Kornimate/medical-research-clean huggingface dataset:
safety and bioactivity of axt107 in subjects with neovascular age-related macular degeneration

Conditions: Neovascular Age-Related Macular Degeneration (nAMD)

Summary: this is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg axt107 in approximately 18 subjects (up to 6 subjects per dose) with namd.

upon providing informed consent, subjects will be sequentially enrolled into the study. decision regarding dose escalation will be based on the recommendation from the data monitoring committee (dmc). the first 3 eligible subjects will receive the low dose of axt107 injection. after the 3 low dose subjects complete a 7-day follow-up, the dmc will review their safety data. if an acceptable safety profile is determined by the dmc, 3 additional subjects will be enrolled to receive the mid dose of axt107 injection. upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the dmc for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of axt107 injection.

Eligibility criteria:
inclusion criteria: * patients 50 years of age or older diagnosed in the study eye with subfoveal choroidal neovascularization (cnv) or juxtafoveal cnv secondary to amd * best corrected visual acuity (bcva) early treatment diabetic retinopathy study (etdrs) letter score of 65 to 10 in the study eye * willing and able to comply with clinic visits and study-related procedures * provide signed inform consent exclusion criteria: * macular edema or cmv secondary to any causes other than amd in the study eye * previously-treated patients who are not responders to anti-vegf * any condition that may preclude improvement in visual acuity in the study eye * previous vitreoretinal surgery, filtration surgery, and cataract surgery within 3 months in the study eye note: other inclusion/exclusion criteria apply

Keywords: asclepix neovascular age-related macular degeneration namd eye diseases retinal diseases axt107 duration of action dose escalation macular degeneration
effect of platelet concentrate in treatment of diabetic ulcers

Conditions: Diabetes

Summary: autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

the treatment of a diabetic wound with apc and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. the study is a prospective, randomized, blinded, multicenter clinical evaluation.

Eligibility criteria:
inclusion criteria:chronic diabetic ulcer - exclusion criteria:steroids, dialysis, vascular disease -

Keywords: diabetes ulcer apc
explorative proteomics in pediatric neuroborreliosis

Conditions: Neuroborreliosis; Facial Palsy; Pediatric Infectious Disease

Summary: this study aims to use proteomic analysis to diagnose lyme neuroborreliosis (lnb) in children. pediatric patients with suspected lnb will be enrolled, and their blood samples will be collected for proteomic analyses. mass spectrometry will be used to compare protein profiles of lnb-positive and lnb-negative patients. the data will be analyzed by bioinformaticians. the expected impact is to establish a non-invasive, reliable method for early lnb diagnosis to improve patient outcomes.

objective: the primary objective of this study is to investigate the utility of proteomic analysis in diagnosing lyme neuroborreliosis (lnb) in children. by identifying specific protein markers associated with lnb (proteomics), the investigators aim to enhance early detection and improve patient outcomes. methods: participant recruitment: the investigators will enroll pediatric patients (aged 1 month to 17 years) presenting with suspected lnb. informed consent will be obtained from parents or legal guardians. sample collection: peripheral blood samples will be collected from each participant in edta tubes. samples will be processed to carry out proteomic analyses. proteomic analysis: mass spectrometry will be employed to compare protein profiles between lnb-positive and lnb-negative patients. data analysis and presentations: protein profiles will be analysed by trained bioinformaticians and mainly presented in volcano plots and heat maps. outcome measures: unique proteomic profiles of children with lnb. expected impact: this study aims to establish a non-invasive and reliable method for diagnosing lnb in children. early identification will facilitate timely treatment and prevent complications associated with lnb.

