Kornimate/medical-research-clean huggingface dataset:
bone marrow derived adult stem cells for dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: a randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary injection of progenitor cells compared to placebo injection in patients with dilated cardiomyopathy who have been pre-treated with g-csf (granocyte™) injections for 5 days, and patients treated with a 5 day course of g-csf (granocyte™) injection only compared to placebo injection


Eligibility criteria:
inclusion criteria: * symptomatic patients with a confirmed diagnosis of dilated cardiomyopathy (nyha ii-iii) attending their local 'heart failure clinic' who are on optimal heart failure treatment, under supervision from their physician or heart failure nurse specialist, and have no other treatment options * patients who are nyha ii that have been hospitalised with a dilated cardiomyopathy related condition * coronary angiography will be performed where necessary to confirm the diagnosis and ensure no other conventional treatment options are indicated * prior to recruitment to the study patients at risk of ventricular arrhythmia will have undergone electrophysiological assessment and appropriate clinical management (including implantable defibrillator insertion) where indicated (as per nice guidelines) exclusion criteria: * nyha i * referral hospitals most recent documented ejection fraction of \>45% (any imaging modality) * the presence of cardiogenic shock * the presence of acute left and/or right sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema * known severe pre-existent left ventricular dysfunction (with a documented ejection fraction of \<10% from referral hospital) prior to randomisation * congenital cardiac disease * cardiomyopathy secondary to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia * cardiomyopathy in association with a neuromuscular disorder e.g. duchenne's progressive muscular dystrophy * previous cardiac surgery * contra-indication for bone marrow aspiration * known active infection * known infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv), htlv or syphilis. * chronic inflammatory disease requiring ongoing medication * serious known concomitant disease with a life expectancy of less than one year * follow-up impossible (no fixed abode, etc) * patients with an irregular heart rhythm (af allowed if paced in a regular rhythm) * patients with renal impairment (creatinine \>200mmol/l) * neoplastic disease without documented remission within the past 5 years * weight\>140kg * subjects of childbearing potential

Keywords: dilated cardiomyopathy adult stem cells bone marrow progenitor cells bone marrow stem cells autologous granulocyte-colony stimulating factor intracoronary injection left ventricular function to determine if patient's own bone marrow derived stem cells can be used to improve cardiac function
feasibility of calm in patients with ovarian cancer

Conditions: Patient Satisfaction; Ovarian Cancer

Summary: the goal of this feasibility trial is to determine the feasibility and acceptability of implementing a brief evidence-based psychotherapeutic intervention, managing cancer and living meaningfully (calm), at the time of a new diagnosis and recurrence of ovarian cancer (oc). the main questions are: 1. is it feasible and acceptable to implement calm for patients with newly diagnosed or recently recurred advanced oc 2. what are the prevalence and correlates of traumatic stress symptoms at baseline in patients with newly diagnosed or recently recurred advanced oc participants will be asked to complete questionnaires at baseline and at 3 and 6 months following a diagnosis or recurrence of stage iii or iv oc. participants will also be invited to participate in 3-6 sessions of calm therapy.

while calm has demonstrated effectiveness in reducing depression, death anxiety and increasing preparation for end of life among patients with advanced cancer later in the illness trajectory, its feasibility and effectiveness in addressing traumatic stress symptoms (tss) soon after a diagnosis of advanced cancer has not previously been established. findings of this study could inform the potential development of a larger randomized effectiveness trial. this study will involve a multi-method, single-arm, feasibility trial, approaching a total of 100 oc patients (50 newly diagnosed and 50 recently recurred) at princess margaret cancer centre (pm). measurements will be administered at baseline, 3 months and 6 months. participants who declined to participate in the intervention will be invited to share their reasons for opting out, contributing valuable insights to our records. a subset of purposefully sampled participants will also complete qualitative interviews following the completion of outcome measures at 6 months.

Eligibility criteria:
inclusion criteria: * new diagnosis or recurrence of stage iii or stage iv oc; * age ≥18 years * able to complete outcome measures and engage in calm in english. exclusion criteria: * evidence of cognitive impairment indicated in the medical record, communicated by the oc clinic team, or determined by research staff at recruitment; * receiving psychological or psychiatric counseling from the department of supportive care at pm at the time of recruitment.

Keywords: ovarian cancer psychological care calm psychotherapeutic intervention psychological distress
evaluation of fid 114657 in sjogren's syndrome subjects

Conditions: Sjogren's Syndrome

Summary: the primary objective of this study is to assess the overall sjogren's syndrome subject's preference for a particular product. dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.


