Kornimate/medical-research-clean huggingface dataset:
fecal calprotectin levels in mycophenolate mofetil induced diarrhea and treatment with octreotide

Conditions: Diarrhea; Immunosuppression

Summary: prospective, observational pilot study of ten post-transplant patients presenting with diarrhea while taking mycophenolate mofetil (mmf). these patients will undergo a standard workup to confirm mmf induced diarrhea. a stool fecal calprotectin will be measured to determine if it may be helpful in confirming the diagnosis of mmf associated diarrhea. once the diagnosis is confirmed, the patients will then be treated with a short course of subcutaneous octreotide which has been shown to cure this type of diarrhea.


Eligibility criteria:
inclusion criteria: * male and female patients between the ages of 18 and 75 years old who are solid organ transplant recipients followed at toronto general hospital on mmf referred to gastroenterology for diarrhea. exclusion criteria: 1. subjects with a known history of ibd or gvhd of the bowel. 2. any subject receiving octreotide for another indication. 3. any patient unable to undergo endoscopy. 4. any patient with a contraindication to octreotide therapy.

Keywords: diarrhea immunosuppression post-transplantation octreotide mycophenolate mofetil fecal calprotectin
internet treatment for weight loss in primary care

Conditions: Overweight; Obese

Summary: this study will test the effectiveness of two distinct treatments for weight loss: 1. motivational interviewing 2. nutritional counseling. these treatments will be compared to treatment as usual. participants will be recruited through local primary care offices.


Eligibility criteria:
inclusion criteria: * bmi 25-55 * daily access to internet and phone exclusion criteria: * co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders) * meets criteria for current substance abuse or dependence * currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating * pregnant, breastfeeding, or plans to become pregnant during the treatment period * cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack * serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function) * uncontrolled diabetes, thyroid conditions, or hypertension
effects of cold application and heparinoid on periorbital edema and ecchymosis

Conditions: Neurological Disorder; Nursing Caries; Periorbital Edema; Ecchymosis; Cryotherapy Effect

Summary: during surgery, blood leaking from damaged blood vessels spread to the periorbital area may cause periorbital edema and ecchymosis after anterior craniotomy. this study was carried out to determine the effects of the cold application and the local heparinoid on periorbital edema and ecchymosis after craniotomy.

periorbital edema and ecchymosis are common after anterior craniotomy. periorbital edema and ecchymosis are not complications, they are natural outcomes of surgical trauma. however, periorbital edema prevents pupil examination and causes the patient to experience fear and anxiety with accompanying ecchymosis. periorbital edema rate after anterior craniotomy was 36.8-100%, ecchymosis rate was 62.5%, and 30% of patients with edema did not have a pupil examination for the first 36 hours after craniotomy.the present study was carried out to determine the effects of the heparinoid creams and regular cold application performed using gel packs in controlling periorbital edema and ecchymosis after craniotomy.

Eligibility criteria:
inclusion criteria: the eligible participants were those * who were aged 18 years and older * who had glasgow coma scale score \> 15 * who had no mental and physical problems that interfere with communication * whose vital signs were normal * who had no ptosis * who volunteered to participate and signed the informed consent form exclusion criteria:the participants excluded from the study; * who had glasgow coma scale score \< 15 * who died during surgery * ptosis formed after surgery * who refused to participate

Keywords: cold application craniotomy heparinoid periorbital edema periorbital ecchymosis
progression of diabetic retinopathy. identification of signs and surrogate outcomes

Conditions: Diabetic Retinopathy

Summary: progression of diabetic retinopathy. identification of signs and surrogate outcomes (progress)

the global aim of this study is to improve the current knowledge of diabetic retinopathy (dr) progression. we aim to characterize both functionally and morphologically initial dr stages and to identify patients at risk of progression to centre involving macular oedema (cme) and/or proliferative diabetic retinopathy (pdr). we want to identify imaging patterns and characteristics that might be used as prognostic biomarkers for dr progression. for this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive retinal imaging methodologies. sd-oct with layer-by-layer segmentation will be performed. furthermore, a state-of-the-art methodology with oct-angiography will be used for identification of areas of capillary drop-out and leakage areas will be identified on sd-oct without the need of a dye injection. in a subgroup of patients we will study neurodegeneration patterns using multifocal erg examination.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus according to 1985 who criteria * aged between 35 years and 80 at baseline in the retrospective period * npdr level \< 20 (ma absent) or mild npdr (levels 20 to 35, based on etdrs criteria- 7 fields cfp) at baseline * bcva ≥ 75 letters (≥ 20/32) at baseline (etdrs charts) * informed consent exclusion criteria: * inadequate ocular media and/ or pupil dilatation that interfere with fundus examinations * hba1c \> 10 % at the screening or previous 6 months in the previous prospective study
short-term effect of positioning cushions and harmonic techniques on paratonia in persons with dementia

Conditions: Dementia; Paratonia

Summary: this study investigated the short-term effect of both harmonic techniques and supporting cushions on muscle tone, range of motion, pain and daily care activities in 22 patients with moderate to severe paratonia. the study consisted of two parts, each part was conducted during one week. in the first part of the study the short-term effect of supporting cushions was examined; in the second part of the study the additional short-term effect of harmonic techniques was investigated.


Eligibility criteria:
inclusion criteria: * dementia (confirmed in medical file) * presence of moderate to severe paratonia (confirmed with pai and mas) * proxy consent exclusion criteria: -

Keywords: harmonic techniques supporting cushions intervention
sepsis electronic prompting for timely intervention and care for emergency department patients

Conditions: Sepsis; Electronic Health Records; Clinical Decision Support Systems

Summary: the goal of this clinical trial is to study systemic inflammatory response syndrome (sirs) electronic health record (ehr) alerts for sepsis in the emergency department (ed). the main question it aims to answer is: do nurse alerts, prescribing clinician alerts, or both nurse and prescribing clinician alerts improve time to sepsis treatment for patients in the ed? nurses and prescribing clinicians will receive sirs alerts based on the group to which the patient is randomly assigned. researchers will compare four groups: no alerts, nurse alerts only, prescribing clinician alerts only, or both nurse and prescribing clinician alerts.

septic is a master protocol for two trials on distinct subpopulations: emergency department (ed) patients and inpatients. this protocol "id: aaau1002 - ed" describes the ed subpopulation study while "id: aaau1002 - ip" describes the inpatient subpopulation study. sepsis is a major cause of death both globally and in the united states. early identification and treatment of sepsis are crucial for improving outcomes. international guidelines recommend hospital sepsis screening programs, which are commonly implemented in the electronic health record (ehr) as an interruptive screening alert based on systemic inflammatory response syndrome (sirs) criteria. despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care. this study tests interruptive (pop-up) ehr alerts. epic systems, the company that produces the ehr, refers to these types of alerts as bestpractice advisories (bpas).

Eligibility criteria:
patient inclusion criteria: * age \> 18 years-old * meets sirs criteria * physically located in the emergency department * not located in a hospital unit that takes care of pregnant and peri-partum patients * not sars-cov-2 pcr positive in past 7 days * does not have an active order for "comfort measures only" patient exclusion criteria: * already having sepsis treatment ordered (if prescribing clinician alert) or collected/completed (if nurse alert) * already enrolled in the septic study (including as an emergency department patient or as an inpatient)

Keywords: sepsis alerts clinical decision support systems informatics health information technology
neural mechanisms and efficacy of dual neurotechnology-aided mirror therapy in chronic stroke: neural and motor plasticity, movement performance, daily function, and quality of life

Conditions: Cerebrovascular Accident

Summary: mirror therapy (mt) has been demonstrated, in terms of neuroplasticity, to improve sensorimotor function of paretic upper extremity (ue) in chronic stroke patients. central and peripheral electrical stimulation techniques such as ranscranial direct current stimulation (tdcs) and functional electrical stimulation (fes) can individually enhance effects of mt, combining both of them with mt can be a potentially valuable approach to maximize neural and functional recovery post stroke. to our knowledge, no studies combined central and peripheral neural network reorganization technique with motor behavioral learning approach to investigate its possible benefit after stroke. this project will be the first to design a "dual neurotechnology-aided mt (dna-mt)", which combines tdcs and fes with contemporary neurorehabilitation approaches (i.e., mt) to stimulate both central and peripheral nervous systems to maximize neural and functional recovery post stroke. investigators will determine the efficacy and neurophysiological and motor mechanisms related to this novel dna-mt approach and identify potential responders to this novel intervention.


Eligibility criteria:
inclusion criteria: * sustained a unilateral stroke with onset ≥ 3 months (figlewski et al., 2017); * ue fugl-meyer assessment (ue-fma) score between 18 and 56 indicating mild to moderate mild motor severity (menezes et al., 2018; woodbury, velozo, richards, \& duncan, 2013); * aged 35 to 85 years old; and * able to follow instructions and perform the tasks (mini mental state examination ≥24). exclusion criteria: * with excessive spasticity or joint contracture of the paretic ue; * enrolled in other rehabilitation experiments or drug studies; * with additional neurological or psychological disorders other than stroke; * having received botulinum toxin injections 3 months before enrollment; * having unstable cardiovascular status such as uncontrolled hypertension or new york heart association (nyha) class iii/iv heart failure; * having contradictions to tdcs including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body (not including dental fillings or hardware)(meeker et al., 2019; rossi, hallett, rossini, pascual-leone, \& group, 2009); * having a history of drug or alcohol abuse, dermatosis preventing tdcs from being applied, brain tumor, brain injury, arteriovenous malformation, other brain diseases (such as intracranial hypertension or cerebral edema), or are not suitable for using tdcs by the physician's assessment; and (8) having existence of skin rash, allergy or wounds at the locations where stimulation electrodes would be placed.

