Kornimate/medical-research-clean huggingface dataset:
effects of sodium nitrate on blood flow in becker muscular dystrophy

Conditions: Becker Muscular Dystrophy

Summary: this study is intended to build on a growing body of literature showing a blood flow abnormality in patients with becker muscular dystrophy. the investigators' laboratory recently showed that this blood flow abnormality could be corrected by a single oral dose of the drug tadalafil (also known as cialis). the investigators now wish to replicate these exciting results using a common nitric oxide donor (sodium nitrate).

there are 2 phases to this research project: (1) an initial baseline study to confirm the blood flow abnormality in becker muscular dystrophy, and (2) a subsequent brief treatment trial. there are also 3 optional study protocols: (a) dose-escalation trial, (b) placebo trial, and (c) increased exercise intensity trial. the baseline study involves an intake history, physical examination, and phlebotomy for blood chemistries and dna followed by non-invasive forearm blood flow studies (near infrared spectroscopy, doppler ultrasound) before and after a brief bout of handgrip exercise (approximately 3-5 hours to complete). blood flow studies will be performed with the subject's lower body enclosed in an airtight chamber. blood flow and oxygen delivery to the forearm muscles will be measured before and during application of lower body negative pressure at rest and during handgrip exercise. lower body negative pressure simulates the blood flow changes that normally occur when a person sits up after lying down. the results of the baseline study will determine which patients meet preset eligibility criteria to participate in the medication phase of the study. these criteria include (1) normal kidney and liver function tests and normal bnp levels (the latter to exclude heart failure), and (2) abnormal blood flow responses to handgrip exercise. eligible patients will be asked to repeat the above laboratory procedures on a subsequent study day after receiving a single dose of sodium nitrate. eligible patients will also be offered the option to repeat the above laboratory procedures on three subsequent study visits, where upon: (a) the dose of sodium nitrate is increased, (b) a placebo is ingested, and/or (c) the level of exercise in increased. the investigators plan to enroll 20 adult men with becker muscular dystrophy.

Eligibility criteria:
inclusion criteria: * men 15-55 years of age with a pre-existing diagnosis of becker muscular dystrophy by a clinical neurologist (based on clinical criteria plus previous muscle biopsy analysis and/or dna analysis). exclusion criteria: * any evidence of cardiopulmonary disease by history or by physical examination * history of hypertension or blood pressure averaging ≥140/90 mmhg * diabetes mellitus or other systemic illness * heart failure by clinical exam, elevated bnp, or heart failure medication * serum creatinine ≥ 1.5 mg/dl * any history of substance abuse (including alcohol) * any history of psychiatric illness
the severity of newly diagnosed asthma patients and the result of initial 12 weeks treatment in china

Conditions: Asthma

Summary: the primary objective of the nis is to evaluate the severity of newly diagnosed asthma patients based on global initiative for asthma (gina) severity category (gina 2006 update).

this is a multi-centre, prospective non-interventional study planned to be conducted in china. the study aims to recruit about 5000 newly diagnosed patients from about 50 tier 3 hospitals with respiratory department. each site recruits about 50-150 patients. the primary variable will be distribution of severity based on gina definition (gina 2006 update) at baseline in the total population. there will be 4 visits for this study, informed consent and following study procedures (acq-5(asthma control questionnaire), severity assessment) will be done at visit 1. after that, according to clinical practice in china patients usually go to the clinic every 4 weeks. asthma control status, acq-5 and sever exacerbation will be assessed at each clinic visit till 12 weeks (visit 2, 3, 4).

Eligibility criteria:
inclusion criteria: 1. newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months. 2. out-patient with an age of 18 years and above 3. signed and dated informed consent the prescription of the medicinal product is clearly separated from the decision to include the subject in the nis. generally, asthma medication refers to those recommended in gina guideline (gina2012 update) and decided by investigator. exclusion criteria: 1. participating in any clinical trial during the last 90 days 2. have copd 3. with asthma exacerbation

Keywords: asthma
edoxaban treatment in routine clinical practice for patients with atrial fibrillation in korea and taiwan (etna-af-kor-twn)

Conditions: Atrial Fibrillation

Summary: in order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the non valvular atrial fibrillation (nvaf) indication, daiichi-sankyo proposed this non-interventional study to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban use in non-preselected patients with nvaf.

