (not including oral sprays/inhalers) or intravenous corticosteroids as part of treatment for cancer or any other condition will be excluded because of the potential of these drugs to induce insomnia

Keywords: surgery chemotherapy radiation acupuncture 16-947
coroflex isar 2000 registry

Conditions: Coronary Artery Disease (CAD)

Summary: postmarket surveillance in terms of the safety and efficacy of sirolimus-eluting coroflex isar stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries

the aim of the study is to assess the safety and efficacy of elective deployment of the sirolimus-eluting coroflex isar stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.

Eligibility criteria:
inclusion criteria: * patients suitable for percutaneous coronary intervention with proof of ischemia * at least 18 years of age exclusion criteria: * intolerance to sirolimus and/or probucol * allergy to components of the coating * pregnancy and lactation * complete occlusion of the treatment vessel * severely calcified stenosis * cardiogenic shock * risk of an intraluminal thrombus * haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy * surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior * severe allergy to contrast media * lesions which are untreatable with ptca or other interventional techniques * patients with an ejection fraction of \< 30 % * vascular reference diameter \< 2.00 mm * treatment of the left stem (first section of the left coronary artery) * indication for a bypass surgery * contraindication for whichever accompanying medication is necessary
flash radiotherapy for skin cancer

Conditions: Basal Cell Carcinoma; Cutaneous Squamous Cell Carcinoma

Summary: this is a single center randomized selected phase ii study of flash radiotherapy (rt) versus standard of care (soc) radiotherapy in patients with localized cutaneous squamous cell carcinoma (cscc) or basal cell carcinoma (bcc). in summary, the aims of the study are to describe and compare the toxicity and efficacy of high dose rate radiotherapy (flash therapy) to soc conventional radiotherapy (according to the standard guidelines per lesion size) through a randomized phase ii selection study in patients presenting localized cscc or bcc requiring a radiotherapy treatment.


Eligibility criteria:
inclusion criteria: * signed study informed consent form * karnofsky performance status (kps) ≥ 60 * age ≥ 60 years * patients with histologically proven cscc or patients with bcc either histologically proven or proven by non-invasive imaging: either optical coherence tomography (oct), line-field oct (lc-oct) or reflectance confocal microscopy (rcm) * patients requiring radiotherapy treatment according to the dermato-oncology tumor board: patients who cannot undergo surgical procedure or patients who decline surgical resection, and/or anatomical locations where surgery can compromise function or cosmesis. * t1-t2 n0 lesions with a small (t1; lesion ≤ 2cm in diameter) or large (t2; 2cm \< lesion ≤ 4 cm) volume (tnm classification of malignant tumours (tnm) union for international cancer control (uicc), 8th edition) * lesions should be at least 4 cm apart if treated with 2 different modalities (including surgical treatment of lesions). lesions should not be located on the face, except on the forehead, above a line situated 1 cm above the eyebrows. lesions located on the scalp can be treated. exclusion criteria: * previous radiotherapy in the treated area * concomitant auto-immune disease with skin lesions * concomitant use of radio-sensitizer drug * cognitive disorders not compatible with the signature of informed consent or that may compromise compliance with the requirements of the study * current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before end of treatment (eot) visit) * concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s)

Keywords: flash therapy basal cell carcinoma cutaneous squamous cell carcinoma high dose rate radiotherapy
low-intensity focused ultrasound pulsation (lifup) for treatment of temporal lobe epilepsy

Conditions: Epilepsy, Temporal Lobe

Summary: we intend to use focused ultrasound to stimulate or suppress brain activity in patients with epilepsy. we hypothesize that focused ultrasound is capable of brain stimulation or suppression visible with functional mri, and will not cause tissue damage.


Eligibility criteria:
inclusion criteria: * subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity. * subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs. * subjects with epilepsy who would clearly benefit from surgical intervention. * subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory epilepsy. exclusion criteria: * subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing. * subjects with dementia, delirium and psychotic symptoms. - subjects with ferromagnetic materials in the head. * subjects with severe cardiac disease, increased intracranial pressure, or a tens unit. * subjects who exhibit primary generalized seizures or pseudoseizures. * subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease. * subjects who have experienced status epilepticus during the 3-week baseline period prior to the operation. * subjects (females) who are pregnant.
antihypertensive effect of continuous positive airway pressure in resistant hypertensive patients with sleep apnea

Conditions: Hypertension

Summary: obstructive sleep apnea syndrome (osas) has been linked to resistant hypertension, but the effect of treatment of osas on the resistant hypertension have no been established. in a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic cpap or placebo cpap for eight weeks in an ambulatory set. the investigators want to determine any difference on hypertension control between the 2 management strategies.

this is a double blind, randomized, placebo controlled trial. participants were consecutive patients with resistant hypertension, defined as uncontrolled bp, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. all participants should have a diagnosis of at least moderate osas, defined by ahi \> 15 in a portable monitoring sleep exam. participants were assigned to active cpap or sham-cpap. the main outcome was change in 24-hour ambulatory blood pressure (abp) monitoring values from baseline to two months of active cpap or sham cpap

Eligibility criteria:
inclusion criteria: * clinical diagnosis of resistant hypertension * apnea/hypopnea index \> 15 exclusion criteria: * cardiac surgery on last 3 months * serious arrhythmias * insulin dependent diabetes * debilitating neurological disease * severe copd

Keywords: hypertension resistant hypertension sleep apnea syndrome treatment
efficacy and safety of alflorex bei reizdarm in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: this post-market clinical-follow up (pmcf) study gains data on the efficacy and safety of "alflorex bei reizdarm", a probiotic based on bifidobacterium longum 35624, in the daily use by irritable bowel syndrome (ibs) patients. the aim of this study is the observation of the influence of "alflorex bei reizdarm" on typical symptoms, severity score and quality of life of ibs patients in medical practice and everyday use.

this post-market clinical-follow up (pmcf) study observes adult patients with irritable bowel syndrome (ibs) which receive "alflorex bei reizdarm", a probiotic based on bifidobacterium longum 35624, for 8 weeks by recommendation of their physician. ibs symptoms are recorded on a weekly basis by the participants. ibs severity score, interference with general life and safety parameters are also recorded. primary objective is the assessment of the change in overall ibs symptoms (sum of abdominal pain, bloating, gas, difficulty in defecating/constipation and urgency/diarrhoea).

Eligibility criteria:
inclusion criteria: adult, diagnosed ibs patients with typical ibs symptoms (abdominal pain, bloating, gas, constipation or diarrhea) and physician's recommendation to take the study medication (probiotic with b. longum 35624) for 8 weeks exclusion criteria: -