Kornimate/medical-research-clean huggingface dataset:
dose ranging study to assess the safety and efficacy of scv-07 for the delay to onset of severe oral mucositis in patients receiving chemoradiation therapy for head and neck cancer

Conditions: Oral Mucositis; Head and Neck Cancer

Summary: oral mucositis (om) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. this study examines the investigational drug scv-07 and it's possible application in treating oral mucositis. studies have shown that scv-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer. the purpose of this study is to assess the safety and tolerability of scv-07 and it's ability to delay the onset of oral mucositis for patients receiving chemoradiation for head and neck cancer.


Eligibility criteria:
inclusion criteria: * subject must have a body weight less than 150 kg at screening * have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is \< 6 weeks prior to initiation of radiotherapy. * plan to receive a continuous course of conventional external beam irradiation * plan to receive a standard cisplatin chemotherapy regimen exclusion criteria: * pregnant or breastfeeding * have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor * prior radiation to the head and neck * have a plan to receive cetuximab (erbitux) in conjunction with chemotherapy * had curative surgery more than 6 weeks prior to the initiation of radiotherapy * have current oral mucositis * presence of active infectious disease excluding oral candidiasis * chronic immunosuppression * seropositive for hiv or hepatitis b surface antigen or c antibody * used an investigational agent within 30 days of randomization * have a known sensitivity to any investigational agent

Keywords: scv-07 oral mucositis
a study of the efficacy and safety of amitriptyline/ketamine topical cream in patients with diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy; Neuralgia

Summary: this is a multicenter, randomized, placebo-controlled, parallel group study of epicept™ np-1 topical cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.

this is a phase ii, multicenter, randomized, placebo-controlled, parallel group study of epicept™ np-1 topical cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (dpn).

Eligibility criteria:
inclusion criteria: * adult patients with chronic pain due to diabetic peripheral neuropathy (dpn) of at least 6 months duration are eligible if they have an average daily pain score of \> 4 during the baseline week. exclusion criteria: * clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this study

Keywords: dpn diabetic nerve pain
time restricted feeding, muscle, and metabolism

Conditions: Overweight; Obesity

Summary: effective nutrition strategies for combatting and/or preventing obesity still need to be identified. this has been the case despite the numerous and different approaches that have been taken. potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. this study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. the objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.


Eligibility criteria:
inclusion criteria: * resides in northwest arkansas * age 25-50 years * bmi \> 25 * all ethnicities * female and male exclusion criteria: * food allergies * pregnant or breastfeeding * dietary restrictions (e.g. vegetarian, vegan, etc.) * trying to lose weight in last 3 months * pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension) * prescription medications related to heart disease or type 2 diabetes * fear of needles * smoker or vaping * currently taking protein supplements or other nutritional supplements which may interfere with study outcomes * consumes \>4 alcoholic beverages per week
the relationship among, serum uric acid, left ventricular hypertrophy and metabolic syndrome

Conditions: Hyperuricemia; Healthy

Summary: hyperuricemia is associated with the prevalence of metabolic syndrome and cardiovascular risks in diverse of the population. whether the dose-response effects on the prevalence of metabolic syndrome and cardiometabolic risks is unclear. the present study is conducted to investigate the relationship between serum uric acid and the prevalence metabolic syndrome and left ventricular hypertrophy.

apparently healthy individuals with an estimated screening number of approximately twenty-thousand individuals undergo an annual health exam in the investigators' hospital. the routine exam includes measurements of body height, body weight, blood pressure, visual and acoustic acuity, physical examinations, basic blood tests, urine analyses, chest radiography, and electrocardiography. the blood tests were performed after individuals fasted for at least eight hours. individuals with any abnormal results underwent a clinical examination at an outpatient department for safety issues, ensuring the accuracy of the data. all data were registered prospectively. the investigators retrospectively collected data from the annual exam.

Eligibility criteria:
inclusion criteria: * individuals with ages of 20-65 years underwent the annual health exam at the investigators' hospital. exclusion criteria: * the individual had no data to define metabolic syndrome, including waist circumference, office blood pressure, serum uric acid, triglyceride, high-density lipoprotein cholesterol, fasting glucose.

