Kornimate/medical-research-clean huggingface dataset:
a trial comparing adductor canal catheter and intraarticular catheter following primary total knee arthroplasty

Conditions: Acute Pain; Regional Anesthesia Morbidity

Summary: the study is a prospective randomized controlled trial comparing intraarticular catheters and adductor canal catheters for postoperative analgesia following a primary total knee arthroplasty (tka).

the study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary tka. eligible primary tka patients must be asa i - iii and require less than 20 mg oxycodone daily (or its equivalent). exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/motor disorder involving operative limb, non-english speaking, asa iv or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with cr \> 2.0 and hepatic failure. when patients agree to participate in the study the following data will be collected by the research staff: asa physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, paindetect score (form included), womac score (form included) and baseline pain management questionnaire. when designated through randomization, intra-articular catheters will be placed intraoperatively by the surgeons, per usual protocol. acc's will be placed postoperatively in the pacu. the catheters will exit the bandage in a similar fashion to blind the personnel collecting data, postoperatively. those collecting data will not be blinded from identifying patients in the control group, as no catheter will exit the bandage. potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. the preceding are commonly listed though infrequent complications of both procedures. continuous ultrasound will guide the placement of the acc.

Eligibility criteria:
inclusion criteria: * age 40-85 * american society of anesthesiologists (asa) physical status (ps) 1-3. * undergoing unilateral, primary, total knee arthroplasty * english as native language exclusion criteria: * patient refusal * history of opioid dependence * contraindication to peripheral nerve block * pre-existing significant neuropathy

Keywords: adductor canal catheter intraarticular catheter arthroplasty, replacement, knee
assessment of efficacy of sacral erector spinae plane block for postoperative analgesia in pediatric rectal biopsies

Conditions: Analgesia; Pain, Acute

Summary: the purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia.

rectal biopsies in pediatric patients are performed under general anesthesia to obtain adequate tissue samples and optimize for patient comfort, well-being and safety. post-operative pain can persist for longer than a day and requires analgesics. this study aimed to evaluate the effectiveness of sacral erector spinae block in decreasing post-operative pain scores and analgesic requirements.

Eligibility criteria:
inclusion criteria: * patients undergoing only rectal biopsy * asa class i-ii exclusion criteria: * asa class iii or more * coagulation disorders * sacral or spinal anatomical abnormalities * infection around the block site * local anesthesia allergy

Keywords: rectal biopsy sacral erector spinae block
thalidomide versus bortezomib in melphalan refractory myeloma

Conditions: Multiple Myeloma

Summary: the purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. the main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.

the study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. in case of failure to the initially given treatment the patient will be crossed over to the alternative treatment. the number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. with 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months. the dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the nordic countries. evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. evaluation of efficacy is done according to the international myeloma working group uniform response criteria. evaluation of toxicity is done by ctcae grading. evaluation of quality of life is done by the eortc qlq30 questionnaires with the addition of the myeloma specific my-24 module which are mailed to the patients at predetermined intervals during the study.

Eligibility criteria:
inclusion criteria: * treatment demanding multiple myeloma * refractoriness to melphalan * acceptance of rules for prevention of pregnancy exclusion criteria: * previous treatment with bortezomib, thalidomide, or lenalidomide * sensory neuropathy grade iii or neuropathic pain grade ii * severe concomitant disorder, e.g. other malignancy or severe heart disease * transformation to plasma cell leukemia or aggressive lymphoma * frequent visits for bortezomib injections not feasible * anticipated non-adherence to study protocol * pregnancy * anticipated non-adherence to rules for prevention of pregnancy * severe thrombocytopenia (thrombocyte count less than 25000/microliter)

Keywords: melfalan refractory multiple myeloma multiple myeloma relapsing refractory thalidomide bortezomib randomized clinical trial
serious illness communication project

Conditions: End of Life Care; Cancer

Summary: the purpose of the study is to evaluate the impact of implementing a "serious illness conversation guide" to guide patient/family-clinician discussions and planning about end-of-life care decisions. the goal of the intervention is to improve achievement of patient care priorities and peacefulness at the end of life for patients with serious and life-threatening illness and their families. we hypothesize that patients whose physician is trained to use and adheres to the elements of the serious illness conversation guide will demonstrate enhanced consistency between documented key priorities and care received, and will experience greater peace in the final month of life; similarly, their families will experience higher satisfaction with care.


Eligibility criteria:
the subjects of this study will be the clinicians (physicians and nurse practitioners) conducting the sicg conversations, their patient with high-risk cancers, and a friend or family member of the patient. clinician inclusion criteria: 1. dana-farber cancer institute medical oncology clinician 2. care for patients with selected high-risk cancers clinician exclusion criteria: 1. dfci gynecology-oncology specialist 2. seeing patients only in the phase i clinical trial disease center patient inclusion criteria 1. over 18 years of age 2. english speaker 3. patient at dana-farber cancer institute, including satellite sites at milford regional medical center and south shore hospital 4. diagnosis of one of the following high mortality or advanced cancers: breast, gastric, intestinal, esophageal, pancreatic, biliary, colorectal, hepatocellular, head and neck, renal, bladder, prostate, acute myeloid lymphoma (aml), acute lymphoblastic lymphoma (all), lymphoma, melanoma, glioblastoma multiforme (gbm), sarcoma, and lung. 5. ability to provide consent patient exclusion criteria 1. diagnosis of advanced obstetric-gynecological cancer 2. cognitive impairment family member inclusion criteria 1. over 18 years of age 2. english speaker 3. friend or family member of study patient (health care proxy, or close friend or family member who is involved in helping the patient think about decisions related to their health care) 4. ability to provide consent
investigation of lithium on signal transduction, gene expression and brain myo-inositol levels in manic patients

Conditions: Bipolar Disorder

Summary: this study investigates the effects of lithium treatment on signal transduction pathways, gene expression and brain neurochemistry and structure in patients with bipolar disorder. it is hypothesized that specific changes in these markers will correlate with lithium treatment responsiveness.

this study investigates the effects of blinded lithium treatment longitudinally in patients with bipolar disorder. at baseline and at multiple time points following the initiation of lithium treatment over 4 or more weeks, measures of signal transduction pathways, gene expression and brain neurochemistry and structure were obtained. it is hypothesized that modulation of these measures will be predictive of lithium treatment responsiveness.

Eligibility criteria:
inclusion criteria: * meet diagnostic criteria for bipolar mood disorder determined by dsm-iv (scid) exclusion criteria: * meeting criteria for any other dsm-iv axis i disorder * psychoactive substance abuse or dependence within the past 1 year * medical conditions placing patients at increased risk for lithium treatment (including renal disease, hepatic disease, hematological disease) * devices/implants or conditions which preclude mri investigation (including cardiac pacemaker/icd, aneurysm clips, neurostimulator device, metallic fragments in or near the eye,claustrophobia)

Keywords: lithium neuroprotection neurotrophic bcl2 gsk3 pkc mri myoinositol mrs alzheimers disease
acupuncture in migraine without aura patients

Conditions: Migraine Without Aura; Acupuncture

Summary: the investigators aimed to investigate the effect of acupuncture treatment on attack frequency, pain intensity, and disability in migraine without aura patients who receive prophylaxis treatment.

acupuncture is a traditional chinese medicine method that has been used for 3000 years to control symptoms, treat illnesses, and relieve pain. acupuncture is widely used in many countries today as a complementary therapy, especially in cases of chronic pain. migraine is one of the diseases in which acupuncture treatment is commonly used. studies conducted so far have focused more on the effect of acupuncture on pain intensity in patients with migraine. data comparing the impact of acupuncture on both the attack frequency and disability in migraine are relatively scarce.

Eligibility criteria:
inclusion criteria: * being diagnosed with migraine according to ihs (international headache association) * receiving migraine prophylaxis treatment * having more than four attacks per month/more than one attack per week * not having received acupuncture treatment before. exclusion criteria: * being diagnosed with migraine with aura/secondary headache * having received acupuncture treatment for any reason within the last year * not giving consent for acupuncture treatment * having a fear of needles.

Keywords: migraine acupuncture midas
study of osteogenesis imperfecta tendon

Conditions: Osteogenesis Imperfecta

Summary: osteogenesis imperfecta (oi) is a rare genetic disease due to a mutation in one of the genes encoding either type i collagen or a protein involved in its synthesis. this leads to bone fragility with fractures and deformities. however, other tissues rich in type i collagen can also be affected, such as teeth or vessel walls. in the literature, several case reports describe tendon ruptures in oi patients, but no original study has really addressed this issue, which is likely to impact the quality of life through a reduction in mobility and pain. recent work carried out by the investigators shows an alteration of the osteotendinous unit in the osteogenesis imperfecta mouse (oim), a validated model of the most severe form of oi. consequently, the project aims to study the damage of tendon and ligament in patients suffering from osteogenesis imperfecta.

this project aims to study the damage of tendon and ligament in a cohort of patients suffering from osteogenesis imperfecta. the data collected will be put into perspective with those of our first experimental work on mice. they will also make it possible to complete the specific care of these patients. indeed, during the anamnesis, particular attention will be paid to the description of tendon-ligament pain in order to propose the most effective treatment for this kind of disorder, mainly in physiotherapy. prevention work will surely be necessary with patients and caregivers.

