Kornimate/medical-research-clean huggingface dataset:
a study on the long-term efficacy, safety and persistence of immune response of a vaccine against herpes zoster in older adults

Conditions: Herpes Zoster

Summary: the purpose of the current zoster-101 long-term follow-up (ltfu) study of zoster-049 (nct02723773) study, an extension of zoster-006 (nct01165177) and zoster-022 (nct01165229) primary studies, is to assess the long-term vaccine efficacy (ve) against herpes zoster (hz) (approximately 11-15 years post primary vaccination in zoster-006/022 studies), persistence of immunogenicity and safety of gsk's herpes zoster subunit (hz/su) vaccine in older adults. the persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of hz/su vaccine administered to a small group of participants in zoster-049 study (approximately 5 years after the initial vaccination in zoster-006/022 studies) will also be assessed.


Eligibility criteria:
inclusion criteria: * participants and participant's caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol. * written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure. * medically stable participants as established by medical history and clinical examination before entering into the study. * participants who completed zoster-049 study (following at least 1 dose of hz/su in zoster-006/022 studies). exclusion criteria: medical conditions * any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. prior/concomitant therapy * use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of hz or varicella zoster virus (vzv) infection at the time of enrolment or their planned use during the study period. * previous vaccination against vzv or hz and/or planned administration during the study of a vzv or hz vaccine (including an investigational or non-registered vaccine other than hz/su administered in studies zoster-006/022 or zoster-049). prior/concurrent clinical study experience * concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of hz or vzv and which may have a possible activity against vzv.

Keywords: shingles herpes zoster subunit vaccine recombinant zoster vaccine (rzv) long-term follow-up study long-term vaccine efficacy prophylactic efficacy safety persistence of immune response older adults
a global study to compare the effects of fulvestrant and arimidex in a subset of patients with breast cancer.

Conditions: Hormone Receptor Positive Breast Cancer

Summary: the purpose of the study is to compare how treatment with fulvestrant (faslodex) or anastrozole (arimidex) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

a randomised, double-blind, parallel-group, multicentre, phase iii study to compare the efficacy and tolerability of fulvestrant (faslodex) 500 mg with anastrozole (arimidex) 1 mg as hormonal treatment for postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy.

Eligibility criteria:
inclusion criteria: * histological confirmation of breast cancer in post menopausal women (age \>=60). positive hormone receptor status (er +ve and/or pgr +ve) of primary or metastatic tumour tissue based on local laboratory assessment. * either locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) or metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease) * at least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment. * postmenopausal women, fulfilling 1 of: * prior bilateral oophorectomy * age \>60 years * age \< 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and fsh and oestradiol in the postmenopausal range exclusion criteria: * presence of life-threatening metastatic disease * any of: * extensive hepatic involvement * involving brain or meninges * symptomatic pulmonary lymph spread * discrete lung metastases are acceptable if respiratory function is not significantly compromised * prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation) * radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). prior hormonal treatment for breast cancer. * current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).

Keywords: hormone receptor positive breast cancer endocrine no hormone therapy hormone breast cancer neoplasm metastatic tumour
study of tissue samples in predicting how well chemotherapy and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the esophagus

Conditions: Esophageal Cancer

Summary: rationale: studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this clinical trial is studying tissue samples in predicting how well chemotherapy and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the esophagus.

objectives: * to search for chemoradiosensitivity-related genes using a pre-treatment biopsy sample in patients with esophageal squamous cell carcinoma treated with cisplatin, fluorouracil, and concurrent radiotherapy. * to establish an algorithm for prediction of chemoradiosensitivity in these patients. outline: patients receive 1 of the following treatment regimens: * regimen 1: patients receive low-dose cisplatin iv on days 1 and 29 and low-dose fluorouracil iv on days 1-4 and 29-32. patients also undergo concurrent radiotherapy on days 1-4 and 29-32. patients undergo salvage surgery if needed. * regimen 2: patients receive high-dose cisplatin iv on days 1 and 29 and high-dose fluorouracil iv on days 1-4 and 29-32. patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1. pre-operative biopsy samples are analyzed by dna microarray chip to establish an algorithm for prediction of chemoradiosensitivity. after completion of study therapy, patients are followed at 12 months.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma of the thoracic esophagus * stage iia, iib, or iii (except t4) disease * tumor diameter \< 8 cm * no tumor extension to the cervical esophagus or cardia of the stomach * no multiple and different histological types of cancer patient characteristics: * ecog performance status 0-1 * wbc ≥ 4,000/mm³ * absolute neutrophil count ≥ 2,000/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 10 g/dl * ast and alt ≤ 100 iu/l * total serum bilirubin ≤ 1.5 mg/dl * creatinine ≤ 1.2 mg/dl * creatinine clearance ≥ 60ml/min * spo_2 (room air) ≥ 95% * not pregnant or nursing * no abnormal ecg findings requiring treatment * no interstitial pneumonitis or no pulmonary fibrosis * no severe complication (e.g., heart failure, renal failure, hepatic failure, or uncontrollable diabetes mellitus) * no collagen disease (e.g., pss or dermatomyositis) * no mental disease * no active bacterial infection * no virus infection (i.e., hbv, hcv, ptha, or hiv) prior concurrent therapy: * no prior surgery for esophageal cancer * no prior chemotherapy * no prior chest radiotherapy

