Kornimate/medical-research-clean huggingface dataset:
a clinical trial to study the effects grc 17536 in patients with painful diabetic peripheral neuropathy (painful extremities due to peripheral nerve damage in diabetic patients).

Conditions: Painful Diabetic Peripheral Neuropathy

Summary: diabetic peripheral neuropathy (dpn) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (qol), morbidity, and costs from a public health perspective. painful diabetic neuropathy affects approximately 16% of patients with diabetes. pharmacological agents used in the management of painful dpn mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. the available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. hence newer therapies are required for the treatment of dpn. the primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.


Eligibility criteria:
inclusion criteria: 1. patients willing to provide voluntary written informed consent 2. male and female patients ≥18 yrs and ≤75 yrs 3. patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months 4. a baseline 24-hour average daily pain intensity score ≥5 5. women must be of non child-bearing potential, defined as post menopausal or surgically sterile exclusion criteria: 1. other chronic pain conditions not associated with dpn, that may confound the assessment of neuropathic pain 2. other causes of neuropathy or lower extremity pain 3. complex regional pain syndrome or trigeminal neuralgia 4. lower extremity amputations other than toes 5. participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study 6. major depression. 7. presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. 8. patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to investigator's medical judgment: could interfere with the accurate assessment of safety or efficacy, or, could potentially affect a patient's safety or study outcome

Keywords: diabetic neuropathy
nurse practitioner led implementation of team huddles in long-term care homes

Conditions: Moral Distress; Job Satisfaction; Mental Health; Physical Health; Support

Summary: a pre-experimental design to conduct a process evaluation and to compare the outcomes after implementing team huddles for the intervention and control groups.

staff working in long-term care (ltc) homes during covid-19 frequently reported lack of communication, collaboration, and teamwork, all of which are associated with staff dissatisfaction, health concerns, perceived of lack of support and moral distress. the purpose of this study was to introduced regular huddles, led by a nurse practitioner, to support ltc staff during covid-19. the objectives were to evaluate the process of huddle implementation and to examine differences between staff attending and not attending the huddles on outcomes of moral distress, job satisfaction, perceived support from the nurse practitioner, and health and mental health. furthermore, we hypothesize that regular huddles can lead to improvements in resident-centred care and resident outcomes.

Eligibility criteria:
inclusion criteria: * all staff working at the ltc home * all residents living in the home between january and december 2021 exclusion criteria: * n/a
an open-label, non-comparative study to document the tolerability to ramipril in patients with at least one high risk for developing a major cardiovascular event

Conditions: Coronary Artery Disease

Summary: primary objective: to document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator. secondary objectives: * to document drug safety at 12-week of treatment in terms of number of adverse drug reaction or serious adverse drug reaction reported. * to describe the population treated as per the hope study indication in current clinical practice (demographics, cardiovascular risk-factors at treatment initiation, concomitant treatments patterns).

the duration of the study period is 8-12 weeks.

Eligibility criteria:
inclusion criteria : * man or woman, age 55 years old or more. * presence of a high risk of developing a major cardiovascular event, defined as at least one of the following underlying conditions: * clinical evidence of coronary artery disease (examples: previous myocardial infarction \[mi\], positive stress test or significant stenosis at coronary angiography, previous percutaneous trans-luminal coronary angioplasty \[ptca\], previous coronary arterial bypass grafting \[cabg\]); * clinical evidence of peripheral vascular disease (examples: history of intermittent claudication with positive doppler or angiography, previous limb bypass surgery, previous percutaneous trans-luminal angioplasty, previous limb or foot amputation); * previous stroke; * diabetes (insulin-dependent or non-insulin dependent) with at least one of the following cardiovascular risk factors: * hypertension (blood pressure \[bp\] \>140/90 mmhg, or patients on antihypertensive treatment); * hypercholesterolemia (total cholesterol \> 5.2 mmol/l \[\>200 mg/dl\]); * low hdl cholesterol (\< 0.9 mmol/l \[\<3.5 mg/dl\]); * current cigarette smoking; * documented microalbuminuria (30-300 mg/24 hours); * evidence of previous vascular disease. exclusion criteria: * patients with contraindications to ramipril use (as per the local ramipril product information) * hypersensitivity * pregnancy, lactation * bilateral renal stenosis * patients with clinically relevant concomitant disease that could compromise the patient's safety or follow up. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
lower limb exonet: development and evaluation for gait assistance with stroke survivors

