Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of insulin glulisine in type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: * to evaluate the superiority in the efficacy of hmr1964 and oha combination therapy as compared with oha therapy. * to evaluate the superiority in the efficacy of hmr1964 mono-therapy as compared with oha therapy. * to evaluate the safety of hmr1964.


Eligibility criteria:
inclusion criteria: * men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a bmi \ 8.0 - \< 11.0% at screening * fasting serum c-peptide at screening \> 0.7 ng/ml * subjects who have been on a stable regimen and at the following doses of su for at least 8 weeks prior to signing informed consent * glibenclamide \> 5 mg/day * glimepiride \> 3 mg/day * gliclazide \> 80 mg/day in addition to receiving the above mentioned su agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent. * subjects willing to administer three hmr1964 injections per day immediately prior to meals for a 16 week exclusion criteria: * subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 iu/kg/day of hmr1964 * subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional oha (including thiazolidinediones, α-glucosidase inhibitors, d-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than hmr1964, systemic corticosteroids, other investigational products * subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult * subjects who are pregnant, breast feeding or wish to become pregnant during the study period * subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent

Keywords: hmr1964, insulin glulisine, diabetes mellitus, type 2
recirculating memory t cells in the pathogenesis of psoriatic arthritis and cutaneous psoriasis

Conditions: Psoriasis; Psoriatic Arthritis

Summary: the aim of the study is to investigate the link between pro-inflammatory t cells responses arising in the skin in patients with cutaneous psoriasis and those present in the joints of patients developing psoriatic arthritis. the study is based on the hypothesis that a fraction of t cells with memory phenotype can recirculate from the skin and relocalize at extracutaneous sites including enthesis or synovial tissue thus propagating the pro-inflammatory cycle. this could represent a pathogenic mechanism in the development of psa. the main aim of the study is to define the phenotypic and functional differences of circulating t cells in patients cutaneous psoriasis, patients with psoriatic arthritis and in control group of healthy subject. to this end the investigators analyze the expression of cell surface markers of central memory (tcm), effector memory (tem) and effector (teff) cells, within this subsets the investigators evaluate the expression of chemokine receptors as well as skin and tissue homing molecules. there will be also an evaluation of the t cell polarization towards th1/tc1 or th17/tc17 phenotype by evaluating the cytokine expression profile. in selected patients with psa the researchers analyze in parallel the phenotype and the cytokine profile of t cell subpopulations in peripheral blood and in synovial fluid, the results of this study could possibly allow to define distinctive features of circulating t cells in patients with psa and to understand the link between circulating and synovial fluid t cells in patients with psa.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of cutaneous psoriasis without clinical signs of psa, * patients with a diagnosis of psa * healthy subjects with a negative family and personal anamnesis for psoriasis. * absence of acute and chronic systemic or cutaneous infections during sample collections. exclusion criteria: * treatment with cyclosporin a, methotrexate, systemic corticosteroids or any other immunosuppressant agent within 3 weeks before the blood samples collections.

Keywords: t-cells circulation synovial fluid psoriasis psoriatic arthritis
development and validation of a novel functional eye-tracking software application for neurological disorders

Conditions: Neurological Disorders

Summary: this study aims to develop and validate a sensitive and non-invasive eye-tracking software application. this study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by neurological disorders and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. the study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of neurological disorders and associated cognitive changes.


Eligibility criteria:
inclusion criteria: * aged 18 years old and above * a score of ≥ 26 on the montreal cognitive assessment (moca) * able to provide informed consent * visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc are permitted). exclusion criteria: * evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control. * evidence or history of significant neurological disorder (e.g. ms, pd, als, dementia) * use of prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics, and anticonvulsants. * diagnosed with an active substance use disorder. * history of stroke. * recent traumatic brain injury (within the last 6 months).

