Kornimate/medical-research-clean huggingface dataset:
development & testing of a decision aid for lvad placement

Conditions: End-Stage Heart Failure; Bridge-to-Transplant LVAD Placement (BTT); Destination Therapy LVAD Placement (DT); Refusal of LVAD Placement (Decliners); LVAD Caregivers

Summary: the goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment. this study seeks to create a decision aid that presents outcomes, risks, projected experiences, and uncertainties about left ventricular assist device (lvad) placement to help patients make values-based decisions about placement. the investigators propose a mixed methods design involving a literature search of clinical evidence, semi-structured patient interviews, and quantitative data from a multi-site trial of patients receiving the decision aid compared to patients not receiving the aid.


Eligibility criteria:
inclusion criteria: * lvad candidates (nyha class iii and iv patients with an acceptable surgical risk/benefit ratio for lvad implantation and with good psychosocial support, coping mechanisms, and financial resources, as determined by "clearance" from the transplant social worker) * lvad patients * lvad decliners * lvad caregivers exclusion criteria: * subjects who lack the capacity to give informed consent

Keywords: end-stage heart failure left ventricular assist device decision aid medical decision-making
the effect of non-invasive hemoglobin measurement in hip surgeries

Conditions: Bleeding; Hemorrhage; Hemodynamic Instability

Summary: bleeding is one of the most important causes of mortality and morbidity in patients. hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. recently, non-invasive techniques where measurement is made from the fingertips have been offered for use. one of these techniques is non-invasive hemoglobin (sphb) measurement. sphb is used as a trend monitor. based on the severity of bleeding, the compensatory mechanisms of patients may be disrupted. this situation may lead to lower levels of toleration of anemia during bleeding. the relationship between blood transfusion and mortality is under debate.


Eligibility criteria:
inclusion criteria: * 18-60 years old * general anesthesia undergoing hip surgery * american society of anesthesiology (asa) scores i-ii-iii exclusion criteria: * receiving inotropic support * uncontrolled diabetes * arrhythmia * hypothermia * hyperbilirubinemia * jaundice * dark skin pigmentation * without voluntary consent * hypovolemia, * hypotension, * sepsis, * blood diseases

Keywords: perioperative bleeding mortality hemoglobin non-invasive monitoring transfusion; sphb
safety and tolerability of repatha® (evolocumab) in indian participants with homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia HoFH

Summary: to describe the safety and tolerability of evolocumab in participants with homozygous familial hypercholesterolemia (hofh) in india. all participants will receive evolocumab over an 8-week period.

an open-label, multicentre, phase 4 study to describe the safety and tolerability of evolocumab in 30 indian participants with hofh. subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. participants will receive evolocumab 420 mg subcutaneous (sc) once monthly (qm) and study visits will occur approximately every 4 weeks. apheresis participants will receive evolocumab 420 mg sc every 2 weeks to correspond with their apheresis schedule. final administration of evolocumab (for all participants) will occur at week 8. the end of study (eos) visit will occur at week 12 for all participants.

Eligibility criteria:
inclusion criteria: * male or female ≥ 12 to ≤ 80 years of age at the time of signing the informed consent * diagnosis of hofh based on low-density lipoprotein cholesterol (ldl-c), familial history and xanthoma * on a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial * fasting ldl-c at screening \> 130 mg/dl (3.4 mmol/l) * fasting triglycerides at screening ≤ 400 mg/dl (4.5 mmol/l) exclusion criteria: * use of mipomersen or lomitapide within 6 months of screening. * known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction * currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies) * female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed * female subjects of childbearing potential unwilling to use an acceptable method of effective contraception * subject has known sensitivity to any of the products to be administered during dosing * history or evidence of any other clinically significant disorder, condition or disease * subject has previously received evolocumab or any other proprotein convertase subtilisin/kexin type 9 (pksk-9)-inhibiting therapy

Keywords: evolocumab hypercholesterolemia
intratympanic steroid treatment for the prevention of inner ear toxicity associated with systemic treatment with cisplatin.

