Kornimate/medical-research-clean huggingface dataset:
temporally-modulated pulsed radiation therapy (tmprt) after prior ebrt for recurrent idh-mutant gliomas

Conditions: Astrocytoma; Oligodendroglioma, Adult; Glioma, Malignant

Summary: this clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (tmprt) in patients with idh-mutant gliomas who have previously received radiation therapy to the brain. tmprt is a radiation technique in which radiation is delivered in multiple small doses on a specific timed interval, instead of delivering one large dose at one time. this technique may improve efficacy while reducing toxicity and improving patient quality of life.


Eligibility criteria:
inclusion criteria: * histologically confirmed recurrent idh-mutant gliomas (either astrocytoma or oligodendroglioma) with prior external beam radiation therapy (ebrt) to the same region. the recurrent tumor may be either histologically confirmed or based on clinical assessment. any number of prior recurrences is allowed. * maxium tumor diameter of 7 cm or less. * prior ebrt is ≥ 2 years ago. * the region for reirradiation should have received at least 45 gy from the prior ebrt but no more than 75 gy. the prior ebrt could be either photon-based or proton-based. * prior srs to the same region is permitted as long as the cumulative dose of ebrt plus srs is no more than 75 gy. the prior srs should be completed at least 6 months ago. * life expectancy ≥ 12 months * at least 18 years of age. * karnofsky performance status (kps) of at least 70%. * females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * able to understand and willing to sign an irb-approved written informed consent document (legally authorized representative permitted). exclusion criteria: * leptomeningeal or metastatic involvement. * prior history of grade 3 or higher radiation necrosis that is at least possibly related to prior radiotherapy. * use of concurrent bevacizumab or other anti-vegf-directed therapy during tmprt is not allowed. if the patient is on bevacizumab, the patient needs to discontinue bevacizumab for at least 4 weeks prior to the start of tmprt and remain stable. other chemotherapy, immunotherapy, or target therapy can be used concurrently or adjuvantly at the discretion of treating physician. * medical contraindication to mri (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis). * pregnant.

Keywords: idh mutant glioma astrocytoma oligodendroglioma
administrative claims analysis of metanx® in diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy (DPN)

Summary: this study will be an observational cohort study utilizing administrative claims data with 100 patients randomly selected taking metanx® meeting the inclusion and exclusion criteria and 400 propensity score matched patients meeting the same criteria to serve as a control cohort for analyses. this data includes medical, and pharmacy claims from the healthcore integrated research database for claims submitted during the time period of 01/01/2002 through 06/30/2007.

the control patients will be matched at a ratio of 4:1 with the metanx® patients. covariates used to select the propensity matched patients will include: age; gender; health plan type and region; dci score; presence/absence of nephropathy; ischemic heart disease; cerebrovascular disease; neoplasm; insulin use; and all-cause health plan costs in the 6-mont pre-index period. claims information about patients selected for the study will be followed longitudinally to the end of data availability. this data stream will be used to determine treatment patterns for metanx®, healthcare resource utilization, and cost.

Eligibility criteria:
inclusion criteria: * patients must have pharmacy claims for \>120 continuous days of metanx®. this will be defined as at least a 90-day supply dispensed within the first 120 days post-index. the first pharmacy claim for metanx® will be the index date. * patients must have a diagnosis of diabetes prior to or including the index date. * patients must have a diagnosis of a peripheral neurological or a peripheral circulation disorder. * patients must have a diagnosis of lower limb ulcer. exclusion criteria: * patients will be excluded if they have \<18 months of eligibility defined as a minimum of 6 months pre and 12 months post-index eligibility. * patients will be excluded if they have taken other l-methylfolate containing products (deplin®, cerefolin®, cerefolin nac®,neevo®) or other prescription folic acid combination products with \>1mg folic acid.

Keywords: metanx® diabetes neuropathy peripheral neurological disorder peripheral circulation disorder folic acid folate l-methylfolate vitamin b6 pyridoxal 5'-phosphate vitamin b12 methylcobalamin
personalized management of type 2 diabetes using ai-guided (genais tm) dietary supplementation

Conditions: Diabetes

Summary: this randomized controlled trial investigates the effectiveness of ai-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing type 2 diabetes (t2d). the study includes 160 participants with t2d, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the ai-guided group (prescriptions determined by genais, an ai system by triangel scientific). the primary objective is to compare the reduction in hba1c levels between the two groups over 6 months. secondary outcomes include changes in fasting glucose, lipid profiles, body weight, bmi, hscrp levels, and adherence to the dietary supplement regimen. the ai system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.


