Kornimate/medical-research-clean huggingface dataset:
angiotensin-converting enzyme polymorphism and acute renal failure (ecarea)

Conditions: Kidney Failure, Acute; Critical Illness

Summary: associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ards, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. based on physiological effects of angiotensin ii, we hypothesized that the i allele of the angiotensin-converting enzyme insertion/deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.

associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ards, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. based on physiological effects of angiotensin ii, we hypothesized that the i allele of the angiotensin-converting enzyme insertion/deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.

Eligibility criteria:
inclusion criteria: * age \> 18 yrs * icu stay \> 48 hours exclusion criteria: * age \< 18 yrs * creatinine \> 180 µmol/l * absence of consent

Keywords: kidney failure, acute genetic polymorphism angiotensin-converting enzyme
effect of acetylcholinesterase inhibitors on the gait of the patients with parkinson disease

Conditions: Parkinson Disease

Summary: cholinergic deficiency in the brain can be related to gait and balance problems in parkinson disease (pd). recent clinical trials suggested a beneficial role of acetylcholinesterase inhibitors (achei) on gait in pd. in this study, the investigators are planning to study the influence of achei on a brain network for gait and balance in pd. as gait problem is prominent in postural instability and gait disturbance (pigd) subtype, this study will focus on the patients with pigd phenotype.

pd patients with pigd subtype will be included. 1. assessment: * overall features of pd are assessed by unified parkinson disease rating scale (updrs). non-motor features including cognition will be assessed by standard scales. gait and balance will be assessed by gait analysis system, which measures physiological parameters of gait such as velocity, variability and center of pressure. positron emission tomography using 18f-fluorodeoxyglucose (fdg pet) will be done to brain activities related to gait and balance. * clinical evaluation will be done at the baseline, 4th, 8th and 12th week * gait analysis and fdg pet will be done at the baseline and 12th week 2. drug dosage * for the first 4 weeks, 5 mg/day * then, 10 mg/day for 8 weeks

Eligibility criteria:
inclusion criteria: * parkinson disease diagnosed by united kingdom parkinson's disease society brain bank criteria * postural instability and gait disturbance phenotype * hoehn and yahr stage ≤ 3 * mini-mental status examination ≥ 24 exclusion criteria: * significant motor complication affecting daily activities * drugs related to acetylcholine metabolism
endpoint validation study (0524a-015)

Conditions: Flushing

Summary: to determine the most effective daily dose of mk0524a when compared with placebo after the 8-week treatment period for niacin induce flushing (nif).


Eligibility criteria:
inclusion criteria: * patients must be male or female between 18 to 70 years * qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control exclusion criteria: * you are a woman who is having hot flashes, receiving hormone replacement therapy (hrt), and/or other therapies for hot flashes * you are currently using niacin/or niacin containing products with a daily dose over 50 mg/day * you are sensitive to niacin * you have a history gout * you drink more than 2 glasses of alcohol per day and you are not willing to stop * you don't have access to a telephone
a phase 2a proof of concept open-label, randomized, controlled study to evaluate the safety and efficacy of mdi-1228-mesylate gel compared with standard of care alone in patients with diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the study will evaluate the treatment effect of mdi-1228-mesylate gel compared with standard of care alone for the complete healing rate at the end of 12 weeks in participants with diabetic foot ulcers (targeted ulcer). in addition, the proportion of subjects whose target ulcer area is reduced by 50% after 12 weeks of treatment.

the study is targeted to enroll approximately sixty subjects with diabetic foot ulcers. all subjects will be randomized at baseline visits at a 2:1 ratio to either receive the study treatment plus standard of care or standard of care alone. all subjects who meet inclusion/exclusion criteria will have all ulcers treated; however, only one ulcer, the largest, will be selected as the target ulcer. before performing any study procedures, all potential subjects will sign an informed consent form (icf). the total study duration is anticipated to be up to 18 weeks, including: * up to a 14-day screening period * up to 12 weeks study treatment * up to 4 weeks of follow-up * end-of-treatment visit will be performed on the last day of treatment (d84) * end-of-study visit will be performed at the follow-up visit (d112) wound photography should be dedicated to one study site personnel to control variance.

