Kornimate/medical-research-clean huggingface dataset:
blood draw validation for ciprofloxacin pharmacokinetic research in pediatric cancer patients

Conditions: Childhood Cancer; Neutropenia

Summary: to validate blood draws via a central venous catheter (port a cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.

the concentration of cipro will be determined using a validated high-performance liquid chromatographic (hplc) method with fluorescence detection. unbound concentration will be determined by adjusting the ph of the plasma samples to physiological ph (7.4) in a co2 incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate (as described above) prior to injection onto the hplc system.

Eligibility criteria:
inclusion criteria: children who * are between 1 month and 18 years of age * are under treatment for any type of childhood cancer * use ciprofloxacin for prophylaxis of febrile neutropenia as part of regular treatment * have a pac for intravenous medication and blood draws. exclusion criteria: children will be excluded from this study if we are unable to * obtain informed consent of both parents and assent of the child (if he/she is over 12 years of age) * aspire blood from the pac.
study on mechanical and electrical alternans

Conditions: Heart Failure; Ischemia; Ventricular Arrhythmia

Summary: the main objective is to investigate mechanical alternans and mtwa in patients with heart failure caused by coronary artery disease to demonstrate a possible correlation between these two phenomena.

in patients with severe heart failure and aortic valve disease mechanical alternans or pulsus alternans (a condition in which there is a beat-to-beat oscillation in the strength of cardiac muscle at a constant heart rate) is observed. the mechanisms linking mechanical to electrophysiological dysfunction in heart failure are still under investigation, but impaired calcium cycling is the most striking abnormality of failing myocytes, and is most responsible for contractile dysfunction. yet it remains unclear how this influences susceptibility to arrhythmias. the mtwa is suggested as a risk marker to identify high risk patients for potential vtes but the underlying mechanism is not completely understood. the aim of this study is to investigate this in a clinical setting by measuring lv parameters using a pv loop conductance catheter and generate twa recording simultaneously to demonstrate a possible correlation between these two phenomena in patients with ischemic heart failure and find out if mtwa could turn into a more valuable risk factor. our hypothesis is that alternating changes in lv filling explains the electrocardiogenesis of twa by changing the position of the heart relative to the body surface electrodes in an alternating way.

Eligibility criteria:
inclusion criteria: * patients with heart failure caused by coronary artery disease * indication for left ventricular radiofrequency (lv rf) ablation * lvef ≤ 35% measured by echocardiogram or mri exclusion criteria: * hemodynamically instable patients * age under 18 and over 85 years, * heart failure not caused by coronary artery disease * severe co-morbidity

Keywords: mtwa mechanical alternans
adherence to activity limitations in diabetes

Conditions: Diabetes; Foot Ulcer

Summary: this study aims to develop and test a theory-based motivation communication training programme for healthcare professionals working with diabetic foot ulcer patients. the investigators will explore the acceptability of the training programme and examine whether the training leads to changes in healthcare professionals' communication style, and results in greater adherence to treatment recommendations (i.e., reduced weight-bearing) in patients.

this is a proof of concept, two-arm non-randomised, controlled before-and-after study. patient outcomes (perceptions of healthcare professional communication style, treatment self-regulation and adherence to activity reduction) will be collected first during a control/usual care period. healthcare professionals will then receive the theory-based motivation communication training programme. subsequently a new group of patients will be recruited as the intervention group and the same outcome measures collected. control group outcomes will be compared to intervention group outcomes. interviews will be conducted with healthcare professionals and patients to assess acceptability of the intervention.

Eligibility criteria:
inclusion criteria: * be aged 18 years and over * have diabetes according to who criteria * have a diabetic foot ulcer being treated at the foot clinic at royal derby hospital * be able to communicate and complete questionnaire measures in english * have capacity to consent and agree to participate. exclusion criteria: - patients who are not currently engaging in walking behaviour (e.g., wheelchair-bound patients) or have other physical limitations that restrict ability to use an accelerometer will be excluded.