Eligibility criteria:
inclusion criteria: * patients must be at least 18 years of age, must read and sign the informed consent form (icf), and must agree to comply with the study requirements. * patients must have a best corrected visual acuity of 0.6 logmar or better in each eye, must report having an ocular examination in the last two years and must be using topical ocular dry eye therapy (artificial tears or restasis) at least 4 times per day. * patients must have been diagnosed with sjogren's syndrome (confirmed or consistent with the american-european consensus criteria 2002). exclusion criteria: * patients cannot wear contact lenses within one week prior to visit 1 and cannot wear their contact lenses during the study. * patients cannot have a history of hypersensitivity to any component of fid 114657, and cannot have diabetes (type 1 or 2). * patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have an eyelid abnormality that might affect lid function. * patients cannot have punctal plugs that were placed less than or equal to 30 days prior to visit 1, and cannot have active infections or inflammations not associated with sjogren's syndrome. * they cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study. * patients cannot have participated in another investigational clinical or research study within 30 days of visit 1 and are not allowed to participate in any other drug or device clinical trial for the duration of this study. * patients cannot have any findings in the vitreous, retina, macula and choroid that show signs of active inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant and/or a score of greater than 0 for the optic nerve. * patients can not have had punctal cauterization within 30 days prior to visit 1, have a history of undergoing prior cataract surgery with complications as a result of the cataract surgery. * participants who have undergone prior cataract surgery without complications must be at least six months post-op with a stable refractive error. * patients cannot have received ocular prescription therapy in the last 30 days (restasis can be used as long as stable for at least 30 days).

Keywords: sjogren's syndrome dry eye
competing risk of death and esrd in incident ckd patients

Conditions: Chronic Kidney Diseases

Summary: although chronic kidney disease (ckd) affects a growing number of people, epidemiologic data on incident ckd in the general population are scarce. screening strategies to increase early ckd detection have been developed. methods: from a community-based sample of 4,409 individuals residing in a well-defined geographical area, investigators determined the number of patients having a first serum creatinine value ≥1.7 mg/dl and present for at least 3 months that allowed us to calculate an annual incidence rate of ckd (stages 3 to 5). ckd (stages 3 to 5) was defined by estimated glomerular filtration rate (egfr) \<60 ml/min/1.73 m2. investigators also described the primary care, outcomes and risk factors associated with outcomes using competing risks analyses for these ckd patients.


Eligibility criteria:
inclusion criteria: * \>= 18 years * first serum creatinine value ≥1.7 mg/dl reached after january 1st, 2004 * and present for at least 3 months * residing in the given geographical area (the urban community of greater nancy (ucgn)) exclusion criteria: * \<18 years * prevalent ckd patient : ckd diagnosis before january 1st, 2004 * patients on dialysis or renal transplanted * refusal of participation

Keywords: chronic kidney disease competing-risk analysis epidemiological study incidence outcomes risk factors
vio imaging for skin tissue assessment (vista)

Conditions: Skin Condition; Skin Diseases; Skin Lesion; Skin Abnormalities; Skin Cancer

Summary: to demonstrate the safety and effectiveness of the vio device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment. to demonstrate that the tissue features identified on the images obtained with the vio device align with the corresponding pathology images procured from the skin biopsy. to evaluate the ability of blinded readers to correctly identify tissue features on images obtained with the vio device.


Eligibility criteria:
inclusion criteria: 1. the subject is between 18 and 99 years of age. 2. the subject or legally authorized representative (lar) is able and willing to provide written informed consent. 3. the subject is planning to undergo a routine skin biopsy. 4. the subject is willing and able to remain still for periods of up to 3 minutes to allow for image capture. 5. the subject or lar has sufficient mental capacity to understand the informed consent form (icf) and comply with the protocol requirements. exclusion criteria: 1. the subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation. 2. the subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin. 3. the subject's lesion targeted for biopsy: 1. is located on the palms of the hands, soles of the feet, fingernails, or toenails. 2. has dense hair that will not be removed prior to the skin biopsy. 3. has clinically significant abraded or ulcerated skin with or without discharge. 4. is associated with a wound or skin condition that in the opinion of the physician precludes them from participation 5. is located in mucosal tissue (i.e., oral, nasal, etc.). 6. is on tattooed skin. 7. is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.) 8. is located in the periorbital region or directly on the eyelid. -
mechanisms of change in psychotherapy

