Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of passiflora incarnata and isoflavona combination in the treatment of climacteric symptoms

Conditions: Climacteric Syndrome

Summary: the purpose of this study is to evaluate the effects of passiflora incarnata and isoflavone combination in relieving the symptoms associated with climacteric syndrome.

it is known that hormone therapy is recommended postmenopausal women to reduce menopausal symptoms and prevent osteoporosis frames and cardiovascular disease. however, only 30 to 40% of women still using hormone therapy. one reason women do not continue or are reluctant to start hormone therapy is realizing that the prescription of hormones is not a natural situation. therefore, there is an increased interest in the use and prescription of estrogen derived from plants, known as fitoestrogênios. the development of a drug containing two standardized extracts was focused on two main symptoms of menopause: hot flashes and anxiety. this product comes from a longing for the doctors themselves can respond more promptly to patients who reach menopause and who already has a framework for mild to moderate anxiety. thus, to meet the woman who develops menopausal symptoms and that these two are highly prevalent during menopause, causing intense discomfort routine for this woman, was produced in association with soy passiflora aiming to control anxiety and hot flushes

Eligibility criteria:
inclusion criteria: * female amenorrheic for at least one (1) year or surgical menopause since dosage of fsh ≥ 30 miu / ml; * age greater than or equal to 40 and less than or equal to 65 years; * cytological examination colpo held at screening visit, pap cytology classification with class i and ii; * by mammography bi-rads classification (fourth edition) rated one (1) or two (2) performed at least six (6) months from the time of inclusion in the screening visit or if the research subject does not present a recent survey ; * line endometrial ≤ 8 mm by transvaginal ultrasound, performed at screening visit, in the case of subjects who have an intact uterus; exclusion criteria: * history of severe liver or renal disease at the discretion of the investigator; * hypertension stage iii uncontrolled (sbp ≥ 180 mmhg or dbp ≥ 110 mmhg); * important cardiovascular disease such as coronary insufficiency or dilated cardiomyopathy advanced; * using estrogens, progestins, steroid or hormone replacement therapy (hrt) in the last 3 months; * estrogen-dependent neoplasia; * thromboembolic disorders for less than one year of screening visit; * anabolic drugs use or illicit drug use; * hemoglobin \ 17 g / dl; * tsh \ 4, 780 uui / l; * ft4 \ 1.8 ηg / dl; * patient that is chronically using mao inhibitors (maois) or levothyroxine
study02001740;22sch740: estradiol for er+ advanced breast cancer (esther)

Conditions: Metastatic Breast Cancer

Summary: determine whether subjects harboring esr1-mutant/amplified breast cancer have a higher rate of clinical benefit from 17b-estradiol therapy than subjects with esr1-wild-type breast cancer

patients with endocrine-resistant breast cancer are eligible. treatment phase: patients will be treated with 17b-estradiol until disease progression. at this point, the patient will end protocol therapy. clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined. observational phase (optional): after disease progression on 17b-estradiol, patients will be treated at their oncologist's discretion. clinical benefit, progression-free survival, and objective response will be measured during this line of treatment of physician's choice until another instance of disease progression. in consented subjects who undergo a clinically indicated tumor biopsy of recurrent or metastatic disease prior to the start of 17b-estradiol treatment, when feasible, acquisition of additional tumor tissue is requested for research purposes. optional: patients will be asked to provide tumor tissue via a research biopsy on day 3-4 of 17b-estradiol treatment. archived tumor tissue and clinical-grade tumor and plasma dna/rna sequencing results will be used for research purposes. blood samples will be obtained at baseline, on day 3-4 of 17b-estradiol therapy (optional), and upon disease progression on 17b-estradiol. plasma and buffy coat will be extracted and frozen. tumor tissue and plasma specimens will be analyzed to identify molecular biomarkers predictive of sensitivity/resistance to 17b-estradiol therapy

Eligibility criteria:
inclusion criteria: * post-menopausal women with er+ breast cancer. * metastatic or locoregional recurrence not amenable to treatment with curative * intent. * received ≥1 prior line of endocrine-based therapy (e.g., including tamoxifen, aromatase inhibitors, fulvestrant, or combinations) in the advanced/metastatic setting exclusion criteria: * during the study treatment phase with 17b-estradiol, no concurrent anti-cancer therapies are allowed with the following exceptions: * exception: trastuzumab is allowed for the treatment of subjects with a history of her2+ disease, and will be used at the physician's discretion. * exception: anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) are permitted. * any investigational cancer therapy in the last 3 weeks. * known cns disease, unless clinically stable for ≥ 3 months. * history of any of the following: * deep venous thrombosis. * pulmonary embolism. * stroke. * acute myocardial infarction. * congestive heart failure. * previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%.