Keywords: motivation communication healthcare professional training adherence diabetes foot ulcer
the effects of weight loss on psoriatic arthritis

Conditions: Psoriatic Arthritis; Obesity

Summary: psoriatic arthritis (psa) is an inflammatory arthritis associated with psoriasis. although the underlying cause of psa is unclear, increased body weight is known to increase the disease symptoms. this study aims to determine the effects of dietary and cognitive exercise therapy approach (bety-bilişsel egzersiz terapi yöntemi) interventions on symptoms. accordingly, 45 overweight/obese subjects with psa aged 20-65 years will divide into "diet", "diet+bety", and "control" groups. dietary, laboratory and anthropometric records, short form health survey, dapsa (disease activity in psoriatic arthritis), haq (health assesment questionnaire) of all subjects will compare at the baseline and at the end of the study.

although the underlying cause of psa is unclear, increased body weight is known to increase the disease symptoms. the present study aims to determine the effects of dietary and cognitive exercise therapy approach interventions on symptoms. * fourt-five overweight/obese subjects with psa aged 20-65 years will divide into diet (n=15), diet+bety (n=15), and control (n=15) groups. * individually diet programs will be applied according to the metabolic, biochemical, and physical activity status of the subjects prepared by a registered dietitian. * bety exercise training will be given by a registered physiotherapist. * the subjects will be followed for 12 weeks. * dietary, laboratory and anthropometric records, short form health survey, dapsa (disease activity in psoriatic arthritis), haq (health assesment questionnaire) of all subjects will compare at the baseline and at study completion.

Eligibility criteria:
inclusion criteria: * overweight/obese * diagnosed with psa exclusion criteria * pregnancy or lactation

Keywords: psoriatic arthritis diet biopsychosocial exercise
part ii: granulocyte-colony stimulating factor adjunct therapy for biliary atresia

Conditions: Biliary Atresia

Summary: the investigators propose to test the hypothesis that gcsf enhances the clinical outcome of biliary atresia in a multi-institutional phase 2 trial to prospectively evaluate the safety and efficacy of gcsf in each of the 2 groups of newly diagnosed ba patients: kba (i.e., kasai-operated) or nok (i.e., patients who did not undergo kasai surgery). subjects who participate in the trial will be followed for 2 years.

this is a prospective, randomized, multi-institutional trial in kba and nok subjects to be conducted under a food and drug administration approved investigational new drug application. the kba group is composed of just operated kasai patients with intraoperative liver biopsy-confirmed ba. their clinical characteristics have been described in the previously completed phase 1 study under cr00005169 (ie. inclusion and exclusion criteria as described below) the nok group will be composed of newly diagnosed ba patients, including the following: * surgical patients in whom the kasai was not performed for intraoperative technical reasons or due to advanced liver disease, who also have no option for rescue liver transplantation. * unoperated patients whose family refuses surgery or who are not operative candidates having met the same inclusion and exclusion criteria as the kasai kbs group, * eligible kba subjects will be randomized to gcsf vs. no-gcsf at the 10 ug/kg/d dose to be given subcutaneously for 3 consecutive daily doses on the third day following the kasai procedure. * eligible nok subjects will be randomized to gcsf vs. no-gcsf at the 10 ug/kg/d dose to be given subcutaneously for 3 consecutive daily doses on the third day following diagnostic liver biopsy.

Eligibility criteria:
inclusion criteria 1. preliminary work up for cholestasis suspected or inconclusive diagnosis of ba. 2. serum direct bilirubin \> 2 mg/dl,ggt\> 100 u/l 3. male or female infants with a gestational age\> 36 weeks 4. admission weight \> 2 kg 5. age \> 14 days - 180 days at diagnosis 6. for kasai operated subjects, type 3 or 4 anatomy of ba 7. for kasai operated subjects, cholangiogram (if performed) diagnostic of ba 8. liver biopsy supporting ba diagnosis exclusion criteria 1. patients having access to liver transplantation for immediate liver failure 2. prior kasai patients 3. major cardiac, renal, central nervous system (cns) malformations 4. intracranial hemorrhage 5. history of recent total parenteral nutrition (tpn) use within the last 2 weeks 6. gl tract obstruction for kasai-operated subjects: type 1 or 2 biliary atresia anatomy 7. current systemic infection 8. wbc \> 20,000 cells/ul 9. platelet count \ 1 million cells/ul 10. concurrent respiratory, metabolic, neurological, cardiovascular, metabolic, and renal illness 11. elevated serum creatinine \> 1 mg/dl 12. purpura fulminans or unexplained vascular thrombosis
can the osteopathic pedal pump reduce lymphedema in the lower extremities in the elderly? a mentorship project.

Conditions: Lymphedema, Lower Limb

Summary: chronic lymphedema is defined as swelling or edema (excess fluid in the interstitial space) that does not fully resolve overnight by elevating the limb or body part to the level of the heart. chronic lymphedema is a major clinical problem that is difficult to treat. osteopathic pedal pump is a simple manipulation technique anecdotally thought to reduce leg edema and chronic lymphedema. however, the clinical evidence is only anecdotal and no clinical trials have ever been conducted to test this observation. the purpose of the research is to measure the effectiveness of the osteopathic pedal pump technique for treating lymphedema by measuring before and after treatment limb volumes. the second purpose of this project is to mentor osteopathic medical students in clinical research. there is also a great need to mentor osteopathic medical students because relatively few pursue careers involving clinical research and the benefits osteopathic manipulative treatment remain under investigated.