Conditions: Depression

Summary: background: major depressive disorder (mdd) is a prevalent psychiatric condition associated with significant disability, mortality and economic burden. mdd is ranked fourth in terms of disease burden as defined by the world health organization (2001). cognitive behavioral therapy (cbt) and psychodynamic psychotherapy (pdt) are found to be equally effective for patients with depression. however, many patients do not respond sufficiently to treatment and relapse rates are high. to be able to offer individualized treatment, a clinically important question is therefore whether some patients profit more from one of the two therapies. at present little is known on which patient characteristics (moderators) may be associated with differential outcomes of cbt and pdt and through what kind of therapeutic processes and mechanisms (mediators) improvements occur in each therapy mode. there are actually only theoretical assumptions sparsely supported by research findings on what moderates and mediates the treatment effects of cbt and pdt. aims: the overall aim of this project is to examine putative moderators and mediators in cbt and pdt and develop more basic knowledge about their impact on outcomes of psychotherapy for patients with mdd. methods and study design: the study is a randomized clinical trial. one hundred patients will be randomized to one of two treatment conditions. the patients will be treated over 28 weeks with either cbt (one weekly session over 16 weeks and 3 booster sessions (monthly) during the rest of the 28 week study period) or pdt (one weekly session in 28 weeks). the patients will be evaluated at baseline, during therapy, at the end of therapy, and at follow-up investigations 1 and 3 years after treatment termination. the outcome measures comprise a large range of clinical and process variables, including assessment tools measuring specific preselected putative moderators and mediators. discussion: the clinical outcome of this trial may guide clinicians to decide what kind of treatment should be offered the individual patient. moreover, it will shed light on what kind of mechanisms in psychotherapy that is followed by symptom improvement and increased psychosocial functioning.


Eligibility criteria:
inclusion criteria: * patients aged between 18-65 years, with depressive disorder according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv; american psychiatric association, 2000) unipolar mdd diagnosis will be included.mini plus (sheehan et al., 1998 will be used as assessment tool. comorbidity is expected to be frequent. written consent will be obtained from all patients. * the participants need to have the ability to speak and understand a scandinavian language, and willingness and ability to give informed consent. exclusion criteria: * current or past neurological illness, traumatic brain injury, current alcohol and/or substance dependency disorders, psychotic disorders, developmental disorders, and mental retardation.

Keywords: cognitive behavior therapy psychodynamic therapy mediators moderators
a study of adalimumab in japanese subjects with intestinal behçet's disease

Conditions: Intestinal Behçet's Disease

Summary: to investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for japanese subjects with intestinal behçet's disease who are refractory to conventional therapies.


Eligibility criteria:
inclusion criteria: * intestinal behçet's disease * patients with typical ulcer at ileocecal region * patients who have failed conventional treatment exclusion criteria: * crohn's disease * history of ileocecal resection * history of tuberculosis (tb) * female subject who is pregnant or breast-feeding or considering becoming pregnant during the study

Keywords: behçet's, intestinal
evaluation of a 'hand-held' fluorescence digital imaging device for real-time advanced wound care monitoring (smh/uhn)

Conditions: Surgical Wounds

Summary: currently, standard wound care practice is suboptimal at assessing wound remodeling and bacterial infection in real-time. an alternative and complimentary means of providing real-time imaging of connective tissue re-modeling and bacterial infection may greatly increase the early detection of infection thus leading to rapid therapeutic intervention. our new device, prodigi(tm), images tissue and bacterial autofluorescence (without agents) and may provide this clinically-important capability. in preliminary preclinical testing, the investigators have discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the connective tissue matrix emit a characteristic green fluorescent signal, while most pathogenic bacterial species emit a unique red fluorescence signal due to the production of endogenous porphyrins. therefore, with autofluorescence imaging, no exogenous contrast agents are needed during imaging, making this approach particularly appealing as a diagnostic imaging method for clinical use. the investigators hypothesize that real-time imaging of tissue autofluorescence signals emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound closure), detect wound bacterial contamination and/or infection that is occult under standard clinical white light evaluation, and guide intervention and wound care.


Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. males and females 3. receiving care as in-patient at st. michael's hospital 4. presenting with abdominal wounds resulting from general surgery with known or unknown infection status. exclusion criteria: 1. treatment with an investigational drug within 1 month before study enrolment 2. any contra-indication to routine wound care and/or monitoring 3. inability to consent
the effect of standardizing the definition of a clinically significant cardiopulmonary event on length of stay

Conditions: Apnea of Prematurity

Summary: a health care initiative will be implemented december 4, 2017 in the newborn intensive care (nicu) setting in an attempt to reduce the length of stay (los) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event (cscpe). we would like to compare los in infants born \< 30 weeks gestation before and after standardization to see if los is reduced.

the los of infants born \< 30 weeks prior to implementation of the standardized definition of a cscpe (11/30/2015-11/30/2017) will be compared to the los for all infants who meet the inclusion criteria and born \< 30 weeks from 6/1/2018 - 12/31/20. data collection will begin june 1,2018, seven months after implementing the cscpe definition. this will allow time for the nursing staff, the physicians and nurse practitioners to become familiar with the new cscpe definition and management. following implementation of the new definition, the researchers will also do a 6 month audit on nursing response to a cscpe based on the current alarm settings. initially we do not plan to change the alarm limits but we may find the lower alarm limits for heart rate and oxygen saturation are set too high and may need to be lowered to more accurately assist nurses in recognizing when an infant is having a cscpe. if the 6 month audit shows nurses are "missing" a cscpe because the current lower alarm limits are set too high, or stimulating an infant inappropriately too early, the alarm limits will be changed at every bedside. if the alarm limits are reset, data collection will begin 6 months after the alarms are changed. this is expected to be starting 1/1/2019 and conclude 12/31/20. if it is decided the lower alarm limits will not need to be changed, data collection will begin 6/1/2018 and conclude 8/31/20 instead of 12/31/20.

Eligibility criteria:
inclusion criteria: * all infants born \< 30 weeks gestation admitted to the swedish hospital nicu from 11/30/2015-11/30/2017 (historical control, pre-standardized defined cscpe) and 6/1/2018 - 12/31/20 (the group following implementation of the standardized defined cscpe). exclusion criteria: * those babies who: * expired during the evaluation periods * transferred in after 30 weeks pma * transferred out and then lost to follow-up * had a significant congenital, neurological, facial or airway anomaly affecting the infant's breathing beyond 36 weeks pca * subjects who are not yet adults (infants, children, teenagers)

Keywords: apnea
peg-intron plus rebetol treatment of chronic hepatitis c subjects who failed response to alpha-interferon plus ribavirin (study p02370)

Conditions: Hepatitis; Hepatitis C, Chronic; Fibrosis; Liver Cirrhosis

Summary: the objective of this study is to determine the effectiveness of peg-intron 1.5 ug/kg/wk plus rebetol (ribavirin) 800-1400 mg/day in adults with chronic hepatitis c with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. patients who do not respond to peg-intron plus rebetol (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of peg-intron monotherapy versus no treatment for the prevention of disease progression (protocols p02569 and p02570).


Eligibility criteria:
inclusion criteria: * age at entry 18-65 * positive for hepatitis c * nonresponder to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin * liver biopsy demonstrating moderate to severe fibrosis or cirrhosis exclusion criteria: * any cause for the liver disease other than chronic hepatitis c * history or presence of complications of cirrhosis * alcohol or illicit drug use or methadone treatment within the past 2 years * treatment for chronic hepatitis c within the previous 6 months * diseases or conditions that could interfere with the subject's participation in and completion of the study
jing si herbal tea and urinary tract symptoms in bladder cancer

Conditions: Lower Urinary Tract Symptoms; Intravenous Drug Usage; Bladder Cancer; Herbal Interaction

Summary: to identify the effects of jing si herbal tea in the treatment of lower urinary tract symptoms after intravesical therapy in patients with bladder cancer.

the patients with bladder cancer usually required trans urethral resection of bladder tumor (tur-bt). post-operative intravesical installation therapy is standard therapy. however, new onset lower urinary tract symptoms often occurred after these installation therapies. jing si herbal tea is a food contain of many herbal extracts with anti-inflammation effects. the current study is to find out the effects of jing si herbal tea in the treatment of this condition. the patients will be divided into two groups by randomly assigned (estimated case number=100, experimental: control = 1: 1). the first group will receive two sachets of jing si herbal tea a day (one in the morning and one in the evening). the second group will receive two sachets of placebo a day (same way as group 1). the therapy will be three days after each intravesical installation therapies. the outcome evaluations will use the american urological association symptom index and 12-item short form survey (sf-12). the baseline symptoms will be recorded before the first intravesical therapy. patients will be asked to fill out the questionnaire every week (the same time for the next installation). every other standard cancer therapies will not be will not be affected.

Eligibility criteria:
inclusion criteria: * clinical diagnosis bladder cancer * under intravesical installation therapy exclusion criteria: * patients under 20 years old or greater than 100 years old * women with pregnancy or breastfeeding plans * bladder cancer are being treated in another hospital * had admitted due to other disease in the past 3 months * unable to understand the questionnaire

Keywords: intravesical installaion bladder cancer lower urinary tract symptoms jing si herbal tea