Kornimate/medical-research-clean huggingface dataset:
subcutaneous administration of teplizumab in adults with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (pd) and pharmacokinetics (pk) of subcutaneously administered teplizumab in adults with relatively recent onset t1dm, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.


Eligibility criteria:
inclusion criteria: * randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes * diagnosis of type 1 diabetes mellitus * currently receiving insulin therapy * detectable fasting or stimulated c-peptide level at screening * one positive autoantibody test result at screening: islet-cell autoantibodies (ica512)/islet antigen-2 (ia-2),glutamic acid decarboxylase (gad) autoantibodies, or insulin autoantibodies exclusion criteria: * any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial * previous treatment with monoclonal antibody * current treatment with oral antidiabetic agents * evidence of active infection

Keywords: type 1 diabetes mellitus t1dm
systems of support (sos) to increase colon cancer screening and follow-up supplement

Conditions: Colorectal Cancer Screening

Summary: ancillary aim #1 we will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary sos study. in this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). the outcome variable of interest is the first time since randomization to have crcs, either based on fobt, fs, or cs. knowing screening rates will not only enable us to make comparisons between groups, but also over time. ancillary aims #2 and #3 we will recruit additional participants for two ancillary study aims. first, we will enroll patients age 50-74 years using the same criteria as for the primary sos study, which includes neither history of colorectal cancer nor evidence of life-limiting disease. participants who return the questionnaire, consent and considered eligible will be randomized to receive one of three different at-home fecal test kits. the kits will be returned to the gh centralized laboratory, and participants will be informed about lab results using standard gh pathways. participants who have a test-positive will receive a series of two follow-up surveys (first at 1-2 weeks post result and second at 4-months post result). a comparison group of test-negative results will be matched based on selected criteria, and this group will also receive the follow-up surveys. participants at both time intervals who do not return the survey via mail will be called and if available, administered the questionnaire via phone.


Eligibility criteria:
inclusion criteria: * not up to date on crcs * continuously enrolled in ghc for 24 months * expected to continue to be enrolled at ghc for 24 months exclusion criteria: * known high risk for crc * history of crc * history of inflammatory bowel disease * current anticoagulation therapy * organ failure * serious illness * debilitating disease * dementia * nursing home resident.

Keywords: colorectal neoplasms mass screening population surveillance randomized controlled trial occult blood colonoscopy sigmoidoscopy health behavior
efficacy and safety of peginterferon alfa-2b in hbeag positive chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this study is aimed to assess the efficacy and safety of peginterferon alfa-2b (40kd, y-shape), in a dose of 180μg/week, in chronic hepatitis b patients, and collects sufficient evidences for the listed of the studied drug.


Eligibility criteria:
inclusion criteria: * age: 18\~65 years. * serum hbsag or hbv dna positive for at least 6 months. * serum hbsag and hbeag are both positive, hbv dna ≥ 20,000iu/ml at screening. * 2×uln≤ alt ≤10×uln at screening (uln=upper limit of normal). * pregnancy tests of female patients must be negative. all patients with effective birth control measures during treatment period and 6 months after the treatment. exclusion criteria: * pregnant or lactating women. * mental disorder or physical disability. * interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis b treatment within the previous 6 months. * anc \< 1500/mm3, or plt \< 90,000/mm3. * co-infection with hav, hiv, hcv, hdv, or hev. * both of hbsag and anti-hbs are positive, or both of hbeag and anti-hbe are positive at screening. * child-pugh ≥ b, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, tbil \> 2uln, alb\<35g/l). * chronic hepatitis caused by any other reason except hepatitis b. * hepatocarcinoma or suffering from any other malignant tumor. * not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus) * significant function damage in any major organs (e.g.: heart, lung, kidney). * other conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).

Keywords: peginterferon hbeag positive chronic hepatitis b
explore the effect of diet intervention on lipid metabolism and body mass index among the patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the prevalence of metabolic syndrome (mets) is increasing all over the world, which is largely related to the increasing obesity population and the current inactive lifestyle of human beings. it is a common problem facing public health and clinical practice.metabolic syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and obesity (especially central obesity).researchers believe that the common pathological basis of these manifestations is insulin resistance, which is generally considered to be a reduction in the biological effects of insulin compared with the normal biological effects of expected biological phenomena.nowadays, there are more and more studies on insulin resistance in the world. we have known that age, poor living and eating habits, high blood fat, high blood sugar and stress all lead to insulin resistance. the researchers hope to reduce weight, reduce body fat rate, improve body fat distribution and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the incidence of chronic diseases in patients with metabolic syndrome through the intervention of lifestyle and diet habits in the early stage of the disease.


Eligibility criteria:
inclusion criteria 1. diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5): 1. waist circumference ≥ 90 cm (men) or ≥ 80 cm (women). 2. elevated tg (use of medications for elevated tg is an alternate indicator) ≥ 150 mg/dl (1.7 mmol/l). 3. reduced hdl-c (use of medications for reduced hdl-c is an alternate indicator) \< 40 mg/dl (1.0 mmol/l) in males \< 50 mg/dl (1.3 mmol/l) in females. 4. elevated blood pressure (use of hypoglycemic medications is an alternate indicator). sbp ≥ 130 and/or dbp ≥ 85 mmhg. 5. elevated fbg (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dl (5.6 mmol/l). 2. age from 18 to 65 years. 3. stable weight (change ≤ 10% current body weight) for 3 months prior to the study. 4. if participates were on hypoglycemic medications, hypotensive medications, lipid-lowering medications and cardiovascular medications, dose adjustment was not permitted during the 3-month intervention. exclusion criteria 1. pregnant or breast-feeding. 2. night shift workers. 3. history of major diseases or related diseases, such as inflammatory disease, rheumatologic disease, adrenal disease, malignancy, type 1 diabetes, cirrhosis, chronic kidney disease, acquired immunodeficiency syndrome, eating disorder, uncontrolled psychiatric disorder and major adverse cardiovascular event. 4. current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite. 5. history of weight-loss surgery.
hemodynamic effects of rolofylline in the treatment of patients with heart failure (7418-503)

Conditions: Heart Failure

Summary: the study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.


Eligibility criteria:
inclusion criteria: * patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure \>95 mm hg exclusion criteria: * patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks
av-101 as adjunct antidepressant therapy in patients with major depression

Conditions: Major Depressive Disorder

Summary: the study will evaluate the safety and efficacy of av-101.


Eligibility criteria:
inclusion criteria: * diagnosed with mdd, single or recurrent, and currently experiencing a mde of at least 8 weeks in duration. * has a history of inadequate response to at least 1 approved antidepressant including at least 1 and no more than 3 during the current depressive episode. * meet the threshold on the total hamd-17 score of \> 20 * if female, a status of nonchildbearing potential or use of an acceptable form of birth control. * body mass index between 18 to 40 kg/m2. * other criteria may apply exclusion criteria: * history of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes. * any axis i or axis ii disorder, which at screening is clinically predominant to their mdd or has been predominant to their mdd at any time within 6 months prior to screening. * women who are pregnant or breastfeeding or a positive pregnancy test at screening or baseline. * currently taking a prohibited adjunct therapy. such drugs must be washed out for at least 4 weeks prior to baseline. * current diagnosis of moderate or severe substance use (including alcohol) disorder (abuse or dependence, as defined by dsm-5), with the exception of nicotine dependence, at screening or within 6 months prior to screening. * in the opinion of the investigator, the subject has a significant risk for suicidal behavior * has received electroconvulsive therapy, or had repetitive transcranial magnetic stimulation in the current episode. * has received vagus nerve stimulation at any time prior to screening. * any current or past history of any physical condition, which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
slow and deep breathing to lower blood pressure in women with pregnancy-induced hypertension

Conditions: Pregnancy-Induced Hypertension

Summary: this study evaluates the effect of slow and deep breathing on lowering blood pressure in women with pregnancy-induced hypertension. slow and deep breathing will be practised daily for 10 minutes from enrolment until the woman gives birth. this feasibility study aims to investigate the practicality of conducting a proposed future randomised controlled trial.

in addition to the slow and deep breathing intervention the women will undertake a short protocol investigating the physiological responses to slow and deep breathing during their initial meeting. the women will undertake 4 separate 5-min breathing exercises with a 5 minute rest period between each exercise. the breathing exercises are normal breathing, and fixed breathing frequencies of 4, 6 and 8 breaths per minute. blood pressure, heart rate and breathing rate will be monitored continuously, and non-invasively, throughout each breathing protocol. the women will also have the opportunity to provide feedback on the intervention and their experiences in an online survey at 36 weeks gestation.

Eligibility criteria:
inclusion criteria: * diagnosed with pregnancy-induced hypertension (pih). defined as "new hypertension presenting after 20 weeks of pregnancy without significant proteinuria (urinary protein:creatinine ratio greater than 30mg/mmol" by nice guidelines (2010) or diagnosed as having one-off high blood pressure but at risk of developing pih; * single pregnancy; * capable of giving informed consent; * age over 18. exclusion criteria: * under 18 years old; * referred immediately to obstetric-care after pih diagnosis for an immediate intervention, with systolic blood pressure over 160 mmhg or diastolic blood pressure over 100 mmhg; * multiple pregnancy (twins, triplets, etc.); * current smoker; * current diagnosis of respiratory diseases; asthma, copd (chronic obstructive pulmonary disease), bronchitis. (a previous occurrence or diagnosis that has not been present for longer than 1 year ago does not exclude participants, i.e. childhood asthma); * allergy/reaction to gel used on ecg tabs; * vulnerable participants who are unable to give informed consent.

Keywords: slow and deep breathing feasibility study
usability and tolerability of novel protection device against potential brain injury during competitive sport

Conditions: Brain Injuries, Traumatic; Brain Injury Traumatic Mild

Summary: the purpose of the study is to assess the usability and tolerability of this jugular vein compression device in a population of helmeted and non-helmeted competitive high school, collegiate and professional athletes in the sports of football and rugby. this study differs from previous work in that it is designed to capture additional data related to the athlete experience wearing the jugular vein compression device in older and more elite playing levels.

significant morbidity, mortality, and related costs are caused by traumatic brain injury (tbi). a simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate tbi resulting from blast trauma or concussive events, would save lives, and the huge costs incurred for life-treatment of surviving victims. an externally-worn medical device that applies mild jugular compression according to the principle of the queckenstedt maneuver (the device) is being developed by q30 sports science, llc (q30). preliminary research suggests that the device has the potential to reduce the likelihood of tbi. the currently developed collar has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities. regarding safety, the externally worn collar is meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar pressure and volume increases not to surpass that of a yawn or the mere act of just lying down. this study will investigate the tolerability of this device in athletes participating in the competitive sports of football and rugby at the high school, collegiate or professional levels.

Eligibility criteria:
inclusion criteria: * normal healthy volunteer * able to provide written consent * must be 14 years or older and a participant in collegiate/professional sports of football or rugby exclusion criteria: * unable to provide written consent * history of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening: * medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis) * glaucoma (narrow angle or normal tension) * hydrocephalus * recent penetrating brain trauma (within 6 months) * known carotid hypersensitivity * known increased intracranial pressure * central vein thrombosis * any known airway obstruction * any known seizure disorder

Keywords: brain injury
a study of jnj-64407564 in japanese participants with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and tolerability in japanese participants with relapsed or refractory multiple myeloma (mm) at the recommended phase 2 dose (rp2d) identified in nct03399799 study.


Eligibility criteria:
inclusion criteria: * documented diagnosis of multiple myeloma according to international myeloma working group (imwg) diagnostic criteria * participants must be relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma (mm) or be intolerant of those established mm therapies, and a candidate for talquetamab treatment in the opinion of the treating physician. prior lines of therapy must include a proteasome inhibitor (pi), an immunomodulatory drug (imid) and an anti-cd38 antibody in any order during the course of treatment. participants who could not tolerate a pi, immunomodulatory drugs or anti-cd38 antibody are allowed * eastern cooperative oncology group (ecog) performance status grade of 0 or 1 at screening and immediately before the start of study treatment administration * women of childbearing potential must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study treatment using highly sensitive pregnancy test either serum (beta-human chorionic gonadotropin \[beta-hcg\]) or urine * participants (or a legally acceptable representative) must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease exclusion criteria: * toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or less except for alopecia or peripheral neuropathy * received a cumulative dose of corticosteroids equivalent to \>=140 milligrams (mg) of prednisone within the 14-day period before the first step-up dose of study treatment (does not include pretreatment medication) * central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. if either is suspected, whole brain magnetic resonance imaging (mri) and lumbar cytology are required during screening * pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation * known allergies, hypersensitivity, or intolerance to the excipients of talquetamab
toric trifocal iol treatment with high astigmatism and hyperopia vs smile enhancement after trifocal iol treatment

Conditions: Astigmatism High Both; Pseudophakia; Hyperopia

Summary: the aim of this study is to assess visual and refractive outcomes after toric trifocal lens implantation and visual outcomes after laser vision correction (lvc) - relex smile to correct residual refraction after 6 months of toric trifocal (iol) implantation.

the current state of the art for the correction of aphakia and presbyopia after lens extraction and refractive lensectomy is the implantation of multifocal intraocular lenses (iol). in this study, the trifocal iol types at lisa tri 839mp and at lisa tri toric 939mp (carl zeiss meditec, germany) were assessed. in this prospective non-randomized study patients with spherical hypermetropia of \>4 d in combination with high astigmatism of \>3.0 d were treated. the first group of 40 eyes of 20 patients underwent refractive lensectomy, followed by implantation of the diffractive trifocal iol type at lisa tri 839mp (carl zeiss meditec, jena, germany) and 6 months later smile surgery. in 40 eyes of 20 patients in the second group iol type at lisa tri toric 939mp were implanted. all patients were adequately consulted preoperatively about this type of iols and they were verbally consented. the study is adherent to the tenets of the declaration of helsinki. all patient are between 20- 45 years old. the current study demonstrates that both the non-toric and toric versions of the trifocal iol evaluated here provide excellent functional vision to patients, with good distance, intermediate and near uncorrected va, a wide range of vision and good contrast sensitivity. before smile,yag-laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. when the yag-laser is applied after the smile, there will be a diopter change. relex smile surgery in pseudophakic patients with trifocal iol was safe, effective, and predictable in a large cohort of patients. it is noteworthy that the decision for a treatment strategy (toric iol or non-toric iol with smile in s second step) should be made carefully, to select the appropriate method for the patient. during phaco surgey the positions of incisions should be determined according to the angle of the highest k value of the patient. for high astigmatic patients, toric trifocal iol is highly effective.

Eligibility criteria:
inclusion criteria: 1. high spherical hypermetropia 2. astigmatismus \>2 d or higher 3. amblyopia 4. strabismus (accomodative esotropia) exclusion criteria: 1. glaucoma 2. retinal detachment 3. corneal disease 4. macular degeneration 5. advanced retinopathy

Keywords: relex smile trifocal iol toric trifocal iol
tumor and treatments impact on neurocognitive functions and quality of life of patients with oms grade ii glioma

Conditions: OMS Grade II Glioma

Summary: this is a multicenter prospective study:2 independant cohorts of patients with oms grade ii glioma will be followed during 5 years. * cohort a: patients in first-line treatment (surgery, radiotherapy or chemotherapy) * cohort b: patients with disease simple monitoring. the primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests.


Eligibility criteria:
inclusion criteria: * oms grade ii glioma * signed informed consent * age \>=18 * ik \>=80% * ability to read, write and undertand french exclusion criteria: * glioma localized to brainstem * other neurologic or psychiatric disease * history of other malignancies, other than curatively treated in-situ carcinoma of the cervix or basal cell carcinoma of the skin, or any other curatively treated cancer with no sign of recurrence within 5 years prior to randomization * neuroleptic concomitant treatment * pregnant or lactating women

Keywords: glioma neurocognitive functions