Kornimate/medical-research-clean huggingface dataset:
evaluation of bay59-8862 in taxane-resistant metastatic breast cancer patients

Conditions: Breast Neoplasms; Breast Cancer, Metastatic

Summary: breast cancer is the most common form of cancer among women in developing countries, accounting for approximately one-fifth of all female cancers in the united states. although mortality rates are declining in some countries, it remains the leading cause of death in women aged 40-55 years. the median survival for women with metastatic breast cancer is 2-3 years but there is significant variability in this population. the primary goals of treatment in patients with metastatic breast cancer are improvement or maintenance of quality of life and prolongation of survival. the taxanes, paclitaxel and docetaxel, were incorporated into the treatment of metastatic breast cancer in the 1990's. the usefulness of the taxanes is limited by the development of tumor resistance to these agents. this phase ii trial with bay59-8862 will be conducted to determine the anti-tumor efficacy of bay59-8862 in taxane-resistant metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * female patients with a proven diagnosis of metastatic breast cancer * measurable disease as defined by the presence of at least one measurable lesion * patients must have received at least 3 weeks of continuous therapy with taxane * patient must subsequently develop progressive disease either during treatment or within 6 months after treatment * patients who failed on hormone therapy * life expectancy of at least 12 weeks. * adequate bone marrow, liver and kidney function * patients with active brain metastases may be included exclusion criteria: * excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia; surgery within 4 weeks of study entry; serious infections; hiv infection; chronic hepatitis b or c; patients with brain metastases must be without a seizure; hypersensitivity to taxanes; organ transplants; some previous cancers * excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant * others: pregnant or breast-feeding patients; women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.

Keywords: taxane breast cancer metastasis
multiple treatments for ebola virus disease (evd)

Conditions: Ebola Virus Disease

Summary: the purpose of this study is to determine whether multiple therapeutic regimens are effective in the treatment of ebola virus disease (evd)

the ongoing epidemic of evd has ravaged parts of west africa, with initial cases reported in december 2013. there is no licensed specific therapy for the disease, which has a case-fatality rate of approximately 50-70%. although anecdotal clinical data, recent studies in animal models, and in vitro screening suggest that treatment of evd patients with anti-viral agents, immune modifying agents, and/or convalescent blood products may be effective, they have not been evaluated in clinical trials. this multi-arm clinical trial will evaluate the efficacy and safety of multiple regimens, both as mono-therapy and combination therapy. provision of these regimens, if found effective and safe, would have a major impact on the current and future epidemics by providing effective treatment options. as described for previous adaptive trials, a randomization probability for each of the treatment regimens is created based on 14-day mortality, and is used for weighting randomization of subsequently enrolled participants. participants will continually be preferentially assigned to regimens with better initial performance. new agents can be added or existing agents removed as the trial evolves.

Eligibility criteria:
inclusion criteria: * males and females aged 6 months and \>8kg in weight * confirmed case of evd * admission to the hospital \< 48 hours prior to enrollment * participant or family member/guardian able and willing to provide signed informed consent exclusion criteria: * prior treatment with any other specific experimental anti-evd product, or expectation to receive another experimental anti-evd product during the course of the study (this does not include general supportive care or nutritional supplements routinely administered to all hospitalized patients with evd) * unresponsive * in the treating physicians opinion, an inability to comply with the study treatment regimen

Keywords: ebola evd adaptive design therapeutics
mobile medically supervised patient management in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the use, usability and feasibility of an application (app) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction.


Eligibility criteria:
inclusion criteria: * age \>= 18 years, owner of app capable device, ra, informed consent exclusion criteria: * non german speaking, no app capable device available
allogene mscs transplantation in patients with chronic liver diseases through peripheral vein.

Conditions: Allogene MSCs Transplantation; Chronic Liver Diseases Patients; Peripheral Vein

Summary: allogene mscs transplantation will be performed in patients with chronic liver diseases through peripheral vein and therapeutic effects including short-term effects and long-term follow-up will be compared and investigated.