Keywords: mirror therapy transcranial direct current stimulation functional electrical stimulation neurotechnology-aided intervention stroke neurorehabilitation
determination of hcc with octanoate breath test vs. mri diagnosis

Conditions: Hepatocellular Carcinoma (HCC)

Summary: an octanoate breath test will be used to assess the presence of hepatocellular carcinoma in subjects with risk. the gold standard will be mri.

1. informed consent will be obtained from all patients prior to enrollment. 2. the trial will be conducted in compliance with this protocol, with gcp standards, and the applicable regulatory requirements. 3. this study will be cross-sectional, where patients will be enrolled on a walk in basis. once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative hcc subjects as defined by mri. 4. all patients will undergo afp and us if they do not have results within the past three months. 5. if the patient undergoes liver fna, the biopsy results will be evaluated for the presence of hcc. 6. for all patients, a case report form will be completed. 7. all patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. furthermore, recent (past 3 months) blood test results, if available, may be recorded. 8. if relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test. 9. all mri negative patients with low obt results will undergo additional mri within 6 to 12 months post obt to rule out hcc occurrence. 10. if available, all additional mri/ct/us results will be recorded within the patient's crf.

Eligibility criteria:
inclusion criteria: 1. any patients with chronic liver disease at risk for hcc. 2. age ≥ 18 years. 3. patient has an mri result (positive or negative for hcc) up to 3 months prior to recruitment or will be scheduled for an mri during the trial period. 4. patient is naïve to hcc treatment (rfa or tace or oral hcc treatments) since last mri. exclusion criteria: 1. any patients with chronic liver disease at risk for hcc. 2. age ≥ 18 years. 3. patient has an mri result (positive or negative for hcc) up to 3 months prior to recruitment or will be scheduled for an mri during the trial period. 4. patient is naïve to hcc treatment (rfa or tace or oral hcc treatments) since last mri. 5. patients currently receiving total parenteral nutrition if they have contraindications to oral drugs. 6. women who are pregnant or breast feeding. 7. patient taking drugs that can interfere with octanoate metabolism or can also cause nafld independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine. 8. patient, based on the opinion of the investigator, should not be enrolled into this study. 9. patient unable or unwilling to sign informed consent. 10. patients that are participating in other clinical trials evaluating experimental treatments or procedures
vaccine responses to influenza a h1n1/09 immunization in high-risk patients

Conditions: HIV Infection; Rheumatic Disease; Cancer; Transplant; Pediatrics

Summary: the objective of this study is to assess vaccine responses to novel adjuvanted influenza a(h1n1) vaccines in patients at high risks of influenza a(h1n1) complications.

this prospective, open-label, parallel-cohorts study will include up to 1250 patients and 250 controls to whom influenza a(h1n1) immunization was recommended. six cohort have been established, enrolling patients with hiv infection, rheumatic diseases, organ transplant, cancer, pediatric patients and healthy controls. subjects will be assessed for specific antibody responses (all), t cell responses (subset) and solicited vaccine adverse events. vaccine safety evaluation will include the influence of immunization on underlying diseases (hiv infected patients, patients with auto-immune diseases) or graft function (transplant patients) - as appropriate.

Eligibility criteria:
inclusion criteria: * medically recommended influenza a(h1n1) immunization * signed informed consent exclusion criteria: * failure or refusal to provide sufficient blood for antibody determination

Keywords: hiv infection transplant rheumatic disease cancer children
in vivo real-time detection of circulating melanoma cells

Conditions: Melanoma

Summary: the objective of this clinical trial is to determine whether a photoacoustic flow cytometry (pafc)-based prototype device can detect circulating tumor cells (ctcs) in the blood of melanoma patients in vivo, in real time, and do so at detection limits at least one order of magnitude below the detection limits of currently existing ex vivo methods.

study population: approximately 80 subjects will be consented in order to achieve an enrollment goal of 75 subjects at this institution in three cohorts as follows: 1. cohort #1 will consist of fifteen healthy control subjects, ten of whom will be caucasian and five of whom will be african-american. subjects in cohort #1 will be used to address the calibration goal of specific aim #1. 2. cohort #2 will consist of 30 subjects who have advanced-stage melanoma will be recruited from the medical oncology clinic at uams, where advanced stages are defined as stages iii or iv. subjects in cohort #2 will be used to address the validation goal of specific aim #2. approximately half of the 30 advanced-stage subjects will be stage iii and the other half will be stage iv. 3. cohort #3 will consist of 30 subjects with early-stage melanoma will be recruited from the surgical oncology clinic at uams, where early stages are defined as stages i or ii. subjects in cohort #3 will be used to address the detection goal of specific aim #3. approximately 10 of the 30 early-stage subjects will be stage i and approximately 20 will be stage ii.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years * histological documented diagnosis of melanoma * signed informed consent form approved by the university of arkansas for medical sciences (uams) institutional review board (irb) * must be able to sit still for 90 minutes exclusion criteria: * active infection * current and significant medical or surgical condition as determined by the investigator * diagnosis or evidence of organic brain syndrome * pregnancy or breastfeeding