Keywords: neurological disorders eye-tracking eye movement biomarkers
prism registry: pseudobulbar affect registry series

Conditions: Alzheimer's Disease; Amyotrophic Lateral Sclerosis (ALS); Multiple Sclerosis (MS); Parkinson's Disease; Stroke; Traumatic Brain Injury

Summary: pba is a neurologic condition that is estimated to impact over a million patients and their families in the united states. pba occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying and/or laughing. progress has been made in better understanding this debilitating condition, but much more needs to be done. that's why a new pba patient registry, prism (pseudobulbar affect registry series), has been initiated. the goal of prism is to establish the prevalence and quality of life (qol) impact of pba in patients with underlying neurologic conditions including * alzheimer's disease * amyotrophic lateral sclerosis * multiple sclerosis * parkinson's disease * stroke * traumatic brain injury because this is an observational registry, it doesn't require you to intervene with any specific treatment or procedure. your participation allows the prism registry to collect and analyze data from your site and also compare it to national numbers captured in the prism registry about pba across all of the major at-risk neurologic populations.


Eligibility criteria:
inclusion criteria: * all participants must have underlying neurologic conditions known to be risk factors of pba: alzheimer's disease, amyotrophic lateral sclerosis, multiple sclerosis, parkinson's disease, stroke, and traumatic brain injury. * the population for this study will be 18 years and over

Keywords: pseudobulbar affect
pediatric powered wheelchair standing devices: an exploratory study

Conditions: Cerebral Palsy; Spinal Muscular Atrophy; Spinal Cord Injuries; Spina Bifida; Development Delay; Genetic Disease

Summary: for children who use a power wheelchair, a powered wheelchair standing device (pwsd) may be considered for daily use. a pwsd allows a child to electronically move between sitting and standing and can be driven in either position. existing published pwsd research in pediatrics is limited to boys with duchenne muscular dystrophy (dmd).(1, 2) while these studies provide some insights into pwsd use in boys with dmd, they do not reflect pwsd use in children with other conditions. the purpose of this exploratory study is to determine the feasibility of a research protocol exploring use of a pwsd in children who have neurodevelopmental conditions other than dmd.


Eligibility criteria:
inclusion criteria: 1. is 5-17 years of age. note: participants must be under 18 for the duration of the study. 2. diagnosed with a neurodevelopmental condition resulting in an inability to functionally ambulate. 3. can safely assume and maintain a supported standing position 4. has sufficient upper extremity and function to safely use a pwsd 5. can communicate pain or discomfort through verbalization, vocalization, use of augmented communication, etc. 6. can safely use the pwsd in areas of their home 7. has at least one parent/caregiver who is able to converse in english and actively participate in a device-use education provided in english 8. the permobil pwsd can be set up to meet the child's specific needs 9. medical clearance to trial the pwsd 10. participants must reside in michigan exclusion criteria: 1. has a diagnosis of duchenne muscular dystrophy. 2. any reason that it would not be safe for the child to use a pwsd
effect of hbm based education on glycemic control of type 2 diabates patients

Conditions: Type 2 Diabetes

Summary: this pre-post-test randomized controlled (parallel group) experimental design study aimed to determine the effect of education based on health belief model and health literacy level of patients with type 2 diabetes on disease management. study was carried out in isparta davraz family health centre between june 17, 2019 and march 02, 2020. sample consisted of 120 patients with type 2 diabetes, selected by simple randomization method, including 60 patients for the intervention group and 60 patients for the control group. patients in intervention and control were also sub-grouped according to their health literacy level. the intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the family health center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks. patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. "patient data form", "health literacy scale among diabetes patients", "health belief model scale in diabetes patients" and "type 2 diabetes self-efficacy scale" used for data collection. data were collected both on the first day of the study and in the 24th week.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabates mellitus at least for a year * literate exclusion criteria: * problems with vision and hearing
evaluate quality of life in type 2 diabetes, before and after change to insuline glargine

Conditions: Diabetes Type 2

Summary: primary objective: to assess quality of life (qol) changes and treatment satisfaction in a real life situation in patients with type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (oad) plus neutral protamine hagedrone (nhp) insulin treatment that are switched to insulin glargine. secondary objective: to determine: change in hba1c, comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine, change in weight, change in insulin dose.


