Kornimate/medical-research-clean huggingface dataset:
tissue changes in diabetes in adults and children using multispectral optoacoustic tomography.

Conditions: Diabetes Mellitus, Type 1; Macroangiopathy

Summary: in this study, blood flow and tissue changes in adult and pediatric patients with diabetes mellitus will be characterized by msot and compared with existing methods (abi testing, neurological testing) (method comparison). the aim is to quantify changes and to possibly allow early detection of concomitant diseases. this could, similar to peripheral arterial occlusive disease, lead to a new possibility of non-invasive assessment of disease progression in the future.

after informing the patients and parents/guardians and checking the inclusion and exclusion criteria, the clinical data of the ill subjects are recorded and the hba1c is measured in the laboratory as part of the routine recording. the blood collection is part of the routine diagnostics on presentation in the outpatient clinic and is performed separately from the study. subsequently, imaging by msot is performed in all study participants. this is performed on both sides of the lower leg over the triceps surae muscle. the examination is analogous to sonography over the corresponding skin layers without further invasive procedures. the anatomical region can be localized by means of built-in sonography; subsequently, the corresponding optoacoustic signals can be derived over it. this is followed by measurement of the arm-brachial-index. after a short recovery time, the test persons perform a physical stress on the examined lower leg muscles. after renewed abi measurement, the imaging examination is repeated using msot. finally, the neurological status is assessed using the neuropathy disability score (nss).

Eligibility criteria:
inclusion criteria: 1. patients with diabetes mellitus type 1 * laboratory-confirmed diagnosis of diabetes mellitus type 1 * age 18-99 years * disease duration of at least 5, preferably 10 years with inadequate medication control (hba1c value \> 8.5 mmol/mol) * written informed consent 2. patients with diabetes mellitus type 1 * laboratory-confirmed diagnosis of diabetes mellitus type 1 * age 6-17 years * duration of disease at least 5, better 10 years with inadequate medication control (hba1c value \> 8.5 mmol/mol) * written informed consent 3. healthy subjects * age 18-99 years * written informed consent exclusion criteria: * pregnancy * nursing mothers * unstable patients: need for continuous cardiopulmonary monitoring (ecg and pulse oximetry). * tattoo in the area of the examination * subcutaneous fat over 3 cm * lack of written consent * inability to perform sufficient (brief) physical exertion
study to evaluate the safety and pharmacokinetics of topically applied 40% lidocaine gel compared with placebo in subjects with acute herpes zoster (shingles) pain

Conditions: Acute-onset Herpes Zoster Pain

Summary: study 2022-hz-011 will utilize a randomized withdrawal (rw), double-blind, placebo controlled design in which the pk and safety of cntx 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.


Eligibility criteria:
inclusion criteria: 1. subject is a male or female ≥ 18 years of age and ≤ 85 years of age. 2. subject has brush-evoked allodynic pain intensity score ≥ 4 using the nprs as determined by pain assessment during the physical examination at screening. a. onset must have occurred ≤ 20 days prior to randomization 3. subject has an average daily pain intensity score of ≥ 4 using the nprs as determined by pain assessment during the physical examination at screening. 4. subject must have a diagnosis of herpes zoster (shingles). 5. subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2. exclusion criteria: 1. subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas. 2. subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm2. 3. subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to lidocaine, ingredients of the study drug, or local anesthetics of the amide type. 4. subject has target skin area (allodynic area and surrounding skin) that is not intact, is inflamed, or in the opinion of the principal investigator, consistent with rash due to acute herpes zoster. 5. subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia. 6. subject is taking class i antiarrhythmic drugs (e.g., tocainide, mexiletine), or medications that could interact with the study drug or interfere with its evaluation.
international electrical storm registry

Conditions: Arrhythmias, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation; Defibrillators, Implantable

Summary: organized ventricular arrhythmias (ventricular tachycardia (vt), torsades de pointes (tdp) and ventricular fibrillation (vf)) represent a major event in the clinical history of a patient and they can lead to hemodynamic instability and sudden cardiac death (scd). recurrences of ventricular arrhythmias and electrical instability have exponentially increased in the last decades and a new clinical entity called "electrical storm" (es) has emerged as major morbidity and mortality factor. the es is defined as a cluster of 3 or more sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia lasting 12 hours or more and that does not respond to treatments. most of the patients presenting es are already implanted with an icd. this is due to 3 factors: first, patients with icd implant are at higher risk to develop ventricular arrhythmias for the cardiac disease that led to the icd implant. second, the device records and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would not be detected. third, and more important, the device gives the possibility to survive to an arrhythmic episode, making it possible for the patient to experience an es. the incidence of es is debated in different studies and ranges from 10 to 60% in patients with icd for secondary prevention and from 4 to 7% in patients with icd for primary prevention. the aim of the electra registry is twofold: 1. to create an international registry on clinical features, optimal therapy, ablation strategy, prognosis and the effect of icd programming on patients with es. 2. to use the data derived from the registry for a prospective, observational study on mortality and rehospitalization rate in patients with es.


