Kornimate/medical-research-clean huggingface dataset:
the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps

Conditions: Postpolypectomy Bleeding

Summary: the aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding

the methods for preventing post-polypectomy bleeding (ppb) are not standardised and there are groups that use hemoclips for this purpose. the aim of our study is to analyze whether the use of hemoclips reduces ppb complications. it is a prospective, randomised study of patients with pedunculated polyps larger than 10mm. the patients were included in two groups (hemoclip before polypectomy -hc- and standard polypectomy -sp-)

Eligibility criteria:
inclusion criteria: * patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen * not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure). exclusion criteria: * patients younger than 18 years of age * patients with a platelet count of less than 50000, inr larger than 1.5 * patients who refused to give their informed consent.
immunogenicity and safety study of priorixtetra™ when co-administered with conjugated menc vaccine in healthy children

Conditions: Rubella; Varicella; Measles; Mumps

Summary: the purpose of this study is to assess the immunogenicity and safety of gsk biologicals' investigational measles, mumps, rubella and varicella (mmrv) vaccine (gsk208136, priorixtetra™) when co-administered along with conjugated meningococcal c (menc) vaccine (meningitec®, nuron biotechs' vaccine) in healthy children.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parent(s)/legally acceptable representatives (lar) can and will comply with the requirements of the protocol. * a male or female between, and including, 13 and 15 months of age at the time of the first vaccination. * written informed consent obtained from the parent(s)/ lar of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or n. meningitidis serogroup c. * history of measles, mumps, rubella, varicella and/or n. meningitidis serogroup c diseases. * known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * family history of congenital or hereditary immunodeficiency. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. * acute disease and/or fever at the time of enrollment. * documented human immunodeficiency virus (hiv) positive subject. * any contraindications as stated in the summary of product characteristics. * administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.

Keywords: safety healthy conjugated immunogenicity children menc vaccine mmrv vaccine
comprehensive® reverse shoulder mini baseplate

Conditions: Rotator Cuff Tear Arthropathy; Osteoporosis; Osteomalacia; Joint; Destruction, Sacroiliac

Summary: evaluate survivorship for the biomet® comprehensive® reverse shoulder mini baseplate.

the primary objective of this prospective clinical data collection is to evaluate survivorship for the biomet® comprehensive® reverse shoulder mini baseplate. secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and constant score. all shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. fda has cleared this device via premarket notification 510(k) k080642. this data collection effort will document the clinical outcomes of the comprehensive® reverse shoulders. the data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Eligibility criteria:
inclusion criteria: patients / cases to be included in this study shall utilize the following inclusion criteria: 1. comprehensive reverse shoulder mini base plate and mini stem in a reverse shoulder configuration. 2. the patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. 3. grossly deficient rotator cuff with severe arthropathy and/or 1. previously failed shoulder joint replacement with a grossly deficient rotator cuff. 2. primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or 3. fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or 4. revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. exclusion criteria: * the exclusion criteria are the same as the indications stated in the cleared labeling for the device: absolute contraindications include infection, sepsis, and osteomyelitis. relative contraindications include: 1. uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. 2. osteoporosis. 3. metabolic disorders which may impair bone formation. 4. osteomalacia. 5. distant foci of infections which may spread to the implant site. 6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
bisphenol and phthalate exposures in triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: in this observational pilot study urine samples will be collected from women receiving neoadjuvant chemotherapy with doxorubicin for triple negative breast cancer to determine whether: 1) exposures bisphenol and phthalate levels change over the course of neoadjuvant chemotherapy, and 2) levels differ between black women and those of other racial groups. the hypothesis is that bisphenol and phthalate levels will be similar to those of the general us female population at the time of diagnosis, however levels will increase during treatment due to exposure to plastics in the medical setting. the investigators also hypothesize that because of differences in personal care product use, black women may have higher urinary levels of bisphenols and phthalates prior to starting chemotherapy.

