Kornimate/medical-research-clean huggingface dataset:
using whole-person-care guide in patients receiving care for cancer or complications from cancer treatment

Conditions: Chemotherapeutic Agent Toxicity; Infection; Malnutrition; Musculoskeletal Complications; Neutropenia; Radiation Toxicity; Thrombocytopenia; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: gathering information about patients with cancer and cancer-related conditions may help doctors learn more about a patient's needs and help doctors plan the best treatment. purpose: this clinical trial is studying how well a whole-person-care guide works in identifying patient needs in patients with cancer or complications from cancer treatment.

objectives: * to determine what patient needs are detected from nest13+ interviews of cancer patients and their caregivers. * to determine the concordance among patient, caregiver, and team goals. * to determine palliative care services provided. outline: participants are assigned sequentially to 1 of 2 intervention groups. * group 1 (nest13+): patients and caregivers undergo nest13+ interviews at the time of admission to northwestern memorial hospital (caregivers answer the nest13+ interviews from the patient's perspective). a nest13+ care plan is then derived from both patient and caregiver responses. research md or rn presents patient's nest13+ findings and recommended interventions for integration with actual care. on the day of discharge, patients and caregivers undergo a second nest13+ interview. * group 2 (control): patients and caregivers undergo a sham interview at the time of admission to northwestern memorial hospital. on the day of discharge, patients and caregivers undergo a nest13+ interview as in group 1. medical charts for all patients are reviewed by a member of the research staff to document needs assessments in domains covered by nest and to document palliative care-related decisions. abstracted chart review by blinded experts is also performed to evaluate palliative care quality based on national comprehensive cancer network guidelines. projected accrual: a total of 500 patients and 250 caregivers will be accrued for this study.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of cancer * admitted to one of the two oncology units at northwestern memorial hospital either for treatment of cancer or treatment-related complications * complications include, but are not limited to, any of the following: * febrile neutropenia * infection * esophagitis from radiochemotherapy * malnutrition * spinal cord compression * bone pain secondary to metastatic bone disease * thrombocytopenia patient characteristics: * able to read and understand english prior concurrent therapy: * see disease characteristics

Keywords: neutropenia infection radiation toxicity chemotherapeutic agent toxicity malnutrition musculoskeletal complications thrombocytopenia unspecified adult solid tumor, protocol specific
generation of a lung biobank for future use

Conditions: Cancer; Lung Cancer

Summary: the aim is to invite 1,000 patients with symptoms triggering the lung cancer diagnostic pathway or with significant risks of lung cancer, referred to the royal marsden nhs foundation trust (rmh) referral centres (kingston hospital nhs foundation trust, epsom and st helier university hospitals nhs trust, croydon university hospitals nhs foundation trust or st george's university hospitals nhs foundation trust) over a 1 year period, to complete a life style questionnaire, document lung function tests and to donate a blood sample for storage with a view to testing for a genetic signature and other biomarkers in future studies from this established biobank.

patients will have been referred under the two week rule (twr) diagnostic pathway, some will have lung cancer, others not, and other patients will have had a diagnosis of lung cancer by other pathways i.e. non twr. there are 3 groups of patients: group a - lung cancer patients at any stage and by any non twr pathway, n=250. group b - lung cancer patients who were referred initially by the twr pathway, n=150. group c - subjects referred by the twr pathway (i.e. with symptoms) who do not have lung cancer, or subjects referred by any pathway who do not have lung cancer but do have radiological changes (that need follow up) or a strong family history of lung cancer, n=600. a strong family history for this study means 1 or more first degree relatives with lung cancer with at least one individual having lung cancer at age \<50 yrs.

Eligibility criteria:
inclusion criteria: one of the following criteria: * patients with lung cancer at any stage or time in their disease. * patients without lung cancer who have been referred by the twr pathway. * patients without lung cancer who have radiological changes on their x-ray or ct scan that need follow up. * patients without lung cancer who have a strong family history of lung cancer. plus * patients aged \>18 years * patients who have signed informed consent form exclusion criteria: * unable to provide informed consent. * bleeding disorder or other medical condition that would make a blood sample hazardous. * within 3 weeks of chemotherapy or radiotherapy (as low lymphocyte may be associated with poor dna yield).
development of gourmet medical cooking workshop for lifestyle changing and its affect on perimenopausal women

Conditions: Perimenopausal

Summary: subjects that participate in the practical workshop will improve their metabolic indexes, decrease their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions

participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. the workshop will consist of 9 lessons with the following lessons: introduction, fats, phytoestrogens, carbohydrates and fibers, calcium and low calorie diet, party's recipes, shopping and farewell dinner. all the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours "hands on" session under supervision of a medical chef. the study population will include healthy women attending the menopause clinic. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only. during 2008 the control group will commence the workshop and will add to the study group.

