Kornimate/medical-research-clean huggingface dataset:
indacaterol 75 μg compared to placebo, assessing time to patient's perception of onset of effect in patients with moderate to severe chronic obstructive pulmonary disease

Conditions: COPD

Summary: this is a phase iv study of indacaterol 75 μg single-dose compared to placebo in moderate-severe copd patients with breathing symptoms to assess time to patient's perception of onset of effect.


Eligibility criteria:
inclusion criteria: * patients who have had a copd exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening * diagnosis of chronic obstructive pulmonary disease (copd) (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease \[gold\] guidelines, 2008) and: * smoking history of at least 10 pack-years * post-bronchodilator forced expiratory volume in 1 second (fev1) ≤ 70% and ≥ 40% of the predicted normal value * post-bronchodilator fev1/fvc (forced vital capacity) \< 70% * breathing symptoms that interfere with daily activities exclusion criteria: * patients who have had a copd exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients who require oxygen therapy for chronic hypoxemia, are receiving bronchodilators or other medications for copd that are dosed once daily, are unable to follow instruction on rescue albuterol use during the study, or are at risk deterioration of copd with study procedures. patients with concomitant pulmonary disease * patients with a history of asthma * patients with uncontrolled diabetes mellitus * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular co-morbid conditions other protocol-defined inclusion/exclusion criteria may apply.

Keywords: copd indacatarol placebo crossover patient perception
virtue® male sling fixation study

Conditions: Stress Urinary Incontinence

Summary: this study is a multi-center study that will assess the efficacy and safety of suture fixation of the virtue® male sling.


Eligibility criteria:
inclusion criteria: * male subject at least 18 years of age with an estimated life expectancy of of more than 5 years * the subject has confirmed stress urinary incontinence (sui) through medical history , urodynamics, and/or physical exam for at least 6 months * the subject has completed post-void residual per protocol within 6 weeks prior to implant * the subject has completed cystoscopy as per protocol within 12 months prior to implant * the subject has intrinsic sphincter deficiency due to one of the following: post-transurethral resection of the prostate (turp), simple open prostatectomy, or radical prostatectomy completed at least 6 months prior to implantation date * the subject has failed at least two non-invasive therapies, eg. pelvic/kegel exercises, behavioral modification or biofeedback for at least 6 months * the subject is willing to have the virtue® male sling implanted * the subject is able and willing to complete all follow-up visits and procedures indicated in the protocol * the subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics committee of the respective site exclusion criteria: * the subject is unable or unwilling to sign the informed consent form (icf)and/or comply with all follow-up requirements according to the study protocol * the subject has an active urinary tract infection or active skin infection in region of surgery * the subject has serious bleeding disorders * the subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, cerebrovascular accident (cva), detrusor-external sphincter dyssynergia, parkinson's disease, or similar condition * the subject had a previous implant to treat stress urinary incontinence * the subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months * the subject is likely to undergo radiation therapy within the next 6 months * the subject has active urethral or bladder neck stricture disease requiring continued treatment * the subject has urge predominant incontinence * the subject has an atonic bladder or a postvoid residual (pvr) greater than or equal to 150 milliliters (ml) * the subject has a condition or disorder likely to require future transurethral procedure * the subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without sponsor's approval * the subject is deemed unfit for male sling implantation or participation in a research protocol as determined by attending physician

Keywords: male sling fixation stress urinary incontinence urinary incontinence
the prevalence of osteoporosis in hemodialysis patients

Conditions: Osteoporosis

Summary: the purpose of this study is to determine the prevalence and severity of osteoporosis in hemodialysis patients and to evaluate potential correlations with renal bone disease indices


Eligibility criteria:
inclusion criteria: * chronic hemodialysis * age \> 18-year old exclusion criteria: * prior specific osteoporosis treatment except vitamin d and calcium supplement administration; active malignancy * recent pregnancy * immobilization
endostar combined with sbrt and envafolimab in the treatment of advanced gastrointestinal tumors

Conditions: Gastrointestinal Neoplasms

Summary: this is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (sbrt) and envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.

