Kornimate/medical-research-clean huggingface dataset:
study to evaluate the pharmacokinetics of tenofovir alafenamide (taf) in adults with normal hepatic function and adults with severe hepatic impairment

Conditions: Hepatitis B Virus

Summary: the primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (taf) and its metabolite tenofovir (tfv) in participants with normal hepatic function and in participants with severe hepatic impairment.


Eligibility criteria:
key inclusion criteria: * screening laboratory parameters within defined thresholds * creatinine clearance must be ≥ 60 ml/min key exclusion criteria: * females who are pregnant or nursing or males who have a pregnant partner * infection with hepatitis b virus (hbv) or hiv * history of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: severe hepatic impairment
enhancing triadic communication about cognition for older adults with alzheimer's disease or related dementias facing a cancer management decision

Conditions: Cancer; Dementia

Summary: building upon prior work, the investigator team developed a communication intervention for older adults with adrd who are considering a decision about cancer management (adapted intervention: coach-cog). the investigators hypothesize that for patients with dual diagnoses of adrd and cancer, coach-cog will increase autonomy support of care partners and patients in the decision-making process, leading to greater acknowledgement and support of cognitive concerns and cognitive-related goals, thereby improving goal concordant care. the investigators are conducting a pilot randomized controlled trial (rct; cluster randomized by physician) including approximately 45 oncology clinicians and 130 patient/care partner dyads evaluating the effect of coach-cog on care partner and patient autonomy support, care partner well-being, goal-concordance, and communication.


Eligibility criteria:
patients: patient inclusion criteria: 1. be age 65 or older 2. have a clinical diagnosis of alzheimer's disease or related dementia (adrd \[alzheimer's disease, vascular dementia, lewy body dementia, frontotemporal dementia, or dementia of unknown subtype\]) 3. have a clinical diagnosis of cancer (any type or stage) 4. anticipate a potential decision about cancer-related management, as confirmed by the patient's primary medical oncology clinician. 5. have a care partner willing and able to participate in the study 6. are able to read and understand english. the communication coaching session will be delivered in english, thus necessitating this requirement. 7. be able to provide informed consent (as measured by ubacc) or have a legally authorized representative to provide informed consent patient exclusion criteria: patient exclusion criteria: none care partner: care partner inclusion criteria: 1. age 18 or over 2. able to read and understand spoken english 3. able to provide informed consent care partner exclusion criteria: none oncology clinician: oncology clinician inclusion criteria: 1. oncology clinicians affiliated with the wilmot cancer institute 2. do not intend to move or retire within the next 2 years. oncology clinician exclusion criteria: none
impact of vaccination in acute covid-19

Conditions: COVID-19

Summary: the aim of this study was to evaluate the association between vaccination with one of the four sars-cov-2 vaccines authorized for use in the european union-bnt162b2, chadox-1s, mrna-1273 or ad.26.cov2.s-and progression to critically severe disease among adult patients with pcr-confirmed acute covid-19.


Eligibility criteria:
inclusion criteria: * age 18 yers or more * hospitalized for acute covid-19 * pcr confirmed infection with sars-cov-2 exclusion criteria: * hospitalized for other conditions
vitamin d homeostasis in sarcoidosis

Conditions: Sarcoidosis; Vitamin D Insufficiency

Summary: this study evaluates the relationship between vitamin-d status and severity of sarcoidosis, and the effects of vitamin-d repletion in vitamin-d insufficient patients with sarcoidosis. half the patients with sarcoidosis who are vitamin-d insufficient will receive standard vitamin-d supplementation via standard regimen while the other half will receive a placebo. sarcoidosis patients who are vitamin-d sufficient will also act as controls.

sarcoidosis is a multi-system inflammatory disease characterized by t-helper lymphocyte hyperactivity leading to granulomatous inflammation. the granuloma cells autonomously convert 25-hydroxy-vitamin-d (25ohd) to the active metabolite 1,25-dihydroxy-vitamin-d (1,25oh2d) independent of normal feedback control but dependent on substrate (25ohd) concentration. circulating 1,25oh2d exerts both anti-inflammatory and mineral metabolic actions. deficiency of 25ohd limits substrate-dependent 1,25oh2d synthesis, diminishes anti-antigenic innate immunity and augments pro-inflammatory adaptive immunity. thus, low vitamin-d stores could aggravate sarcoid inflammation while repletion of vitamin-d stores could mitigate inflammation in sarcoidosis.

Eligibility criteria:
inclusion criteria: * stable medical condition defined as no hospitalization or emergency room visit in the previous 3 months * no evidence of active pulmonary or systemic infection * no other active inflammatory disease, * no active malignancy. * normal serum ionized calcium level exclusion criteria: * hospitalization or emergency room visit in the previous 3 months * evidence of active pulmonary or systemic infection * evidence of active other inflammatory disease * evidence of active malignancy * elevated serum ionized calcium level
effect of enhanced sweat rate on the safety and edema status of chronic edematous patients

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to demonstrate safety and performance of aquapass system for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.

this is a prospective, single-center, open label single arm study, conducted in two phases: up to 6 healthy subjects (phase 1) and up to 16 chronic heart failure (chf) patients (phase 2). after being informed about the study, requirements and potential risks, consenting patients will be enrolled and undergo 3 procedures (each procedure up to 3 (±1) hours operation), with 4-10 days between each procedure. all patients will be followed up for 7 (±2) days from final procedure.

Eligibility criteria:
inclusion criteria: phase 1: healthy subjects: 1. age ≥ 18 2. subject has been informed on the nature of the study and has provided informed consent 3. subject is capable of meeting study requirements phase 2: chf patients: 1. age ≥ 18 and diagnosed with chf 2. subject has 2 or more score for pitting edema 3. subject is taking diuretic medications at home 4. subject has been informed on the nature of the study and has provided informed consent 5. subject is capable of meeting study requirements exclusion criteria: phase 1: healthy subjects: 1. subject is enrolled to another clinical investigation that might interfere with this study 2. subject is pregnant or planning to become pregnant within the study period, or lactating mothers 3. subject has no known sensitivity to neoprene phase 2: chf patients: 1. subject is enrolled to another clinical investigation that might interfere with this study 2. subject is admitted to the hospital for acute decompensated or acute heart failure 3. subject has any known lower body skin problems (open wounds, ulcers) 4. egfr\<15 ml/min/m2 5. subject with severe peripheral arterial disease 6. subject is pregnant or planning to become pregnant within the study period, or lactating mothers 7. subject has known sensitivity to neoprene

Keywords: chf edema
genomic approaches to common chronic disease - ancillary to aric

Conditions: Cardiovascular Disease

Summary: the aric study is a prospective epidemiologic study conducted in four u.s. communities and designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date.

the atherosclerosis risk in communities study (aric), sponsored by the national heart, lung and blood institute (nhlbi), is a prospective epidemiologic study conducted in four u.s. communities. aric is designed to investigate the etiology and natural history of atherosclerosis, the etiology of clinical atherosclerotic diseases, and variation in cardiovascular risk factors, medical care and disease by race, gender, location, and date. aric includes two parts: the cohort component and the community surveillance component. the cohort component began in 1987, and each aric field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community. a total of 15,792 participants received an extensive examination, including medical, social, and demographic data. these participants were reexamined every three years with the first screen (baseline) occurring in 1987-89, the second in 1990-92, the third in 1993-95, and the fourth and last exam was in 1996-98. follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. in the community surveillance component, currently ongoing, these four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and coronary heart disease deaths in men and women aged 35-84 years. hospitalized stroke is investigated in cohort participants only. the study conducts community surveillance of inpatient heart failure (ages 55 years and older) and cohort surveillance outpatient heart failure events beginning in 2005.

Eligibility criteria:
inclusion criteria: * the aric study began in 1987, and each aric field center randomly selected and recruited a cohort sample of approximately 4,000 individuals aged 45-64 from a defined population in their community exclusion criteria: * those not meeting the inclusion criteria

Keywords: cvd
trial to investigate immune responses elicited by a liquid formulation of influenza virus vaccine(caiv-t)in healthy adults aged 18 to 59 and healthy adults aged 60 years and older

Conditions: Influenza

Summary: the purpose of this clinical study was to evaluate immune responses measuring antibodies in serum and secretions and cellular immune responses generated by caiv-t vaccine in healthy adults aged 18 years and older as a means to develop assays for application in investigating potential immunological correlates of protection and/or establishing assays to measure vaccine take.


Eligibility criteria:
inclusion criteria: * healthy adults aged 18 to 59 years or \> 60 years. * female subjects of childbearing potential who had a negative urine pregnancy test result prior to study vaccination. females who were surgically sterile or post-menopausal did not require pregnancy testing. * adults who were determined by medical history, physical examination and clinical judgment eligible for this study. subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination, will be eligible. * subjects who provided written informed consent after the nature of the study was explained. * subjects who were available for the duration of the study (from enrollment to study completion). * subjects who could be reached by study staff for the post-vaccination contact \[via telephone, clinic or home visit\]. exclusion criteria: * for subjects \> 60 years of age only: * subjects who resided in a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care. an ambulatory subject who resided in a retirement home or village was eligible for participation. * subjects with evidence of dementia or other severe cognitive impairment based on mini mental state examination (mmse) scores. note: prior to study vaccination, all subjects \>60 years of age must have completed a mmse. for all study subjects: * subjects who were perceived to be unavailable or difficult to contact for evaluation of study visits during the study period. * subjects with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents. * subjects who resided in the same household as an immunosuppressed or immunocompromised individual. * subjects with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine, placebo or tiv. * subjects who had a current wheezing episode that was considered a change from the subject's usual clinical state.
yoga in treatment of eating disorders

Conditions: Eating Disorders

Summary: purpose: to examine effects of hatha yoga in treatment of eating disorders. methods: participants: patients with dsm-iv anorexia nervosa, bulimia nervosa or eating disorders not otherwise specified will be invited to participate in this study. exclusion criteria will be age under 18, serious medical complications, psychosis or increased risk of suicide. design: randomized controlled single-blinded trial. intervention: 2 x 90 min weekly group sessions for 12 weeks with hatha yoga. main outcome measure: reduction in eating disorders examination score. secondary outcome measures: reduction in body dissatisfaction, depression and anxiety

for the last years, yoga has become a popular "body-mind" form of exercise in western countries (daubenmier, 2005). yoga has shown good effects on increasing muscle strength, flexibility and stability, in addition studies have found reduced stress level, improved mood and breathing (astin et al., 2003; gimbel, 1998b; granath et al., 2006; lavey et al., 2005; manjunatha et al., 2005b; netz \& lidor, 2003a; telles \& naveen, 1997b; yadav et al., 2005b). previous research have shown a tendency for persons practicing yoga improving body awareness and body sensitivity, and reduction of body dissatisfaction (daubenmier, 2005). in addition, two studies have examined yoga in treatment of binge eating disorder (daubenmier, 2005; gimbel, 1998a). results showed reduction in number of binge eating episodes in the intervention group compared to the control group. no available studies have examined effect of yoga in treatment of the eating disorders types anorexia nervosa or bulimia nervosa.

Eligibility criteria:
inclusion criteria: * age 18 or above * dsm-iv anorexia nervosa, bulimia nervosa or eating disorders not otherwise specified exclusion criteria: * serious medical complications * psychosis * suicidal behavior

Keywords: eating disorders yoga body awareness depression anxiety
validation of the chinese version of the seconds

Conditions: Minimally Conscious State; Vegetative State

Summary: the aim of this study was to translate the seconds from english into chinese and determine the validity of this chinese version

the assessment is of great importance for the management and treatment in patients with disorders of consciousness. the simplified evaluation of consciousness disorders is a useful tool to assess consciousness of doc patients in bedside. the aim of this study was to translate the seconds from english into chinese and determine the validity of this chinese version. to test internal reliability and inter-rater reliability, both rater a and rater b assess the perception of pain on day 1; and to obtain test-retest reliability, rater a assessed all patients repeatedly on day 2.

Eligibility criteria:
inclusion criteria: * age ≥ 16 years old; * no administration of neuromuscular blockers or sedation within the 24 hours of enrolment; * the presence of periods of eye opening (indicating wakefulness and rest cycles); * a diagnosis of vs or mcs, based on more than 4 times behavioral assessment performed using the coma recovery scale-revised within 2 weeks. exclusion criteria: * coma; * documented history of prior brain injury; * psychiatric or neurologic illness; * neuromuscular blocking agents or sedative drugs administered within the prior 24 hours; * no documented history of a prior coma, critical illness or unstable medical condition; * upper limb contusions, fractures (based on the imaging examination) or flaccid paralysis (by using noxious stimuli to upper limbs, motor sub-scale scores \<1).

