Kornimate/medical-research-clean huggingface dataset:
dose escalation study of kb001 in cystic fibrosis patients infected with pseudomonas aeruginosa

Conditions: Cystic Fibrosis

Summary: the primary objective of this study is to evaluate the safety and tolerability of a single dose of kb001 in cystic fibrosis patients infected with pseudomonas aeruginosa (pa)

cf patients often have lung infections. pseudomonas aeruginosa (pa) is the most significant bacteria in cf, with up to 80% of cf patients eventually becoming infected. these patients are often treated with antibiotics with variable results. this study will examine the impact of a single-dose of an investigational drug, kb001, on pa bacteria in the cf lung.

Eligibility criteria:
inclusion criteria: * written informed consent * confirmed diagnosis of cf based on the following criteria: positive sweat chloride greater than 60meq/liter, and/or a genotype with 2 identifiable mutations consistent with cf, and one or more clinical features consistent with the cf phenotype * age \>/= 18 years of age with the potential for age 12 \>/= * screening pa sputum culture * fev1% predicted \>/= 40 (based on wang's equations for males aged 12-17 and females 12-15 years, and hankinson's equations for all other patients) exclusion criteria: * evidence of an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to day 0 * use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day 0. * history of positive b. cepacia complex, organ transplantation, hepatic disease or venal dysfunction * current cigarette smoker, history of drug addiction or alcohol abuse * use of investigational medication or participation in an investigational study within 4 weeks prior to day 0 * women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study

Keywords: cystic fibrosis, pseudomonas aeruginosa, pulmonary cf
prevalence of peripheral vascular diseases and presentation in patients with autoimmune diseases

Conditions: Peripheral Vascular Diseases and Presentation in Patient With Autoimmune Diseases

Summary: rheumatic autoimmune diseases include conditions such as systemic lupus rheumatoid arthritis systemic sclerosis in which connective tissues are frequently targeted. autoimmune diseases as a group are among the leading causes of death and morbidity in the industrial world and pose an immense socioeconomic burden despite the considerable accumulative burden of these diseases only a small number of multinational registries for a few selected autoimmune diseases have been devised. numerous autoimmune inflammatory diseases have been associated with various forms of vasculopathy and increase vascular disease risk such as accelerated atherogenesis and thromboembolic events as digital and acral gangrene secondary raynaud syndrome arterial aneurysm and different cutaneous ulcer. the etiopathogenesis os increased risk of peripheral vascular diseases and presentation in autoimmune diseases is not entirely clear but multiple contibutors have been explored especially in the context of systemic inflammation and disordered thrombogenesis.


Eligibility criteria:
inclusion criteria: * all ages * both sexes * recent or past history of vascular diseases or presentation in any proven autoimmune diseases according to the guidlines. exclusion criteria: * patients refuse the study * patients do not have established diagnosis of vascular diseases . * patients not completely approved to have autoimmune diseases.
acupuncture in treating hot flashes in women with breast cancer

Conditions: Breast Cancer; Hot Flashes

Summary: rationale: acupuncture may help relieve hot flashes in women with breast cancer. it is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer purpose: this randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.

