Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate pharmacokinetics and safety of pf-06700841 after single and multiple oral doses as modified release formulations

Conditions: Healthy Participants

Summary: the purpose of the study is to evaluate the pharmacokinetics (pk), safety, and tolerability of pf-06700841 following single and multiple oral doses as modified release (mr) formulations in healthy, adult participants under fasted and fed conditions. the objective of part a is to evaluate the relative bioavailability and food effect of 2 new mr formulations, mr1 and mr2. the objective of part b is to evaluate the pk and safety/tolerability of mr3 formulation following multiple dose administration over a 7-day period. overall, results from both parts will facilitate further development of an mr formulation for future clinical studies.


Eligibility criteria:
inclusion criteria: * healthy male and female participants between 18 -55 years of age. * bmi of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * participants who are willing and able to comply with all scheduled visits, treatment * plan, laboratory tests, lifestyle considerations, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * conditions that affect drug absorption (e.g., gastrectomy cholecystectomy) * history of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives) * positive urine drug test. * history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c; positive testing for hiv, hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab) or hepatitis c antibody (hcvab). hepatitis b vaccination is allowed. * history of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening. binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours
myocardial perfusion imaging in liver transplantation candidates

Conditions: Myocardial Perfusion Imaging; Liver Failure

Summary: the optimal screening strategy for assessment of coronary artery disease in patients with end-stage liver disease (esld) is unclear. although consensus based guidelines support noninvasive stress testing prior to orthotopic liver transplantation (olt), no prospective studies are available to inform the clinician on perioperative risk stratification. this observational cohort study was designed to determine the prognostic utility of single photon emission computed tomography (spect) imaging in olt candidates.

controversy over whether spect imaging offers clinical utility in esld has been fuelled by conflicting reports on its accuracy to diagnose cad in this setting. moreover, there are no studies examining whether spect imaging provides any incremental prognostic value beyond functional testing in this high-risk cohort. we sought to determine the relative importance of cv risk factors, functional capacity and spect perfusion results as independent predictors of cardiovascular mortality in olt candidates.

Eligibility criteria:
inclusion criteria: • liver transplantation candidates with one or more of the following: * inability to perform \>4 mets by history * insulin-treated diabetes mellitus * serum creatinine \>152μmol/l * history of mi, pci or cabg * stable angina * cerebrovascular disease * peripheral vascular disease exclusion criteria: * age \< 18 years * pregnancy * contraindication to liver transplantation
a multicenter, prospective, randomized trial of adjuvant chemotherapy for early-stage cervical cancer patients

Conditions: Uterine Cervical Neoplasms; Cervical Cancer; Uterine Cervical Cancer

Summary: we will conduct a trial to determine whether paclitaxel/cisplatin (tp) as an adjuvant chemotherapy after radical surgery improve disease-free survival (dfs) and overall survival (os), as well as the quality of life (qol) among early-stage (figo stage ib-iia) cervical cancer patients with risk factors.


Eligibility criteria:
inclusion criteria: * figo stage: ⅰb～ⅱa, cervical cancer; * age≤60 years; female, chinese women; * initial treatment is radical hysterectomy + pelvic lymph node dissection; * pathological diagnosis: cervical squamous cell invasive carcinoma; * pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (g2 to g3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter\> 4cm; * laboratory tests: wbc≥4×10(9)/l, neu≥2×10(9)/l, plt≥80×10(9)/l, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, bun, cr≤ normal * performance status: karnofsky score≥60; * no prior treatment; * receiving extensive resection of uterus (type iii) plus pelvic lymph nodes wide resection; pathologically diagnosed with cervical squamous cell carcinoma; * provide written informed consent. exclusion criteria: * with severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy * history of organ transplantation, immune diseases; * history of serious mental illness, a history of brain dysfunction; * drug abuse or a history of drug abuse; * suffering from other malignancies; * concurrently participating in other clinical trials * unable or unwilling to sign informed consents; * unable or unwilling to abide by protocol.
geographic atrophy treatment evaluation

Conditions: Geographic Atrophy; Age-Related Macular Degeneration

Summary: the purpose of this study was to evaluate the safety and efficacy of al-8309b ophthalmic solution versus vehicle administered as a topical ocular drop for the treatment for geographic atrophy (ga) secondary to age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * willing to give written informed consent, make required study visits, and follow instructions. * able to administer eye drops or have a caretaker to administer the eye drops. * study eye: atrophy secondary to age-related macular degeneration, best corrected visual acuity (bcva) of 35 letters (20/200 snellen equivalent) or better, clear ocular media, and adequate pupillary dilation. * other protocol-defined inclusion criteria may apply. exclusion criteria: * pregnant, nursing, or not using adequate contraception. * ocular disease in the study eye, other than non-exudative amd. * history of cataract surgery in either eye within the past 3 months of screening. * history or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening. * any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely. * participation in an investigational drug or device study within 30 days of screening. * other protocol-defined exclusion criteria may apply.