Keywords: hyperuricemia metabolic syndrome left ventricular hypertrophy
online mindfulness-based intervention for adhd

Conditions: Attention-deficit Hyperactivity Disorder

Summary: this study aims to evaluate the efficacies of an online mindfulness-based intervention for emerging adults with adhd in malaysia. the investigators hypothesized that online mindfulness-based intervention may improve adhd symptoms and executive functions of emerging adults with adhd.

attention-deficit/hyperactivity disorder (adhd) is a common neurodevelopmental disorder that often persist to adulthood. in malaysia, the chinese ethnic is having the highest prevalence rate of hyperactivity symptoms. nevertheless, there are only limited evidence-based treatment options targeting the core symptoms of adhd, as well as executive functions in adulthood. in addition, conventional psychotherapeutic approaches for adults with adhd have found to be highly labor-intensive. emerging adulthood is a distinct developmental stage of 18 - 29 years old, with unique challenges that rarely addressed in mental health system. recently, mindfulness-based intervention appears to be a promising treatment for adults living with adhd but it has not been evaluated among malaysian emerging adults with adhd. the investigators proposed a two-arm randomized controlled trial, comparing an eight-week online mindfulness-based intervention program with an online introductory psychology program. the outcomes include changes of inattention symptom, changes of hyperactivity-impulsivity symptom, and changes of executive functions from pretest to posttest, 1-month follow-up and 3-month follow-up. to investigators' best knowledge, this randomized controlled trial will be the first to test the efficacious of online mindfulness-based intervention for adhd among emerging adults. it will provide evidence on the efficacious of online treatment for this often-overlooked population in the mental healthcare system.

Eligibility criteria:
inclusion criteria: * 18 to 29 years old. * diagnosis of adhd. * completed at least six years of chinese education. * participants taking psychotropic prescriptions will be allowed to participate, if they prescriptions were stable for at least 6 weeks prior to their participation in this study. exclusion criteria: * history or current presence of substance dependence, psychotic illness, bipolar disorder, personality disorders, conduct disorder, chronic suicidal, or self-injurious behaviour as reported in the diagnostic interview for anxiety, mood, obsessive-compulsive and related neuropsychiatric disorders (diamond). * non-verbal intellectual ability of percentile ranks 25 or below. * received cognitive-behavioural therapy (cbt) for adhd or any form of mindfulness-based intervention in the past 2 years.

Keywords: mindfulness online intervention malaysia
efficiency of hypervolt device application in the treatment of shoulder impingement syndrome

Conditions: Shoulder Impingement

Summary: the aim of this study is to compare the effects of exercise and hypervolt device on pain, muscle strength and normal joint movement in the treatment of shoulder impingement syndrome.

the study was planned as a randomized controlled trial. the study sample will be divided into two groups by simple randomization method. only exercise will be applied to 30 individuals diagnosed with shoulder impingement in the first group of the study. in the second group, 30 individuals with shoulder impingement diagnosis will be given a hypervolt device in addition to the exercise. disabilities of the arm, shoulder and hand questionnaire, visual analog scale and lawton daily living activities questionnaire will be applied to the participants before and after the treatment. the obtained data will be analyzed statistically.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-50. * having a visual analogue scale (vas) value of 5 or higher. * having a history of shoulder pain for at least 1 month. * volunteer to participate in research. * having been diagnosed with shoulder impingement. exclusion criteria: * having cognitive, mental or psychological problems. * having a condition that prevents him from exercising.
from compliance to alliance: engaging psychiatric patients in illness management

Conditions: Patients Diagnosed With Severe Mental Illness

Summary: the purpose of this study is to determine the benefit and impact on relapse prevention,adherence to treatment and general health indices of participation in psycho-eduational group intervention among psychiatric patients with severe mental illness,recently discharged from inpatient services.

medication non-compliance, estimated to affect 50% of all psychiatric patients, was shown to be strongly associated with an elevated risk for relapse, readmission to psychiatric inpatient care, longer length of stay and suicide, resulting in elevated costs across the health care system. the proposed project seeks to bridge the gap between the significant progress of recent years in psycho-pharmacology that produced more efficient 'newer generation' medications, and the continuing unanswered problem of non-compliance, by applying knowledge from clinical decision-making theories and recent evidence-based research on the management of severe mental illness. in phase i of the project, an epidemiological survey will be conducted to evaluate the magnitude and correlates of the problem in patients attending walk-in crisis clinic , using treatment compliance assessment and decision-making assessment tools, both developed by the researchers. an 8-module psycho-educational intervention protocol emphasizing illness management and optimization of health care decision-making will then be designed and implemented. in phase ii, eligible outpatient clients will be randomly assigned to either intervention or standard care conditions, and followed for a period of 15 months. repeated assessments will include pre-post measures of knowledge, treatment compliance, and decision-making, and on outcome measures of relapse such as hospitalizations and symptoms, functioning, self-efficacy, quality of life, and satisfaction with services.

Eligibility criteria:
inclusion criteria: clinical diagnosis of severe mental illness, younger than 70 years of age, recently discharged from psychiatric inpatient services at the rambam medical health center. exclusion criteria: diagnoses other than schizophrenia, major depression and bipolar disorders; 70 + years of age; organic problems

Keywords: schizophrenia major depression bipolar disorder compliance relapse prevention
non-contrast abbreviated mri for secondary surveillance of hcc

Conditions: Hepatocellular Carcinoma

Summary: this prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated mri in detecting recurrent hcc after curative treatment to that of contrast-enhanced liver ct.

this study was designed as a prospective single-arm intra-individual comparison multicenter study

Eligibility criteria:
inclusion criteria: * age between 20-year old and 85-year old * patients with a history of curative treatment for hcc including surgical resection or local ablation * no recurrence after curative treatment of hcc for more than two years * patient who has the plan to perform contrast-enhanced liver ct for secondary surveillance for hcc (i.e., to detect de novo or recurrent hcc) exclusion criteria: * estimated gfr less than 60 * previous history of severe allergic reaction to the iodinated contrast agent * patients with claustrophobia who can't undergo mr examination * patients having cochlear implants or cardiac pacemaker

Keywords: secondary surveillance of hepatocellular carcinoma contrast enhanced liver ct non-contrast abbreviated mri
study of epratuzumab in serologically-positive systemic lupus erythematosus (sle) patients with active disease

Conditions: Systemic Lupus Erythematosus

Summary: the primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with sle.


Eligibility criteria:
inclusion criteria: * positive ana result at visit 1 * current diagnosis of systemic lupus erythematosus (sle) by american college of rheumatology revised criteria such that at least 4 of the 11 criteria are met * active moderate or severe sle disease activity as demonstrated by british isles lupus assessment group (bilag) a level disease activity in at least one body/organ system or bilag b level disease activity in at least two body/organ systems if no bilag a level disease is present * if on antimalarials, dose regimen must be stable for 4 weeks prior to study entry. exclusion criteria: * patients receiving any live vaccination within 2 weeks prior to visit 1 or during the course of the study * active severe sle disease activity which involves the central nervous system (cns) (defined by bilag neurologic a level activity) including transverse myelitis, psychosis and seizures * active severe sle disease activity which involves the renal system (defined by bilag renal level a activity or grade iii or higher world health organization (who) nephritis) or serum creatinine \>2.5mg/dl or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria \>3.5gm/day * patients with a history of anti-phospholipid antibody syndrome and use of oral anticoagulants or anti-platelet treatment * patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection

Keywords: lupus monoclonal antibody b-cell immunotherapy
moral injury symptom scale/moral injury outcome scale

Conditions: Moral Injury; Anxiety; Depression; Burn-Out

Summary: the purpose of this research is to validate the moral injury symptom scale clinician version short form and the moral injury outcome scale in nurses. participants will be recruited in accordance with adventhealth policy # 400.120: selection and enrollment of adventhealth employees, physicians, and volunteers for research studies. employee participants will be assured participation in this study will not affect performance evaluation or employment-related decisions by peers or supervisors. no employees will be recruited by a direct supervisor. recruitment of potential employees as participants will occur without coercion by the principal investigator (pi), by bulletin board advertisements, or through a third party unassociated in a power/supervisory relationship with the employee (i.e., researchers from center for whole-person research).


