Kornimate/medical-research-clean huggingface dataset:
affect regulation based on brain-computer interface towards treatment for depression

Conditions: Emotion Regulation

Summary: the primary objective is to examine the feasibility and efficacy of a locally developed brain-computer interface (bci) based system training for regulating mood in healthy elderly. the investigators hypothesize that elderly who complete the training program will be better at regulating emotions as compared to controls, based on their ratings of the primary outcome measures.

in this project, we will leverage on a locally developed electroencephalograph (eeg)-based bci technology for decoding affective states of the brain, and thereby develop a closed-loop sensing and stimulation mechanism. the technology uses advanced neural signal computing on the eeg in real-time and audio feedback using a machine learning model that associates individual user's eeg characteristics in relation to music-emotion features. the system is portable and will allow emotion regulation training to be done outside of hospital setting with ease thus potentially addressing the treatment gap for mdd in the elderly. this is a two group randomized study. one group will undergo the intervention which is 24 sessions of bci emotion regulation training (i.e. listening to music with audio feedback to regulate emotions towards positive affect) over an 8-week period. the control group will undergo 8 weeks of music sessions, without any emotion regulation training. both groups will undergo pre- and post- psychometric assessments looking at cognition, quality of life, functioning and emotional states. this study will also carry out functional mri of the brain before and after 8 weeks of either training (intervention) or music music session (control) to examine changes associated with the affective bci training. study findings derived from psychometric assessments, eeg analysis and neuroimaging will provide evidences on efficacy and usability of this technology.

Eligibility criteria:
inclusion criteria: * english-speaking * geriatric depression scale score of 4 and below * fit to provide informed consent * able to travel to study site independently exclusion criteria: * presence of hearing impairment * presence of any known neuropsychiatric disorders (e.g. dementia, epilepsy or mental retardation) * contraindications for mri such as surgical clips, cardiac pacemakers, metal implants and plates, orthodontics and claustrophobia
complementary and integrative pain therapies and functional restoration (imppport) trial)

Conditions: Chronic Pain

Summary: this study aims to evaluate the benefit of a complementary and integrative health (cih) pain management program when added to standard rehabilitative care (sc) compared to sc alone prior to an intensive functional restoration (fr) program in a population of active duty service members. in addition the study aims to identify factors that predict improvement in pain impact following treatment, and to determine the proportion of participants who experience clinically meaningful response. sc included physical and occupational therapy. cih included chiropractic, acupuncture, yoga and foam roller instruction. both treatment groups also received education about pain psychology. participants were randomly assigned to a 3-week course of either sc alone or cih combined with sc prior to a 3-week course of fr. outcomes were collected at baseline, at end of stage 1, and post-fr. outcomes included patient-reported and provider-determined measures.


Eligibility criteria:
inclusion criteria: * significant functional impairment due to pain, requiring modification of military duties. * physically able to participate in up to four hours of physical activity (strength, flexibility, endurance training) per day: 1. can stand up from and sit down on floor independently 2. can walk on treadmill for at least 6 minutes at 2.5 mile/hour pace or faster. 3. able to complete at least 2 of the following: 1. lift 20 lbs from floor to knuckle height 2. lift 20 lbs from floor to shoulder height 3. carry 20lbs at least 40 feet. * inadequate response to previous less intensive treatment * expresses motivation to take active role in regaining function exclusion criteria: * major surgeries within past 6 months or planned within next 6 months * unstable psychological disorders * active substance use disorder * high dose opioids of \>120 milligrams of morphine equivalent doses (med)/day
innovative approach in tuberculosis care in armenia

Conditions: Tuberculosis

Summary: randomized trial tests effectiveness of self-administered drug intake by empowered tb patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and treatment success rates, and thereby forestall tb and mdr-tb epidemics.

the innovative treatment approach integrates several educational, technological, and social evidence-based components. the aim of this study is to pilot the innovative approach for drug-sensitive tb patients during the outpatient phase of tuberculosis treatment. to test the effectiveness of the innovative approach (intervention) a randomized controlled trial with two arms will be conducted. the intervention arm will include drug-sensitive tuberculosis patients that are treated according to the innovative approach, which includes self-administered drug intake supervised by a family member, tb patient and family member training (including distribution of a leaflet about tb) and psychological counseling, reminder text messages to tb patients, and reminder phone call to tb patient family members. the control arm will include drug-sensitive tuberculosis patients that receive the regular directly observed therapy recommended by the world health organization.