Conditions: Cisplatin; Ototoxicity; Intratympanic Steroids

Summary: in this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

cisplatin is a potent and widely used antineoplastic drug. ototoxicity is a serious and dose-limiting side effect. the ototoxic effect of cisplatin is characterized by irreversible, progressive, bilateral, high-frequency, sensorineural hearing loss with tinnitus. 60-80% of patients treated show elevations of hearing thresholds and nearly 15% sustain significant hearing handicap. there are currently no clinical interventions that have been shown to prevent cisplatin ototoxicity in humans. glucocorticoids have significant potential for otoprotection. glucocorticoids are in use for treatment of a variety of cochlear disorders such as autoimmune inner ear disease, meniere's disease and sudden sensorineural hearing loss. intratympanic administration of drugs is a contemporary, safe method of locally treating inner ear disorders, allowing diffusion across the round window into the inner ear. this method achieves much higher steroid levels within the inner ear compared to oral or parenteral routes. local administration prevents the common systemic side effects of steroids. previous animal studies have shown protection against cisplatin-induced ototoxicity after intratympanic steroid injection. asa far as we know, there are yet no studies in humans examining the otoprotective effect of intratympanic steroids in patients treated with cisplatin. in this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

Eligibility criteria:
inclusion criteria: * adults 18 years old at least who are candidates for cisplatin treatment * agreement to participate in the study * have signed an informed consent. exclusion criteria: * refusal to participate * steroid treatment during the past month * external or middle ear disease not enabling intratympanic treatment * inner ear disease causing hearing loss * severe hearing loss for any reason * conductive hearing loss

Keywords: cisplatin ototoxicity intratympanic steroids
comparative effects of sciatic nerve flossing and active release technique in cyclists with sciatica

Conditions: Cyclists; Sciatica

Summary: thus the aim of my study is to determine the comparative effects of sciatic nerve flossing and active release technique on pain, flexibility, and functionality in lower limbs of cyclists with sciatica.

this study investigates the comparative effects of sciatic nerve flossing and active release technique on pain, flexibility, and functionality in cyclists with sciatica. to compare the efficacy of sciatic nerve flossing and active release technique in reducing pain and improving functional performance in cyclists diagnosed with sciatica over a six-week period. a randomized clinical trial was conducted with 32 participants, aged 18 to 35, diagnosed with sciatica persisting for more than six weeks. participants were randomly assigned to two groups: group a received sciatic nerve flossing, while group b underwent active release technique. pain levels were measured using the numeric pain rating scale (nprs), functional performance was assessed using the lower extremity functional score (lefs), and flexibility was evaluated via the sit and reach test.

Eligibility criteria:
inclusion criteria * age between 18 to 30 years (16) * only male participants were included (15) * participates with positive passive straight leg raise (pslr) test (13) * athletes with positive slump test (15) * symptoms more than 6 weeks (16) exclusion criteria: * lower limb fracture(13) * musculoskeletal problems (radiculopathy, myopathy) (13, 14) * sciatica along with vascular disorders and diabetic neuropathy, sciatica due to tumor and fractures (15) * inflammatory arthritis (16) * previous surgical interventions on the lower limbs or spine (15) * neurological conditions affecting lower limb function (e.g., multiple sclerosis, spinal cord injuries) (13, 14) * patients currently undergoing physical therapy or other interventions for sciatica (15) * individuals with contraindications to physical activity or exercise due to health conditions (13, 14)

Keywords: active release technique cyclists functional performance pain management sciatica sciatic nerve flossing technique
nefopam and morphine consumption in the treatment of ureteral calculi

Conditions: Ureteral Calculi, Hyperalgic, Not Complicated

Summary: the administration of néfopam after initial treatment by kétoproféne, could obtain, in patients remaining pain and classically need morphine, analgesia at least the same as morphine alone. the use of néfopam second line after ketoprofen could reducing (or even eliminating) the need for morphine (and its side effects), allowing a reduction in the length of stay of patients in the emergency unit. the main objective is to show that the addition of a néfopam initial treatment with the kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring the use of a treatment by morphine. the secondary objective is to reduce the side effects caused by the morphine, shorten the time to install the appropriate level of analgesia while reducing the risk of failure of the titration morphine, reduce the time spent on titration of morphine and reduce the length of stay patient intake in emergency unit.

the study is prospective, parallel, double-blind, randomized, placebo-controlled analysis with intent to treat. there are 2 groups: * a group n: néfopam * a group p: placebo and all the patient receive, before randomization, 100 mg of ketoprofen (profenid ®) on 20 minutes. the number of subjects is 52.

Eligibility criteria:
inclusion criteria: * age between 18 to 50 years old. * admitted to the emergency room for typical ureteral calculi with severe pain (vas \> or = 60), and microscopic hematuria in the strip without signs of urinary complications. * preliminary agreement patient. exclusion criteria: * patient disagree. * pregnant women (sought by the questioning). * fever \> 38 ° c. * leucocyturie or nitriturie (dipstick). * contraindication to ketoprofen. * contraindication to néfopam. * contraindication to morphine. * contraindication linked to drug interactions as mentioned in the summary of product characteristics of the authorization for placing on the market of acupan ®. * treatment opioid analgesics, nonsteroidal anti-inflammatory or inflammatory or paracetamol in the previous 12 hours. * secondary exclusion to a urinary tract infection or systemic.

