Kornimate/medical-research-clean huggingface dataset:
flecainide in treating patients with chronic neuropathic pain

Conditions: Pain

Summary: rationale: flecainide therapy may help patients with neuropathic pain live more comfortably. purpose: phase ii trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or aids.

objectives: * investigate the effectiveness of flecainide in the management of neuropathic pain. outline: patients are given a brief pain inventory (bpi) form to assess their pain upon enrollment in the study. following a 7 day stabilization period, flecainide is administered. one capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21. bpi forms are completed on days 8, 15 and 22 to assess neuropathic pain. projected accrual: a total of 7-20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * chronic neuropathic pain with diagnosis of cancer or aids patient characteristics: age: * over 18 performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * sgot no greater than 2 times upper limit of normal (uln) renal: * creatinine no greater than 2 times uln cardiovascular: * no clinical history of infarction or angina * no advanced heart failure * no sick sinus syndrome, intraventricular conduction disease, second or third degree av block or arrhythmias requiring treatment (exception may be granted by cardiac consult) * no focal wall motion abnormalities * ejection fraction at least 40% * systolic blood pressure at least 90 mm hg other: * must be able to take oral medication * no known allergy or adverse reaction to flecainide, mexilitene or any other type i antiarrhythmic drug * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * at least 2 weeks since prior chemotherapy that may cause neuropathy endocrine therapy: * at least 2 weeks since prior corticosteroids radiotherapy: * not specified surgery: * not specified other: * no tricyclic antidepressant treatment within past 2 weeks * no concurrent use of flecainide, mexiletene or any other type i antiarrhythmic drug

Keywords: pain
pragmatic open - label randomized clinical trial of ff/umec/vi vs non-ellipta usual care ics-laba for adult participants with uncontrolled asthma

Conditions: Asthma

Summary: the goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (ff/umec/vi) with inhaled corticosteroids/long-acting beta-2 agonists (ics/laba) in adult participants with uncontrolled asthma


Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: 1. has a diagnosis of asthma as defined by global initiative for asthma (gina) 2023 guidelines for at least 3 months prior to randomization. 2. participants who are either: * currently untreated * treated with daily maintenance ics or ics/laba 3. acq-6 score ≥1.5 at randomization. 4. participants able to perform technically acceptable and repeatable fev1 maneuvers (i.e., a minimum of 2 acceptable and 1 repeatable effort) at visit 2 (v2) 5. participants must be able to complete the study questionnaires. exclusion criteria: participants are excluded from the study if any of the following criteria apply: 1. recent history of life-threatening asthma 2. history of \>1 severe exacerbation of asthma within 12 months prior to randomization. 3. women of childbearing potential that are not following at least one highly effective method of contraception. this includes women who are pregnant or lactating or are planning on becoming pregnant during the study. 4. a wocbp must have a negative pregnancy test ≤7 days prior to randomization. 5. exposure to inhaler triple therapy \[ics + long-acting muscarinic antagonist (lama) + laba as single inhaler triple therapy (sitt) or multiple inhaler triple therapy(mitt)\] and/or any lama-containing therapy within 12 months prior to randomization. 6. ongoing need for biologic therapy or recent use of a biologic therapy 7. participants with the diagnosis of chronic obstructive pulmonary disease, as per global initiative for chronic obstructive lung disease (gold 2024) guidelines. 8. participants whose current medications include relvar ellipta and arnuity ellipta are not eligible to enter the study. 9. participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing 10. changes in asthma medication (e.g., maintenance ics/laba) within 3 months prior to randomization. 11. participants with a history of hypersensitivity to any of the study medications

Keywords: asthma ff/umec/vi ics/laba
evaluation of physician and patient knowledge of safety and safe use information for aflibercept

Conditions: Macular Degeneration

Summary: the study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five european countries.


Eligibility criteria:
inclusion criteria: physicians eligibility: * licensed and practicing ophthalmologist * prescribed and administered aflibercept to at least one patient in the past 6 months patients eligibility: * patient has been administered aflibercept at least once within the last 6 months for any indication and is returning for a subsequent visit. * patient is aged 18 years or older. * patient is able to understand and sign the consent form and patient questionnaire. * patient can understand the native language of the country in which the study is being conducted. * patient has not participated in a clinical trial for the treatment of an aflibercept indication (e.g., wamd, crvo, or dme) in the past 12 months.

Keywords: health care surveys vascular endothelial growth factor
a novel hepatitis c microelimination program in non imprisoned sentenced with alternative measures

Conditions: Hepatotropic Virus Infection; Addictive Behaviours o Conducts; Mental Disease; People Sentenced to Non-custodial Sentences

Summary: the objective of this study is to carry out a micro-elimination program for hcv infection in a vulnerable population (people sentenced to non-custodial sentences). this group shares certain peculiarities with the prison population (vulnerability, addictions, mental disorders, etc.), is three times higher than the imprisoned population, and is regularly attended by social insertion centers (cis) in spain. an additional objective is to link these people with the specific plans of the government of cantabria (chronicity plan, care for serious mental disorders, harm reduction programs and the center for attention to drug addicts) as well as the extended bridge program for penitentiary institutions, implementing the figure of a navigator (a specialized professional in charge of helping subjects overcome barriers). it is an observational study based on the screening of disease in accordance with the recommendations of the health authorities. once detected, patients will be referred to the corresponding specialized care following the usual clinical practice.


Eligibility criteria:
inclusion criteria: * the entire population served in the management of penalties and alternative measures service (sgpma) of the josé hierro sic, including new admissions within the study period. exclusion criteria: * they are not willing to participate and do not sign informed consent.

Keywords: hepatitis c virus non-custodial sentences addictive behaviours mental disease navigator screening poct
direct reporting of awareness in maternity patients

Conditions: Awareness, Anesthesia; Obstetric Anesthesia Problems

Summary: dreamy is a prospective, multi-centre observational cohort study using a mixed methods approach to provide quantitative and qualitative data on accidental awareness under general anaesthesia (aaga) in obstetric surgery patients. obstetric patients undergoing surgery, such as emergency caesarian section under general anaesthesia, are thought to be at higher risk than any other surgical cohorts for aaga. patients recruited to the study will be screened for aaga using a standardised questionnaire on three occasions over 30 days. follow up with structured interviews for all aaga patients will occur over 12 months.

background: the challenges of obstetric general anaesthesia practice - including the use of rapid sequence induction, neuromuscular blockade and short duration between anaesthetic induction and start of surgery - may contribute to a higher risk of awareness under general anaesthesia (aaga) in these patients. the 2014 royal college of anaesthetists/association of anaesthetists of great britain and ireland national audit project 5 highlighted a higher risk of spontaneously reported aaga in obstetric patients, but it remains unclear what the full (i.e. non-spontaneously reported) risk is. the aim of dreamy is to establish the incidence of aaga following general anaesthesia in obstetric surgery patients. methods: a standardised brice questionnaire will be used to screen for recall of intraoperative events in women meeting the eligibility requirements. questions asked are: 1. what is the last thing you remember before going to sleep? 2. what is the first thing you remember after waking up? 3. do you remember anything between going to sleep and waking up? 4. did you dream during your procedure? 5. what was the worst thing about your operation? the validity of the aaga incidence will be improved by repetition of the questionnaire on three occasions over thirty days and triangulating using structured follow up interviews in all participants reporting aaga in questionnaire responses. participants will be followed up over 12 months and asked for self-reported symptoms of post-traumatic stress disorder (ptsd) using the pcl-5 checklist. the research is being run as a multi-centre, descriptive study over 12 months. general condition and details of the anaesthetic procedure will also be recorded for a logistic regression analysis.

Eligibility criteria:
inclusion criteria: * female adults (≥18 years) of ≥ 24/40 gestation * receiving general anaesthesia (de novo or regional anaesthesia converted to ga) for surgery with an obstetric indication (e.g. emergency caesarean section, manual removal of placenta, examination under anaesthesia) exclusion criteria: * patients too unwell or confused to be able to complete the questionnaire * patient refusal * general anaesthesia for non-obstetric indication (e.g. colorectal or orthopaedic surgery in a pregnant patient) * surgery ≥48 hours post-partum * unable to communicate verbally/in writing in english language
telo genomics technology to detect & profile multiple myeloma mrd

Conditions: Multiple Myeloma

Summary: the purpose : detect and profile multiple myeloma measurable residual disease(mrd) prognostics for monitoring post-transplant multiple myeloma (mm) patients receiving maintenance therapy.


Eligibility criteria:
inclusion criteria: * confirmed mm diagnosis * transplant eligible patients in a first remission * known mrd level detected by clonoseq (other imwg recognized methodologies can be also employed) * availability of deidentified patient's demographic and clinical follow up data * receiving standard of care treatment * able to provide informed consent exclusion criteria: * failure to meet inclusion criteria
efficacy of transverses abdominis -plane block with bupivacaine versus bupivacaine with morphine postoperatively

Conditions: Abdominal Cancer

Summary: this study aims to compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer surgery.

