Kornimate/medical-research-clean huggingface dataset:
data analysis of a managed care weight reduction trial

Conditions: Overweight; Obesity

Summary: this study will involve secondary data analysis for a study done by wylie-rosett et al. in 2001 that evaluated the costs and effects of incremental components of a weight-loss program. data analysis will involve cross-sectional and predictive analyses and may include: regression analyses to determine predictors of weight loss and cardiovascular risk, correlations between weight reduction strategies and biological indices, and interactions between biomarkers of inflammation and traditional cardiovascular risk factors. this data will also be available for economic modeling.

this study will involve secondary data analysis for a study done by wylie-rosett et al. in 2001. using a 3-arm, 12-month randomized clinical trial, wylie-rosett et al. evaluated the costs and effects of incremental components of a weight-loss program. the study included 588 individuals (bmi\> 25 kg/m2) in a freestanding health maintenance organization and achieved an 81% completion rate. the intervention used a cognitive behavioral approach for tailoring lifestyle modification goals. the incremental levels of interventions included a) a workbook alone, b) the addition of computerized tailoring using onsite computer kiosks with touch screen monitors, and c) the addition of both computers and staff consultations. for the increasing levels of intervention intensity, the mean 12-month weight losses were 2.2, 4.7, and 7.4 pounds, with the respective cost per participant being $12.33, $41.99, and $133.74. the decreases in mean bmis for these respective intervention levels were 0.4, 0.9, and 1.2. all groups reported a decrease in energy and fat intake and an increase in blocks walked (p\<.01). intervention variables that correlated with weight loss included more computer logons, achieving computer-selected goals, more self-monitoring, increased walking, and decreased energy and fat intake, as well as higher attendance in staff consultation group sessions for that treatment condition. weight loss correlated with decreases in fasting glucose and blood pressure. wylie-rosett et al. (2001) concluded that, in a weight-loss program, computers can facilitate selecting behavioral change goals. more frequent usage resulted in greater weight loss, and staff counseling to augment the computer intervention achieved the most weight loss. the purpose of this study will be secondary analysis of the data collected in the original models study.

Eligibility criteria:
inclusion criteria: * bmi of more than 25 (or a bmi of 24 or more plus 1 cardiovascular risk factor), and the willingness to follow the study protocol, which included a refundable $100 deposit exclusion criteria: * intention to move beyond commuting distance in the next 12 months, * medical conditions that would interfere with study participation, * unwillingness to follow the study protocol.
real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists

Conditions: Atrial Fibrillation

Summary: the aim of this study is to assess the real world comparative effectiveness of rivaroxaban prescribed in non-valvular atrial fibrillation (nvaf) routine care patients in germany.


Eligibility criteria:
inclusion criteria: * first dispense date of rivaroxaban (15mg or 20mg - pzn based) or phenprocoumon (pzn based) between january 1, 2012 and december 31, 2015 * at least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of nvaf (icd-10 gm i48.0/i48.1/i48.2/i48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter * patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period) * ≥ 18 years of age exclusion criteria: * patients with valvular af \[4 quarters prior to the index date\] * pregnancy \[4 quarters prior to index date\] * malignant cancers \[4 quarters prior to the index date or "condition after"\] * transient cause of af \[4 quarters prior to index date\] * patients with vte (pulmonary embolism or dvt) \[60 days before index\] * patients with major surgery defined as hip or knee replacement \[60 days before index\] * prescriptions of oacs (rivaroxaban, vka, dabigatran, apixaban) before index date \[4 quarters prior to index date\] * patients receiving more than one anticoagulant substance (apixaban, dabigatran, rivaroxaban or phenprocoumon) or more than one dosage of a substance on the index date * for sensitivity analysis : patient with any of the events defined in the combined endpoints \[4 quarters prior to index date or "condition after" * patients with dialysis \[4 quarters prior to index date\]

Keywords: rivaroxaban, phenprocoumon, retrospective cohort study, non-valvular atrial fibrillation, nvaf
mechanism of human cold pain perception - involvement of trpa1, trpm8, nav1.7 and nav1.8

