Kornimate/medical-research-clean huggingface dataset:
the gem (goals for eating and moving) study

Conditions: Weight Gain; Obesity

Summary: the gem intervention leverages the patient-centered medical home model by using the gem tool to provide individually tailored, patient-centered care, promote standardized weight management counseling by health coaches and primary team members, coordinate care between teams and other weight management service providers/programs (e.g., dietitians, health educators, dpp), and provide feedback to the provider and primary care team about patients' weight management-related goals, progress, and care.

to establish the efficacy of the gem intervention, investigators will conduct a cluster randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare systems with medical home models of care to compare the gem intervention (intervention arm) with enhanced usual care (educational materials; control arm). the specific aims of this study are: * test the impact of the gem intervention on weight change, and clinical and behavioral outcomes. * identify predictors of weight loss in the gem intervention arm related to: a) goal-setting processes and b) intervention components * determine the impact of the gem intervention on obesity-related counseling practices and attitudes in primary care providers.

Eligibility criteria:
inclusion criteria: * between the ages of 18-69 years of age, * body mass index of ≥30kg/m2 or * body mass index of ≥25 kg/m2 with an obesity associated co-morbidity * hypertension * high cholesterol * sleep apnea * osteoarthritis * metabolic syndrome * prediabetes * under primary care team care with at least one prior visit with their provider in the past 24 months * access to a telephone, and ability to travel for in-person evaluations at baseline, 6, 12, and 24 months exclusion criteria: * patients who do not speak english or spanish, * have active psychosis or other cognitive issues, * psychoactive substance use * diabetes * taking prescription weight-loss medication * health condition that may prohibit the patient from walking or physical activity such as chest tightness, a heart condition, or severe arthritis * participated in move!, dpp, or another intensive weight management program (\>3 sessions) in the past year, * have a history of bariatric surgery, * are pregnant, or become pregnant during the intervention period, * metastatic cancer in the last 6 months, current chemotherapy or cancer treatment, * have a provider who states they should not participate, * patients who do not want to lose weight * have self-reported inability to read at 5th grade level.

Keywords: weight gain weight loss
efficacy and safety of patupilone in men (≥18 years) with metastatic hormone refractory prostate cancer

Conditions: Metastatic Hormone Refractory Prostate Cancer

Summary: the objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (psa) in patients with metastatic hormone refractory prostate cancer. additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.


Eligibility criteria:
inclusion criteria: * must be ≥ 18 years of age * confirmed and documented diagnosis of prostate cancer * confirmed and documented evidence of progression of disease (hormone refractory) * low testosterone levels * chemotherapy-naïve exclusion criteria: * recent radiation therapy (within 4 weeks) * known brain metastasis * peripheral neuropathy * active diarrhea * significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections * allergic reactions to patupilone or docetaxel or prednisone or similar compounds other protocol-defined inclusion/exclusion criteria may apply

Keywords: prostate cancer hormone refractory patupilone docetaxel
effect of balint group on burnout and self-efficacy of nurse leaders in china: a randomised controlled trial

Conditions: Burnout; Self Efficacy

Summary: background: burnout is common among nurses and is related to negative outcomes of medical care. this study aimed to explore the effectiveness of balint group activities in burnout reduction among nurse leaders in a chinese hospital. methods: this was a randomised controlled trial with a pre- and post-test. a total of 80 nurse leaders were randomly assigned to either a balint group (n=40) or a non-balint group (n=40). participants in the balint group completed balint training for a period of three months. participants in both groups completed the maslach burnout inventory-human services survey (mbi) and the general self-efficacy scale (gses) at the beginning and end of the study（three months later ）. balint group members also completed the group climate questionnaire-short format the end of the study（three months later ）.


Eligibility criteria:
inclusion criteria: 1. nurse leaders in clinical departments 2. voluntary participation exclusion criteria: a. previous participation in balint groups
campath, calcineurin inhibitor reduction and chronic allograft nephropathy

Conditions: Kidney Transplantation

Summary: the 3c study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney transplants.

the long-term survival of kidney transplants has not improved over the past decade despite reductions in the rate of acute rejection. the commonest cause of late graft loss is chronic allograft nephropathy which is frequently caused by calcineurin inhibitor toxicity. therefore, it may be possible to improve long-term graft outcomes by reducing the amount of calcineurin inhibitor exposure. two possible strategies to do this were tested. firstly, campath-1h (a monoclonal lymphocyte-depleting antibody) was compared to standard basiliximab-based induction. all patients then received tacrolimus-based maintenance therapy for 6-months (using lower doses in the campath-1h arm). at six months, patients were re-randomized between remaining on tacrolimus and converting to sirolimus (and therefore no longer taking calcineurin inhibitors). patients were then followed-up in clinic and through routine nhs registries to collect information on relevant outcomes (including graft function, survival, hospitalisations and death).

