Kornimate/medical-research-clean huggingface dataset:
study in women with metastatic breast cancer whose cancer has gotten worse after anthracycline and taxane therapy

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: this international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. the study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent * must have received any chemotherapy regimen in the past * evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease * must have measurable (by imaging techniques) disease * adequate bone marrow, liver and renal function * must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures. exclusion criteria: * received more than 2 prior chemotherapy regimens for metastatic disease * received in the past another drug of the same class as the investigational drug, i.e. topoisomerase i inhibitor * enrolled in another clinical intervention study * pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods * cardiac or thrombotic event in the last 12 months * brain metastases
value of infection control programs on infection associated with urinary tract catheterization in sohag university hospital

Conditions: UTI

Summary: the aim of this study is to evaluate the effectiveness of an infection control program implemented at sohag university hospital in reducing the incidence of catheter-associated urinary tract infections (cautis) among patients requiring urinary catheterization.


Eligibility criteria:
inclusion criteria: adult patients (≥ 18 years) who are catheterized during their hospitalization. patients who provide informed consent to participate in the study. exclusion criteria: patients with a known history of urinary tract infections prior to hospitalization. patients who have indwelling catheters for more than 14 days before the study. patients with urinary tract anomalies or other conditions that may affect infection rates.

Keywords: uti urinary catheterization
3d imaging of hard and soft tissue in orthognathic surgery

Conditions: Craniofacial Abnormalities; Maxillofacial Abnormalities; Cleft Lip; Cleft Palate

Summary: the primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3d normative value tables.


Eligibility criteria:
inclusion criteria: * dysgnathic deformity * caucasian * \> 15 years * no history of orthognathic surgery * informed consent exclusion criteria: * \< 15 years * history of orthognathic surgery * not caucasian

Keywords: 3d computer assisted imaging maxillofacial surgery cephalometry normative value
effect of psycho-educational interventions in communication partners of older adults with hearing impairment

Conditions: Older Adults; Hearing Impairment; Nursing; Communication Partners

Summary: hearing impairment is a critical health problem throughout the world. in addition, having an impact on the biopsychosocial functioning of older adults, it places enormous stress and burden on communication partners who interact with older adults with hearing impairment every day. these communication partners generally have restrictions to their social lives and an increased communication burden, as well as symptoms of depression and adopting maladaptive coping and poorer quality of life. therefore, group-based multi-component psycho-educational interventions are recommended. the purposes of this study are to examine the effects of group-based multi-component psycho-educational interventions (gmc-peis) on burden, depression, coping and quality of life in communication partners of older adults with hearing impairment. the single-blind, randomized control trial will include communication partners of older adults with hearing impairment. participants will be randomized to either intervention groups or control groups.

the study will be an experimental design featuring repeated measures, with data collected from a pretest, a posttest and a follow-up test. an estimated total of 92 participants will be randomly assigned to experimental and control groups. the experimental group will participate in a 6-week group-based multi-component psycho-educational interventions (gmc-peis), including provide information on communication skills training, clear speech training, psychosocial support, stress management and successful person testimonial, consisting of 60-minute sessions once per week, while the control group will be put on a waiting-list group. each group will be assessed of the outcomes at 3 time points: baseline (t0), three months following the intervention (t1) and again at six months following the intervention (t2). the investigators will use the significant other scale for hearing disability (sos-hear), the 10-item version of the center for epidemiological studies depression scale (10-item ces-d), the brief coping orientation to problems experienced scale (b-cope), the short form health survey (sf-12) and the international outcome inventory for hearing aids-significant other (ioi-ha-so) as the outcome indicators. the principle of intention-to-treat (itt) analysis will be used, and the result will be analyzed mainly by generalized estimating equation (gee).