Eligibility criteria:
inclusion criteria: * diagnosis of drug-sensitive tb * age 18 years old and above * understanding and reading in armenian * completion of the intensive treatment phase exclusion criteria: * involvement in the home based tb treatment program of the national tb control office

Keywords: tuberculosis armenia clinical trial directly observed therapy (dot) self-administered drug intake
a retrospective study of the efficacy and safety of lolatinib in alk+ nsclc patients with brain or meningeal metastasis

Conditions: ALK-positive Non-small Cell Lung Cancer; Brain Metastases; Meningeal Metastasis

Summary: this study was a retrospective observational study. the study included patients with non-small cell lung cancer with alk-fusion brain metastases or meningeal metastases who received first-line and late-line treatment with the third-generation alk tki lorlatinib between june 2022 and june 2023. data were collected from the electronic medical records database and hospital information system of many hospitals in sichuan province. clinical pathology features including gender, age, alk mutation status at diagnosis, and clinical stage at diagnosis were collected from the medical records. the physical condition assessed by ecog-ps before the administration of lorlatinib was recorded. information on anti-tumor therapy was obtained from the records, including dose and time of alk-tki therapy and tumor response, number of prior systemic therapy lines, drug regimen, efficacy, and whether local therapy such as radiotherapy and surgery had been received. in this study, the sample size is not limited, and information is collected according to the maximum number of patients. the study period was from 01 july 2023 to 30 june 2024.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. diagnosis of advanced nsclc with clear pathology and brain metastases confirmed by mri or ct scan of the brain or meningeal metastases confirmed by imaging or lumbar puncture cerebrospinal fluid cytology 3. alk fusion mutation confirmed by tumor histology or hematology 4. treatment with lorlatinib from june 2022 to june 2023 5. survival greater than 12 weeks exclusion criteria: patients treated with lorlatinib for less than 4 weeks
gastric cancer surgery in elderly patients

Conditions: Gastric Cancer

Summary: gastric cancer is most frequent after the fifth decade of life. surgical risk is higher in aged population because of general health condition may affect the postoperative result. aim of the study was to identify risk factors for post-operative mortality in octogenarian patients who underwent surgery for gastric cancer.

236 patients (181: 80-85 years old and 55: \>85 years old) underwent surgery for gastric cancer at the sant'orsola-malpighi university hospital in bologna between 2010 and 2015. the variables of the two groups of patients were compared.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed primary gastric cancer submitted to surgical treatment; * age \> 80 years. exclusion criteria: * patients with histologically confirmed primary gastric cancer submitted to surgical treatment and age \< 80 years; * patients with histologically diagnosis of other neoplastic and non-neoplastic diseases submitted to surgical treatment.
evaluation of reporting of immune checkpoint inhibitor associated cardio-vascular adverse reactions

Conditions: Myocarditis; Cardiac Complication

Summary: immune checkpoint inhibitors (icis) might have high grade immune-related adverse events (iraes) on the cardio-vascular system. this study investigates reports of cardio-vascular toxicity with treatment including anti-pd1, anti-pdl-1, and anti ctla4 classes using the world health organization (who) database vigibase.

icis have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. however, iraes can occur. here the investigators use vigibase (http://www.vigiaccess.org/), the world health organization (who) database of individual safety case reports, to identify cases of cardiovascular adverse drug reaction following treatment with icis.

Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database of individual safety case reports to 12/31/2017 * adverse event reported were including the meddra terms: cardiac and vascular investigations (excl enzyme tests) (hlgt), vascular disorders (soc), skeletal and cardiac muscle analyses (hlt), sudden death (pt), sudden cardiac death (pt), cardiac disorders (soc), cardiac arrhythmias (hlgt), cardiac disorder signs and symptoms (hlgt), cardiac neoplasms (hlgt), cardiac valve disorders (hlgt), congenital cardiac disorders (hlgt), coronary artery disorders (hlgt), endocardial disorders (hlgt), heart failures (hlgt), myocardial disorders (hlgt), pericardial disorders (hlgt) * patients treated with icis included in the atc: ipilimumab (l01xc11), nivolumab (l01xc17), pembrolizumab (l01xc18), durvalumab (l01xc28), avelumab (l01xc31), atezolizumab (l01xc32). exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: anti-pd-1 anti-pd-l1 anti ctla-4 immune checkpoint inhibitors
68-ga-fapi pet imaging in malignancy

Conditions: Cancer

Summary: this feasibility trial studies the use of gallium-68 (68ga)-fapi as the imaging agent for positron emission tomography (pet)/computed tomography (ct), collectively pet/ct, in patients with various cancers. pet uses a radioactive substance called 68ga-fapi, which attaches to cancer activated fibroblasts. the pet scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy tissue. ct uses x-rays to make a picture of areas inside the body. using 68ga-fapi in diagnostic procedures, such as pet/ct, may allow doctors to identify smaller tumors than standard imaging.

primary objective: to assess feasibility and biodistribution of pet imaging in malignancy using 68ga-fapi. outline: patients receive 68ga-fapi intravenously (iv) and then undergo pet/ct approximately 1 hour later. after completion of study, patients are followed up at 24-72 hours.

