Kornimate/medical-research-clean huggingface dataset:
music-listening during deep brain stimulation to relieve anxiety

Conditions: Movement Disorders; Deep Brain Stimulation

Summary: this study aims to demonstrate that music listening in patients undergoing awake deep brain stimulation reduces subjective and objective measures of anxiety. furthermore, the investigators aim to demonstrate that music may alter neuronal firing patterns based on the type of music played and the location in the brain.

while conscious neurosurgical interventions are generally well-tolerated, they often cause some measure of pain and anxiety. patients have been reported to suffer from recurring distressing recollections of, or dreams about, the surgery and other post-operative, post-traumatic stress disorder-like sequelae. high anxiety during surgery correlates with post-operative psychological disturbances. notably, listening to music reduces anxiety in patients undergoing awake surgical procedures. nonetheless, dbs is typically performed without music because ambient noise typically interferes with interpretation of neuronal recordings. recording objective and subjective measures of stress during dbs provides a unique opportunity to determine the effect of music on intra-operative patient anxiety levels in patients listening to music compared to non-music listening control patients. the investigators hypothesize that playing music will improve intra-operative anxiety as measured by objective and subjective measures of stress, including blood pressure, heart rate, cortisol levels and anxiety questionnaires. additionally, previous data in the investigator's lab has demonstrated that the subthalamic nucleus (stn) responds to melodic music by decreasing the average frequency of neuronal firing. the investigator's pilot study also suggests that stn and thalamic neurons respond differently to melodic music; the neurons in the stn increase synchrony of firing, while neurons in the thalamus decrease synchrony of firing over the course of the music clip. the investigators, therefore, aim to characterize the neuronal firing pattern changes in patients undergoing awake dbs procedures in greater detail, drawing from a larger sample size.

Eligibility criteria:
inclusion criteria: * stn or vim targeted dbs surgery, awake dbs surgery exclusion criteria: * no previous dbs surgeries, no history of deafness
lokomat treadmill training effects on ms gait

Conditions: Gait, Unsteady; Multiple Sclerosis

Summary: this study is being done to test the possible benefits of gait-specific training using body-weight supported, lokomat assisted, treadmill training in people with multiple sclerosis.


Eligibility criteria:
main inclusion criteria: * clinical diagnosis of ms * edss level between 3.5-6.0 * problems with ambulation * able to ambulate 25 feet without an assistive device main exclusion criteria: * lower extremity injuries that limit range of motion or function * unable to demonstrate an understanding of the process of the study and or fully understand instructions in order to safely participate in the study and use study equipment * body weight over 150 kg * complete inclusion/exclusion criteria listed in consent form

Keywords: multiple sclerosis gait falls lokomat body-weight support treadmill training
fisher wallace neurostimulation & depression study

Conditions: Major Depressive Disorder

Summary: examine the safety and effectiveness of the fisher wallace cranial electrotherapy stimulator device on major depressive disorder using two 20-minute per day treatment sessions over eight weeks.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 21 * us resident * can receive packages to their home via ups/fedex/usps * major depressive disorder * phq-8 score greater than 10 (show some signs of mild to moderate depression) * phq-8 score less than 20 (given remote study serious depressed should be excluded) * read/write english * have not contemplated suicide in the past year * not been institutionalized for mental health issues. * not currently experiencing problems with alcohol or drug abuse * can commit to not drinking alcohol 4 hours before bedtime for the duration of the study * can commit to two (2) 20 minute sessions per day for 8 weeks * has not used a brain stimulation treatment in one year * no suspected or known history of heart disease * no pacemaker * not under medical supervision for other serious medical condition * not taking opioids * is a resident of states in which we have licensed medical professionals
eribulin treatment as 1st-line or 2nd-line chemotherapy for her2-negative hormone-resistant inoperable or recurrent metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a observational study in a real-world setting, not requiring determining a dosage regimen, dose reduction criteria, rest period criteria and withdrawal criteria. the purpose of the study is to investigate the efficacy of eribulin as the first or second line chemotherapy to prolong overall survival and to explore factors affecting the survival in patients with her2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who scheduled to receive the first or second line chemotherapy in clinical practice in japan. the total duration of the study will be a maximum of 5 years, consisting of 2-year enrollment period and 3-year observational period; the duration of patient participation will be 3 years. all patients will receive adequate treatment for breast cancer which selected by the primary physician after enrollment using the japanese breast cancer society clinical practice guideline of breast cancer and the national comprehensive cancer network (nccn) clinical practice guidelines in oncology. investigators at the investigational sites will enter patient data into an electronic data capture (edc) system up to the third chemotherapy in the study. the end of the study is defined as the time the last patient completes observational period. patients will primarily be assessed by overall survival (os) of the first line chemotherapy.