Eligibility criteria:
inclusion criteria: * being18 or older * living with older adults with hearing impairment * they were indicated that as primary communication partner * no known hearing loss * having normal cognitive function * articulate in the mandarin chinese language * signing a consent form to participate exclusion criteria: * severe psychiatric disorders * the communication partner who is hired as a caregiver

Keywords: group-based multi-component interventions psychoeducation hearing impairment older adults communication partners burden depression coping quality of life
non-interventional study of cough variant asthma treatment with pulmicort®respules® in children outpatients

Conditions: Cough Variant Asthma

Summary: this open label, non-interventional study is to show the efficacy of pulmicort®respules® in cough variant asthma in patient aged 5-year old or younger in outpatient department


Eligibility criteria:
inclusion criteria: * provision of informed consent * patient who has been prescribed pulmicort® respules® according to physician's judgement, irrespective of the inclusion in the study. * the usage of pulmicort® respules® follows local authorised package insert. exclusion criteria: * allergy to any ingredient of pulmicort® respules® * with history of leukotriene modifier (lm) usage prior to 2 weeks of recruitment or following plan. * have used systemic/inhaled steroid prior to 2 weeks of recruitment

Keywords: cough variant asthma pulmicort® respules® chinese patient eligibility
side effects of 4 times bone marrow mono nuclear transplantation in patients with ischemic lower limb

Conditions: Ischemic Ulcer

Summary: critical limb ischemia (cli) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. the limits of peripheral artery disease (pad) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. pad is a widespread disease, affecting up to 15% of all adults older than 55 years. formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. by stimulating these processes the investigators might be able to provide an alternative treatment strategy for patients with lower limb ischemia. in response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (epc) from preexisting vasculature. indeed, recent studies have shown that bone-marrow mononuclear cell (bm-mnc) implantation increases collateral vessel formation in patients with limb ischemia. so the investigators determine to evaluate the efficacy of repeated mnc transplantation in patients with ischemic lower limb.

in this study we transparent bone marrow derived mononuclear stem cells 4 times to the ischemic limb of 11 patients with pad.first of all all the patients evaluate by physical examination,pfwd,abi and serologic tests.then underwent bone marrow aspiration to take sample.in our lab the mnc are separated and divided in to equal doses.one of them inject to the ischemic foot and the othr one are freezed and inject after 3weeks.3 weeks after second injection again patient underwent bone marrow aspiration and the same process repeat.then after 4times transplantation,patients are followed up after 1,3,6,9,12 months after injection and evaluate by physical examination,pfwd,abi and serologic tests.all the data are collected and analysed and the result will be shown.3 patients underwent cell transplantation just one time due to one time bone marrow aspiration.they are followed up after 1,3,6,9,12 months after injection and evaluate by physical examination,pfwd,abi and serologic tests.at the end of the study patients with 4imes injection and 1time injection will be compared.

Eligibility criteria:
inclusion criteria: * ischemic lower limb based on task guide line * rutherford score:2,3 * abi\<0.6 * absolute ankle pressure \< 60 mmhg * both gender * age:20-62years exclusion criteria: * ef\<30% * cr\>2 * hba1c\>8% * bone marrow disorders:leukemia * cognitive disorders * infections * mi with st elevation during last month * malignancy * immunologic or rheumatologic disorders

Keywords: bone marrow mono nuclear stem cell ischemic ulcer
hiv-1 resistance at screening for hiv prevention studies

Conditions: HIV

Summary: mtn-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of arv resistance in the population of women who present to study sites to be pre-screened or screened for participation in an hiv prevention trial. to date, a comprehensive surveillance of hiv drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. the primary goal of mtn-009 is to assess the frequency of hiv drug resistance mutations among women who test hiv-positive when presenting to screen for participation in hiv prevention trials.

mtn-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of arv resistance in the population of women who present to study sites to be pre-screened or screened for participation in an hiv prevention trial. to date, a comprehensive surveillance of hiv drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. the primary goal of mtn-009 is to assess the frequency of hiv drug resistance mutations among women who test hiv-positive when presenting to screen for participation in hiv prevention trials. secondary aims include the identification and evaluation of behavioral indicators including self or sexual partner(s) exposures to antiretroviral (arv) drugs as risk factors for drug resistant hiv infection, as well as the characterization of the degree of immunodeficiency and risk of disease progression by quantifying plasma hiv-1 rna and cd4-positive t cells among women who test hiv-positive when presenting to screen for participation in an hiv prevention trial. exploratory aims include the identification of polymorphic or subtype-specific sequence changes in hiv-1 that may impact susceptibility to arvs, and the estimation of the proportion of hiv-positive women who have chronic versus recent hiv infection. the finding of significant resistance, or lack thereof, to arv-based study products delivered vaginally or taken orally may guide decisions related to future microbicide and prep studies. in addition, mtn-009 will provide valuable comparison data for the resistance data obtained in mtn-015, the mtn seroconverter study.

