Kornimate/medical-research-clean huggingface dataset:
registry for patients treated with benefix in usual care setting in germany

Conditions: Hemophilia B

Summary: the purpose of this observational study is to describe the incidence of adverse events among patients treated with benefix® in usual health care settings in germany.

non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria:
inclusion criteria: * patients with hemophilia b already receiving or starting treatment with reformulated benefix®. exclusion criteria: * patients with hemophilia b treated with a product other than benefix®. * inclusion in the ongoing prospective registry of european hemophilia b patients using benefix®.
a study of echelon 3000 (next generation powered stapler) in general abdominal and thoracic lung resection procedures

Conditions: Laparoscopic Sleeve Gastrectomy (LSG); Thoracic Lung Resection Procedure

Summary: the purpose of this study is to assess the safety and performance of the echelon 3000 stapler (next generation powered stapler) and reload system in participants undergoing laparoscopic sleeve gastrectomy or lung resection procedures (video-assisted thoracoscopic \[ats\] or open approach).


Eligibility criteria:
inclusion criteria: * adult and pediatric participants satisfying the following criteria will be considered eligible for enrollment in this study (procedures may be performed with or without a robot): primary procedure where the echelon 3000 stapler and reload system is planned to be used for tissue transection per the instructions for use (ifu) in either of the following, a) laparoscopic sleeve gastrectomy; b) lung resection procedures (vats or open) * adult participants- willingness to give consent and comply with all study-related evaluations and visit schedule * pediatric participants- the participant's parent/legal guardian must be willing to give permission for the participant to participate in the study and provide documented informed consent for the participants. in addition, assent must be obtained from pediatric participant who possess the intellectual and emotional ability to comprehend the concepts involved in the study. if the pediatric participant is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's documented informed consent for the participant will be acceptable for the participant to be included in the study exclusion criteria: * physical or psychological condition which would impair study participation * procedure is a revision/reoperation for the same indication or same anatomical location * a procedure where surgical stapling is contraindicated * concurrent treatment with medications that the investigator deems could have influence on wound healing * enrollment in a concurrent interventional clinical study that could impact the study endpoints
comparison of two lower limb bypass types : prosthesis versus autologous vein

Conditions: Arteritis; Diabetes

Summary: when medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. this bypass can be performed either with dacron or ptfe prosthesis or with the autologous saphenous vein. both technics are used but they have not been compared regarding bypass permeability and limb salvage. thus, this study will compare the permeability rate of above knee femoro popliteal surgery whether performed with autologous vein versus prosthesis

when medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. this bypass can be performed with either dacron or ptfe prosthesis or with the autologous saphenous vein. the principle disadvantages of prosthesis are their prejudged worse permeability and the risk of infection. too few reliable randomised, multicentric studies in this indication comparing vein bypasses versus prosthesis bypasses have been conducted to firmly confirm the first argument. thus, the purpose of this multicentric, randomised, national study is to compare, 5 years after surgery, the permeability rate of above knee femoropopliteal bypass with vein versus prosthesis. primary and secondary permeability, permeability predictive factors, and leg salvage rate will also be assessed. one hundred enrolled patients with ii to iv level leg arteritis will randomly be assigned to one of the surgery groups : vein or prosthesis (50 each). the recruiting period will last 3 years and a half, and the follow up 5 years for each patient. the main primary outcome, bypass permeability, will be assessed through doppler ultrasonography during five years. secondary endpoints, mortality and morbidity, will be evaluated during the clinical follow up. permeability predictive factors, primary and secondary permeability, leg salvage will also be recorded. if the permeability rates are equivalent between prosthesis and vein, the use of prosthesis will be preferred as this surgery is easier and faster, and as it is important that the vein remains available for distal revascularisation (where it is more efficient) and for revascularisation of coronary arteries

Eligibility criteria:
inclusion criteria: * lower limbs arteritis : ii to iv arteritis level, above knee femoro popliteal bypass indication * signed informed consent exclusion criteria: * no contra indication to the use of prosthesis * available saphenous vein * no major trophic trouble

Keywords: arteritis lower limb ischemia femoropopliteal artery bypass blood vessel prothesis implantation saphenous vein vascular permeability doppler ultrasonography randomized clinical trials efficacy study
targeted vs generic print materials on physical activity and quality of life in young adult cancer survivors

