Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of galvus as add-on therapy to metformin plus glimepiride

Conditions: Type 2 Diabetes Mellitus

Summary: this study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with type 2 diabetes (t2d).


Eligibility criteria:
inclusion criteria * confirmed diagnosis of t2dm by standard criteria. * treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with su, tzds, or glinides * age: ≥18 to ≤ 80 years * hba1c of ≥ 7.5 and ≤ 11.0% * body mass index (bmi) ≥22 to ≤45 kg/m2 exclusion criteria: * fpg ≥ 270 mg/dl (≥ 15.0 mmol/l) * acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months * any of following within past 6 months: myocardial infarction, tia or stroke, coronary artery bypass surgery or percutaneous coronary intervention * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes * acute infections which may affect blood glucose control within 4 weeks prior to screening other protocol-defined inclusion/exclusion criteria may apply
evaluation of granulosa cells function after ivf protocols

Conditions: Infertility; In Vitro Fertilization Protocols

Summary: this study is intended to evaluate ovarian cells after being submitted do different in vitro fertilization protocols. the investigators will analyze hormones secretion and intracellular mechanisms of these cells comparing the gnrh agonist protocol and the gnrh antagonist protocol.


Eligibility criteria:
inclusion criteria: * patient age limit: 39 years * follicle stimulating hormone (fsh) \< 10 micrometer (mu) / liter * antral follicular count \> 12 * regular menses (25 to 35 days) * more than 3 oocytes after ovarian punction * anti mullerian between 1 e 3 ng/ml exclusion criteria: * patients submitted to intracytoplasmatic sperm injection (icsi) * ovarian mass or cyst * clinical / endocrine pathologies

Keywords: infertility ovulation induction luteal phase granulosa cells function gnrh agonist and antagonist hmg fshr
divitum®tka: a biomarker assay for efficacy in hr+ metastatic breast cancer patients

Conditions: HER2-negative Breast Cancer; Hormone-receptor-positive Breast Cancer; Metastatic Breast Cancer

Summary: the purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (tka) in hr+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved cdk4/6 inhibitor.


Eligibility criteria:
inclusion criteria: * pre- or post-menopausal hr+ metastatic breast cancer patients who are: * group 1: scheduled to initiate 1st line combination therapy with an fda-approved cdk4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an fda-approved endocrine therapy for pre- or post-menopausal hr+ metastatic breast cancer (mbc). * group 2: scheduled to initiate second or later lines of therapy with an fda-approved cdk4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an fda-approved endocrine therapy for pre- or post-menopausal hr+ mbc. * group 3: currently receiving 1st line therapy with an fda-approved cdk4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an fda-approved endocrine therapy for pre- or post-menopausal hr+ mbc. * group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an fda approved endocrine therapy (single agent) for pre- or post-menopausal hr+ mbc. note: patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study. exclusion criteria: * treatment including investigational agent or therapies * early breast cancer diagnosis * male breast cancer * currently receiving treatment for other active malignancy at time of registration * exceptions: nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate) * inability to give written informed consent
norepinephrine infusion versus midodrine & octreotide in patients with hepatorenal syndrome type 1.

Conditions: Renal Impairment in Hepatorenal Syndrome

Summary: this study aimed to investigate the efficacy of midodrine plus octreotide versus norepinephrine and to determine the predictive factors of response in patients with hrs-aki.

both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of hrs-aki based on the 2015 international club of ascites (ica) diagnostic criteria \[2\] were eligible for participation. screening and eligibility criteria were verified upon admission to the icu. a diagnosis of aki was established through comparing scr value at time of icu admission to that recorded in the patient's file. patients who meet all other diagnostic criteria of hrs-aki provided by the previous definition \[2\] were enrolled in the study. qualified patients were subjected to baseline assessments after informed consent signature. it included vital sign measurements, presence of comorbidities, height and weight, child-pugh score and sequential organ failure assessment (sofa) score. vital signs, blood urea nitrogen, scr, serum sodium, serum albumin, total bilirubin, and complete blood count with differential were measured at baseline and at daily basis throughout the study period. patients were randomized in a 1:1 ratio to receive either continuous infusion of norepinephrine in an initial dose of 0.5mg/h (maximum 3 mg/h or oral midodrine 5mg three times/day (maximum 12.5mg three times/day) plus octreotide 100μg/6h as subcutaneous injection (maximum 200 μg/6h). duration of treatment was allowed to extend to a maximum of 10 days. administration of albumin at doses of 20 to 40 gm/day was recommended, as clinically indicated, for all patients in both study arms as per current ica guidelines.

