Kornimate/medical-research-clean huggingface dataset:
docetaxel in treating patients with stage iv prostate cancer

Conditions: Pain; Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial of docetaxel in treating patients who have stage iv prostate cancer that has not responded to hormone therapy.

objectives: i. evaluate the efficacy of weekly docetaxel as measured by disease response, strength and duration of pain reduction, and either a decrease in analgesic use without an increase in pain, or a decrease in psa, in patients with hormone refractory metastatic prostate cancer. ii. assess the efficacy of this regimen in terms of survival in this patient population. iii. evaluate the effect of this regimen on quality of life in these patients. iv. determine qualitative and quantitative toxicities of this regimen in these patients. outline: patients receive docetaxel iv over 15-30 minutes weekly for 6 weeks. courses repeat every 8 weeks. therapy continues in the absence of disease progression or unacceptable toxicity. quality of life is assessed at weeks 1, 3, 5, and 7 of each course, and a daily pain medication diary is maintained during treatment. patients are followed for 1 month or until resolution of toxicity, then every 3 months until death. projected accrual: a total of 25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed stage iv hormone refractory adenocarcinoma of the prostate symptoms and evidence of disease progression despite standard hormonal therapy patient characteristics: age: 18 and over performance status: ecog 0-3 life expectancy: at least 3 months hematopoietic: wbc at least 3000/mm3 neutrophil count at least 1500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than upper limit of normal (uln) alt no greater than 2 times uln (no greater than 1.5 times uln if alkaline phosphatase is greater than 2.5 times uln) alkaline phosphatase no greater than 4 times uln (no greater than 8 times uln if known bone involvement and bilirubin and alt in normal range) renal: not specified other: at least 5 years since any prior malignancy except nonmelanoma skin cancer no other significant medical illness that would prevent compliance no hypersensitivity to drugs formulated with polysorbate-80 must be able to complete written questionnaires and diaries prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: see disease characteristics radiotherapy: at least 1 month since prior radiotherapy at least 2 months since prior strontium-89 surgery: not specified other: at least one month since prior investigational agents

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer pain
weight loss following gastric bypass or sleeve surgery

Conditions: Obesity

Summary: the overall aim is to study the multiple factors determining the variation of weight loss after roux-en-y gastric bypass (rygb) and sleeve surgery. the specific aims are to evaluate: a) what explains the large individual differences in weight loss seen after rygb and sleeve surgery, b) if it is possible pre-operatively to identify which patients will not obtain beneficial effects of bariatric surgery in relation to weight loss and quality of life and c) if patients in need of improved care can be identified pre- and/or early post-operatively.


Eligibility criteria:
inclusion criteria: * all patients approved for bariatric surgery at bariatric clinic, køge hospital, denmark exclusion criteria: * inability to comply with the study protocol

Keywords: obesity bariatric surgery
hormone receptor positive metastatic breast cancer (hr+ mbc) biib021 plus aromasin schedule finding

Conditions: Breast Cancer

Summary: the purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing regimens of biib021 in combination with exemestane in women whose hr+ breast cancer had progressed following treatment with a nonsteroidal aromatase inhibitor (ai).


Eligibility criteria:
inclusion criteria: * age 18 years of age * must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer. * must have disease progression during treatment with a nonsteroidal ai for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting. * must be a postmenopausal female. * must have measurable or evaluable disease. * measurable disease is defined as \>=1 lesion with a diameter of \>=10 mm * evaluable disease is defined as bone lesions evaluable by plain x ray, ct scan, or mri. lesions identified only by radionuclide bone scan are not allowed. * one prior chemotherapy regimen for advanced mbc is allowed. * prior radiotherapy is allowed. * must be able to swallow and retain oral medication. * ecog performance status of \<=2 * required laboratory values * plasma cortisol and adrenocorticotropic hormone (acth) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency. exclusion criteria: * her2 overexpressing tumor. * history of central nervous system (cns) metastasis. * previous treatment with exemestane or treatment with an hsp90 inhibitor. * use of proton pump inhibitors. * known history of or positive test result for hepatitis b or c or hiv. * history of gastrectomy or major surgery to small intestine.