Eligibility criteria:
inclusion criteria: * to have an osteogenesis imperfecta exclusion criteria: * none, since we want to study different types of osteogenesis imperfecta and consider the effect of age.

Keywords: osteogenesis imperfecta
the mitraclip® expand study of the next generation of mitraclip® devices

Conditions: Mitral Valve Regurgitation; Mitral Regurgitation

Summary: the mitraclip expand study (a contemporary, prospective study evaluating real-world experience of performance and safety for the next generation of mitraclip devices) is designed to confirm the safety and performance of the mitraclip ntr system and mitraclip xtr system.

the data collected in this study will be used to evaluate device outcomes and characterize trends in patient selection for mitraclip therapy in contemporary real-world use. moreover, the data will be assessed to identify patient or mitral valve anatomical characteristics that may be most appropriate for these next generation devices. the mitraclip expand study will be conducted on commercial mitraclip ntr system and mitraclip xtr system that have received ce mark and/or fda approval as required. up to 1,000 subjects at a maximum of 60 sites in europe and the us were initially planned to enroll in the mitraclip expand study.

Eligibility criteria:
inclusion criteria: 1. subjects who give consent for their participation 2. subjects scheduled to receive the mitraclip per the current approved indications for use 3. subjects with symptomatic mr (≥3+) exclusion criteria: 1. subjects participating in another clinical study that may impact the follow-up or results of this study

Keywords: mitraclip mitraclip ntr mitraclip xtr mitral regurgitation
percutaneous revascularization in infarction with late presentation and absence of viability: effects on left ventricular remodeling and contractility

Conditions: STEMI - ST Elevation Myocardial Infarction; Myocardial Dysfunction; Percutaneous Coronary Intervention

Summary: the purpose of this study is to evaluate whether late recanalization in patients with st elevation myocardial infarction (stemi) without viability on cardiovascular magnetic resonance image (mri) can reduce the reverse remodeling through the reduction of the end systolic volume (esv) at 6 months.

the purpose of this study is to evaluate whether late recanalization in patients with st elevation myocardial infarction (stemi) without viability on cardiovascular magnetic resonance can reduce the reverse remodeling through the reduction of the end systolic volume (esv) at 6 months and through the improvement in segmental contractility of infarcted related artery at mri.

Eligibility criteria:
inclusion criteria 1. stemi not reperfused between 24 hours and 28 days 2. mi-related artery with \> or = 50% 3. segmental dysfunction in the artery related to infarction. 4. technical feasibility for pci recanalization 5. absence of myocardial viability 3.3 exclusion criteria 1. age \> 80 years 2. \< 1 year life expectancy 3. post mi angina 4. clinical instability 5. electrical instability 6. previous infarction with segment disfunction 7. new york heart association (nyha) class iii or iv of heart failure. 8. previous diagnosis of congestive heart failure or cardiomyopathy 9. severe heart valve disease 10. absence of segmental dysfunction in the artery related to infarction 11. coronary angiography without obstructive lesions 12. indication of myocardial revascularization surgery 13. opted for clinical treatment for technical reasons 14. serum creatinine concentration greater than 2.5 mg/dl 15. pacemaker or implantable cardiodefibrillator (icd) 16. brain clip carriers 17. patients with cochlear implants 18. refusal to sign the informed consent form (icf). 19. inability to maintain outpatient follow-up for 6 months.

Keywords: stemi myocardial viability late percutaneous coronary intervention myocardial remodelling myocardial reperfusion
neuromodulation for schizophrenia

Conditions: Schizophrenia

Summary: our proposed study employs a novel approach to determine the clinical and functional imaging effects of brainstem neuromodulation, with an investigational study device, on illness awareness in schizophrenia - a significant contributor to medication non-adherence and poor treatment outcomes, and arguably the most treatment resistant manifestation of the disorder. the study device under investigation provides a safe and non-invasive method of brainstem stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with treatment and illness awareness.


