Kornimate/medical-research-clean huggingface dataset:
transcutaneous spinal cord neuromodulation to normalize autonomic phenotypes

Conditions: Spinal Cord Injuries; Autonomic Imbalance; Autonomic Dysreflexia; Orthostatic; Hypotension, Neurogenic

Summary: this study looks to characterize autonomic nervous system dysfunction after spinal cord injury and identify the potential role that transcutaneous spinal cord stimulation may play at altering neuroregulation. the autonomic nervous system plays key parts in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically encounter complications. for both individuals with spinal cord injury and uninjured controls, experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate sympathetic signals. the investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. in both study populations, transcutaneous spinal cord stimulation will be added, testing previously advocated parameters to alter autonomic neuroregulation. in accomplishing this, the investigators hope to give important insights to how the autonomic nervous system works after spinal cord injury and if it's function can be improved utilizing neuromodulation.


Eligibility criteria:
inclusion criteria: all participants - age 18-30 years old. participants with spinal cord injury * adult onset, traumatic spinal cord injury. * time since injury 1 year, in an effort to limit baroreflex desensitization. * american spinal injury association impairment scale, a, to limit potential confounders. * neurological level of injury, t1-t6, as defined by the international standards for neurological classification of spinal cord injury. exclusion criteria: * history of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes. * women who are pregnant or lactating. * currently taking blood thinners. * taking anti-hypertensive or other medication that could influence any of the dependent autonomic variables.
avelumab, cetuximab, and palbociclib in recurrent or metastatic head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of the study is to find out if the study drugs avelumab, cetuximab, and palbociclib will slow or stop your cancer from getting worse, and whether it causes side effects. the second purpose is to measure whether your cancer responds to the study drugs avelumab, cetuximab, and palbociclib. the study drugs avelumab, cetuximab, and palbociclib are types of drugs called a monoclonal antibody. monoclonal antibodies are made to recognize, target, and bind to specific proteins on cells the building blocks making up your tissues.

this is an open-label phase i trial with a 3+3 dose escalation design. all patients will receive avelumab, cetuximab, and palbociclib. this study will enroll patients with head and neck squamous cell carcinoma not amenable to curative intent therapy. treatment will be administered in 28 day cycles with a pre-defined dose escalation schedule.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy. * presence of measurable tumor lesions per recist criteria v1.1 * life expectancy greater than 12 weeks. * adequate hematologic, hepatic, and renal function * negative serum or urine pregnancy test for women of child bearing potential exclusion criteria: * prior therapy with an egfr inhibitor or pd-1 or pd-l1 inhibitor in the recurrent or metastatic setting * uncontrolled central nervous system metastases (stable metastases permitted) * chemotherapy 28 days prior to first administration of study treatment and/or monoclonal antibody ≤8 weeks prior to first administration of study treatment. * history of other malignancies, * concurrent systemic immunosuppressant therapy (eg, cyclosporine a, tacrolimus, etc., or chronic administration of \>10 mg/day of prednisone or equivalent) * prior organ transplantation * known history of human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv).

Keywords: avelumab palbociclib cetuximab head and neck squamous cell carcinoma cancer recurrent head and neck squamous cell carcinoma metastatic head and neck squamous cell carcinoma
tramadol versus placebo in the management of postoperative pain following bunionectomy

Conditions: Pain Management

Summary: the study evaluates the effectiveness and safety of iv tramadol compared to placebo managing postoperative pain following a bunionectomy

(non-clinical summary) tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.