Keywords: geographic atrophy ga age-related macular degeneration amd
use of canagliflozin in conjunction with insulin in a real-world setting

Conditions: Type 2 Diabetes Mellitus

Summary: this study is a retrospective chart review study aiming to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy. furthermore, the project aims to establish an emr-based cohort of patients with type 2 diabetes mellitus (t2dm) treated with canagliflozin to allow for future longitudinal studies that investigate outcomes over a longer follow-up period, and whether canagliflozin (when used in addition to insulin therapy) has an impact on diabetes-related healthcare costs.

this retrospective study will use data from an electronic medical record (emr)-based database (web based diabetes records (web dr) researchable database), which has been used to study patient's socioeconomic characteristics, treatment patterns and health outcomes of patients with diabetes. the web dr de-identified researchable database contains integrated demographic, clinical and laboratory test result data of patients who received care from outpatient diabetes clinics in london, ontario. the database includes more than 16,000 patients and their clinic visit information since 2000. adult individuals (age\>=18) with type 2 diabetes receiving , registered in web dr who have been treated with canagliflozin in conjunction with insulin therapy will be selected for this study. the baseline period will be 6 months to allow for more complete observation of comorbidities and medication use patterns. the main objective of this project is to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy. hba1c, lipid, blood pressure, weight and other clinical indicators will be gathered from lab results during the baseline period closest to the date of canagliflozin prescription and follow up period (the last clinical value within the follow-up period and \>=30 days after the start of the medication data will be selected. the type of insulin used and dosages prescribed during the study follow-up period will be extracted from the database to examine the insulin dosage prescription pattern and understand the use of insulin with canagliflozin and its impact on clinical outcomes. furthermore, use of oral antihyperglycemic agents (metformin, sulfonylureas, thiazolidinedione, alpha-glucosidase inhibitors, meglitinides, dipeptidyl peptidase-4 (dpp-4) inhibitors, bromocriptine) and injectable antihyperglycemic therapies (pramlintide, glucagon-like peptide-1 (glp-1) receptor agonists) will be measured during the 6 months baseline period and the follow-up period of 3 and 6 months.

Eligibility criteria:
inclusion criteria: * type 2dm \>18 years of age, diabetes patients on insulin who initiated canagliflozin due to a need of tighter glycemic control . exclusion criteria: * glomerular filtration rate (gfr)\<45, pregnancy, type 1

Keywords: canagliflozin diabetes sglt2 real-world data
the effect of hot application on post laparoscopic shoulder pain and analgesic use

Conditions: Pain, Shoulder

Summary: the aim of this study; to evaluate the effect of hot application on postlaparoscopic shoulder pain and analgesic use in patients undergoing upper laparoscopic surgery in general surgery.

among the advantages of laparoscopic surgery; smaller incisions, less postoperative pain, less need for analgesia, shorter hospital stay, earlier return to normal activities and lower morbidity. however, laparoscopic surgery is associated with postoperative shoulder pain, which is rarely seen in open surgeries. the precise mechanism of postlaparoscopic shoulder pain (ploa) is unclear, but it is believed that the carbon dioxide remaining after laparoscopic surgery causes shoulder pain by causing irritation of the phrenic nerve. in some cases, ploa may cause more discomfort to the patient than incisional pain. hot application is an effective method used to relieve pain. hot application activates the gate control mechanism, stimulating tactile receptors, reducing ischemic pain with vasodilation, removing metabolic wastes, increasing the release of endorphins, eliminating muscle spasm, reducing effects such as pressure, stretching and hypoxia on nerve endings as a result of changes in the viscoelastic properties of tissues, raising the pain threshold, it reduces or relieves pain by sedating and creating relief in the patient. hot application is easy to use, inexpensive, requires no prior application, and has minimal adverse side effects when used correctly. heat sources include a hot water heater, an electric heating pad, a warm blanket, and a warm bath or shower. in addition to being used as a pain reliever, heat is used to relieve chills or shivering, reduce joint stiffness, reduce muscle spasm, and increase connective tissue extensibility. in the study of mohamed et al., in which they examined the effect of hot application and early mobilization on shoulder pain, in the experimental group patients who received hot application; postoperative shoulder pain was found to be significantly less than the control group at different evaluation times at 4 hours after surgery and at 6, 12 and 24 hours (p\<0.001).

Eligibility criteria:
inclusion criteria: 1. agreeing to participate in the research, 2. having undergone laparoscopic abdominal surgery 3. those who have no previous history of surgery exclusion criteria: 1. those who did not agree to participate in the research 2. those who have had previous abdominal surgery

Keywords: postlaparoscopic shoulder pain analgesic hot application
immune thrombocytopenia management in adults

Conditions: Immune Thrombocytopenia Purpura

Summary: immune thrombocytopenia treatment has evolved recently. however, none of treatments have only benefits without drawbacks. this study compares the clinical outcomes and adverse drug patterns of different treatment options. medications which will be assessed during the current study are high dose-dexamethasone (hd-dxm) (control group), prednisolone + azathioprine, rituximab, eltrombopag, and romiplostim.

a prospective controlled randomized study was conducted on primary immune thrombocytopenia patients. the study's main objective is to evaluate the efficacy and adverse events profile of the different therapeutic approaches during immune thrombocytopenia. upon the confirmation of the immune thrombocytopenia diagnosis, all patients immediately initiated the high dose-dexamethasone as a frontline therapy for immune thrombocytopenia with a dose of 40 mg/m2 daily for 4 days/week in the first month for one cycle. then, the recruited patients who fulfilled the inclusion criteria are randomly assigned into one of five groups. among these patients, the control group received iv pulse (hd-dxm) therapy with 40 mg/m2 daily for 4 successive days in a 28-day cycle to complete the six cycles. the prednisolone + azathioprine group received 20 mg of prednisolone three times daily and 1 mg/kg of oral azathioprine once daily for two weeks, then tapering the prednisolone dose through the subsequent weeks (6 weeks). while continuing treatment with azathioprine for a total of six months. the rituximab group received 500 mg/m2 intravenously of rituximab once weekly for one month. the eltrombopag group received 50 mg of eltrombopag four hours before or after meals as oral daily doses for 6 months. the romiplostim group received 3μg/kg sub-cutaneous injection of romiplostim once a week for 6 months. the first evaluation date of confirmed itp diagnosis was well-defined as the first index date (baseline). after that, every patient visited the investigational site as the protocol prescribes once weekly to assess and adjust the doses of study medications. the outcome measures were judged at baseline, at the end of treatment (6 months), and after an additional 6-month free treatment period.

Eligibility criteria:
inclusion criteria: * inclusion criteria were adult patients aged 18 years or older, diagnosed with primary itp after excluding secondary causes and with an initial plts count of less than 30 ×109/l or with hemorrhage manifestations. exclusion criteria: * patients with a confirmed secondary itp diagnoses such as (chemicals induced, systemic lupus erythematosus, immune thyroid diseases, a lymphoproliferative disease, or chronic infection, such as helicobacter pylori, human immunodeficiency virus (hiv) or hepatitis c virus (hcv); with cardiac, renal, or liver disease; who had received nsaids or anti-platelets within one month before the initiation of the enrollment were excluded from the study.

Keywords: primary immune thrombocytopenia etrombopag dexamethasone romiplostim rituximab autoimmune disorder
comparative study of the therapy of solar lentigines with a q-switched rubin laser versus a bleaching cream

Conditions: Solar Lentigines

Summary: benign pigmented lesions as solar lentigines are a common finding in caucasian individuals. their removal may be requested for aesthetic reasons. the goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines. the right back of the hand side will be treated with the q-switched sinon rubin 694nm laser, the left back of the hand side with a hydrochinon containing bleaching cream (pigmanorm® cream). the investigators estimate that a physical therapy with a q-switched rubin laser system is more effective in the removal of solar lentigines than a topical chemical therapy with a hydrochinon containing bleaching cream.


Eligibility criteria:
inclusion criteria: * age ≥ 50 * female patient must be in post-menopause (\> 2 years) * clinically and dermoscopic confirmed solar lentigines on both sides back of the hands exclusion criteria: * non melanocytic pigmentation, vitiligo, melanoma and suspicion of melanoma * intolerance against an ingredience of pigmanorm® cream * acute inflammation or eczema on back of the hands * patients with renal disease * intake of photosensibilisating medication in the past 3 months * treatment of solar lentigines on back of the hands in the past 6 months * solarium or sun exposure about 6 weeks before and after treatment * immunsuppressed patients

Keywords: solar lentigines q-switches laser bleaching cream
fenugreek: an emergent allergen

