Kornimate/medical-research-clean huggingface dataset:
rapid intravenous infusion of velaglucerase alfa (vpriv) in treatment-naive patients with type 1 gaucher disease

Conditions: Primary Disease

Summary: during the past two years, the investigator has performed succsefully an iir wherein patients with gd, previously treated with velaglucerase alfa ert were gradually switched to a 10 minutes (rapid) administration of the same ert. the success was expressed as safety (no clinically meaningful aes, no antibodies detected, home therapy), efficacy ("lack of deterioration") and patients' satisfaction. the latter was based not just on specific questionnaires and analog scales, but particularly by the patients' sharing the experience with other patients and consequently repeated requests by many to switch to a rapid administration of their ert. therefore, the investigator is hereby proposing to investigate the safety and efficacy of a 10 minutes administration of velaglucerase alfa in a cohort of treatment-naive patients. the current vpriv label is restricted to a dosage of 60 units/kg body weight every other week (60 units/kg eow) - this dose will be used throughout the study period. the enzyme will be provided by shire, which will also provide a research grant for the conduction of the trial.

protocol: study design: this will be a single-center, open-label trial to assess the safety and efficacy of rapid administration of velaglucerase alfa (vpriv) to treatment-naive patients with type i gaucher disease. the first six infusions will be administered in the hospital: the first three infusions within 60, 30 and 20 minutes each, with the beginning of a 10 minutes administration from infusion #4. following the three uneventful administration of the 10 minutes in the hospital, the bi-weekly ert will continue as home therapy, as outlined in the protocol. the duration of the study will be 12 months, with an extension pending positive results. number of patients: 15. the first ten patients will be adults, and then children will be allowed to enroll in the trial.

Eligibility criteria:
inclusion criteria: * males and females, 18 years or older for the first ten adult patients; 6 years or older for the last five patients. * confirmed enzymatic diagnosis of gaucher disease with a defined genotype and elevated biomarker lysogb1, performed at centogene using dbs methodology. * indications for ert will be guided by fulfilling the moh criteria. * female patients of child-bearing potential who agree to use a medically acceptable method of contraception. * patients who have not received ert or srt in the past or patients who have not received ert or srt in the past 12 months and have a negative anti-glucocerebrosidase antibody exclusion criteria: * currently taking another experimental drug for any condition * presence of neurologic signs and symptoms characteristic of type 2 or type 3 gaucher disease * pregnant or nursing * presence of any medical, emotional, behavioral or psychological condition that in the judgment of the investigator would interfere with the patient's compliance with the study.
active comparator-controlled study to assess safety and efficacy of isis-fxirx in total knee arthroplasty

Conditions: Venous Thromboembolism

Summary: the purpose of this study is: * to assess the safety and efficacy profile of isis-fxirx, including incidence of bleeding and vte, in patients undergoing total knee arthroplasty. * to compare the efficacy and safety profile of isis-fxirx in patients who achieve less than or equal to 0.2 u/ml fxi activity levels to that of enoxaparin.


Eligibility criteria:
inclusion criteria: * give written informed consent * females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. males must be surgically sterile, abstinent, or if engaged in sexual relations of child-bearing potential, must use contraception * undergoing elective, primary unilateral total knee arthroplasty exclusion criteria: * body weight \<50 kg * patients at increased risk of bleeding. history of intracranial or intraocular bleeding. history of gastrointestinal and/or endoscopically verified ulcer disease within the past year. * history of excessive intra- or direct post operative bleeding or a traumatic spinal or epidural anesthesia * brain, spinal, or ophthalmologic surgery within the past 3 months * history of clinically significant liver disease in the past year * screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values * aptt or pt or inr \>uln * factor ix activity \<lln * factor viii activity, vwf antigen or ristocetin cofactor activity \<0.5 u/ml * fxi activity \<0.3 u/ml * urine protein or blood persistently positive by dipstick. in the event of positive test results, eligibility may be confirmed with urine microscopy or 24 hour urine protein measurement as applicable * alt or ast \>1.5 x uln * total bilirubin \>uln * platelet count \<150,000 (or history of thrombocytopenia) * hypersensitivity to enoxaparin * anticipated concomitant use of anticoagulants/antiplatelet agents or the nsaid nimesulide that may affect study outcome or any other drug influencing coagulation (except low dose aspirin and short acting nsaids with a half-life \<20 hours) at least 7 days before surgery or during treatment with isis rx. * anticipated use of indwelling intrathecal or epidural catheters * anemia at screening * have any other conditions which could interfere with the patient participating in or completing the study

Keywords: total knee arthroplasty prophylaxis
water flosser vs string floss vs manual toothbrush safety

Conditions: Soft Tissue Injuries

Summary: evaluation of the safety of a water flosser on gingival and epithelial tissue at different pressure settings

this study is designed to add to the safety data by measuring, oral soft tissue, clinical attachment levels and probing pocket depths on different pressure settings at different time points over a 6 week period. data will be collected at baseline, 2 week, 4 week and 6 week time frames.