Keywords: metastatic locally advanced estradiol therapy estrogen therapy
evaluation of comfort of ocular lubricants in symptomatic contact lens wearers

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.

the expected duration of subject participation is at least 7 days. this study will be conducted in australia and canada.

Eligibility criteria:
key inclusion criteria: * is able to understand and sign an approved information consent letter; * habitually wears daily disposable soft contact lenses in both eyes * uses rewetting drops on a regular basis; * other protocol-defined inclusion criteria may apply. key exclusion criteria: * routinely sleeps in habitual contact lenses; * has any known active ocular disease and/or infection; * is pregnant or lactating; * other protocol specified exclusion criteria may apply.
sodium bicarbonate for acute peripheral vertigo

Conditions: Peripheral Vertigo

Summary: vertigo is defined as the hallucination of spinning sensation or rotatory movement and is frequently combined with severe nausea and vomiting. in taiwan, an average of 3.13 cases per 100 persons suffer from acute vertigo attack per year. and 1 in 3 patients with vertigo will have recurrent attack within a year. the sensation of disequilibrium and severe nausea and vomiting urge patients visit emergent department (ed) for help. therefore, vertigo is one of the most common complaints in ed. vertigo can be divided into central type and peripheral type. central type vertigo included life threatening disease like brainstem hemorrhage or infraction. although peripheral vertigo is mostly benign, the acute symptoms relief are usually needed. the first line therapy of acute peripheral vertigo is using antihistamine or benzodiazepine with other anti-emetic agents. however, these agents usually have side effects of fatigue and lethargy, which will cause increasing patients' length of stay or elders' risk of falling. sodium bicarbonate is widely used in treating hyperkalemia or metabolic acidosis. its safety and no side effect have also been proved. there were few reports of using sodium for treatment of acute vertigo in taiwan and japan. however, there is no strong evidence of comparing this therapy with other medication. this study hypothesized that there is an equivalence of efficacy between sodium bicarbonate and diphenhydramine for treatment of vertigo. using sodium can cause less fatigue or lethargy and can decrease ed length of stay. this study aims to perform a double-blinded randomized controlled trial to evaluate the efficacy of sodium bicarbonate for treatment of acute peripheral vertigo.


Eligibility criteria:
inclusion criteria: * patients with acute onset vertigo exclusion criteria: * pregnancy * first vertigo episode over 24 hours * using any anti-vertigo medicine after onset * drug allergy to sodium bicarbonate or diphenhydramine * diagnosed with central vertigo * heart failure nyha class \>1 * chronic kidney disease (ckd) stage ≥ 3

Keywords: sodium bicarbonate diphenhydramine
observational study to observe variations of gait parameters in patients with neuromuscular diseases

Conditions: Muscular Dystrophies; Myopathies; Spinal Muscular Atrophy (SMA); Charcot Marie Tooth Disease

Summary: this study has the general objective of observing walking parameters during a clinical test to objectively estimate fatigue in patients with neuromuscular diseases. furthermore, the investigators want to evaluate the feasibility of collecting physical activity in daily life conditions during a one-week monitoring period using a wearable sensor.


Eligibility criteria:
inclusion criteria: * ambulant adult patients with genetic diagnosis of muscular dystrophy/myopathy (dystrophinopathies, muscular dystrophies and congenital and non-congenital myopathies), of spinal muscular atrophy (sma) and with molecular diagnosis of charcot-marie tooth 1 or 2. * independent walking, even with assistance; exclusion criteria: * dilated or ischemic heart disease with moderate impairment; * chronic respiratory failure: forced vital capacity (fvc) \< 40%; more than 5% of nocturnal time spent with peripheral oxygen saturation levels \< 90.
study of safety and performance of a novel ocular lubricant in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (ded).

the study will consist of a screening visit, a baseline visit on day 1, a remote compliance check on day 14, and an exit visit on day 30. the expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Eligibility criteria:
key inclusion criteria: * willing and able to understand and sign an approved informed consent form. * exhibit symptoms of dry eye at the screening visit. * best corrected visual acuity equal to or better than 20/80 snellen in each eye at the screening visit. * willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at visit 2/day 1. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * pregnant, breastfeeding, or planning to become pregnant during the study. * ocular abnormalities that could adversely affect the safety or efficacy outcome. * uncontrolled active systemic diseases. * use of systemic medications known to cause dry eye. * other protocol-defined exclusion criteria may apply.
effect of whole body vibration on bone and fall related parameters