Eligibility criteria:
inclusion criteria: * all patients that will be included in the study have cirrhosis as diagnosed by clinical, biochemical, and ultrasound findings, with hrs type 1, the absence of bacterial infections; however, patients with bacterial infections could be included in the study if renal failure persisted after infection resolution by clinical, laboratory indices up to 48 hours. exclusion criteria: * patients will be excluded if there are advanced cardiovascular diseases due to poor prognosis or any extrahepatic disease that could affect the short-term prognosis, the presence of advanced hepatocellular carcinoma or presence of contraindication to norepinephrine as hypotension due to blood volume deficits except emergency measure, mesenteric or peripheral vascular thrombosis unless there is life-saving procedure, profound hypoxia or hypercarbia.
effect of glp-1 on microvascular insulin responses in type 1 diabetes

Conditions: Type 1 Diabetes; Insulin Sensitivity/Resistance

Summary: glp-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with t1dm, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation

the proposed study will determine the effect of glp-1 infusion on microvascular perfusion and microvascular insulin responses in both skeletal and cardiac muscle microvasculature in humans with t1dm. the investigators will study 20 participants with t1dm using a state-of-the-art technology, contrast enhanced ultrasound (ceu), to assess whether glp-1 augments skeletal and cardiac microvascular blood flow (mbf) as a representation of microvascular perfusion, flow-mediated dilation (fmd) as a measurement of endothelial function, and augmentation index (ai) and pulse wave velocity (pwv) as surrogates for large vessel compliance. the investigators will use the combined ceu and euglycemic-hyperinsulinemic clamp approach to determine if microvascular and metabolic ir improves as a result.

Eligibility criteria:
inclusion criteria: 1. history of type 1 diabetes, duration \> 1 year 2. age 18-40 years 3. hba1c \< 8.5% 4. bmi \>/=18, \<30 kg/m2 5. using insulin for diabetes treatment only 6. on stable regimen of non-diabetic medications for the last 6 months, excluding oral contraceptives (ocp) 7. all screening labs within normal limits or not clinical significant exclusion criteria: 1) pregnancy or currently breastfeeding 2) smoking history within 6 months 3) history of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) 4) taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers) 5) ocp use within 3 months or 1 month if menses has subsequently occurred 6) known hypersensitivity to perflutren (contained in definity© contrast) 7) screening o2 saturation\<90% 8) anemia (hemoglobin \<12 g/dl in women, hemoglobin \<13 g/dl in men) 9) diabetic ketoacidosis (dka) on presentation to screening visits or study admission days -
influence of pre-operative back muscle exercise on post-operative outcomes after spine surgery

Conditions: Spine Pain; Spine Surgery

Summary: the purpose of this research study is to gather more information about how improving back muscle function before surgery might influence what happens to the spine and function after surgery. this may assist in developing ways to improve surgical outcomes and determine the benefit of pre-operative exercise, if any.

the investigators intend to enroll patients from ucsd spine clinic. the investigators will include patients who are indicated for a spine surgery. once participants are identified to be surgical candidates, and have an estimated surgical date that is 4-6 weeks from identification, the participants may undergo pre-operative procedures including a pre-operative evaluation and treatment by a physical therapist, data collection (demographics, medical history, etc.), and filling out relevant questionnaires. patients will undergo their surgery as scheduled with the spine surgeon as part of their planned standard care unless the surgeon decides that the surgery is no longer necessary. participation in research does not influence the surgeon's decision. post-operatively, participants may be asked to undergo a post-operative evaluation and fill out questionnaires. upon identification of eligibility, participants may be randomized to one of two study arms using a random number generator. if group characteristics are observed to be unbalanced using this approach, participants may be matched according to demographic or surgical features: 1. pre-habilitation treatment arm 2. standard of care arm participants in the standard of care arm will undergo all pre-operative activities recommended by their surgeon as per standard care.