Eligibility criteria:
inclusion criteria: * present to an mtn-009 study site to pre-screen or screen for an hiv prevention trial * age 18-40 years, verified per site standard operating procedures (sop) * able and willing to provide written informed consent for participation in mtn-009 * able and willing to provide adequate locator information, as defined in site sops exclusion criteria: * any condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achievement of the study objectives

Keywords: hiv drug resistance mutations arv's
a change in diet may decrease the negative consequences of chronic sleep deprivation

Conditions: Sleep Deprivation

Summary: the purpose of this study is to determine whether or not a low calorie, low glycemic index diet with omega-3 fatty acid supplements can prevent some of the negative consequences of sleep deprivation.

this pilot study included 18 medical residents at two academic medical centers in new york city. all residents who participated in the study were assigned to work a night shift schedule for two weeks, and began the study on the morning prior to their first evening shift. the study subjects were randomly assigned to one of two groups: * intervention diet -- consisting of 40% carbohydrates, 30% protein, and 30% fat with 2.4g of long chain fatty acid supplements (n=9) total calories for males was 1600/day, and 1200/day for females * control group -- ad lib diet. main outcome measures included: * weight * resting metabolic rate * percent body fat * lipid profile * crp * fasting glucose and insulin levels * urinary neurotransmitter levels * salivary cortisol * six cognitive tests of memory, attention, and executive function. subjects were tested on day 1, 7, and 14 of the study.

Eligibility criteria:
inclusion criteria: * medical resident in good standing at cabrini medical center or saint vincent's hospital, ny. * must be scheduled for two consecutive weeks of night shift work. exclusion criteria: * febrile illness * smoker * food allergies of any kind * taking any prescription medication * history of diabetes or thyroid dysfunction * body mass index (bmi)\>30 * pregnancy

Keywords: diet chronic sleep deprivation weight cognitive impairment lipids inflammation resting metabolic rate weight gain percent body fat hyperlipidemia
casein glycomacropeptide in ulcerative colitis - anti-inflammatory and microbiome modulating effects (caglucim)

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases

Summary: casein glycomacropeptide (cgmp) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. its use as a food ingredient has proven safe and with no influence on dietary intake. in a pilot study the investigators found, that orally administered cgmp seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis. the investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.


Eligibility criteria:
inclusion criteria: * ulcerative colitis (verified by mucosal histology and endoscopy) * clinically active ulcerative colitis (sccai ≥ 3) exclusion criteria: * endoscopically inactive disease (endoscopic mayo score of 0) * lactose or milk protein intolerance * celiac disease * not able to understand or speak danish. * pregnant or nursing. * growth of pathogenic bacteria in stool culture from 4 weeks before and until randomization (salmonella, campylobacter, yersinia or clostridium difficile.)

Keywords: glycopeptides human microbiome caseinomacropeptide whey protein dietary proteins
the effects of a wrist extensors exercise with blood flow restriction (bfr) in lateral elbow tendinopathy.