Conditions: Fenugreek Hypersensitivity - Cross-reactivity - Food Allergy

Summary: fenugreek or trigonella foenum greacum is an ancient medicinal plant native to the eastern mediterranean, later spread to asia (especially in india); it belongs to rosaceae order, leguminosae family, subfamily of papilonaceae and it is used as a medicinal herb, spice or food. it is a component of spice mix, such as curry, and it is also used as a supplement in wheat and corn flour for bread-making. fenugreek appears to have many health benefits and potential medicinal properties (antioxidant, antidiabetic, hepatoprotective, hypocholesterolemic, antimicrobial, anti-inflammatory, neuroprotective, anticarcinogenic, antiulcer, and antilithigenic) both in vitro and in vivo studies; for this reason it may be increasingly being used as nutraceutical formulations (powder, herbal teas, tablets and various combinations).this study aims to describe patients who came to our operating unit for suspected adverse reaction after ingestion of fenugreek and to highlight possible cross-reactivity between fenugreek and other legumes or other foods. given the increasing use of novel spices in mediterranean cuisine and the possible spread of fenugreek-based nutraceuticals, it is relevant to draw attention to possible allergic reactions.


Eligibility criteria:
inclusion criteria: * age \> 18 yo * history of allergic reactions to spices * history of allergic reactions to phytotherapics containing fenugreek exclusion criteria: * age \< 18 yo * non suggestive history of allergic reactions to spices
a trial to evaluate safety, tolerability and efficacy of elamipretide in subjects with barth syndrome

Conditions: Barth Syndrome

Summary: a randomized, double-blind cross over trial to evaluate the safety, efficacy, and tolerability of elamipretide in subjects with barth syndrome.

a phase 2 randomized, double-blind, placebo-controlled crossover trial to evaluate the safety, tolerability, and efficacy of subcutaneous injections of elamipretide in subjects with genetically confirmed barth syndrome followed by open-label treatment extension. part 1 was a randomized, double-blind, placebo-controlled, crossover trial to assess safety, tolerability, and efficacy single daily subcutaneous (sc) doses of 40 mg elamipretide administered for 12 weeks in subjects with barth syndrome. part 2: this was an open-label extension trial to assess the long-term safety, tolerability, and longitudinal trends in efficacy single daily sc doses of 40 mg elamipretide for up to 192 weeks.

Eligibility criteria:
inclusion criteria: * genetically confirmed barth syndrome * male aged 12 and above * at the screening visit, egfr must meet the following: 1. body weight \>30 kg and egfr ≥ 90ml/min at screening 2. body weight \>40kg and egfr ≥60 but \<90ml/min/ 1.73m² at screening * ambulatory and impaired during the baseline 6mwt * on stable medication for 30 days prior to the baseline visit exclusion criteria: * participated in another interventional clinical trial within 30 days of or is currently enrolled in a non-interventional clinical trial at the baseline visit potentially confounding with this trial * prior or current medical condition that would prevent the subject from safely participating in the trial * undergone any inpatient hospitalizations within 30 days of the baseline visit * is undergoing an apparent pubertal growth spurt * has uncontrolled hypertension * history of substance abused within the year before the baseline visit or is likely to be uncompliant * history of heart transplantation or current placement on the waiting list for a heart transplant * for subjects with an icd: known occurrence of icd discharge in the 3 months prior to the baseline visit * for subjects without an icd: expected to undergo an implantation of an icd during the conduct of the study * currently receiving treatment with chemotherapeutic agents or immunosuppressant agents or has received prior radiation therapy to the chest * recipient of stem cell or gene therapy or is currently being treated by a therapeutic investigational device

Keywords: barth syndrome elamipretide mtp-131 stealth stealth bt bths
evaluation of home-based sensor system to detect health decompensation in elderly patients with history of chf

Conditions: CHF; Congestive Heart Failure

Summary: sensorum health (sensorum) is conducting a pilot study to determine if sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.


Eligibility criteria:
inclusion criteria: * current patient at weill cornell medicine * aged 55 years or older * able to consent * documented diagnosis of congestive heart failure (chf) * at least 1 of the following prior hospital utilization events in the past 12 months * inpatient admission for any reason * facility observation stay for any reason * emergency department visit for any reason exclusion criteria: * significant cardiac valvular disease * end-stage renal disease (esrd) * end-stage chf * end-stage copd
us vs mri for stress injuries

Conditions: Stress Fracture

Summary: the primary purpose of this study is to determine whether or not there is a correlation between mri and ultrasound for the diagnosis of lower limb stress injuries. patients that are seen at the university of iowa sports medicine center with a suspected diagnosis of a lower limb stress injury will be recruited. these patients will undergo a diagnostic ultrasound of the affected region prior to undergoing an mri of that region. then, the ultrasound findings will be compared to the mri findings to determine if a correlation exists.


Eligibility criteria:
inclusion criteria: * age 18-50 * mri confirmed tibial or metatarsal stress injury exclusion criteria: -prior history of stress fracture or fracture in the affected limb at the region of concern.