Keywords: pain, morphine, nefopam, co analgesia, ureteral calculi, emergency
switching to duloxetine in patients with depression

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to help answer the following research question: whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression.


Eligibility criteria:
inclusion criteria: * male or female outpatients aged 18 years or older who meet criteria for major depressive disorder (mdd). * currently receiving a selective serotonin reuptake inhibitor (ssri) or a serotonin-norepinephrine reuptake inhibitor (snri) class of antidepressant for at least a month for the treatment of depression. * females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) to test negative for pregnancy based on a urine pregnancy test and to agree to use a reliable method of birth control. exclusion criteria: * women who are pregnant or plan to be pregnant or are breastfeeding. * to have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication. * diagnosed with treatment resistant depression. * history of bipolar disorder, schizophrenia, or other psychotic disorders. * to have previously taken duloxetine that didn't work. * judged to be at serious suicidal risk in the opinion of the investigator and/or score \>=3 on item 3 (suicide) of the 17-item hamilton depression rating scale (hamd-17) at screening (visit 1) or baseline (visit 2). * a serious medical illness that may need treatment during the study. * taking certain medications that are not allowed in this study. * to have a history of alcohol and/or drug abuse or dependence within the past year. * to have uncontrolled narrow-angle glaucoma. * to have allergic reactions to many medicines. * to have undergone "shock" therapy (electroconvulsive therapy) or "magnet" treatment (transcranial magnetic stimulation) within the past year. * to initiate "talk therapy" (psychotherapy) just before or during the study. * to have chronic pain and you have been taking medicine for it for the last 6 months. * to have certain liver diseases. * to have kidney disease or undergoing dialysis. * abnormal thyroid stimulating hormone (tsh) concentration.
utilizing emg shorts in hip population

Conditions: Hip Injuries

Summary: the purpose of this study is to use a combination of electromyopathy (emg) shorts and muscle monitoring software to collect data from participants performing physical exercises in order to determine the combination's diagnostic efficacy and ability to provide rehabilitative guidance for people who are recovering from hip injuries. both healthy volunteers and duke patients seeking treatment for their hip pain and/or injuries will be enrolled in our research. if participants choose to take part they will be asked to wear these emg shorts and perform various exercises like running on a treadmill, riding a stationary bike, or lifting weights. participation in this study consists of one study visit for healthy volunteers, but will last up to six months for duke patients. at each standard of care clinic visit throughout six months, duke patients will be asked to also come in for a study visit, wear the emg shorts, and perform the same exercises preformed during the first study visit.


Eligibility criteria:
inclusion criteria: inclusion (duke patients): * all subjects must be 18 years of age or older. * any patient that currently has hip pain or injury and is seeking treatment from either dr. mather, dr. lewis, or dr. olson, within the hip preservation clinics. * subjects must be able to fit into the shorts in order to participate. inclusion (healthy volunteers): * all healthy volunteer subjects must be 18 years of age or older. * subjects must be able to fit into the shorts in order to participate. exclusion criteria: exclusion (duke patients): * any recent lower extremity injury (such as an ankle sprain/surgery or knee surgery). * patient is unable to provide written consent, or patient is unable to speak, write, or understand english. * pregnant women (verbal confirmation) * allergic or hypersensitivity to laminate material. exclusion (healthy volunteers): * any recent lower extremity injury (such as an ankle sprain/surgery or knee surgery). * prior hip surgery, or current hip injury, surgery, or pain. * patient is unable to provide written consent, or patient is unable to speak, write, or understand english. * pregnant women (verbal confirmation) * allergic or hypersensitivity to laminate material.

Keywords: emg shorts hip pain
feasibility testing of the alert for atrial fibrillation program

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine the psychometric properties of the knowledge, attitudes, and beliefs about atrial fibrillation survey (kabafs) and to generate critical, practical knowledge about the feasibility of conducting a randomized trial to test the effect of the alert for atrial fibrillation program on treatment-seeking for symptoms of atrial fibrillation (af).

the purpose of the proposed research is to evaluate the psychometric properties of the knowledge, attitudes, and beliefs about atrial fibrillation survey (kabafs), which is an instrument designed to tailor the delivery of the alert for atrial fibrillation program. the proposed research will also test the feasibility of studying the effect of the alert for atrial fibrillation program on treatment-seeking for symptoms of af in a larger, randomized trial. this research is significant, because current research suggests that treatment seeking for af is hindered when people do not recognize symptoms that represent af, attribute those symptoms to alternative causes, or do not believe symptoms are serious enough to require medical evaluation. interventions tailored to modify patient-specific knowledge, attitudes, and beliefs that hinder early treatment-seeking are critically needed in order to improve early detection of af. the long term goal of this research is to improve health outcomes of those at risk for developing af.

