Kornimate/medical-research-clean huggingface dataset:
study of acupuncture in the treatment of hot flashes in patients with hormone receptor-positive breast cancer.

Conditions: Hot Flashes; Breast Cancer; Acupuncture

Summary: this study intends to further evaluate the efficacy of acupuncture by comparing the intervention effects of different acupuncture treatment regimens on hot flashes in breast cancer ; and to explore the central effect regulation mechanism of acupuncture intervention on hot flashes based on integrated pet/mri technology.

this topic combines the theory of "unblocking the governor and warming the yang" with the important findings of modern research, that is, the important mechanism of the spine in the pathogenesis of breast cancer, and innovatively proposes the technique of unblocking the governor and treating the spine. prospective clinical intervention research in rehabilitation, objectively evaluate the clinical efficacy, advantages and disadvantages of this technology, so as to effectively break through the current application dilemma of acupuncture and bone-setting manipulation in tumor diseases.

Eligibility criteria:
inclusion criteria: * aged 30-75 years old; * adjuvant hormone therapy (eg, tamoxifen and/or aromatase inhibitors) with or without ovarian function suppression has been administered for at least 4 weeks and is currently on treatment; * patients with persistent hot flashes for at least 4 weeks and with a frequency of more than 14 hot flashes per week (2 times per day) in the week before inclusion in the study, the weekly average hot flash composite score is 3-4; * patients after surgery and chemotherapy (if any); * eastern cooperative oncology group score of 0-1 points. * sign the informed consent and participate in the clinical observation voluntarily. exclusion criteria: * tumor metastases, undergoing chemoradiotherapy or planning surgery; * pharmacological intervention for hot flashes with hot flash treatment drugs such as selective serotonin reuptake inhibitors (ssris) and/or anticonvulsants for at least 4 weeks prior to study initiation; * patients receiving phytoestrogens, tibolone or analogs, verapril, or specific homeopathic medicines; * started or changed adjuvant hormone therapy within the past week, or who planned to start or change adjuvant hormone therapy in the past 14 weeks, pregnant or breastfeeding patients; * bleeding or coagulation disorders with obvious uncontrolled infection * psychiatric illness or family history; neurological disorder or family history; seizure possibility or history of seizures.

Keywords: breast cancer acupuncture integrated pet/mri technology hot flashes
impact of grape powder consumption on eye health and glycemic status in singapore older adults

Conditions: Macula; Degeneration; Aging; Advanced Glycation End Products

Summary: the purpose of this study is to understand the impacts of regular consumption of freeze-dried table grape powder on eye health and regulation of advanced glycation end products in singapore older adults. the investigators hypothesize that regular consumption of freeze-dried table grape powder will promote improvements in eye health and lower levels of advanced glycation end products when compared to the placebo group.

the study will be a 16-week, double-blind, randomized, placebo-controlled trial using a parallel study design. 46 adults (aged 60 - 85) will be recruited and randomly assigned to the intervention or placebo group to investigate whether regular consumption of freeze-dried table grape powder (46g/d) can improve eye health parameters, blood/skin age and glycemic status, and reduce inflammation and oxidative stress. this study will consist of 1 screening visit and 5 study visits with 4-week intervals.

Eligibility criteria:
inclusion criteria: 1. male and female participants, aged between 60 and 85 years old inclusive 2. english-literate and able to give informed consent in english exclusion criteria: 1. smokers 2. allergy to grapes or food dyes/additives, or had serious food allergies in the past 3. known eye diseases (macular degeneration, cataracts, retinopathy or glaucoma), blindness in at least one eye or have had eye surgery 4. unable to view bright lights or flashing lights 5. has type 1 or 2 diabetes, uremia, cardiovascular disease, abnormal kidney and liver function 6. taking eye medication and/or dietary supplements for the eyes for the past 3 month 7. taking supplements containing carotenoids (e.g. vitamin a, lutein, zeaxanthin) for past 3 months 8. currently on a specialised diet (e.g. vegetarian, vegan, weight loss diet, low fat diet 9. consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine,340ml of beer/cider or 45ml of distilled spirit 10. significant change in weight (≥ 3 kg body weight) in the past 3 months 11. significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week 12. currently on anti-hypertensive, cholesterol-lowering or psychoactive drugs 13. scored ≤ 7 on the abbreviated mental test 14. poor peripheral venous access based on past experiences with blood draw 15. participating in another clinical study

Keywords: vitis vinifera older adults inflammation glycemic status oxidative stress eye health
a phase i/ib study of azd9150 (isis-stat3rx) in patients with advanced/metastatic hepatocellular carcinoma

Conditions: Advanced Adult Hepatocellular Carcinoma; Hepatocellular Carcinoma Metastatic

Summary: this is a phase i/ib open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of azd9150 in patients with advanced/metastatic hepatocellular carcinoma.

a phase i/ib, open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of azd9150 in patients with advanced/metastatic hepatocellular carcinoma.

