Kornimate/medical-research-clean huggingface dataset:
epithelial ovarian cancer- staging and response to chemotherapy evaluated by pet/ct

Conditions: Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Summary: the purpose of this study is to determine, whether there is clinical benefit of using fdg-pet/ct (f-18-fluorodeoxyglucose- positron emission tomography/computed tomography)compared to contrast-enhanced ct in primary treatment of advanced epithelial ovarian cancer (eoc) * objectives * the impact of preoperative pet/ct compared to ct on eoc stage definition * to compare the value of preoperative pet/ct, ct and laparoscopy in intra-abdominal tumour assessment. laparotomy findings evaluated by surgeon and histopathologic results serve as the reference standard. * to compare serum markers he4(human epididymis protein 4) and ca125 (cancer antigen 125) with fdg-pet/ct and ct in treatment response evaluation during neoadjuvant chemotherapy and primary treatment of eoc * to compare fdg pet/ct based treatment response evaluation with recist and gcig criteria * methods * all the patients will undergo fdg-pet/ct prior surgery, after possible neoadjuvant chemotherapy (nact) and 4 weeks after completion of primary platinum-based chemotherapy. * ca125 and he4 levels are measured pre-operatively, with every chemotherapy cycle and regularly during follow-up until 1st disease relapse


Eligibility criteria:
inclusion criteria: * newly diagnosed patients with advanced epithelial ovarian, primary peritoneal cancer or fallopian tube cancer. * age 18-79 years * informed concent exclusion criteria: * diabetes (for pet/ct analyses) * previous cancer

Keywords: pet/ct ovarian cancer he4
contribution of hypnosis in guided hepatic biopsy (ap-hy-pbh)

Conditions: Ultrasound-guided Hepatic Biopsy

Summary: the purpose of this study is to evaluate the contribution of hypnosis on the level of pain felt by the patient during ultrasound-guided hepatic biopsy, by comparing an intervention group (hypnosis) to a control group (routine and benevolent care). single-center randomized controlled trial.

hepatic biopsy puncture (hbp) is a very useful procedure for the assessment of chronic liver disease as well as in certain acute situations, and is also essential in oncology for the histological diagnosis of primary and secondary focal lesions. a study on the prevalence and characteristics of induced pain shows that it is a pain-generating procedure for 84% of patients and that the combination of anxiolytics and local anesthesia is insufficient. the effect of relaxing therapies was evaluated during percutaneous interventional radiology procedures. anxiety and pain measured with visual analogue scales were significantly reduced in the group receiving support from sophrology and hypnosis . the mean evaluation of anxiety per procedure was 2.07 (95% ci, 1.48-2.82) in the group receiving relaxation therapy compared with 5.94 (95% ci, 4.62-7.22) in the other group. the mean level of pain felt was 1.83 (95% ci, 1.23-2.78) for the accompanied procedures versus 4.16 (95% ci, 2.53-6.04) without accompaniment. however, this study did not specifically look at percutaneous liver biopsy, and moreover the relaxation technique used was based on sophrology and not on an ericksonian hypnosis approach. data concerning the use of hypnosis during percutaneous liver biopsies are limited to clinical cases, which report an absence of pain felt, including an observation in a patient who did not receive local anesthesia because of a history of allergy to lidocaine. training in attentive and benevolent patient care already allows this type of procedure to be performed under good conditions in our department. this training of about one hour, carried out internally, does not require specific means. it would therefore seem useful to see what the impact is of using ericksonian hypnosis, a recognized and risk-free technique which would require longer specific training for the staff and would represent a cost.

Eligibility criteria:
inclusion criteria: * patients with an indication for ultrasound-guided hepatic biopsy * over 18 years of age * affiliated to a social security system exclusion criteria * history of psychiatric pathology, psychotropic or anxiolytic treatments * refusal to participate. * people who do not understand and/or speak french. * people who are deaf * patients with impaired cognitive abilities, evaluated by the prescribing service * disorders of hemostasis against percutaneous approach * allergy to lidocaine * patient under national health aids

Keywords: ultrasound-guided hepatic biopsy radiology hypnosis anxiety pain
study of sonographic efficacy of rituximab in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to detect by sonography relapse of disease activity prior to clinical symptoms in ra patients treated by rituximab.


