Kornimate/medical-research-clean huggingface dataset:
multiple ascending dose study in subjects with type 2 diabetes

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following ascending multiple doses of amg 876 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male and female subjects ≥ 18 to ≤ 65 years of age at the time of randomization * female subjects must be of documented non-reproductive potential * diagnosed with type 2 diabetes * hba1c ≥ 6.5% and ≤ 10% * fasting c-peptide value ≥ 0.8 ng/ml * body mass index (bmi) between ≥ 25.0 and ≤ 40.0 kg/m2 at screening exclusion criteria: * female subjects who are lactating/breastfeeding or who plan to breastfeed while on study through 4 weeks after receiving the last dose of study drug. * male subjects with partners who are pregnant or planning to become pregnant while the subject is on study through 4 weeks after receiving the last dose of study drug * evidence or history at screening of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, estimated glomerular filtration rate \< 60 ml/min/1.73m2 (calculated using the modification of diet in renal disease formula) or macroalbuminuria (ie, ≥ +1 proteinuria on urinalysis), diabetic neuropathy complicated by neuropathic ulcers, or severe autonomic neuropathy with gastroparesis, chronic diarrhea, or hypoglycemic unawareness * significant cardiac disease, including but not limited to, evidence or history of coronary artery disease, unstable angina, congestive heart failure, known arrhythmias of atrial or ventricular etiology, unexplained syncope, or syncope/seizures related to arrhythmia * uncontrolled hypertension (systolic blood pressure ≥ 150 mmhg or diastolic blood pressure ≥ 90 mmhg) either on or off therapy at screening * triglycerides ≥ 500 mg/dl (5.64 mmol/l) at screening * hepatic liver enzymes alt, ast, alkaline phosphatase (alp), or total bilirubin (tbil) levels \> 1.5 times the upper limit of normal (uln) at screening * fasting blood glucose \> 270 mg/dl at the screening visit * positive for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hepcab) * an unstable medical condition, defined as having been hospitalized within 28 days before day -1, major surgery within 6 months before day -1, or otherwise unstable in the judgment of the investigator (eg, risk of complications or adverse events unrelated to study participation)

Keywords: type 2 diabetes
pain management smartphone application for patients with stage iii-iv head and neck cancer undergoing radiation therapy

Conditions: Head and Neck Cancer; Pain; Lung Cancer; Esophageal Cancer

Summary: this pilot clinical trial studies a pain management smartphone application for monitoring pain in patients with locally advanced head and neck cancer who are undergoing radiation therapy. the study is also open to patients with esophageal or lung cancer. a smartphone application may allow patients to assess their symptoms in a manner that is closer to real-time than having to recall pain episodes during once weekly on-treatment visits with a health care provider. this real-time monitoring may improve the timing and efficacy of interventions leading to better pain-control and quality of life.

primary objectives: i. obtain consumer input to determine the optimal way to address and monitor the patient's symptoms. ii. train patients to use the pain management smartphone application (pmsa) and determine the compliance characteristics and the number of additional on-treatment visits (otvs) prompted by usage of the application. outline: selected patients are interviewed for input that will help guide the wording of questions of the pmsa. all patients/caregivers are then instructed to download the pmsa and are demonstrated how to properly use the application. beginning on the first day of radiation therapy (day 1), patients are instructed to use the pmsa for the duration of their radiation therapy (up to day 50), although the timing may change based on the availability of the app.

Eligibility criteria:
inclusion criteria: * radiation oncology patients undergoing 5-7 weeks of definitive radiation therapy for head and neck, esophageal or lung cancer. * ability to understand and the willingness to use the pmsa on the patient's personal smartphone * displays ability to use and understand the pmsa as evidenced by successful response to alarm and successful entries while monitored by the principal investigator (pi) * willing and able to provide informed consent and fill out demographic, disease, and pain assessment questionnaires * english speaking exclusion criteria: * radiation oncology patients undergoing palliative courses of radiation * patients who do not own smartphones * patients who are unable to successfully respond to the pmsa alarm and properly enter their data * patients who are unable to eat and drink normally * patients who are unable to validate their understanding of the pain scale

Keywords: smartphone application pain management
efficacy and safety study of loperamide hydrochloride/simethicone chewable tablet in treatment of acute diarrhea with abdominal discomfort and flatulence

Conditions: Diarrhea

Summary: the purpose of this study is to evaluate the efficacy and safety of combined loperamide hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas accumulation.