Eligibility criteria:
inclusion criteria: * age of 45-60 * perimenopause * healthy * bmi over 17

Keywords: gourmet healthy cooking quality of life preimenopause weight lipids
fmri in deep brain stimulation

Conditions: Epilepsy; Chronic Pain

Summary: with fmri, we want to understand the mechanisms of brain neuromodulation in (dys)functional brain circuits, to obtain knowledge on involved brain networks in dbs.

deep brain stimulation represents a neurosurgical treatment option for specific refractory neurological and psychiatric disorders. in these patients a specific brain target is stimulated through an electrode with the use of an implantable pulse generator (ipg). in a functional mri (fmri) experiment, the investigators intend to perform imaging during stimulation on and compare brain activations with the stimulation off condition. in this way, they aim to elucidate the involved brain network in deep brain stimulation. since the connectivity of deep brain structures is complex, different activation patterns are expected in-between subjects and conditions. if specific activation patterns during the stimulation on condition can be related to treatment response, this is of important clinical value. these findings can lead to an optimization of the deep brain target or even to different useful targets for brain stimulation.

Eligibility criteria:
inclusion criteria: * deep brain stimulation system implanted exclusion criteria: * children and pregnant women will be excluded. failure to follow to protocol is also an exclusion criterion.

Keywords: fmri epilepsy pain electrode brain neuromodulation dbs
effects of itb myofascial release on symptoms associated with knee oa.

Conditions: Knee Osteoarthritis

Summary: the aim of this randomized controlled trial is to determine the effects of itb myofascial release with graston technique on symptoms associated with knee osteoarthritis for reducing pain, enhancing knee range of motion and decrease functional disability.

graston technique, instrument assisted soft tissue mobilization (iastm) also known as myofascial release technique is a skilled myofascial intervention used for soft-tissue treatment. graston is a myofascial release tool that decreases adhesions, trigger points and tension in muscles. graston technique on iliotibial band syndrome resulted in a decrease in subjective symptoms and an improvement in muscle function.

Eligibility criteria:
inclusion criteria: * knee oa grade 2 and grade 3 according to kellgren and lawrence grading scale * positive ober's test exclusion criteria: * patient with cardiovascular or medical illness. * patient with any severe trauma or surgery of knee. * knee deformity * low back pain with or without radiculopathy. * neurological illness * participants having any wound or scar on the site of treatment. * pregnant female * participants having co-morbidities such as neoplasm etc.

Keywords: knee oa itb tightness graston technique
how shoes with rocker soles affect walking

Conditions: Diabetic Feet

Summary: the purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles help people with foot deformities to walk better. this study will use modern gait lab techniques to measure the forces on the bottom of the feet and to examine whether there is any effect higher on the leg from the rocker soles.

the rocker sole is the most commonly prescribed external shoe modification. use of rocker soles has been based on theoretical considerations and empirical observations with minimal scientific study and validation. with the passage of the therapeutic shoe bill (pl-100-203, section 4072) authorizing medicare coverage of shoes and shoe modifications for diabetics, it is important to have objective data regarding the effect of rocker soles. this cross-over study will randomize 46 subjects (40 sensate and 6 insensate) to a combination of 3 rocker soles. patients will be evaluated at baseline and after 20 minutes wearing each rocker sole shoe design to determine the effect of the type of rocker sole on plantar pressure and gait.

Eligibility criteria:
inclusion criteria: * healthy individuals * insensate individuals exclusion criteria: * history or physical findings of any trunk, back or lower extremity orthopedic or neurologic abnormalities * inability to walk * inability to follow verbal directions

Keywords: rocker sole plantar pressure diabetic feet insensate feet gait analysis pedorthics gait abnormalities
efficacy and safety of zactima™ in patients with castration-refractory metastatic prostate cancer

Conditions: Prostate Cancer

Summary: this randomized, double-blind phase ii trial is to assess the efficacy and safety of bicalutamide (casodex® ) associated to zd6474 (zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression. the study is blinded, and subjects will be randomised (1:1 ratio) to either zd6474 300 mg or placebo. the blinded design ensures robust, unbiased data collection and assessment. placebo control is necessary to ensure a robust assessment of psa pfs, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). the end of study is fixed 12 months after the last randomised patient's first dose of study treatment.


