Kornimate/medical-research-clean huggingface dataset:
observational study of the switch of metformin alone to metformin combined with repaglinide in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose * signed informed consent * treatment in accordance with the summary of product characterisation exclusion criteria: * any contraindication to metformin or repaglinide
assessment of indocyanine green as a near-infrared fluorescent contrast agent for image-guided liver surgery

Conditions: Liver Neoplasms

Summary: this is a prospective, monocentric, non-randomized, phase i-ii study. the goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver surgery. this study will be performed on patient intended to undergo a liver cancer surgery.it will contain three steps, assessing the following items: * step 1: to assess the faisability of the use of the fluobeam, in actual clinical surgical conditions and validate the data obtained in the preclinical phase, * step 2: to assess the ability of the combination of icg and fluobeam to mark hepatic lesions, * step 3: to assess the ability of the combination of icg and fluobeam to help in guiding per-hepatectomy. 3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the third step. patients will be followed during 4 weeks after the surgery.


Eligibility criteria:
inclusion criteria: * adult patient * affected of hepatic cancerous lesions whatever they are * requiring a one or two steps hepatectomy by laparotomy * ecog performance status (ps)≤ 2 * mandatory affiliation to health security insurance * written informed consent exclusion criteria: * with a contraindication or hypersensitivity to icg administration in medical history * having already undergone a major hepatic surgery (more than three segments) or major biliar surgery (context of major iterative hepatic surgery) * unable to be followed during the duration of the study, for social, family, geographical or psychological reasons * pregnant or breast-feeding woman (urinary strip must be negative at the time of the inclusion in the study for women in age to procreate)

Keywords: intra-operative imaging nir fluorescence liver surgery tumoral margins
study to describe the safety, tolerability, and immunogenicity of bivalent rlp2086 vaccine in laboratory workers ≥18 to ≤65 years of age

Conditions: Meningitis, Meningococcal, Serogroup B

Summary: this study will assess the safety, tolerability and immunogenicity of bivalent rlp2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a month 0, 2, and 6 schedule. the study will recruit laboratory personnel (inclusive of pfizer staff) who work directly with pathogenic neisseria meningitidis in the context of the bivalent rlp2086 vaccine development program. the study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rlp2086 vaccine.


Eligibility criteria:
inclusion criteria: 1. laboratory personnel (inclusive of pfizer staff) who work directly with pathogenic neisseria meningitidis in the context of the bivalent rlp2086 vaccine development program. 2. male or female subject aged ≥18 to ≤65 years at the time of enrollment. 3. negative urine pregnancy test. exclusion criteria: 1. subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 2. a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in b cell function or those receiving immunosuppressive therapy. subjects with terminal complement deficiency are excluded from participation in this study. 3. significant neurological disorder or history of seizure (excluding simple febrile seizure). 4. current chronic use of systemic antibiotics. 5. received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination. 6. any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 7. prior receipt of any vaccine specifically targeting fhbp or lp2086 antigens. 8. history of microbiologically proven disease caused by neisseria meningitidis.
exercise as adjunctive treatment for refractory epilepsy

Conditions: Refractory Epilepsy; Epilepsy

Summary: the purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy. the study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.

this is a randomized, controlled pilot trial to assess the feasibility and fidelity of a 12 week, individualized, telehealth exercise intervention in people with refractory epilepsy. this will be carried out using a 2 arm, parallel group design with a waitlist attention control. participants will undergo formal exercise testing prior to enrollment to determine safety and establish a baseline fitness level. participants will use a wrist-worn garmin device to record activity and sleep. after a 4 week baseline period, participants will be randomized to intervention or wait-list attention control. the intervention group will undergo a 12-week telehealth exercise program designed by a trained health coach and tailored to the individual's personal fitness level and exercise preferences. the intervention is based in social cognitive theory to implement and enforce sustainable behavior change. the wait-list attention control will receive health education but will not be given an exercise program. at the end of the intervention period, the control group will be given the option to participate in the exercise program. the study will assess recruitment and retention as well as fidelity, acceptability and sustainability of a telehealth exercise intervention in this population. the study will investigate objective and subjective measures of the effect of the intervention on the known seizure triggers of sleep and stress as possible mediators of seizure frequency. the study will collect information regarding the effects of the intervention on depression, anxiety, quality of life, cognition, and seizure frequency.

