Kornimate/medical-research-clean huggingface dataset:
effect of metformin on chronic pain after thoracic surgery in diabetic patients

Conditions: Postoperative Chronic Pain

Summary: metformin has been found to have more and more functions as a commonly used hypoglycemic drug in clinic. it has been found that metformin has anti-inflammatory, anti-tumor and lipid metabolism regulating effects. basic studies have shown that metformin as an adjuvant drug combined with gabapentin and tramadol is safe and effective in patients with neuropathic pain. postoperative chronic pain as a common complication has seriously affected the quality of life and mood of patients after surgery.some studies have shown that chronic pain after partial operation manifests as neuropathic pain. the effect of metformin on chronic pain after thoracic surgery in patients with diabetes mellitus was observed in this experiment, which was compared with patients taking insulin to control blood sugar.

the analgesic mechanism of metformin may include the following aspects:(1)metformin relieves neuropathic pain mainly because it can activate adenosine monophosphate-activated protein kinase (ampk), which plays a crucial role in pain regulation as an important endogenous kinase controlling energy metabolism.(2)in addition, metformin can also inhibit erk signaling pathway, further inhibit sodium channel, prevent the development of peripheral sensitization and achieve the effect of relieving neuropathic pain. (3)metformin has been shown to alleviate bone cancer pain in rats by reducing stat3 phosphorylation.clinical research in this field is limited to basic research and ethical requirements are rarely reported at home and abroad. li chunye et al. of jiangsu university designed a clinical trial to compare the efficacy of metformin and gabapentin combined with tramadol on neuropathic pain. the results showed that metformin had a better effect. the incidence of chronic pain after thoracic surgery is higher. postoperative chronic pain is a complex pain. the nature and mechanism of chronic pain after thoracic surgery are still controversial. some studies have shown that some chronic pain after thoracic surgery manifests neuropathic pain, the mechanism may be related to surgical incision, nerve injury caused by trauma and increased pain sensitization. can metformin alleviate chronic pain after surgery? the research on this aspect is still blank at present.this study was designed as a prospective cohort study to observe whether there was a difference in the incidence of chronic pain after thoracoscopic lobectomy between patients taking metformin and patients injecting insulin to control blood sugar.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 70 2. diabetes history. use metformin or insulin to control blood sugar 3. the type of operation is selective thoracoscopic lobectomy. exclusion criteria: 1. newly diagnosed diabetic patients at admission 2. complication of severe cardiopulmonary diseases 3. refuse to participate in this experiment 4. participate in other trials 5. patients with diabetic complications (including diabetic nephropathy, peripheral neuropathy, etc.)
prophylaxis prior to cataract surgery conjunctival flora and optimal ocular sterilization technique prior to cataract surgery

Conditions: Endophthalmitis; Cataract Surgery; Prophylaxis

Summary: the purpose of this study is to evaluate the conjunctival flora prior to cataract or vitrectomy surgery comparing mupirocin ointment applied to the conjunctiva along with standard ocular sterilization vs. standard ocular sterilization alone.

bacterial endophthalmitis is a rare but devastating complication of intraocular surgery. given the devastating ocular sequelae of endophthalmitis, one cannot underestimate the need to develop a sterilization strategy which most effectively prevents intraocular infection. the most common organisms causing bacterial postoperative endophthalmitis are gram-positive cocci, particularly coagulase-negative staphylococci and staphylococcus aureus. it is thought that the most common sources of bacterial contamination predisposing to endophthalmitis are the eyelids and conjunctiva (ariyasu). the two main techniques used to reduce the bacterial flora on the ocular surface include treatment of the ocular surface with topical antibiotics prior to surgery and the instillation of 5% povidone-iodine during the prep immediately prior to beginning the surgical procedure (speaker). mupirocin ointment is a logical choice for surgical prophylaxis as it has been reported that mupirocin treatment applied to the nose resulted in elimination rates (of s. aureus from the nares) of 91% directly after therapy (doebbeling). use of mupirocin ointment applied to the nares prior to eye surgery resulted in a significant decrease in the bacterial load on the conjunctiva at the time of surgery (alexandrou, in press). using mupirocin ointment directly to the conjunctiva, in addition to standard ocular sterilization techniques, may result in an even greater decrease in conjunctival flora prior to eye surgery.

Eligibility criteria:
inclusion criteria: * included in the study will be any patient eligible for cataract or vitrectomy surgery. no populations will be excluded on the basis of demographics. exclusion criteria: * excluded will be those patients who have known sensitivity or allergy to mupirocin ointment, or patients using topical ocular or systemic antibiotics during a two week period prior to entry into the study. additionally, patient's using topical corticosteroids will be excluded as well
rapid sequence intubation at the emergency department

Conditions: Emergency

Summary: all patients undergoing emergent endotracheal intubation (rsi) at the emergency department will be screened for inclusion in this clinical study. the indication of endotracheal intubation is an exclusively clinical decision and is not affected by this study protocol in any aspect. if fulfilling the in- and exclusion criteria's, patient will be randomly assigned to one of two groups 1. c-mac videolaryngoscope in appropriate size 2. conventional endotracheal intubation using macintosh blade in appropriate size randomization (1:1) will be based on computer-generated codes maintained in sequentially numbered opaque envelopes that will be opened immediately before randomization.


Eligibility criteria:
inclusion criteria: * patients requiring emergency rapid sequence intubation at the emergency department * male and female subjects 18 years to 99 years of age * written confirmation by a physician not involved in this study * written informed consent by the participant (obtained afterwards) * patient not showing remarkable rejection in participation in this study exclusion criteria: * maxilla-facial trauma * immobilized cervical spine * indication for fiberoptic guided intubation (known difficult airway) * ongoing cardio-pulmonary-resuscitation (cpr) * involvement in any other clinical trial during the course of this trial, within a period of 30 days prior to its beginning or 30 days after its completion * severe or immediately life-treating injury requiring immediate medical treatment

Keywords: patients departement requiring rapid sequence intubation (rsi)
effect of exercise frequency on metabolic control and heart function in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes exclusion criteria: * insulin treatment * severe chronic diabetic complications * liver dysfunction * kidney dysfunction * inflammatory diseases * heart failure * myocardial ischemia * major cardiovascular event history * physical exercise more than current guidelines for type 2 diabetes * inability to exercise

Keywords: exercise therapy time factors
effect of prone position onv/q matching in non-intubated patients with covid-19

Conditions: Covid19

Summary: a prospective physiologic study, in participants with covid-19-related pneumonia requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (hfnc)) less than 24 hours. the investigators assessed the effect of prone position on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (eit).

once enrolled, an eit dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an eit monitor (pulmovista 500; dräger medical gmbh, lübeck, germany). baseline data were collected during supine position (timepoint sp1), including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (fio2). the participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 ml of 5% nacl solution was injected via the central venous catheter. subsequently, each participant was helped into the prone position and data collection，end expiratory occlusion and 10% nacl solution injection were preformed again after approximately 30 min (timepoint pp1). the participant was then encouraged to maintain the prone position for at least 3 h before being helped back into the supine position. clinical data collection, end expiratory occlusion and injection of a bolus of 10 ml of 5% nacl solution were repeated again 1 h after resupination (timepoint sp2).

Eligibility criteria:
inclusion criteria: 1. aged 18 to75 years 2. admitted to intensive care unit with a confirmed diagnosis of covid-19-related pneumonia 3. requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (hfnc)) less than 24 hours, 4. gave written or witnessed verbal informed consent. exclusion criteria: 1. uncollaborative or had an altered mental status, 2. new york heart association class above ii 3. history of severe chronic obstructive pulmonary disease 4. contraindications to the use of eit (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician) 5. impending intubation (on the basis of clinical judgment, including clinical and physiological parameters).

Keywords: covid-19 prone position ventilation and perfusion matching
vitamin k and glucose metabolism in children at risk for diabetes (vita-k 'n' kids study)

Conditions: Obesity; Insulin Resistance; Insulin Sensitivity; Prediabetes; Dyslipidemia; Diabetes

Summary: the undercarboxylated fractions of the two vitamin k-dependent proteins osteocalcin and matrix gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). clinical trials are needed to isolate the effects of vitamin k manipulation on carboxylation of these two proteins (osteocalcin and matrix gla protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk. the purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin k2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease risk.