Eligibility criteria:
inclusion criteria: * males presented with a confirmed histological diagnosis of adenocarcinoma of the prostate with evidence of metastases (including bone, lymph nodes, or other site) radiologically or histologically documented and despite a serum testosterone ≤1.73 nmol/l (50 ng/dl) proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in psa . exclusion criteria: * radiotherapy or surgery or antiandrogens (except lhrh analogue) or bilateral orchiectomy within the 30 days preceding visit 1. incompletely healed surgical incision. * concomitant anticancer therapy other than surgical castration or continuous medical castration. * biology restriction. * clinical significant cardiovascular event or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia. * history of arrhythmia which is symptomatic or requires treatment (ctcae grade 3), symptomatic despite treatment, or asymptomatic sustained ventricular tachycardia. subjects with atrial fibrillation controlled on medication are permitted. * hypertension not controlled by medical therapy * ecg /qtc prolongation * presence of left bundle branch block (lbbb).
a-constant optimization of a toric monofocal iol

Conditions: Cataract

Summary: the study is a prospective series study to determine the iol constant of a hydrophilic toric monofocal intra-ocular lens (iol)

the study is a prospective series study with he principal objective to determine the iol constant. the secondary objectives of this study are to determine the rotational stability of the ankoris intraocular lens and to measure the residual astigmatism after ankoris iol implantation with respect to the targeted astigmatism correction. although there may be no direct benefit to the subjects under study, the investigation will determined the optimized constant for accurate iol power calculation and will assess the stability and efficacy of the toric optics: this would result in a benefit for the patient population. since the material, the overall design of the iol as well as the measuring procedure in this study is well tolerated in standard clinical practice and the iol is readily available and ce-marked, the benefit/risk ratio appears acceptable.

Eligibility criteria:
inclusion criteria: * patient older than 50 years old * age-related cataract * corneal astigmatisme \>1 d * age 21 and older * visual acuity \> 0.05 * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant. exclusion criteria: * relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies * previous ocular surgery or trauma.
a study designed to determine the safety and pharmacological response ofmkc253 inhalation powder in adults with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: 20 eligible subjects will be enrolled into the treatment phase of the trial.

trial objectives are to determine the safety \& pharmacological response of mkc253 inhalation powder.

Eligibility criteria:
inclusion criteria: * non-smoking males and females between 18 and 70 years of age * body mass index (bmi) of \< 32 kg/m2 * diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, without any dose adjustments within the preceding 8 weeks. for subjects taking both metformin and sulfonylurea or meglitinide or alpha glucosidase inhibitor, one or both oral agents must be less than 1/2 the maximal allowable dose as cited in the product label. * hba1c = 6.2 to = 8.5%. fasting c-peptide = 0.5 ng/ml. on the last 3 days of the washout period (day -3, -2, and -1) subjects should have a fbg (finger stick) = 13.5 mmol/l. * normal pulmonary function and performance on pulmonary function tests * written informed consent * treatment with any type of anti-diabetic therapy other than metformin, sulfonylurea, meglitinide and alpha glucosidase inhibitors within the preceding 12 weeks \[ie, thiazolidinediones (tzds), dipeptyl peptidase inhibitors (dpp-iv), symlin (pramlintide acetate) and or byetta (exenatide)\]. exclusion criteria: * exposure to any investigational medications or devices within the previous 90 days prior to trial entry or participation in another clinical trial while participating in this trial. * use of any prescription medication within 90 days prior to screening, other than allowed anti-diabetic therapy, that has not been approved by the pi and sponsor. the use of alpha blockers, antihypertensives, proton pump inhibitors and cholesterol medication as co-medications is allowed throughout the study. * significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of 12% and 200 ml in either fvc or fev1). * serum creatinine above upper limit of normal (uln) as defined by the laboratory * any other condition which, in the opinion of the pi, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial.