Eligibility criteria:
inclusion criteria: * men or women aged over 18 years * recipient of kidney transplant (planned in next 24 hours) exclusion criteria: * recipients of multi-organ transplant * previous treatment with campath-1h * active infection (including hiv, hepatitis b or c) * history of anaphylaxis to humanized monoclonal antibody * history of malignancy (except adequately treated non-melanoma skin cancer) * loss of kidney transplant within 6 months not due to technical reasons * medical history that might limit the individual's ability to take trial treatments for the duration of the study

Keywords: kidney transplantation alemtuzumab sirolimus basiliximab tacrolimus campath-1h
autologous umbilical cord blood transfusion for preterm neonates

Conditions: Prematurity; Respiratory Distress Syndrome; Anemia of Prematurity; Intraventricular Hemorrhage

Summary: this is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature \<35 weeks of gestation.

in egypt, 12-15.8% of live neonates are low birth weight and it is estimated that about one third of such infants are preterm \[1\] (unicef, 2001). in a study that campbell et al. (2004) conducted in egypt, the neonatal mortality rate was estimated to be 25 per 1000 live births. prematurity was considered the main cause of neonatal deaths (39%), followed by asphyxia (18%), infection (7%), especially in the late neonatal period, and congenital malformations (6%). a substantial proportion (29%) could not be classified \[2\]. in developing countries, prematurity was the main cause of early neonatal deaths (62%)\[3\] autologous cord blood transfusion will be safe, and cheap. the preterm neonates need transfusion of whole blood or any of its components at a time during nicu admission.

Eligibility criteria:
inclusion criteria: * preterm neonates less than 34 weeks of gestation. * low birth weight less than 1500 grams exclusion criteria: * congenital malformations. * suspected inborn error of metabolism. * suspected inherited neurologic disease.

Keywords: preterm neonates. autologous cord blood transfusion.
study of epoetin alfa to treat anemia after kidney transplantation

Conditions: Anemia

Summary: the primary purpose of this study is to determine the effect of epoetin alfa (procrit) on the change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. the investigators hypothesize that epoetin alfa will raise hemoglobin.

anemia has become an increasingly recognized problem in kidney transplant recipients, and erythropoietin is often prescribed as treatment despite limited data regarding outcomes. multiple clinical trials have demonstrated correction of anemia with erythropoietin in patients with chronic kidney disease (pre-transplant) and patients on dialysis. no large clinical trials of erythropoietin treatment have been done in anemic kidney transplant recipients, however. the investigators hypothesize that when used for the treatment of post-transplant anemia, epoetin alfa increases hemoglobin (hb). the investigators further hypothesize that epoetin alfa suppresses pathogenic alloimmunity directed at the kidney transplant and as a consequence, prevents immune-mediated injury and thereby preserves renal function. finally, the investigators hypothesize that treatment of post-transplant anemia with epoetin alfa also results in improved patient-reported outcomes (quality of life) and decreased left ventricular mass. in order to test these hypotheses, the investigators propose a randomized controlled trial of epoetin alfa in anemic kidney transplant recipients (9.0 \< hb \< 11.0). 100 study subjects will be randomized to either treatment with epoetin alfa at a starting dose of 150 units/kg/week or no treatment (50 subjects/arm). the primary outcome of change in hb will be measured by cbc at 6 weeks, 3 months, 6 months, and 1 year of enrollment. secondary outcomes to be measured include change in renal function (egfr), change in t cell phenotype, change in patient-reported outcomes (sf-36 form), and change in left ventricular mass (by cardiac mri).