Conditions: Pain

Summary: animal studies suggest that the transient receptor potential ion channels trpm8 and trpa1 are cold sensors and that sodium channels nav1.8 and nav1.7 are essential for detecting pain induced by cold temperatures. this study aims to validate these findings in humans.

it is essential for human survival to be able to perceive potentially harmful cold. the perception of slight cooling in animals depends on the ion channel trpm8, but this may represent a largely separate mechanism from painful cold. in mice, trpm8 and trpa1 appear to be involved, but also the sodium channels nav1.7 and nav1.8, through their temperature-dependent function. these receptors might be redundant, so that failure of individual receptors only leads to no or only a partial reduction in the detection of cold. since results obtained in animals do not always translate to humans, the investigators want to clarify whether trpm8, trpa1, nav1.7 and nav1.8 are involved in the perception of cold pain in humans. in order to induce cold pain experimentally, an increasingly cooled solution (down to 3°c) is injected into the skin, and the inhibitors for the mentioned targets are added individually and in combination.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 years * full legal capacity to ensure an equal number of each sex in the study population, only volunteers of one sex will be included as soon as the number of subjects with the other sex has reached half of the calculated sample size. exclusion criteria: * participant of another study, ongoing or within the last 4 weeks * medication intake (except contraception) or drug abuse * female subjects: positive pregnancy test or breastfeeding * body temperature above 38°c, diagnostically verified * known allergic diseases, in particular asthmatic disorders and skin diseases * sensory deficit, skin disease or hematoma of unknown origin in physical examination of the test site

Keywords: psychophysics human physiology cold perception transient receptor potential ion channels voltage-gated sodium channels sensory neuron
real-world outcome of adalimumab on rheumatoid arthritis patients in taiwan

Conditions: Rheumatoid Arthritis

Summary: the study is designed as a prospective, observational study to assess the effect of adalimumab on health-related quality of life (qol) and work productivity in patients with rheumatoid arthritis (ra) in taiwan.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of ra as defined by the 1987 revised american college of rheumatology (acr) classification criteria and/or the acr/the european league against rheumatism (eular) 2010 classification criteria (any duration since diagnosis). * male or female subjects \>= 18 years of age (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label. * patients with moderate to severe ra defined as disease activity score in 28 joints (das28) erythrocyte sedimentation rate (esr) or das28 c- reactive protein (crp) \>3.2 * biologically treatment naïve and initiated adalimumab at baseline visit * availability of clinical data of the previous 12 weeks prior to baseline * ability to self-complete patient questionnaires * subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol. exclusion criteria: * patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks. * participation in any ra-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline * patients, who in the clinician's view, may not be able to accurately report their qol or prior resource utilization * patients, who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.

Keywords: quality of life (qol) work productivity rheumatoid arthritis (ra)
gender-based differences in the outcome of the treatment of persistent septic shock with hydrocortisone

Conditions: Septic Shock

Summary: the aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

because of their pleiotropic effects, corticosteroids are widely used as adjunctive therapy in sepsis for their anti-inflammatory, metabolic, and immune-suppressing actions. moreover, the treatment benefits of corticosteroids in terms of hemodynamics and organ functions for septic shock were established. hydrocortisone reduces the duration of mechanical ventilation and critical care treatment and reduces the time needed for shock reversal. hydrocortisone use at a daily dose of ≤400 mg for at least 3 days was associated with survival benefits. interestingly, corticosteroid treatment was reported to be more cost-effective in females than in males with septic shock, compared with placebo. this may be explained by the fact that sex hormones modulate the expression and sensitivity of glucocorticoid receptors differently, potentially influencing the body's response to cortisol. to the best of our knowledge, the data available on whether females and males may be more or less likely to acquire a better or worse prognosis of persistent septic shock when treated with hydrocortisone is sparse. the aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

Eligibility criteria:
inclusion criteria: * adult patients of both sexes with persistent septic shock received hydrocortisone during their intensive care unit (icu) stay. exclusion criteria: * patients with incomplete data sets.