Keywords: diabetic adult male, diabetic postmenopausal women
safety surveillance of menacwy-crm vaccine in children

Conditions: Meningococcal Disease

Summary: the purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following menacwy-crm vaccination administered as part of routine clinical care. this us fda post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of menacwy-crm vaccine in subjects 2 to 10 years of age within a large us healthcare maintenance organization. the 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. all events are collected retrospectively.

this is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. vaccinated subjects are not actively recruited. events of interest: diabetes mellitus, rheumatoid arthritis, idiopathic thrombocytopenic purpura, iridocyclitis, acute glomerulonephritis, nephrotic syndrome, grave's disease, autoimmune hemolytic anemia, myasthenia gravis, new onset asthma, allergic urticaria, anaphylaxis, meningococcal disease, intentional injury

Eligibility criteria:
inclusion criteria: * registered with the hmo for at least 6 months prior to vaccination. * between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination. * received any menacwy-crm vaccination during the vaccination period at the participating centers. exclusion criteria: * none

Keywords: observational serogroup a, b, y, w meningococcal meningitis meningococcal vaccines safety menacyw-crm post-marketing children
13 valent pneumococcal conjugate vaccine in chronic dialysis patients

Conditions: Chronic Kidney Failure

Summary: to assess the immunogenicity of the pcv13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the ppv23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the ppsv23 vaccine or are ppv23 vaccine naïve by measuring the elisa and opa (opsonophagocytic assay) titers after 4 and 52 weeks.

the immunogenicity of the pcv13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the ppv23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the ppv23 vaccine or are ppv23 vaccine naïve will be measured by elisa and opa (opsonophagocytic assay) titers after 4 and 52 weeks.

Eligibility criteria:
inclusion criteria: 1. they are under chronic dialysis treatment 2. are 50 years or older and not pregnant 3. have no immediate life threatening conditions 4. are not allergic to one of the compounds of the vaccine 5. have a known pneumococcal vaccination status 6. give their informed consent. exclusion criteria: patients not fulfilling the inclusion criteria.

Keywords: pneumococcal vaccination dialysis immune response
phase iib safety and efficacy study of four dose regimens of bay1021189 in patients with heart failure and preserved ejection fraction suffering from worsening chronic heart failure (socrates-preserved)

Conditions: Heart Failure

Summary: objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sgc) bay1021189 for phase iii that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (hfpef)


Eligibility criteria:
inclusion criteria: * worsening chronic heart failure (wchf) requiring hospitalization (or intravenous diuretic treatment for hf without hospitalization) with initiation of study treatment after clinical stabilization * left ventricular ejection fraction (lvef) \>/= 45% by echocardiography at randomization exclusion criteria: * intravenous inotropes at any time after hospitalization

Keywords: worsening heart failure heart failure with preserved ejection fraction
diabetes self-management & support live

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether participation in virtual environment which incorporates real-time diabetes self management and support (dsmt/s) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web-based dsmt/s.


Eligibility criteria:
inclusion criteria: * live in close proximity to duke university medical center (dumc) or nyu endocrinology clinic, or faculty practice and bellevue medical center to facilitate follow-up research appointments * diagnosis of type 2 diabetes (t2d) * \>= 21 years old * able to read and understand english * access to a computer with broad band internet connection in a private location * reachable by telephone * no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (e.g. * are able to travel to a clinical lab for blood work exclusion criteria: -

Keywords: diabetes virtual environment self-management
randomized controlled trial to study the outcome of intravenous phosphate supplementation in live donors undergoing hepatectomy for living donor liver transplantation (ldlt)

Conditions: Complication, Postoperative; Regeneration Liver

Summary: in this study, we aim to analyse the effect of phosphate supplementation on donors undergoing partial hepatectomy for ldlt. in group a, we are going to supplement phosphate in donors postoperatively from day 1 to day 5. we will analyse the trend of serum phosphate levels in donors postoperatively, its correlation with occurrence of postoperative complications and status of liver regeneration by ct volumetry on day 7. group b will constitute the controls for the study and hence attempt to find out the effect of phosphate supplementation in all donors postoperatively. we will analyse the data and elucidate the value of phosphate supplementation in reducing the occurrence of complications and effect on liver regeneration in donors in ldlt.


Eligibility criteria:
inclusion criteria: * all donors evaluated as per institutional protocol for donor hepatectomy and found fit * those who consent. exclusion criteria: * patients refusing to consent for inclusion in the study. * minor hepatectomy * those who develop profound hypophosphatemia in the control group