Conditions: Behaviour Change

Summary: young adult cancer survivors (yacs) are an understudied group in cancer survivorship research that have unique psychosocial, medical and survivorship issues. physical activity (pa) has important effects on health-related outcomes in middle-aged and older cancer survivors and preliminary research suggests similar benefits in yacs (18-39 years). unfortunately, only about half of yacs report meeting public health pa guidelines and there are no interventions or resources available to help yacs increase their pa. the purpose of this study is to test a physical activity guidebook that was developed for yacs based on the theory of planned behavior (tpb). the pa guidebook will be evaluated in a randomized controlled trial. specifically, 300 yacs will be randomly assigned to (a) canada's pa guidelines for adults or (b) the yacs pa guidebook. yacs will complete assessments of pa, quality of life, and psychosocial variables at baseline (prior to randomization), 1 month, and 3 months. the primary endpoint in the trial will be change in self-reported pa minutes from baseline to 3 months. secondary endpoints will include changes in tpb constructs and quality of life. it is hypothesized that the group receiving the yacs pa guidebook (targ) will report a greater increase in pa minutes compared to the group receiving canada's pa guidelines (cpag).


Eligibility criteria:
inclusion criteria: * diagnosed with cancer in alberta, canada * still living in alberta, canada * read english exclusion criteria: -

Keywords: physical activity young adult cancer behavior change
prothrombotic inflammatory markers in women with metabolic syndrome - effect of atorvastatin

Conditions: Metabolic Syndrome

Summary: little is known regarding the association of individual components of the metabolic syndrome (mbs) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood. the purpose of this study is two fold; 1. to determine basic differences in biochemical and cardiovascular structural markers in women with and those without mbs and their association with the individual components of mbs. 2. to determine the impact of atorvastatin to lower the risk factors of metabolic syndrome. atorvastatin is one of the most effective drugs approved by the united states food and drug administration (fda) for the treatment of high cholesterol. it belongs to a class of drugs called statins and its role in primary prevention is still unclear. thus this population seems to be an ideal group that may benefit from this intervention.

the first phase of the study is an observational phase as previously described. the second phase was a prospective evaluation of the effect of a well known "statin" drug (lipitor) on different biochemical factors measured in the blood. the eligible study participants had blood work done upon enrollment and if criteria was met(according to the adult treatment panel iii), they were given dietary counseling (nyha - new york heart association step 1 diet) as a lead in phase. lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for mbs,randomization for either atorvastatin (lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.

Eligibility criteria:
inclusion criteria: * women between the ages of 18-75 with metabolic syndrome * abdominal circumference \> 35 in * hypertriglyceridemia \> 150mg/dl * hdl \<50 * blood pressure \>130/85 * fasting glucose \>100 exclusion criteria: * pregnant or planning to become pregnant in the next 6-12 months * receiving lipid-lowing drugs * obstructive hepatobiliary disease or serious hepatic disease * diabetes, cardiovascular disease (cvd), hypothyroidism, active infection, cancer, recent surgery * fulfill criteria to receive statin based on ldl levels, risk factors, and framingham risk scoring outlined on atp111/ncep 111 recommendations * documented allergic reaction to statin in past * unexplained elevation in creatinine kinase levels \> 3 times upper limit

Keywords: metabolic syndrome atorvastatin women
effect of esketamine on reducing postoperative anxiety and depression in adolescent patients

Conditions: Anxiety-depression

Summary: this study intends to conduct a prospective, double-blind, randomized, controlled trial. adolescents aged 8-17 years old are selected as subjects. esketamine is used as intervention before surgery, vital signs data, serum il-6, crp and other inflammatory indicators are collected during surgery, and the incidence and degree of anxiety and depression are evaluated after surgery. to determine the effect of esketamine on reducing anxiety and depression in adolescents after surgery, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after surgery.


Eligibility criteria:
inclusion criteria: 1. 8 years ≤ age ≤17 years; 2. patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h; 3. asa grade i-ii exclusion criteria: 1. patients expected to be admitted to icu after surgery; 2. patients who need to return to the ward with tracheal intubation after surgery; 3. allergic to the active ingredients or excipients of isketamine hydrochloride injection; 4. patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction; 5. patients with congenital heart disease and severe developmental delay; 6. patients with one of the following contraindications to esketamine :(a) patients at risk of a significant increase in blood pressure or intracranial pressure; (b) patients with ocular hypertension (glaucoma) or penetrating ocular trauma; (c) patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmhg or resting diastolic blood pressure greater than 100 mmhg); (d) untreated or undertreated hyperthyroidism; 7. previous history of ketamine abuse or dependence, drug or alcohol dependence for more than 6 months, previous ketamine ineffective tests or adverse reactions.
ametop compared to ametop with pain ease spray

Conditions: Analgesia; Topical Anesthetic

Summary: the investigators propose to examine if pain ease spray, used as an adjunct to the topical anesthetic ametop gel, can improve the percentage of pain-free iv starts.

purpose: the aim of this study is to assess the effectiveness of pain ease® spray, used as an adjunct to ametop gel™. hypothesis: the investigators hypothesize that using pain ease® spray as an adjunct to the standard use of ametop gel™ will increase the number of pain free venipunctures from 30% to 50% or more. objectives: primary objective 1. to determine if using pain ease® spray as an adjunct to ametop gel™ will increase the number of pain free venipunctures secondary objectives 2. to document the side effects of pain ease® spray and ametop gel™ 3. to document the number of attempts for a successful iv insertion research design: the investigators propose a patient-blinded randomized control trial of ametop gel™ with and without pain ease® spray as an adjunct. statistical analysis: an interim analysis will be performed at the study's halfway point after recruitment of 120 participants. a score on the faces pain scale - revised (fps-r) of either 0 or 2 will be considered a pain-free iv start, while a score of 4-10 will be considered a painful iv cannula insertion. fischer's exact test will be used to determine statistical significance; a critical alpha of 0.05 will be considered for significance.

Eligibility criteria:
inclusion criteria: * asa i \& ii * elective day case procedure requiring an iv exclusion criteria: * planned iv insertion after inhalation induction * developmental delay or inability to interpret the revised faces pain scale (fps-r)10 * ametop gel™ application \< 30 minutes before estimated iv start at time of screening * allergies to any of the components in ametop gel™, pain ease® spray, or adhesives * patients receiving sedative pre-medication * severe needle phobia

Keywords: pain ease ametop gel
extension study of bg00012 in pediatric subjects with relapsing remitting multiple sclerosis (rrms)

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective of the study is to evaluate the long-term safety of bg00012 in subjects who completed study 109ms202 (nct02410200). secondary objectives are as follows: to evaluate the long-term efficacy of bg00012 and to describe the long-term multiple sclerosis (ms) outcomes in subjects who completed study 109ms202 (nct02410200).


Eligibility criteria:
key inclusion criteria: * ability of parents, legal guardians, and/or subjects to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. subjects will provide assent in addition to the parental or guardian consent, as appropriate, per local regulations. * subjects who completed, as per protocol, the previous bg00012 clinical study 109ms202 (nct02410200) and remain on bg00012 treatment. key exclusion criteria: * unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol. * any significant changes in medical history occurring after enrollment in the parent study 109ms202 (nct02410200), including laboratory test abnormalities or current clinically significant conditions that in the opinion of the investigator would have excluded the subject's participation from the parent study. the investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment. * subjects from study 109ms202 (nct02410200) who could not tolerate study treatment. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: pediatrics
comparison of three methods for early detection of breast cancer

Conditions: Proliferative Breast Disease

Summary: subjects with suspicious breast lesion (birads category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with contrast enhanced dual energy mammography (cedm), contrast enhanced breast mr (cemr) and contrast enhanced ultrasound (ceus).

the co-primary endpoints are to estimate the sensitivity and specificity of ceus relative to pathology determined diagnosis. 1. positive predictive value of cedm in detecting lesions seen on mr 2. estimate the negative predictive value (tn/(tn+fn)) of ceus as an adjunct. 3. compare the frequency of recommendation of biopsy of mg±us vs mg±us plus ceus as an adjunct based on birads scores. 4. comparison of background enhancement seen on ceus with that seen on cedm and cemr.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * patients, greater than 30 years of age * in good general health as evidenced by medical history * birads 4 or 5 suspicious breast lesions who are scheduled for breast biopsy. exclusion criteria: * patients who are less than 30 years of age * have known or suspected cardiac shunts * have history of hypersensitive allergic reactions to any imaging contrast agents * pregnant (a urine pregnancy test will be given at no cost to the patient) * are nursing babies * poor renal function * are unwilling or unable (such as having a pacemaker) to undergo a cemr
molecular characterization for understanding biliary atresia

