Kornimate/medical-research-clean huggingface dataset:
regadenoson for acute vasoreactivity testing in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to see if regadenoson may offer improved ease of use, single dose administration, and better tolerance for testing for pulmonary hypertension than ino. you will be screened to make sure regadenoson is safe for you with a clinical evaluation, blood tests, and an ecg.

pulmonary hypertension (ph) is an increase of blood pressure in the pulmonary vascular system that could cause shortness of breath, dizziness, leg swelling and heart failure. . the diagnosis of ph requires confirmation of elevated pulmonary pressures.. right heart catheterization (rhc) is a procedure to determine the diagnosis of ph. . this research study is looking at the effect of intravenous infusion of the medication regadenoson on pulmonary vasodilator response compared to the inhaled nitric oxide (ino) response. ino is the current standard of care practice. the purpose of this study is to see if regadenoson may offer improved ease of use, single dose administration, and better tolerance for testing for pulmonary hypertension than ino. you will be screened to make sure regadenoson is safe for you with a clinical evaluation, blood tests, and an ecg. you will be asked to sign this informed consent form. then, you will undergo right heart catheterization as part of your clinical care. those who are positive for pulmonary hypertension will then undergo regadenoson infusion and a inhaled ino. prior to the infusion, subjects will be asked if they have had in the last 12 hours any caffeine-containing foods or beverages, caffeine-containing medications such as theophylline 12 hours prior. vital sign measurements will be taken to measure your heart. for those subjects that have low heart volume they will be given 500 cc of normal saline in their iv. vital sign measurements will be taken again to make sure your heart volume is in the normal range. the doctor will administer regadenoson 0.4 mg intravenously and this will cause your heart rate to increase. the doctor will be taking heart measurements 90 seconds, 5 minutes, 10 minutes, and 20 minutes after administration. approximately 30 minutes after the regadenoson has been administered you will be given ino by facemask for 5 minutes.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years old 2. diagnosis of rhc-proven ph * mean pulmonary artery pressure (mpap) \> 25 mmhg * pulmonary vascular resistance (pvr) \> 3 woods units * pulmonary capillary wedge pressure (pcwp) \< 15 mmhg). exclusion criteria: 1. second- or third-degree av block or sinus node dysfunction 2. known hypersensitivity to adenosine or regadenoson 3. systolic blood pressure \< 90mm hg 4. active bronchospasm 5. autonomic dysfunction as defined by prior diagnosis of: * postural orthostatic tachycardia syndrome (pots) * neurocardiogenic syncope (ncs) * neurally mediated hypotension (nmh) * vasovagal syncope 6. hypovolemia 7. \> 40% left main coronary stenosis 8. moderate or \> valvular stenosis 9. pericarditis/pericardial effusions 10. \> 70% carotid artery stenosis 11. positive urine pregnancy test
phase 2 study of amg 337 in met amplified gastric/esophageal adenocarcinoma or other solid tumors

Conditions: Stomach Neoplasms

Summary: this is a multi-centre phase 2 study. the study will evaluate the activity and safety of amg 337 in patients who have met amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other met amplified solid tumors. the study is designed to estimate the objective response rate of amg 337 by tumor type.

this is a phase 2, multicenter, single arm, 2 cohort study to assess the safety, efficacy and pharmacokinetics of amg 337 in met amplified gastric/esophageal adenocarcinoma or other solid tumors. approximately 140 subjects will be enrolled to either cohort 1 (subjects with met amplified g/e adenocarcinoma with measurable tumor) or cohort 2 (subjects with met amplified solid tumors with measurable tumor/up to 10 subjects with met amplified g/e adenocarcinoma with non-measurable tumor/up to 10 subjects who have received prior met antibody therapy). all subjects will self-administer amg 337 300 mg daily until disease progression or other protocol specified end of treatment criteria is met. tumor tissue, biomarkers, pharmacokinetics and patient reported outcomes will all be assessed. tumor assessment by recist 1.1 will be followed during study treatment.

