Kornimate/medical-research-clean huggingface dataset:
oxaliplatin plus capecitabine in treating patients with metastatic or recurrent solid tumor

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of oxaliplatin combined with capecitabine in treating patients who have metastatic or recurrent solid tumors.

objectives: i. determine the maximum tolerated dose of capecitabine when administered in combination with oxaliplatin in patients with metastatic or recurrent solid tumors. ii. determine the toxicities of this treatment regimen in this patient population. outline: this is a dose escalation study of capecitabine. patients receive oxaliplatin iv over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. patients are followed for disease progression and survival. projected accrual: a total of 12-15 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed metastatic or recurrent solid tumor that has failed standard therapy or for which no standard therapy exists no known brain metastases or carcinomatosis meningitis patient characteristics: age: 18 and over performance status: swog 0-2 karnofsky 60-100% life expectancy: at least 12 weeks hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 2 times normal ast no greater than 2.5 times normal renal: creatinine normal or creatinine clearance greater than 60 ml/min calcium no greater than 12 mg/dl cardiovascular: no symptomatic congestive heart failure no unstable angina pectoris no cardiac arrhythmia other: no evidence of neuropathy no history of allergies to platinum compounds or antiemetics that would preclude study no other uncontrolled illness (e.g., ongoing or active infection) no medical, social, or psychological factors that would preclude study not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: at least 4 weeks since prior immunotherapy and recovered chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered prior fluorouracil or cisplatin allowed endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy and recovered surgery: recovered from prior surgery other: at least 30 days since prior investigational drugs no concurrent antiretroviral therapy (haart)

Keywords: unspecified adult solid tumor, protocol specific
effects of cognitive behavioral therapy through a mobile app on patients with refractory functional dyspepsia

Conditions: Functional Dyspepsia; Self-help Mobile Cognitive Behavioral Therapy; Antipsychotic Drug

Summary: functional dyspepsia (fd) is a common gastrointestinal disease, which is associated with decreased life quality and increased medical cost. antipsychotic drugs were demonstrated to be effective in relieving symptoms in fd patients, especially for patients with refractory fd. however, the use of those drugs was associated with obvious adverse events. cognitive behavioral therapy (cbt) has extensive applications and exhibited potential treatment effects in clinical practices, especially for treating anxiety, depression, pain or stress disorders. several previous rct studies have confirmed the effects of psychological intervention on improving dyspepsia in fd patients. our hypothesis was that 8-week smartphone-based cbt would be non-inferior to conventional pharmacotherapy in reducing fd-related symptoms in patients with refactory fd.


Eligibility criteria:
inclusion criteria: 1. age 18-80 2. refractory functional dyspepsia (patients with rome iv functional dyspepsia remained symptomatic after treatment of 8 weeks of proton pump inhibitor and 4 weeks of prokinetics) 3. negative or unrelated-to-fd symptom findings of gastroscopy, upper abdominal ultrasound, hp test and routine blood tests within the past 1 year. exclusion criteria: 1. severe mental illness (phq-9 ≥20 or gad-7 ≥15) or suicidal ideation; 2. known hp infection, active gastrointestinal peptic ulcer, cholecystitis, gallstones, suspected or known bowel obstruction, gastroparesis, major gastrointestinal surgery etc.; 3. known or suspected malignant tumor, significant heart/brain/liver/kidney diseases, obvious hematologic abnormalities or endocrine diseases etc., which may be -related to fd symptoms; 4. known or suspected drug-related fd (e.g.nsaids-related fd); 5. unable to access to mobile networks or unable to manage mobile app properly. 6. allergy or other contradictions to flupenthixol or melitracen 7. taking any antipsychotics drugs or cbt interference within 12 weeks 8. pregnant or lactating women; 9. unable to provide informed consent.
food replacement on weight control in overweight volunteers

Conditions: Weight Gain

Summary: volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. for protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. for normal dietary group, they will take regular dinner every day for 8 weeks. weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.


Eligibility criteria:
inclusion criteria: * age 18-60 years * body mass index more than 23 kg/m2 * no heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases * wiling to attend the study exclusion criteria: * allergic to protein, grains, guar gum * take medicine, supplement, herbal substance for weight control within 1 month * during intermittent fasting * take birth control pill, steroids, anti-depressant drugs, and anti-epilepsy drugs * cushing syndrome's * pregnancy and lactation
patient-ventilator interactions in chronic obstructive pulmonary diseases (copd) under non-invasive ventilation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: non-invasive ventilation (niv) in severe hypercapnic chronic obstructive pulmonary diseases (copd) may be associated - during sleep - with recurrent episodes of patient ventilatory asynchrony, which in turn may affect quality of sleep, efficacy of ventilation and comfort of nocturnal niv.polysomnography (psg) under niv is necessary to detect these events. adjusting ventilator settings according to respiratory events detected by psg with niv may improve quality of sleep, efficacy of ventilation and comfort of nocturnal niv.

patients under niv for hypercapnic copd have several reasons to develop patient-ventilatory asynchrony: delayed cycling, and insufficient expiratory time may induce progressive dynamic hyperinflation, and increase intrinsic positive end-expiratory pressure (peepi); too high levels of pressure support may also contribute to dynamic hyperinflation. increase in peepi is associated with two respiratory events: unrewarded inspiratory efforts, and auto-triggering. our hypotheses are: 1/that these events occur frequently in copd under niv and that they are not detected by medical history or usual monitoring tools (spo2; ptcco2); 2/ that they can be easily detected by polysomnography; 3/ that simple adjustments of ventilator parameters aiming to reduce dynamic hyperinflation and unrewarded inspiratory efforts may improve efficacy of ventilation, quality of sleep and comfort of treatment. the present study compares the results of two consecutive sleep studies: 1.psg under niv in severe stable copd under "usual ventilator settings" with 2.psg under niv after adapting ventilator settings to results of initial psg.

Eligibility criteria:
inclusion criteria: * copd, with chronic hypercapnic respiratory failure, treated by niv, in stable clinical condition, aged above 18 years exclusion criteria: * unstable clinical condition

Keywords: non-invasive ventilation chronic obstructive pulmonary disease patient-ventilator synchronisation sleep study polysomnography
cognitive functional therapy for chronic low back pain

Conditions: Low Back Pain; Back Pain; Pain; Signs and Symptoms; Neuromuscular Manifestations

Summary: there is evidence, of a single randomized controlled trial, that cft is better than combined manual therapy and motor control exercise for chronic low back pain. however, this study had significant methodological shortcomings regarding the failure to carry out the intention to treat analysis and a considerable loss of follow-up of patients. it is important to replicate this study through a randomized clinical trial with similar objectives in another domain, but correcting these methodological shortcomings. therefore, the aim of the study is to assess the efficacy of cognitive functional therapy in patients with chronic non specific low back pain.

one hundred and forty eight patients with chronic low back pain from two outpatient physiotherapy clinics in brazil will be randomized to receive either cognitive functional therapy or combined manual therapy and motor control exercises. intervention: 4-10 sessions of cft. control: 4-10 sessions of combined manual therapy and motor control exercises. measurements: clinical outcomes will be assessed at the baseline, 3 months, 6 months and 12 months after randomization. analysis: intention-to-treat analysis will be performed, and linear mixed models will be calculated to evaluate the effect of the intervention. non-specific predictors, moderators and mediators of outcome will also be analysed. discussion: this study will investigate whether the results of the first cft clinical trial can be replicated. in addition, the results will contribute to a better understanding of the efficacy of the cft approach.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years * low back pain for more than 3 months * disability score of 14% or more on the oswestry disability index (odi) * being able to walk independently with or without support * understand portuguese well enough to be able to fill in the questionnaires exclusion criteria: * main pain area is not the lumbar spine (from t12 to buttocks) * main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis) * less than 6 months after lumbar spine, lower limb or abdomen surgery * invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last 3 months * pregnancy * inflammatory/rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, scheuermann's disease)

Keywords: back pain physiotherapy exercise therapy cognitive functional therapy low back pain backache lower back pain lumbago multidimensional biopsychosocial
biomechanical and metabolic assessment pre and post vertebroplasty in multiple myeloma patients with vertebral collapse

Conditions: Multiple Myeloma

Summary: in patients with multiple myeloma (mm), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. the introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. the aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with mm

in patients with multiple myeloma (mm), bone lesions can lead to multiple vertebral lesions, with vertebral collapses. the introduction of minimally invasive procedures such as percutaneous vertebroplasty allow patients to return to a fair level of function and a significant reduction in pain. despite medical therapies, radiotherapy, analgesics and vertebroplasty procedures, patients with multiple spinal injuries often complain of pain and stiffness that limit their mobility, daily activities and work. the aim of this study is to measure how the biomechanical, thermo-metabolic and algic parameters change after vertebroplasty in patients with mm

Eligibility criteria:
inclusion criteria: * age≥ 18 years; * diagnosis of multiple myeloma; * clinical indication and eligibility for vertebroplasty procedure; * performance status (ecog) 0-2; * life expectancy greater than three months; * low-resolution full skeletal ct scan at disease onset and/or at follow-up; * spine pain with stiffness and functional impediment pre vertebroplasty; * able to express appropriate consent for participation in the study (e.g. able to understand italian, patient with intact cognitive abilities) exclusion criteria: * presence of spinal cord compressions; * unstable spinal injuries, requiring an orthopaedic back brace; * risk of spinal cord injury; * body mass index bmi\>28 kg/m2. * absence of signed informed consent form
effects of intralipid versus olive oil infusions on endothelial function, immune function, inflammatory markers

Conditions: Diabetes; Hypertension; Obesity

Summary: recent evidence suggests that increased levels of a circulation fat (free fatty acids or ffas) can cause high blood pressure and cardiac complications. intralipid is the only type of fat approved by the fda for clinical use. it is usually used as nutrition support in malnourished patients. the investigators' preliminary studies indicate that intralipid results in a significant rise in blood pressure, blood vessel stiffness, and inflammation in obese subjects. olive oil can also be used as nutrition support. the effect of olive oil intravenous (iv) on blood pressure and inflammation is not known. in this study, the investigators will compare the effect of intralipid and olive oil on blood pressure, blood vessel stiffness and inflammation in healthy subjects. the investigators hypothesize that olive oil emulsions will result in less vascular changes and less inflammatory response than intralipid solutions. accordingly, the investigators propose a systematic evaluation of the effects of intralipid, olive oil and normal saline on blood pressure, endothelial function (vascular stiffness), inflammation in normal subjects. a group of obese subjects will be admitted to the clinical research center on 3 occasions. subjects will receive repeated infusions of intralipid, clinoleic, and normal saline at 20 ml/hour for 24 hours.


Eligibility criteria:
inclusion criteria: * healthy males or females * bmi 25 -35 kg/m2, between the ages of 18 and 65 years * bp \< 140/80 mm hg and no prior history of hypertension exclusion criteria: * pregnancy or breast feeding * history of diabetes, hypertension, fasting triglyceride levels \> 250 mg/dl, liver disease (alt 2.5x \> upper limit of normal), serum creatinine ≥ 1.5 mg/dl, -smokers or ex-smoker \< 3 months of cessation, drug or alcohol abuse * mental condition rendering the subject unable to understand the scope and possible consequences of the study

Keywords: lipid emulsion endothelial function inflammatory markers oxidative stress insulin sensitivity carbohydrate metabolism
the effect of binasal occlusion on balance following a concussion

Conditions: Concussion Post Syndrome

Summary: this study evaluates the effect of binasal occlusion (bno) glasses on balance and eye movement in adults with dizziness after a concussion. participants will stand on a force plate while rapidly reading a series of numbers both with and without the bno glasses. it is thought that the bno glasses will improve both balance and the time to read the numbers.

while most individuals will recover within the first month after concussion, a significant number will continue to experience dizziness, balance problems, cognitive deficits, and vision problems. single-task measures of static balance may not be sensitive enough, however, to capture mild postural changes still associated with incomplete recovery. increasingly there is an interest in dual-task paradigms of balance assessment as a more accurate representation of functional postural control associated with activities of daily living and sport participation. binasal occlusion (bno) has been proposed as a means of providing visual stabilization to improve postural control in individuals with vision-related balance problems following a concussion.