Eligibility criteria:
inclusion criteria: * 65 years of age or older * under the care of providers from the department of medicine * english-speaking * community dwelling, * have access to and ability to communicate via a telephone * have one or more risks for developing af * not be diagnosed with af exclusion criteria: * documented cognitive impairment * uncompensated hearing or visual deficits * scheduled for surgery or have undergone a surgical procedure in the last 30 days, * undergoing active treatment for a malignancy * receiving hospice care will be excluded
vitamin d supplementation and acute respiratory infection in older long-term care residents

Conditions: Respiratory Infection

Summary: this study will test the role of high dose vitamin d supplementation in prevention of acute respiratory infection in older nursing home residents. the investigators hypothesize that residents on high dose vitamin d supplementation will have a lower incidence of acute respiratory infection that those on standard dose vitamin d supplementation.

this study is a double-blinded, parallel group, randomized controlled phase ii trial of oral high vs. standard dose vitamin d3 supplementation administered monthly for 12 months.

Eligibility criteria:
inclusion criteria: * age 60+ years * resides in nursing home exclusion criteria: * terminal illness (expected survival \<6 months) * anticipated discharge within 12 months * unable to take whole or crushed tablets * active cancer, except squamous/basal cell carcinoma * severe malnutrition (body mass index \<18 kg/m2) * current immunosuppressive medications (including corticosteroids) * renal failure (estimated glomerular filtration rate \< 15 ml/min/1.73m2) * currently taking \>1,000 iu/d vitamin d supplementation * history (or strong family history) of kidney stones * history of sarcoidosis or other granulomatous disorders associated with hypercalcemia * elevated baseline hypercalcemia (albumin-adjusted serum calcium \>10.5 mg/dl) * baseline serum 25ohd level ≥ 100 nmol/l * inability to provide informed consent and no available healthcare legally authorized representative * inability of participant or legally authorized representative to speak/understand english

Keywords: vitamin d deficiency respiratory infection nursing home residents geriatrics immunosenescence prevention
addiction risk: psychoeducational intervention to change risk perception among alcohol patients in residential treatment

Conditions: Alcohol Use Disorder

Summary: based on previous research (odenwald \& semrau, 2012) the investigators know that psychoeducation on comorbid mental disorders during residential alcohol detoxification can improve subsequent treatment utilization. in this study they will study a hypothesized psychological mechanism that contributes to this behavior change. the investigators will recruit alcohol dependent patients in residential detox treatment who all receive treatment as usual. participants will be randomly assigned to an additional psychoeducational group therapy (intervention group) or to an additional neuropsychological group training (control group). measurements will take place on the day before study inclusion, one week later and one month after release from index residential treatment. measurements will include alcohol-related risk perception, alcohol use, treatment motivation, comorbid psychiatric symptoms and whether the patient has regularly completed treatment and whether he/she has been transferred to subsequent treatment. furthermore, six months after release from index treatment information on re-admission to the clinic is assessed from patient files. the investigators hypothesize that the behavioral effects of psychoeducational group intervention will be mediated by adaptive changes of the individual's alcohol-related risk perception.


Eligibility criteria:
inclusion criteria: * alcohol dependence (according to icd-10) exclusion criteria: * treatment episode is acute crisis intervention * acute psychosis * acute suicidality * no command of german language (reading writing)
dysphagia following anterior cervical spine surgery; single dose steroid vs saline (dysdexvssal)

Conditions: Dysphagia

Summary: this prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative iv steroid versus saline on swallowing after anterior cervical spine surgery

this investigation is a prospective, randomized, double-blind, controlled trial testing a single dose of peri-operative steroid versus saline and the effect on swallowing after anterior cervical spine surgery. swallowing symptoms will be measured using the patient reported bazaz (bazaz) scale, the eat10 survey, and the dysphagia short questionnaire (dsq). swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. patient clinical outcomes will be captured using web-based progress reports. patients will complete the quality of life (qol-12), neck disability index (ndi), and visual analog scale (vas) questionnaires electronically pre-operatively and at one year post-operatively. this outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.

Eligibility criteria:
inclusion criteria: * elective anterior approach to subaxial cervical spine (c3 - t1); * ages 18-80 exclusion criteria: * traumatic or tumor etiologies * undergoing anterior-posterior operations * neoplastic, or infectious conditions requiring surgery * a history of previous anterior cervical spine surgery * any patient requiring a halo vest * patients on chronic steroids * patients remaining intubated post-operatively (please see more under risks below) * less than 18 years of age * pregnant women * no phone