Conditions: Healthy

Summary: stroke-related gait impairments, such as poor limb coordination, imbalance, and reduced push-off strength, are often addressed using robotic systems or electrical stimulation, which can be costly, invasive, or insufficient for long-term recovery. current devices often assist movement but fail to promote functional motor learning. research supports rehabilitation strategies that amplify gait errors to drive neuroplasticity and adaptation. the legexonet (exoskeletal network for elastic torque) is a novel, passive wearable exoskeleton designed to address this need by enabling both assistive and therapeutic gait training. it stores and releases elastic energy to aid movement while allowing natural joint motion. the system aims to support individuals post-stroke transitioning to independent rehabilitation by offering a lightweight, affordable, and adaptive solution. initial testing will focus on healthy individuals to assess safety and feasibility before expanding to stroke populations. the legexonet has the potential to enhance gait recovery and reduce therapist burden through error augmentation and personalized support, both in clinical and at-home settings.


Eligibility criteria:
inclusion criteria: * age 18-70 years old * ability to provide informed consent * capable of ambulating without the use of assistive devices for 2 hours exclusion criteria: * history of stroke, sci, or other neurological medical diagnoses * pregnant * severe medical diagnoses (e.g. cardiovascular, orthopedic) * skin allergies or irritation; open wounds * prisoners * cognitively impaired adults
regenerative stem cell therapy for stroke in europe

Conditions: Stroke

Summary: stroke is the second leading cause of death in the world population. when not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. building on emerging preclinical and pilot clinical evidences, resstore will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.

resstore european multicentre randomised phase iib will explore the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (adsc) in 400 stroke patients. therapeutic effects of adscs will be assessed and monitored in patients using clinical rating scales, multimodal mri and blood biomarkers. the european regenerative therapy capacities (france, spain, finland, united kingdom and czech republic), developed in resstore will cover the full value chain in the field (large scale gmp cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, biobanking...).

Eligibility criteria:
inclusion criteria: * hemispheric ischemic stroke (\>1.5cm) * inclusion from 1 to 4 days post-stroke * nihss \> or = 7 * no craniectomy * able to follow a rehabilitation program * modified rankin scale = 0 before stroke onset exclusion criteria: * coma * severe leucoariosis * previous stroke * active endocarditis, pneumonia, aids, active hepatic disease due to hbv or hcv * history of cancer * pregnancy, breast feeding

Keywords: cell therapy stem cell transplantation graft recovery repair stroke mesenchymal stem cell regenerative
a study of ly3039478 in combination with dexamethasone in participants with t-all/t-lbl

Conditions: T-cell Acute Lymphoblastic Leukemia; T-cell Lymphoblastic Lymphoma

Summary: the main purpose of this study is to evaluate the safety of the study drug known as ly3039478 in combination with dexamethasone in participants with t-cell acute lymphoblastic leukemia or t-cell lymphoblastic lymphoma (t-all/t-lbl).


Eligibility criteria:
inclusion criteria: * have acute t-cell lymphoblastic leukemia (t-all) or t-cell lymphoblastic lymphoma (t-lbl). * t-all or t-lbl participants with relapsed/refractory disease. * have had at least 60 days between prior hematopoietic stem cell transplantation (sct) and first dose of study drug. * have a performance status of 0 to 2 on the eastern cooperative oncology group (ecog) scale for adults. * lansky score \>50% for participants \<16 years old. * have adequate organ function. * are at least: * adult phase 1 part a and phase 2: ≥16 years old at the time of screening * pediatric phase 1 part b: 2 to \<16 years old * men and women with reproductive potential: must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug(s) or country requirements, whichever is longer. * females with childbearing potential: have had a negative serum pregnancy test ≤7 days before the first dose of study drug and also must not be breastfeeding. * are able to swallow capsules and tablets. exclusion criteria: * have previously completed or withdrawn from this study or any other study investigating ly3039478 or other notch inhibitors. * have evidence of uncontrolled, active infection \<7 days prior to administration of study medication. * have current or recent gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease. * have active leukemic involvement of the central nervous system (cns).
comparison of different helicobacter pylori detection methods in patients with chronic atrophic gastritis