Keywords: squamous cell carcinoma of the esophagus stage iia esophageal cancer stage iib esophageal cancer stage iiia esophageal cancer stage iiib esophageal cancer stage iiic esophageal cancer
synaptic density and progression of huntington's disease.

Conditions: Huntington Disease

Summary: aim: to assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with hd. design: the investigators will include 20 hd mutations carriers and 15 healthy controls. all subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11c-ucb-j pet-ct and 18f-fdg pet-mr at baseline and after 2 years.


Eligibility criteria:
inclusion criteria: * age 20-75 years. * capacity to understand the informed consent form. * for hd group: cag repeat expansion in htt ≥ 40. * premanifest hd mutation carriers: \* no clinical diagnostic motor features of hd, defined as unified huntington's disease rating scale (uhdrs) diagnostic confidence score \< 4. * early manifest hd patients: * clinical diagnostic motor features of hd, defined as unified huntington's disease rating scale (uhdrs) diagnostic confidence score = 4. * uhdrs-tfc score 7 or higher (shoulson-fahn stage 1 and 2). exclusion criteria: * neuropsychiatric diseases other than hd * major internal medical diseases * white matter lesion load on flair fazekas score 2 or higher or other relevant mri abnormalities * history of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug abuse * contraindications for mr * pregnancy * previous participation in other research studies involving ionizing radiation with \>1 msv in the previous 12 months.

Keywords: huntington disease pet 11c-ucb-j 18f-fdg sv2a
inhaled nebulized furosemide & physical activity-related breathlessness

Conditions: Breathlessness

Summary: breathlessness on exertion is a common and troublesome complaint of individuals with restrictive lung disorders. in these adults, breathlessness contributes to physical activity-limitation and avoidance and an adverse health-related quality-of-life, often in a self-perpetuating cycle. it follows that alleviating dyspnea and improving exercise tolerance are among the principal goals in the management of adults with restrictive lung disorders. nevertheless, effective management of breathlessness and physical activity-limitation remains an elusive goal for many healthcare providers and current therapies (e.g., antifibrotic agents, oxygen, exercise training) are only partially successful in this regard. thus, research aimed at identifying breathlessness-specific medications to complement existing therapies for the management of physical activity-related breathlessness in restrictive lung disorders is timely and both clinically and physiologically relevant. the purpose of this randomized crossover study study is to examine the acute effects of two doses of inhaled nebulized furosemide (a loop diuretic) on the perception of breathlessness during laboratory-based cycle exercise in healthy, young men in the presence of an external thoracic restriction to mimic a 'mild' restrictive lung deficit. to this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled furosemide (40 mg and 120 mg) on detailed assessments of breathlessness (sensory intensity and affective responses) and its physiological determinants (ventilation, breathing pattern, dynamic operating lung volumes, cardio-metabolic function) symptom-limited, high-intensity, constant-work-rate cycle exercise testing with external thoracic restriction sufficient to mimic a 'mild' restrictive pulmonary deficit in healthy, men aged 18-40 years.