this randomized study will be approved by the local ethics committee of south egypt cancer institute, assuit university, egypt after written informed consent. this study will include approximately 60 asa i-ii cancer patients with age range (18-60) years, weight (50- 85) kg who will be scheduled for lower abdominal cancer surgery (abdominal hysterectomy, oophorectomy and radical cystectomy). exclude from the study patients with known drug allergy to study drugs, significant cardiac, respiratory, renal or hepatic disease, coagulation disorders and those with psychiatric illnesses that would interfere with perception and assessment of pain. preoperatively, patients will be taught how to evaluate their own pain intensity using the visual analog scale (vas), scored from 0-10 (where 0= no pain and 10=worst pain imaginable). patients will be randomly assigned using an online research randomizer into two groups, 30 patients in each group: group 1: 30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall. group 2: 30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall. surgery will be performed under standard general anesthesia and ultrasound guided tap block will be performed before induction of ga.

Eligibility criteria:
inclusion criteria: * 60 asa i-ii cancer patients with age range (18-60) years, * weight (50- 85) kg exclusion criteria: * with patients with known drug allergy to study drugs * with significant cardiac, respiratory, renal or hepatic disease * with coagulation disorders * those with psychiatric illnesses that would interfere with perception and assessment of pain.

Keywords: major abdominal cancer
radiotherapy in combination with checkpoint inhibition for patients with metastatic kidney cancer

Conditions: Metastatic Renal Cell Carcinoma ( mRCC); OligoProgressive Metastatic Disease

Summary: to evaluate progression of metastatic renal cell carcinoma from the initiation of pulsar radiotherapy in combination with imsa101 injectable onward.

the study expects to accrue the 20 patients over a 3-4 year period. patients with oligoprogressive disease (1-3 lesions) after treatment with anti-pd1 / anti-ctla-4 will continue anti-pd1 (nivolumab). all patients will have a mandatory pd-l1 pet (pre-treatment and week 12). all patients will undergo baseline biopsy (just before the administration of imsa101 of the same lesion to be injected). sabr will be delivered in 3 fractions at 12 gy every 4 weeks (pulsar regimen) to all progressing lesions. one lesion will also receive 5 intratumoral injections of imsa101 (c1d1, c1d8, c1d15, c2d1, c3d1) immediately after radiation either on the same day or within 72 hours after the pulse. selected phase 2 dosing of imsa101 (1200mcg) will be utilized. at disease progression, patients have the option to undergo additional imaging and tissue/blood collections.

Eligibility criteria:
inclusion criteria: * patients must have metastatic ccrcc. * patients must have oligoprogression defined as progression in ≤3 lesions. * all oligoprogression lesions must be suitable for radiation. * patients must have at least one site of disease that can be safely injected with imsa101. lung metastases are excluded. * ecog performance status 0-2. * age ≥ 18 years. * patients must have adequate organ and marrow function within 14 days prior to study entry. * all imdc risk categories are allowed. exclusion criteria: * patients with progressive ultracentral/central chest lesions will be excluded

Keywords: renal kidney mrcc metastatic cancer sting pulsar sabr spark nivolumab imsa 101
selenium in treating patients who are undergoing brachytherapy for stage i or stage ii prostate cancer

Conditions: Prostate Cancer

Summary: rationale: the use of nutritional supplements, such as selenium, may stop prostate cancer from growing. internal radiation, such as brachytherapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. giving selenium before brachytherapy may be an effective treatment for prostate cancer. purpose: this randomized phase i trial is studying selenium to see how well it works compared to placebo in treating patients who are undergoing brachytherapy for stage i or stage ii prostate cancer.

objectives: primary * compare the effects of selenium vs placebo on tissue biomarkers of prostate cancer susceptibility, using tissue samples from biopsies before and after treatment, in patients undergoing brachytherapy for stage i or ii prostate cancer. secondary * determine the effects of selenium on antioxidant enzyme activities in these patients. * determine, preliminarily, whether there is a threshold effect among patients with low baseline levels of selenium treated with this drug. outline: patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral selenium for 3-6 weeks. patients then undergo brachytherapy. * arm ii: patients receive oral placebo for 3-6 weeks. patients then undergo brachytherapy. after completion of study treatment, patients are followed at 1 and 6 months.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * must have undergone ≥ a sextant biopsy * clinical stage t1a-t2a disease * gleason score \< 8 * prostate-specific antigen \< 20 ng/ml patient characteristics: age * not specified performance status * not specified life expectancy * more than 5 years hematopoietic * not specified hepatic * not specified renal * not specified other * no other prior malignancy except nonmelanoma skin cancer prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * no prior hormonal therapy radiotherapy * no prior radiotherapy surgery * not specified other * more than 30 days since prior and no concurrent participation in another clinical trial involving a medical, surgical, nutritional, or lifestyle intervention (e.g., dietary modification or exercise) * no selenium at doses \> 50 mcg/day as a dietary supplement, including multivitamin supplements