Eligibility criteria:
key inclusion criteria: * the patient is male or female 18-75 years of age undergoing unilateral first metatarsal bunionectomy surgery * willing to give consent and able to understand the study procedures * female patients must be of non-childbearing potential or be practicing a highly effective contraception * the patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 72 hours after surgery. * the patient meets definition of american society of anesthesiologists (asa) physical class 1, or 2. exclusion criteria: * patient is not expected to receive a continuous infusion nerve block as described in the post-op anesthetic procedures protocol * patient is undergoing bilateral or revision bunionectomy surgery * the patient has allergy or hypersensitivity (or is intolerant) to opioids or tramadol the patient has known physical dependence on opioids * the patient has taken other prior/concurrent chronic medications that have not been at a stable dose for at least 2 weeks prior to screening * the patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of cyp2d6 or cyp3a4 or inducers of cyp3a4 * the patient has taken monoamine oxidase (mao) inhibitors, trazodone, or cyclobenzaprine within 14 days prior to surgery * the patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, maoi inhibitors) or which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors (ssris), serotonin norepinephrine reuptake inhibitors (snris), tricyclic antidepressants, triptans). * the patient has a history of epilepsy, or is known to be susceptible to seizures * the patient has a history of long qt syndrome or a relative with this condition * the patient has expressed suicidal ideation or is considered to be at risk of suicide. * the patient is morbidly obese (body mass index \[bmi\] ≥ 40 kg/m2) or has documented sleep apnea requiring pharmacological or device intervention. * clinically significant abnormalities in the judgement of the investigator * the patient was administered an investigational product within 30 days prior to screening. * the patient has previously participated in a clinical study with ave-901.
incidences, causes, and outcomes of febrile illness in rural south and southeast asia

Conditions: Febrile Illness

Summary: the study will collect information to understand the causes and outcomes of febrile illness in rural areas in countries across south and southeast asia ( including cambodia, laos, myanmar and bangladesh). the findings will be used to identify new tests and treatments that can improve the management of febrile patients in the future. this study is funded by the uk wellcome trust. the grant reference number is 215604/z/19/z

this study aims to better understand and quantify the burden of febrile illness, the aetiological causes and the manner in which it affects the people living in rural areas in south and southeast asia, all on a scale which has not been attempted before. the seactn rfi project will collect information to help better understand and predict these outcomes based on a multitude of factors, which will form the basis for interventions within the network in the future. determining the incidence, causes and outcomes of febrile illness in these settings will be done through two work packages. the first of these, work package a (wp-a), the subject of this study, will be carried out at the community level, primarily by engaging village health worker (vhws) and low-level health centres (hcs) which serve the communities to recruit patients presenting with a febrile illness. these patients will be assessed for presenting symptoms and followed up for clinical outcomes. collection of specimen for diagnostic investigations in these settings is challenging. currently, mrdts are conducted by vhws and hcs in these networks, therefore by using the same process, but also applying blood to filter paper and allowing it to dry (dbs), investigators will test for certain other pathogens, which will increase the aetiological yield.

Eligibility criteria:
inclusion criteria: * documented fever (≥ 37.5°c axillary), hypothermia (\< 35.5°c) and/or history of fever in the last 24 hours. * willingness and ability to comply with study protocol for the study duration. * written informed consent given to participate in the trial. exclusion criteria: * currently enrolled in the study * accident or trauma is the cause for presentation * presentation ≤ 3 days after routine immunisations

Keywords: febrile illness incidence causes outcomes
perspective memory and executive functions in hiv+ patients

Conditions: HIV Infections

Summary: the primary goal of this observational study is to evaluate prospective memory in hiv+ patients compared to healthy subjects. the secondary goal is to examine the relationship between prospective memory and hot cognition (mechanical cognitive abilities) and cold cognition (cognitive abilities supported by emotion and social perception). the main questions it aims to answer are: * do hiv+ patients have more impaired prospective memory than healthy subjects? * is there a greater influence of hot cognition on prospective memory than cold cognition? participants will undergo a battery of neuropsychological tests: memory for intentions screening test (mist), montreal cognitive assessment (moca), interpersonal reactivity index and modified five point test.


