Kornimate/medical-research-clean huggingface dataset:
cabozantinib in the elderly with metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of cabozantinib in the treatment of patients with renal cell carcinoma.


Eligibility criteria:
inclusion criteria: * age 70 years * histological diagnosis of renal cell carcinoma (any histology, with the exclusion of urothelial carcinomas) * locally advanced disease or metastatic disease (any site, measurable or non- measurable lesions), progressing after at least one line of vegfr-targeted therapy (as per official registration of the drug at aifa, in case of extension to first-line treatment, tki-naïve patients will also be eligible), with or without previous exposure to check-point inhibitors. * life expectancy of at least 3 months * adequate hepatic, renal and bone marrow function as judged by the treating oncologist. * written informed consent exclusion criteria: * inability to swallow cabozantinib tablets * serious comorbidities or cognitive impairment, which may interfere with cabozantinib administration and/or patient's follow up, as judged by the treating physician * absence of a reliable caregiver, as judged by the treating physician

Keywords: cabozantinib
improving motor skill development in infants after cardiac surgery

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life.

congenital heart disease (chd) and the need for life-saving heart surgery and intensive care during infancy may have effects on infant behavior and development. children who require open heart surgery before their first birthday are vulnerable to developmental delays, especially related to motor skills (mobility) in the first year of life. early delays in gross motor functioning (e.g., rolling, crawling, walking) have implications for learning and psychosocial development through adulthood. to date, no interventions to improve the gross motor functioning of children born with chd have been developed. the purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three months of life. activities will be tailored based on the individual infant's motor ability and medical status.

Eligibility criteria:
inclusion criteria: * all hospitalized infants under age 4 months having cardiac surgery before age 3 months * intubation \>/= 24 hours \</= 14 days exclusion criteria: * prematurity \</= 36 weeks gestation * pre-operative clinical evidence of a central nervous system (cns) anomaly or history of cns insult
battlefield acupuncture following shoulder surgery

Conditions: Shoulder Injuries; Pain, Postoperative; Acupuncture, Ear; Pain Management

Summary: the purpose of this randomized clinical trial is to determine the effectiveness of battlefield acupuncture (bfa) in addition to standard post-surgical shoulder physical therapy compared to a standard shoulder rehabilitation program in reducing medication use and pain in patients who have undergone shoulder surgery. measurements of medication (opioid, nsaid, acetaminophen, etc.) use (daily number of pills consumed), pain rating, patient specific functional scale and global rating of change will be taken at 48-hours (baseline), 72-hours, 1-week, and 4-weeks post-surgery. it is hypothesized that the inclusion of battlefield acupuncture will result in a decrease in post-surgical pain levels, reduced opioid medication use, and improved patient mood when compared to rehabilitation alone.


Eligibility criteria:
inclusion criteria: * age 17-55 department of defense beneficiaries (17 only if an emancipated cadet at the u.s. military academy) * prior to or within 48 hours post shoulder stabilization surgery * prior to or within 48 hours post rotator cuff repair surgery exclusion criteria: * self-reported pregnancy * history of blood borne pathogens, infectious disease, or active infection * history of metal allergy * history of bleeding disorders or currently taking anti-coagulant medications * participants who are not fluent in english
assessment of community transmission of sabin type 2 virus in bangladesh

Conditions: Vaccine Virus Shedding

Summary: the strategic advisory group of experts on immunization (sage) has set a plan to replace trivalent oral polio vaccine (topv) with bivalent opv (bopv) plus inactivated polio vaccine (ipv) in routine immunization globally, to be instituted in 2015-2016. at the community level, the impact of the change from topv + ipv to bopv + ipv on sabin virus fecal-oral transmission (duration of circulation, degree of genetic reversion) and the persistence of environmental contamination are unknown. also unknown is the impact of the change from topv to bopv on community circulation of sabin 2 after a special immunization (si) activity with monovalent oral poliovirus type 2 (mopv2). finally it is unknown at the level of an individual child if type 2 fecal shedding will be limited by cross-protection from oral vaccination with sabin type 1 and 3. the investigators propose to measure at a community level transmission of sabin 2 virus in bangladesh, a low income country, where fecal-oral transmission and environmental exposures are high, comparing transmission in the setting of vaccination with topv+ipv vs. bopv+ipv. the study will be conducted in 67 villages in matlab, bangladesh, using a cluster-randomized study design. villages in matlab will be randomly assigned to receive as part of routine immunization (ri) activities: (1) topv (6,10,14 weeks) plus ipv at 14 weeks; (2) bopv (6,10, 14 weeks) plus ipv at 14 weeks; or (3) bopv (6,10, 14 weeks) plus ipv at 14 and 18 weeks. community and environmental surveillance for sabin 2 virus will be conducted in each village over the 9 month period of these ri activities. in addition, a si activity with mopv2 will occur 9 months into the study to model an outbreak response. for the 6 months following the mopv2 challenge, the impact of the different vaccination regimens on sabin 2 transmission in the community will be determined, as well as individual level protection (as measured by fecal shedding from days 7-70 after mopv2 challenge).