this is a single-arm, prospective and exploratory clinical study. sixteen patients with gastric or colorectal cancer who did not have standard treatment or refused standard treatment/chemotherapy after multi-line treatment were enrolled. the patients were treated with endostar combined with stereotactic body radiation therapy (sbrt) and envafolimab to evaluate the efficacy and safety of this regimen. the primary endpoints were objective response rate (orr) and disease control rate (dcr). the secondary endpoints were safety, progression-free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * 18 to 75 years old, regardless of gender * advanced gastrointestinal tumors confirmed by histopathology or cytology; * patients with gastrointestinal tumors who did not or refused standard treatment at enrollment；each line of treatment for advanced disease includes one or more drugs for one or more cycles； the pre-permissible treatment was combined with molecular targeted drugs (except endostar)； patients with previous pd-1 treatment were eligible * ecog-ps score of 0-2 * the main organ function was normal and met the following requirements: blood routine examination (no blood transfusion within 14 days) : a. hb≥80g/l; b. anc ≥1.5×109/l; c. plt ≥60×109/l; ② biochemical examination should meet the following criteria: a. bil\<1.5 times the upper limit of normal (uln); b. alt and ast\<2.5×uln; alt and ast\< 5×uln，if liver metastasis was present; c. serum cr≤1×uln, endogenous creatinine clearance ≥50ml/min (cockcroft-gault formula) * predicted survival time ≥3 months * patients voluntarily participated in this study and signed the informed consent form (icf) exclusion criteria: * hypertensive patients whose blood pressure could not be reduced to normal range by antihypertensive drugs (systolic blood pressure\>140 mmhg/diastolic blood pressure \>90 mmhg); patients with ≥ grade ⅱ coronary artery disease, arrhythmia (including qtc prolongation \> 450 ms in men and \> 470 ms in women) and cardiac insufficiency * patients with active immune diseases * abnormal coagulation function (inr\>1.5×uln, aptt\>1.5×uln) with bleeding tendency * symptomatic central nervous system metastasis * pregnant or lactating women * other patients deemed ineligible for enrollment by the treating physician
clinical long term evaluation of glutamine supplement in melas syndrome

Conditions: MELAS Syndrome

Summary: the purpose of this study is to assesses the clinical efficacy of oral supplementation with glutamine over 3 years.

mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (melas) syndrome is a genetically heterogeneous disorder. the most common mutation is in the mtdna gene mt-tl1 encoding the mitochondrial trnaleu (uur). for understanding the development of seizures in patients with mitochondrial disease, a study has recently emphasized the deficiency of astrocytic glutamine synthetase, creating a disinhibited neuronal network for seizure generation. the investigators propose to evaluate nine patients with mitochondrial dna mutation and melas. patients will receive oral supplementation with 12-18 g/day of glutamine (adjusted for weight and plasma concentrations). the primary outcome measures modification in clinical scales.

Eligibility criteria:
inclusion criteria: * melas syndrome clinically and genetically confirmed. * patients have already participated in gln-9-mit study exclusion criteria: * subjects harboring a melas-related pathogenic mtdna mutation no fulfilling the complete diagnostic criteria for the melas phenotype

Keywords: melas glutamine oral supplements amino acids
glucose reduction by early acarbose treatment in basal insulin

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetic patients whose blood glucose levels were inadequately controlled with insulin glargine alone or in combination with metformin.


Eligibility criteria:
inclusion criteria: * aged 18-79 years * type 2 diabetes inadequately controlled with insulin glargine alone or in combination with metformin * diagnosed of type 2 diabetes for at least 6 months prior to screening * treated with tolerable, stable dose of insulin glargine and/or metformin for at least 3 months prior to screening * hba1c \> 7.0 and \</= 10.0% at screening exclusion criteria: * type 1 diabetes patients * myocardial infarction, unstable angina or coronary artery bypass surgery within previous 6 months * clinical evidence of active liver disease, or serum alt or ast 3 times the upper limit of the normal (uln) range * serum creatinine \>/= 1.5 mg/dl for males, \>/= 1.4 mg/dl for females * active proliferative diabetic retinopathy * any other anti-diabetic medications except insulin glargine and metformin within 4 weeks prior to study entry * gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesis, malabsorption syndrome, chronic diarrhea states, enteropathies, inflammatory bowel disease, partial intestinal obstruction, and large hernias) * galactose intolerance * pregnancy * delivery, abortion, or lactation within less than three cycles before the start of treatment * no use of contraceptive in childbearing aged. women of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration. * hypersensitivity to the active substances or any of gradient of the study drug ingredients * treatment with any medication including corticosteroid or herb medication that can affect blood glucose level in the 3 months prior to study entry * any disease or condition that in the opinion of the investigator may interfere with completion of the study