triple-negative breast cancer (tnbc) is an aggressive breast cancer subtype that does not express estrogen, progesterone, or the human epidermal growth factor (her2/neu) receptors, and has a low overall survival rate compared to other types of breast cancer. unlike hormone and her2/neu positive breast cancers, targeted therapies are not available for tnbc. thus, the systemic chemotherapeutic agent doxorubicin is widely used for the treatment of tnbc. however, doxorubicin resistance is common, and leads to poorer treatment outcomes. understanding factors that contribute to doxorubicin resistance is critical to improving cancer treatment outcomes among women with tnbc. pre-clinical in vitro studies indicate that exposure to endocrine disrupting chemicals, such as bisphenols and phthalates, contribute to doxorubicin resistance, but these findings have not been evaluated in humans.

Eligibility criteria:
inclusion criteria: * diagnosis of stage i - iii triple negative breast cancer * scheduled to receive a neoadjuvant chemotherapy regimen including doxorubicin * receiving treatment at the george washington university cancer center exclusion criteria: * diagnosis of other types of breast cancer * not scheduled to receive doxorubicin as part of the neoadjuvant chemotherapy regimen * not planning to receive neoadjuvant chemotherapy at the george washington university cancer center

Keywords: bisphenol phthalate doxorubicin
neuronal effects of exercise in schizophrenia

Conditions: Schizophrenia

Summary: this study plans to learn more about how common drugs prescribed to individuals with schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and the brain's response to food. in this study, the investigators will be evaluating how participants' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. the investigators may also ask participants to complete an exercise or diet intervention to see how this changes brain responses or food preferences.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * between 21 and 70 years of age * currently prescribed either olanzapine, risperidone, clozapine, or haloperidol, or not currently being treated with any neuroleptic medications * weight stable within 5 percent for the last 6 months exclusion criteria: * pregnancy * substance abuse * significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia) * mri-specific exclusion criteria (e.g., claustrophobia, metal in the body)
glycemic fluctuations in newly diagnosed growth hormone-secreting pituitary adenoma and cushing syndrome subjects

Conditions: Pituitary Adenoma

Summary: glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. people with growth hormone-secreting pituitary adenoma and cushing syndrome are at risk of impaired glucose metabolism. glycemic variability is poorly studied in the nondiabetic individuals. the aim of the study is to investigate the characteristics of glucose fluctuations in the newly diagnosed growth hormone-secreting pituitary adenoma and cushing syndrome individuals.

glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. compared with traditional monitoring methods, continuous glucose monitoring system(cgms) techniques provides a much more detailed understanding of shifting blood glucose levels throughout the day.it is considered reliable to evaluate glucose variability not only in patients with diabetes but also in nondiabetic individuals. people with growth hormone-secreting pituitary adenoma and cushing syndrome are at risk of impaired glucose metabolism and developing diabetes mellitus.some researchers have shown that 15-30% growth hormone-secreting pituitary adenoma are suffering from diabetes, 15-36% impaired glucose regulation. the rate of cushing syndrome individuals is 10-30% and 40-45% separately. glycemic variability is poorly studied in the nondiabetic individuals and has not been studied in the newly diagnosed growth hormone-secreting pituitary adenoma and cushing syndrome individuals. in this study cgm was used to dynamically monitor patients being newly diagnosed with growth hormone-secreting pituitary adenoma and cushing syndrome.