Eligibility criteria:
inclusion criteria: * patient with current malignancy confirmed via pathology or imaging * patient must be \> 18 years old * patient must be willing and able to provide written informed consent for the trial * patient of reproductive potential will have a pregnancy test exclusion criteria: * pregnant or breastfeeding
effect of e-liquid flavor on respiratory symptoms in people using electronic nicotine delivery systems

Conditions: Electronic Cigarette Use

Summary: this is a randomized, parallel-group open-label trial to evaluate respiratory symptoms in ends users switching from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches.


Eligibility criteria:
inclusion criteria: * ends users as determined by: (a) using banned flavored ends with nicotine such as fruit, candy, dessert flavors, and/or any product that indicates such flavors (b) using ends daily, regularly for the past 6 months (self-reported). * no smoking tobacco or using smokeless tobacco for the past 6 months. * subjects should be free of acute respiratory illness within the proceeding 30 days prior to recruitment (self-reported). * participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure. * after receiving information regarding the nys flavor ban individuals must not want to quit vaping or stop using their flavored product for the next 90 days. exclusion criteria: * individuals with health conditions and therapies that may affect immune responses and levels of inflammatory markers, including allergic rhinitis, aspirin/nsaid therapy, asthma, immunodeficiency (hiv or other), guillain-barre syndrome, copd, or fever/respiratory illness within 30 days prior to entry into study (self-reported). * pregnant or nursing female participants (self-reported on telephone screener, pregnancy test on visit#1) * unable to communicate in english. * unable or unwilling to follow protocol requirements. * self-report having active, untreated medical/psychiatric conditions. * history of serious side effects from nicotine or from any nicotine replacement therapies. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners. * any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug. * after receiving information about the nys flavor ban, participants who report that they are thinking about quitting or stop using their flavor within the next 90 days.
biomarker study accompanying the aio-trk-0114 study (marble)

Conditions: Non-small-cell Lung Cancer With Somatic EGFR Mutations

Summary: to compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic egfr mutated non-small-cell lung cancer progressing after first-line treatment with afatinib as first tyrosine kinase inhibitor with respect to progression-free survival

patients who have progressed after first-line treatment with afatinib as first tyrosine kinase inhibitor (tki) will be screened while they are receiving second-line (induction) treatment consisting of cisplatin / carboplatin plus pemetrexed given in 21-day cycles. patients who do not progress (i.e. complete or partial response, or stable disease - cr, pr or sd) after completion of at least three and not more than four chemotherapy cycles will be randomized (1:1 ratio) to receive maintenance therapy with either afatinib (40 mg/d or last tolerated dose during first-line treatment with afatinib as first tki) or pemetrexed (500 mg/m2 or 375 mg/m2 if dose reduction was required every 21 days) until disease progression or treatment discontinuation because of patient decision or toxicity.

Eligibility criteria:
inclusion criteria: 1. participation in the aio-trk-0114 (marble) study (eudract-no. 2014-001983-36) 2. written informed consent exclusion criteria: 1. patients who do not meet the inclusion criterial of the aio-trk-0114 (marble) study (eudract-no. 2014-001983-36)
high dose trial in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of bea 2180 br to tiotropium 5 μg and placebo when each was delivered by the respimat® inhaler once daily for four weeks in patients with copd.


Eligibility criteria:
1. patients must have relatively stable, moderate to severe airway obstruction with an fev1 \>=30% and \<= 60% of predicted normal and fev1 \<=70% of fvc at the baseline pfts at visit 1 (at both timepoints). 2. all patients must have an increase in fev1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g atrovent mdi. 3. male or female patients 40 years of age or older. 4. smoker or ex-smoker with a history of more than 10 pack years. 1. patients with any other significant disease will be excluded. 2. patients with a history of asthma or allergic rhinitis will be excluded.
the posa trial - positional therapy for positional osa