Eligibility criteria:
inclusion criteria: * - individuals undergoing spinal surgery * individuals who have been deemed medically safe to participate in an exercise-based physical therapy program exclusion criteria: * - individuals with comorbid conditions or spinal injury inappropriate for participating in an exercise-based physical therapy program as determined by the surgeon (e.g. unstable vertebral fracture) * individuals that do not have the ability to commit to the therapy schedule either in-clinic or using the web-based interface * non-english speaking individuals (some questionnaires are validated only in english)

Keywords: prehabilitation exercise
safety and efficacy trial of aav gene therapy in patients with cngb3 achromatopsia (a clarity clinical trial)

Conditions: Achromatopsia

Summary: this will be a non-randomized, open-label, phase 1/2 study of the safety and efficacy of agtc-401 administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the cngb3 gene. the primary study endpoint will be safety and the secondary study endpoint will be efficacy.

this will be a non-randomized, open-label, phase 1/2 study of the safety and efficacy of agtc-401 administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the cngb3 gene. the primary study endpoint will be safety and the secondary study endpoint will be efficacy. subjects will be enrolled sequentially in seven dosing groups. subjects in groups 1, 2, 3, 4, 5, and 6 will be at least 18 years of age and will receive varying dose levels of study agent. subjects in group 4a will be 6 to 17 years of age and will receive the same dose as group 4. subjects in groups 5a and 7 will be between 4 and 8 years of age. subjects in group 5a will receive the same dose as group 5, and subjects in group 7 will receive the maximum tolerated dose identified in groups 1, 2, 3, 4, 4a, 5, 5a, and 6. safety will be monitored by evaluation of ocular and non-ocular adverse events and hematology and clinical chemistry parameters. efficacy parameters will include visual acuity, light discomfort testing, color vision, static visual field, erg, adaptive optics retinal imaging, functional mri (fmri), color brightness test and oct.

Eligibility criteria:
inclusion criteria include: 1. male or female subjects with documented mutations in both alleles of the cngb3 gene; 2. retinal disease consistent with a clinical diagnosis of achromatopsia; 3. at least 18 years of age for groups 1, 2, 3, 4, 5 and 6. at least 6 years of age for group 4a, and 4-8 years of age for groups 5a and 7; 4. able to perform tests of visual and retinal function; 5. visual acuity in the study eye not better than 55 etdrs letters (snellen equivalent 20/80) based on the average of two examinations at the baseline visit; 6. acceptable laboratory parameters; 7. for females of childbearing potential: a negative pregnancy test within 2 days before administration of study agent. exclusion criteria include: 1. best-corrected visual acuity difference between the two eyes of \> 15 etdrs letters (3 lines); 2. evidence of degenerative myopia in the study eye; 3. pre-existing eye conditions that would contribute to vision loss in either eye or increase the risk of subretinal injection in the study eye.
a safety and efficacy study of the combination of vx-222 and telaprevir in treatment-naïve subjects with genotype 1 chronic hepatitis c virus infection

Conditions: Chronic Hepatitis C Virus Infection

Summary: the purpose of this study is to assess the safety and efficacy of combination treatment with vx-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. the subjects enrolled in this study are chronically infected with hepatitis c virus (hcv) genotype 1 and will not have previously received treatment for their hcv infection. this study will include an investigational phase and extension phase. these phases will contain a treatment period and a follow-up period. all subjects will be enrolled in the investigational phase of this study. subjects who fail treatment during the investigational phase will have the option to enter the extension phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks. based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, vertex may elect to enroll up to two additional treatment arms (treatment arm e and treatment arm f) that will evaluate telaprevir/vx-222-based combination therapy. the components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. if enacted, up to 25 patients are expected to enroll in each additional treatment arm. if treatment arm e or treatment arm f is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing rollover phase. subjects who do not meet the eligibility criteria to enter the rollover phase may elect to enter the extension phase.