Eligibility criteria:
inclusion criteria: * aged at least 18 years. patient from japan and taiwan aged at least 20 years * histologically or cytologically confirmed hcc (with the exception of fibrolamellar carcinoma or mixed variants of hcc with fibrolamellar histology or clinically diagnosed hcc for patients with difficulty in obtaining histological diagnosis) * relapsed, refractory, intolerant or unlikely to benefit from sorafenib (for example due to comorbidity) * metastatic or locally advanced meeting any of the criteria below: * hcc not suitable to receive local therapy * disease recurred or was refractory to last therapy (local or systemic) * eastern cooperative oncology group (ecog) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 8 weeks exclusion criteria: * more than 2 prior systemic treatments for hcc * prior grade 3 hematologic toxicity related to treatment with a jak or stat3 inhibitor * presence of hepatic encephalopathy within 4 weeks of 1st dose * uncontrolled massive ascites * high likelihood of bleeding

Keywords: child-pugh a to b7, advanced/metastatic hepatocellular carcinoma, azd9150, antisense oligonucleotide inhibitor of stat3
alcohol and innate immunity

Conditions: Binge Drinking

Summary: alcohol leads to a leaky gut and translocation of bacterial products. this may lead to inflammation and immune dysfunction as well as the typical hangover symptoms.

alcohol binge drinking, defined as 5 or more drinks for men and 4 or more drinks for women at one time, is the most frequent form of alcohol consumption worldwide, especially in younger people. this drinking pattern is popular and leads to increased mortality and morbidity. therefore binge drinking is a major public health issue. the behavioural and neurological consequences of binge drinking are well characterized. less is known about the systemic effects on the gut as the first organ in contact with alcohol. chronic alcohol intake can lead to increased gut permeability, bacterial translocation and alterations in the gut microbiome in animal models. recently bacterial translocation has been shown in healthy volunteers after a single alcohol binge. on immune cells, acute alcohol intake seems to have dichotomous effects. on the one hand immunosuppressive and anti-inflammatory effects have been described, however, alcohol induced liver injury is driven by pro-inflammatory reactions. these immune effects seem to be driven by endotoxin or other bacterial products via toll-like receptors that are translocated to the circulation via a defective gut barrier. immune effects of alcohol have also been linked to hangover symptoms after an alcohol binge. furthermore there is evidence that endotoxemia might also contributes to alcohol dependence by promoting prolonged and increased voluntary alcohol intake in mice. on the other hand mutant mice lacking important genes for immune responses exhibit decreased alcohol consumption. this indicates that immune signaling promotes alcohol consumption. therefore it is tempting to speculate that increased gut permeability leading to increased bacterial translocation after an acute alcohol binge could promote the desire for further alcohol consumption. the investigators aim to test in this pilot trial whether one alcohol binge damages gut barrier function, increases bacterial translocation and causes innate immune dysfunction. furthermore the effect of glucose and fructose will be studied too.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * age above 18 years * willingness to abstain from alcohol 48h prior to the study visits exclusion criteria: * alcohol abuse .alcohol use disorders identification test ≥ 8 in men or ≥ 7 in women or cage test ≥ 2 (both men and women) * elevated liver function test * any disease or medication that does not allow concomitant consumption of alcohol * women: pregnancy and lactation
bioequivalence study between lamivudine formulations in the form of coated tablet of 150 mg in healthy volunteers

Conditions: HIV INFECTIONS

Summary: the objective of this research is to check whether the test drug (lamivudine in the form of coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the epivir in the form of coated tablet 150 mg glaxosmithkline administered to 28 volunteers of both genres under fasting condition.

it is an open, randomized, crossover 2x2, single dose, with the administration of medicine with 28 healthy volunteers, adults aged 18-50 years, of both genders (14 males and 14 females). of the 28 volunteers planned in the study protocol to start, gave up one (woman) before the start of phase i. so the study was initiated and completed with the participation of 27 volunteers. the volunteers were in hospital for a period of approximately 36 hours in each stage.

