Kornimate/medical-research-clean huggingface dataset:
selective transvenous chemoembolization of primary pancreatic tumors

Conditions: Pancreatic Adenocarcinoma

Summary: catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.

overall, subjects with resectable, borderline-resectable and/or locally-advanced pancreatic cancer are eligible to be entered into the study. each enrolled study subject will receive a single neoadjuvant pancreatic retrograde venous infusion (prvi) administration of the gemcitabine/lipiodol® emulsion. complete enrollment in 12 months from date of enrollment of first study subject.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * pathologically and radiologically-confirmed pancreatic adenocarcinoma confined to the pancreas with initial diagnosis within 8 weeks of consent * resectable, borderline-resectable or locally-advanced primary pancreatic adenocarcinoma per nccn guidelines * the patient is deemed a candidate for the study by the johns hopkins multidisciplinary pancreatic tumor board * preserved liver function (child-pugh a-b class) without significant liver decompensation * eastern cooperative oncology group (ecog) performance status of 0-1 at study entry * measurable or evaluable disease that will be directly treated with intra-pancreatic therapy (as defined by response evaluation criteria in solid tumors \[recist 1.1\] * suitable for prvi, based on blood parameters such as platelet count, lfts including bilirubin and coagulation status including international normalized ratio (see "exclusion criteria" below) * the patient is able to give informed consent * the patient, if a woman of childbearing potential, has a negative pregnancy test * the patient is willing and able to comply with study procedures, scheduled visits, and treatment plans * life expectancy of at least 3 months exclusion criteria: * serum total bilirubin \> 3.0 mg/dl * creatinine \> 2.0 mg/dl * platelets \< 75,000/μl * hgb \< 8.0 g/dl * anc ≤ 1,000/μl * inr \> 2.0 * complete portal vein thrombosis or significant cavernous transformation of the portal vein * ascites (trace ascites on imaging is ok) * the patient is pregnant or breast-feeding * the patient is allergic to contrast media that cannot be readily managed or prevented with premedication * patients with peripheral neuropathy \[\> grade 1, according to the national cancer institute common toxicity criteria v5.0 (ctae v5.0)\]

Keywords: retrograde venous infusion chemotherapy gemcitabine lipiodol
pre-emptive sciatic bloc to prevent lower limb phantom pain

Conditions: Phantom Limb Pain

Summary: phantom limb pain is a complication of amputation. although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this. peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain. this a prospective case series in which the investigators hope to show a decrease, against historical control, of the incidence of post-operative amputation lower limb phantom pain. the investigators established the block at least 24 hours pre-operative and continue it for at least 2 days. patient are followed daily for the 1st 3 days and then up to 3 month for the incidence of phantom limb pain. the investigators hope to recruit 30 patients.


Eligibility criteria:
inclusion criteria: * patient scheduled for lower limb amputation exclusion criteria: * inability to consent * contraindication to peripheral nerve block * inability to perform the block * inadequate time frame (less than 24 hours prior to surgery)

Keywords: pre-emptive analgesia peripheral nerve block (sciatic) phantom lomb pain
safety and efficacy of pletal(cilostazol) for the treatment of juvenile primary and secondary raynaud's phenomenon

Conditions: Raynaud's Disease

Summary: juvenile primary raynaud's (ray-knows) phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. when children with primary raynaud's phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. children with primary raynaud's phenomenon have no underlying systemic disease. the cause for their symptoms is unknown. the investigational drug, pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. it has been used in a variety of other conditions in which blood flow is decreased. this study will test the safety and effectiveness pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of primary raynaud's episodes in juvenile patients.


Eligibility criteria:
inclusion critera: * 5 to 6 years old * fulfill diagnostic criteria for primary or secondary raynaud's

Keywords: circulatory vascular idiopathic
pressure-wire guided ptca: drug eluting stent versus drug eluting balloon (windeb study)

Conditions: Coronary Artery Disease

Summary: the aim of the study is to show the safety and efficacy of the sequent® please (drug eluting balloon or deb) vs. commonly used drug eluting stents in the treatment of small vessel disease and side branches by pressure wire guided percutaneous coronary intervention.

this study is a randomized, prospective, multi-center, efficacy study with a des control group assessing the 6-month loss in ffr in patients treated with the "matrix coated paclitaxel-eluting ptca-balloon catheter" sequent® please and commonly used des for small vessel de novo and side branch lesions. 100 patients will be studied in total with two equivalent treatment groups deb \& des of 50 patients each.