Eligibility criteria:
inclusion criteria: 1. chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease. 2. age: 15-65 years old. exclusion criteria: 1. pregnant women and women in lactation. 2. other systems and organs disfunction 3. space-occupying lesion were found in liver. 4. concurrent infection with hiv and other immunodeficiency diseases. 5. dic and active bleeding were confirmed.

Keywords: allogene mscs transplantation chronic liver diseases peripheral vein
assessment of the optimal dosing of piperacillin-tazobactam in intensive care unit patients: extended versus continuous infusion

Conditions: Infectious Disease

Summary: piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. similar to other beta-lactam antibiotics, piperacillin-tazobactam exhibits time-dependent killing and the t \> mic appears to be the best outcome predictor. because a majority of infections are treated empirically, it is necessary to achieve a t \> mic equal to 50% of the dosing interval (50% t \> mic) against the most likely pathogens, including those with only moderate susceptibility the aim of this study is to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion. a pharmacokinetic study will be performed in patients treated by extended (loading dose 4 g/30 min followed by 4 x 4 g /3h) and continuous infusion (loading dose 4 g/30 min followed by 16g /24h). a population pharmacokinetic analysis with monte carlo simulations will be used to determine 95% probability of target attainment (pta95) versus mic


Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years) admitted on the intensive care unit (surgical and medical surgery). * starting a treatment with piperacillin/tazobactam * signed informed consent * hematocrit \>= 21% * available arterial line exclusion criteria: * age \ 75 years * patient's weight \ 100 kg * renal insufficiency (estimated clearance \< 50 ml /min) * haemodialysis * wbc \< 1000 103 µl * estimated survival \<5 days * meningitis or other proven infections of the cns * ige-mediated allergy to penicillins * pregnancy * patients having participated in another study \<30 days before inclusion in the present study * retrospectively, marked deterioration of the renal function during the study period * retrospectively, treatment \< 96 h

Keywords: infectious disease piperacillin continuous infusion extended infusion
effect of exercise training and soy-based nutritional supplementation on prevention of osteoporosis

Conditions: Osteoporosis; Osteopenia

Summary: the purpose of the study is to determine the effectiveness of combining exercise training (i.e. weight lifting and walking) and dietary supplementation with a soy-based nutritional supplement for increasing bone mineral density. we hypothesize that the exercise training and soy-based supplement will be additive for increasing bone mineral density.

exercise training is effective for increasing bone mineral density and preventing osteoporosis, but the effects are small. when estrogen replacement is given to post-menopausal women the effectiveness of exercise training for improving bone mineral density is increased. currently many women are concerned about the risks of taking hormone-replacement therapy and are seeking alternative therapies. the purpose of our study therefore is to use an estrogen-like dietary supplement derived from soy called a phytoestrogen (soy isoflavone) combined with exercise training for improving bone mineral density. comparisons: four groups are being compared: 1) exercise training (i.e. weight lifting 2 times per week and walking 4 times per week) plus soy isoflavone (90 mg aglycone equivalents per day); 2) exercise training plus placebo; 3) exercise placebo (flexibility exercises four times per week) plus soy isoflavone; 4) exercise placebo plus placebo.

Eligibility criteria:
inclusion criteria: * post-menopausal women exclusion criteria: * diagnosed osteoporotic * previous fragility fractures * previous breast cancer * previous endometrial cancer * taken bisphosphonates in past 12 months * taken hormone replacement therapy in past 12 months * taken selective estrogen receptor modulators in past 12 months * taken parathyroid hormone in past 12 months * taken calcitonin in past 12 months * currently taking corticosteroids * currently taking a thiazide diuretic * crohn's disease * cushing disease * allergy to soy * severe osteoarthritis * currently participating in vigorous exercise

Keywords: osteoporosis bone exercise soy isoflavone phytoestrogen menopause lipids
a study of invasive hemodynamic for machd registry

Conditions: Healthy; Congenital Heart Disease

Summary: this research study is being done to provide comparative data to the mayo clinic adult congenital heart disease registry.