Conditions: Atrophy

Summary: the effect of whole body vibration (wbv) on bone strength and fall frequency in older adults is still vague. although there is some evidence that wbv may impact bone mineral density in very frail elderly, there is a lack of data concerning the effect of wbv in community-living elderly woman. we hypothesize that wbv significantly affects bone parameters as assessed by dxa, qct, us and bone markers with parallel positive changes of fall related risk factors (power, strength, balance, and reaction time). we further hypothesize that the effects of wbv were superior to conventional resistance exercise.


Eligibility criteria:
inclusion criteria: * community living elderly females \>/=65 years * live expectation \> 2 years exclusion criteria: * secondary osteoporosis * cvd-events including stroke * participation in other studies * medication and illness affecting bone metabolism within the last 2 years * medication with impact on falls * low physical performance (\<50 watt during ergometry) * excessive alcohol-intake

Keywords: whole body vibration exercise elderly woman bone mineral density falls higher age
oxaliplatine based adjuvant chemotherapy for stage ii/iii colorectal cancer: 8 cycles versus 12 cycles

Conditions: Colorectal Cancer

Summary: the purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.

we administered 5-fu, lv and oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with stage ii or stage iii colorectal cancer. the study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Eligibility criteria:
inclusion criteria: * age \< 75 years with histologically proven adenocarcinoma of the colon or rectum * no severe major organ dysfunction * who performance status of 0 or 1 * stage ii (t3-4, n0, m0) or stage iii (t0-4, n1-2, m0) disease (according to the 1997 revision of the international union against cancer tnm staging system) exclusion criteria: * age \>= 75 * severe major organ dysfunction * who performance status of \>1 * stage i or stage iv

Keywords: oxaliplatine colorectal cancer chemotherapy
elective mucosal irradiation in head-and-neck cancer of unknown primary

Conditions: Head-and-neck Cancer; Carcinoma of Unknown Primary

Summary: the optimal treatment of hncup remains controversial and lacks evidence from prospective randomized trials. the management of these patients relies primarily on surgery and radiotherapy. the role of radiotherapy in sterilizing putative mucosal sites remains controversial. the main debate concerns the extent of the radiation field. although pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). most single institution retrospective studies have not shown any advantage for more extensive irradiation.therefore, elective mucosal irradiation may might be appropriate only for these patients.


Eligibility criteria:
inclusion criteria: 1. carcinomas metastatic to cervical lymph node with unknown primary 2. squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma 3. all patients must be suitable to attend regular follow-up and undergo toxicity assessment. 4. stage t0, n1-3, m0 disease 5. karnofsky score over 60 6. no significant cardiac, chest, gastrointestinal or renal morbidities exclusion criteria: 1. previous radiotherapy to the head and neck region 2. previous malignancy except non-melanoma skin cancer 3. previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
a study of roactemra/actemra (tocilizumab) in adult patients with rheumatoid arthritis (svoboda programme)

Conditions: Rheumatoid Arthritis

Summary: this open-label, single arm study evaluated the efficacy and safety of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis. patients received roactemra/actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age * confirmed moderate or severe rheumatoid arthritis * intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (dmards) exclusion criteria: * presence of infectious diseases \[tuberculosis (tb), human immunodeficiency virus (hiv), virus hepatitis a/b/c\] * inadequate hematologic, renal or liver function * peptic ulcer disease (in acute phase) * pregnant and lactating women
physiological and biomechanical data collection study in epilepsy subjects

Conditions: Epilepsy

Summary: the purpose of this study is to gather changes in physiological and biomechanical data during daily activity and sleep in epilepsy subjects.

the purpose of this study is to gather changes in physiological and biomechanical data such as ecg, respiration, and accelerometry data during daily activity and sleep in pediatric and adult subjects with epilepsy. subjects will use a device that enables monitoring of the human state in everyday, free-living environments.