edoxaban was approved by the ministry of food and drug safety (mfds) in korea (date: 25th, august 2015) for the reduction in the risk of stroke and systemic embolism in patients with nvaf, treatment of deep vein thrombosis (dvt) and pulmonary embolism. edoxaban was approved by the taiwan food and drug administration (tfda) in taiwan (date: 24th, february, 2016) for the prevention of stroke and systemic embolism in adult patients with nvaf with one or more risk factors, such as congestive heart failure, hypertension, age at least 75 years, diabetes mellitus, prior stroke or transient ischemic attack (tia), or treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), following 5 to 10 days of initial therapy with a parenteral anticoagulant. real world evidence data of routine clinical practice use of edoxaban up to two years will be collected and evaluated in approximately 2,500 patients, treated by specialized as well as non-specialized physicians in hospital centers.

Eligibility criteria:
inclusion criteria: * nvaf-patients treated with edoxaban according to summary of product characteristics (smpc). * written informed consent for participation in the study (icf). * not simultaneously participating in any interventional study. exclusion criteria: * none

Keywords: non valvular atrial fibrillation non-interventional study efficacy/safety real world evidence
a study to assess the safety, pharmacodynamics, and immunogenicity of pxvx0047

Conditions: Adenoviral Infection

Summary: pxvx0047 (adenovirus type 4 and type 7 vaccine \[a549 cells\], live, oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. the primary goals of this phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immunogenicity of pxvx0047.


Eligibility criteria:
inclusion criteria: * male or female * age 18 to 35 * seronegative for ad4 and ad7 by cpe-based assay * (if female of childbearing potential) using an acceptable method of contraception * if male, subject agrees to use a highly effective method of contraception with female sexual partners of childbearing potential * able and willing to provide informed consent for study participation exclusion criteria: * current acute febrile illness * current acute gastrointestinal illness * clinically significant cardiac, respiratory, or gastrointestinal disease * (if female of childbearing potential) pregnant or nursing, or who plan to become pregnant or nurse during the study * persons with occupations which may create an increased risk of transmission of vaccine virus (including but not limited to health care workers, child or elderly care providers, food handlers or preparers) who also have expected occupational contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through day 29. * expected household contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through day 29. * laboratory evidence of infection with hepatitis b/c or hiv. * history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine. * inability to swallow capsules or tablets whole without chewing or crushing. * immunosuppressed individuals, including those treated or planned to be treated with systemic immunosuppressive medications within the 30 days prior to enrollment through 30 days after study treatment. * concomitant or planned use of other vaccines, investigational agents, cidofovir, ribavirin, or medications expected by the investigator to have antiviral activity against adenovirus within 30 days prior to enrollment through day 29. * any other condition that, in the opinion of the investigator, creates an unacceptable risk to the subject. * any other condition that, in the opinion of the investigator, may interfere with the conduct of the study or the validity of the data.
the impact of dental health on complications during and following radiotherapy in the head and neck region.

Conditions: Head and Neck Neoplasms; Radiotherapy; Complications; Extracting Own Teeth

Summary: study the risk of complications after dental extractions in patients recieving radiotherapy.

dental extractions before radiotherapy in the head and neck region is an established part of the treatment plan for patients with malignant disease. there are contradictory results in the literature regarding the importance timing and magnitude of extractions. it is important to minimize complications in this patient group since the regular therapy is already detrimental to the affected tissues. patients were extracted from the artscan register were the population was followed for 4 years for several factors, including development of osteoradionecrosis. the aim is to evaluate which diagnoses are more prone to develop complications after extraction. if there is a relationship between occurrence of complication and magnitude of dental pathology.

Eligibility criteria:
inclusion criteria: * malignant diagnosis * radiotherapy pre or postoperative exclusion criteria: -
esp block in mis lumbar spine surgery

Conditions: Patients With Spinal Stenosis Indicated for MIS TLIF

Summary: this is a prospective, randomized controlled trial of patients undergoing minimally invasive transforaminal lumbar interbody fusion. this study will randomize patients into one of two groups: erector spinae plane (esp) block and no esp block.

minimally invasive (mis) spinal surgical procedures such as mis transforaminal lumbar interbody fusion (tlif) are being increasingly performed due to reduced morbidity. however, the mainstay for perioperative analgesia after these surgeries remains to be opioid pain medications, which have a number of associated adverse effects such as respiratory depression, hyperalgesia, and opioid habituation. recently, the erector spinae plane (esp) block has been introduced as an opioid-sparing regional anesthetic for lumbar spinal surgery with touted benefits including opioid use reduction and improved pain control. the proposed study aims to enroll patients in a double blind randomized controlled trial to undergo mis tlif with an esp block or as conventional control group. preoperative patient demographics, comorbidities, history of opioid use, and operative details will be obtained. comprehensive assessment of opioid utilization, postoperative pain, non-opioid pain medication use, opioid-induced complications, time to opioid cessation, time to physical therapy clearance, length of stay, as well as other related outcomes will be performed.