Eligibility criteria:
inclusion criteria: * a male or female infant at least 6 weeks of age (42-48 days) at the time of enrollment * for the special immunization activity (sia) only, being age 5 years or younger at the time of the sia * an infant whose parent or guardian's primary residence, at the time of first expanded program on immunization (epi) vaccinations, is a village selected to receive polio vaccine. * written informed consent obtained from the parent or guardian of the participant, prior to the participants's first study vaccination exclusion criteria: * history of prior polio vaccination (in the 810 infants enrolled at 6 weeks of age only) * hypersensitivity to the active substance or any component in the vaccine * subjects with uncorrected congenital malformation * infants with known or suspected immunodeficiency
can a person-centred-care intervention improve health-related quality of life in patients with head and neck cancer

Conditions: Health Related Quality of Life

Summary: at all of the follow-ups, including the worst period (between four and ten weeks), the intervention group reported higher scores than the control group, suggesting in this rct that adopting the person-centred-care concept was a promising way to improve function and wellbeing in patients with hnc.

background: the incidence of head and neck cancer (hnc) is increasing slightly. hnc and its treatment may affect general domains of health-related quality of life (hrqol) and provoke a variety of adverse symptoms and side effects, both during and after treatment. the objective of this study was to compare a person-centred care intervention in terms of hrqol, disease-specific symptoms or problems, with traditional care as a control group for patients with hnc. methods: the intervention and control groups comprised 54 and 42 patients, respectively. outcome measures used were: the eortc qlq-c30 and the eortc qlq-c35. both groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of treatment. the questionnaires' scores were compared between groups by using independent samples test (student's t-test) and non-parametric test (mann-whitney u test) for continuous variables. for categorical data, fisher's exact test was used. longitudinal data were analysed using repeated measures in covariance pattern models. results: at baseline, the intervention and control groups were comparable in terms of medical and sociodemographic variables, clinical characteristics, hrqol and disease-specific symptoms or problems. at all the follow-up points, even during the worst period for the patients, the person-centred-care group consistently reported higher scores than the control group. the differences were numerically but not always statistically significant. when using repeated measures in covariance pattern models, statistically significant results were found for hnc-specific problems, swallowing (p= 0.014), social eating (p=0.048) and feeling ill (p=0.021).

Eligibility criteria:
inclusion criteria: * eligible for this study were patients diagnosed with hnc, older than 18 years and able to read and write swedish and, in addition, suitable for outpatient treatment with chemo- and/or radiotherapy, either as primary treatment or in a postoperative setting. exclusion criteria: * patients were excluded if they had a previous or concomitant malignancy or were diagnosed and treated for depression as stated in their medical record. * in order to minimize the risk of bias, none of the patients were to be included if they were taking part in other research studies

Keywords: head and neck cancer person centred care health related quality of life eortc qlq-c30 eortc qlq-c35
prevention of post-traumatic seizures with levetiracetam

Conditions: Epilepsy, Post-Traumatic

Summary: post-traumatic seizures can appear frequently after a severe traumatic brain injury. two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy.