Eligibility criteria:
inclusion criteria: * age 8 to 17 years * bmi less than 85th percentile for age and gender * subject and parent/guardian understands the study protocol and agrees to comply with it * informed consent form signed by the parent/guardian and assent signed by the subject exclusion criteria: * subjects using vitamin supplements containing vitamin k * subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders * subjects presenting chronic degenerative and/or inflammatory diseases * subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics) * subjects receiving corticosteroid treatment * subjects using oral anticoagulants * subjects with a history of soy allergy * subjects who have participated in a clinical study more recently than one month before the current study

Keywords: vitamin k vitamin k2 menaquinone-7 osteocalcin children obesity insulin resistance insulin sensitivity beta-cell function prediabetes matrix gla protein arterial stiffness endothelial function
one more for chronic pain in latinos

Conditions: Chronic Pain

Summary: this study will be a single-site, two-arm randomized controlled trial conducted among spanish-speaking chronic pain patients. chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either one more or a wait-list control condition (wlc). one more will be delivered individually either in-person or via a hipaa compliant virtual meeting platform.


Eligibility criteria:
inclusion criteria: * spanish-speaking * age 18+ * diagnosed with a chronic pain condition * average pain in the previous week \> or = 3 * willingness to participate in study interventions and assessments. exclusion criteria: * non spanish-speaking * score of 10 or greater ('high risk') on the suicidality subsection of the mini * psychotic episode within the last 12 months as deemed by the corresponding subsection of the mini * presence of clinically unstable illness judged to interfere with treatment or study procedures * unable or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier) * communication or cognitive impairment that limits participation in treatment or study procedures.

Keywords: mindfulness
potential injection of human umbilical cord secretome in the case of trophic ulcers (pre-post intervention)

Conditions: CM-MSC ; Stem Cell ; Trophic Ulcer ; Leprosy ; Morbun Hansen; Secretom

Summary: background: trophic ulcer is one of the complications that arise due to leprosy infection of the skin and includes diseases that trigger permanent disability and reduce the quality of life of the person. the facts in the field that more than 50% of chronic ulcers, especially trophic ulcers due to leprosy fail to heal with usual treatment. therefore it is important to do a new method in healing trophic ulcers. stem cell therapy or one of them is conditioned medium mesenchymal stem cell is a promising therapy because of its biological and physiological processes resembling the mechanism of wound healing method: this research is a clinical trial research "open trial". phase 1 to see the side effects caused by the intervention. minimum sample size of 20 respondents with trophic ulcers due to leprosy that is difficult to resolve with usual treatment. the main outcome is wound healing in terms of the length and extent of the wound. the secondary outcome is treatment toxicity 4 weeks after administration. follow-up visits will be scheduled at 2, 4, and 12 weeks post-treatment. if the results confirm safety, feasibility and potential efficacy, large multicenter randomized controlled trials with longer follow-up will begin with a focus on the effectiveness of therapy


Eligibility criteria:
inclusion criteria: * chronic ulcers in morbus hansen's patients aged 18-80 years * not recovering with routine therapy for at least 1 months * trophic ulcers degrees 2 and 3 * willing to take part in the study * as well as with the respondent's good health to follow this study. exclusion criteria: * patients who took anticoagulants, * patients had hypertension * patients had any staging kidney failure * patients had a history of blood disorders and pregnancy.
thalidomide, cyclophosphamide, oral idarubicin and dexamethasone (t-cid) in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: background: in some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (mm). in this study, the researchers have chosen a regimen which can be administered on an outpatient basis. induction therapy: to evaluate the efficacy and toxicity of thalidomide, cyclophosphamide, oral idarubicin and dexamethasone (t-cid) in patients with relapsed or refractory multiple myeloma. maintenance therapy: randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after t-cid.

background: in some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (mm). in this study, the researchers have chosen a regimen which can be administered on an outpatient basis. after 3-8 cycles of t-cid patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression.