Eligibility criteria:
inclusion criteria: 1. willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures; 2. male or female 18-75 years; 3. meet diagnostic criteria for a diabetic ulcer with the presence of at least one target ulcer that meets the characteristics: * located on dorsal or plantar surface of foot or below the knee. * wagner grade 2, ulcerated lesion at or below the knee, without systemic infection. * the target ulcer should be the largest, and all each individual ulcers size should be less than 25cm2. all ulcers will be treated the same as the target ulcer. * target ulcers persisted for at least 12 weeks prior to enrollment and have been on standard of care for at least 4 weeks prior to enrollment. * there is a minimum 3cm margin between the qualifying target ulcer and any other ulcers on the specified foot (post-debridement). exclusion criteria: 1. allergy to the main components or excipients of mdi-1228_mesylate gel, allergy to jak inhibitors (tofacitib, baricitinib, ruxolitinib), or individuals with allergic constitution. 2. skin ulcers or chronic wounds caused by electroshock, chemicals, radioactive material etc. 3. the target ulcer has reduced in size by ≥30% in the last 4 weeks under standard treatment. 4. those with cancerous ulcers or connective tissue diseases including lupus erythematosus, rheumatoid arthritis, scleroderma, etc.

Keywords: diabetic foot ulcer
cyclophosphamide in treating patients who are undergoing a donor bone marrow transplant for fanconi's anemia

Conditions: Fanconi Anemia

Summary: rationale: giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. it also stops the patient's immune system from rejecting the donor's bone marrow. the donated bone marrow stem cells may replace the patient's immune system and help destroy any remaining abnormal cells. sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. giving cyclosporine and methotrexate before or after transplant may stop this from happening. purpose: this phase i trial is studying the side effects and best dose of cyclophosphamide in treating patients who are undergoing a donor bone marrow transplant for fanconi's anemia.

objectives: * decrease the conditioning-related toxicity of cyclophosphamide without decreasing the engraftment rate to \< 90% in patients undergoing allogeneic bone marrow transplantation for fanconi's anemia. outline: this is a multicenter, dose-finding study of cyclophosphamide. * nonmyeloablative conditioning regimen: patients receive cyclophosphamide iv on days -5 to -2. cohorts of 5-10 patients receive decreasing doses of cyclophosphamide until the optimal dose (od) is determined. the od is defined as the dose at which ≥ 4 of 5 patients achieve engraftment and \< 1 of 10 patients experiences dose-limiting toxicity. * allogeneic bone marrow transplantation (bmt): patients undergo allogeneic bmt on day 0. * graft-vs-host-disease (gvhd) prophylaxis: patients receive cyclosporine orally or iv twice daily beginning on day -1 and continuing until day 49, followed by a taper on days 50-180 in the absence of gvhd. patients also receive methotrexate iv on days 1, 3, 6, and 11. after completion of study treatment, patients are followed periodically for 5 years. projected accrual: a total of 27 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of fanconi's anemia by chromosome fragility with a diepoxybutane (deb) or mitomycin c test * hemoglobin ≤ 8.0 g/dl, absolute granulocyte count ≤ 1,000/mm\^3, or platelet count ≤ 50,000/mm\^3 * no refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or acute leukemia * hla-identical related donor available patient characteristics: * glomerular filtration rate ≥ 30% predicted for age * no liver disease (e.g., active hepatitis or moderate to severe portal fibrosis/cirrhosis by biopsy) * no symptomatic cardiac insufficiency or symptomatic arrhythmia * no other diseases that would severely limit the probability of survival * no hiv seropositivity * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: * not specified

Keywords: fanconi anemia
lumateperone monotherapy for the treatment of bipolar depression conducted globally

Conditions: Bipolar Depression

Summary: the study will evaluate the efficacy and safety of iti-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with bipolar i or bipolar ii disorder having a major depressive episode.


Eligibility criteria:
major inclusion criteria: * male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of bipolar i or bipolar ii disorder * experiencing a current major depressive episode * able to provide written informed consent major exclusion criteria: * any female subject who is pregnant or breast-feeding * any subject judged to be medically inappropriate for study participation
serum nesfatin-1 and human cartilage glycoprotein-39 levels in knee osteoarthritis

Conditions: Osteoarthritis of Knee; Degenerative Osteoarthritis

Summary: in this study, our objective was to assess the correlation between serum human cartilage glycoprotein-39 (ykl-40) and nesfatin-1 values, the patient's clinical condition, ultrasonographic cartilage thickness measurements, and the response to prp treatment in knee osteoarthritis (oa)

the objective of this study is to assess the correlation between serum human cartilage glycoprotein-39 (ykl-40) and nesfatin-1 values, clinical condition, ultrasonographic cartilage thickness measurements, and response to prp treatment in knee osteoarthritis (oa). thirty patients diagnosed with grade 2 and 3 knee osteoarthritis (oa) according to american college of rheumatology (acr) diagnostic criteria, and scheduled for leukocyte-poor platelet-rich plasma (lp-prp) injections, were enrolled in the study. patients were assessed at three time points: before treatment (day 0), after exercise treatment (day 14), and after two doses of lp-prp treatment combined with exercise treatment once a week (day 28). the evaluation included the numeric rating scale (nrs), western ontario and mcmaster universities osteoarthritis index (womac), cartilage thickness measurement by ultrasonography (usg), 6-minute walk test (6mwt) parameters, and measurements of serum ykl-40 and nesfatin-1 levels.

Eligibility criteria:
inclusion criteria: * having patient consent, * having stage 2-3 knee osteoarthritis according to the kellgren-lawrence scale, * being diagnosed with knee osteoarthritis according to acr (american college of rheumatology), * being over the age of 18 - under the age of 75, * having nrs 4 and above exclusion criteria: * those who have had knee surgery before, * those who have had any local injections such as physical therapy, intra-articular steroid or hyaluronic acid injection in the knee area in the last 3 months, * malignancies, * those with local infection, wound, scar in the relevant area, * infections, hepatitis, immunosuppression, * inflammatory arthropathies, * uncontrolled hypertension, uncontrolled diabetes mellitus, decompensated heart failure, coronary artery disease, asthma * recent trauma, * epileptic patients, * pregnant women, * corticosteroid use, * avascular necrosis * anemia, bleeding coagulation disorder
brain activity during complex walking in people with atypical parkinsonian syndromes

Conditions: Gait Disorders, Neurologic; Atypical Parkinson Disease; fNIRS; Aging

Summary: every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. however, the process of aging or the sequelae of neurological diseases such as atypical parkinson's disease (apd) compromises motor-cognitive interaction necessary for an independent lifestyle. while motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions. the challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecologically valid state. the investigators aim therefore to explore brain function during complex walking in healthy and apd by investigating the effects of age and neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fnirs) and advanced gait analysis in real time in older healthy adults and people with apd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of psp according to movement disorder society (mds) (2017) or * msa according to mds criteria (2022) * the ability to walk with or without a mobility device for ≤5 minutes continuously exclusion criteria: * cognitive difficulties affecting the ability to understand and/or follow verbal/written - instructions * severe freezing of gait * severe hearing or visual impairments that affect participation in the assessments * other neurological diseases * other diseases that can affect gait or balance.
bio refine for functional mitral regurgitation - a safety & feasibility study

Conditions: Functional Mitral Regurgitation

Summary: the purpose of this study is to evaluate the safety and feasibility of the bio refine coriofix system and determine if it might help in treatment of functional mitral regurgitation. the study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive). potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure. all enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge. additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.


Eligibility criteria:
inclusion criteria: * local heart team has determined that mitral valve surgery will not be offered as a treatment option * symptomatic secondary mitral regurgitation (3+ or 4+) * adequately treated in compliance with optimal guideline-directed medical therapy for heart failure for at least 90 days * nyha functional class ii, iii or ambulatory iv * lvef ≥30%. * written informed consent has been obtained exclusion criteria: * untreated clinically significant coronary artery disease requiring revascularization. * cabg, pci or tavr within the prior 90 days. * aortic or tricuspid valve disease requiring surgery or transcatheter intervention or severe tricuspid regurgitation. * copd requiring continuous home oxygen therapy or chronic outpatient oral steroid use. * cva or tia within prior 180 days. * hypotension * any history of ventricular arrythmia * patients implanted with any kind of cied * life expectancy \<12 months due to non-cardiac conditions * prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure * tee is contraindicated or high risk * pregnant or planning pregnancy within next 12 months * currently participating in an investigational drug or another device study that has not reached its primary endpoint
fecal microbiota transplantation for treatment of refractory graft versus host disease-a pilot study

Conditions: Fecal Microbiota Transplantation in GVHD

Summary: the study evaluates safety and efficacy of fecal microbiota transplantation (fmt) for the treatment of refractory graft-versus-host-disease (gvhd) of the gut. fmt might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

graft-versus-host-disease (gvhd) is a major complication after hematopoietic stem cell transplantation (hsct). gut is the most vulnerable target organ of acute gvhd. patients who have a gastrointestinal acute gvhd received a first-line standard treatment of corticosteroids. for patients who do not respond or progress after an initial response have a high mortality. therefore, the investigation of effective second line therapy for these patients are in need. the study evaluates safety and efficacy of fecal microbiota transplantation (fmt) for the treatment of refractory gvhd of the gut. fmt might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

Eligibility criteria:
inclusion criteria: * 3-18 years of age * allo-sct patients with acute steroid-resistant gi-related gvhd grade iii-iv. steroid-resistant gi-related gvhd will be defined as lack of improvement (same stage) or worsening of gi symptoms after 7 days of steroid therapy (≥ 2 ml/kg of iv methylprednisolone) * no definite contraindication for gastrointestinal endoscopy * signature of informed consent by the legal guardians of patients exclusion criteria: * prior inclusion to an interventional study * previous allo-sct * known multi-drug resistance carriage prior to stool collection * severe colitis of any etiology or a history of inflammatory bowel disease (ibd) * uncontrolled infection (hemodynamic instability, ongoing high fever or bacteremia within 3 days after antibiotics administration) * active gi bleeding * absolute neutrophil count \< 500 cells/microl * absolute platelet count\< 10 x 109 /l * patients who cannot give informed consent

Keywords: fmt gvhd hsct
tracheal intubation in covid-19 patients

Conditions: COVID-19 Pneumonia; Tracheal Intubation

Summary: the emergency endotracheal intubation of a patient who is covid-19 positive is a high-risk procedure and an additional challenge to an intensivist due to barrier enclosures that have been developed to reduce the risk of covid-19 transmission to healthcare providers during intubation. although the incidence of difficult airways is commonly higher in critically ill patients, the evidence of severe hypoxemia without sign of respiratory distress could complicate the scenario.this silent hypoxia often leads to a delayed recognition of the severity of respiratory failure and to a late intubation which is often characterized by a high risk of complications related to the actual airways' management, hemodynamic and cardiac. it has been shown that non-survivors had worse blood gas analyzes than survivors, both before and after intubation. few studies have reported the implications and adverse events of performing endotracheal intubation for critically ill covid-19 patients admitted to intensive care units (icus).


Eligibility criteria:
inclusion criteria: * critically ill patient above 18 year old, admitted in the intensive care of san bortolo hospital, vicenza, and san matteo hospital, pavia; * positive specimen for sars-cov2 pcr; * tracheal intubation for respiratory distress related to sars cov2 pneumonia exclusion criteria: * negative specimen for sars-cov2 pcr * out of hospital intubation * intubation during cardiac arrest * intubation in the contest of general anesthesia for surgery
influence of ozone therapy on postoperative pain relief in the surgical treatment of lower third molars: randomized controlled trial

Conditions: Extraction of the Lower Third Molars

Summary: patients will undergo a split-mouth protocol which includes: a control group: in which the extraction of the lower third molar will be performed according to the standard protocols of the structure. a study group: in which ozone will be used in addition, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to therapeutic scheme prescribed at the time of discharge. primary objective: to evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery. secondary objectives: * evaluate the functional limitation in opening the mouth (trismus) 7 days after surgery. * evaluate if there is a reduced intake of analgesic drugs in the 7 days following the operation. * evaluate the perceived quality of life in the 7 days following the intervention.

patients will undergo a split-mouth protocol which includes: a control group: in which the extraction of the lower third molar will be performed according to the standard protocols of the structure. a study group: in which ozone will be used in addition, in two formulations: gaseous, injected into the site of the pre- and post-surgery operation, and topical, in the form of a gel, applied at the end of the operation and for home use according to therapeutic scheme prescribed at the time of discharge. primary objective: to evaluate whether the use of ozone in patients undergoing extraction of impacted third molars reduces post-operative pain 7 days after surgery. secondary objectives: * evaluate the functional limitation in opening the mouth (trismus) 7 days after surgery. * evaluate if there is a reduced intake of analgesic drugs in the 7 days following the operation. * evaluate the perceived quality of life in the 7 days following the intervention.

Eligibility criteria:
inclusion criteria: * lower third molars included * pell-gregory class ii-b * absence of systemic diseases exclusion criteria: * hyperthyroidism; * g6phd (glucose 6 phosphate dehydrogenase) deficiency; * anemia * myasthenia * pregnancy and breastfeeding * allergy to ozone * local infections