this is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), parallel-group (each group of participants will be treated at the same time), multi-center (when more than one hospital or medical school team work on a medical research study) study. all eligible participants will be randomly assigned to receive either a combination of loperamide hydrochloride and simethicone or loperamide hydrochloride. the study includes screening visit (from -24 to 0 hours), baseline visit (at 0 hour) and concluding visit (within 48 to 96 hours following the start of the trial). the timing of each bowel movement, stool characteristics and the degree and duration of abdominal discomfort caused by gastrointestinal gas accumulation will be recorded for each participant for 48 hours after the first trial drug administration. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial * participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container) * participant's most recently produced stool must be unformed stool * participant must give a positive answer to the following question: "have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour" * female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal exclusion criteria: * participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis * participant shows an axillary temperature greater than (\>) 38.2 degrees celsius (c) or an oral temperature \> 38.6 degrees c * participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at \> 3 per high power field * participant shows a sitting systolic blood pressure less than (\<) 90 millimeter of mercury (mmhg) and/ or diastolic blood pressure \< 60 mmhg * participant is unable to take medication orally or tolerate oral rehydration

Keywords: diarrhea flatulence abdominal discomfort loperamide hydrochloride simethicone placebo
treatment of post-ocriplasmin therapy vitreolysis induced subretinal fluid with eplerenone (mineralocorticoid antagonists)

Conditions: Vitreomacular Traction; Subretinal Edema

Summary: evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion.


Eligibility criteria:
inclusion criteria: * age \> 18 years of age * symptomatic vma, vmt, or macular hole * bcva 20/30 - cf 3' snellen equivalent * willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments * jetrea® treatment naïve exclusion criteria: * patients who are pregnant, planning to become pregnant, or breastfeeding a child * uncontrolled ocular hypertension or glaucoma in study (defined as iop ≥ 25mm hg or a cup to disc ratio (cdr) \> 0.8 despite treatment with anti-glaucoma medication) * active malignancies within the last 12 months except appropriately treated carcinoma in situ of the crevices, melanoma, and prostate cancers treated with a curative intent * inability to comply with study or follow-up procedures * women who may become pregnant or lactating or intend to become pregnant during the study * known drug allergy to ocriplasmin or eplerenone * patients with known contraindications eplerenone as outlined in the package insert
donor breast milk and breastfeeding rates

Conditions: Breastfeeding, Exclusive; Breastfeeding

Summary: the purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (nicu) is feasible.

in late preterm infants and term neonates in the nicu whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the nicu, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.

Eligibility criteria:
inclusion criteria: * gestational age \>34 weeks and 0 days * mother's intent to breast feed * nicu admission which is predicted to be at least 72 hours from time of admission exclusion criteria: * confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., trisomies) * common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc) * commonly accepted contraindications for breast feeding (hiv, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana) * infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications * any infant whose care is considered futile by the primary medical team

Keywords: late preterm donor breast milk
study of rebamipide eye drops to treat dry eye

Conditions: Keratoconjunctivitis Sicca

Summary: the purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

there is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. the goal of this study is to assess the impact of rebamipide on dry eye symptom.

Eligibility criteria:
inclusion criteria: * must have symptoms of dry eye for a minimum of 6 months * must be able to sign and date an informed consent exclusion criteria: * presence of anterior segment disease * glaucoma or ocular hypertension * using restasis * use of topically instilled ocular medications during study * use of contact lenses * history of ocular surgery within 12 months * females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception * presence of stevens-johnson syndrome * any anticipated change in medication through-out study * concurrent involvement in another study or previous receipt of this drug * cannot be safely be weaned off of ocular medications

Keywords: dry eye keratoconjunctivitis sicca
edoxaban for the treatment of coagulopathy in patients with active cancer and acute ischemic stroke: a pilot study. (enchase study)

Conditions: Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)

Summary: purpose: cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. with rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin k oral anticoagulants (noacs) could be safe alternative without the need for injection subcutaneously. furthermore, noacs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to enoxaparin.


Eligibility criteria:
inclusion criteria: * adults over 20 years old * acute cerebral infarction within 30 days of symptom onset was confirmed by diffusion-weighted brain magnetic resonance imaging (dwi) * cancer-related stroke, not diagnosed with other classic (arteriosclerosis, cardioembolicm, small-vessel occlusion, etc.) cerebral infarction, within six months of diagnosis, chemotherapy, surgery for cancer. * with informed consent from the patient or next-of-kin, when the subject becomes able to decide whether to participate in the study, the researcher acquires further consent directly from the subject. exclusion criteria: * patients with primary intracranial malignancy * patients with classic causes of cerebral infarction * patients with infectious or immunological disease that may affect blood d-dimer levels * patients whose cerebral infarction is thought to be caused by tumor (vascular occlusion due to tumor tissue) * patients who can not use anticoagulants with thrombocytopenia (platelet \<50,000), anemia (hemoglobin \<8) * decreased renal function (creatine clearance \<15 ml / mim) * patients who received intravenous tissue plasminogen activator * patients with uncontrolled severe hypertension * patients who received prosthetic heart valve replacement requiring anticoagulation * patients with moderate to severe mitral stenosis * pulmonary embolism requiring hemodynamically unstable or thrombolysis or pulmonary embolization * pregnant and lactating women * patients who are hypersensitive to the major component or constituent of the test drug * patients with liver diseases associated with blood clotting disorders and clinically significant bleeding risks