Eligibility criteria:
inclusion criteria: * patients with multiple myeloma according to british columbia cancer agency criteria * stage iia/b or iiia/b according to durie/salmon * symptomatic or progressive disease * status of disease: * refractory disease after standard induction therapy * or relapse after standard induction therapy * or relapse after high-dose chemotherapy/stem cell transplantation * or patients with plasma cell leukemia * patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration * written informed consent exclusion criteria: * age \< 18 years * life expectancy of less than 3 months * intolerance to the study drugs * no change or progressive disease after prior therapy with idarubicin or cyclophosphamide * cardiac insufficiency new york heart association (nyha) grade 3 or 4 * acute infection * actually decompensated diabetes mellitus * total bilirubin \> 3.0 mg/dl * pregnant or breast-feeding women * polyneuropathy grade 2 or higher * ulcus ventriculi or duodeni * narrow or open angle glaucoma * not-compensated psychiatric diseases * prior erythroblastopenia * prior therapy with investigational drugs within the last 4 weeks
enhancing recovery capital amid opioid use disorder pharmacotherapy: a pilot randomized trial

Conditions: Opioid Use Disorder

Summary: the aims of the current study are to: aim 1. develop and refine a novel intervention protocol for individuals receiving medication treatment for opioid use disorder that assertively links them to recovery community centers; aim 2. determine the feasibility, acceptability, and preliminary efficacy of assertive linkage to recovery community centers relative to a matched control condition, via a pilot randomized controlled trial; aim 3. explain quantitative findings by gaining an in-depth understanding of the intervention's feasibility, acceptability, and preliminary efficacy via qualitative interviews.

this 5-year project seek to advance our understanding of the clinical and public health utility of recovery community centers and help bridge the gap between clinical treatment and community-based recovery support services. as a first step in this work, the investigators will develop and test a new intervention for peer-facilitated assertive linkage of patients receiving opioid use disorder pharmacotherapy to recovery community centers (rccl), relative to a matched control condition (cc). this study aims to: aim 1. develop, manualize, and refine rccl and cc protocols via stakeholder feedback. rccl and cc protocols will be developed and manualized by adapting published community-based mutual-help linkage protocols. upon preliminary manual development, feedback cycles will be conducted with relevant stakeholders (recovery coaches, recovery community center members, pharmacotherapy prescribers) to inform protocol revision, and promote its feasibility, acceptability, and adoptability. aim 2. determine the feasibility, acceptability, and preliminary efficacy of rccl versus cc, via a pilot randomized controlled trial. more specifically, the feasibility of study procedures and rccl/cc interventions, acceptability of interventions, and preliminary efficacy of rccl relative to cc will be assessed. aim 3. explain quantitative findings by gaining an in-depth understanding of rccl feasibility, acceptability, and efficacy via qualitative interviews in a subset of rccl participants, peer facilitators, and linkage managers.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * past-year opioid use disorder diagnosis per the diagnostic and statistical manual of mental disorders, fifth edition * currently undergoing outpatient buprenorphine treatment through a provider or program at massachusetts general hospital * current residence in massachusetts exclusion criteria: * non-english fluency * active suicidality * neurodevelopmental disorders or neural trauma preventing informed consent * active psychosis * past-year attendance at a recovery community center or recovery support center
phase iia safety and efficacy study of spp635 in mild to moderate hypertension

Conditions: Hypertension

Summary: this study is conducted to investigate the effect of the oral renin inhibitor spp635 on blood pressure in patients with mild to moderate hypertension.

renin-angiotensin system blockade is a well established target for treatment of high blood pressure. blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. this study investigates the safety and efficacy of a novel oral renin inhibitor, spp635.

Eligibility criteria:
inclusion criteria: * male or female patients with mild to moderate hypertension exclusion criteria: * female patients of child-bearing potential or breast-feeding
a trial investigating the pharmacodynamic properties of nn5401 in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (idegasp) at steady state in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for at least 12 months * body mass index (bmi) 18.0-28.0 kg/m\^2 (both inclusive) * glycosylated haemoglobin (hba1c) maximum 9.5 % * fasting c-peptide maximum 0.3 nmol/l exclusion criteria: * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to screening