Eligibility criteria:
inclusion criteria: * for phase one subjects must be age 18 or older, be a medical students at rowan university school of osteopathic medicine and not have leg edema which does not resolve with overnight limb elevation. for phase two subjects must be patients at the njisa in stratford, nj age 55 and over and have lower limb lymphedema. lymphedema is defined as edema that does not resolve with overnight elevation of the lower limb. exclusion criteria: * exclusion criteria is the same for both phases. because the measurements involve placing the lower limb into water subjects with an open wound, sore or cellulitis in the lower limbs will be excluded to ensure good hygiene. because lymphatic pumping can cause a redistribution of volume in the body, subjects with decompensated heart failure, acute asthma, copd exacerbation, or active cancer will be excluded. for obvious reasons, those with a non-healed or healing bone fractures will be excluded. due to potential problems with informed consent those with a diagnosis of dementia on the chart problem list will be excluded.
validation of the 3d-cam to detect postoperative delirium

Conditions: Postoperative Delirium

Summary: the 3d-cam is a new 3-minute diagnostic assessment for confusion assessment method-defined delirium. the primary objective of this study is to translate the 3d-cam into the german language, as well as to validate its use to detect postoperative delirium in the recovery room. the validation will be based on comparisons to the nu-desc (nursing delirium screening scale), cam (confusion assessment method), and dsm-5 criteria (diagnostic and statistical manual of mental disorders).

approximately 200 patients will be enrolled in the study. they will followed up until the third postoperative day. calculation and analysis of demographic and perioperative influencing factors on postoperative delirium according to routine parameters (age, sex, body height, body weight, diagnosis, physical status according to the american society of anaesthesiologists (asa ps), duration of surgery, physiological and operative severity score (possum), type of anesthesia, medication against pain and delirium) will be performed.

Eligibility criteria:
inclusion criteria: * male and female patients with age ≥ 18 years * admission to recovery room (rr) or post anaesthesia care unit (pacu) following elective general anaesthesia and scheduled * inpatient treatment not less than 24 hours. exclusion criteria: * patients with psychiatric diseases and mental retardation * analphabetism * anacusis or hypoacusis with hearing aid device, * amaurosis * lacking willingness to save and hand out data within the study * accommodation in an institution due to an official or judicial order * patients with unability speaking german or english language * participation in other clinical studies during the study period * coworker in the study site
study of itca 650 (exenatide in duros) in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine safety, efficacy and tolerability of various doses of itca 650 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * males or females age 18-70 years * type 2 diabetes mellitus for ≥ 6 months prior to screening visit 1 * on a stable (\> 3 months prior to screening visit 1) treatment regimen of metformin monotherapy; * fasting plasma glucose \< 240 mg/dl at screening visit 1 * hba1c ≥ 7% and ≤ 10% at screening visit 1 exclusion criteria: * prior treatment with exenatide * treatment with any of the following antidiabetic agents within 3 months prior to screening visit 1: tzds, sulfonylureas, dpp iv inhibitors, acarbose, or insulin (injected or inhaled) * history of type 1 diabetes and/or history of diabetic ketoacidosis * body mass index ≥ 40 kg/m2; * history of organ transplantation
effects of a mindfulness programme on competitive athletes with physical disabilities

Conditions: Athletic Injuries; Physical Disability; Chronic Pain

Summary: pain affects the athlete's sporting career directly or indirectly. directly, the injury affects other areas of the body causing a physical decompensation in the athlete and this affects the correct execution of the sporting technique, or how technical gestures can cause pain. indirectly, through the psychological consequences of pain that generate a series of negative consequences and feelings. some studies suggest that psychological skills are an important tool for pain management. for that reason, a mindfulness intervention programme would be a useful tool for manage pain in this population.

the study hypothesised that the mindfulness sports performance enhancement (mspe) programme adapted for this population, was more effective than mindfulness-based relaxation training as a treatment for chronic pain and associated emotional disturbances in para athletes with physical disabilities, and that it contributes more to modifying psychological variables that have been shown to be related to or have modulatory value in the experience of chronic pain.