Keywords: cancer-related stroke coagulopathy d-dimer edoxaban enoxaparine
identifying characteristic signature of attention deficit / hyperactivity disorder (adhd) and ritalin treatment

Conditions: "Attention Deficit Hyperactivity Disorder"

Summary: in this study we try to identify the signature of brain activity in the eeg of attention deficit disorder (adhd) patients compared to healthy subjects under different doses of ritalin (methylphenidate) treatment.

in this study we try to identify the signature of brain activity in the eeg of attention deficit disorder (adhd) patients compared to healthy subjects under different doses of ritalin (methylphenidate) treatment. all subjects will undergo 1-4 eeg sessions. in each session we will use a different dose of ritalin or placebo. a detailed neuropsychological tests will be done during the eeg recording. a powerful machine-learning techniques will be used in order to find a specific signature of adhd and ritalin treatment in the eeg recording.

Eligibility criteria:
inclusion criteria: * healthy subjects, aged 18-50 years. * subjects aged 18-50 years diagnosed with adhd and treated with ritalin regularly (at least once a week). exclusion criteria: * patients previously diagnosed as suffering from a brain disease except for adhd. * patients after traumatic head injury. * patients who are unable to express their consent to participate in the study.

Keywords: eeg attention deficit / hyperactivity disorder (adhd) ritalin machine learning
mind your heart study

Conditions: Medication Non-adherence

Summary: this study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.

this project seeked to study the role of mindfulness training (mt) in the promotion of medication adherence among patients with chronic heart failure (hf). a prospective pre/post design study was conducted among 50 stable outpatients with hf and sub-optimal self-reported medication adherence. mt sessions (one 30-min session/week over 8 weeks) were phone-delivered by qualified mindfulness instructors. assessments were conducted at baseline, 3 months (end of the intervention) and 6 months since baseline. the primary outcomes were feasibility and acceptability. we hypothesized we would meet recruitment goals (n=50) within the study timeline, with \ 80% of participants would report high (=grade 5) enjoyment ratings on a self-report intervention enjoyment scale (range:1 to 5). secondary outcomes were self-reported and objectively assessed medication adherence and functional capacity (a clinical marker of medication adherence. we hypothesized we would observe significant pre-post intervention improvements in medication adherence and functional capacity. additional outcomes included possible mediators of intervention effect, i.e., cognitive function, mood, sleep quality, and interoceptive awareness.

Eligibility criteria:
inclusion criteria: * age \> = 18 * fluency in english language * a confirmed diagnosis of heart failure * sub-optimal adherence to medications * access to a telephone * ability to understand and speak english exclusion criteria: * unwillingness/inability to provide informed consent * new york heart association (nyha) class iv heart failure or clinically unstable * severe hearing impairment not allowing phone delivery * severe depressive symptoms * acute psychosis * severe cognitive impairment * recent hospitalization (\< 6 weeks) * current (at least once a month) mind/body practice

Keywords: medication adherence heart failure mindfulness interventions
a study to assess the adverse events and effectiveness of rapid acoustic pulse (rap) device for the appearance of cellulite in adult participants

Conditions: Cellulite

Summary: cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. its appearance and texture are often likened to that of "cottage cheese" or an orange peel. rapid acoustic pulse (rap) is an electrohydraulic (eh) device developed to improve the appearance of cellulite through microscopic disruption of the connection between the skin and underlying tissue leading to a reduction in the severity of dimples and ridges. the purpose of this study is to assess adverse events and effectiveness of rap in adults seeking treatment of cellulite. rap is an fda approved device for the short-term improvement in the appearance of cellulite in the buttocks and thighs. participants 18-50 years of age seeking treatment of cellulite will be enrolled. up to 15 participants will be enrolled in the study at 1 site in the united states. participants will receive 3 separate cellulite treatment sessions. each treatment session will consist of rap treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides. the study duration is up to 72 weeks. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a clinic. the effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * participants seeking treatment of cellulite in the thigh and/or buttock areas. * areas of moderate to severe cellulite on bilateral thigh and/or buttock using the cellulite dimple - at rest scale at baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial. * participant will not have had invasive or energy-based cellulite (liposuction, subcision, rf, laser, eswt, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months. * participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial * participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial. exclusion criteria: * metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas. * active electronic implants such as pacemakers, defibrillators * history of coagulopathy and/or on anticoagulant medication * skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas. * medical disorder that would hinder wound healing or immune response. * any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study. * any other condition/disease/situation which, as deemed by the pi, would preclude participant from safely participating in or completing the study visits or that may confound study results.

Keywords: rapid acoustic pulse rap cellulite