Eligibility criteria:
inclusion criteria: * age between 40 and 75 years. * diagnosed with type 2 diabetes (hba1c between 7.0% and 10.0%). * stable anti-diabetic medication regimen for at least 3 months prior to the study. * willingness to provide genetic and metabolic data. exclusion criteria: * type 1 diabetes or other specific types of diabetes. * significant renal, hepatic, or cardiovascular diseases. * use of dietary supplements that affect glucose metabolism within the last 3 months. * pregnancy or breastfeeding

Keywords: ai-guided dietary supplementation personalized supplementation hba1c reduction genetic and metabolic profiling
a study evaluating the effects of ataciguat (hmr1766) on aortic valve calcification

Conditions: Aortic Valve Stenosis

Summary: the primary objective of the current study is to determine whether ataciguat (hmr1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis. secondary and tertiary objectives are to determine whether ataciguat slows progression of aortic valve function, reduces systemic inflammation, and prevents left ventricular dysfunction in patients with moderate calcific aortic valve stenosis.

patients with moderate calcific aortic valve stenosis may be eligible for enrollment in this study. participation lasts 12 months, which includes a total of 3 study visits (baseline/screening visit, 6 month follow up visit and 12 month follow up visit). during each visit, a blood sample will be taken along with other research related tests (orthostatic tolerance standing test, ct scan, echocardiogram, dexa scan). qualifying participants will be supplied with 6 months worth of study medication or placebo during visits 1 (baseline/screening visit) and 2 (6 month follow up visit) in which they will take at home daily with food. on visit 3 (12 month follow up visit), any remaining study medication or placebo will be returned to study staff.

Eligibility criteria:
inclusion criteria 1. age \> 50 years 2. male or female sex 3. aortic valve area greater than 1.0 cm2 but less than 2.0 cm2 4. aortic valve calcium levels greater than 300 au from chest ct 5. ejection fraction \>50% exclusion criteria 1. orthostatic intolerance or symptomatic hypotension prior to study or during study visits 2. positive pregnancy test during screening visit 3. nitrate use or α-antagonist medication use within 24 hours 4. systolic blood pressure \<110 mm hg 5. mean systemic arterial pressure \<75 mm hg 6. severe mitral or aortic regurgitation 7. retinal or optic nerve problems 8. recent (≤30 days) acute coronary syndrome 9. oxygen saturation \<90% on room air 10. congenital valve disease 11. hepatic dysfunction/elevated liver enzymes 12. prescription of drugs known to alter no-sgc-cgmp signaling (sildenafil, nitrates, etc.) 13. prescription of warfarin (coumadin) for chronic anticoagulation 14. concomitant participation in other trials at mayo clinic or elsewhere 15. use of phenytoin or related compounds for any indication 16. chronic midazolam treatment for any indication 17. use of monoamine oxidase inhibitors for any indication 18. use of anti-diabetic drugs in the sulfonylurea family

Keywords: stenosis aortic valve aorta calcified calcific calcification
efficacy and safety stress urinary incontinence study

Conditions: Urinary Incontinence, Stress

Summary: study f1j-mc-sbbt will examine the effect of duloxetine treatment in women with sui. the inclusion and exclusion criteria of this phase 3 study will ensure that all subjects have a clinical diagnosis of sui.


Eligibility criteria:
inclusion criteria: * are greater than 20 years of age. * are female outpatients. * present with sui based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of sui for a minimum of 3 months prior to study entry. * are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device \[iud\], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study. * have no language barrier, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study. exclusion criteria: * suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation). * has a physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject. * are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study. * have had any major inpatient surgery within 3 months prior to study entry. * have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract: ureteric, bladder, urethral, or rectal fistula * uncorrected congenital abnormality leading to urinary incontinence * detrusor instability or noncompliant bladder * adult enuresis * voiding difficulty (i.e., subject complains of difficulty emptying their bladder).
plate fixation versus intramedullary nailing of 3 and 4 part proximal humerus fractures

Conditions: Shoulder Fractures; Humeral Fractures, Proximal

Summary: the purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (phf) with an angular stable plate (philos) with that of an intramedullary nail (multiloc) in light of complications, radiological, economical, functional and clinical outcome.

randomized controlled trial (rct) from akershus university hospital in norway. randomization between two implants. the investigators will use deltopectoral or deltoid split as surgical access. all patients will have calcar screws and cuff sutures. when lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. postoperative radiographs of both shoulders and ct of operated shoulder will be taken.

Eligibility criteria:
inclusion criteria: 1. patients \> 18 years 2. severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. fractures with more than 50% displacement of the head against the surgical neck 3. the greater or lesser tubercles must be fractured in a 3 or 4-part fracture. the degree of displacement is not critical for inclusion. exclusion criteria: exclusion criteria: 1. fracture more than 3 weeks' old 2. caput humeri just a thin shell or split 3. ipsilateral damage that will influence the recovery and scoring systems 4. incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. 5. pathological fracture 6. neurovascular injury 7. open fracture 8. noncompliance 9. congenital anomaly 10. ongoing infectious process around the incision site for plate osteosynthesis 11. systemic disease that may influence healing processes or scoring systems (ra/ms) 12. fracture dislocation 13. substance abuse 14. inability to read and understand norwegian 15. patients not residing in our catchment area 16. patients with too small humerus diameter to use a nail 17. patient not able to commit and understand written consent

Keywords: multiloc philos locking plate straight nail randomized controlled trial 3 and 4 part fractures
lóa project: an exploratory pilot randomised controlled trial of a remotely-delivered brief cognitive intervention to reduce intrusive memories of trauma for women in iceland

Conditions: Intrusive Memories of Traumatic Event(s)

Summary: intrusive memories are sensory memories of a traumatic event(s) that spring to mind involuntarily, evoke strong emotions, and disrupt functioning in daily life. previous research has demonstrated that a brief cognitive intervention can prevent the development of intrusive memories as well as reduce the number of intrusive memories of long-standing trauma. initial pilot work (using case studies) with women in iceland indicates that the intervention is acceptable and feasible. this exploratory pilot trial will compare remote delivery of the intervention (i.e. brief, digitally delivered imagery-competing task intervention, n = 12) to an attention-placebo control condition (i.e., brief, digitally delivered relaxation exercise task; n = 12). we will explore whether (relative to the control condition) the intervention: (i) reduces the number of intrusive memories (primary outcome), and (ii) improves other symptoms and functioning. this study is funded by the oak foundation (ocay-18-442) and the strategic research and development program: societal challenges in iceland (200095-5601).

the proposed study will involve a brief intervention (c. 2 guided sessions with the researcher; options for up to 6 additional booster sessions) delivered digitally and remotely (i.e., not physically in-person), and with initial guided support (remotely delivered) from a researcher. participants will be asked to fill out a diary indicating the number of intrusive memories they experienced, along with self-report questionnaires, at baseline (i.e., one week prior to commencement of the intervention), week 1 (week after the second intervention/control session), week 5 (primary outcome; 5 weeks from the second intervention/control session), and at 1-, 3- and 6-months follow-up. monitoring will be performed by a clinical trial unit to verify that the study is conducted and data are generated and documented in compliance with gcp and the applicable regulatory requirements. potentially eligible participants for this pilot study will be identified using data collected in the saga cohort study (an epidemiological study of trauma among icelandic women).

Eligibility criteria:
inclusion criteria: * aged: 18-69 (at time of enrollment to cohort study) * able to speak and read study materials in icelandic or english * willing to be contacted remotely and having access to a smartphone or computer * experienced intrusive memories in past month (pcl-5 item 1 score is ≥ 2) * experienced 2 or more intrusive memories of a traumatic event in the past week * willing to monitor intrusive memories in everyday life * willing and able to complete remote study sessions exclusion criteria: * suicide risk indicated in the initial assessment (response of 'nearly every day' to item 9 on phq-9) and by responses on mini during follow-up telephone risk assessment
evaluating the effectiveness of aromatherapy for alleviating distress in breast cancer patients before radiotherapy.

Conditions: Breast Cancer

Summary: aster is a multi-part study that aims to prospectively establish evidence for the implementation of aromatherapy as complementary therapy within cancer care in the singapore context. aster 2 study evaluates how extracts from asian aromatic plants with familiar aromas introduced as inhalation therapy can alleviate distress in breast cancer patients scheduled to undergo radiotherapy (rt).

on the day of ct simulation, a research coordinator from the team will obtain consent from the eligible patients. patient related outcomes will be collected from the consented patients. study team will meet the patient 2 weeks later, on the day of their first radiotherapy session. patient will be given an hour before the radiotherapy session begin. during this time distress score will be assessed, blood pressure and pulse rate will be measured, and saliva sample be collected. patients will then be provided with the inhaler stick containing 2 drops of either carrier oil (placebo), or asian plant extract blend (intervention), which will be prepared prior to the study recruitment. patient will be instructed to hold the inhaler stick at about 8 cm (a hand fist's distance) away from their nose, to take up to 3 sniffs. this will be repeated with every 5 minutes of interval for 20 minutes of duration. after completion of the inhalation procedure, anxiety \& distress score will be assessed, blood pressure and pulse rate will be measured, and saliva sample be collected. a total of 300 breast cancer patients scheduled to undergo radiotherapy for the first time will be recruited in a randomized double-blind, 2-arm study: 150 patients in a placebo-control-group, 150 patients in the aromatherapy-intervention-group.

Eligibility criteria:
inclusion criteria: 1. aged 21 years old and above 2. confirmed diagnosis of breast cancer of any stage 3. scheduled to undergo radiotherapy for the first time 4. capable of providing informed consent exclusion criteria: 1. physically or mentally incapable of providing verbal/written consent 2. known or suspected hypersensitivity/allergy to essential oils or any components of the formulations 3. airway hypersensitivity to fragrances, paint fumes or turpentine 4. taking medications for anxiety (e.g. benzodiazepines) before radiotherapy 5. pregnant, breastfeeding, or intending to conceive during study period

Keywords: inhalation aromatherapy
study of 2 modalities of dialysis and nutrition on the nutritional status of malnourished chronic renal disease patients

Conditions: Renal Insufficiency

Summary: describe the impact of dialysis by high permeability and adsorbent membrane (pepa®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.

the study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).

Eligibility criteria:
inclusion criteria: * patient with renal failure, on hemodialysis for at least 12 months; * hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type); * malnourished patient, on intradialytic parenteral nutrition for at least 6 months; * patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy: * patient who signed an informed consent form to participate in the study exclusion criteria: * known allergy to pepa® ; * protected patient (under legal protection, or deprived of liberty by judicial or administrative decision); * patient with a chronic infection in progress; * patient with life expectancy \<6 months according to the investigator; * inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.); * pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding; * patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * patient not benefiting from a social security scheme.
impact of digital communication assist tools in endoscopic team communication during covid-19

Conditions: Endoscopy; Communication

Summary: team work is highly challenged by the covid-19 pandemic. necessary protective equipment as ffp-mask and face shields impair communication significantly.objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures.

optimal communication is crucial for team work in high class endoscopy. team work is highly challenged by the covid-19 pandemic. necessary protective equipment as ffp-mask and face shields impair communication significantly. digital enhanced approaches to maintain team communication during endoscopic procedures are mandatory not only in actual circumstances. materials and methods:a prospective, two-armed interventional study will be performed at an endoscopy unit at a tertiary center. 200 endoscopic examinations (egd, colonoscopy, eus, ercp) were randomly assigned (1:1) to a group that was performed with dect equipped endoscopy team or with standard communication. all examinations were performed under protective equipment. primary outcome was rate of communication associated adverse events. secondary outcomes included team subjectively perceived comfort with dect enhanced communication during endoscopic work, duration of examinations, sae.

Eligibility criteria:
inclusion criteria: * member of staff of the endoscopic team (doctor, nurse) exclusion criteria: * deafness * significantly impaired hearing

Keywords: endoscopy team communication endoscopic procedure covid-19