Kornimate/medical-research-clean huggingface dataset:
arimoclomol in sporadic inclusion body myositis - open label extension trial

Conditions: Inclusion Body Myositis

Summary: a multicenter, nonrandomized, open-label, uncontrolled clinical extension trial designed to compare the efficacy and safety of early versus delayed start of arimoclomol in the treatment of inclusion body myositis (ibm)

this was planned to be a 40-month open-label extension trial of the 20-month randomized, double-blind, placebo-controlled ibm4809 trial. the open-label trial was terminated early by the sponsor as a consequence of the results of ibm4809 which did not meet any of its efficacy endpoints. therefore, the actual average duration of open-label treatment was approximately 28 weeks.

Eligibility criteria:
inclusion criteria: 1. patient is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures. 2. patient has completed the ibm4809 trial on treatment with investigational medicinal product (imp). exclusion criteria: 1. known or suspected allergy or intolerance to arimoclomol or its constituents. 2. exposure to any other investigational treatment within 30 days or \<5 half-lives of the baseline visit or taking part or planning to take part in another interventional trial. 3. significant protocol deviation in the blinded ibm4809 trial based on the investigator's judgement in discussion with the medical monitor. 4. women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants up to 3 months after last dose. premenopausal women must have a negative pregnancy test prior to dosing with trial medication. acceptable methods of birth control are: * hormonal methods associated with inhibition of ovulation such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before arimoclomol administration. * total abstinence from sexual intercourse since the last menses before arimoclomol administration. (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. periodic abstinence \[calendar, symptothermal, post-ovulation\] methods are not acceptable methods of contraception). * intrauterine device (iud) or intrauterine hormone-releasing system (ius). 5. any concurrent condition that in the investigator's opinion will significantly interfere with assessment of safety or efficacy. 6. inability to comply with the protocol-specified procedures/evaluations and scheduled visits as per the investigator.

Keywords: ibm
validation of noninvasive hemoglobin, comparison of pvi to standard methods, and validation of clinical efficacy of ori

Conditions: Surgery

Summary: the study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (sphb) system with hemoglobin as measured by other validated devices. the study will also evaluation oxygen reserve index (ori) to correlate with partial pressure of oxygen (pao2), and to evaluate pleth variability index (pvi) with stroke volume variation (svv) or pulse pressure variation (ppv) values.


Eligibility criteria:
inclusion criteria: * admitted into the icu * aged 18 years or older * mechanically ventilated * arterial line placed * vigileo/flotrac system being used for guidance of fluid management exclusion criteria: * pregnancy * prisoner status * extreme hemodynamic instability * multiple vasopressors in use with questionable peripheral blood flow * lack of appropriate sites for sensor placement * patient or patient's legal representative refusal
a study of roactemra/actemra (tocilizumab) in combination with methotrexate versus roactemra/actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: this randomized, double-blind, parallel-group study will evaluate the efficacy and safety of roactemra/actemra (tocilizumab) in combination with methotrexate versus roactemra/actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. all patients will receive roactemra/actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. patients achieving low disease activity at week 16 will be randomized to receive a further 12 weeks of roactemra/actemra treatment plus either methotrexate or placebo. anticipated time on study treatment is 28 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * active moderate to severe rheumatoid arthritis (das28 \>/= 3.2) at baseline * currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (day 1) * body weight \< 150 kg * oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day exclusion criteria: * pregnant or nursing women * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline * rheumatic autoimmune disease other than ra * functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis * prior history of or current inflammatory joint disease other than ra * treatment with a biologic agent at any time prior to baseline * treatment with traditional dmards other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline * intraarticular or parenteral corticosteroids within 6 weeks prior to baseline * previous treatment with roactemra/actemra * history of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies * known active current or history of recurrent infection * history of or currently active primary or secondary immunodeficiency * active tuberculosis requiring treatment within the previous 3 years * positive for hiv infection
the association of sex with guideline-based perioperative care in hip fracture surgery

Conditions: Hip Fractures; Gender Bias; Surgery; Anesthesia

Summary: the investigators will use multilevel multivariable regression analysis to measure the association of sex with provision of guideline-based perioperative care for hip fracture surgery in ontario.

in 2013, the ontario ministry of health and longterm care published a 'quality based procedures' guideline for care of hip fracture patients. the adjusted association of sex with receipt of 5 perioperative processes of care that can be accurately measured in health administrative data within this guideline will be investigated.