Keywords: critical care, septic shock, hydrocortisone, gender
effect of hyperandrogenism on ivf outcomes in pcos patients

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Summary: ovulatory dysfunction affects 18 to 25% of infertile women, the most common identifiable condition is polycystic ovarian syndrome (pcos). the most frequent symptoms of pcos are oligo-anovulation, hyperandrogenism and polycystic ovary appearance. hyperandrogenism is the main contributor that affects oocyte and embryo quality and decreases the success rates in pcos patients undergoing ivf treatments. the aim of this study is to determine the effect of hyperandrogenism as an independent factor on ivf success rates and oocyte/embryo quality in pcos patients undergoing ivf.

despite that pcos patients obtain a higher yield of oocytes retrieved in ivf treatments, they often have lower fertilization, cleavage and implantation rates and a higher rate of miscarriage, which can be attributed to a poor quality of retrieved oocytes and the resulting embryos. multiple studies compared ivf outcomes in pcos patients to control groups and found that pcos might negatively affect oocyte maturation rate, fertilization rate in conventional ivf and miscarriage rate. hence, it seems that pcos might be associated with poor outcomes in ivf cycles when compared to non-pcos patients.

Eligibility criteria:
inclusion criteria: * women between ages of 18 - 39 inclusively * ≥15 oocytes collected on the day of oocyte retrieval and/or anti-mullerian hormone (amh) ≥ 4.0 ng/ml in the participant's medical chart in the last 24 months exclusion criteria: * male factor necessitating testicular sperm aspiration (tesa), testicular sperm extraction (tese) or micro-tese * fertility preservation * recurrent pregnancy losses (rpl) (defined as 2 or more failed clinical pregnancies as documented by ultrasonography or histopathologic examination,or 3 or more failed pregnancies before 14 weeks of gestation) * oocyte donation * medical diagnosis of non classic congenital adrenal hyperplasia diagnosed based on 17 hydroxyprogesterone level

Keywords: hyperandrogenism fertility issues
screening day latin america

Conditions: Nutritional Status; Malnutrition; Caloric Deficit

Summary: this is a survey which will be performed on a specific day (the "screening day") in latin american icus. in eligible patients who receive enteral or parenteral nutrition a retrospective calculation of the "caloric deficit" will be performed. the caloric deficit is the difference between energy target of each patient and actually administered calories.

the screening day latin america is a non-interventional, cross-sectional and retrospective study. the study focusses on patients receiving enteral (tube feeding, en) and/or parenteral nutrition (pn). all patients hospitalized on the defined screening day in participating icus will be checked for eligibility. in eligible patients the patient charts will be reviewed and the following parameters will be documented: * caloric deficit (daily target energy - actually administered energy via en and pn). the caloric deficit will be calculated for 1 to up to 5 days before the screening day. the analysis will be done for each day and for the complete documentation period up to 5 days. primary focus will be the caloric deficit on day -1. * nutritional status of the patient based on information from the patient charts. for this, three tools will be applied independently: subjective global assessment (sga), nutric score, espen diagnosis of malnutrition the study will be performed in 8 latin american countries. data will be recorded anonymously in an electronic case report form. the study data of this explorative study will be analyzed using descriptive statistical methods.

Eligibility criteria:
inclusion criteria: patients will be included if the following criteria are fulfilled: * critically ill adult (≥18 years of age) patients, including critically ill major gastrointestinal surgery patients * patient is hospitalized in intensive care unit (icu) on the screening day * patients receiving enteral nutrition (en; tube feeding only) and/or parenteral nutrition (pn) on the screening day and the day before the screening day * initiation of enteral nutrition (en) and/or parenteral nutrition (pn) during icu admission and at least one day before the screening day a critically ill patient is defined as a patient with at least one organ failure. exclusion criteria: the following patients are excluded from the documentation: * critically ill burn patients * patients on the intensive care unit (icu) for surveillance without needing enteral nutrition (en) and/or parenteral nutrition (pn)

Keywords: nutritional status malnutrition energy intake caloric deficit icu hospital enteral nutrition parenteral nutrition nutrition
long-term follow-up study for multiple myeloma patients who received study treatment (plerixafor or placebo) in the amd3100-3102 study (nct00103662).

