Kornimate/medical-research-clean huggingface dataset:
safety of a single intravenous dose of recombinant factor xiii in children with congenital fxiii a-subunit deficiency

Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency

Summary: this trial is conducted in europe and united states of america (usa). the aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor xiii (rfxiii)) in children with congenital fxiii a-subunit deficiency. young children (1 to less than 6 years old) with congenital fxiii deficiency are evaluated.


Eligibility criteria:
inclusion criteria: * signed informed consent by subject's parents or subject's legally acceptable representative before any trial related activities. trial related activities are any procedures that would not have been performed during the normal management of the subject * age 1 to less than 6 years old at the time of enrolment * congenital fxiii subunit-a deficiency previously documented by genotyping or evaluated by genotyping through blood sampling at screening visit * body weight at least 10 kg exclusion criteria: * known antibodies to fxiii * hereditary or acquired coagulation disorder other than fxiii a-subunit congenital deficiency * platelet count (thrombocytes) of less than 50 × 10\^9/l (at screening visit) * previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus * previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis * known or suspected allergy to trial product or related products * any surgical procedure in the 30 days prior to enrolment and any planned surgery during the trial period * any disease or condition which, judged by the investigator, could imply a potential hazard to the subject or interfere with the trial participation or trial outcome including renal and/or liver dysfunction
efficacy of low dose intravenous proton pump inhibitor for peptic ulcer bleeding

Conditions: Peptic Ulcer Hemorrhage; Peptic Ulcer, Acute With Hemorrhage; Peptic Ulcer; Proton Pump Inhibitor Overdose

Summary: we prepare this study to compare the efficacy of intermittent intravenous ppi infusion (relatively low dose ppi therapy) than continous ppi infusion method. our hypothesis is that intermittent (40mg as a bolus injection daily for 72 hours) ppi therapy is not inferior to conventional high dose therapy.

background current guidelines recommend an intravenous bolus dose of a proton pump inhibitor(ppi) followed by continuous ppi infusion after endoscopic therapy in patients with high-risk peptic ulcer bleeding. however, intermittent ppi have not been inferior to continuous ppi infusion regimens in recent studies. objective the aim of this study was to compare the effect of intermittent (40mg as a bolus injection daily for 72hours) versus continuous (40mg as a bolus injection followed by continuous infusion at 8mg/hr for 72hours) intravenous pantoprazole for prevention of bleeding after endoscopic therapy of peptic ulcer bleeding. also, the same comparison was performed in high-risk patients (rockall scores ≥6). methods this single center cross-sectional study was conducted from january 2010 through december 2013. patients who presented with overt or suspected upper gastrointestinal bleeding based on hematemesis and/or melena were eligible. these eligible patients were required to have a peptic ulcer with bleeding on emergency endoscopy performed within 24 hours after hospitalization. exclusion criteria were refusal of endoscopy, gastrointestinal malignancy, mallory-weiss syndrome, variceal bleeding, bleeding d/t endoscopic procedure, small bowel bleeding, serious medical disease, etc. demographic and medical data were obtained from the patients' medical records. current or past history of medical diagnosis and drug history were also recorded. statistical analysis performed using spss 21.0 software.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older who had undergone gastroscopy for melena, hematochezia or hematemesis due to bleeding peptic ulcers were eligible. these eligible patients were required to have a peptic ulcer with bleeding on emergency endoscopy performed within 24 hours after hospitalization exclusion criteria: * refusal of endoscopy, gastrointestinal malignancy, mallory-weiss syndrome, variceal bleeding, bleeding d/t endoscopic procedure, small bowel bleeding, serious medical disease
cosmetic outcomes of umbilical hernia incisions

Conditions: Umbilical Hernia

Summary: this will be a single institution, prospective, randomized controlled trial. patients presenting as an outpatient for repair of umbilical hernias who meet our inclusion criteria, whose parents provide permission to participate in the study, will receive the umbilical hernia repair that they are randomized to. the appropriate data will be collected on day of surgery, and patients will be followed with a delayed parental submission of incisional photograph.


Eligibility criteria:
inclusion criteria: * patient presenting with umbilical hernia that is \<1.5cm in size based on physical exam for outpatient repair * treated at cmh adele hall or cmhk from 09/11/24 - 09/11/25 * subjects \<10 years of age exclusion criteria: * umbilical hernia \> 1.5 cm in size * patients with prior umbilical surgery * subjects ≥10 years of age

Keywords: umbilical hernia
pilot study of dribble vaccine for prostate cancer patients

Conditions: Adenocarcinoma of the Prostate

Summary: this is a pilot study of the dribble vaccine in patients with advanced prostate cancer.

the primary objective of this pilot study is to assess the safety and tolerability of dribble vaccine, cyclophosphamide, imiquimod, and ceravix in castrate resistant prostate cancer. this study will also assess: * the immune profile of tumor biopsy specimens if sites amenable to biopsy are present * humoral and cellular responses to cancer antigens after dribble vaccination * the response to a reporter antigen vaccine (ceravix) after dribble vaccination an exploratory objective is to characterize the microbiome before and after study drugs administration and correlate prostate cancer responses.

Eligibility criteria:
inclusion criteria: * subjects have measurable or evaluable metastatic castrate resistant adenocarcinoma of the prostate with progression after chemotherapy, combined androgen blockade and/or peripheral androgen or androgen receptor suppression. either histologic or serum marker diagnosis is acceptable. * eastern cooperative oncology group (ecog) performance status 0 or 1 * ability to give informed consent and comply with the protocol. * prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment. * patients must have normal organ and marrow function as determined by routine blood tests exclusion criteria: * active autoimmune disease except vitiligo or hypothyroidism. * active other malignancy. * known hiv positive and/or hepatitis b or c positive. * other medical or psychiatric conditions that in the opinion of the principal investigator would preclude safe participation in protocol.

Keywords: prostate adenocarcinoma metastatic dribble immunotherapy microbiome
open-label extension study of tofacitinib in psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: this is a phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active psa who have previously participated in randomized studies of tofacitinib for this indication. this study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg bid administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg bid continued in combination with methotrexate. the sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.


Eligibility criteria:
inclusion criteria: * previous participation in qualifying psa study involving tofacitinib exclusion criteria: * time from end of study visit of qualifying study is \>3 months. * pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter. sub-study inclusion criteria: * subjects who have completed at least 24 months of treatment with tofacitinib in the extension study * subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week) sub-study exclusion criteria: -subjects who are receiving methotrexate by a route other than oral

Keywords: tofacitinib psoriatic arthritis xeljanz cp-690550 jak-inhibitor oral treatment psoriasis opal balance methotrexate pruritus itch dlqi
team play (positive lifestyles for active youngsters)

Conditions: Obesity

Summary: the purpose of this study is to determine whether an intense family-centered program to help children, 4 to 7 years old, control their weight is more effective than the advise and referrals their health provider gives in the primary care office.

this randomized controlled trial is designed to determine whether an intense 6 month family-centered intervention to increase physical activity and health eating patterns, primarily directed at parents, followed by a 6 month maintenance period, will be significantly more successful in controlling weight in overweight/obese children, ages 4-7 years, than usual standard care, at 2 years after enrollment. the intervention group (180 children with a bmi \> 85% percentile) will receive standard of care, as well as, additional parental counseling. parents will receive intense counseling regarding developmentally appropriate physical activity, strategies for reducing sedentary behaviors, nutritional counseling, and behavioral counseling including a self-management program to use with their children at home. the group will meet once a week for the initial 8 weeks, biweekly for 8 weeks, and monthly for 2 months. following this period (the next 6 months), a case manager will call the family on a monthly basis and the family will be sent educational and support information by mail. the control group (60 children with a bmi \> 85% percentile) will receive standard care provided by their primary care provider and be offered a six week optional parenting class. all children will have a medical history, physical examination, and anthropometric measures, nutritional assessment, measurement of physical activity, and behavioral/psycho-social measures provided by study personnel. outcome measurements will be done at baseline, 6, 12, 18, and 24 months.

Eligibility criteria:
inclusion criteria: * children 4 to 7 years of age, male or female, of any race who have a bmi \> 85% for age. * all participants and parents must be able to speak and understand english. exclusion criteria: * history of diabetes mellitus * history of significant renal, hepatic, cardiovascular,or gastrointestinal disease * receiving drugs known to alter glucose homeostasis * physical disabilities that limit physical activity (i.e. orthopedic, congenital) * diagnosis of hypertension by a medical provider that requires limited physical activity * psychological disabilities that might limit participation; * lack of access to a telephone * lack of access to transportation for the intervention * current participation in another clinical trial (current participation in an observational study is not an exclusion.) * other medical or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol. * unable to speak and understand english

Keywords: children overweight obesity family intervention control randomized physical activity diet nutrition behavior body mass index
training induced reduction of lower-limb joint loads during locomotion in obese children

Conditions: Pediatric Obesity; Lower Extremity Biomechanics

Summary: childhood obesity is one of the most critical and accelerating health challenges throughout the world. it is a major risk factor for developing varus/valgus misalignments of the knee joint. the combination of misalignment at the knee and excess body mass may result in increased joint stress and damage to articular cartilage. a training programme, which aims at developing a more neutral alignment of the trunk and lower limbs during movement tasks may be able to reduce knee loading during locomotion. despite the large number of guidelines for muscle strength training and neuromuscular exercises that exists, most are not specifically designed to target the obese children and adolescent demographic. the purpose of this study is to evaluate a training programme which combines strength and neuromuscular exercises specifically designed to the needs and limitations of obese children and adolescents and analyse the effects of the training programme from a biomechanical and clinical point of view.


Eligibility criteria:
inclusion criteria: * male or female * age: 10 -18 years * bmi greater than the 97th percentile * availability: can participate in two exercises session per week for a period of 12 weeks exclusion criteria: * present syndromes * chronic joint diseases, osteoarthritic surgery or * neuro-motor diseases

Keywords: gait analysis knee adduction moment physiotherapy obesity
hydrocolloid dressing for catheter exit site care in peritoneal dialysis patients

Conditions: Peritoneal Dialysis Catheter Exit Site Infection

Summary: the study aims to examine the use of hydrocolloid dressing for catheter exit-site care in peritoneal dialysis patients. it is a pilot study, and participants will be randomized to either receiving weekly hydrocolloid dressing or daily topical gentamicin cream for exit-site care in peritoneal dialysis patients.

peritoneal dialysis (pd) related infection is one of the main reasons for patients to discontinue pd therapy. routine exit-site care is crucial for the prevention of infections, however, daily antibiotics use has been associated with the risk of developing drug-resistant bacteria. moreover, the burden of daily exit-site care can lead to non-compliance with treatment. hydrocolloid dressing has been used in the management of acute and chronic wounds and is required to change once weekly, but its use has not been examined in the exit-site wound in pd patients. the study primarily aims to examine pd-related infection (exit site infection or peritonitis rates) between patients using weekly hydrocolloid dressing (experimental group) and those using daily topical application of gentamicin (control group) for exit-site care in pd patients. secondary aims include time to the first episode of pd-related infection, technique failure, pd infection-related hospitalization, and adverse events. the study will also assess the acceptability of dressing and quality of life between the two groups. a total of 60 adult peritoneal dialysis patients will be recruited for the study. patients will be randomly assigned to either the experimental group or the control group. participants will be followed up at the 4th, 12th, and 24th week of study. the acceptability of the dressing will be assessed using the treatment acceptability questionnaires. the quality of life will be assessed using the ed 5d-5l questionnaires.

Eligibility criteria:
inclusion criteria: * all adult peritoneal dialysis patients (≥ 21 years old) and are followed up at singapore general hospital (sgh) exclusion criteria: * patients who are unable to provide valid consent, patients who have known allergy to hydrocolloid dressing, patients who have peritoneal dialysis catheter exit site infection or peritonitis within the past 3 months, patients who have dialysate leak at pd catheter exit site, pregnant women, patients with life-expectancy of \< 1 year or patients who are currently involved in another study for peritoneal dialysis catheter exit site care.