Keywords: cancer of breast cancer of the breast
evaluation of a plasma protein profile as a predictive biomarker for metastatic relapse in triple negative breast cancer patients

Conditions: Triple Negative Breast Cancer

Summary: the instigo study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. it also aims to look at other potential biomarkers of metastatic relapse such as tumor-infiltrating lymphocytes, circulating tumor dna, figurative elements in blood, or a tumor rna signature.

the investigators propose to carry out a study that measures the concentrations of a set of plasma proteins in order to assess their ability to predict metastatic relapse of triple negative breast cancer. a plasma protein profile could be an interesting biomarker since it is easily accessible and quantifiable. the investigators also propose to search relation between metastatic relapse in tnbc and other biomarkers or potential biomarkers such as tumor-infiltrating lymphocytes (tils), figurative blood components and circulating tumour dna (ctdna). finally, they also want to validate a tnbc rna signature, established at jean perrin center, by analyzing the rna expression of 8 genes. before treatment begins, the patient will take an initial blood sample. a second blood sample will be taken on the day of the first surgery or the day of the surgery post chemotherapy. a third blood sample will be done on the day of the beginning of the radiotherapy. a 4th and a 5th blood sample will be done at 6 months and 1 year respectively after the end of the radiotherapy. a part of these blood samples will be used for the quantification of circulating proteins, for the determination of the blood's figurative elements and for the quantification of circulating tumour dna.

Eligibility criteria:
inclusion criteria: * female * age \> 18 years * diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer * patient able to understand the french language * patient affiliated to social security * obtaining signed written consent exclusion criteria: * persons deprived of their freedom or under guardianship or incapable of giving consent * refusal to participate
reteval all comers trial (react)

Conditions: Retinal Disease, Electroretinogram

Summary: the primary objective of this study is to collect electroretinogram erg measurements from visually normal and abnormal subjects using the fda cleared reteval device (k142567). data from the visually normal subjects will be used to create reference intervals for the device. secondary objectives of the study are to provide erg waveforms representative of disease states encountered and to analyze how well an erg detects the various disease states encountered.


Eligibility criteria:
inclusion criteria: * all volunteers (age 0.5 to 95) willing to participate in the study as a part of their routine eye exam. * while not specifically targeting vulnerable groups such as for example children and pregnant women, we invite them to participate in the study. collecting normative data from these less represented populations is particularly difficult and we welcome the opportunity to gather these rare data. * subjects under the age of 18 will be included with the assent of the subject (for those at least 10 years of age) and consent from one parent/guardian (for those under age of 10). * in any case patient is not able to provide the consent by him/her self and is willing to participate in the study the same person that is consenting for the routine eye exam can consent for the react study. exclusion criteria: * subjects with photosensitive epilepsy , allergies to pupil dilating agents, or history of cardiac dysrhythmia will not be invited to participate in this study. - subjects with history of glaucoma can either be included in the group of non dilated subjects or can have dilated ergs if the dilation was recommended by the health professional as the part of the routine eye exam. * exclusion criteria will be based on volunteer's providing this information at the time of signing the consent form. * if patient is not aware of his photosensitive epilepsy and it occurs during the recording, the test will be interrupted immediately. * statistically, 1 person out of 3600 people can suffer from photosensitive epilepsy in us. * there is a rather small possibility we will encounter such a person during the collection of ergs from the group of 1000 volunteers
l-citrulline supplementation during sepsis

Conditions: Sepsis; Multiple Organ Failure

Summary: the purpose of this study is to study the stimulating effects of prolonged (8h) enteral l-citrulline supplementation on the normalisation of the plasma citrulline concentrations and the arginine-no metabolism, the microcirculation, the systemic hemodynamics, vascular permeability, and organ function and disease severity scores.

no synthesis is compromised during sepsis through lack of arginine de novo synthesis and may thereby contribute to impaired microcirculation and organ dysfunction. supplementation of l-citrulline in septic patients will increase no production without increased arginase activity and these effects will be studied on arginine-no metabolism,improved organ function, vascular permeability and microcirculation.

