Kornimate/medical-research-clean huggingface dataset:
a study of the treatment of type 2 diabetes with an insulin infusion pump

Conditions: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this trial is conducted in the united states of america (usa). this is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period. a telephone contact visit is scheduled as a follow-up for the final clinic visit. a subject's participation in this trial would be expected to be up to 16 weeks.


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosis at least 2 years ago * body mass index (bmi): 26-40 kg/m\^2 (both inclusive) * hba1c: 7.5-10% (both inclusive) * fpg values at least 140 mg/dl (7.8 mmol/l) exclusion criteria: * use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action or glucose utilization (steroids or non-specific beta-blockers) * current addiction to alcohol or substances of abuse or positive results on urine screen for drug and alcohol use * known or suspected allergy to trial products or related products

Keywords: pump diabetes
effect of aprepitant on cyclophosphamide pharmacokinetics in patients with breast cancer

Conditions: Breast Cancer; Nausea and Vomiting

Summary: rationale: antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and vomiting in patients undergoing chemotherapy. purpose: this randomized clinical trial is studying aprepitant to see how well it works compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for breast cancer.

objectives: primary * to evaluate the effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma auc in patients with breast cancer. secondary * to evaluate total control of nausea and vomiting, as defined by no vomiting episodes and no use of rescue medication, 72 hours after courses 1 and 2 of chemotherapy. outline: patients are randomized to 1 of 2 treatment arms. * arm i: patients receive aprepitant 125 mg orally once daily on day 1 and 80 mg orally once daily on days 2 and 3. beginning 1 hour after receiving aprepitant, patients receive an infusion of cyclophosphamide on day 1. during course 2, patients crossover and receive treatment (placebo) as in arm ii. * arm ii: patients receive a placebo 125 mg orally once daily on day 1 and 80 mg orally once daily on days 2 and 3. beginning 1 hour after receiving the placebo, patients will receive an infusion of cyclophosphamide infusion on day 1. during course 2, patients crossover and receive treatment (aprepitant) as in arm i. patients complete a diary documenting nausea and vomiting on days 1, 2, and 3 of both courses. patients also complete the functional living index-emesis (flie) questionnaire documenting compliance, rescue antiemetic therapy, and any adverse effects and record them in the diary for each course. information in the patient's diary is obtained by the coordinator via telephone on day 4 of each course. patients undergo blood sample collection periodically for pharmacokinetic studies via high performance liquid chromatography.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * planning to receive cyclophosphamide 600 mg/m²-1,000 mg/m² iv infusion * no cyclophosphamide dose change between courses 1 and 2 patient characteristics: * life expectancy ≥ 2 months * anc ≥ 1,500/μl * platelet count ≥ 100 x 10\^9/l * hemoglobin ≥ 9.0 g/dl * serum creatinine ≤ 1.5 mg/dl * ast/alt ≤ 2 times upper limit of normal * not pregnant or nursing * no contraindication to aprepitant prior concurrent therapy: * see disease characteristics * no concurrent medications that are cyp3a4 substrates, inhibitors, and/or inducers, with the exception of the dexamethasone contained as part of the standard antiemetic regimen

Keywords: nausea and vomiting breast cancer
ultraviolet-a and riboflavin treatment for infectious keratitis

Conditions: Infectious Keratitis

Summary: this study is to evaluate the efficacy of ultraviolet-a (uva) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.


Eligibility criteria:
inclusion criteria: 1. subjects must be 18 years of age or older. 2. ability to provide written informed consent. 3. likely to complete all study visits. 4. subjects must have one eye that with a diagnosis of infectious keratitis. exclusion criteria: 1. a corneal perforation. 2. descemetocele. 3. pregnancy or breastfeeding. 4. active herpes corneal disease. 5. patient is unwilling or unable to comply with a medication regimen and follow up appointments.