Conditions: Helicobacter Pylori Infection

Summary: as we know，helicobacter pylori is closely related to many gastrointestinal diseases such as chronic gastritis, peptic ulcer disease,gastric carcinoma and gastric mucosa-associated lymphoid tissue lymphoma，as well as extra-digestive diseases such as urticaria and chronic obstructive pulmonary diseases and so on.the diagnosis of h. pylori infection is based on invasive methods requiring endoscopy and biopsy(e.g. histology, culture, rapid urease test, pcr) or on non-invasive methods (e.g. serology, 13c urea breath test, stool antigen test).histology has the highest specificity among the others,and also allows us to determine the underlying disease and perform antibiotic sensitivity testing.serological tests are widely available and more appropriate for epidemiological studies, their main weakness for clinical use is low specificity.the 13c urea breath test is the most accurate method in patients irrespective of age.stool antigen testing,as a promising method, is easy to perform, and its accuracy may be improved by the use of monoclonal antibodies recently proposed for capturing h. pylori antigen in stool specimen.sensitivity and specificity, usefulness,and limitation of tests should be considered for selection of detection methods of h. pylori. our objective is to review the current methods that are used for the detection of h. pylori infection among patients with chronic atrophic gastritis.except that,patients with hp positive will be further treated with 10-day minocycline-based quadruple therapy,to observe the efficacy and safety of minocycline-based regimen for h.pylori eradication as a first-line therapy.

consecutive outpatients (18 to 70 years), with endoscopically proven chronic atrophic gastritis will be enrolled in our study.5 different methods，including histology,13c urea breath test,stool antigen test,serological antibody test for h.pylori and serologic test with a current infection marker of h.pylori，will be performed to detect h. pylori infection.and patients with hp positive will be further treated with 10-day minocycline-based quadruple therapy.our objective is to compare specificity and sensitivity of the current methods among patients with chronic atrophic gastritis,meanwhile,to observe the efficacy and safety of minocycline-based regimen for h.pylori eradication as a first-line therapy.

Eligibility criteria:
inclusion criteria: * participants was confirmed chronic atrophic gastritis by endoscopy * participants has not been previously received treatment for h.pylori infection. exclusion criteria: * patients who were allergic to any study medications * patients who had taken antibiotics,bismuth agent,ppi or h2 receptor antagonist (h2ra) 4 weeks before the study * patients with previous gastrectomy * patients with malignancy or severe comorbidity * pregnant or lactating women * patients with poor treatment compliance or could not express themselves correctly * patients who participated in other drug trial recently (within 3 months of enrollment).
continuous glucose monitoring (cgm) with a low carbohydrate diet to reduce weight in patients with pre-diabetes

Conditions: Pre-diabetes

Summary: this study will recruit pre-diabetic patients to see if continuous glucose monitoring (cgm) with a low carbohydrate diet can reduce the percentage of time the cgm readings are above the normal range. through this study it will demonstrate the feasibility of using cgm with a low carbohydrate diet to reduce weight and risk of developing diabetes in patients with pre-diabetes. patients that appear to be eligible will be recruited from michigan medicine in the family medicine clinic at the livonia center.


Eligibility criteria:
inclusion criteria: * a1c glucose measurement between 5.7 to 6.4 (for most recent a1c test, not older than 1 year) * no diabetes medication including metformin * bmi (body mass index) \>30 * must speak, read, and write in english * no current pregnancy or breastfeeding * must not classify as either vegan or vegetarian * must be a patient at the livonia health center exclusion criteria: * previous bariatric surgery

Keywords: pre-diabetes, low carbohydrate diet
thermosoftening of double-lumen tube for airway exchanger catheter

Conditions: Intubation Complication; Hoarseness; Sore Throat

Summary: the purpose of this study is to investigate the effect of double-lumen tube thermal-softening before intubation on the success rate of tube exchange by airway exchange catheter.


Eligibility criteria:
inclusion criteria: * patients undergoing thoracic surgery that requires bronchoscopy study before the placement of double-lumen tubes exclusion criteria: * preoperative hoarseness or a sore throat * history of upper airway diseases * anticipated difficult airway

Keywords: double-lumen tube intubation airway exchange catheter thermosoftening
randomized cross over study to assess efficacy and safety of bdp/ff and glycopyrrolate

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of bdp/ff in copd patients.

a multicentre, randomised, double-blind, active-controlled, 4-way cross-over study to evaluate the efficacy and safety of a free combination of 3 doses of glycopyrrolate with fixed combination beclomethasone dipropionate plus formoterol (foster®) in a metered dose inhaler for the treatment of patients with chronic obstructive pulmonary disease (copd)