Eligibility criteria:
inclusion criteria: * •newly diagnosed gh-releasing pituitary adenoma * •newly diagnosed cushing syndrome exclusion criteria: * •history of diabetes mellitus and being treated with drugs * •being treated with drugs which affect glucose metabolism in the lately 3 months * •with other hormones affecting glucose metabolism secreted abnormally by pituitary * •serious comorbidity like malignant tumour, severe hepatosis or nephropathy, serious hypertension(blood pressure\> 180/110mmhg) * •pregnant or breastfeeding women * •patients allergic to patches or metal

Keywords: glucose fluctuation gh-secreting adenoma cushing syndrome
different low-flow sevoflurane anesthesia techniques

Conditions: Anesthesia

Summary: after reaching 1 mac level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 mac. for 35 patients, after reaching 1 (mac) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 mac.

the primary aim of this study is to compare the instantaneous and total consumption of sevoflurane using 2 different concentrations and different minute / fresh gas flow to fill the system in the initial phase of anesthesia. its secondary purpose is to compare the depth of anesthesia and hemodynamic parameters between the two groups. a total of 70 patients between the ages of 18-65 will be included in the study.in 2.5 % sevoflurane grup after reaching 1 mac level with 4 lt / min fresh gas flow and 2.5% sevoflurane concentration in the initial stage in 35 patients, anesthesia maintenance will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 mac. in sevoflurane 8 % group for 35 patients, after reaching 1 (mac) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 mac. . the depth of anesthesia for both groups will be measured by the bispectral index (bis). bis values between 40 and 60 are appropriate values for general anesthesia, for this value 1 mac sevoflurane inhalation anesthesia and remifentanil infusion (0.1-0.3mcg / kg / min) will be used.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18-65 * asa1,2,3 group patients * patients under general anesthesia * patients scheduled for elective surgery exclusion criteria: * the patient's refusal to participate in the study * patients with less than 90 minutes of total anesthesia time * patients whose total anesthesia time exceeds 180 minutes

Keywords: inhalation
targeted levothyroxine dosing in infants with congenital hypothyroidism

Conditions: Congenital Hypothyroidism

Summary: this is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. the main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.


Eligibility criteria:
inclusion criteria: * newborns diagnosed with congenital hypothyroidism (ch). * newborns with ch who are treated by a pediatric endocrinologist at riley hospital for children or satellite location. * newborns with ch who have thyroid imaging performed (thyroid ultrasound or technetium scan) at diagnosis. exclusion criteria: * newborns who do not have ch. * newborns with ch who have not had thyroid imaging performed at diagnosis.
efficacy and feasibility of baby triple p - a pilot study

Conditions: Mental Disorders During Pregnancy

Summary: in the present pilot study the feasibility and efficacy of baby triple p- an antenatal parent training- are investigated. healthy becoming first time parents were randomly allocated to either the baby triple p parent-training group or a care as usual control group. it is expected that 78 couples of becoming first time parents are recruited. it is hypothesized that parents and their infants in the parent training group will show significantly less psychopathology / regulation problems and better partnership quality than participants in the control condition.

in this pilot study, the efficacy and feasibility of the baby triple p parenting training is investigated in a pilot study using a randomized controlled trial. according to the efficacy of the parenting training, it is expected that parents in the training condition show higher scores on mental health scales (bsi-18) and quality of partnership (pfb). furthermore, it is expected that infants whose parents has taken part in the parenting training have lower severity ratings of regulatory disorders assessed with the baby-dips diagnostic interview than infants of parents in the care as usual control condition.

Eligibility criteria:
inclusion criteria: * becoming first time parent * participants have a basic level of german literacy which allows them to understand the baby triple p materials * unborn baby is developing well and does not have a pre-diagnosed medical condition exclusion criteria: * baby has a disability or pre-diagnosed medical condition. * the parents are intellectually disabled
effect of ai monitoring blind spots of egd on the inspection time and lesion dection rate

Conditions: Upper Gastrointestinal Symptoms

Summary: the goal of this clinic trial is to learn about the effect of ai monitoring blind spots on the inspection time to egd. patients are randomly assigned to undergo an egd with or without the assistance of ai. in the ai group, except for the original videos, there is additional information presented to endoscopists:(1)the virtual stomach model monitoring;(2)time;(3)scoring. researchers will compare intervention group to see if it have a shorter inspection time compared with the control group.