Eligibility criteria:
inclusion criteria: * patients of at least 18 years of age. * patients with stable angina pectoris (ccs class 1-3) or with unstable angina pectoris (braunwald class 1-2, a-c) or documented ischemia or with documented silent ischemia * patients must agree to undergo the angiographic 6-month and clinical follow-ups at 12 and 36 months. * de novo coronary lesions including side branches in native coronary arteries (reference vessel between ≥ 2.0 and ≤ 3.0 mm, lesion length ≤ 25 mm as angiographically documented) * diameter stenosis pre procedure must be either ≥ 70 % or ≥ 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ecg, stress echocardiography, scintigraphy, mrt, or suspected based on angina pectoris. * fractional flow reserve (ffr) must be less or equal to 0.75. exclusion criteria: * patients with a life expectancy of less than 12 months * patients that were treated with one or more des during the last 12 months which would not allow 3-month dual antiplatelet therapy if the patient were randomized in the deb treatment group. * patients who are obliged to be on dual antiplatelet aggregation therapy for more than 3 months following study inclusion * patients with acute (\< 24 h) or recent (48 hours) myocardial infarction * patients with severe congestive heart failure or with severe heart failure nyha iv or with severe valvular heart disease * patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmhg requiring inotropic support, iabp and/or fluid challenge) * des treated lesion(s) during the last 12 months. * thrombus burden (stemi, nstemi) and/or total occlusion in the culprit segment * in-segment stenosis of the native vessel within the 5 mm adjacent to the stent

Keywords: drug eluting stent, drug eluting balloon, fractional flow reserve, des, deb, ffr
managing patient expectations in pediatric weight management

Conditions: Obesity

Summary: as part of children's hospital association's focus on a fitter future iii obesity task force, this project will target patient and family expectations across the domains of nutrition, physical activity and behavior change/family support as a means of patient engagement and retention in pediatric weight management. this will be a prospective, non-randomized, uncontrolled, single-arm trial for children between 2 and 18 years of age and a parent/guardian, who are starting a pediatric weight management program/clinic in one of the participating centers. the parent/guardian and child if 12 years of age or older receive a survey at the first visit, which asks about their expectations and goals for the visit. this information will then be used as part of clinical care to tailor treatment. after 3 months, the parent/guardian and adolescent, if applicable, will receive a follow up survey asking about their progress in these areas.


Eligibility criteria:
inclusion criteria: * subject conversant in english or spanish * parent/guardian conversant in english or spanish * patient aged 2-18 years exclusion criteria (for adolescent): • parent-reported cognitive issues preventing completion of the form, such as in-school aide\>50% of the school day; special education classes \>50% of school day

Keywords: obesity children adolescents attrition
follow-up with preimplantation genetic testing patients

Conditions: Infertility; Genetic Disease; IVF

Summary: the main purpose of this study is to perform longitudinal evaluations of clinical outcomes and personal perspectives following utilization of preimplantation genetic testing (pgt). patients indicating willingness to participate in research during informed consent to perform pgt will be eligible for inclusion. a licensed genetic counselor will conduct a recorded interview.

purpose: to perform longitudinal studies of clinical outcomes and personal perspectives following utilization of pgt. background: preimplantation genetic testing (pgt) is a commercially available adjunct to in vitro fertilization (ivf) and is now performed in over 40% of treatment cycles in the united sates (society for assisted reproductive technology annual report, 2018). several clinical genetics entities offer pgt services, including genomic prediction clinical laboratory (clia# 31d2152380, cap# 8488628). it is common practice to perform interviews with, and record reviews of patients following clinical interventions. results may provide instrumental information for the scientific and medical community to improve clinical care. we would like to review medical records in order to recruit patients to participate in longitudinal studies of clinical outcomes and personal perspectives following utilization of pgt. study design and methods: patients indicating willingness to participate in research during informed consent to perform pgt will be eligible for inclusion. patients who opted out of participating in research during informed consent to perform pgt will be ineligible for inclusion. clinical pgt consent forms will be reviewed to identify patients that indicated willingness to participate in research. eligible patients will be counseled on the study and consented for participation by a licensed genetic counselor. a total of 10,000 patients will be recruited. following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings. as it is in standard practice, all external communication of results will maintain de-identification of all protected health information of all subjects (hipaa guidelines). a licensed genetic counselor will conduct a recorded interview. patient pgt, family history, and ethnicity data and information may be included in cohort analyses.