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage ii prostate cancer
a single and repeated dose escalation of rbd1016 in subjects with chronic hepatitis b virus (hbv) infection

Conditions: Chronic Hepatitis B

Summary: this is a randomized, double-blind, placebo-controlled, single (part a) and repeated dose (part b) escalation, phase i clinical study to evaluate the safety, pharmacokinetics (pk) and preliminary pharmacodynamics (pd) of rbd1016 in subjects with chronic hbv infection.

the study consists of two parts. part a is the single dose escalation study where subjects with chronic hbv infection will be assigned to receive single dose of rbd1016 or placebo . part b is the multiple dose escalation study where subjects with chronic hbv infection will be assigned to receive two doses of rbd1016 or placebo.

Eligibility criteria:
inclusion criteria: 1. subjects who voluntarily participate in this clinical trial, are able to correctly understand and have signed the informed consent in writing; 2. male or female volunteer aged 18-55 years (inclusive); 3. body mass index (bmi) of 18-30 kg/m2 (inclusive); 4. subjects with chronic hbv infection, including immunotolerant subjects, treatment naïve subjects and treated subjects. 5. ability to cooperate with study staff and comply with the study requirements and follow the protocol-specified procedures. exclusion criteria: 1. subjects with liver diseases other than hepatitis b, including hepatitis c, hemochromatosis, primary sclerosing cholangitis; alcoholic, drug-related or autoimmune liver diseases; primary liver cancer and indeterminate nodules on liver imaging test; 2. a history or manifestations of liver decompensation (e.g. child-pugh class b or c, or ascites, gastrointestinal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis, etc.); 3. transient elastography at screening revealing fibroscan value ≥ 9 kpa or liver biopsy evidencing hepatic fibrosis within 24 months; 4. the following laboratory findings: total serum bilirubin\> 2×uln; serum alpha-fetoprotein\>50μg/l; serum albumin \ 1.25; serum creatinine \> 1.5×uln; any laboratory outliers of clinical significance that in the investigator's opinion may interfere with the interpretation of efficacy or safety data; 5. 12-lead ecg abnormalities with clinical significance; 6. pregnant or lactating women or women of child-bearing potential who are unwilling to take effective contraception throughout the course of the study (refer to appendix 3 for details); 7. other factors that in the investigator's opinion would make it inappropriate for the subject to participate in the study.

Keywords: chb chronic hepatitis b infection
gabapentin oral solution in decreasing desflurane associated emergence agitation

Conditions: Emergence Agitation After Desflurane Anesthesia

Summary: to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane anesthesia in pediatrics undergoing starbismus surgery


Eligibility criteria:
inclusion criteria: * pediatric patients (2-6 years old), with an american society of anesthegiologists physical status (asa) i-ii who were undergoing strabismus surgery (for more than one muscle) exclusion criteria: * failure to obtain consent, mental retardation or developmental delay, epilepsy, psychiatric or neurological diseases that impair communication, current use of gabapentin, psychotropic or opioids.
effects of yakson method and swaddling on pain and physiological parameters

Conditions: Pain During Heal Lancing

Summary: type of study: the study was planned to be conducted in a randomized controlled experimental design. place and time of the research: institutional permission will be obtained from the balcalı training and research hospital in adana for the collection of research data. researchers commit to start data collection after obtaining institutional permission. the data collection process will take 1 year after obtaining the institutional permission. 48 newborns who are suited the inclusion criteria will be included in the study. participants will be assigned to 3 groups according to randomization: swaddling, yakson method, and control.

total processing time and baby's crying time are calculated by watching video recordings. in order to find the total procedure time, starting from the puncture of the baby's heel, the time until the dry cotton is placed on the baby's heel after the blood collection process is completed is calculated. the heart rate and spo2 are noted by the investigator during the heel lancing procedure. pain assessment of infants is done by two independent neonatal nurses, apart from the researcher, by watching video recordings. the scores given by the two observers will be evaluated by making inter-observer harmony. before the evaluation, the nurses will be trained about the scale and its evaluation.

Eligibility criteria:
inclusion criteria: inclusion criteria for newborn: * born at term (38-42 weeks) * healthy newborn * absence of congenital anomaly * no analgesic or sedative medication has been administered in the last 6 hours * parent's consent for inclusion in the study in accordance with the consent form inclusion criteria for mother: * mother's willingness to participate in the study * the mother can be mobilized and not have a physical disability (so that she can appyl yakson therapy for her baby) * being communicative exclusion criteria: * babies whose blood cannot be drawn on the first try

Keywords: nonfarmacology pain heal lancing yakson method