Eligibility criteria:
inclusion criteria: * copd over 40 years of age (30 to 60% post-bronchodilator fev1 predictive value) * patients under double * patients under triple therapy (for 1 mo prior screening) exclusion criteria: * pregnant or lactating women * patients experiencing a copd exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization * concommitant diseases impacting feasibility or safety
human placental mesenchymal stem cells treatment on diabetic foot ulcer

Conditions: Diabetic Foot Ulcer

Summary: this study is designated to: 1. investigate the tolerance and safety of treatment of human placental mesenchymal stem cells gel on human diabetic foot ulcer. 2. learn the primary effectiveness of human placental mesenchymal stem cells gel on human diabetic food ulcer. 3. study the pharmacokinetics of human placental mesenchymal stem cells gel on human diabetic food ulcer.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and age ≤ 75 * type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0% * diagnosed as condition of diabetic foot ulcer, wagner grade at 1 or 2 after clinical treatment * full understand the informed consent form, and signed it voluntarily exclusion criteria: * pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception * be allergic to any component of the drug or showed allergic constitution * showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by mri * have malignancy in the ulcer pathology test, or have a history of malignant tumor * unable to clean the wounds due to the formation of tract between the ulcer and other condition * infected with hepatitis b virus (hbv), hepatitis virus c (hcv), human immunodeficiency virus (hiv), or treponema pallidum * alanine transaminase (alt) or aspartate transaminase (ast) exceeds 2.5 times of the normal value, or cr\>200 μmol/l * have a history of apoplexy, unstable angina pectoris, myocardial infarct * have a psychiatric history, drug abuse or alcohol abuse history * had participated in any other clinical trials in the past 3 months * any other circumstances judged by the researchers disqualify the patient to participate in the trial

Keywords: human placental mesenchymal stem cells gel
effects of abdominal hot compresses on indocyanine green elimination in healthy subjects

Conditions: Healthy

Summary: we investigated, whether abdominal hot compresses effect hepatic blood flow. our hypothesis was, that the hot compresses might either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system increase hepatic blood flow.

abdominal hot compresses are traditionally used by patients with liver diseases as self help. this study investigated the effect of abdominal hot compresses on hepatic blood flow measured by elimination of indocyanine green (icg), a non-toxic green dye. it was presumed, that abdominal hot compresses increase hepatic blood flow either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system. in healthy volunteers icg elimination was measured with and without hot compress at two investigations in a weekly interval. at each investigation icg was injected as bolus after a rest period of 10 minutes. after the injection blood was taken in regular intervals for analysis of icg concentration over a period of 40 minutes and half life was calculated. the time interval between the investigations was 8 days, the sequence was randomly assigned.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * iodine allergy * any acute or chronic disease \[with exception of pollinosis because it is common\] * elevated levels of alanine amino transferase \[alt\], aspartate amino transferase \[ast\], gamma glutamyltransferase \[ggt\] or bilirubin * heat urticaria * pregnancy * alcohol intake \>30 g/d * any medication except contraceptives * body mass index (bmi) \>30 kg/m2

Keywords: healthy subjects
study of pemetrexed for second-line pancreas cancer

Conditions: Pancreas Cancer

Summary: this study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine. in this study a drug called pemetrexed is being tested. this drug is approved by the fda for use in lung cancer and mesothelioma. the purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. subjects will receive pemetrexed iv once every 21 days until disease progression or unacceptable side effects occur.

this is an open label phase ii trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. subjects will receive pemetrexed 500 mg/m2 iv every 21 days until disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the pancreas * prior treatment for distant or locally advanced disease with gemcitabine-based therapy * measurable or evaluable disease * ecog performance status 0-2 * adequate hematological parameters * adequate baseline liver function * at least 28 days from any major surgery * at least 2 weeks from the last radiation treatment * must have recovered from reversible toxicities of prior chemotherapy * must be able to discontinue any nonsteroidal anti-inflammatory medications * must be willing to receive intramuscular vitamin b12 shots and take oral folate supplements exclusion criteria: * any prior treatment with pemetrexed * more than one prior chemotherapy regimen * hiv positive on antiretroviral therapy * pregnant or lactating * prior organ allograft * on concurrent antitumor therapy including radiation therapy or other chemotherapies * creatinine clearance 45 ml/min or less * absolute neutrophil count \< 1500 * platelets \< 75,000 * bilirubin \> 1.5 times the upper limit of normal * transaminases \> 3 times the upper limit of normal except in known liver metastasis wherein they may be \</= 5 times upper limit of normal * clinically significant ascites or pleural effusion that cannot be drained * any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment

Keywords: pancreas metastatic recurrent