Conditions: Biliary Atresia

Summary: although considered a rare disease, biliary atresia (ba) is the leading cause of neonatal cholestasis and liver transplantation in children. little is known about the molecular mechanisms that drive ba. the purpose of this study is to collect the fluid samples, explanted liver tissue samples and dermal biopsy samples to enable investigators to perform the genetic and molecular analyses that might point to the gene(s) and cellular pathway involved in etiology of ba disease.

biliary atresia (ba) is a disease characterized by intra- and extra-hepatic bile duct obstruction diagnosed in the neonatal period. if left untreated, this obstruction leads to biliary cirrhosis and early death. although considered a rare disease (between 1/15,000 and 1/20000 births), it is the leading cause of neonatal cholestasis and liver transplantation in children. the reasons for this obstruction are still poorly known and might involve several factors (immune, infectious and possible toxin effect). the accumulating evidence point to genetic factors involved, yet they are not of the classic monogenic or mendelian types. the purpose of this study is to collect the fluid samples, explanted liver tissue samples and dermal biopsy samples to enable investigators to perform the genetic and molecular analyses that might point to the gene(s) and cellular pathway involved in etiology of ba disease.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of biliary atresia in patients * parents of ba patients exclusion criteria: * no
surufatinib combined with tislelizumab in advanced lung cancer with neuroendocrine differentiation

Conditions: NSCLC

Summary: currently, there are no standard treatment and relevant exploration for nsclc patients with ned. the study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of nsclc with ned, in order to provide a new treatment option for nsclc patients with ned.

this is a single-arm, open, single-center, prospective and exploratory clinical study. we planned to enroll 29 patients who would receive surufatinib plus tislelizumab until disease progression, intolerance, or withdrawal of consent. the study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of nsclc with ned, in order to provide a new treatment option for nsclc patients with ned.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed locally advanced or metastatic unresectable lung cancer (iiib-iv) with an abnormal ned or ne phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (cd56, cga, syn)); * have at least one measurable lesion according to recist v1.1; * ecog performance status: 0-1; * patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy; * urine protein \< ++ . if urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g; * expected survival time \> 3 months; exclusion criteria: * pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma); * prior anti-vegf/vegfr-targeted therapy or anti-pd (l)1 antibody; * have uncontrolled hypertension, defined as systolic blood pressure \>150 mmhg or diastolic blood pressure \>90 mm hg, while under anti-hypertension treatment; * patients with active ulcer, intestinal perforation and intestinal obstruction; * with active bleeding or bleeding tendency; * severe history of cardiovascular and cerebrovascular diseases; * other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

Keywords: nsclc neuroendocrine differentiation surufatinib tislelizumab
opioid titration in the hospice setting: barriers assessment and modification of the model order sheet and protocol

Conditions: Cancer Pain

Summary: the purpose of this study is to modify the opioid titration order sheet to meet the needs of the outpatient hospice population and to conduct a pilot trial to assess feasibility, utility, and derive preliminary efficacy data.


Eligibility criteria:
inclusion criteria: * patient eligibility includes: * alive hospice outpatient * diagnosis of carcinoma * pain requiring fixed dose opioids * age \> 21 years * not pregnant or lactating * willing and able to sign informed consent * able to speak/comprehend english caregiver eligibility will include: * caregiver for an alive hospice patient * willing and able to sign informed consent * able to speak/comprehend english hospice staff eligibility will include: * currently on staff at alive hospice * willing and able to sign informed consent * able to read/speak english. referring physician eligibility will include: * having recently referred patients to alive hospice * willing and able to sign informed consent and able to read/speak english. exclusion criteria: * patients \< 21 years of age * pregnant or lactating * patients, caregiver and or hospice staff that does not speak/comprehend english

Keywords: oncology pain management in outpatient hospice setting