Eligibility criteria:
inclusion criteria: * non-elective hospital admission * hip fracture diagnosis * hip fracture surgery exclusion criteria -none
lipid encapsulation for ileal brake activation

Conditions: Appetite Regulation

Summary: this study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without gi symptoms. every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.


Eligibility criteria:
inclusion criteria: * bmi between 25-30 kg/m2 * voluntary participation exclusion criteria: * milk (-protein or lactose)- allergy/intolerance * history of serious gi complaints/surgeries * pregnancy, lactation * excessive alcohol consumption (\>20 per week) * abnormal eating behaviour * intention to stop smoking * reported unexplained weight loss or gain in the month prior to screening * self-admitted hiv-positive state
preoperative versus postoperative start with thromboprophylaxis in tha (total hip arthroplasty)

Conditions: Arthritis of the Hip; Transfusion Related Complications; Infection; Wound Discharge

Summary: the purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with lmwh (low molecular weight heparin) is initiated before or after surgery.


Eligibility criteria:
inclusion criteria: -patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis exclusion criteria: * allergy to low-molecular-weight -heparin * bleeding disorders * renal failure * hepatic disease * active treatment for malignancy * history of deep venous thrombosis or pulmonary embolism * major operations,trauma,stroke or cardiac infarction the last 3 months before surgery.

Keywords: cemented total hip arthroplasty blood loss wound discharge thromboprophylaxis biomarkers
cancer chronic pain predicted by emotional and cognitive status

Conditions: Chronic Pain; Cancer

Summary: the aim of this study is to investigate the predictive dimension of cognitive-emotional status of cancer patients on the chronic pain development 6 months after different cancer treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy ...).

this is an observational, longitudinal and multicenter study assessing in cancer patients the link between the cognitive-emotional status and the development of chronic pain. cognition, anxiety, depression, quality of life, social vulnerability, cancer perception, pain and analgesic consumption are assessed.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * cancer patient with one or more programmed cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...) * acceptance to sign the non-opposition form exclusion criteria: * history of cancer and cancer treatment protocols (chemotherapy, surgery, hormone therapy, radiation therapy, targeted therapy, ...) * history and/or presence of primary brain tumors (glioblastoma, meningioma, neurofibroma ...) * history of neurological disorders (parkinson's disease, alzheimer's disease, dementia, epilepsy, moderate to severe head injury, ...) * history of psychiatric disorders (schizophrenia, bipolar disorder, ...) * medical and surgical history incompatible with the study

Keywords: cancer treatment protocols chronic cancer pain cognitive function quality of life anxiety depression
using stories to address disparities in hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine if patients with high blood pressure are better able to control their blood pressure after watching a dvd about blood pressure.