Eligibility criteria:
inclusion criteria: 1. female patients with histologically or cytologically confirmed breast cancer. 2. patients with inoperable or recurrent metastatic breast cancer regardless of the metastatic site and number, excluding symptomatic central nervous system metastases. 3. patients with her2-negative disease confirmed as ish negative or ihc 0, 1+ or 2+ (those with ihc 2+ are eligible, if the additional ish test results are negative. those are ineligible who are with any positive results of estrogen receptor or progesterone receptor test on primary and recurrent lesion). 4. patients who are resistant to hormone therapy. 5. patients with indication for the first or second line chemotherapy in her2-negative hormone-resistant inoperable or recurrent metastatic breast cancer who are scheduled to receive the chemotherapy. 6. patients with the eastern cooperative oncology group (ecog) performance status score 0-3 at the time of enrollment. 7. patients with adequate bone marrow and major organ function judged by the primary physician. 8. patients who have signed written informed consent to participate in this study. exclusion criteria: 1. patients with symptomatic metastasis in the central nervous system. 2. patients with a previous history of hypersensitivity to any component of drugs which will be administered in the treatment. 3. patients who are considered to be inappropriate for the study participation by the primary physician.

Keywords: breast cancer eribulin her2-negative hormone-resistant inoperable recurrent metastatic
mixed tree nut food challenges

Conditions: Food Allergy

Summary: the purpose of this prospective study is twofold: 1) to establish oral tolerance to selected tree nuts and to examine potential predictors of oral tolerance and 2) to determine the usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut allergy and oral tolerance.

to evaluate the absence of tree nuts (tn) allergy, referred patients from one of the arkansas children's hospital (ach) allergy clinic physicians with current serum immunoglobulin e (ige) to tns that meet eligibility criteria will be invited to undergo a series of open mixed tn food challenges. a questionnaire pertaining to their tn allergy will be administered a brief physical exam will be performed. skin prick tests using selected nut allergen extracts along with a positive (histamine) and a negative (salt-water) control will be performed at the first oral food challenge visit. each food challenges will be performed to 1 to 3 tns. two telephone follow-up phone calls will evaluate inclusion/exclusion of tree nuts in the diet post food challenge.

Eligibility criteria:
inclusion criteria: * any patient between 3-21 years of age followed by the allergy and immunology department at arkansas children's hospital on tree nut avoidance diet. * has current serum ige test within the past 12 months to major nuts in question. all tn serum ige are \<10 * children must have a stable baseline examination prior to undergoing challenge without significant symptoms of atopic dermatitis, allergic rhinoconjunctivitis, current urticaria or other allergic symptoms deemed important by the physician. * children must have stable asthma and no wheezing or repetitive cough prior to challenge, nor have been treated with oral steroids for a significant asthma exacerbation within 1 month of challenge. asthmatics that undergo lung function testing. * children must have no current illness (e.g., fever or viral illness) at time of challenge. * the subject will be asked to restrict the use of antihistamines (short acting, 72 hours: long acting, 5-7 days), (b-agonists (12 hours), theophylline (12 hours), and cromolyn (12 hours) prior to the first mixed tn food challenge. other medications may be continued. exclusion criteria: * any tn serum ige ≥10. * life-threatening reaction (respiratory involvement requiring medications, or shock, or gastrointestinal reaction requiring intravenous fluids) to any tn. * history of a reaction in the past year or severe reaction in the past 2 years or a history of a severe reaction anytime with a tn serum ige \>5 * unstable asthma, gastrointestinal disease, cardiovascular disease, chronic lung disease, beta-blocker use.

Keywords: food allergy tree nuts
efficacy and safety of medifoamⓡ and betafoamⓡ in pressure ulcer

Conditions: Pressure Ulcer

Summary: this study aims to exploratively assess the efficacy and safety of hydrophilic polyurethane foam dressing (medifoamⓡ or betafoamⓡ) in pressure ulcer specifically. the target enrolment is 20 patients, with 10 patients per arm.

as the primary objective, the percentage of completely healed patients and the time to complete healing will be assessed after applying the study device, medifoamⓡ or betafoamⓡ, for 12 weeks to pressure ulcer patients. in addition, the pressure ulcer size reduction rate over 12 weeks will be evaluated. patients will make once weekly site visits. there are 14 visits in total, including a screening visit 14 days (maximum) before the baseline visit.

Eligibility criteria:
inclusion criteria: 1. adults aged at least 19 years old as of the consent date 2. pressure ulcer of national pressure ulcer advisory panel (npuap) stage iii at screening 3. pressure ulcer size of 3-10 cm2 at screening 4. written consent provided by the subject or representative exclusion criteria: 1. any study ulcer of npuap stage i, ii or iv 2. diabetic ulcer or venous ulcer (or stasis ulcer) 3. past history of surgical treatment within 1 year or irradiation at the target pressure ulcer within 1 year 4. hypersensitivity reaction to this product or povidone iodine 5. hyperthyroidism or thyroid disorder requiring drug treatment 6. signs of a current underlying systemic infection (sepsis/bacterial infection/tuberculosis) or cellulitis or osteomyelitis 7. type 1 diabetes 8. current malnutrition 9. heavy smoker: current smoking level of ≥1 pack (20 cigarettes)/day of tobacco 10. drug or alcohol addiction 11. requirement of immune-suppressants during the study, or current chemotherapy or radiotherapy 12. application of other investigational product/medical device within 1 month prior to the investigational device application 13. pregnant or breast-feeding women 14. other renal, hepatic, neurological or immunological disorder that may interfere with the wound healing process, at the discretion of the investigator

Keywords: foam dressing medifoamⓡ betafoamⓡ povidone iodine
effects of exercise training and genetic factors in hypertensive patients with obstructive sleep apnea sleep

Conditions: Exercise Training; Genetic Polymorphism

Summary: the objective is to investigate the effects of exercise training in hypertensive individuals with obstructive sleep apnea (osa) in neurovascular control taking into account genetic factors. seventy-two hypertensive patients with osa \>15 events/hour of sleep revealed by nocturnal polysomnography will be randomized into a control or physical training group. all will be evaluated for the t786 genotypes of the enos gene gene. the study will investigate the effect of the exercise program on vascular control in different alleles of the t786 genotypes of the enos gene.

experimental design. all participants underwent overnight polysomnography study. the apnea-hypopnea index (ahi) will be calculated by total number of respiratory events (apneas and hypopneas) per hour of sleep. obstructive sleep apnea will be defined as a cessation of respiratory airflow for 10 seconds with thoracoabdominal effort, which was detected by piezo respiratory effort sensor. individuals with \>70% of obstructive events were defined as individuals with osa. muscle blood flow will be evaluated by pletismography tecnique. heart rate and blood pressure. heart rate (hr) was beat-by-beat continuously measured during the test obtained in a computer-recorded electrocardiographic tracing. blood pressure (bp) was monitored noninvasively from an automatic leg blood pressure cuff (nondominant leg) using automated oscillometric device. the systolic, diastolic and mean blood pressures will be registered. cardiopulmonary exercise test. maximal exercise capacity was determined by means of a maximal progressive cardiopulmonary exercise test peak vo2 will be defined as the maximum attained vo2 at the end of the exercise period in which the subject could no longer maintain the walk velocity.

Eligibility criteria:
inclusion criteria: * sedentary, * hipertensive patients exclusion criteria: * severe cardiovascular, respiratory, renal or severe neuropsychiatric disease
efficacy of intravenous melatonin on mortality in adult patients admitted to the intensive care unit with covid-19

Conditions: COVID-19; SARS-CoV 2; Coronavirus Infection

Summary: there is an urgent need to evaluate effective treatments for covid-19 patients. melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. this randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in covid-19 patients in the icus.

icu covid-19 patients show high risk of death mainly due to sepsis and respiratory disfunction. prevention of these critical conditions is mandatory to reduce mortality and to improve patient's outcome. melatonin is an endogenous hormone involved not only in circadian rhythm control, but also in the cell protection due to its outstanding anti-inflammatory and antioxidative effects. high doses of melatonin have shown high efficacy against bacterial (sepsis) and viral infections. melatonin is a safe product that consistently has shown lack of side-effects when it is administered to humans. sars-cov 2 infection may yield severe forms of the disease that require the patients admission to the icu. these patients may develop an excessive inflammatory response and a burst of free radicals, constituting the major cause of death in these subjects. our hypothesis is that high doses of melatonin intravenously administered to covid-19 icu patients might reach enough blood levels able to prevent/counteract the developing of sepsis and the production of free radicals, reducing mortality and hospital stay.

Eligibility criteria:
inclusion criteria: * patient, family member or legal guardian has provided written informed consent. * age ε 18 years. * confirmed sars-cov-2 infection with compatible symptoms and a positive rt-pcr. * admission to the icu with acute hypoxemic respiratory failure attributed to sars-cov-2 infection. * icu length of stay of less than 7 days prior to randomization with or without mv and without signs of improvement in respiratory failure (murray score at randomization greater or equal to the murray score at icu admission). exclusion criteria: * participant in a different covid-19 study in which the study drug is under clinical development and hasn't been previously authorized for commercialization. * liver enzymes \> 5 times the upper normal range. * chronic kidney disease with gfr \< 30 ml/min/1.73 m2 (stage 4 or greater) or need for hemodialysis. * pregnancy. a pregnancy test will be performed on every woman younger than 55 years of age prior to inclusion. * terminal surgical or medical illness. * autoimmune disease. * any patient condition that can prevent the study procedures to be carried out at the treating physician's judgement.

Keywords: melatonin intravenous placebo intravenous icu patients covid-19
quetiapine sr as adjunctive treatment in mixed states of bipolar disorder

Conditions: Bipolar Disorder

Summary: to assess the acute and long-term bimodal efficacy of qtp, as an adjunct to ongoing treatment with lithium (li) or divalproex (div) or lamotrigine (lam) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in bd.


Eligibility criteria:
inclusion criteria: * male or female; * age 18 years and older * patients on: * li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5 meq/l or * div dose for 4 weeks or longer, and a serum level at screening of 45 g/ml or * lam (dosage/day ≥100mg) at a stable dose for 4 weeks or longer or * any combination 3a, 3b, or 3c * patients meeting dsm-iv tr diagnosis of bipolar disorder, i or ii, as assessed using the mini, (sheehan et al., 1998) plus any one of criteria 5 or 6 or 7 * patients meeting dsm-iv tr diagnostic criteria for a mixed manic episode with young mania rating scale (ymrs) score\>/=14 and montgomery asberg depression rating scale (madrs) score\>/=14 * patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of young mania rating scale (ymrs) score\>/=14 plus montgomery asberg depression rating scale (madrs) score\>/=14 ; * patients meeting dsm-iv tr diagnostic criteria for a major depressive episode with the simultaneous presence of madrs score\>/=14 plus meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of young mania rating scale (ymrs) score\>/=14 exclusion criteria: * patients with a current axis i diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or aids induced mania * women with a positive pregnancy test or who are lactating * women of child-bearing potential who are not practicing a clinically accepted method of contraception * patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases. * patients whose clinical status requires inpatient or day hospital treatment * history of severe side effects associated with therapeutic doses of li, div, lam * alcohol or drug dependent at time of enrollment * suicidal at time of enrollment. * current or previous exposure to qtp

Keywords: bipolar disorder, mania, depression
ofatumumab with fludarabine and cyclophosphamide in b-cll patients

Conditions: Leukaemia, Lymphocytic, Chronic

Summary: to investigate the safety and efficacy of two dose regimes of ofatumumab in combination with chemotherapy in previously untreated patients with b-cll


Eligibility criteria:
inclusion criteria: 1. patients with active b-cll and with an indication for treatment 2. age ≥ 18 years 3. following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out exclusion criteria: 1. any previous treatment for b-cll or any other treatments that can be considered active against b-cll 2. glucocorticoid unless given in doses ≤ 10 mg /day for other indications than b-cll (e.g. asthma) 3. known transformation of b-cll 4. known cns involvement of b-cll 5. past or current malignancy, except for: 1. cervical carcinoma stage 1b or less 2. non-invasive basal cell and squamous cell skin carcinoma 3. malignant melanoma with a complete response of a duration of \> 10 years 4. other cancer diagnoses with a complete response of a duration of \> 5 years 6. chronic or current infectious disease requiring systemic treatment 7. clinically significant cardiac disease 8. significant concurrent, uncontrolled medical condition 9. history of significant cerebrovascular disease 10. known hiv positive 11. positive serology for hepatitis b, unless due to vaccination 12. leukapheresis, except as a safety measure before chemotherapy 13. ecog performance status of 3 or 4 14. patients who at the time of inclusion are not expected to be able to complete the ofatumumab-fc regimen 15. patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to visit 1 16. current participation in any other interventional clinical study 17. patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder) 18. breast feeding women or women with a positive pregnancy test at visit 1 19. women of childbearing potential not willing to use adequate contraception for up to one year after last dose of ofatumumab. adequate contraception is defined as hormonal birth control or intrauterine device. for patients in the usa the use of a double barrier method is also considered adequate.

Keywords: b-cell cyclophosphamide fludarabine chronic lymphocytic leukemia ofatumumab