Eligibility criteria:
inclusion criteria: * patients indicating willingness to participate in research during informed consent to perform pgt exclusion criteria: * patients who opted out of participating in research during informed consent to perform pgt

Keywords: pgt follow-up
facial patterns and masticatory symmetries

Conditions: Facies

Summary: the purpose of this study is to evaluate chewing side preference, and lateral asymmetry of occlusal contact area and bite force of individuals with different craniofacial patterns

dolichofacial subjects presents poorer mechanical advantage, less efficiency in masticatory muscles during mastication and in generating bite force, smaller occlusal contact area and masticatory capacity when compared to brachyfacial individuals. wide, bilateral chewing cycles were related to better masticatory performance, however, unilateral chewing was reported to be very common in population, and it has been associated to lateral asymmetry on bite force and occlusal contact area. it has been reported that dolichofacial subjects need greater muscular effort during mastication when compared to meso and brachyfacial subjects. this may cause functional overloading of weaker masticatory muscles, and may lead to functional asymmetries.

Eligibility criteria:
inclusion criteria: * full dentition, good general and oral health exclusion criteria: * facial deformities * severe malocclusion * history of signs and symptoms of temporomandibular disorder * history of parafunctions * history of maxillofacial surgery or jaw injuries and orthodontic treatment concluded in the last 2 years

Keywords: bite force dental occlusion face mastication morphology
rehabilitation needs of the malaysian haematological cancer survivors

Conditions: Haematological Malignancy; Leukemia, Acute; Lymphoma; Myeloma Multiple; Blood Cancer; Quality of Life

Summary: many cancers are being treated more effectively nowadays due to the raised awareness and early detection as well as advancement in researches and technology. despite the rising number of cancer survivors in the coming years, these survivors are still plagued by the poor quality of life due to physical and psychological impairment. according to the national cancer registry report from 2007-2011, haematological cancer is one of the ten most common cancers in malaysian population. many haematological cancer survivors in malaysia are reportedly having poor quality of life due to multiple physical and emotional impairments which leads to further disability in life. it is thus an important effort to identify the rehabilitation needs in these cancer survivors to implement alternatives to improve the disease outcome through cancer rehabilitation.

a cross-sectional questionnaire-based study will be employed to identify the rehabilitation needs and predictors of needs in outpatient hemato-oncological cohort at ummc hemato-oncology clinic for 12 months. the validated questionnaire employed evaluates the potential disabilities that could affect the aforementioned patients in domains such as communication, independence in mobility, self-care, social participation, handling relationships and domestic activity of daily living a month prior to the survey. participants of age between 18 to 80 years old, diagnosed with haemato-oncological illnesses will be screened; excluding potential participants who are too ill or cannot understand english, malay, or chinese; to be recruited in the research. based on the findings from the analysis, rehabilitation needs could be tailored accordingly to improve quality of life of these patients

Eligibility criteria:
inclusion criteria: * patient with haematological malignancy * agreeable to participate in the interview exclusion criteria: * ill at the time of follow up * unable to understand english, malay or chinese * refuse to be interviewed

Keywords: cross sectional study
effect of intrathorathic oscillations on pulmonary functions in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: aim: to investigate the effect of intrathoracic oscillations on forced expiratory volume at first second and peak expiratory flow in the children with cerebral palsy. methods and procedures: children were randomly assigned into two groups (study group and control group). each child was evaluated before and after 6 successive weeks.

methods and procedures: 24 children with spastic cerebral palsy from both sexes, there ages from 6 to 8 years old. children were randomly assigned into two groups (study group and control group). each child was evaluated before and after 6 successive weeks. the children of the control group received traditional chest physiotherapy. while, the children of the study group received 4 sessions per week for 6 weeks with quake device.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy * age from 6 to 8 years old * the degree of spasticity from 2 to 2+ * grade 4, 5 according to gmfcs exclusion criteria: * uncontrolled convulsions * any psychiatric disorders
inspire pipeline™ shield post approval study

Conditions: Intracranial Aneurysm

Summary: the purpose of the pipeline™ flex embolization device with shield technology™ post approval study (pas) ("pipeline™ shield pas") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (ia) using the pipeline™ flex embolization device with shield technology™ ("pipeline™ shield device") in a real-world post approval setting within the united states.

the inspire pipeline™ shield post approval study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the pipeline™ flex embolization device with shield technology™ according to the intended use. the primary objective of this study is to evaluate the on-label use of the pipeline™ shield device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the u.s. this study is conducted under the product surveillance registry (nct01524276) and is a sub-study to the therapy specific neurovascular product surveillance registry (nct02988128).

