Kornimate/medical-research-clean huggingface dataset:
feasibility trial testing the bionic pancreas with zp4207

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study was to determine whether the bionic pancreas with zp4207 (dasiglucagon\*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus. \*dasiglucagon is the proposed international nonproprietary name (pinn) for zp4207

this was a single-center, open-label, 2-part, randomized cross-over trial. the trial was to enrol up to 20 adult patients with type 1 diabetes mellitus and assess the safety and efficacy of the bionic pancreas (bp) using either the ilet or iphone platform when used with the glucagon analogue zp4207 (dasiglucagon) versus lilly glucagon. in part 1, patients participated in two 1-day treatment arms in random order (iphone-based bp using zp4207 (dasiglucagon) and iphone-based bp using lilly glucagon) according to a pre-generated randomization scheme. in part 2, it was planned to enrol additional patients to participate in two 1-day treatment arms in random order (ilet using zp4207 (dasiglucagon) and ilet using lilly glucagon) according to a pre-generated randomization scheme. however, due to unavailability of the ilet, the sponsor decided to stop the trial upon completion of part 1. part 2 of the trial using the ilet was consequently not conducted. one day the bp will use glucagon analogue zp4207 (dasiglucagon) and the other day the bp will use lilly glucagon. subjects will also receive insulin lispro through the bp on both days. the trial will be conducted at single center, the massachusetts general hospital diabetes center in boston, ma.

Eligibility criteria:
inclusion criteria: 1. patients with t1dm for at least 1 year, as defined by the american diabetes association 2. age ≥ 18 years 3. prescription medication regimen stable for \>1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator) 4. diabetes managed using an insulin pump for \>=6 months 5. patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms \[ecgs\], laboratory assessments), as judged by the investigator exclusion criteria: 1. previous exposure to zp4207 or adverse reaction to glucagon 2. history of liver disease or current abnormal liver function tests (lfts) 3. renal failure 4. anemia 5. history of coronary artery disease or congestive heart failure (class iii or iv) 6. history of transient ischemic attack or stroke 7. seizure disorder 8. cystic fibrosis, pancreatitis, or any other pancreatic disease besides t1dm 9. other endocrine disorders 10. use of oral anti-diabetic medications 11. electronically powered implants 12. hypertension (≥160/100 mm hg despite treatment) 13. inadequate venous (vein) access as determined by trial nurse or physician at time of screening

Keywords: glucagon type 1 diabetes mellitus bionic pancreas diabetes ilet iphone beta bionics anti-hypoglycemia glucagon analog
mindfulgarden in treatment of hyperactive delirium in a hospital setting

Conditions: Hyperactive Delirium

Summary: this pilot study is designed to address feasibility for a larger randomized control clinical study that will determine the efficacy of exposure to the mindfulgarden - an interactive digital technology - in reducing hyperactive delirium in hospitalized older adults.

the primary objective of the study is to establish whether the key components necessary for conducting a full randomized control study in the future, such as recruitment, consent, randomization, and treatment processes are working well and all function together. as a secondary objective, the investigators will determine trends in patients exposed to mindfulgarden (mg), for example: 1. at the first and second administration of the confusion assessment method - short form (cam) after admission to a medical ward are there more, the same or fewer patients in the intervention group than in the control group whose cam scores change from positive to negative? 2. during the first 24 hours after admission to a medical ward, did fewer, the same, or a greater number of patients in the intervention than in the control group experience significant events/alerts (e.g. aggressive/violent behaviours, falls, code white)? 3. during the first 24 hours after admission to a medical ward, were fewer, the same, or a greater number of patients in the intervention than in the control group administered psychotropic drugs (e.g. haloperidol, risperidone, quetiapine, lorazepam)? were more, the same, or fewer administered sleeping aids (e.g. trazodone, melatonin)? 4. during the first 24 hours after admission to a medical ward, were fewer, the same, or a greater number of patients in the intervention than in the control group physically restrained? 5. was mean length of stay from time of admission to a medical ward until discharge due to death, return to place of residence before admission or to a different place of residence longer, the same or shorter in the intervention than in the control group? 6. were there more, the same or fewer deaths or discharges to a higher level of care (e.g. to assisted living, to a complex care facility in patients who previously lived at home) in the intervention than the control group? additionally, to the extent that movement and vocalization are reflective of anxiety, agitation and/or aggression (i.e. responsive behaviours) the investigators also want to determine whether there is a correlation between changes in these as recorded by the mg and any of the indicators listed in 1-6 above.

Eligibility criteria:
inclusion criteria: - all patients aged 65 years or older admitted to the emergency department who have a diagnosis of hyperactive delirium as defined by the short cam exclusion criteria: * patients with severe vision impairment or who are legally blind * patients for whom a bed in a medical ward was not available within 12 hours of a diagnosis of hyperactive delirium (i.e. who remained in the emergency department more than 12 hours)

Keywords: delirium hyperactive aggression anxiety digital therapy
a study to evaluate the efficacy and safety of tacrolimus in korean nephropathy patients

Conditions: IgA Nephropathy

Summary: this study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive iga nephropathy after 16 week treatment with tacrolimus (prograf) or placebo.


Eligibility criteria:
inclusion criteria: * patients with iga nephropathy confirmed by renal biopsy * serum creatinine measurement ≤1.5mg/ml or mdrd estimated gfr ≥ 45ml/min/1.73m2 (mdrd: modification of diet in renal disorder) * uacr level between 0.3 and 3.0 * blood pressure measurements \< 130/80mmhg exclusion criteria: * use of immunosuppressants for more than two weeks within last one month * concomitant use of ace inhibitor, arb, steroids or immunosuppressant, ndhp-ccb, diuretics, omega-3 fatty acids and its analogue \& additional dietary to treat iga nephropathy (ace: angiotensin converting enzyme, arb: angiotensin receptor blocker, ndhp-ccb: non-dihydropyridine-type calcium channel blocker * pregnant or breast-feeding patients. patients who plan to bear children or breast-feed during the study and within 6 month after completion of study * hypersensitivity to the investigational drug or macrolide agents * use of potassium-sparing diuretics * persistence of liver function abnormality more than 1 month or presence of acute active hepatitis * other investigational drug within last 30 days

Keywords: tacrolimus prograf calcinurin inhibitor albuminurea proteinurea fk506
innovation platform

Conditions: Malaria

Summary: in this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (poc). this study aims to support product development efforts and aims to provide early stage (tlr\~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.


Eligibility criteria:
inclusion criteria: * aged 5 years or older * presenting at the study site with symptoms and signs suggestive of malaria * freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17) * willing to provide sample at enrolment exclusion criteria: * presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by who guidelines
study on efficacy and safety of divaza in patients with chronic cerebral ischemia and cognitive disorders

Conditions: Chronic Cerebral Ischemia

Summary: an open-label, prospective, observational, multicenter study. the study enrolls adult outpatients with cci from 8 federal districts of the russian federation.

medical data (demographic and clinical characteristics - diagnosis, moca test results) are collected from patients to whom divaza is prescribed to be taken according to the following regimen: 2 tablets 3 times per day for 12 weeks. neurologists assess the patients' cognitive functions with moca scale before starting therapy with divaza (visit 1) and 12 weeks after the treatment (visit 2). the efficacy of divaza for the treatment of cognitive impairment in patients with chronic cerebral ischemia (cci) is evaluated. safety is assessed based on the frequency and severity of adverse events. in addition, the relationship between moca test performance and gender or regional social and economic factors is evaluated.

Eligibility criteria:
inclusion criteria: 1. patients of either gender aged 18+ years. 2. diagnosis of chronic cerebral ischemia (cci) based on the clinical history of underlying vascular disease(atherosclerosis and/or arterial hypertension) and neurological signs. 3. unchanged basic therapy of cci and underlying vascular disease for a previous 3 month. 4. signed informed consent form. exclusion criteria: 1. other neurological diseases. 2. any known allergy to/intolerance of any constituent of the medication. 3. pregnancy, breast-feeding. 4. participation in other clinical trials for 3 months prior to enrollment in this study. 5. the patient is related to the research personnel of the investigative sites that are directly involved in the study, or is the immediate relative of the investigator, or the employee of ooo npf materia medica holding.
observational prospective study on patients treated with norditropin®

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Adult Growth Hormone Deficiency; Genetic Disorder; Turner Syndrome; Foetal Growth Problem; Small for Gestational Age; Chronic Kidney Disease; Chronic Renal Insufficiency; Noonan Syndrome

Summary: this observational study is conducted globally. the aim of the study is to investigate the effectiveness and safety of real-life treatment with norditropin®. the study population will consist of children and adults who are on treatment with norditropin® in accordance with normal clinical practice.


Eligibility criteria:
inclusion criteria: * judged by the physician as per the norditropin® label exclusion criteria: * judged by the physician as per the norditropin® label
clinical and biological efficacy of mirasol-treated fresh whole blood for the prevention of transfusion-transmitted malaria

Conditions: Malaria

Summary: the trial will evaluate the efficacy of the mirasol pathogen reduction technology for whole blood to prevent malaria transmission by transfusion of whole blood.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient is blood group o+ * anticipated to be hospitalized for at least 3 consecutive days after initial study transfusion * expected to require no more than 2 units of fresh whole blood in the 3 days following randomization * agree to return to the hospital for the follow-up visits * women of child bearing potential must have a negative pregnancy test within 72 hours before randomization when warranted and must agree to practice a medically acceptable contraception regimen or agree to abstain from heterosexual intercourse during their study participation. * patient or legally authorized representative has given written informed consent exclusion criteria: * symptoms of clinical malaria (confirmed by microscopy) * patient has received antimalarial treatment within 7 days prior to randomization * fever (central body temperature greater than 38.5°c) * massive bleeding expected to require more than two fresh whole blood units within 3 days from randomization * transfusion(s) of a blood product within 1 month prior to randomization * acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the patient to receive protocol treatment * previous treatment with other pathogen-reduced blood products * females who are pregnant

Keywords: whole blood transfusion plasmodium malaria pathogen reduction technology whole blood transfusion
reducing high risk behavior in treatment court

Conditions: Substance Abuse; HIV

Summary: this study will be the first to examine the efficacy of using a brief, computerized hiv risk reduction intervention in treatment courts.

four hundred consenting treatment drug court participants will be randomly assigned to either an hiv intervention group (n = 200) or an attention control group. all clients will attend their regularly scheduled status hearings which are scheduled approximately every six weeks. clients in the hiv intervention group will receive a brief computerized, self-administered hiv risk reduction intervention following each of their first three status hearings. clients in the attention control condition will view a series of educational life-skill videos of matched length following each of their first three status hearings. the primary outcome will be engagement in high risk behaviors as measured by the risk assessment battery (rab). secondary hiv-related outcomes will include: (1) rate of hiv testing, (2) condom procurement, and (3) self-reported condom use. tertiary outcomes related to treatment court compliance will include: (1) drug court graduation, (2) urinalysis-confirmed drug abstinence, (3) case management attendance, and (4) satisfaction with case management. in addition, we will conduct preliminary cost and cost-effectiveness analyses on the delivery of the brief computerized hiv intervention. assessments will be conducted at baseline and 9- and 15-months post admission.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age; 2. be charged with a non-violent felony offense 3. have no more than two prior non-violent convictions or diversionary opportunities 4. be willing to participate in the treatment court program for at least 12 months 5. be in need of treatment for substance abuse or dependence as assessed by case management. exclusion criteria: * elderly subjects and those with medical problems will be included in the research as long as they do not have any physical or psychiatric condition that would impede their ability to give competent consent to research participation or to understand the research instruments. * those individuals who are intoxicated, cognitively impaired, or psychiatrically unstable when approached will not be included; however, such individuals may subsequently be included if the disqualifying condition subsides. * spanish speaking only individuals. * client remanded to jail or residential treatment facilities at the time of treatment court enrollment.

Keywords: high risk behavior drug court clients substance abuse hiv intervention treatment court clients
impact of chronic ankle instability on gait loading strategy

Conditions: Ankle Sprains

Summary: compare the dynamic foot print outcomes in subjects suffering from chronic ankle sprain to heathy subjects


Eligibility criteria:
inclusion criteria: * subjects were suffering from chronic ankle sprain. * age ranged from 20-30 years old. * normal bmi (ranged from 18 to 24.9 kg/m2) exclusion criteria: * not suffering from any neuromuscular disorders , deformities
thromboelastographic methods in deciding therapy on moderate to severe covid-19 patients

Conditions: COVID-19

Summary: this study is a prospective observational study that compares the anticoagulant therapy decision time among moderate and severe covid-19 patients whose coagulation profiles were tested with thromboelastography (teg) to those with a standard coagulation profile laboratory examination.

a prospective observational study was conducted among moderate to severe covid-19 patients in the high care unit and intensive care unit at kiara ultimate, cipto mangunkusumo hospital, indonesia. we consecutively recruited 100 moderate and severe covid-19 patients in the high and intensive care units. baseline characteristic data collection was carried out when the patient was admitted to the icu or hcu. venous blood was taken by nurses within 30 min of admission. the samples were sent to the centralized hospital laboratory for a standard hemostasis panel which consisted of platelets, pt/aptt, fibrinogen, and d-dimer. the hospital used sysmex® cs-2500 and 5100 (sysmex corp., japan) for coagulation tests by using plasma derived from centrifuged whole blood samples. bedside teg examination was done by using teg 5000 hemostasis analyzer (haemonetics corp., usa) with 2.5 ml of a whole blood sample. samples of patients with heparin thromboprophylaxis were given heparinase, which binds to heparin so that the coagulation profile can be assessed. except for teg, all patients received equal diagnostic tests and treatment, including anticoagulant therapy, as indicated according to the national guideline. a trained doctor from the research team recorded time from blood samples taken until the coagulation panel or teg results were obtained. test result timestamp, anticoagulation decision timestamp, mortality, and length of stay in higher care were objectively retrieved through online medical records. we compared the result turnaround time, time to decision of anticoagulant therapy, and clinical outcomes (length of stay and 30-day mortality) between those who had teg examination in addition to standard coagulation profile examination (thrombocyte count, pt, aptt, d-dimer, and fibrinogen) and those who had a standard coagulation profile laboratory examination only.

Eligibility criteria:
inclusion criteria: 1. confirmed covid-19 (positive sars-cov-2 pcr test), 3. moderate or severe symptoms (we defined moderate covid-19 as patients with clinical signs of pneumonia with spo2 \>93% in room air and severe covid-19 as pneumonia with spo2 ≤93% in room air or ventilator support requirement), and 4. the family signed the informed consent exclusion criteria: 1. history of blood clotting disorders (eg, hemophilia and von willebrand's disease), 2. have contraindications to the administration of anticoagulants, for example: 1. platelet count \< 25,000 2. has bleeding manifestations 3. history of heparin allergy or heparin-induced thrombocytopenia 3. pregnant

Keywords: thromboelastography blood coagulation disorder mortality intensive care unit
preoperative massage in breast surgery patients

Conditions: Anxiety; Presurgical Anxiety; Breast Cancer

Summary: this randomized controlled interventional study is designed to determine whether breast cancer surgical patients receiving presurgical massage therapy performed by a licensed massage therapist have decreased average anxiety levels compared to the control group of breast cancer surgical patients who do not receive massage therapy.


Eligibility criteria:
inclusion criteria: * male or female * must speak english * able to give consent * 18 years of age or older * undergoing first procedure outpatient breast/axillary surgery at vassar brothers medical center exclusion criteria: * anxiolytics or antidepressants medications during the previous 24 hours * any condition that would prohibit receiving a massage * iv medications prior to presurgical holding vas assessment

Keywords: anxiety presurgical anxiety breast cancer
measles vaccine in hcw

Conditions: Covid19

Summary: till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, one speculation for lower sars infectivity is that cross-protective antibodies against measles vaccine ( mv). in mice susceptible to measles virus, recombinant mv induced the highest titers of neutralizing antibodies and fully protected immunized animals from intranasal infectious challenge with sars-cov, the primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of covid-19. we hypothesized that, measles vaccine may lower the incidence of serologically proven sars-cov-2 infection and reported respiratory illness


Eligibility criteria:
inclusion criteria: * age 18-50 years old * subjects who are willing to comply with the requirements of the study protocol and scheduled visits (for example, completion of the subject diary, return for follow-up visits) and who are willing to make themselves available for the duration of the study with access to a consistent means of telephone contact exclusion criteria: * acute severe illness * recent receipt of a blood product * history of thrombocytopenia * pregnant females * any chronic medical condition * any participant receiving any immune suppressive medication * immunocompromised staff * participants who have egg allergy * participants who care for immune compromised hosts * participants who test positive for covid-19 serology prior to randomization

Keywords: mmr vaccine, respiratory failure,