Eligibility criteria:
inclusion criteria: * failure to at least one tnf-blocking agent exclusion criteria: * pregnant or childbearing woman * rituximab contraindication * woman unable to use contraceptive means

Keywords: rituximab sonography clinical response
collection of specimens and clinical data for patients with recurrent or metastatic breast cancer or male breast cancer

Conditions: Breast Carcinoma; Metastatic Breast Carcinoma; Recurrent Breast Carcinoma

Summary: this study is being done to create a resource of samples and information that can be used to improve our understanding of the development, progression and treatment of recurrent or metastatic breast cancer or male breast cancer.

primary objective: i. to collect blood samples and fresh tissue from biopsies of metastatic lesions from mayo clinic patients with metastatic breast cancer. outline: this is an observational study. patients undergo blood sample collection, tumor biopsy and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * female participants must have histologically or cytologically confirmed invasive breast cancer. * male participants must have biopsy proven breast cancer. * age must be \>= 18 years, and all must be able to understand and willing to sign an informed consent document. exclusion criteria: * dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; a history of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine). * any other condition, which in the opinion of the patient's treating oncologist, or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.
innovative food structures to enhance nutrient bioavailability

Conditions: Vitamin D Deficiency; Aging Well

Summary: this randomized controlled trial (rct) will compare the change in vitamin d status (25-hydroxyvitamin d nmol/l) after a 4 week intervention with 4 groups: 1. vitamin d enriched (20ug) olive oil emulsion drink 2. vitamin d enriched (20ug) coconut oil emulsion drink 3. placebo emulsion drink 4. vitamin d supplement (20ug) participants will be randomized to 1 of 4 intervention group. hypothesis 1: 25-hydroxyvitamin d concentrations are higher in the olive oil emulsion drink group compared to the placebo emulsion drink group post intervention. hypothesis 2: 25-hydroxyvitamin d concentrations are higher in the olive oil emulsion drink group compared to the coconut oil emulsion drink group post intervention.


Eligibility criteria:
inclusion criteria: • healthy adults exclusion criteria: * pregnant/lactating * smokers * individuals who are not free-living * an inability to read, write or understand english * following a strict diet for any reason, insulin dependent diabetes, coeliac etc. * disease that requires chronic therapeutic nutritional or medical treatment * those with conditions that may affect kidney function * those with osteoporosis * those taking supplemental vitamin d * those who have been on a sun holiday in the last 2 months * those with a milk protein allergy or lactose intolerance

Keywords: vitamin d bioavailability aging fortified foods vitamin d status 25-hydroxyvitamin d
post marketing surveillance on safety evaluation of pomalyst® (pomalidomide) treatment of multiple myeloma in korea

Conditions: Multiple Myeloma

Summary: pms period: 09jun2017 \~ 08jun2023 target no.: 600patients indication: pomalyst in combination with dexamethasone is indicated in the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib the primary objective of this drug use examination (due) is to evaluate safety of pomalyst® (pomalidomide) treatment of multiple myeloma in the clinical routine practice in korea. the secondary objective of this due is to evaluate effectiveness of pomalyst® (pomalidomide) treatment of multiple myeloma in the clinical routine practice in korea.


Eligibility criteria:
inclusion criteria: the main criteria for inclusion of this due is the same as the approved package insert of pomalyst® in korea. based on the current pi, patients who are treated with pomalyst® based on the following criteria, can be registered into this due. * pomalyst® in combination with dexamethasone is indicated in the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib. the actual inclusion criteria and patient population who can start with pomalyst® treatment will be narrowed down according to the local health insurance reimbursement condition. exclusion criteria: * there's no exclusion criteria

Keywords: multiple myeloma pomalyst® pomalidomide observational korea post marketing surveillance[pms] relapsed and refractory multiple myeloma
clinical trial to evaluate the safety and efficacy of an implantable neural acquisitor & stimulator system in patients with motor disability

Conditions: Tetraplegia

Summary: through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the wechat app and other physical aids）with brain signals to improve the patients quality of life.

to evaluate the safety and efficacy of an implantable neural acquisitor \& stimulator system in patients with motor disability（complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders). through brain-computer interface alternative technology, patients can control the external equipment（wheelchairs, robotic arms, the wechat app and other physical aids）with brain signals to improve the patients quality of life.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 80 years of age; 2. complete or incomplete quadriplegia due to spinal cord injury, brain stem stroke, amyotrophic lateral sclerosis and other motor neuron disorders; 3. after the neurological assessment, the brain motor-related cortex is functional, and there is no obvious organic disease or functional disease； 4. the above diseases have been diagnosed for at least 12 months and stable for at least 6 months after standard treatment； 5. the patient had normal cognitive function, good compliance and volunteered to participate in the clinical trial. exclusion criteria: 1. visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses； 2. combined with progressive neurological disease； 3. combined with surgical contraindications identified by surgeons and anesthesiologists; 4. participating in other clinical trials; 5. other conditions deemed inappropriate by investigators and medical staff.
a single-center, open-label, exploratory study of the volumizing effect of sculptra measured by three dimensional digital surface imaging

Conditions: Mid Facial Contour Deficiencies

Summary: * measure the mid-facial volumetric correction from sculptra treatment, using three-dimensional digital surface imaging * determine the mean change from baseline in facial contour deficiency as measured by the dermik nasolabial photo-numeric scale * correlate volumetric correction with clinical improvement as measured by the dermik nasolabial photo-numeric scale * correlate the mean volumetric change in mid-facial treatment area with the amount of product used * evaluate subject and investigator global assessment of improvement and subject treatment satisfaction at the end of treatment * obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment * collect safety data


Eligibility criteria:
inclusion criteria: * subjects must sign a statement of informed consent. * subjects must be 18-75 years of age, of any race or gender. * female patients of childbearing potential must have a negative urine pregnancy test prior to the first treatment with the product and must use an acceptable form of birth control throughout the study (e.g., oral/systemic contraceptives, an intrauterine device (iud) or norplant starting at least 28 days prior to study entry and throughout the study). * subjects must display signs of facial contour deficiencies in the area of the nasolabial folds \[nasolabial fold scores greater than or equal to 2 (bilaterally) on the dermik nasolabial photo-numeric scale. * subjects must be a suitable candidate for sculptra treatment. * subjects must be able to understand the requirements of the study and be willing to comply with the study requirements exclusion criteria: * subjects with an allergy to any of the constituents of the product. * subjects with a known history of keloids or bleeding disorders. * subjects of childbearing potential who are pregnant, or plan to become pregnant within the study timeframe, or who are nursing. * subjects with significant facial hair (e.g. mustaches, beards, etc.) * subjects with an active inflammatory process or infection in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease in the treatment area). * subjects who plan to undergo major facial surgery \[e.g., rhinoplasty (with or without implant), facelift, congenital defect repair, etc.\] during the course of the study. * subjects who have used or plan to use exclusionary medications/treatments.
the impact of bariatric surgery induced weight loss on lung function in adolescents

Conditions: Obesity

Summary: in this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at schneider children's medical center of israel (scmci).

morbid obesity leads to restrictive as well as obstructive ventilatory defects via mechanisms that include mechanical, as well as inflammatory factors. we hypothesise that multiple breath nitrogen washout will be more sensitive to changes in small airway function than conventional lung function testing. we will invite adolescents with morbid obesity, scheduled to undergo bariatric surgery at scmci during 2016-2018, for pulmonary function testing, including spirometry, plethysmography, nitrogen multiple breath washout, lung transfer factor and 6 minute walk. these tests will be conducted prior to the operation as well as during follow-up appointments at 3, 6 and 12 months. we will also evaluate oxidative stress using highly sensitive c-reactive protein as surrogate marker.

Eligibility criteria:
inclusion criteria: * adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of schneider children's medical center during 2016-2018 exclusion criteria: * adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders)

Keywords: obesity lung function test bariatric surgery
dextrose infusion by burettes versus dextrose boluses in prevention of neonatal hypoglycemia

Conditions: Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.

Summary: null hypothesis • there is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in special care unit- mulago hospital. alternate hypothesis • use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30% compared to 10% dextrose infusion by burettes among preterms admitted to special care unit in the first 72 hours of admission.


Eligibility criteria:
inclusion criteria: - selection criteria inclusion criteria * preterms whose care givers/ mothers gave informed consent * preterms whose age was \< 24 hours of life * preterms with birth weight ≥1kg * preterms with random blood sugar ≥ 2.6 mmol/l at admission into scu. exclusion criteria * absence of a biological mother or abandoned baby * presence of gross congenital abnormalities. * very sick (apgar score ≤ 5 at 5 minutes
programmed intermittent bolus dosing versus continuous epidural infusion for epidural analgesia in abdominal surgery.

Conditions: Pain, Acute

Summary: epidurals are an effective means for providing neuraxial anesthesia and analgesia. prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. the effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. we plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. the primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.

see brief summary

Eligibility criteria:
inclusion criteria: * american society of anesthesia physical classification i - iii, scheduled for surgery with anticipated an epidural anesthesia (including but not limited to colorectal, surgical oncology, urology, gynecology) as part of their perioperative treatment exclusion criteria: * age younger than 18 years of age, non-english speaking, contraindication for neuraxial anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score \> 5 each day for greater than 3 months, daily opioid consumption \> 100 oral morphine equivalents for 14 consecutive days prior to surgery, patient refusal.
microcirculatory guided goal directed fluid therapy in septic shock; a feasibility study

Conditions: Septic Shock

Summary: prospective single centre study to assess the feasibility of fluid resuscitation guided by macrocirculatory and microcirculation parameters in patients in the early stages of septic shock. the investigators will utilise a novel point of care tool to assess microcirculatory sublingual perfusion in patients with septic shock. this, in combination with conventional haemodynamic monitoring will determine the timing and volume of resuscitative fluid administration. the feasibility of this technique will be determined prior to embarking on a pilot rct.


Eligibility criteria:
inclusion criteria: age \> 18 years within 6 hours of icu admission evidence of suspected or confirmed infection serial organ failure assessment (sofa) score increase of 2 or more (assuming baseline 0 if no previous measures) requiring vasopressor therapy to maintain a map \> 65mmhg lactate \> 2 mmol/l despite initial fluid resuscitation requirement for advanced haemodynamic monitoring (picco system) in the opinion of the attending clinician exclusion criteria: patients not expected to survive 24 h in whom the intent of treatment is palliative patients in whom the primary cause of the shock state is cardiogenic -
childcare outdoor learning environments as active food systems

Conditions: Pediatric Obesity; Sedentary Behavior

Summary: the aim of this project is to assess the effectiveness of the fruit and vegetable (fv) gardening component of the preventing obesity by design strategy to support preschool fresh fruit and vegetable knowledge, liking and consumption, and physical activity in children 3-5 years old living in under-resourced communities and attending childcare using a randomized controlled trial research design. sample: 15 childcare centers, 286 children.

objective: to assess the effectiveness of a gardening component on preschool children's knowledge, liking and consumption of fruit and vegetable consumption, and their level of physical activity during gardening season. intervention: fruit and vegetable garden installation. childcare centers were randomly assigned to one of three groups: group 1, intervention (5 centers); group 2, wait list control (5 centers); group 3, no-intervention control (5 centers). in year 1 (spring), baseline data was collected from groups 1 and group 2 (waitlist). group 1, initial intervention centers, received the garden intervention in the summer and both groups were assessed in the fall, post intervention. no further data was collected from group 1. in year 2 (spring), group 2 (waitlist, now intervention) and group 3 were assessed. group 2, received the garden intervention in the summer of year 2 and both groups were assessed in the fall of year 2. no further data was collected. sample: 15 centers. children: 286 (4 and 5 years old). center demographic profile includes child data: age, gender, parental education, race/ethnicity, special needs, and height/weight (bmi). to avoid losing "graduating" five year old children, post-intervention data was gathered before school start date.

Eligibility criteria:
inclusion criteria: * children enrolled in selected childcare centers * parental consent * child consent to participate at the time of data collection exclusion criteria: * no parental consent

Keywords: childhood obesity gardening fruit consumption vegetable consumption