Eligibility criteria:
inclusion criteria hiv+: * consent to participate in the study * diagnosis of hiv * current antiretroviral therapy * age \>18 years * native italian speaker exclusion criteria hiv+: * age \<18 years * presence of major psychiatric disorders within the past 6 months * additional neurological conditions that may impair the performance of the tests (alzheimer's disease, outcomes of head-brain trauma, cerebrovascular episodes) * alcohol and drug addiction within the past 6 months * additional medical conditions that may impair neurocognitive profile and functional abilities (cerebrovascular damage, cardiac problems with functional impairment, severe liver disease) inclusion criteria hiv- : * consent to participate in the study * absence of hiv infection (hiv-rna negative) * age \>18 years * native speaker of italian exclusion criteria hiv+ : * age \<18 years * presence of major psychiatric disorders within the past 6 months * additional neurological conditions that may impair the performance of the tests (alzheimer's disease, outcomes of head-brain trauma, cerebrovascular episodes) * alcohol and drug addiction within the past 6 months * additional medical conditions that may impair neurocognitive profile and functional abilities (cerebrovascular damage, heart problems with functional impairment, severe liver disease).
memory rehabilitation strategies in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the clinical characteristics of ms are extremely variable from one patient to another. in about 60% of cases, motor disabilities are associated with cognitive deficits. the present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with ms: rehabilitation of verbal memory with the rehacom program; combined rehabilitation, associating a motor rehabilitation path with the rehacom program; only motor rehabilitation course. aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with ms compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months. for these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with ms according to mc donald's criteria revisited by polman (2011). the study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (t0) assessment. subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (t1). finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (t2). statistical analyzes will be of two types: within group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at t0 with those at t1 and t2); between group (aimed at comparing the results obtained by each group with those of the other 2 groups at t0, t1, and t2).


Eligibility criteria:
inclusion criteria: * diagnosis of ms defined according to mcdonald's diagnostic criteria revised in 2011. * rrms or spms phenotype. * language italian mother tongue. * edss score \<6.0 exclusion criteria: * neurological or psychiatric pathologies other than ms that can interfere with cognitive functioning * clinical relapses in the three months prior to enrollment * severe mental illness * psychiatric disorders severe enough to interfere with cognitive functioning * medications steroid therapy in the 3 months prior to enrollment * motor limitations upper limb dysfunction (paralysis or tremor) that does not allow to hold the pc mouse * sensory limitations visual acuity impaired enough to not allow reading of the instructions to the various tests

Keywords: cognitive rehabilitation motor rehabilitation cognitive impairment
influenza vaccine in hiv study

Conditions: Influenza, Human

Summary: the aims of this study are: 1. to investigate if hiv infection alters the antibody responses to influenza and 2. to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in hiv-infected and hiv-uninfected subjects.


Eligibility criteria:
inclusion criteria: * hiv-1 positive by licensed diagnostic test (for hiv-positive group only) * planning to receive the seasonal influenza vaccine outside the study * provision of written informed consent exclusion criteria: * previous allergy to influenza vaccination * pregnancy or planning to become pregnant * unwilling or unable to provide blood samples
changes in everyday life after a tai chi or eurythmy intervention in elderly people at risk of falling: a qualitative exploration as a sub-study of the entaier study

Conditions: Increased Risk of Falls

Summary: the entaier fall prevention study investigates the efficacy and safety of eurythmy therapy and tai chi in older people with chronic diseases and an increased risk of falls. in the course of the entaier study, the participants observed changes in themselves and in their everyday life and described them in conversation, which could not be recorded with the research methods used. a qualitative exploration of these subjectively experienced changes among participants of the entaier study will be conducted as part of a sub-study. for this purpose, group interviews will be conducted.


Eligibility criteria:
inclusion criteria: * enrolled and randomized participant of entaier main study * written informed consent for participation in eyt_13 sub-study * participation in eurythmy or tai chi intervention for 24 weeks (-28d/+21d) (the standard care group will be time-equated to eurythmy and tai chi) exclusion criteria: * early termination of the intervention (less than 20 weeks) (the standard care group will be time-equated to eurythmy and tai chi)

Keywords: old age chronic disease risk of falls fear of falling fall prevention eurythmy tai chi
citrate versus heparin anticoagulation: effect on molecules clearances