Eligibility criteria:
inclusion criteria: * age 18-80 * patients scheduled for mis tlif (any level) with the principal investigator * asa 1, 2, 3 exclusion criteria: * asa 4 or higher * bmi \>40 * chronic opioid use (daily use for \> 3 months) * revision surgery, any history of previous lumbar spine surgery * allergy to any of the study medications * non-english speaking * chronic renal insufficiency or failure (creatinine \>2) or severe hepatic disease (cirrhosis, failure) * pregnancy * any concomitant surgery

Keywords: erector spinae plane (esp) block transforaminal lumbar interbody fusion (tlif) minimally invasive spine surgery lumbar spine spinal fusion
curcumin supplementation for gynecological diseases

Conditions: Curcumin Use for Gynecological Conditions

Summary: to use curcumin supplementation as an additive treatment to induce clinical, biochemical response and remission in patients with suspected pelvic inflammatory disease, tubo ovarian abcess, endometritis, wound infection. hypothesis: an addition of oral curcumin to highly suspected pid/endometritis/wound infection patients may augment clinical and biochemical response and accelerates the improvements of the sign symptoms and reported outcomes of those diseases.

pelvic inflammatory disease (pid), endometritis, wound infection are infections of the female reproductive system. although pid is a well known pathophysiology the diagnosis method i not well established and its true magnitude is unknown. many women report that they have been treated for pid when they did not suffer from it and vice versa. hence the main way to diagnose remains clinical and currently there is no well-established biochemical marker. in endometritis and wound infection the cause may be known but the pathogens involved in the disease formation vary as for this broad spectrum antibiotic is needed. aims: to use curcumin supplementation as an additive treatment to induce clinical, biochemical response and remission in patients with suspected pid, tubo ovarian abcess, endometritis, wound infection. hypothesis: an addition of oral curcumin to highly suspected pid/endometritis/wound infection patients may augment clinical and biochemical response and accelerates the improvements of the sign symptoms and reported outcomes of those diseases. rational: curcumin treatment has been shown to safe and efficient in inflammatory states such as in mild-moderate ulcerative colitis (uc), obesity, and type ii diabetes mellitus when used as an add-on to conventional treatment. in the gynecology and especially in the pid/tubo ovarian abcess diseases the use of curcumin as a supplement has never been studied. in the future it is necessary to study the use of curcumin in different gynecological diseases (e.g endometriosis/premenstrual syndrome (pms) and also in gynecology oncology) in which inflammatory and immune response are involve in the disease.

Eligibility criteria:
inclusion criteria: * age above 18 * the patient was admitted with a diagnosis of pelvic inflammatory disease / tubo ovarian abcess, surgical wound infection, endometritis * no antibiotic treatment was given prior to her recruitment for the study * the women is not in menopause exclusion criteria: * age below 18 and above 52 * antibiotic treatment was given prior to her recruitment for the study * the women is in menopause * pregnant women. known other inflammatory disease.
effects of exenatide long-acting release on glucose control and safety in subjects with type 2 diabetes mellitus(duration - 1)

Conditions: Type 2 Diabetes Mellitus

Summary: a randomized, open-label, multicenter, comparator-controlled study to examine the effects of exenatide long-acting release (lar) on glucose control (hba1c) and safety in subjects with type 2 diabetes mellitus managed with diet modification and exercise and/or oral antidiabetic medications.

this trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. the study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly. long-term safety and efficacy will be monitored during the open-ended assessment periods. this study will be conducted in approximately 300 subjects with type 2 diabetes treated with diet modification and exercise alone or in combination with a stable regimen of metformin, su, thiazolidinedione (tzd), a combination of metformin and su, a combination of metformin and tzd, or a combination of su and tzd.