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. kidney transplant recipient at least 8 weeks post-transplant 3. mild to moderate anemia, defined as 9.0 g/dl \< hb \< 11 g/dl) 4. estimated gfr (by mdrd) \< 60 ml/min (not on dialysis) 5. transferrin saturation \> 20% and ferritin \> 100 ng/ml exclusion criteria: 1. history of erythrocyte-stimulating agent (esa) use in the previous 8 weeks 2. red blood cell transfusion in previous 30 days 3. history of hiv/aids 4. nonfunctioning graft, defined as patient requiring chronic dialysis 5. hypersensitivity to esas or albumin 6. uncontrolled hypertension, defined as screening bp \> 180/100 7. new-onset seizures (diagnosed within the last 3 months) or seizure disorder uncontrolled on medications (breakthrough seizures on medication) 8. history of any neoplasm except: adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary cns lymphoma) treated with curative therapy and disease-free for more than 5 years. 9. pregnancy or lactating 10. vitamin b12 deficiency (vit b12 \< 180 pg/ml) 11. untreated folate deficiency (folate \< 6.6 ng/ml)

Keywords: anemia kidney transplant alloimmunity
exactech shoulder post market clinical follow-up study

Conditions: Osteo Arthritis Shoulders; Osteonecrosis; Rotator Cuff Tears; Rotator Cuff Tear Arthropathy; Ankylosing Spondylitis; Post-traumatic Osteoarthritis; Rheumatoid Arthritis; Fracture; Infections

Summary: the objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. this study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.


Eligibility criteria:
inclusion criteria: * patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty) * patient is skeletelly mature * patient is expected to survive at least 2 years beyond surgery * patient is willing to participate by complying with pre- and postoperative visit requirements * patient is willing and able to read and sign a study informed consent form exclusion criteria: * osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved * inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * medial humeral bone loss resulting in compromised humeral stem fixation * proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation * neuromuscular disorders that do not allow control of the joint * significant injury to the brachial plexus * non-functional deltoid muscles * patient's age, weight, or activity level would cause the surgeon to expect early failure of the system * the patient is unwilling or unable to comply with the post-operative care instructions * alcohol, drug, or other subtance abuse * any disease state that could adversaly affect the function or longevity of the implant * patient is pregnant * patient is a prisoner * patient is contraindicated for the surgery * revision cases in which a stemmed humeral component was used (stemless shoulder system) * metal allergy or sensitivity to the implants materials (stemless shoulder system) * acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (stemless shoulder system) * acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (stemless shoulder system)
database and calibration of a non-invasive glucose monitoring device

Conditions: Diabetes

Summary: this clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

subjects will collect 2-4 daily optical raman readings paired with capillary blood glucose comparator in own home with maintaining usual routines. subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.

Eligibility criteria:
inclusion criteria: * male and female subjects 18 years of age or older * diabetic (all types) patients exclusion criteria: * pregnant women * subjects not able to understand and read danish * in investigator's opinion, subject is not able to follow instructions as specified in the protocol * subjects not able to hold hand/arm steadily * extensive skin changes, tattoos or diseases on probe application site * rejection by prescreening optical measurements * known allergy to medical grade alcohol used to disinfect skin
high protein weight loss diet, high sensitivity c-reactive protein and cardiovascular risks among obese women

Conditions: Body Mass Index Quantitative Trait Locus 8 Disorder; Tangier Disease

Summary: the investigators aimed to determine the effects of hp diet on cvd risk factors and hs-crp among overweight and obese women.

background: studies regarding the effects of high protein (hp) diet on cardiovascular (cvd) risk factors have reported contradictory results. objective: in present study, we aimed to determine the effects of hp diet on cvd risk factors and hs-crp among overweight and obese women. design: in this randomized controlled trial, we recruited 60 overweight and obese women, aged 20-65 years into hp or control energy restricted diets for three months (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. fasting blood samples, hs-crp, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Eligibility criteria:
inclusion criteria: * women aged between 20-65 years * bmi \> 25 kg/m2 * were no smoker * no history of renal, liver, metabolic diseases or type 1 or 2 diabetes exclusion criteria: * had gastrointestinal, respiratory, cardiovascular, metabolic, liver and renal -diseases * had macroalbuminuria * were pregnancy or lactating

Keywords: body weight low-density-lipoprotein-type
focal recurrent assessment and salvage treatment

Conditions: Progression of Prostate Cancer

Summary: radiotherapy is the commonest form of prostate cancer treatment in the uk. in one in four men, radiotherapy will fail to control the cancer. these men are offered hormonal treatment which has significant side effects. few men are offered a further treatment such as surgery, hifu or cryotherapy. only half of these men are cancer free at 5 years. the investigators believe this is due to poor imaging tests such as ct and bone scan that cannot accurately detect whether cancer has come back inside or outside of the prostate or both. also radiotherapy damages tissue surrounding the prostate which affects tissue healing for example after surgery. treating just the cancer in the prostate only (focal treatment) rather than the whole prostate may limit this damage and cause fewer side-effects. the investigators want to see if new imaging tests can better identify cancer that has spread outside of the prostate and areas of cancer inside the prostate. our new tests are whole-body mri (for distant disease) and mri guided biopsies (mri-tb) (for local disease). first, the investigators will compare the results of whole-body mri to existing imaging tests (bone-scan, and choline pet/ct) that try to find distant spread. second, the investigators will compare the results of mri-tb to a very detailed and accurate biopsy of the prostate called template prostate mapping which will show us where and how aggressive the cancer is. third, if the cancer is confined to the prostate, the investigators will treat men using focal salvage therapies hifu and cryotherapy. the investigators believe that these new imaging tests could better identify those who will benefit from early hormone treatment and those who will benefit from local salvage treatment. our study may help justify carrying out a larger trial looking at how good the treatment is in controlling cancer in the medium and long-term.


Eligibility criteria:
inclusion criteria: 1. previous external beam radiotherapy with or without neo-adjuvant/adjuvant hormone therapy 2. biochemical failure as defined by the phoenix criteria (psa nadir + 2ng/ml) 3. men considering local salvage treatment for radio-recurrent disease 4. life expectancy of 5 years or more exclusion criteria: 1. have taken any form of hormones (except 5-alpha reductase inhibitors) within the previous 6 months 2. unable to have mri scan as defined by standard care practice 3. metallic implant likely to cause artefact and reduce scan quality 4. psa doubling time of 3 months or less 5. psa value 20ng/ml or greater 6. prior prostate biopsies following biochemical failure 7. any prior local intervention to the prostate (e.g., laser/electrical resection or incision, cryotherapy, hifu, any other ablative modality, any other radiotherapy, any other prostate injection therapy for symptoms or cancer control) 8. unable to have general or regional anaesthesia 9. unable to give informed consent

Keywords: biochemical failure radiotherapy radiorecurrent prostate cancer mri prostate whole body mri bone scan choline pet focal salvage treatment hifu cryotherapy
effects of hbo therapy on muscular insulin resistence in type 2 diabetes

Conditions: Obesity; Non-insulin-dependent Diabetes Mellitus

Summary: hyperbaric oxygen therapy (hbo) is applied for several diseases. the effect on insulin sensitivity is yet unknown. hypothesis: hbo therapy improves insulin sensitivity in patients.

hbo therapy is applied to improve wound healing in diabetic patients with foot ulcera. however, it might induce oxidative stress as well as improve antioxidative capacity. the effects on insulin sensitivity in humans and will be tested in the study.

Eligibility criteria:
inclusion criteria: * aged ≥ 30 years- ≤ 70 years * balanced sex (50: 50) * bmi 20- 25 kg/m 2 normal- weight group * bmi 35- 39,9 kg/m 2 (obese typ ii) exclusion criteria: * acute illness 2 weeks before start of examination * autoimmune or immune disorder deseases (leukozyten \< 5000/µl * renal insufficiency (kreatin \> 1,5 mg/dl) * heart disease, condition after heart attack * anemia (hb \<12g/l, contolled before every day of eximination) or blood donations 4weeks before eximinatin. * participation in another trial within the last 2 weeks * pharmacological- immuno therapy (cortisol, antihistaminika, ass) * thyroid disorders * glitazone or insulin- therapy * pragnancy, lactation, menstruation * smoking cigaretts, alcohol- and drug abuse * psychiatric disorders * risk for/ or diagnosed hiv/ aids or hepatitis b/c * liver disease, which are not caused by non- alcoholic steato- hepatitis * working on night shifts or irregular rhythem of night- day * impaired wound healing or clotting disorders * allergic reaction to local anesthetics * malignant cancer

Keywords: oxidative stress insulin resistance