Eligibility criteria:
inclusion criteria: * considered healthy after undergoing a clinical evaluation; * agree freely and sign the recruitment and informed consent term, after all the content of the protocol was clear before any procedure; * present the body mass index greater than 19 and less than 30. exclusion criteria: * results of laboratory tests outside the range considered normal, unless they were considered clinically irrelevant; * allergic to lamivudine or any other drug; * positive outcome of the pre-admission pregnancy test; * regular medication within four (4) weeks prior to the start of the study or use of any medication to present interaction with lamivudine one week before the start of the study; * use abusive alcoholic beverage; * use of illicit drugs and tobacco; * history of liver disease, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric; hypo- or hypertension of any cause that required pharmacological treatment; myocardial infarction, angina and / or heart failure;

Keywords: lamivudine bioequivalence test pharmacokinetics high-performance liquid chromatography 3tc lc-ms/ms mass spectrometry
feasibility study of the revent sleep apnea system

Conditions: Obstructive Sleep Apnea (OSA)

Summary: this is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the revent sleep apnea system for the treatment of obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * diagnosis of osa with ahi 15-40 * body mass index (bmi) ≤ 32 * refused or failed continuous positive airway pressure (cpap) * evidence of airway collapse at soft palate and/or base of tongue exclusion criteria: * prior osa surgery * anatomy unable to accommodate implants * chronic immunosuppressive therapy or known problems with wound healing * type i or ii diabetes * active systemic infection * pregnancy * other major medical conditions that could confound outcome measures or interfere with study completion
a study of ljpc-401 for the treatment of iron overload in adult patients with hereditary hemochromatosis

Conditions: Hereditary Hemochromatosis

Summary: this study is a phase 2 multicenter, randomized, placebo controlled, single-blind study. the primary objective of the study is to compare the effect of weekly dosing of ljpc-401 (synthetic human hepcidin) versus placebo on transferrin saturation (tsat) in an adult hereditary hemochromatosis patient population.


Eligibility criteria:
inclusion criteria: 1. patients with clinical diagnosis of hereditary hemochromatosis 2. patients who are prescribed therapeutic phlebotomy for treatment of hereditary hemochromatosis 3. patients with serum ferritin and tsat levels above treatment guidelines 4. female patients of child bearing potential must have a negative pregnancy test and must be using a highly effective method of contraception during participation in the study, and for 30 days after the last dose of study drug 5. males must be surgically sterile (vasectomy), or using a highly effective method of contraception during participation in the study, and for 30 days after the last dose of study drug 6. patient must be willing and able to provide written informed consent exclusion criteria: 1. patients receiving iron chelation therapy within 7 days prior to the first dose of study drug 2. patients initiating phlebotomy treatments less than 3 months prior to the first dose of study drug 3. pregnant or lactating women 4. patients taking an immunosuppressive agent without prior sponsor approval 5. patients participating in an unapproved investigational drug or investigational therapeutic device within 30 days of study drug 6. patients who are unwilling or unable to comply with the study protocol requirements 7. patients with type 1 or poorly controlled type 2 diabetes 8. patients with a concomitant disease, disability or condition, including laboratory abnormality and ecg findings, which may interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, clinically significant arrhythmias, alcohol dependency or abuse, drug dependency or abuse, or psychiatric disease
optical guided sentinel node biopsy for staging of vulvar cancer (i)

Conditions: Vulvar Cancer; Sentinel Lymph Node

Summary: the aim of this study is to investigate whether sentinel node biopsy can be performed without the use of lymphoscintigraphy and with icg as a mono-tracer in women with vulvar cancer, unifocal tumor \< 4 cm (clinical stage ib and ii). further, to investigate the accuracy of combined pet-ct and ultrasound (us) of the groins with us-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor \< 4 cm.


Eligibility criteria:
inclusion criteria: * patients with primary vulva cancer, figo stage ib (tumor \< 4 cm) * patients with unifocal recurrence in the vulva (tumor \< 4 cm) located on the side where the patient is surgically naïve in the groin exclusion criteria: * prior irradiation of the vulva or groins * prior snb or inguinal lymphadenectomy in the relevant groin * known allergy to icg or iodine (icg contains 5% sodium iodine)
cognitive therapy for recurrent depression

Conditions: Depression

Summary: this study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

cognitive therapy (ct) is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. evidence suggests that ct is effective in treating a number of psychiatric conditions, including anxiety and anger. this study will determine the effectiveness of cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression. this study lasted approximately 36 months and comprised three phases. for the first 12 weeks, all participants received between 16 and 20 ct sessions. participants were then randomly assigned to receive additional ct sessions, antidepressants, or placebo for an additional 8 months. upon completing treatment, participants entered follow-up study visits once every 4 months for the next 24 months. clinician-rated scales and questionnaires were used to assess depressive symptoms of participants at study start and at the end of each study phase.