Eligibility criteria:
lists of inclusion and exclusion criteria: inclusion criteria: * patients with type 2diabetes inadequately controlled on a combination of oad + nph insulin for more than three months * stable oad therapy for at least three months, according to the following specified daily dose: glibenclamide\> 3, 5 mg, glipizid \>5 mg, glimeperid \>2mg, metformin\>1000 mg, acarbose \>150 mg * hba1c \> 7,0% * ability to perform qol assessment * body mass indes: women \<30 and men \<32 exlusion criteria: * autoimmune diabetes, as defined by who * ongoing treatment with tiasolidindion drug * retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry * drug abuse * hypersensitivity to insulin glagine excipients the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
non-inferiority randomized controlled trial of cognitive targeted biopsy versus software targeted biopsy

Conditions: Prostate Cancer

Summary: this is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a pca.

this trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. this study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a pca.

Eligibility criteria:
inclusion criteria: 1. age \> 18 2. psa increase to 4-20 ng/ml and/or abnormal dre; 3. sign the informed consent exclusion criteria: 1. have acute or chronic prostatitis 2. contraindications to prostate biopsy 3. contraindications to mri 4. other reasons that not suitable for this trial

Keywords: prostate cancer cognitive fusion targeted biopsy software-based fusion targeted biopsy
acupuncture for irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to determine whether acupuncture is effective in reducing the symptoms of irritable bowel syndrome (ibs).

ibs is a disorder that affects colon functioning. although it does not cause permanent harm or lead to more serious conditions, ibs can cause a great deal of discomfort and distress. the effectiveness of acupuncture in treating various conditions has been investigated in numerous studies. however, little is known about acupuncture's efficacy in treating ibs. this study will determine whether acupuncture can alleviate the symptoms of ibs, including pain relief with defecation, changes in stools, and changes in the frequency of bowel movements. participants in this study will be randomly assigned to receive bi-weekly sessions of either active or placebo acupuncture or no treatment for 6 weeks. study visits will occur at study start, week 3, and week 6 (study completion). at each study visit, blood collection will occur to measure levels of cortisol, a stress hormone associated with ibs. participants will also complete questionnaires about their ibs symptoms. selected participants will be interviewed at each visit, in order to determine whether participants' interpretations and understanding of ibs influences their response to treatment. any subject who does not receive active acupuncture during the trial is eligible for 6 free acupuncture treatments after the study is over.

Eligibility criteria:
inclusion criteria: * irritable bowel syndrome of moderate severity for at least 12 weeks within 1 year prior to study entry * colonoscopy or flexible sigmoidoscopy/air contrast barium enema within 5 years prior to study entry * able to walk * able and willing to cooperate with the study * sufficient knowledge of english to be able to participate in the study exclusion criteria: * medications that affect the gastrointestinal tract or visceral sensation, unless the participant is on a stable dose for at least 1 month prior to study entry and for the duration of the study * history of severe or intractable ibs * history of acupuncture treatment * score between 37 and 150 on the functional bowel disorder severity index (fbdsi) * any concomitant bowel problem that would interfere with the study * history of laxative abuse * abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry * history of metabolic or inflammatory disease that may affect bowel movement * history of significant psychiatric, neurological, metabolic, hepatic, renal, infectious, hematological, cardiovascular, gastrointestinal, or pulmonary illness. participants who are stable for more than 1 year with conditions that will not interfere with the study are not excluded. * history of drug or alcohol abuse within 2 years prior to study entry * positive for opiates at the initial visit drug screen * abnormal vital signs, physical examination results, or clinical laboratory values, unless these abnormalities are judged to be clinically insignificant * pregnancy or breastfeeding
study evaluating enbrel (etanercept) in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to investigate the incidence of adverse events for patients with as treated with enbrel in usual care settings.


Eligibility criteria:
inclusion criteria: * diagnosis of ankylosing spondylitis exclusion criteria: * contraindications according smpc
rtms treatment for positive and negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: this study will examine the effects of rtms on the negative and positive symptoms of schizophrenia using 2 treatments in sequence applied to related brain areas.