Eligibility criteria:
inclusion criteria: * male * aged 18-40 years * fev1 ≥80% predicted * fev1/fvc \>70% exclusion criteria: * current or ex-smoker * body mass index \ 30 kg/m2 * self-reported history of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction * taking doctor prescribed medications * allergy to sulfa medications

Keywords: furosemide exercise restrictive pulmonary disorder
compare celecoxib and ibuprofen sr in the management of acute pain post orthopedic or gynecological surgery

Conditions: Pain, Postoperative

Summary: to validate the analgesic efficacy and safety of celecoxib compared with ibuprofen sr in the management of acute pain post orthopedic or gynecological surgery


Eligibility criteria:
inclusion criteria: * undergone uncomplicated orthopedic surgery or abdominal gynecological surgery under epidural anesthesia * baseline pain intensity of more than 45 mm as measured by vas and a severity of pain graded as moderate or severe on the categorical pain intensity scale exclusion criteria: * a previous history of intolerance or hypersensitivity to any nsaids, cyclooxygenase inhibitor, sulfonamides, or any analgesic, or to drugs with similar chemical structures
the role of percutaneous angioplasty in ischemic leg ulcer healing

Conditions: Ischemic Foot Ulcers

Summary: the aim of our study was to evaluate the technical and clinical effectiveness of pta in the management of ischemic foot ulcers. all consecutive patients presenting with a foot ulcer at the outpatient vascular surgery clinic of our hospital were evaluated. if non-invasive parameters suggested peripheral arterial disease (pad) anatomic imaging (cta and/or dsa) was performed and a pta was carried out when feasible during the same session. all patients were followed until healing, amputation, death, or for at least two years. short-term and long-term clinical success of pta was evaluated based on ulcer size and appearance. patients with worsening ulcers after pta underwent bypass grafting or amputation.

the aim of our study was to evaluate the technical and clinical effectiveness of pta in the management of ischemic foot ulcers. methods: all consecutive patients presenting with a foot ulcer at the outpatient vascular surgery clinic of our hospital were evaluated. preoperative evaluation included foot pulse assessment, ankle-brachial-index (abi) and duplex scanning. if non-invasive parameters suggested peripheral arterial disease (pad) anatomic imaging (cta and/or dsa) was performed and a pta was carried out when feasible during the same session. all patients were followed until healing, amputation, death, or for at least two years. short-term and long-term clinical success of pta was evaluated based on ulcer size and appearance. patients with worsening ulcers after pta underwent bypass grafting or amputation.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients with ischemic foot ulcer and * patients aged 18 years or older. exclusion criteria: * refusal to participate * refusal of pta therapy * lesions not amenable to endovascular revascularization by vascular team's consensus based on preinterventional imaging * absolute contraindication to contrast media injection, as determined by the investigator * uncontrollable coagulopathy * unwilling or unable to provide informed consent or return for required follow-up evaluations and * previous or concurrent participation in another clinical research study
weaning from prolonged mechanical ventilation

Conditions: Acute Mechanical Ventilatory Failure

Summary: patients requiring the use of artificial ventilation (also called mechanical ventilation) for more than 21 days account for more than 37% of all icu costs. as such, these patients are now transferred to centers that specialize in weaning patients from the respirator; these units are referred to as long-term acute care (ltac) facilities. despite the increase of ltac facilities, research on the fastest method for disconnecting the patient from the respirator is lacking. in addition, little information is available regarding the long-term survival and quality of life after a prolonged course of artificial ventilation. the purpose of this study is to determine the fastest method for disconnecting the patient from the respirator at a ltac facility and its effect on long-term survival and quality of life.

patients requiring prolonged mechanical ventilation (defined as more than 21 days) account for more than 37% of all icu costs. as such, these patients are now transferred to centers that specialize in weaning from mechanical ventilation, so called long-term acute care (ltac) facilities. despite the proliferation of ltac facilities, research on methods for expediting weaning is lacking. in addition, little information is available regarding long-term survival and patient's perception of quality of life after a prolonged course of mechanical ventilation. in patients receiving mechanical ventilation in an icu, randomized trials have revealed that ventilator duration was significantly influenced by weaning methods. the two most common weaning methods are pressure support and spontaneous breathing trials. unlike the icu, the relative efficacy of these two techniques in weaning patients requiring prolonged ventilation at a ltac facility is largely unknown. the aim of this proposal is to determine whether the length of time required for weaning from prolonged ventilation differs with pressure support versus spontaneous breathing trials. the second aim is to determine the long-term impact of prolonged ventilation on survival, functional status and quality of life.