Eligibility criteria:
inclusion criteria: 1. age \>= 18 years old 2. patient with severe brain injury defined as follow: * initial glasgow coma score (assessed on the scene of the accident) \<= 8 related to the brain injury * stage 2 to 4 on the tdm us tcdb classification 3. initial brain ct scan performed within 48 hours after hospital admission 4. either a male or a nonpregnant, non-lactating female who is using adequate contraceptive method (a urine laboratory pregnancy test must be negative at baseline) 5. written informed consent from the patient's next-of-kin. if no relative is present as the time of inclusion, the patients will be included according to the emergency procedure exclusion criteria: 1. isolated extradural hematoma 2. medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, hiv, etc.) 3. current participation in an other protocol or within one month before study entry 4. previous treatment with levetiracetam 5. patient's follow-up judged to be difficult by the investigator 6. known allergy to either levetiracetam or products derived from pyrrolidone or one of its excipients 7. epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol)
tranexamic acid (txa) in hip arthroscopy

Conditions: Hip Pain Chronic; Hip Impingement Syndrome; Hip Injuries; Blood Loss; Femoro Acetabular Impingement

Summary: the primary goal of this study will be to determine if perioperative iv tranexamic acid (txa) administration will reduce intra-operative bleeding and subsequently improve visual clarity during surgery and reduce operative traction time in patients undergoing hip arthroscopy. additionally, this study aims to determine whether iv txa injections will reduce post-operative pain and affect hip-specific patient-reported outcomes in patients undergoing hip arthroscopy.


Eligibility criteria:
inclusion criteria: * age 18 years or older * scheduled to undergo primary hip arthroscopy for any intra-articular procedure * able to complete and understand study materials in english exclusion criteria: * age under 18 years * cannot complete and understand study materials in english * patients undergoing revision surgery * patients who have had previous surgery to the study joint * patients on drugs that interfere with coagulation or txa clearance * patients with a known allergy to txa * patients with any of the following comorbidities * bleeding and/or coagulative disorders * renal impairment * sickle cell disease * thrombotic diseases * comorbidities preventing surgery (including pregnancy)

Keywords: hip arthroscopy tranexamic acid intra-operative blood loss labral repair of the hip acetabuloplasty
safety and blood donations in adults vaccinated with rmenb+omv nz.

Conditions: Meningitis, Meningococcal, Serogroup B

Summary: the purpose of this trial is to assess the safety of a meningococcal group b vaccine and to collect blood donation. sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the meningococcal group b vaccine in other studies.


Eligibility criteria:
inclusion criteria: 1. individuals of 18 through 50 years of age on the day of informed consent; 2. individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry; 3. individuals who could comply with study procedures including follow-up; 4. males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method. exclusion criteria: 1. progressive, unstable or uncontrolled clinical conditions; 2. hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study; 3. abnormal function of the immune system; 4. chronic clinical significant conditions; 4. been administered any group b meningococcal vaccine at any time prior to informed consent; 5. current or previous, confirmed or suspected disease caused by n.meningitidis.
genetic counseling through virtual visits in parkinson's disease

Conditions: Parkinson Disease

Summary: the research study is being conducted to compare methods of virtual genetic counseling for people with parkinson's disease.

this research will evaluate different virtual methods of pre-test genetic counseling and post-test genetic results disclosure in people with parkinson's disease. participants will be randomized to receive different methods of genetic counseling using web-based, telephone, or telehealth methods. in both pre- and post-test counseling phases, remote genetic counseling methods will be compared to demonstrate equivalence. the primary outcomes will be equivalence on genetics knowledge and outcomes scales, and the revised impact of events scale. the purpose is to develop effective and scalable approaches to genetic counseling. this work is crucial for patient safety and will improve access to care through novel genetic counseling approaches.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to have clinical confirmation genetic testing, and comply with all study procedures and availability for the duration of the study * male or female, over the age of 21. * english speaking exclusion criteria: * prior genetic counseling and/or clinical testing specifically for parkinson's disease * montreal cognitive assessment (moca) \< 21, or a prior diagnosis of dementia during the screening phase
study of erythrocyte parameters and hypercoagulability in sickle cell disease (scd-tga)

Conditions: Sickle Cell Disease; Vaso-occlusive Crisis

Summary: sickle cell disease (scd) is an inherited haemoglobinopathy disorder caused by mutations in hbb gene with amino-acid substitution on β globin chain. the consequence is synthesis of altered haemoglobin s (hbs) which polymerises in red blood cell (rbc) at deoxygenated state. scd is associated with chronic haemolytic anaemia, vaso-occlusive crisis (voc) leading to frequent hospitalisation. the aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict voc development in confirmed scd patients.