Keywords: peritoneal dialysis exit-site care exit-site dressing
adipose-derived stem cells (adscs) for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: 1. to assess the safety of allogeneic injection of expanded adscs to patients with knee osteoarthritis 2. to assess the efficacy of allogeneic injection of expanded adscs to patients with knee osteoarthritis


Eligibility criteria:
inclusion criteria: 1. aged 40-80 years (inclusive) 2. kellgren-lawrence grading i-iii, as determined by american college of rheumatology (acr) criteria for osteoarthritis of the knee 3. western ontario and mcmaster universities osteoarthritis index (womac) pain score of 7-17 in the study knee even if treated with chronic doses of non steroidal anti-inflammatory drugs 4. having provided informed consent exclusion criteria: 1. with previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint 2. with previous intra-articular intervention on the target knee joint within past 3 months (e.g. steroid, anaesthetic, sodium hyaluronate) 3. known or suspected infection of the target knee joint 4. ascertained hypersensitivity to any component used in the study 5. administered with systemic anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drug or steroid ) or topical anti-inflammatory drugs on target knee within 7 days prior to administration in the study 6. with serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. new york heart association grade iii or iv), hepatic (e.g. child-pugh class c), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, , or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the patient 7. with any evidence of malignant disease with life expectancy of less than 1 year 8. pregnant or lactating women or planning to be pregnant during the study period 9. with body mass index (bmi) greater or equal to 35 kg/m2 10. with joint diseases except knee osteoarthritis considered by investigator not eligible to enter the study 11. with known history of human immunodeficiency virus (hiv) infection. 12. judged to be not applicable to this study by investigator such as difficulty of follow-up observation 13. with any other serious diseases/medical history considered by the investigator not in the condition to enter the trial 14. having participated other investigational study within 4 weeks of entering this study 15. with known history of claustrophobia 16. having any existing active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator, etc... 17. having any existing metallic intraocular foreign body
post-operative pain control of testicular sperm extraction using liposomal bupivacaine

Conditions: Male Infertility

Summary: the study is a drug trial comparing the post-operative pain control provided by liposomal bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the local anesthetic) for men undergoing testicular sperm extraction.


Eligibility criteria:
inclusion criteria: * men scheduled for surgical sperm retrieval for infertility * men 18 years and older who can provide informed consent * no documented allergy to bupivacaine or celecoxib exclusion criteria: * prior history of substance abuse * any narcotic use within the last 3 months * concomitant use of aspirin * any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses * medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
animal allergy in korean veterinary researcher

Conditions: Rhinitis, Allergic; Asthma; Dermatitis, Atopic; Urticaria

Summary: the investigators will evaluate sensitization to animal allergens and allergic symptom during contacting animal allergens in korean veterinary researchers who attend their annual conference. the investigators will compare sensitization to animal allergen and other clinical and occupational factors between subjects who suffer from allergic symptom during contacting animal and those who do not.

the investigators will visit annual conference of korean veterinary researchers. after informed consent, korean veterinary researchers who attend their conference and agree to enrollment into this study will be asked to respond to questionnaires regarding their gender, age, underlying allergic diseases, family history of allergic diseases, occupation and it's duration, contact animal and contact duration. subjects will also be requested to report allergic symptom, causal animal and situation of contact including veterinary service, animal experiment, pet ownership, and ingestion if subjects suffer from allergic symptom when subjects contact animal. then, subjects will also be asked to undergo skin prick test for animal allergens including chicken feather and ten mammal epithelia as well as cow's milk, and hen's egg, four fish flesh and seven animal meats. subjects will be divided into two group, subjects who suffer from allergic symptom during contacting animal and those who do not. between two groups, sensitization to animal allergens as well as other demographic and occupational factors including gender, age, underlying allergic diseases, family history of allergic diseases, occupation and it's duration, contact animal and contact duration will be compared.

Eligibility criteria:
inclusion criteria: * veterinary researchers attending their annual conference exclusion criteria: * veterinary researchers who receive medication including antihistamine (h1 and h2 blocker), systemic glucocorticosteroid which can effect on the result of skin prick test * veterinary researchers who do not want to participate in this study

Keywords: allergen veterinary allergy animals
measuring comfort and clarity with low gain feature in pediatric hearing aid users

Conditions: Hearing Loss

Summary: comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the adaptive situational gain (asg) feature in study documents.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss * must use oral mode of communication * must speak english exclusion criteria: -