Keywords: infectious keratitis
study to evaluate the efficacy and safety of aliskiren alone and in combination with amlodipine in essential hypertension

Conditions: Hypertension

Summary: evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: * msdbp ≥ 90 mmhg and \< 110 mmhg at the visit prior to visit 3 (visit 2 or optional visit 201) * msdbp ≥ 95 mmhg and \< 110 mmhg at visit 3 (day 1 / randomization). * all patients must have an absolute difference of ≤ 10 mmhg in their msdbp during the last 2 visits of the single-blind run-in period (visit 2 and 3 or visits 201 and 3). exclusion criteria: * severe hypertension * pregnant or nursing (lactating) women * women of child-bearing potential * previous or current diagnosis of heart failure (nyha class ii-iv). * serum potassium ≥ 5.3 meq/l (mmol/l) at visit 1. * uncontrolled type 1 or type 2 diabetes mellitus * hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures * history of malignancy within 5 years * history of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (tia), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention

Keywords: hypertension, aliskiren, amlodipine
safety and efficacy of oral bt-11 in crohn's disease patients with moderate to severe disease

Conditions: Crohn's Disease

Summary: this is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (bt-11) in patients with moderate to severe crohn's disease (cd).


Eligibility criteria:
key inclusion criteria: 1. male and female subjects age 18 to 75 years, inclusive. 2. diagnosis of cd for at least 6 weeks prior to screening 3. moderate to severely active cd as defined by all of the following: * cdai score of 220-450 * pro-2 stool frequency (sf) ≥ 4 and/or abdominal pain (ap) ≥ 2 * ses-cd ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader key exclusion criteria: 1. participant has ulcerative colitis 2. participant is at imminent risk of ileo-colectomy 3. prior enrolment in the current study and had received study treatment.
investigate role of metabolic imaging in predicting tumor response/outcome after pancreatic ca tx

Conditions: Pancreatic Cancer

Summary: to test the ability of new imaging techniques to monitor and predict response of pancreatic cancer to radiation and/or chemotherapy.


Eligibility criteria:
inclusion criteria:- adult patients (\>18) with histologically confirmed adenocarcinomas of the pancreas with a - treatment plan consisting of definitive or palliative radiation therapy and/or chemotherapy with or without surgery. * negative urine pregnancy test if a woman of child-bearing potential (wocbp). * wocbp must be using an adequate method of contraception to avoid pregnancy throughout the study period. * all patients will be evaluated in a uniform manner at the stanford gi combined modality tumor board to determine eligibility. exclusion criteria:1. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 2. any concurrent malignancy other than non-melanomaskin cancer, or carcinomainsitu of the cervix. patients with a previous malignancy without evidence of disease for \>5 years will be allowed to enter the trial. 3. wocbp who is pregnant or breastfeeding. 4. inability to sign written consent.
effects of platelet rich fibrin (prf) in treatment of non-healing sternum wound after open-heart surgery

Conditions: Sternal Wound Repair

Summary: sternal wound and there complication such as infection, bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%. several approaches have been proposed for treatment of chronic sternal wounds in these patients. however, underlying confounding factors such as old ages,diabetes mellitus, systemic hypoxia, atherosclerosis and malnutrition have main role against wound repairing. in this study investigators aimed to treatment of patients with open heart surgery and need to strict monitoring of sternal wound repair by platelet rich fibrin.


Eligibility criteria:
inclusion criteria: * the patient has been diagnosed with an acute stemi or nstemi (confirmed by segment elevation (st) changes on serial ecg, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography) * the patient is scheduled to undergo coronary artery bypass surgery. * the patient does not possess any contraindication for cardiovascular magnetic resonance (cmr). * the patient is capable of giving informed consent. * the patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study. exclusion criteria: * the patient is over the age of 65 years. * the patient has previous myocardial infarction (mi) (other than the qualifying event) and/or has scar or non-viable myocardium identified by cmr in any other left ventricular (lv) territory. * the patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery). * the patient requires emergency surgery (i.e. operative intervention (cabg or ventricular assist device) within 24-hrs of assessment). * the patient has undergone previous cardiac surgery. * the patient's postsurgical life expectancy is less than 45 days, in the investigator's opinion. * the patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery. * the patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
optimal strategy of primary pci for left main coronary artery occlusion induced ami

Conditions: Acute Myocardial Infarction; Percutaneous Coronary Intervention

Summary: this study will compare clinical outcomes of immediate stent implantation with deferred stent implantation(4-10days after primary angiography) for patients presented with acute myocardial infarction due to left main coronary artery occlusion.