Eligibility criteria:
inclusion criteria: * presenting at a pediatric ward with facial nerve palsy and/or suspicion of lyme neuroborreliosis * parental informed consent exclusion criteria: * parents or legal guardians unable to understand given information or comply with study criteria * patient unable to cooperate to study procedures (blood sample) * unclear etiology after lumbar puncture

Keywords: neuroborreliosis pediatric infectious disease proteomics
cerebral blood flow and petco2 on neuromuscular function during environmental stress

Conditions: Healthy Males; Neuromuscular Function

Summary: environmental stress, such as low oxygen availability (hypoxia), has been associated with impaired neuromuscular performance; however, the mechanisms associated with these performance decrements remain unclear. while the majority of research suggests that the observed fatigue is related to the central nervous system, the influence of changes in cerebral blood flow (cbf) and associated changes in cerebral ph (partial pressure of carbon dioxide; pco2) remains unexamined. in response to hypoxic stress, humans hyperventilate to maintain oxygen consumption, resulting in a hypocapnia mediated decrease in cbf and cerebral alkalosis (decreased pco2). previous research suggests that hyperventilation induces changes in neural excitability and synaptic transmission; however, it remains unclear if these changes are related to hypocapnia mediated decrease in cbf or cerebral alkalosis or both. the purpose of the proposed research program is to examine the influence of changes in cbf and cerebral alkalosis on neuromuscular function during environmental stress. the research program will consist of 2 separate projects, summarized below in a table outlining the proposed protocols and resultant physiological manipulations. during each manipulation, neuromuscular function will be evaluated and compared to baseline (normoxic) conditions using a repeated measures design. the research program will consist of 2 separate projects. project 1 will examine the changes in cbf and alkalosis by using (a) indomethacin (decrease cbf; no change pco2) and (b) hypocapnia (decrease cbf; decrease pco2). using a similar experimental design, project 2 will examine the change in cbf and alkalosis during hypoxia by using (a) poikilocapnic hypoxia (decrease po2; decrease cbf; decrease pco2), (b) isocapnic hypoxia (decrease po2; no change cbf; no change pco2) and (c) isocapnic hypoxia + indomethacin (decrease po2; decrease cbf; no change pco2). during each manipulation, neuromuscular function will be evaluated and compared to baseline (normoxic) conditions using a repeated measures design. therefore, project 1 will examine the separate and combined effect of changes in cbf and cerebral alkalosis on neuromuscular function independent of environmental manipulations. subsequently, project 2 will examine neuromuscular function during hypoxia while controlling cbf and cerebral alkalosis. it is hypothesized that changes in pco2 and therefore, changes in cerebral alkalosis will contribute to neuromuscular fatigue independent of changes in cbf and oxygen availability.


Eligibility criteria:
inclusion criteria: * 18 to 25 yrs old; healthy males exclusion criteria: * diagnosed medical condition; nsaid allergy; smoker; high altitude exposure; implants
risk of recurrence of cervical artery dissection during pregnancy and puerperium

Conditions: Cervical Artery Dissection

Summary: cervical artery dissection (cad) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). many cases of cad during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for cad. the purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for cad.

in this study, all women of childbearing age who had had a cad between 2005 and 2017 are selected. women are identified using the icd10 diagnostic coding system. in addition, a text search with key words ("cervical or carotid or vertebral dissection") has been created in a data warehouse of the university hospital of nantes. to determine the recurrence of cad during pregnancy and puerperium, the participating women will be asked to answer to a questionnaire, by phone or mail. the questionnaire will be conducted by the same investigator, an experienced neurologist. information about recurrence of cad, number of pregnancies before and after the event will be recorded, as well as, the site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case of further pregnancy. in case of no further pregnancy after the dissection, the reason will be explored.

Eligibility criteria:
inclusion criteria: * extracranial carotid or vertebral dissection * symptomatic dissection (with symptom onset within the last four weeks) * spontaneous dissection * imaging evidence of dissection on mri/mra, cta or ultrasound. exclusion criteria: * minors or adults under guardianship * intracranial artery dissection * traumatic or iatrogenic dissection * patient refusal to participate

Keywords: pregnancy puerperium recurrence cervical artery dissection
performance evaluation of the nanomix elab® crp, pct, and lac assays with the nanomix elab system