Eligibility criteria:
inclusion criteria: * mechanical ventilation for at least 21 days exclusion criteria: * hypoxemia (oxygen saturation \ 0.40, and positive end-expiratory pressure \> 5 cm h2o * hemodynamic instability (requiring intravenous vasoactive agents, such as dopamine \> 5 mg/kg/min) * profound neurological deficits (large stroke) * documented bilateral phrenic nerve injury * previous admission to rml hospital * life expectancy less than 3 months

Keywords: mechanical ventilation weaning pressure support spontaneous breathing long-term acute care facility mortality
short term reproducibility of office white-coat effect

Conditions: White Coat Hypertension

Summary: while a theoretical increase in systolic blood pressure (bp) of 10 mmhg can triple the relative risk of cardiovascular disease (cvd), the potential presence of a white coat effect (wce) can interfere with the assessment of blood pressure control in the consultation. however, it is often difficult to assess the presence of a white coat effect (a quantitative variable) in general practice because of the difficulties in performing ambulatory bp measurements (self-measurement of blood pressure or ambulatory bp measurements). we have therefore previously described a surrogate concept of wce obtained during a consultation with a general practitioner. it corresponds to a reduction of 10mmhg or more in systolic bp between the start and the end of the consultation. we have named it 'office white coat effect tail' (owcet) and we have shown that owcet, as a dichotomous variable, in a large italian population cohort, with a follow-up of more than 18 years, was associated with an excess incidence of stroke, myocardial infarction (mi) and cvd and with excess mortality from mi and cvd. this concept appears to be more prevalent in women and is independent of blood pressure variability (regression to the mean). in addition, there is a genuine correlation between wce and owcet. to our knowledge, the reproducibility of the owcet has never been studied, which could distort the relevance of this concept in the context of cardiovascular risk stratification in primary care.


Eligibility criteria:
inclusion criteria: * adult patients ; * not taking any antihypertensive medication; * free of any cardiovascular pathology. exclusion criteria: * patients who are minors or protected adults ; * patients with bp ≥160/105 mmhg; * history of secondary hypertension; * taking a treatment that may affect blood pressure.

Keywords: white coat effect reproducibility primary care
who versus iadpsg diagnostic criteria of gestational diabetes mellitus and their associated maternal and neonatal outcomes

Conditions: Gestational Diabetes Mellitus

Summary: aim for this study is to measure the prevalence of gestational diabetes mellitus (gdm) using world health organisation (who) versus international association of diabetes in pregnancy study group (iadpsg) criteria among pregnant mother in universiti kebangsaan malaysia medical centre (ukmmc)

it will then be used to measure the incidence of adverse maternal and neonatal outcomes in women diagnosed with gdm using either of the criteria. patients with risk factors for gdm will be recruited and randomised to either group once fulfilled the inclusion and exclusion criteria and agreed to join this study. subjects will then undergo 75g oral glucose tolerance test and diagnosis will be established based on the group assigned.

Eligibility criteria:
inclusion criteria: * malaysian citizen and able to speak and understand malay or english * pregnant women with one or more risk factors for gdm between 14-37 gestational weeks * singleton pregnancy exclusion criteria: * inability to complete ogtt * women previously diagnosed with type 2 and type 1 dm * pregnant women who refuse to participate
experience of mutaflor suspension use in preterm infants for immunity improvement

Conditions: Neonatal Infection

Summary: ecn has been registered as a medical drug under the brand name mutaflor® suspension in ukraine in 2010. indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in children, prophylactics of pathological colonization in newborns including premature newborns, and improvement of immunity in newborns (mature and premature). the aim of this trial was to observe efficacy and safety of mutaflor® suspension use for immunity improvement in preterm newborn infants

study design: open-labeled, controlled, parallel group, non-interventional 3-weeks-study with followed prospective observation during 1 week and 1 year follow-up period. patients of group i take the probiotic mutaflor orally in the dose 1 ml once a day during first week of life and three times per week during the second and third week of life. patients of the group ii don't take specific probiotic for immunity strengthening.

Eligibility criteria:
inclusion criteria: * age 12-24 hours of life; * 1st degree of prematurity (functionally mature infant, gestational age 35-36 weeks); * exclusive breast feeding during study; * both parents must sign and date an informed consent for infant's participation in the study. exclusion criteria: * perinatal asphyxia ( apgar score less than 8); * significant concomitant disease (congenital birth defects, perinatal encephalopathy, torch - infections and other infectious disease of newborn, respiratory distress syndrome ets); * clinically significant changes in blood analyze results (if needed); * use of other probiotics or prebiotics during the first 28 days of study participation.

Keywords: preterm newborn neonatology ecn nissle mutaflor prophylaxis infection