Eligibility criteria:
inclusion criteria: * has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening. * hemoglobin a1c (hba1c) of 7.1% to 11.0%, inclusive, at screening. * body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive, at screening. * (for sub-study) currently participating in open ended assessment period of main study 2993 lar105 exclusion criteria: * has been previously exposed to exenatide (byetta®), exenatide lar, or any glucagon-like peptide-1 (glp-1) analog. * received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening. * has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: * alpha glucosidase inhibitor or meglitinide within 30 days of screening; * insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening; * regular use (\> 14 days) of drugs that directly affect gastrointestinal motility; * regular use (\> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption; * regular use (\> 14 days) of medications with addictive potential such as opiates and opioids; * prescription or over-the-counter weight loss medications within 6 months of screening. * (for sub-study) subjects will be terminated from study who do not participate in the dual chamber pen substudy

Keywords: diabetes exenatide long acting release lar amylin lilly
a study of navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large b-cell lymphoma (navigate)

Conditions: Diffuse Large B-Cell Lymphoma

Summary: this randomized, open-label, multicenter study will evaluate the efficacy and safety of navitoclax in addition to bendamustine and rituximab in patients with relapsed diffuse large b-cell lymphoma. patients will be randomized to receive navitoclax in addition to bendamustine and rituximab or bendamustine and rituximab alone for 6 cycles.


Eligibility criteria:
inclusion criteria: * histologically documented diagnosis of diffuse large b-cell lymphoma * patients must have relapsed or developed progressive disease following salvage therapy, or must have relapsed or progressed following initial therapy and in the opinion of the investigator are medically unfit to receive high dose chemotherapy with autologous stem cell transplant (sct) or other salvage therapy of higher priority * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * patients who have undergone stc must be more than 100 days from autologous stem cell infusion prior to first dose of study drug, must have recovered from any transplant related toxicity and must have adequate bone marrow function as defined by protocol independent of any growth factor support * patients who have not undergone sct must have adequate bone marrow function as defined by protocol independent of any growth factor support * adequate coagulation, renal and hepatic function exclusion criteria: * refractory dlbcl * history of other malignancies within 2 years prior to initiation of study treatment except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, low-grade localized prostate cancer treated surgically with curative intent or one that carries a good prognosis, in situ ductal carcinoma of the breast treated with lumpectomy (with and without radiation) with curative intent * active infection requiring parenteral antibiotics or antiviral or antifungal agents * inherited or acquired bleeding diathesis, anticoagulant drugs or drugs that inhibit platelet function, underlying conditions that predisposes to abnormal bleeding, or refractoriness to platelet transfusions * clinically significant cardiovascular disease, new york heart association grade ii or greater congestive heart failure, or ventricular tachyarrhythmias requiring medication within 1 year prior to the initiation of study treatment * positive for hepatitis b, hepatitis c or hiv infection
sglt2 inhibitors in patients with pcos

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. patients with pcos presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. metformin has been clarified as an option in patients with pcos. however, the clinical responses to metformin are limited and different. sodium glucose co-transporter 2 (sglt2) inhibitors are novel drugs for the treatment of type 2 diabetes, with weight loss, reducing insulin resistance and cardiovascular benefits. limited data is available on the efficacy of sglt2 inhibitors in patients with pcos.

this clinical study aims to determine the safety and efficacy of canagliflozin vs metformin in polycystic ovary syndrome (pcos) patients with insulin resistance (ir). methods: a single center, prospective, randomized open-label study (ratio 1:1), non-inferiority trial was conducted in the department of endocrinology, shanghai tenth people's hospital between july 2019 and april 2021. pcos women aged 18-45 years with ir were enrolled and randomly assigned to either canagliflozin 100 mg (n = 33) or metformin 1500-2000 mg (n = 35) daily for 12 weeks. the primary outcome was changes in homa-ir after 12 weeks treatment. the secondary outcomes included changes in anthropometric, menstrual frequency, sex hormone and metabolic parameters.

Eligibility criteria:
inclusion criteria: * fmale aged 18- 45; * meet rotterdam criteria; * insulin rsistance exclusion criteria: * women who are pregnant or have a pregnancy plan within six months; ·congenital adrenocortical hyperplasia; * hyperprolactinemia; * hyperthyroidism or hypothyroidism; * abnormal liver function (≥ 3 times of the upper limit of normal range); * abnormal renal function (gfr\<60ml/min/1.73m2); * adrenal or ovarian tumors secreting androgens; * used contraceptives, metformin, glp-1ra, sglt2i, pioglitazone and contraceptives in the last 3 month.

Keywords: polycystic ovary syndrome (pcos); insulin resistance (ir) sodium-glucose co-transporter-2 inhibitors (sglt-2i) canagliflozin