Conditions: Sepsis; SIRS

Summary: the performance of the elab c-reactive protein, procalcitonin, and lactate assays will be demonstrated during a method comparison study in which venous whole blood and plasma samples are used. elab results will be compared to an fda cleared predicate device. demographic information will be collected for the subject. venous blood will be collected in 2 li-heparinized tubes (2-4ml per tube). one tube will be used for testing at the site and the second tube will be processed to plasma for storage and subsequent shipment to a designated testing site. whole blood samples will be tested on the elab c-reactive protein, procalcitonin, and lactate test as soon as possible after collection; testing on whole blood must be completed within 30 minutes of collection. a predicate lactate test will also be run as soon as possible after collection; testing of wb on the predicate must be completed within 30 minutes of collection. plasma will be separated from the whole blood via centrifugation within 30 minutes of collection and tested on the elab c-reactive protein, procalcitonin, and lactate assays and started on predicate crp and pct devices (if available at the site) within 30 minutes of the elab whole blood test. the remainder of the plasma specimen and plasma from the second collection tube will be frozen within one hour of collection, then stored at approximately -20 degrees c or colder.


Eligibility criteria:
inclusion criteria: * must be 18 years of age or older * must have provided written informed consent * admitted to icu, emergency department or other medical wards for acute illness and observation of infection and meeting sirs criteria (such as elevated heart rate, tachypnea, hypotension, fever, hypothermia, or elevated respiratory rate) exclusion criteria: * pregnant or nursing * admitted to icu after trauma * admitted to icu after surgery * cardiogenic shock
assessing the feasibility of a prevention m-health app intervention for informal caregivers of outpatients

Conditions: Telemedicine; Caregivers; Pressure Ulcer

Summary: the present quasi-experimental study aims to compare the level of preventive behaviours amongst caregivers who will be instructed to operating one mhealth app or given a relevant instruction manual. to achieve this, a comparison between the behavior of caregivers before and after the intervention and a comparison between the two groups (intervention group with the control group) will be performed. specifically, data within the two groups will be collected via an online questionnaire consisting of three parts: prior to the intervention (baseline), two (2) and four (4) months after the intervention. the self-administered questionnaire consists of fifty-two (52) questions and uses three valid and reliable scales with a part that was developed via a bibliography research and consultations from experienced specialists. the questionnaire scales have been translated from the english language to greek.


Eligibility criteria:
inclusion criteria: * the main adult caregiver is able to provide care / support to a bedridden patient. * willingness to participate in the study. * basic knowledge of the greek language such that the user can understand the intervention and be able to complete the self-administered questionnaire. * possession of a mobile android or ios device. * the patient is bedridden for no longer than four (4) months. * during the assessment for predicting the risk of patient pus development, the score according to the braden scale must be between medium to severe risk (≤ 18). exclusion criteria: * the user does not have basic knowledge of the greek language such that he/she is not able to understand the intervention or complete the self-administered questionnaire. * possession of a different mobile device other than android and ios or no possession of a mobile device. * the patient is bedridden for four (4) months or longer. * a mild risk score using the braden scale (15-18).

Keywords: pressure ulcer prevention, mhealth, quasi-experimental
povidone-iodine vs saline solution in colorectal surgeries and its effects on the surgical site infection

Conditions: Surgical Site Infection

Summary: considering the relatively high incidence of surgical site infection (ssi) in colorectal surgery, this trial will compare rates of ssi in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. the trial will be conducted in a large university hospital in southern brazil.

patients will be randomized to one of the following intervention groups: group 1: intraoperative irrigation/washing of the surgical incision with povidone-iodine (pvp-i); detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of povidone-iodine solution (pvp-i). the exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. " group 2: intraoperative irrigation/washing of the surgical incision with saline solution (nacl 0.9%); detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of saline solution (nacl 0.9%). the exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. note: other care routines for participating patients will not be changed by this study. patients will receive mechanical colon preparation and antibiotic prophylaxis according to routines already in place by the assistant team. randomization: the block randomization method will be used (blocks of 4 patients each). groups 1 and 2 will be compared with each other regarding the outcomes.

Eligibility criteria:
inclusion criteria: patients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the hospital de clinicas de porto alegre - division of coloproctology. exclusion criteria: * age under 18; * surgery classified as dirty; * urgent/emergency surgery; * patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ); * known allergy to iodine.