Eligibility criteria:
inclusion criteria: 1. subject must be six (6) years of age or older 2. subject has a clinical diagnosis of epilepsy 3. subject is currently taking at least one antiepileptic medication. 4. subject must be in good general health and fully ambulatory. 5. subject or guardian must be willing and able to complete informed consent and/or assent for children and hipaa authorization. exclusion criteria: 1. subjects with chest circumference smaller than 29 inches or greater than 47 inches. 2. subjects with existing signs of skin irritation, rash, damage or infection on the torso that in the opinion of the investigator would prevent the subject's participation in the study. 3. subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the study. 4. subjects with implanted defibrillators, pacemakers or neurostimulators (e.g., vagus nerve stimulators or pain stimulators). 5. subjects who are pregnant or lactating. 6. subjects with severe psychiatric disease that in the opinion of the investigator would prevent the subject's successful completion of the study. 7. subjects 6 to 16 years of age with moderate/severe learning difficulties or those who may be at risk of self-harm. 8. subjects prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. these include, but are not limited to, beta adrenergic antagonists ("beta blockers"). 9. subjects with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to activity, stress, or seizure. this would include but not be limited to chronic atrial fibrillation or chronotropic incompetence. 10. subjects with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by dsm iv-r. 11. subjects currently participating in another clinical study.

Keywords: epilepsy ecg accelerometer
non-invasive contrast enhanced ultrasound sonography in intestinal acute graft-vs-host disease

Conditions: Intestinal GVHD; Neutropenic Enterocolitis

Summary: intestinal acute graft-vs-host disease (gvhd) is a life-threatening complication after allogeneic hematopoietic cell transplantation. non-invasive diagnostic procedures are still lacking and diagnosis is difficult. we hypothesized that contrast-enhanced ultrasound sonography (ceus) could detect microcirculation changes of the bowel walls during intestinal gvhd and help to detect and monitor treatment response. we employed ceus to prospectively evaluate intestinal gvhd in 83 consecutive transplant patients between 2008 and 2011. fourteen /83 patients with biopsy-proven intestinal gvhd were selected as study group. fourteen patients with biopsy-proven stomach gvhd without intestinal symptoms (n=16), normal volunteers (n=6) and patients with neutropenic enterocolitis (n=4), were chosen as control group. all patients were evaluated with both standard transabdominal ultrasonography (us) and ceus at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms. standard us revealed non-specific bowel wall thickening, and simultaneous involvement of multiple intestinal segments in 9/14 patients. ceus showed three distinct patterns of microcirculation changes that correlated with gvhd activity. these findings were not observed in the control group. moreover, ceus findings correlated with treatment response and predicted flare of intestinal symptoms. ceus is a non-invasive, easily reproducible bed-side tool to detect and monitor intestinal gvhd.


Eligibility criteria:
inclusion criteria: * bone marrow transplant * intestinal acute graft versus host disease * stomach gvhd * neutropenic enterocolitis exclusion criteria: no biopsy proven intestinal or stomach gvhd no neutropenic enterocolitis

Keywords: allogeneic transplantation; intestinal graft-vs.-host disease; contrast enhanced ultrasound sonography
comparison of high-dose rosuvastatin versus low statin dose plus fenofibrate versus low statin dose plus niacin in the treatment of mixed hyperlipidemia

Conditions: Dyslipidemia

Summary: statin therapy does not fully eliminate the cardiovascular disease (cvd) risk associated with low high density lipoprotein-c (hdl-c) and high triglyceride levels. it is currently unknown what would be the best treatment option for patients with mixed hyperlipidemia who fail to meet their lipid targets with statin monotherapy at conventional does, i.e. high dose rosuvastatin or conventional statin dose plus micronized fenofibrate or conventional statin dose plus niacin/laropiprant. the aim of the present study is to compare the efficacy of high-dose rosuvastatin vs conventional statin dose plus micronized fenofibrate vs conventional statin dose plus extended-release niacin/laropiprant on lipid profile in patients with mixed hyperlipidemia. the primary efficacy endpoint will be changes in non-hdl-c levels at 6 months after treatment initiation.


Eligibility criteria:
inclusion criteria: * non-hdl-c above target goal according to ncep-atp iii after 3 months of treatment with conventional statin doses, e.g. simvastatin 10-40 mg, atorvastatin 10-40 mg or rosuvastatin 5-20 mg exclusion criteria: * known cvd, triglycerides \> 500 mg/dl, renal disease (serum creatinine levels \> 1.6 mg/dl), hypothyroidism \[thyroid stimulating hormone (tsh) \> 5 iu/ml\], liver disease (alt and/or ast levels \> 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption \> 3 drinks/day for men and \> 2 drinks/day for women, and current or previous gout. * patients with diabetes will be included in the study if they are adequately controlled (hba1c \<7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period). * patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period). * patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded.