Kornimate/medical-research-clean huggingface dataset:
vaccination response in tecfidera-treated versus interferon-treated participants with relapsing forms of multiple sclerosis.

Conditions: Relapsing Forms of Multiple Sclerosis

Summary: primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (td) in participants with relapsing forms of multiple sclerosis (ms) who have been treated with tecfidera (bg00012) versus those treated with non pegylated interferon (ifn). secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (ppsv23) \[a mostly t cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (mcv4) \[t cell-dependent neoantigen response\].


Eligibility criteria:
key inclusion criteria: * must have a confirmed diagnosis of relapsing remitting ms per the 2010 mcdonald criteria. * must have a known tetanus immunization history with most recent tetanus vaccination given 2 to 15 years prior to screening and an anti-tetanus serum immunoglobulin titer at screening that is less than or equal to one-half the upper limit of detection for the assay. * must have been on a stable approved dose of tecfidera (240 mg twice daily \[bid\]) \[group 1\] for ≥6 months or on a stable approved dose of a non-pegylated ifn (e.g., avonex, betaseron, rebif, extavia) \[group 2\] for ≥3 months prior to day 1. key exclusion criteria: * clinical relapse requiring treatment within 30 days prior to day 1. * pneumococcal vaccination within 5 years prior to screening. * previous exposure to meningococcal vaccines. * known hypersensitivity to td, ppsv23, or mcv4 or their components. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: vaccine pneumococcal meningococcal tetanus diphtheria immune response
beta- probe and surgery in gep net: evaluation of a new probe

Conditions: Neuroendocrine Tumors

Summary: radioguided surgery (rgs) with beta- radioisotopes is a novel approach focused on developing a new probe which, detecting electrons and operating with low background, provides a clearer delineation of the margins of lesions with low radiation exposition for surgeons. to validate this procedure, ex vivo specimens of tumours expressing somatostatin receptors, as small-intestine neuroendocrine (si-net), will be tested

small intestinal neuroendocrine patients, with a positive ga-68-dotatoc pet/ct, will receive a small amount of beta- radiopharmaceutical (y-90-dotatoc), and then operated, as clinical indicated. tissue samples will be tested ex-vivo with a beta-probe prototype

Eligibility criteria:
inclusion criteria: * si net patients, ga-68-dotatoc pet/ct positive, proposed for surgery exclusion criteria: * negative pet/ct; pregnancy

Keywords: beta- probe radioguided surgery
a study to compare cefdinir and cephalexin for the treatment of mild to moderate uncomplicated skin infections

Conditions: Mild to Moderate Uncomplicated Skin and Skin Structure Infections

Summary: the purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.


Eligibility criteria:
inclusion criteria: * ambulatory male or female subjects \> 13 years old. * a female subject must be non-lactating and at no risk for pregnancy. * diagnosis of usssi with 2 or more of the following local signs and symptoms: * pain/tenderness * swelling * erythema * localized warmth * purulent drainage/discharge * induration * regional lymph node swelling or tenderness * extension of redness * acceptable usssi include, but are not limited to: * cellulitis * erysipelas * impetigo * simple abscess * wound infection * furunculosis * folliculitis * a sample for microbiologic culture must be obtained from the primary infection site within 48 hours prior to study drug administration. exclusion criteria * medical history of hypersensitivity or allergic reaction to penicillin and/or cephalosporin (including cefdinir and cephalexin) antibiotics according to the judgment of the investigator. * subject with a complicated skin and skin structure infection as judged by the investigator. * a chronic or underlying skin condition at the site of infection (e.g., a secondary infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic hardware). * a wound secondary to burn injury or acne vulgaris. * any infection site that requires: * intraoperative surgical debridement; * excision of infected lesions or body parts. * infections that can be treated by surgical incision alone according to the judgment of the investigator. * any other infection that necessitates the use of additional concomitant oral or parenteral antibiotic therapy. * known significant renal or hepatic impairment indicated by: * serum creatinine \> 2.0 mg/dl (176.8 mol/l) * sgot (ast) \> 3x the upper limit of the reference range * sgpt (alt) \> 3x the upper limit of the reference range * alkaline phosphatase \> 2x the upper limit of the reference range * total bilirubin \> 2x the upper limit of the reference range * underlying condition and/or disease that, according to the judgment of the investigator, would be likely to interfere with completion of the course of study drug therapy or follow-up. * the investigator considers the subject an unsuitable candidate for cefdinir or cephalexin administration

Keywords: cefdinir cephalexin skin infection
vaginal probiotics and pessaries and their impact on the vaginal microenvironment

Conditions: Pelvic Organ Prolapse; Inflammatory Response; Dysbiosis

Summary: in this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, wbcs, cellular debris, epithelial cells, and bvab-1), and inflammatory environment (cytokines).


Eligibility criteria:
inclusion criteria: * postmenopausal (no menstruation \>12 months) * subjects presenting for 2 week post initial pessary insertion appointment or presenting for routine pessary care follow up appointment * planning on continuing to use a pessary for treatment for at least 3 months * pessary maintenance performed by provider (as opposed to self-care) * able to understand english * able/willing to sign informed consent document exclusion criteria: * lack of cognitive ability to consent to participate in study and to complete the questionnaires * planned prolapse surgery less than 3 months from enrollment * presence of vaginal fistulas * pessary self-care (patient changes and cleans her own pessary) * receiving immunosuppressive therapy or history of immunodeficiency * presence of an indwelling vascular access line or structural heart disease * within 6 weeks from any abdominal or pelvic surgery or other major surgery * allergy to lactobacillus (contents of probiotic) * allergy to beta-lactam antibiotics, erythromycin and clindamycin * use of any probiotic pills, creams, or suppositories currently

Keywords: pessary use probiotics cytokines microenvironment
does indocyanine imaging scoring predicts postoperative parathormone levels at 24 hours after total thyroidectomy

Conditions: Thyroid; Parathyroid; Deficiency

Summary: the aim of the present study is to evaluate the prognostic value of intra-operative indocyanine staining scoring concerning 24 hours post-operative pth levels and the possible advantages that its' use can give in terms of clinical practice compared to conventionally operated patients.

study objectives are: * detecting the changes of practice in performing total thyroidectomy with icg. * comparing icg-performed minimal invasive total thyroidectomy * identifying the cut-off points that predict low pth levels (less than 20pg/ml) * identifying and analyzing problematic groups of patients the study is designed as a prospective observational multi-center study. any patient that has indication for a total thyroidectomy will be considered eligible. the study will be conducted until 60 subjects are included. it is estimated that it will take up to 3 months to enroll the patients. pre-surgery: procedures preformed such as routine hospital examinations, antibiotic prophylactic treatment, anticoagulant treatment and diet will be according to the standard management protocol and will be recorded for the study. the following pre-surgery information will be recorded: 1. demographic information including: name, age, gender, ethnicity 2. height, weight, bmi and american society of anesthesiologists physical status classification system (i-vi) 3. behavioral history (smoking, alcohol or drug use) 4. preoperative labs (wbc, ht, hgb, ca2+, p, ft3, ft4, tsh, pth, vitd) 5. diagnosis including clinical observations and previous imaging results 6. pre-operative characteristics of the adenoma 7. medications 8. current and past history of surgical and medical comorbidities intra-operative: the surgeon will perform the preplanned operation. the following intraoperative variables will be recorded for all patients: 1. surgery date 2. duration of surgery 3. operation performed 4. procedure related comments 5. number and location of the visualized glands 6. intra-operative icg score (ranging from 1 to 3 \[5\]) for each grand pathology data form: the following pathology data will be recorded for all patients: 1. post-operative diagnosis including pathology report 2. possible parathyroids excised postoperative follow-up: follow-up evaluation will be performed during hospitalization 1 postoperative labs (wbc, ht, hgb, ca2+, p, ft3, ft4, tsh, pth)

Eligibility criteria:
inclusion criteria: * patient is over 18 years old * patient scheduled for a non-emergency operation * patient eligible for total thyroidectomy exclusion criteria: * patient is participating in another clinical trial which may affect this study's outcomes * prior operation in the neck * primary or secondary hyperparathyroidism * vitamin d deficiency * use of drugs that influences calcium metabolism (vitamin d analogues, oral calcium supplements, bisphosphonates, teriparatide, thiazide diuretics, aromatase inhibitors)

Keywords: indocyanine green near infrared imaging total thyroidectomy
insulin requirement for pure-protein meal in children with type 1 diabetes on insulin pumps.

Conditions: Diabetes type1

Summary: this is a randomized, cross-over study. the aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day. prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and cgms.

the square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. the required insulin dose will be calculated based on patient's insulin-exchange ratio. pure protein meal will be given 3 hours after a first breakfast. to provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and \<100 kcal from protein and fat for the first breakfast (without any extended bolus) patients receive a standardized pure protein meal at a second breakfast time. meal insulin will be given as a square bolus or no meal -insulin will be given at all. the 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (smbg) (every 30 minutes) and continuous glucose monitoring system (cgms). the intervention is taking part under in-patient clinical conditions.

Eligibility criteria:
inclusion criteria: * duration of type 1 diabetes longer than 12 months * insulin pump therapy longer than 3 months * written informed consent by patients and parents * insulin requirement more than 0,5 units/kg/day exclusion criteria: * diabetes related complications (e.g. nephropathy) * chronic kidney diseases * any disease judged by the investigator to affect the trial * withdrawal of consent to participate in the study

Keywords: diabetes type 1 insulin pump prandial insulin requirement pure protein meal high protein meal square bolus square-wave bolus insulin bolus dietary protein
safety and efficacy of lacosamide as additional therapy in patients suffering from epileptic tonic-clonic seizures

Conditions: Epilepsy

Summary: assessment of long-term safety and efficacy of oral lacosamide (lcm) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (pgtcs) in subjects \>= 4 years of age with idiopathic generalized epilepsy (ige). this study will enroll subjects from the lcm sp0982 \[nct02408523\] study.


Eligibility criteria:
inclusion criteria: - subject must have completed or be an eligible baseline failure from the parent study (sp0982 \[nct02408523\]). note: other subjects screened for sp0982 may be considered for roll-over to ep0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (lcm) and based on prior discussion with and approval from the ucb study physician or representative exclusion criteria: * subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (lcm) * subject meets the withdrawal criteria for sp0982 or is experiencing an ongoing serious adverse event (sae) * subject has an active suicidal ideation as indicated by a positive response ("yes") to either question 4 or question 5 of the "since last visit" version of the columbia-suicide severity rating scale (c-ssrs) * subject has \>=2x upper limit of normal (uln) of any of the following: alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphatase (alp), or \>uln total bilirubin (≥1.5xuln total bilirubin if known gilbert's syndrome). if subject has elevations only in total bilirubin that are \>uln and \ uln for alt, ast, alp, or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic case report form (ecrf). tests that result in alt, ast, or alp up to 25% above the exclusion limit may be repeated once for confirmation.

Keywords: lacosamide vimpat epilepsy children primary generalized tonic clonic seizures idiopathic generalized epilepsy adults
telerehabilitation using a dance intervention in people with parkinson's disease

Conditions: Parkinson Disease

Summary: the aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.

this is a feasibility study that aims to investigate the safety and efficacy of dance classes via an online platform in people with and without parkinson's disease. the intervention will last 2 months and the classes will be conducted twice a week (60 minutes) using the zoom platform. evaluations will be performed before and after the intervention by means of the zoom platform as well and will include questionnaires of quality of life, depression, anxiety, and activities of daily living.

Eligibility criteria:
inclusion criteria: * individuals with and without parkinson's disease according london brain bank criteria * minimal cognitive ability to understand commands (mmse) * able to stand at least 10 minutes with or without support * dopamine medication stable at least 6 weeks before the beginning of the study * portable device and internet connection exclusion criteria: * severe visual or auditive disturbances * neurological disease (other than parkinson's for those included) or severe neuromuscular disorders that prejudice the proposed activities
ieik13 for neurosurgery

Conditions: Oozing (Hemorrhage) During Intracranial Procedures

Summary: the objective of this clinical investigation is to determine the performance and safety profile of nu-max® when used as a topical hemostat for oozing bleedings encountered during intracranial procedures, in which control of bleeding by conventional hemostatic techniques is either ineffective or impractical.


Eligibility criteria:
inclusion criteria: 1. have been informed on the nature of the clinical investigation and provided written informed consent, prior to initiation of any study activities. 2. able and willing to comply with the clinical investigation follow-up schedule. 3. male or female human subjects aged 18 years or older at time of enrollment. 4. requiring hemostasis during elective intracranial procedures, in which the intradural space is accessed and where the control of bleeding by conventional hemostatic techniques is either ineffective or impractical. 5. nu-max® is used at least once intraoperatively. exclusion criteria: 1. patients undergoing emergency craniotomy for traumatic lesions or patients undergoing surgery for primary intracranial hemorrhage. 2. patients undergoing surgical procedures using a transsphenoidal approach. 3. intraoperative use of a different topical chemical hemostatic agent prior to the use of nu-max® during the same procedure and on the same bleeding point or in the same resection cavity. 4. patients with a coagulation disorder or medical treatment affecting coagulation or platelet function, unless corrected or stopped prior to surgery. 5. pregnant patients or patients planning to become pregnant during the clinical investigation. 6. patients with known allergies to any of the components of nu-max®. 7. patients currently participating in, or having been recently exited from (within 30 days from enrollment in this clinical investigation), or planning to enroll in another clinical investigation that may impact participation or outcomes (at the discretion of the sponsor) of this clinical investigation. 8. patients with a condition, disorder, or other factor that, in the investigator's opinion, would interfere with study participation. 9. fever (body temperature \>38.5°c) prior to surgery, on the day of the procedure. 10. patients with a nickel allergy
a study to assess the effect of a single infusion of vay736 on disease activity in patients with relapsing-remitting multiple sclerosis

Conditions: Relapse Remitting Multiple Sclerosis

Summary: this was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of vay736 on disease activity as measured by brain mri scans in patients with relapsing-remitting multiple sclerosis (rrms).

the study was planned to be conducted in approximately 96 patients. however, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.

Eligibility criteria:
key inclusion criteria: * male and female patients aged 18 to 55 years. * diagnosis of ms as defined by the 2010 revised mcdonald criteria (polman et al 2011). * a relapsing-remitting course of disease with: * at least 1 documented relapse during the previous 12 months (but not within 30 days prior to randomization ), or * a positive gd-enhancing lesion on brain mri scan at screening. * an expanded disability status scale (edss) score of 0-5.0 inclusive at screening. * no evidence of a relapse within 30 days prior to randomization. key exclusion criteria: * a manifestation of another type of ms other than rrms. * findings on screening or baseline brain mri inconsistent with the diagnosis of ms. * history of chronic disease of the immune system other than ms, or a known immunodeficiency syndrome. * score "yes" on item 4 or item 5 of the suicidal ideation section of the c-ssrs, if this ideation occurred in the past 6 months, or "yes" on any item of the suicidal behavior section, except for the "non-suicidal self-injurious behavior" (item also included in the suicidal behavior section), if this behavior occurred in the past 2 years. * women of child-bearing potential and pregnant or nursing (lactating) women. * screening cbc (complete blood count) laboratory values as follows: * hemoglobin levels below 10.0 g/dl * total leukocyte count less than 3,000 cells/µl * neutropenia, defined as absolute neutrophil counts less than 1500 cells/mm3 * platelets less than 100,000/µl

Keywords: multiple sclerosis relapsing-remitting multiple sclerosis magnetic resonance imaging vay736 lanalumab monoclonal antibody gadolinium [gd]-enhancing lesions b-cell
helios-b: a study to evaluate vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy

Conditions: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Summary: this study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (sc) once every 3 months (q3m) compared to placebo in patients with attr amyloidosis with cardiomyopathy.


Eligibility criteria:
inclusion criteria: * has a documented diagnosis of transthyretin (attr) amyloidosis with cardiomyopathy, classified as either hereditary attr (hattr) amyloidosis with cardiomyopathy or wild-type attr (wtattr) amyloidosis with cardiomyopathy meeting pre-specified diagnostic criteria * has medical history of heart failure (hf) with at least 1 prior hospitalization for hf or clinical evidence of hf exclusion criteria: * has known primary amyloidosis or leptomeningeal amyloidosis * has new york heart association (nyha) class iv heart failure * has nyha class iii heart failure and is at high risk based on pre-specified criteria * has a polyneuropathy disability (pnd) score iiia, iiib, or iv at the screening visit * has estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m\^2 * has received prior ttr-lowering treatment * has other non-ttr cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease

Keywords: attr cardiomyopathy amyloidosis ttr transthyretin ttr-mediated amyloidosis amyloidosis, hereditary amyloidosis, hereditary, transthyretin-related familial amyloidosis rnai therapeutic transthyretin amyloid cardiomyopathy ttr cardiomyopathy attr-cm wild-type ttr v122i ttr amyloidosis amyloidosis, wild type