Eligibility criteria:
inclusion criteria: * written consent prior to participation * good general health and non smoker * have scorable ramfjord's teeth exclusion criteria: * probing depth \>4mm on ramfjord's teeth * moderate to severe gingivitis * advanced periodontitis * medications that impact soft tissue.
efficacy and safety of tisagenlecleucel in adult patients with refractory or relapsed follicular lymphoma

Conditions: Follicular Lymphoma

Summary: this is a multi-center, phase ii study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory fl.

this single-arm, open label study had the following sequential phases: screening, pretreatment, treatment and follow-up. in the pre-treatment phase, the patient could undergo bridging therapy (optional) and lymphodepleting (ld) chemotherapy. treatment and follow-up phase included tisagenlecleucel infusion, and safety and efficacy follow-up for at least 24 months. for all the patients who received tisagenlecleucel infusion, additional survival follow-up was to be performed to determine survival status every 3 months.

Eligibility criteria:
inclusion criteria: * refractory or relapsed follicular lymphoma (grade 1, 2, 3a) * radiographically measurable disease at screening exclusion criteria: * evidence of histologic transformation * follicular lymphoma grade 3b * prior anti-cd19 therapy * prior gene therapy * prior adoptive t cell therapy * prior allogeneic hematopoietic stem cell transplant * active cns involvement by malignancy other protocol-defined inclusion/exclusion criteria may apply.

Keywords: refractory or relapsed follicular lymphoma refractory relapsed follicular lymphoma ctl019 tisagenlecleucel chimeric antigen receptor car19 car-t
ultrasound-guided peripheral intravenous catheter placement in an oncologic emergency department - a prospective, randomized controlled trial of catheter lengths

Conditions: Oncologic Complications and Emergencies

Summary: to learn about the effects of the length of the catheter on the failure and success rate of usiv placement.

primary objectives: - the rate of catheter failure, defined as removal of the catheter for any reason other than "care complete" (i.e. a composite of removal due to "infiltration," "leaking," "catheter damage," "occlusion"), by day 10. secondary objectives: 1. time from catheter placement to removal (i.e. survival or dwell time). 2. per catheter length rate of failure analysis 3. rate of repeat catheterization 4. rate of infection 5. rate of thrombosis

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old. 2. provision of signed and dated informed consent form. 3. predetermined to have difficult iv access necessitating usiv placement 4. expected admission to hospital with anticipated stay \> 48 hours (per discussion with treating physician). exclusion criteria: 1. expected/anticipated discharge disposition from the accc (per discussion with treating physician). 2. inability to give informed consent. 3. pregnant women. 4. non-english speaking participants.
tension-free repair of inguinal hernia with "undissociate spermatic cord"

Conditions: Inguinal Hernia, Without Mention of Obstruction or Gangrene

Summary: the theory of "undissected spermatic cord (us)" only transected the hernia ring ends in the abdominal cavity, the hernia ring, hernia sac and spermatic cord will not be dissected. its significance lies in that inguinal hernia repair can get rid of the "entanglement" of hernia sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia sac.

in recent years, with the deepening of the anatomical cognition of the inguinal region and the renewal of the hernia repair concept, inguinal hernia repair has become increasingly mature surgical approach. however, no matter how the hernia repair modes change, the treatment and repair of the hernia ring has always been the focus, so that the treatment of the hernia sac has been neglected. from march 2014 to may 2019, there were 132 patients underwent inguinal hernia repair with "undissociate spermatic cord" theory (undissected spermatic cord and hernia sac, hernia ring and sac exclusion). all the patients were followed up for 18\~63 months (mean of 41.5 months) without recurrence. its significance lies in that inguinal hernia repair can get rid of the "entanglement" of hernia sac and spermatic cord and fundamentally change the treatment mode of hernia ring and hernia sac.

Eligibility criteria:
inclusion criteria: * inguinal hernia patients who can tolerate surgery exclusion criteria: * patients who cannot tolerate surgery

Keywords: undissociate spermatic cord inguinal hernia hernia exclusion hernial sac
a retrospective non-interventional study to evaluate the impact of eculizumab in korean pnh patients

Conditions: PNH

Summary: this study is a retrospective non-interventional study, and the main objective of this study is to identify the impact of eculizumab treatment and the improvement of complications before and after eculizumab treatment, and to evaluate the safety during the treatment and the clinical unmet needs during the treatment in pnh patients in real-world.


Eligibility criteria:
inclusion criteria: * patients with pnh aged 18 years or older who started eculizumab treatment in accordance with drug label between 2012 and january 31st, 2020. (however, patients who have received eculizumab as part of a clinical trial or an expanded access program/compassionate use program prior to 2012 are also eligible.) * patients who are vaccinated against neisseria meningitidis at least 2 weeks prior to starting eculizumab treatment. patients who have been treated with appropriate prophylactic antibiotic therapy for 2 weeks after vaccination if they received eculizumab within 2 weeks after the vaccination. exclusion criteria: * pediatric patients with pnh aged under 18 years * patients with hypersensitivity to the active ingredients of eculizumab, murine protein, or other components * patients with untreated severe meningococcal (neisseria meningitidis) infection * patients who received other complement inhibitors for pnh before or during eculizumab treatment
assessment of the cross-face nerve graft in the treatment of facial paralysis

Conditions: Facial Palsy

Summary: a retrospective and cross-sectional analysis of standard of care for facial paralysis involving the cross-face nerve graft in the past 20 years. * imagery analysis * questionnaires

the investigators will retrospectively and cross sectionally analyze all patients treated with a cross-face nerve graft and another nerve transfer in our institution by image analysis and sending out quality of life questionnaires.

Eligibility criteria:
inclusion criteria: * treated with one of the described procedures exclusion criteria: * evaluation material present
registry for ambulant therapy with ras-inhibitors in hypertension-patients in germany

Conditions: Arterial Hypertension

Summary: in germany nearly half of the population present elevated values of blood pressure, with - as a result of lifestyle factors and a growing average age - further increasing numbers. consequences of arterial hypertension may be cardiovascular diseases, cerebrovascular events, and renal insufficiency. thus, hypertension therapy focuses on the reduction of these complications. the aims of the 3a-registry are the characterization of outpatients with hypertension, their diagnostic procedures and medical treatment (esp. with renin inhibitors), therapy compliance and success, clinical events, and an assessment of overall guideline adherence in the treatment of these patients. patients fulfilling the relevant criteria are enrolled and followed up by their general practitioner or medical specialist.


Eligibility criteria:
inclusion criteria: * treatment as outpatient * arterial hypertension * treatment with a renin inhibitor, ace inhibitor, arb, or without ras blockade * informed consent exclusion criteria: * foreseeable difficulties to perform follow up

Keywords: renin inhibitor ace inhibitor arb (at1 receptor blockers) ras blockade
autologous peripheral blood stem cell transplantation with in vivo purging as an alternate stem cell transplantation program for pts w/aml in 1st & 2nd complete remission w/no hla matched related donor

Conditions: Leukemia, Monocytic, Acute

Summary: autologous peripheral bld stem cell transplantation with in vivo purging as an alternate stem cell transplantation program for pts w/aml in 1st \& 2nd complete remission w/no hla matched related donor


Eligibility criteria:
inclusion criteria: * patients with aml in 1st \& 2nd complete remission w/no hla matched related donor

Keywords: aml in 1st & 2nd complete remission w/no hla matched related donor
the influence of cholecystectomy on secretion of incretin hormones

Conditions: Glucose Metabolism Disorders

Summary: the effect of cholecystectomy on postprandial plasma glp-1 responses (primary endpoint) and glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic cholecystectomy.

this is an observational, parallel-group study in 30 patients with gallstone disease and 10 healthy control subjects. in patients undergoing cholecystectomy a 4h-meal test (liquid mixed meal) will be conducted at baseline (1-2 weeks before surgery) and again within 4 weeks after the cholecystectomy. healthy subjects will be submitted to a single 4h-meal test. secondary endpoints include changes in plasma glucose, insulin, glucagon, gip, pyy, gastrin, cck, fibroblast growth factor 19 (fgf-19) and bile acids. furthermore, secondary endpoints include changes in gastric emptying (evaluated by the paracetamol method).