objectives: primary * determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer. secondary * determine the long-term effects of acupuncture on hot flashes. outline: this a randomized, placebo-controlled, multicenter study. patients are stratified according to concurrent treatment with selective estrogen receptor modulators, gonadotropin-releasing hormone analogs, or aromatase inhibitors (yes vs no), concurrent use of hot flash medication or selective serotonin reuptake inhibitors (ssris) (yes vs no), baseline hot flash frequency (\> 7 per day), and menopausal status at diagnosis (premenopausal vs postmenopausal). patients are randomized to 1 of 2 treatment arms. * arm i (treatment): patients receive 8 acupuncture treatments over 4 weeks. * arm ii (control): patients receive 8 placebo acupuncture treatments over 4 weeks. beginning at week 7, patients are offered 8 true acupuncture treatments over 4 weeks. patients in both arms complete a "hot flash" diary for 1 week before treatment and then periodically during and after treatment. after completion of study treatment, patients are followed periodically. projected accrual: a total of 80 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer (including in situ disease) * must be receiving treatment for breast cancer at memorial sloan kettering cancer center (mskcc) or its regional site (commack) * has an average of 3 or more hot flashes a day during 1 week of baseline diary recording * hormone receptor status not specified patient characteristics: * female * pre- or postmenopausal * karnofsky performance status 70-100% * ambulatory * no skin infection prior concurrent therapy: * more than 3 weeks since prior and no concurrent treatment with any of the following during the 6 week evaluation period of the trial: * surgery * initiation of a new chemotherapy regimen * initiation of immunotherapy * initiation of radiotherapy * initiation or cessation of hormonal therapy * more than 6 weeks since prior acupuncture treatment (6 months for acupuncture specifically for the treatment of hot flashes) * no concurrent pharmacological treatment for hot flashes unless dose has been stable for 4 weeks * no concurrent selective serotonin reuptake inhibitors (ssris) unless dose has been stable for 4 weeks

Keywords: breast cancer in situ stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iv breast cancer recurrent breast cancer stage iiic breast cancer hot flashes
tandem-2: closing the gap to interventions for tand

Conditions: Adult Caregivers of Individuals with TSC; Tuberous Sclerosis Complex (TSC)

Summary: the goal of this pilot study is to determine the feasibility, acceptability and impact of a brief behavioral intervention - the "well-beans for caregivers" program, for adult caregivers of individuals with tuberous sclerosis complex (tsc) of any age. the main questions of the study are: 1. can this innovative, ultra-brief caregiver well-being intervention be delivered feasibly to caregivers via an online modality? 2. how do the caregivers experience the program (acceptability)? 3. does limited efficacy testing suggest the program has an impact on caregiver's well-being?

the investigators hypothesize that an innovative, ultra-brief caregiver wellbeing intervention developed for caregivers of children with developmental disabilities can be adapted as a universal caregiver wellbeing intervention in tuberous sclerosis complex (tsc), that it can be delivered feasibly in an online modality, and will result in changes in key caregiver wellbeing factors. to test these hypotheses, the researchers will adapt the 3-session 'well-beans for caregivers' program through a participatory method with the tand consortium (the tand consortium is an international group of clinical and research professionals as well as family members living with individuals with tsc - tand stands for tsc-associated neuropsychiatric disorders - see tandconsortium.org). the input from the tand consortium will be augmented by members of tsci (tuberous sclerosis international), the global network of tsc non-profit organizations. for step 2 (pilot intervention), two specialist facilitators and four trainee observers will deliver the 3-session program using zoompro, a secure online platform to two groups of 10-12 caregivers. caregivers are those who provide long-term, day-to-day support and care, and this group includes parents, partners, relatives, or other family members (not paid professional caregivers). these sessions will not be recorded to ensure that participants can join the program without feeling concerned about being recorded. data collection will use a quasi-experimental pre-post-test design. eligible and consented participants will therefore complete baseline data as 'pre-test' and then 'post-test' data after the 3-week intervention. following this, they will complete 3-month and 6-month data collection. caregiver wellbeing measures will only include open access and freely available measures. the program as well as data collection will be conducted in english.

Eligibility criteria:
inclusion criteria: * adult caregiver of an individual with tuberous sclerosis complex (tsc) of any age exclusion criteria: * not an adult caregiver of an individual with tsc

Keywords: caregiver well-being psychological flexibility acceptance and commitment therapy (act) tuberous sclerosis complex (tsc) tsc-associated neuropsychiatric disorders (tand)
medlineplus health prescriptions: developing a pragmatic approach for clinic use