Keywords: surgical site infection colorectal surgey
safety and effectiveness of nivolumab in recurring kidney cancer participants

Conditions: Kidney Cancer; Renal Cancer

Summary: a non-interventional, medical record review of clinical data collected from japanese participants with recurring kidney cancer


Eligibility criteria:
inclusion criteria: * a patient with rcc with distant metastasis treated for the first time with nivolumab exclusion criteria: * patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with rcc other protocol defined inclusion/exclusion criteria could apply
efficacy and tolerance of a follow-on formula fed to children from 36-48 months of age

Conditions: Acute Respiratory Infection; Diarrheal Disease

Summary: the purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.


Eligibility criteria:
inclusion criteria: * child 36-48 months of age * child is currently attending a daycare and has attended for 6 months or less * has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization * signed informed consent exclusion criteria: * child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization * child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child * child with diarrhea or acute respiratory infection during the 48 hours prior to randomization * child's z-score of weight for height \< -3 according to world health organization criteria
spinal fusions steroid study

Conditions: Spinal Fusion

Summary: current efforts to improve pain alleviation focus on non-opioid pharmaceuticals. intravenous perioperative corticosteroid administration has been suggested as an alternative method for post-operative pain control. the evidence regarding perioperative intravenous corticosteroids to help alleviate post-operative pain is mixed. some meta-analyses report decreased opioid consumption and decreased pain intensity after a variety of surgical procedures. however, a study of larger orthopedic procedures found no benefit. the catabolic and immunosuppressant effects of corticosteroids also pose issues with wound healing and infection, which can have severe consequences after spine surgery. there is limited data on the effect of perioperative intravenous steroid administration on pain alleviation in children having surgery to address spine deformity. a recent retrospective review demonstrated that perioperative corticosteroid administration was associated with a statistically significant decrease in opioid medication utilization among children and adolescents after spinal deformity surgery. while not increasing the risk of postoperative complications. the investigators hypothesize that the administration of perioperative intravenous dexamethasone will demonstrate a clinically meaningful and statistically significant decrease in postoperative pain intensity, need for opioid medications, time to ambulation, and length of stay in children recovering from surgery for spine deformity.


Eligibility criteria:
inclusion criteria: * meets operative criteria for posterior spinal instrumented fusion for ais * parental consent exclusion criteria: * revision procedure * other associated conditions which may alter the postoperative course
preoperative oral midodrine versus intraoperative intravenous norepinephrine in preventing post-spinal anesthesia hypotension in cesarean section: a prospective double-blind randomized clinical trial

Conditions: Post Spinal Anesthesia Hypotension

Summary: neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, prevention of this spinal anaesthesia induced hypotension is of utmost importance, techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as positioning and leg compression. midodrine is an orally active α-adrenergic agonist ,used in clinical management of patients with orthostatic hypotension or hypotension secondary to other clinical conditions or drug therapies. midodrine is almost completely absorbed after oral administration and undergoes enzymatic hydrolysis to form its pharmacologically active metabolite, de-glymidodrine , causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature, however ,midodrine may cause several side effects as chills ,numbness , tingling ,paresthesia ,polyuria ,dysuria and headache. on the other hand, norepinephrine is a vasoconstrictor that predominantly stimulates α1 receptors to cause peripheral vasoconstriction and increase blood pressure. it also has some β1 receptor agonist activity that results in a positive inotropic effect on the heart at higher doses. norepinephrine also may cause side effects as headache, blurred vision, chest pain ,nervousness, bradycardia or tachycardia.


Eligibility criteria:
inclusion criteria: 1. the study will include 90 adult female patients, 45 in each group (between 18-35 years old). 2. patients of asa physical status class i and class ii. 3. patients scheduled for elective cesarean section under spinal anesthesia. exclusion criteria: 1. patient refusal. 2. contraindication to spinal anesthesia . 3. patients known allergic to midodrine or norepinephrine. 4. patients with preexisting cardiovascular or cerebrovascular disease. 5. patients with diabetes mellitus. 6. patients with psychiatric disease or on psychiatric treatment.