Conditions: Septic Shock

Summary: sepsis is responsible for 50% of all acute kidney injury (aki) in intensive care units (icus), contributing greatly to multiple organ dysfunction syndrome (mods). special types of continuous renal replacement therapies (crrt) have been proposed as adjuvant therapies for septic shock due to their ability to remove middle molecular weight molecules such as inflammatory mediators involved in mods pathophysiology. these therapies are called extracorporeal " blood purification " therapies. when crrt is used, an anticoagulation is required to prevent clotting of the extracorporeal circuit, possibly causing bleeding in selected patients. many anticoagulation strategies have been proposed and the most commonly used in 2013 is still unfractionated heparin. regional citrate anticoagulation (rca) is an interesting alternative as it dramatically decreases the bleeding risk. the investigators hypothesize that the use of citrate with super high flux continuous veno-venus hemodialysis (shf-cvvhd) would be highly beneficial over time by preserving the filter effectiveness via limiting protein adhesion (which subsequently reduces filter pore sizes (protein cake)), as compared to heparin. consequently, higher clearances of the inflammatory mediators could be maintained over time with citrate as compared to heparin anticoagulation. in other words, for the same duration of filter use, middle molecular weight molecules and cytokines clearances would be greater with citrate as compared to heparin. to test this hypothesis, the investigators will perform a clinical randomized controlled trial which aim would be to compare middle molecular weight molecules and cytokines clearances in shf-cvvhd using rca versus systemic heparin anticoagulation in septic patients with aki.


Eligibility criteria:
inclusion criteria: * male or female critically ill patients over the age of 18 years old * acute kidney injury requiring crrt defined using the risk, injury, failure, loss, end-stage renal disease (rifle) classification with criterion i or worse. * septic shock as defined by the american college of chest physicians/society of critical care medicine consensus conference. * written informed consent obtained from the patient or a patient's legal representative * patient patient's legal representative able to agree to patient's enrollment in the study with informed consent. exclusion criteria: * pregnancy * participation in another research study protocol * known heparin induced thrombopenia or contraindication to heparin * pre-existing chronic renal failure on chronic dialysis * therapeutic anticoagulation with heparin for another reason (e.g. chonic arrhythmia) * severe liver failure (15% prothrombin time)

Keywords: cytokines blood purification super high flux hemodialysis
the effect of progressive relaxation exercise on caregiver burden, fatigue and quality of life in caregivers of patients with advanced cancer: randomized controlled clinical study

Conditions: Caregiver Burnout; Cancer

Summary: caregivers of patients with advanced cancer will be entered. participants will be randomized to one of two study arms: arm 1: progressive muscle relaxation; arm 2: attention matched control. hypothesis: progressive muscle relaxation will decrease caregiving burden and severity of fatigue and improve quality of life.

previous reports have revealed that progressive muscle relaxation to use to decrease symptom burden associated with cancer. however, there have been limited studies that directly focus on supporting caregivers of advanced cancer patients who face serious problems in diagnosis and treatment process, at least as much as cancer patients. besides, till date, no study has been conducted to determine the effects of progressive relaxation exercise on caregiver burden, fatigue and quality of life in those providing care for patients with advanced cancer. the present study investigates the effects of progressive muscle relaxation in a single-site, 2-arm, randomized, controlled study of 64 caregivers of patients with advanced cancer. arm 1: relaxation; arm 2: attention matched control. the investigators hypothesize that progressive muscle relaxation will decrease severity of caregiver burden and fatigue and improve quality of life.

Eligibility criteria:
inclusion criteria: * literate * providing care for advanced cancer patients (stage iii-iv) for at least 6 months * primary caregiver (caring for the longest time) * no communication problem * not using any other non-pharmacological approach during the study period exclusion criteria: * providing care for individuals with early-stage (stage i-ii) cancer * caregivers who providing care services for a fee * having a history of psychiatric disorder (major depression, etc.) * not willing to participate in the study

Keywords: caregiver burden, fatigue, relaxation, quality of life.
efficacy and safety of maridebart cafraglutide in adult participants with type 2 diabetes mellitus who have obesity or are overweight

Conditions: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Summary: the primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * body mass index ≥ 27 kg/m\^2. * history of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. * diagnosis of t2dm. exclusion criteria: * type 1 diabetes mellitus. * self-reported change in body weight \> 5 kg within 90 days before screening. * proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment. * obesity induced by other endocrinologic disorders. * family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2. * history of chronic pancreatitis or history of acute pancreatitis within 180 days before screening. * history of unstable major depressive disorder (mdd) or other severe psychiatric disorder within 2 years before screening. * lifetime history of suicide attempt.

Keywords: type 2 diabetes mellitus t2dm obesity overweight maridebart cafraglutide amg 133 maritide chronic weight management