Keywords: oral hypoglycemic agent
zevalin post-marketing surveillance in japan

Conditions: Non-Hodgkin's Lymphoma (NHL)

Summary: this study is a regulatory post marketing surveillance in japan, and it is a local prospective and observational study of patients who have received zevalin for relapsed or refractory, cd20+, low grade b-cell non-hodgkin's lymphoma and mantle cell lymphoma. the objective of this study is to assess safety and efficacy of using zevalin in clinical practice. this study is also all case investigation of which the enrollment period is five years, and all patients who received zevalin will be recruited and followed 13 weeks after the administration.


Eligibility criteria:
inclusion criteria: patients who received zevalin for relapsed or refractory: * cd20+ * low grade b-cell non-hodgkin's lymphoma * mantle cell lymphoma exclusion criteria: * patients who are contraindicated based on the product label

Keywords: zevalin cd20+ non-hodgkin's lymphoma mantle cell lymphoma
hormonal contraception and risk of chlamydia and gonorrhea

Conditions: Chlamydia Infection; Neisseriaceae Infection

Summary: there are biological reasons to suspect that hormones may affect the risk of a woman becoming infected with a sexually transmitted disease. the evidence on this issue to date is mixed and previous studies have methodologic flaws making it difficult to draw conclusions about the results. this study compares the risk of developing either chlamydial or gonorrheal infection among three groups of women: those using combined oral contraceptives (birth control pills); those using the injectable hormone (brand name depo provera); and those women using non-hormonal contraceptive methods.

the study was designed to examine the relationship between hormonal contraceptive use and possible increased risk of chlamydial and gonococcal sexually transmitted infections, and to determine if any increased risk appeared to be mediated by the extent of cervical ectopy. eight hundred and nineteen women, ages 15 to 45 years, were recruited from an inner city clinic and from a nearby suburban clinic. the women were classified into three groups based on type of contraceptive used. one group used oral contraceptives; the second used injectable depo-medroxyprogesterone acetate (dmpa); and the third group used non-hormonal contraceptive methods. women from each group were followed at 3, 6, and 12 months after enrollment to determine if a new infection with chlamydia or gonorrhea had occurred and to evaluate the extent of cervical ectopy present.

Eligibility criteria:
inclusion criteria: * female age 15 to 45 years * no hormone use at enrollment * not pregnant or planning pregnancy exclusion criteria: * cervical cancer presently or in history * hysterectomy, cone biopsy, or cervical cryotherapy

Keywords: epidemiology relative risk cervical ectopy hormonal contraceptives sexually transmitted infections
glucagon in mody (maturity onset diabetes of the young)

Conditions: MODY1; MODY3

Summary: the aim of this study is to determine whether fasting and post-prandial glucagon secretion is suppressed by gliclazide in patients with hnf1-/4-alpha mody. participants will undergo an oral glucose tolerance test (ogtt) before and after omitting their gliclazide medication for 3 days.


Eligibility criteria:
inclusion criteria: * diagnosis of hnf1-alpha or hnf4-alpha mody. * currently on gliclazide treatment exclusion criteria: * currently taking any anti-diabetic medication other than gliclazide and metformin * oral steroid treatment 30 days prior to the start or at any time during the study period. * known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol. * felt to be unsuitable to participate in the study in the opinion of the chief investigator. * currently participating in a clinical trial involving an anti-diabetic medication

Keywords: gliclazide glucagon diabetes
nsabp biospecimen discovery project

Conditions: Breast Cancer

Summary: this study is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for dna and protein analysis, as well as paired tumor-normal exome dna and rna sequencing.

this study will be conducted at select nsabp sites where investigators are willing to give paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination as the initial component of neoadjuvant therapy as a pilot for a comprehensive 'omics approach using next generation sequencing and protein expression and post-translational modification analysis using mass spectrometry (ms) based and reverse phase protein array-based proteomics. tumor samples will be obtained at baseline and 48 to 72 hours after initial drug treatment to study variation in the biological responses to these agents. the study of tumors both before and early after the first treatment probes the biological responses to treatment and is rich source of predictive biomarkers.

Eligibility criteria:
inclusion criteria: * the diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy. * the breast cancer must be her2-positive based on current asco/cap (american society of clinical oncology/college of american pathologists) guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. * the patient must have a mass in the breast measuring greater than or equal to 2.0 cm by physical exam and/or ultrasound that is accessible and safe for repeat biopsy. patients with a diagnosis of inflammatory breast cancer are eligible if there is a palpable or detectable breast mass that is accessible and safe for repeat biopsy. * planned initial treatment with a combination of paclitaxel and trastuzumab or a trastuzumab/pertuzumab-based combination. schedule for paclitaxel/trastuzumab or trastuzumab/pertuzumab administration is per the investigator. exclusion criteria: * excisional biopsy or lumpectomy performed prior to registration. * previous therapy with chemotherapy or targeted therapy for any malignancy. * treatment, including radiation therapy (rt), chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to registration. * other nonmalignant systemic disease that would preclude the patient from receiving chemotherapy and targeted therapy.

Keywords: national surgical adjuvant breast and bowel project (nsabp) paclitaxel trastuzumab pertuzumab her2 positive (human epidermal growth factor receptor 2) proteomics neoadjuvant therapy anthracycline therapy locally advanced operable biomarkers
neurovascular product surveillance registry

Conditions: Intracranial Aneurysm; Stroke, Ischemic

Summary: post market surveillance registry

an observational, prospective, multi-center, single-arm registry to provide continuing evaluation and periodic reporting of safety and effectiveness of medtronic neurovascular market-released products used in the treatment of intracranial aneurysms and acute ischemic stroke. mdt16056 and mdt17077 are conducted under the product surveillance registry (nct01524276).

Eligibility criteria:
for mdt16056 and mdt17077 inclusion criteria: * patient or legally authorized representative (lar) provides authorization and/or consent per institution and geographical requirements * patient has, or is intended to receive or be treated with, an eligible medtronic product * patient is consented within the enrollment window of the therapy received, as applicable * patient is at least 18 years of age at time of enrollment. exclusion criteria: * patient who is, or is expected to be inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results * female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. for mdt24028 and mdt22032: general inclusion criteria: * patient or legally authorized representative (lar) provides authorization and/or consent per institution and geographical requirements. * patient is treated or intended to be treated with an eligible medtronic neurovascular product. * patient is an adult per local law at time of consent. medtronic business restricted this document is electronically controlled confidential 056-f275 rev f clinical investigation plan template general exclusion criteria: * patient who may be unable to complete the study follow-up * patient with any contraindications per the applicable instructions for use document * female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study * patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results. additional criteria may be required, refer to cohort-specific addendum, as applicable, for further guidance.

Keywords: embolization device flow diverter intrasaccular device vascular reconstruction device ruptured intracranial aneurysm unruptured intracranial aneurysm large vessel occlusion stent retriever aspiration catheter revascularization device
gemcitabine plus cisplatin in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well gemcitabine and cisplatin work in treating patients with metastatic kidney cancer.

objectives: * assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin. * assess toxicity of this regimen in these patients. outline: patients receive gemcitabine iv over 30 minutes on days 1, 8, and 15 and cisplatin iv over 60 minutes on day 15. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed every 4 months. projected accrual: approximately 29-38 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven metastatic renal cell carcinoma * no brain metastases patient characteristics: age: * over 18 performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * wbc at least 3,500/mm\^3 * hematocrit at least 30% * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 2.0 mg/dl * ast and alt no greater than 1.5 times upper limit of normal renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 60 ml/min cardiovascular: * no uncontrolled hypertension * no myocardial infarction within the past 8 weeks other: * not pregnant or nursing * fertile patients must use effective contraception * no other prior malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of cervix, prostate intraepithelial neoplasia, or superficial bladder cancer * no significant psychiatric disease * no active infection prior concurrent therapy: biologic therapy: * no more than 2 prior biologic response modifier regimens * no concurrent biologic therapy chemotherapy: * no prior chemotherapy * no other concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * prior radiotherapy allowed if measurable disease is outside radiation port * at least 28 days since prior radiotherapy * no concurrent radiotherapy surgery: * prior surgery allowed

Keywords: stage iv renal cell cancer recurrent renal cell cancer