Conditions: Acne Vulgaris; Allergic Rhinitis; Anxiety; Asthma; Back Pain; Prostatic Hyperplasia; Bursitis; Chronic Obstructive Pulmonary Disease; Cough; Coronary Artery Disease; Depression; Diabetes Mellitus; Diarrhea; Gastroesophageal Reflux; Fibromyalgia; Headache; HIV Infections; Hypothyroidism; Hyperlipidemia; Hypertension; Influenza; Sleep Initiation and Maintenance Disorders; Irritable Bowel Syndrome; Migraine Disorders; Obesity; Obstructive Sleep Apnea; Osteoarthritis; Senile Osteoporosis; Shoulder Pain; Sinusitis; Smoking Cessation; Tobacco Use Cessation; Menopause; Urinary Incontinence; Urinary Tract Infection; Vaginitis; Vertigo

Summary: the specific aim of this proposed pilot study is to compare two standardized processes (paper and electronic) to deliver a customized medlineplus health information prescription.

the specific aim of this proposed pilot study is to compare two standardized processes (paper and electronic) to deliver a customized medlineplus health information prescription. primary hypothesis. individuals in the paper prescription group will be just as likely to seek information using medlineplus compared with individuals in the group who receive the same customized information through an email prescription. secondary hypothesis. individuals in the paper prescription group will be just as likely to have successful behavioral outcome measures as those in the group who receive the same customized information through an email prescription.

Eligibility criteria:
inclusion criteria: * one of the 40 target health conditions. exclusion criteria - absence of at least one of the target 40 conditions

Keywords: hiv knee pain colonoscopy mammography vaccination
post approval study of the acrysof® iq toric intraocular lens (iol) models sn6at6-sn6at9

Conditions: Cataracts; Astigmatism

Summary: the purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.

in this prospective, non-randomized, unmasked study, subjects with pre-existing corneal astigmatism ≥2.57 diopters will choose to be implanted with either the acrysof® iq toric high cylinder power iol or the acrysof® iq aspheric natural monofocal iol.

Eligibility criteria:
inclusion criteria: * diagnosed with bilateral cataracts and in the targeted astigmatism range. * planned cataract removal by phacoemulsification. * pupil size greater than or equal to 6 mm after dilation. * able to undergo second eye surgery within 30 days of first eye surgery. * other protocol-defined inclusion criteria may apply. exclusion criteria: * irregular corneal astigmatism. * any inflammation or swelling of the cornea. * any corneal abnormality other than regular corneal astigmatism. * previous corneal refractive surgery. * amblyopia. * diabetic retinopathy. * uncontrolled glaucoma. * currently participating in another investigational drug or device study that may confound the results of this investigation. * other protocol-defined exclusion criteria may apply.

Keywords: intraocular lens cataracts astigmatism toric
bone properties in hypoparathyroidism: effects of pth

Conditions: Hypoparathyroidism

Summary: whereas much information is known about the properties of bone in primary hyperparathyroidism, a disorder of parathyroid hormone (pth) excess, virtually nothing is known about the skeleton in hypoparathyroidism, a disorder in which pth is absent. the purpose of this research project is to test the hypothesis that the skeleton in hypoparathyroidism is abnormal in its metabolic, densitometric, geometric, biomechanical and microarchitectural features. we will also test the hypothesis that the skeleton is dependent upon pth for normal structure and function. using non-invasive approaches as well as direct analysis of bone itself, the human hypoparathyroid skeleton will be thoroughly characterized. with each patient serving as his/her own control, we will determine how, to what extent, and in what ways the administration of pth restores skeletal dynamics and structure to the hypoparathyroid skeleton. in this way, we will identify those structural and dynamic elements of the skeleton that are influenced by or dependent upon pth. methods to be utilized include dual energy x-ray absorptiometry, quantitative central and peripheral computed tomography, geometry and size quantification, histomorphometry by standard and microct methods, finite element analysis, biochemical bone markers, quantitative back scattered electron imaging, and fourier transform infrared spectroscopy. this research project will extend our knowledge of the skeletal effects of pth to its deficient range and thus complete our understanding of pth action on bone gained by our many years of studying pth overexpression in primary hyperparathyroidism. this investigation may also provide insight into the means by which pth helps to restore the skeleton when it is used to treat osteoporosis.

a detailed description of the methods used in this study include the following: direct analysis of bone itself. skeletal dynamics and structure such as dual energy x-ray absorptiometry, quantitative central and peripheral computed tomography, geometry and size quantification, histomorphometry by standard and microct methods, finite element analysis, biochemical bone markers, quantitative back scattered electron imaging, and fourier transform infrared spectroscopy.