Conditions: Lateral Epicondylitis

Summary: a randomized cross-over trial comparing the immediate effects of a wrist extensor exercise with and without blood flow restriction (bfr) on pain perception in patients with lateral elbow tendinopathy (let).

patients with let will participate in the study performing an exercise with and without blood flow restriction (bfr) in a randomized order (two occasions). a target of 20 patients for enrollment has been set for 80% power, p\<0.05 (effect size= 1). two interventions will be used lasting 40 minutes each. intervention: a wrist extension exercise (concentric-eccentric) with blood flow restriction (30-15-15-15 reps). exercises will be performed using dumbbells according to a pain monitoring approach (\<2/10 in numerical pain rating scale). control group: a wrist extension exercise (concentric-eccentric) without blood flow restriction (30-15-15-15 reps). exercises will be performed using dumbbells according to a pain monitoring approach (\<2/10 in numerical pain rating scale). primary outcomes: pressure pain thresholds lateral epicondyle, cervical spine and tibialis anterior (bilateral). secondary outcome: pain free grip strength

Eligibility criteria:
inclusion criteria: * men and women diagnosed with lateral elbow tendinopathy (let) * symptoms for over 2 weeks * pain provoked by palpation on the lateral epicondyle * positive: cohen's test, maudsley test, mill's test * decrease in pain grip strength \>5% in elbow extension compared to flexion exclusion criteria: * shoulder tendinopathy * cervical radiculopathy * rheumatoid arthritis * neurological deficit * radial nerve entrapment * past treatment for the elbow before entering the study * professional athletes * lateral elbow tendinopathy of the same side in the last 3 years * serious cardiovascular diseases * venous deficiency * history of heart surgery * cancer history * breast surgery * orthopaedic surgeries during the last 6 months * thrombosis * body mass index ≥ 30 * crohn syndrome * family or personal history of pulmonary embolism

Keywords: tennis elbow pain threshold elbow tendinopathy bfr hypoalgesia
use of exome sequence analysis and circulating tumour in assessing tumour heterogeneity in braf mutant melanoma

Conditions: Melanoma

Summary: despite recent advances in cancer treatment, little impact has been made on curing as opposed to controlling cancers over the last several decades. part of the problem is that investigators have an incomplete understanding of how tumours behave as they evolve and in response to treatment. in this trial, the investigators hope to better understand the evolution of braf melanoma in response to drugs a patient may have received such as vemurafenib or dabrafenib. importantly, the investigators want to understand how the tumours evolve resistance to these drugs and whether this can be predicted through blood tests, in particular of the circulating tumour dna.

study population: braf mutant melanoma patients pre-mortem bloods will be taken from the patient on three occasions at one to thirty days apart from each other, with the first blood draw taking place on the patient's first clinic visit. six 7 ml edta and one 6 ml sst vacutainers of blood (a total of approx. 50 ml of blood) will be taken from the patient. when death is expected within the next 48-72 hours, the medical oncologist/ radiation oncologist/ hematologist or delegate will revisit the rap process with the patient and/or family/substitute decision maker to ensure that they are still in agreement. the patient and the families will also be provided with an additional consent form for participation including blood sampling.

Eligibility criteria:
inclusion criteria: uhn adult patient with braf mutant melanoma exclusion criteria: non braf mutant melanoma patient pediatric patient non-uhn patient

Keywords: braf mutant melanoma circulation tumour dna tumour heterogeneity liquid biopsy
pediatric healthy weight clinic

Conditions: Pediatric Obesity

Summary: the overall goal of this study is to increase access to and adoption of the healthy weight clinic package in primary care settings serving low income families in the united states who have a disproportionately high prevalence of childhood obesity. two federally-qualified health centers in mississippi and two health centers in massachusetts will be implementing a healthy weight clinic program. the healthy weight clinic is staffed by a medical provider, a dietitian/nutritionist, and a community healthy worker. patients attend individual medical visits (once per month for 12 months) with the multidisciplinary team, group visits led by a member of the team (once per month for 6 months), and phone follow-up between visits. all patients who receive care at the pilot implementation sites will be exposed to the systems-level intervention. a subset of patients will be invited to participate in a research evaluation of the program.


Eligibility criteria:
inclusion criteria: * child is age 2 through 18 years at referral * child's bmi meets or exceeds the 85th percentile for age and sex * parent can read and respond to interviews and questionnaires in english or spanish * received care at one of the participating pilot sites exclusion criteria: * children who do not have at least one parent who can report on their child's daily activities for 1 year * families who plan to leave their pediatric health center in the next year * children who have conditions or take medications that substantially interfere with growth, physical activity, or dietary recommendations