Eligibility criteria:
inclusion criteria: * able to daily self-administer amg 337 orally as a whole capsule * male or female 18 years of age or over. * pathologically confirmed advanced g/gej/e adenocarcinoma (cohort 1) or other solid tumor (cohort 2) for which subject has received prior therapy for advanced disease, for which no standard therapy exists, or subject refuses standard therapy * tumor met amplified by protocol-specified centralized testing. * measurable disease per recist 1.1 guidelines. cohort 2 may include up to 10 subjects with advanced met amplified, g/gej/e adenocarcinoma with non-measurable tumor per recist v1.1 * (ecog) performance status of 0, 1 or 2 exclusion criteria: * known central nervous system metastases * candidate for curative surgery or definitive chemoradiation * peripheral edema \> grade 1 * persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding. significant gastrointestinal disorder(s) that in the opinion of the investigator may influence drug absorption * acute hepatitis b. chronic hepatitis b eligible if condition is stable and, in the opinion of the investigator or amgen physician, if consulted, would not pose a risk to subject safety * detectable hepatitis c virus (indicative of active hepatitis c) * currently receiving any anti-tumor treatments, or less than 14 days prior to enrollment since ending anti-tumor treatment * prior treatment with small molecule inhibitors of the met pathway. other protocol defined inclusion criteria may apply.

Keywords: met amplified gastric / gastroesophageal junction / esophageal adenocarcinoma, or other solid tumors.
inferior alveolar nerve lateralization with simultaneous implant placement in atrophic posterior mandible

Conditions: Dental Implant

Summary: the aim of this study is to evaluate the effect of sticky bone on acceleration of recovery of the neurosensory dysfunction of the inferior alveolar nerve following inferior alveolar nerve lateralization surgery for implant placement in patients with posterior vertical bone deficiency in order to overcome the main disadvantage of this technique \& provide a reliable,saving time - computer guided simultaneous implant placement- and improved technique.

lateralization of ian allows simultaneous implant placement with longer implants and primary stability.2 ian lateralization provides an option to avoid costly, prolonged bone graftt and also healing periods can be reduced by this option of treatment vestibular depth remains intact as there is no augmentation in the underlying bone defect. 2 ian lateralization technique has also some advantages such as less morbidity and less of peri-implant disease.2 in case of the ian is located in the superior part of the body of the mandible , and presence of mild atrophy of the edentulous alveolar ridge will fetch the alveolar ridge in a close relation to the neuro-vascular bundle, the incidence of "high" ian locations ranges from 14.6 to 30.7%. 1however there is some complications such as numbness after surgery which is considered as the most common one also prevent thermal conductivity via implants(kahnberg et al., 2000) so sticky bone is going to be used to act as an insulator between dental imlants \& inferior alveolar nerve and it contains a number of growth factors so it is predicted to play an important role to enhance recovery of the inferior alveolar nerve after surgery

Eligibility criteria:
inclusion criteria: * adult patients requiring oral rehabilitation with dental implants in vertically atrophied * posterior mandibular region, less than 8mm of bone above the mandibular canal. * patients should be free from any systemic conditions that may affect normal healing. * absence of any pathological conditions involving mandibular bones. exclusion criteria: * patients under bisphosphonates treatment. * any contraindication for general anaesthesia. * osteoporotic patients. * patients with neurological disorders (neuralgias, parkinson' s disease). * patients with systematic disease that may complicate healing.
biomarkers of ischemia: xanthine, hypoxanthine and inosine levels during carotid stenting procedures

Conditions: Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood; Ischemia/Hypoperfusion of Brain

Summary: the purpose of the study is to determine if a new blood test can help the doctor determine if there is brain injury or ischemia. ischemia occurs when not enough oxygen gets to the brain. in this study the investigators are analyzing your blood for a new test that might help doctors decide if symptoms are from a neurologic problem.

we will compare a new blood test with routine tests that the doctor will order as part of your normal care. this study will measure new biomarkers (biomarker is a specific distinguishing feature used to measure or indicate the effects or progress of a disease or condition) of neurologic stress called xanthine, hypoxanthine, and inosine. blood will be drawn as a part of the study to measure these biomarker levels in your blood. this blood will be analyzed i the laboratory at virginia commonwealth university and possibly at a future date at another institution. no names will be associated with the blood sample

Eligibility criteria:
inclusion criteria: * men and women over age of 18 non * women who are not pregnant * subject who are not prisoners * subjects presenting to the operation room for a carotid artery stenting procedure * hemoglobin greater than or equal to 11mg/dl * subjects who speak english * subjects 18 years of age or older exclusion criteria: * hemoglobin less than 11mg/dl * women who are pregnant * children under age of 18 * prisoners * non english

Keywords: biomarkers of ischemia carotid stenting procedure levels xanthine hypoxanthine and inosine peripheral blood
the cantata-m (canagliflozin treatment and trial analysis - monotherapy) trial

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (t2dm) inadequately controlled with diet and exercise.

canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (t2dm). this is a randomized (study drug assigned by chance), double blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group, 3 arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients diagnosed with t2dm who are not achieving an adequate response from diet and exercise to control their diabetes. approximately 450 patients with inadequate glycemic control with diet and exercise will receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or 26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo group to improve glycemic control and remain in the study). patients will participate in the study for approximately 60 to 68 weeks (referred to as the main study). the study will also include a high glycemic substudy in 50 to 100 patients with t2dm who have poorer glycemic control with diet and exercise. patients in the substudy will be assigned to receive double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient participatation in the substudy will be approximately 34 to 42 weeks. during treatment, if a patient's fasting blood sugar remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. patients will take single blind placebo for 1 or 2 weeks (wks) before randomization to the main study or the high glycemic substudy.

Eligibility criteria:
inclusion criteria: * all patients must have a diagnosis of t2dm * patients in the main study must have a hemoglobin a1c (hba1c) between \>=7% and \<=10% and a fasting plasma glucose (fpg) \<270 mg/dl (15 mmol/l) * patients in the high glycemic cohort substudy must have an hba1c between \>10% and \<=12% and a fpg \<=350 mg/dl (19.44 mmol/l) exclusion criteria: * history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Keywords: diabetes mellitus, type 2 canagliflozin placebo hemoglobin a1c type 2 diabetes mellitus
brain and pelvic floor muscle activity of patients who had or are undergoing robot-assisted radical prostatectomy

Conditions: Prostate Carcinoma

Summary: this trial investigates brain and pelvic floor muscle activity in patients undergoing robot-assisted radical prostatectomy. this trial may help identify the brain waves that are associated with muscles involved in giving patients control over the bladder.

primary objectives: * identify pelvic floor muscle (pfm) activity on electromyogram (emg) and electroencephalography (eeg). * identify any synchrony in emg and eeg for pfm activity. * identify any relationship between eeg activity and uds findings. secondary objectives: i. identify changes in eeg and emg activity with kegel exercise. ii. examine relationship between eeg activity and continence. exploratory objective: i. examine feasibility of replacing emg with eeg monitoring for muscle activity. outline: patients perform standard of care kegel exercises while undergoing brain and muscle activity monitoring by eeg and emg and uds, respectively, before surgery, 6 weeks after surgery, 3,months after surgery and 6 months after surgery.. patients complete questionnaires over 5-10 minutes about urinary function.

Eligibility criteria:
inclusion criteria: * adults who had or are undergoing robot-assisted radical prostatectomy (rarp) * must be continent preoperatively * participant or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure exclusion criteria: * unwilling or unable to follow protocol requirements * any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation
u-500r insulin in type 2 diabetes with severe insulin resistance via omnipod

Conditions: Type 2 Diabetes; Insulin Resistance

Summary: patients with type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (u100 insulin formulations) will receive 5x concentrated insulin (u500 regular insulin)infused via insulin pump.

patients with type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard u-100 insulin formulations are used. this is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. the hypothesis that using a concentrated form of insulin called u-500 regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.

Eligibility criteria:
inclusion criteria: * type 2 diabetes on stable insulin regimen with or without oral agents for at least 3 months * hba1c \> 7% * no significant cardiovascular, renal or other serious medical diseases exclusion criteria: * hba1c \< 7% * chronic renal, hepatic, cardiovascular, or other serious medical illness * females of childbearing age not using adequate contraception * use of glp mimetic

Keywords: type 2 diabetes insulin resistance continuous subcutaneous insulin infusion u-500 insulin omnipod
electrolyte state in patients with covid-19

Conditions: Electrolyte Imbalance

Summary: initial case reports and cohort studies have described many clinical characteristics of patients with coronavirus disease 2019 (covid-19), an emerging infectious disorder caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2). in early covid-19 studies, some evidence has been provided that electrolyte disorders may also be present upon patients' presentation, including sodium, potassium, chloride and calcium abnormalities the aim of the study is identification of elements that affect covid-19 pathology to improve survival and decrease mortality rate.

sars-cov-2 invades human cells through binding angiotensin i converting enzyme 2 (ace2) on the cell membrane. ace2 is widely distributed in many types of human tissues, especially in the vital organs, such as heart, liver, kidney, and lungs. ace2 is viewed as the principal counter-regulatory mechanism for the main axis of renin-angiotensin system (ras) that is an essential player in the control of blood pressure and electrolyte balance. the final effect is to increase reabsorption of sodium and water, and thereafter increase blood pressure and excretion of potassium (k+). besides, patients with covid-19 often had gastrointestinal symptoms such as diarrhea and vomiting early studies proved that high percentage of covid-19 patient were presented with electrolyte disorders, including sodium, potassium, chloride and calcium abnormalities. such electrolyte disturbances have important implications not only for patient management but also for identifying potential pathophysiologic mechanisms underlying covid-19 that could drive novel therapeutic opportunities

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old who were confirmed by the real-time pcr on the respiratory tract samples as positive of sars-cov-2. exclusion criteria: * patients who had other causes of electrolyte disturbances (9): * chronic organ dysfunction (e.g., hepatic or renal dysfunction), * terminal cancer, immunodeficiency, and * patients with a history of long-term use of hormones \& diuretics were excluded.

Keywords: electrolytes; covid-19
protecting kidneys through a low protein diet: a stepwise multiple-choice system approach

Conditions: Chronic Kidney Diseases

Summary: nephrology care continues to progress and recommendations are now focused on delaying as much as possible the need for renal replacement therapy ("intent-to-defer"strategy). protein restriction is a valuable tool for stabilizing chronic kidney disease (ckd) and retarding the need for renal replacement therapy, but the best diet to be prescribed is still matter of discussion. this study is aimed at identifying implementation strategies for nutritional management of advanced ckd.

the recent paradigm on dialysis start suggests that an intention to defer policy should be preferred to beginning dialysis early ("the earliest the best" strategy). this strategy is further supported by the consideration that patient profiles are changing with the increasing proportion of older and higher comorbidity patients. in high comorbidity patients, survival is not necessarily improved by dialysis. nutritional care, adapted to each patient's needs and preferences, could in part answer these demands. indeed, renal function has a strict correlation with dietary patterns. low protein diets may have two favourable effects: 1) slowing down kidney function decline and 2) delaying the need of replacement therapy (metabolic stabilizing). in dialysis, the nutritional state is the most important survival indicator, and nutritional follow-up should allow starting dialysis in a good nutritional status. the study proposed here is an implementation study with a principal aim to improve the use of low protein diets in the clinical setting, by offering a multiple choice approach and by adapting the diets to the patients' needs.

Eligibility criteria:
inclusion criteria: * all adult patients followed on the unit for advanced ckd, with kidney disease stage 4-5 or stage 3 with fast progression and without contraindications. exclusion criteria: * malnutrition or short life-expectancy * patients aged less than 18 years old * pregnant women, * incapacity to complete the free-consent form, * pateints refusing participation in the study, * patients without healthcare coverage.

Keywords: low-protein diet pre-dialysis chronic kidney disease nutritional care start of dialysis incremental dialysis
safety and efficacy of oral etrasimod in adult participants with moderate-to-severe alopecia areata

Conditions: Alopecia Areata

Summary: the purpose of this study is to evaluate the safety and efficacy of etrasimod monotherapy (2 milligrams \[mg\] and 3 mg) in participants with moderate-to-severe alopecia areata (aa).


Eligibility criteria:
key inclusion criteria: * men or women between ≥18 and ≤70 years of age at the time of informed consent * moderate-to-severe alopecia areata as assessed by a salt score of ≥25 and \<95 at screening and day 1/baseline. * current episode of hair loss for ≥6 months but \<5 years * stable disease condition (no significant growth of hair) in the last 6 months as assessed by the investigator * willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study key exclusion criteria: * history of male or female pattern hair loss \>hamilton stage iii or \>ludwig stage ii * other types of alopecia (eg, cicatricial/scarring alopecia \[including central centrifugal cicatricial alopecia\], traction alopecia, or telogen effluvium) or other diseases that could cause hair loss * active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the salt assessment * previous use of janus kinase (jak) inhibitor (oral or topical), including participation in clinical studies of jak inhibitors

Keywords: t-cell-mediated autoimmune skin disorder alopecia areata alopecia apd334 etrasimod hair loss
investigating the role of ginger tea orac value in hypertension management

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the antihypertensive effects of ginger tea. by examining its impact on blood pressure levels, this research aims to determine whether ginger tea can be an effective, natural adjunct to conventional hypertension treatments.

this investigation will provide insights into its potential role in reducing the burden of hypertension and improving cardiovascular health

Eligibility criteria:
inclusion criteria: * adults aged 30-65 years * diagnosed with stage 1 or stage 2 hypertension * not currently taking antihypertensive medication * willing to provide informed consent and adhere to study protocols. exclusion criteria: * pregnant or breastfeeding women * participants on antioxidant supplements or other herbal teas.