Kornimate/medical-research-clean huggingface dataset:
an open-label safety, efficacy and pharmacokinetic study of a recombinant fviii compared to recombinant human antihemophilic fviii in patients with severe hemophilia a

Conditions: Hemophilia A

Summary: this is an open-label, non-randomized, efficacy, safety and pharmacokinetic (pk) study comparing octocog alfa and rviii-singlechain. the study consists of three parts, a pk period (part 1), a continuation of dosing safety and efficacy period (part 2) and a safety, efficacy, and repeat pk period (part 3) and also includes a surgical sub-study for subjects enrolled in parts 2 and 3.


Eligibility criteria:
inclusion criteria: * diagnosis of severe hemophilia a defined as \<1% fviii:c documented in medical records. * males between 18 and 65 years of age (parts 1 and 2). * males between 12 and 65 years of age (part 3). * subjects who have received or are currently receiving fviii products (plasma-derived and/or recombinant fviii) and have had \>150 exposure days (eds) with a fviii product * written informed consent for study participation obtained before undergoing any study specific procedures. exclusion criteria: * any history of or current fviii inhibitors * any first order family history of fviii inhibitors * use of an investigational medicinal product within 30 days prior to the first rviii-singlechain administration. * administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of rviii-singlechain or reference product. * known hypersensitivity (allergic reaction or anaphylaxis) to any fviii product or hamster protein. * any known congenital or acquired coagulation disorder other than congenital fviii deficiency. * platelet count \< 100,000/µl at screening. * human immunodeficiency virus (hiv) positive subjects with a cd4 count \< 200/mm3, in their medical history or at screening if available results are older than one year. (hiv positive subjects may participate in the study and antiviral therapy are permitted, at the discretion of the investigator). * subject currently receiving iv immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment. * subject with serum aspartate aminotransferase (ast) or serum alanine aminotransferase (alt) values \> 5 times (x) the upper limit of normal (uln) at screening. * subjects with serum creatinine values \> 2 x uln at screening. * evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to day 1. * experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to day 1.
promoting physical activity among patients with type 2 diabetes

Conditions: Type 2 Diabetes; Physical Activity

Summary: the purpose of this study is to determine the effects of a tailored, print-based physical activity intervention for patients diagnosed with type 2 diabetes.

given the growing rates of type 2 diabetes and the documented benefits of physical activity in the treatment of this illness, further research is needed to examine methods of targeting this patient group to achieve improvements in physical activity behavior. the primary aim of this planning grant is to implement a pilot study examining the feasibility and efficacy of an individually-targeted, theoretically-based physical activity intervention for patients with type 2 diabetes. the physical activity intervention is compared to usual care, and the primary outcome is weekly physical activity at a one-month follow-up. these pilot data would demonstrate the feasibility of partnering with a community agency for participant recruitment and program implementation, as well as the potential efficacy of this intervention to promote physical activity in this high-risk population.

Eligibility criteria:
inclusion criteria: * adults diagnosed with type 2 diabetes * current patients referred to diabetes center exclusion criteria: * medical contra-indication to moderate-intensity physical activity

Keywords: diabetes physical activity print-based intervention tailored intervention
gangwon pci prospective registry

Conditions: Coronary Artery Disease

Summary: comparison of * biolimus-eluting stent, biomatrix, or biomatrix flex stent, biosensors, singapore * everolimus-eluting stent, xience v, or xience prime, or xience xpedition stent, abbott, usa * zotarolimus-eluting stent, endeavor resolute, or endeavor resolute integrity stent medtronic, usa in patients with coronary artery disease treated with percutaneous coronary intervention


Eligibility criteria:
inclusion criteria: * age \> 19 years * subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure * subject must have significant stenosis (\>50% by visual estimate) on a native or in-stent coronary artery * subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ecg consistent with ischemia). in subjects with coronary artery stenosis \>75%, evidence of myocardial ischemia does not have to be documented exclusion criteria: * subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus a9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. however, those with true anaphylaxis to prior contrast media should not be enrolled.) * subject in use of systemic (intravenous) biolimus a9, everolimus or zotarolimus within 12 months. * female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study * subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment * subject with non-cardiac co-morbid condition with life expectancy \< 2 year or that may result in protocol non-compliance (per site investigator's medical judgment) * subject with cardiogenic shock at presentation * subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period
effects of modified constraint-induced movement therapy with and without electrical stimulation in erb's palsy

Conditions: Erb's Palsy

Summary: erb's palsy is an injury of upper section of the brachial plexus (c5-6) leading to an internally rotated and adducted shoulder and a pronated forearm. modified constraint-induced movement therapy improves the functionality of the affected limb, while electrical stimulation helps in the improvement of active range of motion and muscle strength in erb's palsy patients. this study aims to investigate the effects of modified constraint-induced movement therapy with and without electrical stimulation on range of motion, muscle strength, and motor functions in patients with erb's palsy.

this randomized clinical trial will be conducted at the children's hospital. the sample size will consist of 34 participants. participants who meet the inclusion criteria will be randomly allocated into two groups using an online randomization tool; group a will receive modified constraint-induced movement therapy with electrical stimulation and group b will receive modified constraint-induced movement therapy only. both groups will receive routine physical therapy as a part of treatment. all participants will receive a 60-minute session, 6 times a week for 16 weeks. universal goniometer will be used to assess range of motion, the medical research council scale for muscle strength, and the active movement scale for motor function at baseline, 4th, 8th, 12th, and 16th weeks after treatment discontinuation. the data will be analyzed using spss version 26 for windows software.

Eligibility criteria:
inclusion criteria: 1. children with a confirmed diagnosis of erb's palsy. 2. muscle power of the affected limb should be between 1 to 4. 3. active finger range of motion,10-degree wrist extension, and thumb abduction. exclusion criteria: 1. children having contracture and stiffness of affected limb. 2. muscle power of affected limb 0 or 5. 3. children with cerebral palsy, visual, hearing, and cognitive problems, or any neuromuscular, and skeletal disorders. 4. previous history of neurological and orthopedic surgery

Keywords: erb's palsy erb paralysis electric stimulation active movement scale randomized clinical trial motor function
reduction of covid 19 transmission to health care professionals

Conditions: COVID 19

Summary: when the covid-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate. the pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "abo" system on their surface. this secretory status can be established by determining the antigens of the lewis blood group system. when the virus replicates in an "secreting" individual, the antigens of the "abo" system of the infected individual will be present on the surface of the viruses formed in his/her lungs. it was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "abo" system carried by the virus. a patient of group "o" would thus defend himself much better against a virus carrying antigens of blood group "a", the natural antibodies "anti-a" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. the first data collected in wuhan (china) seems to confirm this hypothesis. a covid-19 virus transmission model can therefore be established on the basis of blood groups. in order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "abo" and "lewis" blood groups of patients and "abo" of nursing staff in health care units, if operational and human conditions allow.


Eligibility criteria:
inclusion criteria: * covid19 positive patients admitted within the chu brugmann hospital exclusion criteria: * none
pain and discomfort with anterior versus posterior builds-up

Conditions: Malocclusion; Deep Bite

Summary: orthodontic build-ups are made by composite/resin material bonded to the palatal or occlusal surfaces of teeth (usually molars or incisors). their primary purpose is to prevent heavy contact of the upper teeth with lower fixed appliances in patients with overbite reduction to avoid brackets detachment. these appliances disarticulate the posterior teeth, deprogram the masticatory muscles and allow for eruption, extrusion, and uprighting of the posterior teeth. build-ups are usually placed in the first months of the fixed orthodontic treatment and contribute to increasing the perception of pain. in the orthodontic daily practice, the pain is the most frequent symptom during treatment and is the one that most frightens/worries the patients. literature shows that fear of pain is one of the primary reasons that patients fail to seek orthodontic care. pain has a negative effect on patients' compliance, oral hygiene, and missed appointments. its effects on patients' daily lives is a major reason for discontinuance of orthodontic treatment. in the literature the prevention of pain and management of orthodontic builds-ups is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice. so, the aim of the present study is to investigate and analyze the perception of pain and function impairment with different type of build-ups (anterior or posterior) to identify an efficient clinical management protocol and an effective pain and discomfort prevention strategy.


Eligibility criteria:
inclusion criteria: * patient with reduced overbite treated with orthodontic fixed appliance * angle class i, class ii or class iii malocclusion exclusion criteria: * hypodontia in any quadrant excluding third molars * craniofacial syndromes, or cleft lip or palate
a multi-center human study to evaluate the efficacy and safety of ®gi flora in subjects with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: a multi-center, randomized, double-blinded, placebo-controlled human study to evaluate the efficacy and safety of probiotic mixture(®gi flora) in subjects with irritable bowel syndrome. regimen: 6 probiotics mixture \>10\^9/d for 8 weeks primary variable: visual analogue scale(vas) assessment for abdominal pain secondary variable: 1. change of vas score for abdominal pain/discomfort after 4/8-week treatment 2. daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete evacuation), flatulence , feces shape, frequency of bowel movements


Eligibility criteria:
inclusion criteria: * irritable bowel syndrome patients according to rome iii criteria * recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool. exclusion criteria: * intolerable or hypersensitive to gi flora. * patients with active colon diverticulitis. * history of gi surgeries except hernia repair, appendectomy, primary closure due to perforation. * history of inflammatory bowel disease, malignancy requiring surgery or chemotherapy or radiation within 5 years. * patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the requirements of the study.

Keywords: gi flora
measuring patient engagement in diabetes care

Conditions: Diabetes Mellitus, Type II

Summary: we will develop a new measure of patient engagement/activation specific to the context of diabetes self-care


Eligibility criteria:
inclusion criteria: 1. patient is age 21 and older 2. patient is english speaking 3. patient has been diagnosed with type ii diabetes by a health care provider exclusion criteria: 1. severe, uncorrectable vision 2. hearing impairments 3. cognitive impairment
bile duct injuries during laparoscopic cholecystectomies: an 11-year population-based study

Conditions: Bile Duct Injury

Summary: the aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (bdi) during laparoscopic cholecystectomy (lc) in a population-based cohort during 2008-2018 in estonia.

the aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (bdi) during laparoscopic cholecystectomy (lc) in a population-based cohort during 2008-2018 in estonia. background data: iatrogenic bile duct injuries (bdi) following laparoscopic cholecystectomy (lc) result in major morbidity and incidental mortality. there is a lack of unselected population-based cross-sectional studies on the incidence, management, and outcomes of bdi. we hypothesised that due to improved imaging capabilities and collective laparoscopic experience, the bdi incidence will decrease over the study period and compare favourably with contemporary literature. after irb approval, all cholecystectomies performed at national public healthcare facilities between 2008 and 2018 were retrospectively reviewed. bdis were classified according to the strasberg classification. we hypothesized that due to improved imaging capabilities and collective laparoscopic experience the bdi incidence will decrease over the study period and compare favourably to contemporary literature.

Eligibility criteria:
inclusion criteria: * all patients with bdi during laparoscopic cholecystectomy (lc) exclusion criteria: * the sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method
a phase ia/ib study of ibi315 in patients with her2-expressing advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: the primary objective of this phase i study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (rp2d) of ibi315, a her2/pd-1 bi-specific antibody in patients with advanced solid tumors

this phase ia/ib, open-label, multicenter study has two stages. the ia stage is a dose-escalation study that will focus on safety, tolerability, efficacy and rp2d . patients with her2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase ia study. dlt observation period is 28 days.

Eligibility criteria:
inclusion criteria: * written (signed) informed consent. * life expectancy ≥12 weeks. * patients with her2-expressing advanced solid tumor who failed on current standard of care * according to recist 1.1, at least one measurable lesion (radiation-naïve) exists. * ecog performance status 0-1. * adequate organ and marrow function evaluated by laboratory tests as follow: * cbc: absolute neutrophil count (anc) ≥ 1.0×109/l (ia stage) or 1.5×109/l (ib stage); platelet (plt) ≥ 75×109/l; hemoglobin (hgb) ≥ 9.0g/l; * liver function: total bilirubin (tbil) ≤ 1.5×upper limit of normal value (uln) for patients without hepatic metastases, ≤ 2×uln for patients with hepatic metastases or gilbert syndrome; alanine aminotransferase (alt) ≤ 2.5×uln; aspartate transferase (ast) ≤ 2.5×uln; * renal function: clearance of creatinine (ccr) by cockcroft-gault formula or 24-hour urine collection ≥ 50ml/min; * urinalysis: urine protein \< 2+ or urine protein in 24-hour urine collection \< 1g; * coagulation function: activated partial thromboplastin time (aptt）≤ 1.5×uln; international normalized ratio (inr）≤ 1.5 * left ventricular ejection fraction (lvef) ≥ 50% by echocardiography; * accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2; * agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment. * post-menopause female subject or pre-menopause female with negative hcg level in urine or blood. exclusion criteria: * any greater than nci ctcae 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue; * received major surgery or having unhealed wound, ulcer, or bone fracture;• received whole pelvic radiation; * plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy; * cns metastasis, spinal compression, or carcinomatous meningitis * active autoimmune disease or inflammatory disorders. * primary immunodeficiency diseases; * pregnant or breast-feeding female.
icg fluorescence guided lymph node mapping for determination of bowel resection margins in colon cancer

Conditions: Colon Cancer

Summary: the study is aimed at investigating feasibility of defining colon resection margins for colon cancer with icg by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination

in this study 2.5 mg/ml indocyanine green solution is injected subserosally into colonic wall near the tumour in 4 points (1 ml each). the fluorescence is assessed before specimen removal (at least 30 min after injection) and its mesenteric distribution is marked by surgeon on the specimen. proximal and distal colonic resection margins are chosen to be at least 10 cm long and to include the whole area of fluorescence. after removal, lymphatic node groups according jsccr are also marked on fresh specimen. during pathological examination each lymph node is assessed not only for presence of metastases but also for its exact location in relation to margins of indocyanine distribution.

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid) 2. tnm t1-4a n0-2 m0-1 3. clinical indications to colonic resection 4. ecog - 0-2 5. signed informed consent. exclusion criteria: 1. medical or psychiatric reasons interfering with patient's decision to participate in the study. 2. pregnancy or breastfeeding. 3. medical conditions contraindicating surgical procedure. 4. acute bowel obstruction, bleeding or perforation. 5. hypersensitivity to indocyanine green, sodium iodide or iodine 6. hyperthyroidism or autonomic thyroid adenomas 7. kidney failure of any aetiology 8. hepatic failure of any aetiology 9. poorly tolerated indocyanine injection in the past.

Keywords: colon cancer lymphatic mapping indocyanine green
radicle energy2: a study of health and wellness products on fatigue and other health outcomes

Conditions: Fatigue; Energy

Summary: a randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes

this is a parallel group, randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the united states. eligible participants will (1) endorse a desire for more energy, (2) have the opportunity for meaningful improvement in their health outcome score, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. those taking certain medications will be excluded. self-reported data are collected electronically from eligible participants over 7 weeks. participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. all study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility criteria:
inclusion criteria: * adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed * resides in the united states * endorses more energy as a primary desire * has the opportunity for at least 20% improvement in their primary health outcome score * expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study exclusion criteria: * reports being pregnant, trying to become pregnant, or breastfeeding * unable to provide a valid us shipping address and mobile phone number * reports a diagnosis of liver or kidney disease * reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * unable to read and understand english * reports current enrollment in another clinical trial * lack of reliable daily access to the internet * reports current use of chemotherapy or immunotherapy * reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, maois (monoamine oxidase inhibitors), or thyroid products * reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: nyha (new york heart association) class iii or iv congestive heart failure, atrial fibrillation, uncontrolled arrhythmias