primary percutaneous coronary intervention for patients presented with acute myocardial infarction caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major cardiac adverse events. deferred stent implantation may improve prognosis of primary pci through reducing distal embolization and no-reflow phenomenon. there is no randomized clinical trial focuses on the effect and outcome of deferred stent implantation on primary pci for left main coronary artery occlusion in contrast with conventional strategy. this prospective, multicenter, randomized trial is aimed to compare immediate stenting with deferred stenting for lm-ami with 30 centers in china involved. we hope to determine whether deferred stenting is superior to conventional strategy for primary pci of ami caused by left main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute myocardial infarction occured within 12 hours * left main coronary artery occlusion confirmed by angiography * left main coronary artery occlusion (timi flow 0,1 or 2) confirmed by primary angiography, timi flow grade 3 achieved after pretreatment of thrombus aspiration or balloon dilatation exclusion criteria: * life expectancy less than 1 years * cardiogenic shock * chronic kidney disease, stage 4 by kdoqi(gfr\<30ml/min) * contraindications to aspirin or other anti-platelet drugs * allergy to contrast agent, rapamycin or paclitaxel * patients who are included in other ongoing trials * pregnant female

Keywords: acute myocardial infarction percutaneous coronary intervention deferred stent implantation
comparison of corneal stromal tissue consumption (latac)

Conditions: Disorders, Refractive

Summary: in refractive surgery, stromal ablation depth is fundamental because it determines the thickness of the residual posterior wall. the posterior wall is an essential element that guarantees the refractive stability and the long term prevention of corneal ectasia after corneal refractive surgery. a minimum thickness of more or less 300 microns is universally accepted. its calculation is based on well-known formulas, such as munnerlynn ones. with the excimer laser platform last generation wavelight® allegretto® ex-500 of alcon, a new treatment option called "wavefront optimized" is offered for myopia, astigmatism and hyperopia. the ablation profile has been developed to save stromal tissue consumption and to favor the quality of vision, by optimizing connections between the optical zone and the transition zone of the photoablation. alongside the theoretical formulas, evaluation of the depth of ablation may be defined by differential ultrasonic pachymetry or by topographical analysis pre and postoperatively. the latter is currently the method of reference to assess the corneal thickness.


Eligibility criteria:
inclusion criteria: * patients having a refractive disorder and for whom a refractive surgery is programmed. exclusion criteria: * patient opposed to participation in the study * another refractive surgery technique * hyperopic patient * pregnant or lactating woman * patient under a measure of legal protection * absence of affiliation to social security or universal health coverage (cmu)
the effect of bone grafts on facial gingival profile in maxillary anterior single tooth replacement

Conditions: Facial Gingival Profile

Summary: the purpose of this investigator-initiated study is to evaluate the facial gingival profile following immediate implant placement and provisionalization in conjunction with connective tissue graft with or without bone graft

thirty subjects who are at least 18 years old with a failing upper front tooth seeking for implant treatment will be recruited at loma linda university school of dentistry (llusd), where the consent will also take place. the subjects will be randomly divided into 3 groups. the subjects will receive immediate implant placement and provisionalization (iipp) in conjunction with connective tissue graft (ctg) with (group i) or without (group ii) bone graft in the extraction socket; and with bone graft in extraction socket and at the facial aspect of failing tooth (group iii). clinical, radiographic and model assessments will be performed at different time intervals (pre-treatment to 12 months after implant placement) and statistically analyzed (α = 0.05) to evaluate peri-implant tissue response and facial gingival profile of the implants. complications, if any, will also be recorded and appropriately addressed.