Conditions: Sleep Apnea, Obstructive; Positional Sleep Apnea

Summary: vibro-tactile feedback may be beneficial for some patients, who have positional obstructive sleep apnoea (osa). aim: to determine whether positional therapy, applied by a discrete neck-worn vibro-tactile feedback device, is an effective treatment for positional osa, in reducing the disease severity and associated symptoms, compared to sham-positional therapy. the interaction between treatment and age will also be assessed, since pathophysiology, symptoms and treatment tolerance varies with age. methods: a prospective randomised, parallel, double-blinded trial comparing positional therapy (night shift™; advanced brain monitoring, usa) with sham-positional therapy, performed in older (\>65 years) and younger patients with positional osa (apnoea/hypopnea index (ahi)\>5 events/hour, 2:1 when supine). the primary endpoint, ahi at 3 months, will be measured by a repeat study with the device in situ, and compared between positional therapy and sham-positional therapy. patients' subjective symptoms, wellbeing and quality of life, will be assessed by questionnaires at baseline and 3 months. adherence to therapy will be measured.


Eligibility criteria:
inclusion criteria: * aged ≥18 * ability and willingness to provide informed consent * ahi \>5 events/hour (aasm 2012 scoring criteria) with events occurring at a frequency of 2:1 when supine, compared to non-supine; total % supine sleep \>20, \<90% of total sleep; central apnoeas \<20% total apnoeas; recording of ≥4 hours of analysable signals * ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation exclusion criteria: * unstable cardiac disease * cardiac arrhythmia corrected with an artificial pacemaker * supplemental oxygen * secondary sleep pathology e.g. periodic limb movement syndrome, narcolepsy, circadian disorder, obesity hypoventilation syndrome; or shift workers * concerns about sleepy driving or any other potentially dangerous symptom from physician * bmi ≥40 kilogram/m2 * inability to sleep in a non-supine position * skin sensitivity or an open wound around neck * neck circumference \ 22inches (55cm) * tics or tremors of the head * sleep with head in upright position * a female of child-bearing potential that is pregnant or intends to become pregnant

Keywords: positional therapy quality of life
motion correction in dynamic contrast enhanced magnetic resonance imaging (mri) in ovarian cancer: a pilot study

Conditions: Ovarian Cancer

Summary: the purpose of this study is to develop new image analysis method using dynamic contrast enhanced magnetic resonance imaging (dce-mri) for ovarian cancer. mri is not currently part of the standard care for ovarian cancer. in this method, a contrast agent is used to make ovarian cancer visible during imaging.


Eligibility criteria:
inclusion criteria: * patients with measurable disease with evidence of at least one uni-dimensionally measurable tumor (\> 1 cm) by ct or mri scan according to recist (response evaluation criteria in solid tumors) that the tumor has not been initially treated with surgery or radiation therapy. * patients who will start treatment with bevacizumab combined with or without cytotoxic chemotherapy within 14 days from signing consent. patients treated on an approved irb therapeutic protocol for recurrent ovarian cancer with bevacizumab are eligible. * patients with histologically confirmed ovarian epithelial cancer including primary peritoneal and fallopian tube adenocarcinoma. * patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception. * patients who are older than 21 years of age. * patients who are able to understand and sign informed consent. exclusion criteria: * patients treated on an approved irb therapeutic protocol with a blinded arm of bevacizumab or placebo are not eligible (irb 07-078 and irb 05-138). * patients with cardiac pacemakers. * patients with certain prosthetic devices and implants who are not compatible with the high magnetic field present in the dce-mri scanners. * patients who have experienced a prior adverse reaction to the gadolinium complex contrast agent used in dce-mri imaging and who don't meet criteria for creatinine and nephrogenic systemic sclerosis risk per guidelines of department of radiology. * patients prone to claustrophobia. * patients on dialysis.

Keywords: ovary mri 08-132
comparison of three soft bifocal contact lenses

Conditions: Presbyopia

Summary: the primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.


Eligibility criteria:
inclusion criteria: * the subject must between 35 and 70 years of age. * the subject must respond positively to at least one symptom on the "presbyopic symptoms questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.). * the subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye. * refractive cylinder must be less than or equal to -0.75 d in each eye. * the subject must have an add power of +0.75d to +2.50d in each eye. * the subject must have best corrected visual acuity of 20/20-3 or better in each eye. * the subject's must have at least 20/30-distance vision with the study contact lenses. * the subject must agree that they are comfortable with their vision prior to being dispensed the study lenses. * the subject must be an adapted soft contact lens wearer in both eyes. * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * the subject must read and sign the statement of informed consent and be provided a copy of the form. exclusion criteria: * ocular or systemic allergies or disease that may interfere with contact lens wear. * systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear. * clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. * clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear. * any ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * pregnancy or lactation * any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., hiv). * history of diabetes. history of binocular vision abnormality or strabismus.