Eligibility criteria:
inclusion criteria: 1. male or female inpatients or outpatients ≥ 18 years of age 2. having a dsm-v diagnosis of schizophrenia or schizoaffective disorder 3. voluntary and capable of consenting to participation in the research study 4. fluent in english 5. moderate-to-severe lack of illness awareness ≤7 on the vagus-sr, which corresponds to a rating of ≥3 on panss g12 insight and judgment item 6. on a stable dose of antipsychotic and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study exclusion criteria: 1. unwilling or unable to consent to the study 2. use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease 3. had eye surgery within the previous three (3) months 4. ear surgery within 6 months prior to entering the study 5. active ear infection or perforated tympanic membrane 6. diagnosis of vestibular dysfunction 7. unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures 8. acute suicidal and/or homicidal ideation 9. formal thought disorder rating ≥4 on panss item p2 10. dsm-v substance dependence (except caffeine and nicotine) within one month prior to entering the study 11. positive urine drug screen at the screening visit 12. metal implants or a pacemaker that would preclude the mri scan 13. pregnancy

Keywords: neuromodulation
compli-picc: study on picclines' complications

Conditions: PICC Line Placement

Summary: this is a prospective monocentric study of picc line complications use in 5 medical and one surgical units of brest medical university hospital. to evaluate the incidence of the following complications: infections, thromboses, mechanical and hemorrhagic, at month 3 post-intervention. also evaluating: * the management of these picc line related complications, * risk factors for such complications, * and the mortality-related outcomes.

all eligible patients fulfilling the inclusion criteria, after picc line placement, will receive oral and written patient information describing the study deployment and follow-up. patients will be followed up until picc line removal if it occurs during the first 3 months after placement or until death if it occurs during the first 3 months, or during 3 months in the absence of complications. * infectious complications are described in accordance with idsa 2009 guidelines and include bloodstream infection, endocarditis, local infection and septic thrombophlebitis. * thrombotic complications are defined as symptomatic, deep, or superficial venous thrombosis, confirmed by ultrasound and echo-doppler or asymptomatic venous thrombosis diagnosed fortuitously. * mechanical complications are defined as impairments related to picc line device: occlusion, rupture, accidental removal. * hemorrhagic complications are defined as hematoma or bleedings of puncture site. in the event of picc line-related complications, patient will be followed up for an additional 3 months, from the date of complication diagnosis, i.e. maximum follow-up duration of 6 months. each week during the first month, then once monthly during the follow-up (i.e. w1, w2, w3, w4, m2, m3, +/- m4, m5, m6), all patients data related to the picc line retention or removal, use and all its related complications will be collected.

Eligibility criteria:
inclusion criteria: * patient \> 18 yo * patients \> 18 yo hospitalized in internal medicine, pneumology, nutrition, oncology, hematology, and cardiac and vascular surgery - who underwent picc line placement between october 10, 2016 and march 9, 2017 exclusion criteria: * patients hospitalized in other units than those cited above * patients verbal refusal to participate in the study

Keywords: picc line complications thrombosis infection
hpv self-testing in transgender individuals

Conditions: HPV Infection

Summary: human papillomavirus (hpv) is a common virus that spreads through skin-to-skin contact. some hpv types can cause changes in cells that lead to cancer and are known as 'high-risk' hpv (hrhpv). hrhpv is linked to cancers of the cervix (opening of the womb), throat, and anus (exit of the bowel). it is not known if transgender people (individuals whose gender identity does not align with their sex assigned at birth) are at increased risk of hrhpv or cancers caused by hrhpv compared to cisgender people (individuals whose gender identity does align with their birth sex). there is also little knowledge about hpv in the vagina for transgender women who have surgery to make one. transgender men may be at higher risk of cervical cancer than cisgender women because they are less likely to go for screening. this can be because of physical discomfort and emotional distress during screening when a swab is taken directly from the cervix. the investigators seek to examine how common hrhpv is in transgender people in different parts of the body. in the study, participants will take swabs from the vagina and anus, a urine sample, and use mouthwash. transgender men will also have an extra swab taken by a clinician as part of routine cervical screening. this is to see if the swab from the vagina is as good as the one from the cervix for finding cells that might lead to cancer. participants will also take an online survey to measure the acceptability of self-sampling compared to clinician sampling. this research can inform hpv prevalence and decision-making about hpv screening among transgender people.


Eligibility criteria:
inclusion criteria for trans men and non-binary adults with a cervix: * identify as transgender or non-binary * be between 25 - 65 years of age * be registered with a general practitioner * have an intact cervix * have used testosterone therapy within the last year * be willing, and able to understand and consent to study procedures inclusion criteria for trans women and non-binary adults : * identify as transgender or non-binary * be 18 years of age or older * have undergone vaginoplasty by any method at least 1 year ago * be willing, and able to understand and consent to study procedures exclusion criteria: * have a variation of sex characteristics (also known as a disorder of sex development) * have an allergy to any of the ingredients in the oral rinse (scope) * be diagnosed with, or under investigation for, an inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease). this does not include irritable bowel syndrome - participants with this are eligible to enroll. * be a member of a vulnerable population, which includes pregnant people, fetuses, children, prisoners, or anyone unable to independently offer consent.

Keywords: transgender trans men trans women non-binary individuals