Eligibility criteria:
inclusion criteria: * written informed consent from close relative * age \> 18 years * patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 48 h prior to study inclusion. * patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure \<15 mm hg) during 2h without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration. * systemic arterial catheter in place with continuous pressure monitoring. * patients in whom the clinician is prepared to provide full life support during the duration of the study exclusion criteria: * shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury etc.) * prolonged or high dose corticosteroid use * liver cirrhosis * chronic pancreatitis * insulin-dependent diabetes mellitus * metastases, haematological malignancies or chemotherapy * patients on dialysis (cvvh or other) * pre-existent renal failure (on dialysis)

Keywords: sepsis microcirculation nitric oxide citrulline
seroprevalence study of hepatitis a, varicella-zoster, cytomegalovirus, herpes simplex and bordetella pertussis

Conditions: Viral Hepatitis Vaccines; Hepatitis A; Cytomegalovirus; Varicella-Zoster Virus; Bordetella Pertussis Infection; Herpes Simplex (1 and 2)

Summary: the purpose of this study is to determine the seroprevalence of hepatitis a virus (hav), varicella-zoster virus (vzv), cytomegalovirus (cmv), herpes simplex (hsv) and bordetella pertussis (bp)infections in mexico.

in order to document the epidemiological changes in the sero-prevalence of hepatitis a, human simplex virus (1 and 2), varicella-zoster virus and cytomegalovirus infections, we propose to conduct a population based, seroprevalence, cross-sectional study, in mexico. this will allow the identification of susceptible populations, which in turn, will serve as evidence for the elaboration of recommendations for the prevention of hepatitis a, human simplex virus, varicella-zoster virus and cytomegalovirus infection in the region. this study was conducted using data and serum samples from a random sample of subjects that participated in the 2006 national health and nutrition survey.

Eligibility criteria:
inclusion criteria: • previously enrolled subjects aged \>= 1 to 70 years for national health and nutrition survey 2006 in mexico, with previously obtained informed consent exclusion criteria: * information required for the study is not available or incomplete. * inadequate or insufficient serum sample to detect viral agents required for the study. * serum sample wrongly identified.
comparison of dexmedetomidine & ketamine for control of shivering in vaginal hysterectomy under spinal anesthesia

Conditions: Chills

Summary: comparison of dexmedetomidine and ketamine for control of shivering in vaginal hysterectomy proceeded under spinal anesthesia.

in this study the participants aim to compare dexmedetomidine and ketamine for control of shivering in vaginal hysterectomy proceeded under spinal anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.

Eligibility criteria:
inclusion criteria: 1. patients of age 45-55 years requiring vaginal hysterectomy 2. american society of anesthesiology (asa) of grade i-ii exclusion criteria: 1. patients unwilling or non-cooperative for spinal anesthesia 2. patients with uncontrolled hypertension, vascular or coronary disease, 3. patients with increased intraocular or intracranial pressure 4. patients with known bleeding and psychiatric disorders 5. patients taking anti platelets drugs.

Keywords: spinal anesthesia vaginal hysterectomy shivering
a brief mi intervention in the ed to increase child passenger restraint use

Conditions: Child Restraint Systems; Seat Belts

Summary: this study involves an emergency department (ed)-based intervention utilizing motivational interviewing (mi) techniques and patient-centered (e.g., tailored) print materials to promote the correct and consistent use of size-appropriate child passenger restraints (car seats, booster seats, and seat belts). this study is designed as a randomized pilot trial.

motor vehicle collisions (mvcs) remain a leading cause of death among children after the first year of life despite substantial improvements in passenger safety. deaths and severe injuries from mvcs can be reduced significantly through the consistent use of size-appropriate child passenger restraints. still, 10% of children ride completely unrestrained and roughly one-quarter do not use the recommended restraint for their size. new approaches are needed to motivate behavior change among parents who do not consistently use size-appropriate passenger restraints for their children from birth through age 10. emergency department (ed) visits represent unique opportunities to reach vulnerable children and their parents who have difficulty accessing the primary care settings where childhood injury prevention information is commonly provided. motivational interviewing (mi) in the ed has been used to encourage a variety of health behaviors among at-risk patients. however, mi has not been previously evaluated for child passenger safety promotion programs. this study will involve an ed-based intervention utilizing mi techniques and patient-centered (e.g., tailored) print materials to promote the correct and consistent use of size-appropriate child passenger restraints. this study is designed as a randomized pilot trial of the intervention utilizing a 2x2 factorial design to examine the independent and additive effects of ed-based mi and tailored print materials on the consistent use of size-appropriate child passenger restraints. aim 1) to assess the feasibility and acceptability of the ed-based intervention among parents of children from birth through age 10; aim 2) to determine the impact of the intervention on child passenger restraint attitudes and practices at 6-month follow-up in comparison to baseline assessments.

Eligibility criteria:
inclusion criteria: * must be an adult (18+ years) parent or caregiver who regularly drives with their child, * are able to speak and read english, * who is presenting to the ed with their child age birth to 10 years. * child must be \<4'9" in height. exclusion criteria: * adult participants must be able to speak and read english
pneumological acute coronary syndrom (acs) phenotyping aachen

Conditions: Acute Coronary Syndrom; Chronic Obstructive Pulmonary Syndrom

Summary: in this open, monocentric, observational study acute coronary syndrom (acs) patients will be characterized by pneumological examination concerning a concomitant chronic obstructive pulmonary disease (copd). often copd coexists with acs; therefore acs patients benefit either from prevention or potential therapy of chronic hypoxia.

in this study patients with either non st-segment-elevation myocardial infarction (nstemi) or st-segment-elevation myocardial infarction (stemi) will be included. after amnesis patients will undergo blood withdrawal, blood-gas analysis and examinations concerning pulmonary function (bodyplethysmography). in addition to routine blood withdrawal for differential blood count, 9 ml blood sample is takenfor molecular analysis of relevant prognostic chronic obstructive pulmonary disease (copd)-blood based biomarkers, an for establishing a library of biomaterial in form of a biobank.

Eligibility criteria:
inclusion criteria: * written declaration of consent * patients with acute myocardial infarct which can be either non st-segment-elevation myocardial infarct (nstemi) or st-segment-elevation myocardial infarct (stemi), in both cases exaggeration of cardiac ischaemic markers exclusion criteria: * patients not fulfilling the incluson criterias or: * pregnant or breastfeeding women * participation in other studies * persons in depency from the sponsor or working with the sponsor * persons without mental ability or capacity to understand and follow the instructions of the investigator

Keywords: acute coronary syndrom chronic obstructive pulmonary disease myocardial infarction blood based biomarkers
becoming children with perinatal anoxo-ischemic encephalopathy without indication of therapeutic hypothermia

Conditions: Anoxic-Ischemic Encephalopathy

Summary: there are 3 levels of severity of anoxo-ischemic encephalopathy (eai): mild, moderate and severe. therapeutic hypothermia is beneficial in children with moderate eai. it is ineffective in severe eai and may be deleterious if there is no eai. he continues to question his interest in light eais. there are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia. the main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.


Eligibility criteria:
inclusion criteria: * full-term children, gestational age\> 36 weeks of amenorrhea * between the 1st of january 2012 and the 31st of december 2016 * hospitalized in the neonatal resuscitation department of croix rousse in lyon * perinatal asphyxia with clinical signs of encephalopathy * indication of therapeutic hypothermia not retained because eai mild * where parents were informed and did not object to participation in the study exclusion criteria: * dysmorphic syndrome * stroke * children transferred for other criteria (respiratory distress, heart failure ...)
exercise effects in multiple sclerosis

Conditions: Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Summary: a growing body of work suggests that regular exercise can support symptom management and improve physical function for people living with multiple sclerosis (ms). although exercise is known to be beneficial for managing many symptoms related to ms, its effects on the central nervous system, and whether these effects change with different types of exercise, are not well understood. here, the investigators have designed a clinical trial that compares the effects of distinct exercise protocols on aspects of physical function, physical fitness, and central nervous system function. this research will be the first to compare the effects of different types of exercise on central nervous system changes in people with ms.

a total of 69 participants with multiple sclerosis (ms) and moderate motor disability in the province of saskatchewan, canada will be randomly assigned to receive one of three distinct exercise programs. all exercise programs will be delivered three times per week in 60-minute group sessions over the course of 12 weeks under the supervision of clinical exercise physiologists. exercise programming will include activities focused on mobility, fitness, and flexibility. assessments of physical function, physical fitness, and central nervous system function will be conducted immediately before, after, and six weeks following completion of the exercise programs.

Eligibility criteria:
inclusion criteria: * diagnosis of progressive ms by a neurologist * physician clearance for exercise * a patient-determined disease steps (pdss) score between 3 and 7 (i.e., moderate motor disability) * a timed 25-foot walk (t25-fw) test time \> 6.0 s. exclusion criteria: * a baseline score \>24 on the godin-shephard leisure time physical activity questionnaire (i.e., high physical activity levels) * absolute contraindications to tms (e.g. history of seizure) * a history of any neurological conditions other than ms * relapse in the past three months (self-reported, neurologist confirmed) * psychiatric diagnosis * substance abuse

Keywords: progressive multiple sclerosis relapsing-remitting multiple sclerosis central nervous system motor learning transcranial magnetic stimulation mobility limitation