Eligibility criteria:
inclusion criteria: 1. patients must be 18 years of age or older, are no longer growing and able to read and sign an informed consent. 2. good oral hygiene. 3. a single failing maxillary anterior tooth (#6-11) with the presence of healthy adjacent teeth. 4. adequate bone volume to accommodate an implant with minimum dimensions of 3.6 mm diameter and 10.0 mm length. 5. presence of opposing dentition (natural teeth, fixed or removable prostheses) 6. healthy soft tissue at the future implant site. exclusion criteria: 1. a medical history that would complicate the outcome of study such as alcohol or drug dependency, poor health ,uncontrolled diabetes, immunodeficiency diseases, taking any medication that may cause gingival over growth or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and required follow-up examinations. 2. dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion 3. smoker. 4. history of head and neck radiation. 5. soft tissue defect (inflammation, tissue cleft, unhealthy tissue) around a future implant site. 6. inability to achieve primary implant stability following immediate implant placement.
comparing the therapeutic efficacy of pimecrolimus cream with betamethasone cream for discoid lupus erythematosus

Conditions: Discoid Lupus Erythematosus

Summary: discoid lupus erythematosus lesions are commonly treated with corticosteroids, but corticosteroids may induce side effects such as thinning of the skin or scarring. therefore, an alternative medication with the same efficacy, but without the side-effects is sought after. pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. its efficacy in treating discoid lupus erythematosus has not been studied extensively yet. however studies performed till now show promising results. long-term topical use of this medication has not shown any serious side-effects in other skin diseases. in this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic choice, betamethasone valerate 0.1% cream, to see if pimecrolimus can be used as an alternative medication in treating discoid lupus erythematosus.


Eligibility criteria:
inclusion criteria: * patients harboring discoid lupus erythematosus lesions on their face or neck exclusion criteria: * patients with discoid lupus erythematosus in the setting of systemic lupus erythematosus * patients having a more disseminated disease

Keywords: discoid lupus erythematosus pimecrolimus 1% cream betamethasone valerate 0.1% cream
pompe pregnancy sub-registry

Conditions: Glycogen Storage Disease Type II (GSD-II); Pompe Disease (Late-onset); Glycogenesis 2 Acid Maltase Deficiency

Summary: this sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the pompe registry, regardless of whether she is receiving disease-specific therapy (such as ert with alglucosidase alfa or avalglucosidase alfa) and irrespective of the commercial product with which she may be treated. no experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. the primary objective of this sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with pompe disease during pregnancy, regardless of whether they receive disease-specific therapy, such as ert with alglucosidase alfa or avalglucosidase alfa.

study design time perspective: retrospective and prospective

Eligibility criteria:
inclusion criteria: eligible women must: * be enrolled in the pompe registry (nct00231400) * be pregnant, or have been pregnant with appropriate medical documentation available. * provide a signed informed consent and authorization form(s) to participate in the sub-registry prior to any sub-registry-related data collection being performed. note: it is recommended that pregnancy data be collected on eligible women regardless of infant enrollment. in the event of patients having multiple pregnancies, participation in this sub-registry is encouraged for each individual pregnancy. exclusion criteria: there are no exclusion criteria for this sub-registry

Keywords: glycogen storage disease type ii (gsd-ii) gsd-ii pompe disease pompe disease (late-onset) acid maltase deficiency disease glycogenosis ii
liposomal bupivacaine versus standard analgesia in total joint arthroplasty (tja)

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis, Shoulder

Summary: the purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.

liposomal bupivacaine (exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. it is designed to be injected at the time of surgery into the local soft tissues. because of its unique liposomal delivery system, liposomal bupivacaine (exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. this makes it an attractive option in total joint arthroplasty patients. combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (exparel®) may provide extended pain relief following total joint arthroplasty. this has the potential to avoid the need for opioid medications. with better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of osteoarthritis 2. elected to undergo primary tka, tha, or tsa exclusion criteria: 1. age \< 18 years 2. pregnant or breastfeeding 3. non-english speaking 4. unable to give informed consent 5. previous open hip, knee or shoulder surgery 6. pre-determined patients discharging to ecf 7. patients with allergies to bupivacaine 8. patients currently taking opioid pain medication 9. patients with contraindication to nerve blocks 10. patients undergoing simultaneous bilateral joint replacement, as this would require \>1 dose of liposomal bupivacaine (exparel®) per patient for each surgical site 11. patients with severe hepatic disease 12. patients with chronic heart disease as defined as a decreased ejection fraction

Keywords: total knee arthroplasty total shoulder arthroplasty total hip arthroplasty total joint arthroplasty hip replacement knee replacement shoulder replacement