Eligibility criteria:
inclusion criteria: * hypoparathyroidism exclusion criteria: * bisphosphonate use
umbilical cord mesenchymal stem cells injection for diabetic foot

Conditions: Diabetic Foot; Critical Limb Ischemia; Mesenchymal Stem Cells; Umbilical Cord

Summary: the purpose of this study is to determine whether umbilical cord mesenchymal stem cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the sevier pain of ischemia.

type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. patients in transplanted group received the stem cells treatment,patients in control group received the standard treatment. after culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * age 18 - 75 years * subject has an ankle-brachial index \< 0.9 * subject has had previous conservative treatment which resulted in little or no improvement * subject has had no stem cell treatment within the past 6 months * no sufficient response to best standard care delivered for six weeks. * no surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist * signed informed consent * absence of life-threatening complications from the ischemic limb * life expectancy more than 2 years * negative pregnancy test when applicable exclusion criteria: * diabetic retinopathy * history of neoplasm or hematological disease * uncontrolled high blood pressure (\>180/110) * severe cardiac insufficiency (new york heart association \[nyha\] iv) or ejection fraction\<30% * malignant ventricular arrythmia * deep venous thrombosis during the last 3 months * active bacterial infection * body mass index \> 35 kg/m2 * stroke or myocardial infarction during the last 3 months

Keywords: diabetic foot critical limb ischemia mesenchymal stem cells umbilical cord
epo906 therapy in patients with advanced melanoma

Conditions: Melanoma

Summary: this study will examine whether the new investigational drug epo906, given by intravenous infusion (iv directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.


Eligibility criteria:
inclusion criteria the following patients may be eligible for this study: * patients with advanced metastatic melanoma defined as poor prognosis stage iii melanoma and stage iv disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation) * patients with poor prognosis stage iii melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis) * must have a life expectancy of greater than three (3) months * prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed \> 4 weeks prior to treatment * prior vaccine therapy is permitted, but must have been completed \> 4 weeks prior to treatment * patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed). exclusion criteria the following patients are not eligible for this study: * patients with choroidal ocular melanoma * patients with symptomatic cns metastases or leptomeningeal involvement * patients with renal or hepatic dysfunction * patients with any peripheral neuropathy or unresolved diarrhea greater than grade 1 * patients with severe cardiac insufficiency * patients taking coumadin or other warfarin-containing agents with the exception of low dose coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports * patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study * patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy) * patients receiving chemotherapy within the last four weeks * history of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ * patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae * hiv+ patients * pregnant or lactating females.

Keywords: melanoma cancer tumor tumour malignant metastatic intravenous epothilone
ltr for treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: study of tongue implant for treatment of obstructive sleep apnea

subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping. subjects will be followed a year with primary endpoint of ahi results through polysomnography readings (psg) testing in an overnight sleep lab.

Eligibility criteria:
inclusion criteria: * ahi\>10 * 18 years of age exclusion criteria: * subjects with \>20% of their ahi accounted for from central apnea. * mallampanti score of 4 * tonsillar hypertrophy (4+) * prior uvulopalatopharyngoplasty (uppp) procedure * narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination or x-ray * tongue thickness \<40 mm measured on lateral cephalogram x-ray from the frenulum to linea terminalis * more than 10% of sleep time with blood o2 desaturation below 70% * unable and/or unwilling to comply with study requirements * females of child bearing age who are pregnant or intending to become pregnant * allergy to silicone * history of radiation therapy to neck or upper respiratory tract * subjects with bleeding disorders, impaired immunity for any reason, or heart attack within the last six months