Keywords: disorders of consciousness vegetative state minimally conscious state consciousness
the effects of reiki and back massage on the pain and vital signs

Conditions: Pain; Abdominal Pain

Summary: the practice of reiki and back massage applications in support of pharmacological treatment is among the nursing initiatives and these practices increase the autonomy of the profession. the aim of this study was to determine the effects of reiki and back massage on pain, analgesic use and vital signs in women who had undergone open abdominal hysterectomy. this was an experimental study with a single, blinded, pretest-posttest control group. the population of the study consisted of women who had abdominal hysterectomy in the obstetrics clinics at gazi yasargil training and research hospital and dicle university hospital between july 2017 and february 2018. the patients were divided into three groups: reiki, back massage and control, with 34 patients in each group. reiki or back massage were applied for 20 minutes once a day to the patients in the reiki and back massage groups.

the study was carried out to determine the effect of reiki and back massage application on pain, analgesic use and vital signs in women underwent open abdominal hysterectomy. this study used an experimental pretest and posttest design with two experimental groups (reiki and back massage), and a control group. the population of the study consisted of women who underwent abdominal hysterectomy in the obstetrics clinics of the gazi training and research hospital and dicle university hospital between july 2017 and february 2018. open abdominal hysterectomy is usually performed in clinics on a planned basis.the data were collected by the researcher in the clinic by the face-to-face interview method using the patient information form, the numeric pain rating scale (nprs), and the vital signs and postoperative analgesic follow-up form.

Eligibility criteria:
inclusion criteria: * patients who underwent surgery in elective conditions, * were hospitalized for at least two days after surgery, * did not develop any serious complications after surgery, * were operated on under general anesthesia, * had no previous reiki or back massage, * had a pain level of 3 or above according to the numeric pain rating scale, * had no cognitive, affective or communication problems, * used only one type of analgesic (a non-narcotic analgesic) * did not use patient-controlled analgesics. exclusion criteria: * patients with chronic disease (such as hypertension, cardiovascular disease), * severe complications after surgery (such as bleeding, infection), * those who were taking narcotic analgesics.

Keywords: back massage hysterectomy pain reiki
prospective evaluation of the resection margins and the ganglionic status using a quality standard resection for adenocarcinoma of the head of the pancreas

Conditions: Pancreas; Adenocarcinoma

Summary: this multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.

primary objective: * evaluation of the prognosis role of the invasion of the margins on the overall survival after a standard resection of adenocarcinoma of the head of the pancreas. secondary objectives: * evaluation of the prognosis role of the invasion: * of margins on the overall survival. * of each margins (distal pancreatic margin, gastric, posterior, retro-venous, retro-arterial) on the overall survival. * of the ganglionic group of the superior mesenteric artery and the other nodes.

Eligibility criteria:
inclusion criteria: * a head of the pancreas tumor compatible with adenocarcinoma diagnosis * tumor apparently removable * patient aged from 18 to older * signed consent non inclusion criteria: * pregnancy, breast feeding * patient in an urgency situation or patient with legal protection exclusion criteria after surgery: * tumor other than adenocarcinoma of the head of the pancreas. * analysis of the margins not done with the defined criteria * nonadhesion to the surgical protocol

Keywords: pancreas adenocarcinoma
a study of intravenous or subcutaneous methoxy polyethylene glycol-epoetin beta (ro0503821, mircera) in chronic kidney disease patients with renal anemia

Conditions: Anemia

Summary: this study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (esas) in phase ii or iii clinical studies. they continued to receive methoxy polyethylene glycol-epoetin beta or comparator esas at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.


Eligibility criteria:
inclusion criteria: * written informed consent * adult patients (≥ 18 years old) with chronic renal anemia * maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: ba16528\[nct00048048\], ba16285\[nct00048035\], ba16286\[nct00364832\], ba16736\[nct00077597\], ba16738\[nct00081471\], ba16739\[nct00077610\], ba16740\[nct00077623\], ba17283\[nct00077766\] and ba17284\[nct00081484\] * hemoglobin (hb) concentration between 10.5 and 13.0 g/dl * adequate iron status defined as serum ferritin ≥ 100 ng/ml or transferrin saturation (tsat)≥ 20% or percentage of hypochromic red blood cells (rbcs) \< 10% exclusion criteria: * poorly controlled hypertension * history of epileptic seizure * pure red cell aplasia * chronic congestive heart failure \[new york heart association (nyha) iv\] * high likelihood of early withdrawal or interruption of the study * active malignant disease (except non-melanoma skin cancer) * life expectancy less than 12 months * pregnancy or breast-feeding