Eligibility criteria:
inclusion criteria: * diagnosis of es (documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h).in order to fulfill this criterion, a patient with a previous episode of es could also be enrolled during routine screening. * age ≥18 * written informed consent exclusion criteria: * patient without icd * confirmed or suspected use of drugs or narcotics with known direct pro-arrhythmic effect * inability to express an informed consent for the study

Keywords: electrical storm
gemcitabine/cisplatin versus gemcitabine/epirubicin for non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy of gemcitabine/cisplatin versus gemcitabine/epirubicin in stage iiib/iv nsclc in terms of response rate and overall survival.

most patients suffered from nausea, vomiting and prolonged anorexia after cisplatin treatment. epirubicin is an anthracycline that was used widely in the treatment of cancer. our previous study of an epirubicin and paclitaxel combination in non-small cell lung cancer patients showed a response rate of 52.6% and good median survival. however, most patients suffered from paclitaxel-related neurotoxicity. chemotherapy may increase an average of 1 to 2 months of median survival in inoperable non-small cell lung cancer patients treated with chemotherapy. however, chemotherapy may not provide a cure for these patients. reduction of side effects and enhancement of life quality of the patients are as important as life prolongation for these patients. we designed a combination chemotherapy using gemcitabine with epirubicin in the treatment of inoperable non-small cell lung cancer. the treatment will be compared to gemcitabine and cisplatin combination.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of stage iiib/iv nsclc * no prior chemotherapy * age \> 18 years * ecog score \< 0 to 2 * bi-dimensionally measurable lesions * wbc \> 4,000/ml, anc \> 1,500/ml, platelets\>100,000/ml * hb\>10g/dl. * alt/ast \< 5 times x unl, bilirubin \< 1.5times x unl, creatinine \< 1.25 times x unl, normal calcium level * life expectancy \> 12 weeks exclusion criteria: * cns metastases, concomitant myelosuppressive radiotherapy, c/t, hormonal therapy or immunotherapy. * active congestive heart failure, angina and/or arrhythmia requiring therapy or previous myocardial infarction

Keywords: combination, chemotherapy,non-small cell lung cancer
cerebral oxygen desaturation and post-operative delirium in thoracic surgical patients

Conditions: Delirium; Thoracic Surgery

Summary: this study will assess the incidence and risk factors for post-operative delirium in patients undergoing thoracotomy. specifically, the study will assess if there is any relationship between an intra-operative decrease in brain oxygen levels which can occur during one-lung ventilation, and the occurrence of delirium in the post-operative period.

this will be a prospective, observational study on 200 patients. consenting thoracic surgical patients presenting for open thoracotomy or vats will be assessed pre-operatively for baseline cognitive status and clinically relevant risk factors for delirium. intra-operatively, patients will undergo cerebral oxygenation monitoring using near infra-red spectroscopy cerebral oximetry. postoperatively, patients will be assessed twice daily for the presence or absence of delirium using the confusion assessment methodology (cam) scoring system during their hospital stay. a clinically relevant desaturation will be defined as a 25% decrease from the patient's baseline saturation, which will be determined while the patient is breathing room air pre-operatively. the severity and duration of any desaturation will be recorded and subsequently analyzed for correlation with post-operative delirium. bivariate associations between the risk of delirium and predictor variables will be sought. if appropriate, logistic regression models will be constructed with the outcome of delirium. significance: previous studies at our centre have resulted in over 35% of thoracic surgical patients developing significant, intra-operative cerebral desaturation. we propose to study a convenience sample of 200 consecutive patients. depending on the relative risk of developing delirium with a significant cerebral desaturation, this study may be adequately powered to determine the associated risk of delirium. this study will provide background information in planning further interventional trials to prevent desaturation and possibly reduce the incidence of delirium, as well as aid in the planning of larger multi-center trials to more accurately assess the risk of intra-operative decreases in cerebral oxygenation and the role this event contributes to the occurrence of delirium.

Eligibility criteria:
inclusion criteria: * patients undergoing a thoracic surgical procedure with one-lung ventilation. exclusion criteria: * inability to communicate in english * lack of informed consent

Keywords: postoperative one-lung ventilation cerebral oximetry cerebral desaturation
glucose variability in cancer patients receiving dexamethasone

Conditions: Hyperglycemia; Cancer

Summary: dexamethasone is a steroid commonly used for the prevention of chemotherapy-induced nausea and vomiting (cinv). while effective, high dose dexamethasone is associated with numerous side effects, even when used for a short duration. one such effect is elevated blood glucose, or hyperglycemia. current literature suggests increased risk of infection, poor wound healing, and increased mortality in non-cancer surgical patients with steroid-induced hyperglycemia. there is also evidence to support that elevations in blood glucose are associated with worsened outcomes in cancer patients. much of this data comes from cancer patients that are treated in an inpatient setting where blood glucose is routinely checked. limited data is available describing the fluctuations in blood glucose following dexamethasone administration in cancer patients being managed in an outpatient setting, such as the anschutz cancer pavilion (acp) infusion clinic. this study aims to characterize the effects dexamethasone has on blood glucose in cancer patients by utilizing continuous glucose monitoring (cgm) devices. these devices are minimally invasive, are fda approved, and can produce real-time data of blood glucose fluctuations over a course of 3-7 days. by inserting the devices under the skin of the abdomen, the investigators can evaluate the temporal relationship between glucose abnormalities and dexamethasone administration. results from this study will not only increase the knowledge base of dexamethasone-induced hyperglycemia and identify patients at increased risk, but also allow future research to be conducted in order to determine if standard protocols can proactively minimize steroid-induced glucose fluctuations.


Eligibility criteria:
inclusion criteria: * non-pregnant adult patients * between 18-75 years of age * are seen in the uch outpatient cancer clinics for management of solid tumor and/or non-leukemia malignancies * are prescribed high dose dexamethasone for cinv for no longer than 5 days, and * have an absolute neutrophil count (anc) \> 1,500/mm3 and platelet count \> 100,000/mm3 at time of glucose sensor placement. * anc of 1,500/mm3 is standard criteria for receiving outpatient chemotherapy. exclusion criteria: * leukemia-type malignancy * require inpatient administration of chemotherapy * are receiving chronic steroids * have an ecog/who/zubrod score of 3 or 4 * have an anc \< 1,500 cells/mm3 at time of cgm device placement or are anticipated to have a decrease in anc \< 1,500 cells/mm3 during 5 days after sensor placement, * have an active infection, or have significant cognitive impairment limiting their ability to use the cgm or complete a take-home diary. * to further minimize the potential for infection, patients receiving chemotherapy regimens associated with a high (\>20%) risk of febrile neutropenia, according to the 2014 nccn guidelines, will also be excluded from study

Keywords: dexamethasone
intralesional 5-fluorouracil injection for the treatment of oral leukoplakia

Conditions: Oral Leukoplakia

Summary: this is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-fu injections for the treatment of oral leukoplakia (ol).

primary objective: i. evaluate the feasibility of intralesional 5-fluorouracil (5-fu) injection for the treatment of oral leukoplakia secondary objective: i. evaluate the safety profile and side effects of the study drug. outline: participants diagnosed with ol will receive multiple intralesional injections of 5-fu solution over a maximum period of 6 weeks, followed by a follow-up visit after 3 months.

Eligibility criteria:
inclusion criteria: * adults, 18 years of age or older * any gender, race, or ethnicity * clinical diagnosis of oral leukoplakia and biopsy proven dysplasia (any grade) * oral leukoplakia at least 1 cm in largest diameter * ability to understand and willingness to sign a written informed consent document * willingness to provide blood and tissue from diagnostic biopsies * any smoking history is permitted exclusion criteria: * pregnant or lactating women * men and women unwilling to use contraception while on study * history of malignancy that required cytotoxic chemotherapy within the previous 3 months * use of 5-fu (systemic or topical) within 3 months prior to study enrollment * history of allergic reaction or severe hypersensitivity to 5-fu and/or lidocaine * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
health at every size and acceptance and commitment therapy vs. behavioral weight loss for obesity and depression in women

Conditions: Depression; Obesity

Summary: the primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined health at every size and acceptance and commitment therapy (haes/act) treatment, known as accept yourself! compared to a commercial behavioral weight loss program, weight watchers (ww). obese women (bmi ≥ 30) with major depressive disorder will be randomly assigned to one of these two treatments. depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.


Eligibility criteria:
inclusion criteria: * english-speaking * major depressive disorder (assessed using the structured clinical interview for dsm-iv, scid-iv) * body mass index (bmi) greater than or equal to 30 * not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study) exclusion criteria: * current substance dependence * history of psychotic symptoms * high risk of suicide/self-harm * current enrollment in a weight-loss program * weight loss surgery in the past year * current psychotherapy * inability to postpone weight loss or depression treatment interventions for the duration of the study * taking antipsychotic, tricyclic, or oral corticosteroid medication * unwilling to be randomized to the study treatments
local treatment for bone metastases

Conditions: Bone Metastases

Summary: this study will carry out a prospective randomized controlled study to study the effect of different local treatment on disease control, quality of life, economic cost and even survival period of patients by randomly giving local radiotherapy or observation to patients with newly diagnosed bone metastases or patients with bone metastases after vertebroplasty.


Eligibility criteria:
inclusion criteria: 1. patients who are definitely diagnosed as malignant tumor by pathology or cytology; 2. at least one bone metastasis site; 3. aged over 18; 4. ecog：0-1； 5. the pain score is less than 5 or after vertebroplasty within 1 month. exclusion criteria: 1. the expected life span is less than 3 months; 2. spinal metastatic tumor stability score (sins) is greater than 7; 3. spinal cord compression; 4. the patient refused the treatment decision of the integrated team.
relationship between auto nrt and behavioural t & c levels with the nucleus freedom cochlear implant

Conditions: Hearing Loss

Summary: cochlear implants require programming on an individual basis to provide appropriate levels of electrical stimulation. this program, or "map", is placed in the speech processor of the cochlear implant. success of implantation largely depends on the adequacy of this map. cochlear implant fitting remains a difficult challenge in congenitally or pre-linguistically deafened children. it requires competence of experienced audiologists with expertise in behavioral techniques for hearing function assessment.our goal is to establish the offset correlation between objective measurements (nrt and esrt) and the behavioral measurements of t \& cs in different stimulation rates in the freedom sp system.

an open trail. the implantees will go through their routine programming sessions after implantation, the specified data will be collected and analyzed in order to establish the offset correlation which we seek for.

Eligibility criteria:
inclusion criteria:patients eligible for the study should be capable of providing reliable subjective counted thresholds (e.g. children older than 12 years of age at ci or adults) and has good nrt recordings, implanted with the nucleus freedom system - exclusion criteria:implantees with any other serious illness, who can not give a reliable subjective counted thresholds -

Keywords: cochlear implant threshold (t) measurement comfort (c) level profound hearing loss auditory stimuli profound hearing loss patients eligible for the study should be capable of providing reliable subjective counted thresholds and has good nrt recordings, implanted with the nucleus freedom system
action observation, imagery and execution for stroke rehabilitation

Conditions: Stroke

Summary: the specific study aims will be: 1. to investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (aoie) compared with an action observation therapy (ao) group and a control treatment group as controls on different aspects of outcomes in patients with stroke. 2. to examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients. 3. to examine the correlations between aoie-induced brain activation changes and the clinical efficacy of aoie. 4. to identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.

the investigators propose a 3-year randomized controlled trial to (1) investigate the short- and long-term treatment efficacy of aoie, action observation alone, versus control treatment on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and activation changes after the 3 interventions by using an advanced brain imaging technique, magnetoencephalography (meg), (3) determine the correlations between neural activation changes and clinical outcomes, and (4) identify who are the good responders to the aoie therapy. an estimated total of 96 patients with subacute stroke will be recruited in this study. all participants will be randomly assigned to receive 1 of the 3 interventions for 3 weeks (a total of 15 sessions). clinical outcome measures will be conducted at baseline, immediately after treatment (3 weeks), and at 3 months follow-up. the meg assessment will be conducted at baseline and immediately after treatment (3 weeks). for the meg study, the investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging evaluation because of the specific eligibility criteria and high costs of meg. the patients can still participate in the study, receiving rehabilitation therapy and clinical evaluations, even if the participants will not be included in the meg study.

Eligibility criteria:
inclusion criteria: * diagnosed as having a unilateral stroke; * 1 to 12 months after stroke onset * from 20 to 80 years of age * a baseline score of the fugl-meyer assessment (fma) of 20 to 60 * able to follow the study instructions * capable of participating in therapy and assessment sessions. exclusion criteria: * patients with global or receptive aphasia, * severe neglect * major medical problems, or comorbidities that influenced ue usage or caused severe pain additionally, if patients have no metal implants, no head traumas or neurosurgical operations, and can perform meg motor tasks, the participants can additionally participate in the meg assessment.

Keywords: stroke neurorehabilitation mirror neuron system action observation motor imagery meg