Eligibility criteria:
inclusion criteria: * capacity to consent * bmi \</= 30 * systolic bp \</= 140mmhg * diastolic bp \</= 90 * egfr \> 30 (within prior 3 months) to confirm kidney function * able to undergo an mri exclusion criteria: * history of cardiovascular disease that may affect the results of the testing performed. * any current orthopedic limitations * currently taking any cardiac medication * pregnancy
well-being training for adolescent depressive symptoms (teenwell study)

Conditions: Depression

Summary: this study is being done to see if the healthy minds program app helps adolescents with elevated depressive symptoms. up to 200 participants will be on study for 20 weeks.

participants will be randomized into one of two groups: healthy minds program intervention group (hmp) or a water tracking active control group. the groups will use different mobile health apps for eight weeks. all participants will complete assessments pre-intervention, after weeks 2, 4, and 6 of the intervention, at week 8 (post-intervention), and at week 20 (follow-up). participants will complete a short daily diary set of questions on their social interactions that day. participants will wear a biostrap band for continuous collection of heart rate, movement, and daily sleep indices, and geolocation data will be extracted from participant phones using the followmee app. participants will receive access to the app they were not assigned to after follow-up. primary objective * assess acceptability and preliminary efficacy of an 8-week mhealth meditation training program on depressive symptoms. secondary objectives * investigate effects of the meditation training program on symptoms of anxiety, behavior (social isolation), psychophysiological processes related to health and disease (e.g., sleep). test changes in behavior and psychophysiology as mechanisms of improved mental health. test whether improved mental health is associated with improved academic outcomes.

Eligibility criteria:
1. age 14 to 19 2. currently in high school (i.e., 9th to 12th grade) or if not attending school, would be in high school if enrolled 3. proficient in english 4. able to understand and provide informed consent (greater than or equal to 18 years old) or assent and parent/guardian consent (if less than 18 years old) 5. promis depression scale t-score greater than or equal to 60 or sum of patient health questionnaire-2 (phq-2) greater than or equal to 2 6. if on a psychotropic meditation, has been receiving a stable dose for greater than or equal to 4 weeks 7. willing and able to complete all study procedures exclusion criteria: 1. has received a high school diploma or a high school equivalency diploma (hsed or ged) 2. weekly or more frequent meditation practice 3. prior use of the healthy minds program app 4. prior use of the water tracking app 5. endorses current suicidal thoughts on the baseline screen 6. self-reported history of psychosis or mania 7. currently receiving, history of receiving in the last 6 months, or planning to start any of the following types of therapy within the next 5 months: acceptance commitment therapy (act), dialectical behavior therapy (dbt), and other mindfulness-based therapies (e.g., mindfulness-based cognitive therapy). for history of receiving only, only excluded if the participants has used the techniques on a weekly more frequent basis in the last 6 months.

Keywords: adolescent meditation
validation of a method to search residual disease in auto-cryopreserved ovarian tissues

Conditions: Neoplastic Pathology; Minimal Residual Disease; Cryopreserved Ovarian Tissue

Summary: cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. the main part of the ovary is preserved, as primordial and primary follicles are resistant to freezing / thawing protocols. in the absence of other techniques (in vivo maturation, injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is currently the only technique allowing fertility to be restored. autograft is possible only if the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant pathology with a low risk of ovarian metastasis. in other cases of neoplastic pathologies, particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of any codified technique for evaluating residual disease (mrd). the team has for two years been developing and validating a technique to look for residual disease in fragments of ovarian cortex in cases of acute leukemia. this technique is based on an original protocol for dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be analyzed by multicolor flow cytometry. the specificity and sensitivity of the technique have been demonstrated in an experimental model. this model consists in using 8 color flow cytometry to look for characterizable leukemia cells added in different dilutions to a population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of 10-5. when the molecular markers were present on diagnosis, they were found by real-time quantitative polymerase chain reaction (rq-pcr) with the same dilutions. the model tissue came from laparoscopic ovarian drilling in patients with polycystic ovary syndrome. the main objective of this project is to validate techniques that have been previously codified with different populations of leukemia cells that may be characterized. the investigators then aim to adapt and validate this technique to look for mrd using 8 color flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are at risk of metastasis. secondary objectives will be to implement procedures for oncological qualification of grafts in cases of malignant pathology and to consider the recommendations for using this cryopreserved ovarian tissue through the autograft technique for these indications.