Eligibility criteria:
inclusion criteria: * sickle cell disease exclusion criteria: * \<18 years * pregnancy * patient under protective guardianship or curatorship

Keywords: sickle cell disease vaso-occlusive crisis reticulocyte count thrombin generation assay hypercoagulability
nocturnal/diurnal intraocular pressure-lowering effect of netarsudil ophthalmic solution

Conditions: Ocular Hypertension; Open Angle Glaucoma

Summary: to evaluate effect of netarsudil ophthalmic solution 0.02% on nocturnal and diurnal intraocular pressure.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older. 2. ocular hypertension or open-angle glaucoma in both eyes. 3. unmedicated intraocular pressure \> 17 mmhg in one or both eyes and \< 30 mmhg in both eyes. 4. corrected visual acuity in each eye equivalent to 20/200 or better. 5. able and willing to give signed informed consent and follow study instructions. exclusion criteria: 1. glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles. 2. intraocular pressure ≥ 30 mmhg. 3. use of ocular medications within 30 days. 4. known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination. 5. previous eye surgery (other than cataract). 6. ocular trauma within 6 months. 7. clinically significant ocular disease that might interfere with the study. 8. central corneal thickness greater than 620 µm.
fibromyalgia in patient with impaired fasting glucose

Conditions: Fibromyalgia

Summary: to assess the frequency of fibromyalgia among women with impaired fasting glucose.

objective: to assess the frequency of fibromyalgia among women with impaired fasting glucose. materials and methods: the sample was selected from the patients who applied to the internal medicine clinic and whose fasting blood glucose level were ≥100 and \<126 mg/dl in their routine examination \[group1 \] and patients whose fasting blood glucose were less than 100 constituted the control group \[group2 \]. oral glucose tolerance test \[ogtt \] has been applied to patients with impaired fasting glucose and whose 2nd hour ogtt levels were under 140 has been included. patients were evaluated in terms of fibromyalgia according to modified 2010 acr fibromiyalgia criteria. functional status was assessed by using the fibromyalgia impact questionnaire \[fiq \].

Eligibility criteria:
inclusion criteria: * the study group subjects: fasting blood glucose level was between 100 and 126 mg/dl; * the control group subjects: fasting blood glucose level was \< 100 mg/dl. exclusion criteria: * patients with a severe systemic disease (chronic kidney disease, liver disease etc. ), * psychiatric disease, * hypothyroidism or hyperthyroidism, * any connective tissue disease * patients who used medications that influenced the fibromyalgia symptoms, such as analgesics, antidepressants, and anticonvulsive medications
help-hy: health education and sleep program in hypertension

Conditions: Prehypertension; Hypertension

Summary: hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. the escalating prevalence of inadequate sleep now parallels that of hypertension. observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed. in this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (≤6.5 hours/night).


Eligibility criteria:
inclusion criteria: * age: 18 to 65 (inclusive) * gender: both males and females * body mass index (bmi): 18.5-34.9 kg/m2 * habitual sleep duration \ 45 min catch-up sleep during weekends or holidays) * presence of prehypertension (office systolic bp (sbp) 120-139 mmhg and/or diastolic bp (dbp) 80-89 mmhg) , stage 1 hypertension (office sbp 140-159 mmhg and/or dbp 90-99 mmhg ) , or currently taking antihypertensive medications * either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions * not pregnant or breast feeding and not intending to become pregnant or breast feed * not a current smoker or tobacco user * ability to provide written informed consent. exclusion criteria: * vulnerable study populations will be excluded * pregnancy * smoking * shift-work * travel across \>2 time zones in the previous month * presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep/circadian disorders, psychiatric disorders * if taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month * sleep aids * habitual sleep duration ≥7 hours * excessive alcohol (\>14 drinks/week in men and \>7 drinks/week in women) and/or excessive caffeine intake (\>400 mg) * currently on a diet and/or actively trying to lose weight * history of drowsing driving * severe daytime sleepiness (score \>15 at the epworth sleepiness scale) * current or previous (during the past 2 months) participation in other research studies at the discretion of study personnel * blood/plasma donation during the past 2 months * unwillingness or inability to adjust sleep schedule