Eligibility criteria:
inclusion criteria: 1. are voluntary and competent to consent to treatment 2. have a diagnosis of schizophrenia or schizoaffective disorder 3. are between the ages of 18 and 75 4. are willing and able to adhere to the treatment schedule 5. pass the tms adult safety-screening (tass) questionnaire 6. have normal thyroid functioning based on pre-study blood work. patients may be reassessed for the study once thyroid levels have normalized. 7. are willing and able to cooperate with interviews and follow simple instructions exclusion criteria: 1. do not pass the tass safety screening questionnaire 2. have a significant history of seizures 3. have active suicidal intent 4. are pregnant or may be pregnant. a pregnancy test will be performed for fertile women. 5. have failed a course of electroconvulsive therapy (ect) in the current or previous episode 6. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ect, cerebral aneurysm, parkinson's disease, huntington's chorea, multiple sclerosis, or head trauma resulting in loss of consciousness greater than or equal to 5 minutes 7. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed 8. have had changes in dose or initiation of any psychotropic medication in the 4 weeks prior to screening. patients may be re-screened once medications have been stable for 4 weeks. 9. currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rtms efficacy

Keywords: rtms
feasibility and effect of resistance training and protein supplementation in patients with advanced gastroesophageal cancer

Conditions: Gastro-esophageal Cancer

Summary: patients with advanced gastroesophageal cancer are in great risk of losing skeletal muscle mass and developing cancer cachexia. low skeletal muscle mass has a negative impact on quality of life, impairs physical function, increases toxicity from anti-neoplastic treatment, as well as increases risk of death. resistance training and protein supplements have the potential to stimulate muscle anabolism and counteract loss of skeletal muscle mass. therefore, the investigators have designed a randomized controlled feasibility trial to evaluate the feasibility, safety and the therapeutic effect of resistance training and protein supplements in patients with advanced gastroesophageal cancer undergoing first line chemotherapy. a total of 54 patients with advanced gastroesophageal cancer will be recruited from the department of oncology, copenhagen university hospital, rigshospitalet and randomly allocated 2:1 to standard care plus resistance training 3 times pr. week and a daily supplement of protein or to standard care alone.


Eligibility criteria:
inclusion criteria: * histologically verified, non-resectable cancer of the esophagus, stomach, or gastroesophageal junction * referred to first line chemotherapy. exclusion criteria: * age \< 18 * living outside the greater copenhagen area * any other malignancy requiring active treatment * not eligible for chemotherapy * performance status \> 2 * not able to swallow liquids * parenteral nutrition or enteral nutrition via feeding tube * physical or mental disabilities that prohibit execution of test or training procedures * pregnancy * inability to understand the danish language

Keywords: exercise oncology resistance exercise cancer cancer cachexia protein supplements sarcopenia palliative chemotherapy
modafinil for wakefulness in the critical care units

Conditions: Critical Illness; COVID-19; Cognitive Dysfunction

Summary: it has been well documented that patients in the intensive care unit (icu) are susceptible to developing neurocognitive and musculoskeletal complications because of various factors, including the nature of the critical illness, medications, over-sedation, and pain. neuro-stimulants are used to speed up physical and mental processes through the increase in neurotransmitter, which translates into increase in arousal, wakefulness, attention, memory, mental and motor processing speed. the investigators reviewed the literature and described the clinical characteristics for a case series of adult patients admitted to covid and non-covid icu between january 2017 and june 2020, who received modafinil to promote wakefulness and improve cognition at the king faisal specialist hospital and research centre (kfsh\&rc) in riyadh, saudi arabia. the secondary goals to describe the change of glasgow coma scale (gcs) before and after the start of modafinil therapy, icu and hospital length of stay, discharge disposition, adverse drug effects, and mortality rate.


Eligibility criteria:
inclusion criteria: 1. icu patients 18 years and older 2. admitted to covid and non-covid units between january 2017 and june 2020 3. icu stay for at least 48 hours 4. started on modafinil during icu stay for at least 48 h 5. required ventilatory support. exclusion criteria: * those who did not receive modafinil or received modafinil for indications other than icu wakefulness