Eligibility criteria:
inclusion criteria: * age 18 or older * focal or generalized epilepsy, as clinically determined by a wake forest baptist health epileptologist. * seizure frequency of at least 1 clinically observable seizure in the year prior to enrollment * able to ambulate independently without assistive device * access to a smartphone with application capabilities * internet access or cellular data plan to attend virtual sessions exclusion criteria: * diagnosis of nonepileptic or psychogenic spells * seizures associated with frequent falls with injury * \<50% adherence with wearing the device or completing the study diary during the baseline period. * currently in an exercise program * medical conditions that would limit ability to participate in an exercise intervention such as: * stage iii or iv congestive heart failure (chf) * end-stage renal disease * severe dementia or significant cognitive impairment * uncontrolled hypertension (htn) * motor conditions that limit ambulation

Keywords: exercise telehealth adjunctive treatment
68ga-grazytracer pet/ct for early assessment of response to neoadjuvant immunotherapy in resectable nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to explore the effectiveness of 68ga-grazytracer pet/ct in early evaluation of neoadjuvant immunotherapy response in resectable nsclc.

it is challenging to noninvasively early evaluate the immunotherapy response of cancer. the study will evaluate the application value of 68ga-grazytracer pet/ct in the early evaluation of neoadjuvant immunotherapy response in resectable non-small cell lung cancer (nsclc). potential participants will be assessed for inclusion, including the verification of clinical stage and eligibility. eligible patients with clinically stage ib-iiia nsclc will be received standardized neoadjuvant immunotherapy (every 3 weeks for 3 cycles). patients with nonsquamous nsclc will be received pembrolizumab plus platinum-pemetrexed, and lung squamous cell carcinoma patients will be received pembrolizumab plus platinum-paclitaxel. 68ga-grazytracer pet/ct imaging will be performed at baseline and before cycle 3. pathological response of the primary (mpr vs. non-mpr), imaging response (ipr vs. non-ipr; mr vs. md), and 68ga-grazytracer pet/ct imaging (positive vs. negative) will be given special attention.

Eligibility criteria:
inclusion criteria: 1. pre-treatment stage as clinical ib-iiia (ajcc/uicc 8th edition); 2. curative resectability has to be explicitly verified by the experienced surgical investigator; 3. histologically confirmed diagnosis of primary non-small lung cancer. 4. men and women aged 18 years to 75 years; 5. eastern cooperative oncology group (ecog) performance status: 0-1; 6. expected survival ≥ 6 months; 7. sign on the informed consent form (icf). exclusion criteria: 1. histologically confirmed were not nsclc; 2. lung cancer that can not be resected or has distant metastasis, or for other reasons can not tolerate surgery; 3. patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period; 4. any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. the subjects were innate or acquired immunodeficiency (such as hiv), or active hepatitis (hepatitis b reference: hbsag) positive; hepatitis c reference: hcv antibody positive; 5. uncontrolled diabetes or fasting blood glucose ≥11.0 mmol/l on the day of the test; 6. women who are or may become pregnant, and lactating women are excluded; 7. having a history of severe cardiovascular disease, severe myelosuppression and severe hepatic and renal insufficiency. having a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 8. any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
wearable bioimpedance analyzer for tracking body composition changes

Conditions: Obesity; Knee Osteoarthritis

Summary: obesity, namely at body mass index (bmi) levels exceeding 40kg/m2 (class iii obesity), is a risk factor for many diseases including osteoarthritis (oa). in arthroplasty, patients in this population frequently present for and are turned away from surgical intervention. subsequently, efforts are made to decrease bmi through simple weight loss, yet these have been suggested as ineffective and counterproductive. furthermore, simple weight loss may include muscle mass loss, which is an additional risk factor for surgery. at the university of iowa hospitals and clinics orthopedics department, efforts have been made to encourage muscle mass gain and body fat loss over simple weight loss where progress has been tracked through stationary, multi-frequency bioimpedance analysis (bia). bia is a readily available technology offered to industry and consumers, and bia has recently been incorporated into wearable devices. in the uihc orthopedics department, a novel clinic aimed at holistically serving the osteoarthritic-class iii obese population for controlled and monitored weight loss through bia. this study, a randomized controlled trial, aims to recruit adult patients with class iii obesity presenting to the arthroplasty-obesity clinic. while all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass, they will be randomized to one of two cohorts: the study group will receive a wearable bia wristband (inbody band 2) and instruction on its use in addition to the standard coaching, and the control group will only receive the standard coaching. this study aims to identify if the use of a wearable bia wristband aids in the desired body composition changes. in addition, this study aims to quantify the body composition changes exhibited by each cohort. finally, this study aims to track surgical outcomes for those patients that are indicated for total joint arthroplasty.


Eligibility criteria:
inclusion criteria: * adults \>/= 18 years * bmi \> 40kg/m2 * presenting to bariatric arthroplasty clinic with desire for total joint arthroplasty procedure * owns a smartphone capable of handling ios or google play apps * has a wrist circumference less than or equal to 7.7" exclusion criteria: * has a pacemaker or other electronic pacemaker placement * inability to complete study protocols * inability to stand unsupported for 60-90 seconds * does not own a smart phone capable of handling ios or google play apps * has a wrist circumference greater than 7.7"

Keywords: total knee replacement obesity total joint replacement bioimpedance orthopedics body composition fitness tracker
study of tap and laparoscopic and robotic gynecologic procedures and obese women

Conditions: Pain

Summary: study the effect of the transversis abdominis plane (tap) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.


Eligibility criteria:
inclusion criteria: * bmi greater than or equal to 30, women undergoing laparoscopic or robotic in-patient procedures exclusion criteria: * conversions, non-obese women

Keywords: transversis abdominis plane block obese robotic surgery laparoscopic surgery
allosure in simultaneous pancreas kidney transplant

Conditions: Kidney Pancreas Transplant

Summary: this study will observe donor derived cell free dna percentages (via the allosure test) in combined kidney-pancreas transplant recipients to establish both stable and dysfunctional allosure assay levels

simultaneous kidney-pancreas transplantation is the optimal treatment for select patients with type 1 diabetes and kidney failure. limited biomarkers are utilized to monitor the health of the allografts. for kidney transplantation serum creatinine remains the most commonly monitored biomarker; for the pancreas allograft blood glucose and serum amylase and lipase are measured. however, these biomarkers are imprecise and non-specific for rejection. in kidney transplantation cell free donor derived dna at of value of \>1% has emerged as an effective immune monitoring tool as a marker for renal allograft rejection and injury. thus far, a discriminatory donor derived cell free dna value for a stable and rejecting allografts has not been established for recipients of combined kidney-pancreas transplants. study aim will be to help establish a normal range of donor derived cell free dna in stable kidney-pancreas graft function in combined kidney pancreas transplant recipients while determining changes in cell free dna in kidney-pancreas recipients with biopsy proven allograft rejection.

Eligibility criteria:
inclusion criteria: * age ≥18 years * kidney-pancreas transplant recipients * patient must have stable creatine, lipase, amylase for at least a two month span after transplant or patient must receive a biopsy within one year post transplant exclusion criteria: * presence of non-renal or pancreas transplanted organ * patient is not enrolled within 1 year after transplant

Keywords: kidney pancreas transplant deceased donor cell free dna
rotigotine restless legs syndrome dose finding trial

Conditions: Idiopathic Restless Leg Syndrome

Summary: the objective of this trial is to demonstrate clinical efficacy of four different dosages of spm 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in rls subjects. it is anticipated that rotigotine (spm 936) will be more effective than placebo. the tolerability and safety of rotigotine will be assessed.


Eligibility criteria:
inclusion criteria: * idiopathic restless leg syndrome * subject has responded previously, according to medical history information, to l-dopa therapy and/or treatment with a dopamine agonist, if pre-treated exclusion criteria: * secondary restless legs syndrome due to, e.g., renal insufficiency (uremia), iron deficiency anemia, rheumatoid arthritis. * secondary restless legs syndrome associated with previous or concomitant therapy with dopamine d2 receptor antagonists, butyrophenones, metoclopramid, atypical antipsychotics (e.g., olanzapine), tri- and tetracyclic antide-pressants, mianserine, lithium or h2-blockers (e.g., cimetidine), or due to withdrawal from drugs such as anticonvulsants, benzodiazepines, barbitur-ates, and other hypnotics. * history of sleep disturbances like sleep apnea syndrome, narcolepsy, myoclonus epilepsy observed during polysomnography (psg) or explored in subject history. * clinically relevant cardiac dysfunction and/or arrhythmias (e.g., suspected conduction system dysregulations, second or third degree av block, complete left or right bundle branch block, sick-sinus-syndrome, congestive heart failure class iii or iv by nyha, myocardial infarction within twelve months prior to enrollment). * clinically relevant renal dysfunction (serum creatinine \>2.0 mg/dl) * clinically relevant hepatic dysfunction (total bilirubin \>2.0 mg/dl or alt and/or ast greater than two times the upper limit of the reference range). * qtc-interval in resting ecg \> 450 msec in males and \> 470 msec in females. * history of symptomatic orthostatic hypotension within 28 days prior to screening visit (visit 1), or a systolic blood pressure (sbp) less than 105mmhg at trial entry.
e-cigarettes and sna

Conditions: Nicotine Dependence

Summary: randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on sympathetic nerve activity and markers of oxidative stress.

participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and measures of autonomic tone, including heart rate variability (hrv) and sympathetic nerve activity (msna: microneurography), and oxidative stress will be measured pre and post exposure.

Eligibility criteria:
inclusion criteria: healthy exclusion criteria: * cardiac disease * respiratory disease * diabetes mellitus

Keywords: nicotine autonomic tone oxidative stress
workplace interventions preventing risky use of alcohol and sick leave

Conditions: Alcohol Consumption; Sick Leave; Workplace Interventions; Presenteeism

Summary: the aim of this study is to investigate the effectiveness of two workplace interventions (the riskbruk model and balance) in reducing risky alcohol consumption, sickness absence and presenteeism. the purpose is to assess whether the riskbruk model should be implemented in the norwegian workforce in its entirety, whether the less extensive and costly alternative balance is sufficient, or if neither one of them show effectiveness compared to usual care.


Eligibility criteria:
inclusion criteria: * employees screening positive for at-risk drinking (8+ on the audit) exclusion criteria: -

Keywords: alcohol consumption sick leave workplace interventions presenteeism
efficacy of intralesional triamcinolone injection in the treatment of vitiligo

Conditions: Vitiligo; Treatment; Intralesional Injection; Corticosteroid

Summary: a randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo

intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention. the investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. the paired symmetric vitiliginous lesions will be randomized to either control or injection groups. all lesions will be treated with narrowband uv-b phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. the degree of repigmentation will be assessed as % from baseline.

Eligibility criteria:
inclusion criteria: 1. age : 19 or older 2. a patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study 3. a patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk 4. a patient who has no further response to excimer laser or short wavelength ultraviolet b therapy, which is a conventional treatment for vitiligo exclusion criteria: 1. patients under the age of 19 2. patients with enlarged or spreading lesions of vitiligo 3. patients who do not want to do so or who refuse to write a consent form 4. patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients) 5. others those who are deemed unsuitable for the examination at the discretion of the examiner

Keywords: vitiligo intralesional injection corticosteroid triamcinolone
zalutumumab in head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: the purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx. * primary or recurrent disease for which no curative or established palliative treatments are amenable * who performance status of 1 or 2. exclusion criteria: * received certain other treatments within 4 weeks prior to administration of study drug * previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis). * skin disease requiring systemic or local corticosteroid therapy. * known brain metastasis or leptomeningeal disease. * signs or symptoms of acute illness. * bacterial, fungal or viral infection. * certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases. * pregnant or breast-feeding women. * women of childbearing age who are unable or unwilling to use an iud or hormonal birth control during the whole trial. * simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.

Keywords: head and neck cancer squamous cell carcinoma of the head and neck