Eligibility criteria:
inclusion criteria: * patients who have cryopreserved their ovarian tissue * patients with premature ovarian insufficiency * patient aged from 18 to 43 years for the restoration of ovarian function * no objection from the patient exclusion criteria: * patients under 18 years * patients older than 43 years * patients refusing to be included * patients (adults) under guardianship, curators ans safeguard justice
ventilatory variables in subjects with acute respiratory distress syndrome due to covid-19

Conditions: Respiratory Mechanics; Respiration, Artificial; Respiratory Distress Syndrome

Summary: research question: are the ventilatory variables related to mechanical power associated with the outcome of subjects who received mechanical ventilation (mv) for acute respiratory distress syndrome (ards) secondary to pneumonia (nmn) due to covid-19?

primary objective: - to evaluate the association between the ventilatory variables of mechanical power and the outcome of the subjects in terms of mortality, days on mv and days free of mv at 28 days (both in survivors). secondary objectives: - evaluate the association of demographic and gas exchange variables with the outcome of the subjects. methodology study design: retrospective and observational, analytical. operational definition of variables ventilatory variables: * global mechanical power: 0.098 × tidal volume × respiratory rate × (peak pressure - ½ distension pressure) * dynamic elastic mechanical power: 0.098 × tidal volume × respiratory rate × 0.5 × distension pressure * static elastic mechanical power: 0.098 × tidal volume × respiratory rate × peep * resistive mechanical power: 0.098 × tidal volume × respiratory rate × (peak pressure - plateau pressure) * cyclic strain: dp x 4 + respiratory rate. * driving pressure adjusted to predicted body weight: driving pressure / tidal volume (in ml / kg of predicted weight). demographic variables: * age: in years. * sex: female / male. * ards classification: * mild (pao2 / fio2 ≤ 300 mm hg and \> 200 mm hg) * moderate (pao2 / fio2 ≤ 200 mm hg and \> 100 mm hg) * severe (pao2 / fio2 ≤ 100 mm hg) * body mass index: weight in kilograms divided by height in meters squared. gas exchange variables: * ventilatory quotient: (respiratory rate x tidal volume x pco2) / (predicted weight x 100 ml x 37.5) * pa/fio2: arterial oxygen pressure/ fraction of inspired oxygen outcome variables * mortality * mv-free days at 28 days * mv days population and scope of study: subjects registered in the icu 2 database of the francisco santojanni donation hospital of the autonomous city of buenos aires, who have received mv for ards with a confirmed diagnosis of covid-19 pneumonia by polymerase chain reaction. study period: data from subjects admitted from april 2020 to august 2021 will be analyzed. results analysis plan: a descriptive analysis of the clinical variables will be performed using the mean and standard deviation (sd), if the distribution is normal, or the median and interquartile range (iqr) otherwise. categorical variables will be presented as absolute number of presentation and percentage. a value of p\<0.05 will be considered as statistically significant. spss software will be used for data analysis.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pneumonia due to covid-19. * need of mechanical ventilation in intensive care unit. exclusion criteria: * patients with data loses
conventional vestibular training versus immersive virtual reality- based vestibular in multiple sclerosis

Conditions: Multiple Sclerosis; Vestibular Disease; Dizziness; Balance Disorders; Fatigue; Quality of Life; Usability; Cybersickness

Summary: the effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). however, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis. the primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.


Eligibility criteria:
inclusion criteria: * both male and female subjects from 18-65 years old * clinically diagnosed with any type of multiple sclerosis in accordance with the revised mcdonald criteria * with walking ability according to the expanded disability status scale score (edss =6) * with the objective presence of dizziness symptoms (dizziness handicap inventory = 16) exclusion criteria: * blurred vision * cognitive impairment (mini mental state examination =24) * another neurologic disorder contributing to balance impairment * relapse within the last 3 months * changes in pharmacotherapy within the last 3 months * history of vestibular rehabilitation within the last 6 months * acute cardiovascular of respiratory illness * any other contraindication to physical activity