this project consists of two phases: (1) collecting of stories and creating a stories dvd; and (2) delivering the dvd in a randomized control trial (rct). both phases are described below. the investigators will make two dvds of african-american veterans who will tell their success stories with controlling hypertension (htn). the investigators want to help african-american veterans control their hypertension by showing them stories that are interesting and that they can identify with, as well as giving them information about ways they can manage hypertension in their everyday lives. this is important because a disproportionate number of minority patients, including veterans, have poorly controlled blood pressure. by showing them stories, rather than using more traditional methods of health education, the investigators hope to overcome some typical barriers to htn control among the african-american population, including: lower levels of health literacy and numeracy, less trust in the medical system, and different (non-medical) models to explain their illness. the veteran storytellers will come from three va sites (charleston, chicago, and philadelphia) and their stories will be chosen based on (1) the proven effectiveness of the strategies they suggest for controlling bp and (2) how authentic they are, or how much they will "ring true" with the experiences of other veterans, including their struggles and lessons learned. after the dvd is complete, the investigators will conduct a randomized control trial to evaluate how effective it is in helping vets control their hypertension: 780 african-american vets with uncontrolled hypertension, from the same three va sites, will participate. half of them will watch the "stories" dvd the investigators created; and the other half will watch a control, a dvd with the same medical information but without the narrative component. the investigators will measure their blood pressure (bp) just before they watch the dvd and again six months later. the investigators hypothesize that, six months after enrollment, the veterans who watched the "stories" dvd will have greater reduction in bp, as compared with those who watch the control. the investigators will also test the "stories" dvd's impact on medication adherence and htn management behaviors.

Eligibility criteria:
inclusion criteria: * african-american * diagnosis of htn * uncontrolled bp as defined by bp \>140/90 twice in the preceding 12 months exclusion criteria: * active substance abuse * severe mental illness * cognitive disabilities that might prevent them from actively or reliably participating in the interviews

Keywords: hypertension healthcare disparities minority health health behavior
efficacy and safety of early versus delayed administration of everolimus in de novo renal transplant patients

Conditions: Renal Transplantation

Summary: the purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.


Eligibility criteria:
inclusion criteria: * recipients of cadaveric kidney transplants * patients at risk of dgf defined as one or more of the following: * donor age \> 55 years * cold ischemic time (cit) ≥ 24 hours but \< 40 hours * second or subsequent renal transplantation exclusion criteria: * patients who have received an investigational drug within 4 weeks of baseline period * patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney * patients with body mass index (bmi) \> 32 kg/m2 other protocol-defined exclusion criteria may apply.

Keywords: renal transplantation everolimus immunosuppressants wound-healing
neuro-cardiac-guided transcranial magnetic stimulation: replication and dose-response.

Conditions: Major Depressive Disorder

Summary: autonomic regulation is disturbed in patients with major depressive disorder (mdd), indicated by a higher heart rate (hr) and lower heart rate variability (hrv). moreover, the heart seems to be functionally connected via the vagus nerve (vn) to other brain structures that are dysregulated in depression, such as the subgenual anterior cingulate cortex (sgacc), and the dorsolateral prefrontal cortex (dlpfc), suggesting dysregulated network function in mdd. in line with this network dysregulation hypothesis of mdd, optimal transcranial magnetic stimulation (tms) sites are currently thought to be those that show functional connectivity to the sgacc such as the dlpfc and multiple studies have shown that stimulation of the dlpfc, sgacc and nervus vagus decreased heart rate, suggestive of parasymphatetic action. it is hypothesized that this influence on parasympathetic activity can be used as a functional outcome measure reflecting adequate targeting of the dlpfc-sgacc network, similar to the motor evoked potential (mep) as functional key measure for primary motor cortex stimulation. recently, a pilot study was conducted, proposing a new functional neuronavigation method for localizing the frontal area representation of dlpfc-sgacc connectivity using hr, called: neuro-cardiac-guided tms (ncg-tms), which is being replicated in the current study. .


Eligibility criteria:
inclusion criteria: * healthy * between ages 18-60 exclusion criteria: * no prior experience with epilepsy * no pregnancy * no metal in the head * no cochlear implants

Keywords: target engagement tms heart-brain pathway depression neuromodulation dlpfc heart rate
a study to investigate safety and tolerability, pharmacokinetics and pharmacodynamics of jnj-63733657 in healthy subjects and subjects with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess the safety and tolerability of jnj-63733657 following single ascending intravenous (iv) dose administration in healthy subjects (part 1) and multiple ascending iv dose administrations in subjects with prodromal or mild alzheimer's disease (ad) (part 2).


Eligibility criteria:
inclusion criteria: general inclusion criteria: * body mass index (bmi) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive (bmi = weight/height\^2) and body weight greater than 40 kilogram (kg) but less than 110 kg at screening * women must not be of childbearing potential specific inclusion criteria part 2: each potential subject enrolled in part 2 must satisfy all of the following specific criteria in addition to the general criteria to be enrolled in the study: * clinical dementia rating scale (cdr) global rating score of 0.5 or 1.0 at screening * must have a reliable informant (example, relative, partner, friend) * must have cerebrospinal fluid (csf) finding consistent with alzheimer's disease (ad) pathology exclusion criteria: general exclusion criteria any potential subject who meets any of the following criteria will be excluded from participating in the study: * history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including but not limited to neurodegenerative disease (excluding ad for part 2) \[example, parkinson's disease\], seizure disorders, transient ischemic attacks, etc.), hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the investigator considers should exclude the subject * relevant history of or current neurological disease (other than prodromal ad or mild ad for part 2), which in the opinion of the investigator may make interpretation of possible new neurological signs or symptoms difficult * history of human immunodeficiency virus (hiv) antibody positive, or tests positive for hiv at screening (per screening evaluations) * history of hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hepatitis c virus \[hcv\]) positive, or other clinically active liver disease, or tests positive for hbsag or anti-hcv at screening (per screening evaluations) specific exclusion criteria part 1 - mini-mental state examination (mmse) score less than or equal to (\<=) 27 at screening specific exclusion criteria part 2 - evidence of brain disease, other than ad, that could explain the cognitive deficit (including, but not limited to, vascular encephalopathy or strokes, as imaged by cerebral magnetic resonance imaging (mri)
study of corneal biomechanics in glaucoma patients using brillouin microscopy

Conditions: Glaucoma

Summary: this pilot study evaluates the biomechanical properties of the cornea in glaucoma patients using brillouin microscopy, a non-contact imaging technique. the study aims to compare corneal stiffness between patients with normal-tension glaucoma, high-tension glaucoma, and healthy controls, and to assess changes in corneal biomechanics following intraocular pressure (iop)-lowering treatment. the goal is to determine whether brillouin-derived biomechanical measurements can serve as biomarkers for glaucoma risk and progression.

this study explores the biomechanical properties of the cornea in patients with glaucoma using a novel, non-contact imaging technique called brillouin microscopy. the technology allows in vivo assessment of tissue stiffness without physical perturbation, potentially offering new insights into glaucoma risk and response to therapy. the study includes two parts: a cross-sectional comparison between patients with normal- and high-tension glaucoma and healthy controls, and a longitudinal analysis of biomechanical changes following iop-lowering treatment with either prostaglandin analogs or beta blockers. the goal is to determine whether corneal biomechanics can serve as a biomarker for glaucoma susceptibility and progression, and to evaluate the feasibility of integrating brillouin imaging into clinical glaucoma care.

Eligibility criteria:
inclusion criteria: - age 18 years or older diagnosis of primary open angle glaucoma (poag) or no history of glaucoma (for controls) open angle on gonioscopy (shaffer grade 3 or 4) best-corrected visual acuity of 20/25 or better refractive error between +3.00 and -5.00 diopters no prior use of topical glaucoma medications diagnosis of: high tension glaucoma (iop ≥ 22 mmhg on 3 visits) normal tension glaucoma (iop ≤ 21 mmhg on 3 visits) or age-matched control with normal optic nerve and visual fields exclusion criteria: corneal abnormalities or conditions interfering with brillouin or applanation tonometry retinal diseases affecting rnfl (e.g., macular traction) history of ocular surgery or laser diagnosis of diabetes history of uveitis history of prolonged steroid use neurodegenerative or systemic diseases (e.g., multiple sclerosis, alzheimer's, parkinson's, schizophrenia) unreliable visual fields contraindications to beta blockers (e.g., bradycardia, severe pulmonary disease) moderate to severe glaucoma (per hodapp-anderson-parrish criteria) history of contact lens use low blood pressure

Keywords: glaucoma cornea biomechanics