Eligibility criteria:
inclusion criteria: * recurrent unipolar major depressive disorder * have experienced at least two episodes of major depression * have experienced at least one period of recovery during a depressive episode or have a history of dysthymia (a mood disorder characterized by depression) prior to the onset of current or past depressive episodes * willing and able to comply with all study requirements * able to speak and read english exclusion criteria: * active alcohol or other substance dependence within 6 months prior to study entry * currently at risk for suicide * mood disorders due to a medical condition or substance abuse * bipolar, schizoaffective, obsessive compulsive, or eating disorders * schizophrenia * unable to stop mood-altering medications * current use of medication or diagnosis of a medical disorder that may cause depression (e.g., diabetes, head injury, stroke, cancer, multiple sclerosis) * previous failure to experience a reduction in depressive symptoms after 8 weeks of cognitive therapy with a certified therapist * previous failure to experience a reduction in depressive symptoms after 6 weeks of 40 mg of prozac * pregnancy or plan to become pregnant in the next 11-12 months * unable to attend clinic twice weekly during business hours * unable to complete questionnaires

Keywords: cognitive therapy antidepressants psychotherapy
screening for deep vein thrombosis in intensive care

Conditions: Deep Vein Thrombosis

Summary: background: venous thromboembolism (vte) is a common complication in critically ill patients, admitted to the intensive care units (icus). at the present time, there is no validated score to estimate risks and benefits of antithrombotic pharmacological prophylaxis in this subset of patients. results of a pilot study showed that ultrasound (us) screening for deep vein thrombosis (dvt) is associated with a reduced incidence of proximal dvt, up front to an overall increased discovery rate of dvts. the reduced incidence of proximal dvt could be attributed to an early diagnosis of distal and muscular dvts, which would eventually receive a more adequate management. proximal dvts are associated with a worse long-term prognosis than distal or muscular dvts, so it can be hypothesized that the active us screening could lead to an improvement of in-hospital and long-term prognosis of patients admitted to the icu. aim of the study: to test whether an active us screening may reduce the incidence of proximal dvt and improve the in-hospital and long-term prognosis of patients admitted to the icu. expected relevance: systematic screening for dvt could improve the management of the pharmacological antithrombotic treatment, leading to a reduction of thromboembolic and bleeding complications. this will eventually lead to an improved in-hospital and long-term prognosis.


Eligibility criteria:
inclusion criteria: * any patient admitted to icu with a length-of-stay in icu \>96 hours exclusion criteria: * pregnancy * sars-cov-2 infection * established dvt or pulmonary embolism at admission * established coagulation disorder * presence of inferior vena cava filter at the admission * admission from the icu of another hospital
pilot study to assess the effect of high dose n-acetylcysteine (nac) in chronic obstructive pulmonary disease (copd) patients

Conditions: COPD

Summary: studies suggest that n-acetylcysteine (nac) potentially reduces inflammation and hyperinflation in patients with copd. in this pilot study the efficacy, safety and tolerability of high dose nac in 12 patients with moderate copd will be examined. these patients will receive a placebo for 12 weeks and nac for 12 weeks in a dosage of 3 times 600 mg a day on top of their usual medication in a randomized crossover design. all subjects will be followed for 28 weeks. the effect of high dose nac on small airways will be assessed by measuring the total and peripheral airway resistance calculated with computational fluid dynamics (cfd). the effect on oxidative stress will be assessed by measuring exhaled no and specific markers (crp, erythrocyte sedimentation rate, il-6, 8-isoprostane, h2o2, tnf-alfa, glutathione, gpx, sod and il-8) in blood and exhaled breath condensate (ebc). dynamic and static lung volumes will be assessed by spirometry, body plethysmography and diffusion. quality of life and symptoms will be assessed by the st george respiratory questionnaire.


Eligibility criteria:
inclusion criteria: 1. patients with documented copd based on the following criteria: * smoking history of at least 10 pack-years * decreased tiffeneau index (fev1/(fvc \< 0.70) 2. patients aged ≥ 40 years 3. patients who stopped smoking since more than 1 month 4. patients who present moderate copd with an fev1 between 50 and 80% of predicted (gold 2) 5. patients should be treated according to gold guidelines exclusion criteria: 1. unstable patients who developed an exacerbation during the last 8 weeks 2. patients who are current smokers or stopped less than 1 month 3. patients who are allergic to acetylcysteine or to another element of the product 4. patients with phenylketonuria or an untreated active peptic ulcer 5. patients with any stage kidney and/or heart insufficiency or hypertension 6. patients already treated with nac for more than 6 months or during the last 3 months 7. patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids 8. patients who are pregnant or are breast-feeding 9. patients who are treated with orally administered cephalosporins 10. patients using supplements containing antioxidants as vitamins c or e