the goal of this clinic trial is to evaluate the effect of real-time artificial intelligence for monitoring blind spots on the inspection time of egd. patients are randomly assigned to undergo an egd with or without the assistance of ai. in the ai group, except for the original videos, there is additional information presented to endoscopists:(1)the virtual stomach model monitoring;(2)time;(3)scoring. researchers will compare intervention group to see if it have a shorter inspection time in the case of non-inferior detection rate of gastric neoplastic lesions.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years or older 2. patients able to give informed consent 3. american society of anesthesiology risk class 1,2 or 3 exclusion criteria: 1. patients with absolute contraindications to egd examination 2. patients with a history of previous gastrectomy 3. patients with a serious underlying disease 4. pregnant patients 5. researchers believe that the patient is not suitable to participate in the trial

Keywords: esophagogastroduodenoscopy artificial intelligence blind spot
comparison of 5 cp-690,550 doses vs. placebo, for the treatment of rheumatoid arthritis in japan

Conditions: Arthritis, Rheumatoid

Summary: to evaluate the dose-response relationship of 5 dose of cp-690,550, compared to placebo for the treatment of signs and symptoms in patients with active ra who failed an adequate trial of therapy with at least 1 dmard in a 12-week therapy.


Eligibility criteria:
inclusion criteria: * subjects must have failed an adequate trial of therapy with at least 1 dmard due to lack of efficacy or toxicity. exclusion criteria: * current therapy with any dmard

Keywords: phase 2 monotherapy in japan
impact of sourdough bread consumption on long-term energy intake: a pilot study of feasibility

Conditions: Appetite Regulation; Energy Intake; Body Weight Changes; Eating Behavior; Overweight and Obesity

Summary: the present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants.


Eligibility criteria:
inclusion criteria: * female and male participants * age range 18 - 50 * bmi range \>20 kg/m2 at screening visit * regular eating pattern (3 meals per day on at least 5 days per week) * habitual brown bread consumption of at least 1 slice per day (assessed by the european prospective investigation into cancer (epic) norfolk ffq) * stable body weight for the last 6 months exclusion criteria: * currently smoking or willingness to smoke during the study period * pregnancy, lactation or wish to become pregnant during the study period * previous or current gastrointestinal or endocrine disorders * previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week) * coeliac disease or gluten sensitivity * allergy/intolerance to milk, egg, nuts, soy or sesame * habitual sourdough bread consumption of at least 1 slice per day (assessed by the european prospective investigation into cancer (epic) norfolk ffq) * excessive concern about eating habits or body weight as evidenced from scores \< 18 on the restraint and disinhibition subscales of the three-factor eating questionnaire (stunkard \& messick, 1985)
evaluating renal masses using ultrasound intravenous microbubble contrast

Conditions: Renal Cancer; Kidney Cancer

Summary: the purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound microbubble contrast material, and to see if results from ultrasound contrast studies can predict if a kidney mass is benign or malignant. patterns of blood flow in the kidney mass will be examined to see if: 1. benign kidney masses can be distinguished from kidney cancers and 2. if slow growing, lower risk cancers have different blood flow compared to clear cell cancer which is the most common type of kidney cancer.


Eligibility criteria:
inclusion criteria: * any adult patient who is planned or scheduled for surgical excision or biopsy of a solid or complex cystic renal mass would be eligible for the study * histology of the renal mass must be unknown at the time of enrollment * patients who have renal masses that are evident on conventional us imaging * patients will have a correlative abdominal ct and/or mri exclusion criteria: * patients with any history of cardiac shunts. * patients with history of pulmonary hypertension or unstable cardiopulmonary conditions, including patients on mechanical ventilation. * patients without peripheral iv access * pregnant patients and children * patients with any known contrast allergies, allergy to perflutren, or any components of definity or microbubble contrast * patients who have renal masses that are not evident on conventional us imaging

Keywords: ultrasound 07-165