Keywords: melanoma cancer
neuroprotective effects of itbs in pd

Conditions: Neuroprotection; Parkinson Disease; Intermittent Theta Burst Stimulation

Summary: intermittent theta burst stimulation (itbs) is an emerging non-invasive neuron regulation technique, which is widely used in neuropsychiatry for a variety of diseases and is widely accepted by patients due to its non-invasive, operable and relatively precise localization. combining the results of previous studies and our group's previous research, sixty qualified pd patients would be enrolled to conduct a prospective single-center randomized double-blind sham controlled clinical trial to verify the long-term curative effects of itbs treatment protocol and explore the neuron-protection of itbs on neuronal loss of pd patients.


Eligibility criteria:
inclusion criteria: * meet the revised clinical diagnostic criteria for parkinson's disease of the movement disorder society (mds) international (2015 version). * aged \>20 years and \<80 years, regardless of gender. * 2 ≤ hoehn-yahr stage≤ 4. * maintain medication stability during the study period. * good compliance, written informed consent, and consent for long-term interventional treatment with itbs. exclusion criteria: * patients with severe neuropsychiatric disorders or previous history of severe neurological disorders (e.g., epilepsy, cerebrovascular accidents, etc.) or history of traumatic brain injury or brain surgery. * patients with significant cognitive impairment (mmse \< 24) or inability to complete questionnaires independently. * prior treatment with tms, dbs or scs. * severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease. * have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc. * are currently taking other investigational drugs. * any other condition that the investigator deems unsuitable for participation in this study.
efficacy of metformin in achieving glycaemia goals as recommended for the treatment of gestational diabetes in non obese women

Conditions: Gestational Diabetes; Metformin; Treatment; Oxidative Stress

Summary: gestational diabetes (gd) is defined by a hyperglycemia discovered during pregnancy, leading to fetal and maternal complications which may be prevented by reaching very strict glycaemia targets. prevalence depends on patient's ethnic group and is about 6 to 14%. this prevalence is increasing due to increased gd risk factors (obesity, pregnancy over 35) and also because criteria of screening have been strengthened after the results of last studies. usual treatment is diet and in case of failure insulin therapy with multiple injections which may lead to hypoglycemia and weight gain and is very difficult to manage for patients. some studies have shown the comparable effect of metformin and insulin in about 50% of gd obese patients. the aim of our study is to evaluate efficacy of metformin, outcomes in mother and fetus and baby of metformin. in case of metformin failure, insulin will be added in order to obtain glycaemia in desired goals.oxidative stress will be assessed in mother blood, baby umbilical cord blood, baby umbilical cord and placenta in 90 women and the oxidative stress compared between insulin and metformin alone treated patients.


Eligibility criteria:
inclusion criteria: women. * age more than 18 and less than 40 years. * unique spontaneous pregnancy.-bmi less than 30kg/m2 before pregnancy. * 24 to 30 weeks of amenorrhea or 22 to 28 weeks of gestation. * gestational diabetes. * social security affiliated subject.- patient able to understand and signed informed consent. exclusion criteria: * contraindications to metformin. * metformin treatment prior to protocol inclusion. * multiple pregnancies. * diabetes diagnosed prior to pregnancy. * high blood pressure prior to pregnancy. * pregnancy hepatic complication * high blood pressure prior to study inclusion. * pre or eclampsia.- premature membranes rupture.
acceptance & commitment therapy for psychotic inpatients

Conditions: Acute Psychosis

Summary: the overarching aim of the research project is to investigate whether acceptance \& commitment therapy (act) is an efficacious psychotherapeutic method of treatment for inpatients suffering from acute psychosis. the method will be applied in two ways. firstly, as an individual treatment for patients. secondly, as an integrated part of the daily work on an inpatient ward, administered by nurses and assistant nurses trained in the method.


Eligibility criteria:
inclusion criteria: * admitted to a specified psychiatric inpatient ward during the time-period of the study; psychotic spectrum diagnosis as specified in patient charts; assessed by contact person on the ward as having delusions or hallucinations. exclusion criteria: * cognitive difficulties to an extent where informed consent cannot be given.

Keywords: acceptance and commitment therapy cognitive behavior therapy