Eligibility criteria:
inclusion criteria: * males and females of non-childbearing potential * genotype 1 chronic hepatitis c * laboratory evidence of hcv infection for 6 months * histologic evidence of chronic hepatitis c * subjects who have a body mass index (bmi) of ≤35 kg/m² (bmi = weight in kg / height² in meters) * treatment arm e: this arm will enroll only subjects infected with hcv genotype 1b virus * treatment arm f: this arm will enroll only subjects infected with hcv genotype 1a virus exclusion criteria: * subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis c * subjects with any contraindications to peginterferon alfa-2a and/or ribavirin * subjects with any other cause of significant liver disease in addition to hepatitis c, which may include, but is not limited to malignancy with hepatic involvement, hepatitis b, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, wilson's disease, nonalcoholic steatohepatitis (nash), or primary biliary cirrhosis * histologic evidence of hepatic cirrhosis

Keywords: vx-950
change in taste sensation after orthognathic surgery

Conditions: Orthognathic Surgery; Altered Taste

Summary: orthognathic surgery refers to jaw operations that can be performed on the upper jaws (le fort i osteotomy) and lower jaws (sagittal split ramus osteotomy). in orthognathic surgery practice, taste perception could be affected by potential damage to peripheral nerves that conduct chemosensory information regarding gustation from the palate and tongue. this study aimed to evaluate the changes in the sense of taste after le fort i osteotomy, sagittal split ramus osteotomy, and bimaxillary surgery.

the subjects were orthognathic surgery patients with facial skeletal deformities who applied to the department of oral and maxillofacial surgery. thirty-five patients, aged 17-42 years, gustatory functions were evaluated by administering localized taste tests and whole mouth taste tests preoperatively and at postoperative 1st, 3rd, and 6th months. in the tests, solutions containing sucrose for a sweet taste, sodium chloride for a salty taste, citric acid for a sour taste, and quinine hydrochloride for a bitter taste were used. patients were compared between the operation group they were in and between operation groups.

Eligibility criteria:
inclusion criteria: * dentofacial deformity * american society of anesthesiologists category 1 or 2 exclusion criteria: * zinc, iron, and/or vitamin deficiencies * oncological, neurological, endocrinological, and rheumatological diseases * chronic drug use due to systemic disease * smokers * history of chemotherapy and radiotherapy to the head and neck region, orthognathic surgery, maxillofacial trauma, and damage to the nerves related to the taste sensation

Keywords: gustation; taste sense
the influence of remote ischemic preconditioning on acute kidney injury after cardiac surgery

Conditions: Acute Kidney Insufficiency; Acute Renal Insufficiency; Acute Kidney Injury; Ischemic Preconditioning

Summary: acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. the investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: * patient undergoing heart surgery on cardiopulmonary bypass. exclusion criteria: * known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection. * end-stage renal disease. * inability to give informed consent.

Keywords: acute kidney insufficiency acute renal insufficiency acute kidney injury cardiac surgical procedures ischemic preconditioning
the use of rf in premature jowl and neck laxity following facialplasty

Conditions: Premature Jowl and Neck Laxity Following Facialplasty

Summary: study is to evaluate the efficacy of treatment radio frequency in premature jowl and neck laxity following facialplasty


Eligibility criteria:
inclusion criteria: * adult females and males between the ages of 40-80 inclusive, having premature jowl and/or neck laxity one to fifteen years following facialplasty, seeking skin tightening treatments. * lack lipodystrophy in the jowl or neck area or at least not amenable to liposuction improvement (not a candidate for liposuction). * lack of previous face lift complications (no nerve injury or hematoma history). * the patients should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the informed consent form, (including thepermission to use photography). * the patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period. exclusion criteria: * pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. * the handpiece should be used at least 1cm away from cochlear implants in the ear. * superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance. * current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles. * severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases. * pregnancy and nursing. * history of bleeding coagulopathies or use of anticoagulants * impaired immune system due to immunosuppressive diseases such as aids and hiv or use of immunosuppressive medications. * poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonalvirilization. * any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. * history of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. * use of isotretinoin (accutane®) within 6 months prior to treatment. * any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing. * allergies, in particular to anesthesia. * mental disorders such as body dysmorphic disorder (bdd). * as per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
timing of optimal platelet inhibition after acute coronary syndrome

Conditions: Acute Coronary Syndrome; Coronary Stenting; Antiplatelet Therapy

Summary: comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for acs. efficiency and tolerance évaluation


Eligibility criteria:
inclusion criteria: * acs and coronary stenting one month ago exclusion criteria: * age under 18 and pregnancy