Conditions: Multiple Myeloma; Autologous Transplantation

Summary: this is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the amd3100-3102 protocol (nct00103662).

this is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled study to evaluate amd3100 plus granulocyte colony stimulating factor (gcsf) versus g-csf plus placebo to mobilize and transplant multiple myeloma (mm) patients (protocol amd31003102ltf \[nct00103662\]). the objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol amd3100-3102 (nct00103662).

Eligibility criteria:
inclusion criteria: * all patients who received a dose of study treatment (plerixafor or placebo) in protocol amd3100-3102 (nct00103662) exclusion criteria: * no exclusion criteria
effects of tdcs combined with cbi on postsurgical pain

Conditions: Total Knee Arthroplasty (Postoperative Pain); Total Hip Arthroplasty (Postoperative Pain)

Summary: the purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a cognitive-behavioral intervention (cbi). this new medical technology, is called transcranial direct current stimulation (tdcs), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. the electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles. this study will investigate the effects of tdcs, the cognitive-behavioral (cb) intervention and their combination on pain among veterans following total knee arthroplasty (tka) or total hip arthroplasty (tha). the veteran may benefit in the form of decreased pain and opioid requirements following knee or hip replacement surgery. however, benefit is only likely if veterans are randomized to one of the 3 (out of 4) groups. this study hopes to determine the effects of these interventions and combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

the proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tdcs, brief cognitive-behavioral (cb) intervention and their combination on pain among veterans undergoing unilateral tka or tha. 132 patients undergoing tka/tha will be randomly assigned to one of four groups: 1. group1- real tdcs + real cb intervention 2. group2- real tdcs + education-only-control intervention 3. group3- sham tdcs + real cb intervention 4. group4- sham tdcs +education-only-control intervention participants will receive 2 tdcs/cbi treatments on the day of their surgery, and 2 tdcs/cbi treatments the day after their surgery. participants' perioperative medication usage and pain ratings will be tracked during postoperative hospital stay. follow-up data regarding pain and opioid use will be collected at 1, 3 and 6-months.

Eligibility criteria:
inclusion criteria: participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing tka or tha surgery at the ralph h. johnson vamc in charleston sc. * mentally capable of reading, writing, giving consent, and following instructions * cleared for, and scheduled for unilateral tka or tha surgery * able to hear cb intervention and understand educational materials through headphones in english exclusion criteria: * implanted medical devices above the waist * pregnant * history of seizures * allergic to latex rubber * psychiatric conditions except for depression and/or anxiety disorders (commonly seen in this population).

Keywords: total knee arthroplasty pain postsurgical pain opioid transcranial direct current stimulation tdcs brain stimulation total hip arthroplasty tka tha
diagnostic research in patients with rare diseases - solving the unsolved rare diseases

Conditions: Rare Diseases; Genetic Predisposition

Summary: the dirip study will enroll patients (n = 3500) with unclear rare diseases and suspected genetic reasons. in group 1 (n = 500) subjects are clinically characterized in the context of outpatient/ inpatient standard care at the ukt or cooperating location, ngs analyzes and other omics analyzes (transcriptomics, proteomics, metabolomics), functional cell biology studies will be performed. in group 2 diagnostics is already performed. the dirip-study fully integrates with the newly formed european reference networks (erns) for rare diseases, and in particular the ern-rnd, -euro-nmd, -ithaca, and -genturis.

in the dirip-rd study (monocentric, prospective, open-label diagnostic study), patients with genetically unexplained diseases will be analyzed or re-analyzed from existing datasets for further omics analysis. these are evaluated with regard to the following questions: primary: * verification of the genetic causes of unclear genetic diseases secondary: * improve number of diagnoses of unclear syndromes * further characterization of the identified gene defects * number of patients receiving appropriate therapy after successful diagnosis. in addition, patient phenotype and genotype data can be collected using a software tool for collecting and analyzing phenotypic information of patients with genetic disorders ( phenotips®) software to facilitate data exchange within the ukt, with external collaborators and data transfer to the solve-rd project.

Eligibility criteria:
inclusion criteria: * unclear diagnosis * suspected genetic cause of the disease exclusion criteria: * missing informed consent of the patient/ legal guardian

Keywords: rare diseases genetic predisposition omics technology next generation sequencing (ngs)