Eligibility criteria:
inclusion criteria: forty adults with persistent symptoms one month or more following a concussion will be recruited for the study. individuals will be considered eligible if they have been diagnosed with a concussion as defined in the 2016 berlin consensus statement (mccrory et al., 2017) as a traumatic brain injury induced by biomechanics forces, which was caused by either a direct or indirect blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head, which may or may not have involved loss of consciousness, and included one or more of the following clinical domains: * symptoms (e.g. headache, nausea, fatigue, feeling like in a fog, difficulty concentrating or remembering, and/or emotional lability) * physical signs (e.g. loss of consciousness, amnesia, neurological deficit); * balance impairment (e.g. gait unsteadiness) * behavioural changes (e.g. irritability) * cognitive impairment (e.g. slowed reaction times) * sleep/wake disturbance (e.g. somnolence, drowsiness) participants must also meet the following inclusion criteria: (1) aged 18-65 years; (2) sustained the concussion 4 or more weeks ago; (3) report persistent dizziness or balance problems not accounted for by a pre-existing musculoskeletal, neurological, or vestibular condition; (4) have normal vision or visual impairments that can be corrected with contact lenses; (5) are proficient in english or french; (6) are able to provide informed consent. exclusion criteria: * do not meet criteria stipulated in the inclusion criteria

Keywords: balance dual-task king-devick test saccades binasal occlusion
prostate cancer screening trial using imaging

Conditions: Prostate Neoplasm

Summary: participants will be recruited from the community and attend a screening clinic and undergo the following screening tests: 1. bi-parametric mri - reported by a radiologist and cad-ai system 2. multiparametric ultrasound - including shearwave elastography 3. a standard-of-care psa test a systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.


Eligibility criteria:
inclusion criteria: 1. men aged between 50 and 69 years inclusive at the time of study entry 2. participants must be fit to undergo all procedures listed in the protocol 3. estimated life expectancy of 10 years or more 4. an understanding of the english language sufficient to understand written and verbal information about the trial and consent process 5. participants must be willing and able to provide written informed consent exclusion criteria: 1. previous psa test or prostate mri within the prior two years of screening/consent visit 2. evidence of a urinary tract infection or history of acute prostatitis within the last 6 months 3. previous history of prostate cancer, prostate biopsy or treatment for prostate cancer 4. any potential contraindication to mri 5. any potential contraindication to prostate biopsy 6. dementia or altered mental status that would prohibit the understanding or rendering of informed consent. 7. any other medical condition precluding procedures described in the protocol
optimal pacing rate for cardiac resynchronization therapy

Conditions: Atrial Fibrillation, Persistent

Summary: this is a prospective, randomized crossover study. the objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. the investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.

cardiac resynchronization therapy (crt) after atrioventricular node (avn) ablation for permanent atrial fibrillation (af) has led to better outcomes in heart failure (hf) patients with reduced ejection fraction (hfref) and with preserved ejection fraction (hfpef) compared to pharmacotherapy. emerging evidence has demonstrated patients with hfpef may benefit from a higher heart rate compared to standard heart-lowering therapies. the optimal pacing rate for crt after avn ablation in persistent af and hfpef remains unknown. this is a prospective, randomized crossover study. the objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. the investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa. patient mortality and hf hospitalizations will be recorded at each phase. an electrocardiogram, echocardiogram, pacemaker interrogation, bnp and creatinine levels, kccq-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. history of persistent or permanent atrial fibrillation 3. implantation of crt or conduction system pacing in prior 3 months to 5 years of study start 4. history of intrinsic avn block or have undergone avn ablation in prior 3 months to 5 years of study start 5. lvef ≥ 50% 6. n-terminal pro-b-type natriuretic peptide (nt-probnp) \>400 pg/ml in the last 24 months 7. clinical hf diagnosis or nyha class ii or higher 8. able to provide informed consent exclusion criteria: 1. lvef \<50% 2. wide qrs (greater than 150ms) 3. isolated rv pacing 4. severe valvular disease 5. severe coronary artery disease as defined by one of the following: 1. acs or pci within 1 year 2. any angina (ccs class 1+) 3. unrevascularizable severe cad (\>70% stenosis in 1+ major vessels and/or based on functional assessment) 6. esrd 7. significant primary pulmonary disease on home oxygen 8. major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test 9. ventricular ectopy \>15% premature ventricular contractions (pvc) 10. end stage cancer diagnosis 11. life expectancy less than one year 12. palliative or hospice care 13. hypertrophic cardiomyopathy (hcm) 14. uncorrected ventricular septal defect 15. infiltrative cardiomyopathy (cm) 16. uncontrolled hypertension as defined by blood pressure \>160/100 mm hg on two measurements ≥15 minutes apart 17. hemoglobin \<7 g/dl 18. age \>90 years old 19. pregnant or intends to become pregnant