Eligibility criteria:
inclusion criteria: 1. patient or legally authorized representative (lar) provides authorization and/or consent per institution and geographical requirements. 2. patient is intended to receive or be treated with an eligible medtronic product. 3. patient is consented within the enrollment window of the therapy received, as applicable. 4. patient or patient's legally authorized representative (lar) has provided written informed consent using the irb and medtronic approved informed consent form and agrees to comply with the study requirements. hipaa/data protection authorization has been provided and signed by the patient (or patient's lar). 5. patient has already been selected for endovascular treatment of the target aneurysm with the pipeline™ shield device as the appropriate treatment per the pipeline™ shield device instructions for use (ifu). exclusion criteria: 1. patient who is, or is expected to be, inaccessible for follow-up. 2. participation is excluded by local law. 3. patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the psr results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness). 4. female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. 5. patient is contraindicated for the device or procedure per the pipeline™ shield device ifu. 6. the investigator determined that the health of the patient may be compromised by the patient's enrollment. 7. patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from medtronic.
a study of multi-electrode circular irreversible electroporation (ire) catheter and multi-channel ire generator in paroxysmal atrial fibrillation (af)

Conditions: Refractory Paroxysmal Atrial Fibrillation

Summary: the purpose of this study is to evaluate the long term off-antiarrhythmic drug (aad) effectiveness of biosense webster, inc. irreversible electroporation (bwi ire) system in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation (paf).


Eligibility criteria:
inclusion criteria: * diagnosed with symptomatic paroxysmal atrial fibrillation (paf) (physician's note indicating recurrent self-terminating atrial fibrillation \[af\]). at least one electrocardiographically documented af episode within twelve (12) months prior to enrollment. electrocardiographic documentation may include, but is not limited to, electrocardiogram (ecg), holter monitor, or telemetry strip * failed at least one class i or class iii antiarrhythmic drug (aad) as evidenced by recurrent symptomatic af, contraindicated or intolerable to both class i and class iii aad * able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements * willing and capable of providing consent exclusion criteria: * af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, untreated documented obstructive sleep apnea and acute alcohol toxicity) * previous left atrium (la) ablation or surgery * participants known to require ablation outside the pulmonary vein (pv) region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and wolff-parkinson-white) * previously diagnosed with persistent af (greater than \[\>\] 7 days in duration) * severe dilatation of the la (documented lad \>50 millimeters \[mm\] antero-posterior diameter by transthoracic echocardiography (tte) within 6 month prior to enrollment)
a study to observe the effectiveness of empagliflozin, other sglt-2 inhibitors, or dpp-4 inhibitors in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * dispensation or any other record of empagliflozin, any sglt-2 inhibitor, or any dpp-4 inhibitor use during the study period * no dispensation or any other record of any other sglt-2 inhibitor or dpp-4 inhibitor use during the preceding 12 months including at index date * having a diagnosis of t2dm before the index date, based on icd-10 codes or other available data exclusion criteria: * aged \<18 years on the first dispensation date or date of the first record of empagliflozin, any sglt-2 inhibitor or any dpp-4 inhibitor use * type 1 diabetes mellitus * secondary diabetes * gestational diabetes * having a diagnosis of esrd during the 12 months before the index date * \<12 months of available data before the index date, and/or no complete history of drug dispensations/other records of the drug use during this period * missing or ambiguous data on age or sex
a multicenter study to evaluate the safety and efficacy of pep005 topical gel when used to treat actinic keratoses on the head (face or scalp)

Conditions: Actinic Keratosis

Summary: this phase iib study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% pep005 topical gel when applied to an area of skin, containing 4-8 ak lesions on the face or scalp.


Eligibility criteria:
inclusion criteria: * must be male or female * female patients must be of * non-childbearing potential; * childbearing potential, provided negative pregnancy test and using effective contraception * 4 to 8 ak lesions on the face or scalp exclusion criteria: * cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area. * treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks. * treatment with 5-fu, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of treatment area

Keywords: peplin actinic keratosis pep005