Eligibility criteria:
inclusion criteria: 1. currently working as a registered nurse (licensed practical nurse, registered nurse, assistant nurse manager, nurse manager, nurse educator) at identified hospital within the state of florida 2. access to computer or mobile device to complete the survey 3. ability to read and understand english exclusion criteria: 1. any employee at identified hospitals who is not a licensed nurse
fluorine f 18 clofarabine pet/ct in imaging patients with autoimmune or inflammatory diseases

Conditions: Autoimmune Disease; Crohn Disease; Inflammatory Disorder; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Takayasu Arteritis

Summary: this pilot trial studies how well fluorine f 18 clofarabine positron emission tomography (pet)/computed tomography (ct) works in imaging patients with autoimmune or inflammatory diseases. fluorine f 18 clofarabine is an imaging agent or tracer which may be taken up by inflammatory tissue in the body. diagnostic imaging, such as pet/ct scans, can be used to measure the amount of injected tracer that is taken up by inflammatory tissue. pet/ct scan may help to determine how fluorine f 18 clofarabine is distributed throughout the body.

primary objectives: i. determine how fluorine f 18 clofarabine (18f-clofarabine) is distributed in the body, in patients with autoimmune and inflammatory diseases. ii. determine whether 18f-clofarabine can be used to image patients with autoimmune and inflammatory diseases. outline: patients receive fluorine f 18 clofarabine intravenously (iv) and undergo a single pet/ct scan for up to 120 minutes.

Eligibility criteria:
inclusion criteria: * must be 18 years or older. * diagnosed with an autoimmune and inflammatory disorder. exclusion criteria * women of childbearing age will have to undergo a pregnancy test that will be provided free of charge. * patients unable to undergo or comply with pet/ct scanning due to pre-existing medical conditions including claustrophobia.
appropriateness of colonoscopy indication: an evaluation of the clinical and economic impact.

Conditions: Colorectal Cancer Control and Prevention

Summary: the aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.

colonoscopy is the most frequently conducted endoscopic examination in industrialized countries, occupying a considerable number of personnel and resources. however, colonoscopy is often over-prescribed, resulting in great waste of resources and increased risk to the patient with no discernible benefit. colonoscopy has many indications and needs precise prescribing criteria to avoid inappropriate use of resources, especially in an open-access health care system such as the italian one, criteria recently systematized by epage (european panel for appropriateness in gastrointestinal endoscopy) and asge (american society for gastrointestinal endoscopy) based on a set of observational studies. in these studies, it has been shown that colonoscopies with an appropriate indication frequently find significant lesions compared with colonoscopies prescribed according to inappropriate criteria, which are often negative. the aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.

Eligibility criteria:
inclusion criteria: * age \>18 years * patients undergoing outpatient and inpatient colonoscopy for any pathology, as part of the normal care process * obtaining informed consent. exclusion criteria: * investigations performed in an emergency/emergency setting
onchocerciasis-associated epilepsy, an explorative case-control study

Conditions: Onchocercal Subcutaneous Nodule; Epilepsy; Virus

Summary: this is an exploratory case control study with the aim to compare the onchocerca volvulus virome between persons with onchocerciasis-associated epilepsy (oae) and persons with onchocerciasis but without epilepsy. the main question we want to address is: is there a virus contained in the o. volulus worm that may have a pathogenic role in causing oae. in maridi county, south sudan, 20 persons with oae with onchocerciasis nodules, and 20 age- and village-matched controls without oae will be enrolled in a nodulectomy study.the adult o. volvulus worms will be extracted from the nodules and a viral metagenomic study of the worms. the o. volvulus virome of persons with and without oae will be compared.

a high prevalence of onchocerciasis-associated epilepsy (oae) has been observed in onchocerciasis-endemic areas with high ongoing onchocerca volvulus transmission. however, the pathogenesis of oae remains to be elucidated. we hypothesise that the o. volvulus virome could be involved in inducing epilepsy. with this study, we aim to describe the o. volvulus virome and identify possible viruses linked to oae. in maridi county, south sudan, 20 persons with oae with onchocerciasis nodules, and 20 age- and village-matched controls without oae will be enrolled in the study. for each study participant, two skin snips at the iliac crest will be obtained to collect o. volvulus microfilaria, and one nodulectomy will be performed to obtain adult worms. a viral metagenomic study will be conducted on microfilariae and adult worms, and the o. volvulus virome of persons with and without oae will be compared. moreover, the prevalence, numbers and localisation of onchocerciasis nodules in persons with and without oae in villages with a high prevalence of epilepsy in maridi will be described.

Eligibility criteria:
inclusion criteria: * onchocerciasis nodules * age 12-35 years old * informed consent signed * living in maridi county, western equatorial state, south sudan exclusion criteria: * below the age of 12

Keywords: onchocerciasis epilepsy metagenomics south sudan pathogenesis