Eligibility criteria:
inclusion criteria: * caucasians above 18 years of age, having an elective cholecystectomy performed because of gallstone disease. * normal fasting plasma glucose and hba1c * normal hgb * normal gallbladder ejection fraction exclusion criteria: * liver disease * kidney disease * diabetes * ongoing infection * abdominal pain not related to gall stones * bmi \ 30 kg/m2 * prior abdominal surgery
efficacy of digital breast tomosynthesis + standard 2- dimensional mammography in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if a 3-dimensional mammogram (dbt) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. this would impact surgical planning and improve patient outcomes.

primary objective: the primary objective of the study is to measure the frequency with which dbt alters the surgical plan to mastectomy versus lumpectomy. only positive findings, like an additional site of cancer or dcis, will be taken into account when estimating the frequency of changes to surgical management. secondary objectives: 1. to measure the frequency and nature of additional findings like atypical pathology (atypical ductal/ lobular hyperplasia, papilloma, lobular carcinoma in situ (lcis) , requiring surgical intervention). 2. to identify variables on 2d (e.g. dense breasts, architectural distortions, non calcified masses) that might predict which patients would benefit from dbt. 3. to measure the proportion of patients undergoing additional work-up following the dbt, and the subset of these patients with benign findings (i.e. false positives).

Eligibility criteria:
inclusion criteria: * new diagnosis of breast cancer * new diagnosis if a previous breast cancer patient with negative surgical margins * patients willing to sign a written informed consent form exclusion criteria: * high risk benign lesions as the primary pathology diagnosis

Keywords: mastectomy lumpectomy 3-dimensional mammogram digital breast tomosynthesis
erector spinae plane block vs. usual care for ed patients with mechanical back pain

Conditions: Back Pain

Summary: the goal of this clinical trial is to compare the erector spinae plane (esp) block, a nerve block, to usual care in emergency department patients with back pain. the main question it aims to answer: is the esp block superior to usual care in the treatment of back pain in the emergency department? participants will be randomly assigned to the esp or the usual care group. pain improvement at the time of emergency department discharge will be compared.


Eligibility criteria:
inclusion criteria: patients deemed to have mechanical back pain with a component of paravertebral tenderness or paravertebral spasm reported by the patient or noted on examination by treating physician. exclusion criteria: * previous recipient of erector spinae plane block * exam concerning for cauda equina syndrome * current iv drug use * organ transplant recipient * history of or suspected bleeding diathesis * current use of anticoagulants * sepsis or soft tissue infection at site of the block within last three months * pregnancy * overt malignancy involving skin or underlying soft tissue at the site of block * allergy to any of the research medications * inability to participate in telephone follow-up

Keywords: nerve block back pain regional anaesthesia analgesia
determination of the feasibility of tumoural somatic mutations detection in blood of patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: bovary-pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. the purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. the method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. the concordance of somatic mutations (snv) found in tissue and in cell-free dna (cfdna) extracted from blood will then be compared


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient with stage iii to iv non-treated high grade ovarian cancer or recurrent high grade ovarian cancer * adequate haemoglobin rate ≥ 9 g/dl * patient who can benefit from an additional blood sample of 20ml. the total volume of each sample meets with the indications of the order in force establishing the list of researches mentioned in 2 ° of article l. 1121-1 of the public health code. * availability of tumor samples from biopsy or surgery * patient affiliated to a social security scheme * ability to provide written informed consent exclusion criteria: * any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study * contraindication to a blood sample of 20 ml * pregnant or breast-feeding women * ongoing treatment for the newly diagnosed cancer or the recurrence * patient pre-treated with poly-adp-ribose-polymérase-1 (parp) inhibitors * patient under guardianship or curatorship or deprived of liberty.

Keywords: brca 1/2 genes circulating tumor dna/blood* somatic tumor mutations hrd genes
study evaluating the safety and efficacy of gemtuzumab ozogamicin in patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the primary objectives are a) to establish the maximum tolerated dose (mtd) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.


Eligibility criteria:
inclusion criteria: * all adult patients with relapsed or refractory aml, as well as younger de novo aml patients are eligible for the study * relapsed, refractory, and de novo aml patients are allowed in phase i of this study * phase ii will only allow enrollment of younger de novo aml exclusion criteria: * aml following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration * de novo patients with m3 aml * aml secondary to exposure to chemotherapy or radiation

Keywords: acute myeloid leukemia