Eligibility criteria:
inclusion criteria: * have a physical disability * a minimum of 5 points on a likert-type scale from 1 (no pain) to 10 (worst pain imaginable) at the time of recruitment * be at least 15 years of age * have been a competitive athlete (regional, national, world and/or paralympic games level) in any sport discipline. * have an official regional or spanish federation of sports for people with physical disabilities licence * be willing to participate in a mindfulness programme for pain management * sign an informed consent form. exclusion criteria: * not having at least one of the criteria mentioned as inclusion.

Keywords: athlete injuries physical disability chronic pain psychological abilities mindfulness
comparing food and cash assistance for hiv-positive men and women on antiretroviral therapy in tanzania

Conditions: HIV

Summary: the importance of good nutrition and food security among people living with hiv infection (plhiv) is widely recognized. in resource-constrained settings, food insecurity is increasingly recognized as an important barrier to retention in care and adherence to antiretroviral therapy (art). however, there are few studies demonstrating that food and nutrition assistance programs can improve hiv-related outcomes. this study will address this gap by comparing the effectiveness of three models for short-term support for plhiv. food insecure women and men on art will be randomized into one of three groups: 1) nutrition assessment and counseling (nac) alone, 2) nac plus food assistance, or 3) nac plus cash transfers. the investigators will compare the effect of the three approaches on art adherence and retention in care after 6, 12, and 24-36 months of follow-up. the investigators hypothesize that nac plus short-term support in the form of food or cash assistance will result in better adherence to art and retention in care than nac alone, and that the effects of nac plus food assistance will be the same as nac plus cash assistance. the results from the study will provide evidence about which assistance modalities for plhiv work best to improve art adherence and retention in care, and under what conditions. this study will be conducted in shinyanga region, tanzania, where approximately 17 percent of households have poor or borderline food consumption and 7.4 percent of people are living with hiv infection.

the investigators will randomize 785 food insecure women and men who recently initiated art (determined with the household hunger scale1) into one of three groups: 1) nac alone , 2) nac plus food assistance, or 3) nac plus cash transfers. food assistance will be a standard food ration consisting of maize flour, groundnuts, and beans. the cash transfer will be the equivalent value as the food ration (approximately $13 usd/month). participants will receive the monthly food ration or cash transfer for up to six months if they continue to receive monthly hiv care (the standard of care). the investigators will compare the effect of nac and food or cash assistance to the effect of nac alone on art adherence and retention in care at 6, 12, and 24-36 months (objective #1). the investigators will also compare the effectiveness of nac plus food assistance and nac plus cash transfers to determine if their effects are the same (objective #2).

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age; 2. living with hiv infection; 3. initiated antiretroviral therapy (art) for hiv infection in the last 90 days; 4. food insecure, as measured with the household hunger scale; and 5. willing and able to provide written informed consent for the study. exclusion criteria: plhiv who are severely malnourished (bmi\ 18.5).

Keywords: hiv food insecurity antiretroviral therapy
68ga-rm2 pet/ct in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer

Conditions: Stage II Prostate Adenocarcinoma; Stage III Prostate Adenocarcinoma; Stage IV Prostate Adenocarcinoma

Summary: this phase ii trial studies how well gallium ga 68-labeled gastrin-releasing peptide receptor (grpr) antagonist bay86-7548 (68ga-rm2) positron emission tomography (pet)/computed tomography (ct) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68ga-rm2 pet/ct scan may be able to see smaller tumors than the standard of care ct or magnetic resonance imaging scan.

primary objectives: i. to evaluate 68ga-rm2 pet/ct for detection of intermediate and high-risk prostate cancer prior to prostatectomy. outline: patients receive 68ga-rm2 intravenously (iv). within 45-60 minutes, patients undergo a pet/ct scan. patients may undergo a second pet/ct scan immediately after the first scan for attenuation correction. patients may undergo also a repeat 68ga-rm2 pet/ct scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician. after completion of study, patients are followed up at 24-48 hours and within 3-12 months.

Eligibility criteria:
inclusion criteria: * biopsy proven prostate adenocarcinoma * planned prostatectomy with lymph node dissection * intermediate to high-risk disease (as determined by elevated psa \[psa \> 10\], t-stage \[t2b or greater\], gleason score \[gleason score \> 6\] or other risk factors) * able to provide written consent * karnofsky performance status of \>= 50 (or eastern cooperative oncology group \[ecog\]/world health organization \[who\] equivalent) * diagnostic ct or magnetic resonance imaging (mri) performed within 30 days prior to the 68ga-rm2 pet exclusion criteria: * inability to lie still for the entire imaging time (approximately 30 minutes) * inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance