Kornimate/medical-research-clean huggingface dataset:
study evaluating refacto af in severe hemophilia a

Conditions: Hemophilia A

Summary: to characterize the safety and efficacy of refacto af in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.


Eligibility criteria:
inclusion criteria: * severe hemophilia a (fviii:c less than or equal to 2% at local laboratory) * previously treated patients with greater than or equal to 250 exposure days to any factor viii product * age greater than or equal to 12 years * history of prophylaxis dosing at least twice per week on any factor viii product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study * adequate laboratory results exclusion criteria: * presence of any bleeding disorder in addition to hemophilia a * concomitant therapy with immunosuppressive drugs * current or historical factor viii inhibitor * treatment with any investigational drug or device within the past 30 days

Keywords: severe hemophilia a
comparative bioavailability study of film-coated tablet and granule formulations of rg1662

Conditions: Healthy Volunteer

Summary: this study will compare the pharmacokinetic performance of film-coated tablet and granule formulations of rg1662 under fed and fasted conditions in healthy volunteers. a randomized, four-period, four-treatment crossover design is used. in each period, each volunteer will receive a single oral dose of the tablet or granule formulation either with or without food.


Eligibility criteria:
inclusion criteria: * male or female volunteers, 18 to 60 years of age, inclusive exclusion criteria: * a history of epilepsy, convulsions or significant head injury * any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
clinical outcomes for offering genetic testing in a tiered approach

Conditions: Breast Carcinoma; Colon Carcinoma; Malignant Solid Neoplasm; Ovarian Carcinoma; Pancreatic Carcinoma; Prostate Carcinoma

Summary: this clinical quality improvement study reviews and develops a clinical operations workflow to identify cancer patients who meet criteria for genetic counseling and testing. this study may improve utilization of genetic counseling and testing amongst community-based oncology providers caring for cancer patients in a rural and underserved area.

outline: medical oncologists at olympic medical center (omc) participated in this study and received a peer coaching intervention during phase ii to help identify patients who meet criteria for genetic counseling and testing phase i: patients' medical data are collected; no intervention. phase ii: olympic medical center (omc) patients complete family history questionnaires and their medical data are collected. seattle cancer care alliance (scca) subject matter experts and omc providers review patients' medical data at bi-weekly virtual conferences. omc providers will be consenting to release their patients' medical records to scca so that scca subject matter experts (cancer geneticist and/or genetic counselor) can identify patients with an underlying hereditary cancer syndrome to be offered genetic counseling and testing. omc providers receive coaching from scca subject matter experts for guidance on providing genetic counseling and testing to their patients.

Eligibility criteria:
inclusion criteria: * medical oncology providers at omc who see patients with an active diagnosis of breast, ovarian, prostate, colon, or pancreatic cancer exclusion criteria: * omc providers who do not see patients with an active diagnosis of cancer * omc providers who see patients who are minors * omc providers who see patients with precancerous lesions such as ductal carcinoma in situ (the presence of abnormal cells inside a milk duct in the breast) or colon polyps (a small clump of cells that form on the lining of the colon or rectum)
vaginal wound infiltration analgesia for postoperative pain after laparoscopic hysterectomy: a randomized trial

Conditions: Postoperative Pain

Summary: in cases of laparoscopic hysterectomy , women were randomized to two groups: ropivacaine ( vaginal wound infiltration analgesia) vs. control group. results regarding postoperative pain and need of oxycodone.

women assigned to laparoscopic hysterectomy were randomly divided into two groups as regard surgery: a ropivacaine group (rg) (n=41) and a control group (cg) (n=40). general anesthesia and use of local anesthetics were standardized. visual analog scale (vas) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours.

Eligibility criteria:
inclusion criteria: the criteria for inclusion were scheduled laparoscopic hysterectomy exclusion criteria: the exclusion criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol), language difficulties ( inability to understand and speak finnish or swedish)

Keywords: laparoscopic hysterectomy postoperative pain local analgesia vaginal wound
nsaid treatment of patients with osteoarthritis

Conditions: Osteoarthritis,Knee

Summary: the study investigates associations between pre treatment pain intensity and central pain mechanisms on the effect of 8-week treatment of nsaids in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * diagnosed knee ostoarthritis exclusion criteria: * current ulcer diagnosed by endoscope * asthma or other allergic reaction to nsiads * kidney disease * myocardial infarction within the last six months * severe hyper tension (systolic ≥180mmhg, diastolic ≥110mmhg) * severe thrombocytopenia (thrombocyst count \<50x10\^9/l) * insufficience lever or kidney function
effects of selective dorsal rhizotomy on non-ambulant children with bilateral spastic cerebral palsy

Conditions: Bilateral Cerebral Palsy

Summary: children with spastic bilateral cerebral palsy are late developers. delayed gross and fine motor development require early intervention to improve the child performance and avoid secondary impairments.

increased tone of lower extremity muscles interfere with the child sitting posture and trunk control. delayed sitting and lack of trunk control contribute to the impairments of upper extremity functions. selective dorsal rhizotomy is a surgical procedure to control increased tone of the lower extremities. therefore, the current study is carried out to investigate the effects of selective dorsal rhizotomy on trunk control, selectivity and upper extremity function of non-ambulant children with bilateral spastic cerebral palsy

Eligibility criteria:
inclusion criteria: * cp, spastic diplegia * 4-7 years of age * on level iv-v on gross motor function classification system * at least six months after the last botulinum toxin a injection in the lower extremities * average intelligent quotient according to medical records for active participation * partial trunk control (sitting with support). exclusion criteria: * structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months * ankle clonus * exaggerated deep tendon reflex in the legs * babinski sign; * moderate to severe signs of dystonia, athetosis or ataxia.

Keywords: bilateral cerebral palsy selective dorsal rhizotomy segmental trunk control motor development
prevalence of macrovascular disease in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the study aim is to establish a consecutive population of newly referred type 2 diabetes mellitus patients and among these to describe the degree of macrovascular disease by evaluating left ventricular systolic and diastolic function (echocardiography), myocardial perfusion (single-photon emission computed tomography (spect)), the peripheral vascular perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a. carotis communis). further, the degree of microvascular disease will be evaluated (glomerular filtration rate assessment, fundus photography and biotesiometry). finally the cohort will be followed the next two years to assess the prognostic value of the above-mentioned parameters


Eligibility criteria:
inclusion criteria: * age: ≥ 20 years. * fasting c-peptide \> 300 pmol/l. exclusion criteria: * verified medical history of macrovascular disease (stroke, myocardiac infarct, coronary revascularisation or strain gauge toe blood pressure \< 30 mmhg). * suspected short lifespan because of malignant disease or end-stage kidney disease. * pregnancy or planned pregnancy during the study period. * body weight \> 150 kg. * physical or mental disability not enabling participation in the study.

Keywords: type 2 diabetes mellitus macrovascular disease diastolic dysfunction intima media thickness single- photon emission computed tomography (spect)
the effects of journaling on health-related mood and clinical outcomes in post-mi patients

Conditions: Myocardial Infarction; Psychosocial Factors

Summary: psychosocial factors, including positive affect, finding meaning in the event, and managing emotional distress, influence prognosis following a heart attack or myocardial infarction (mi). gratitude, typically defined as a feeling or attitude in acknowledgment of a benefit that one has received or will receive, is associated with higher levels of well-being, and people who are more grateful experience less stress, are less depressed, have higher levels of control over their environment, and more positive ways of coping. the present project will examine the potential benefits of a gratitude intervention (i.e., 8 weeks of gratitude journaling) to increase positive health behaviors, psychological health, and physical functioning in post-mi patients as compared to journaling about memorable events as well as care as usual alone. the investigators will study psychological and physical functioning at baseline, following 8 weeks of gratitude journaling or care as usual, and at 4-month follow-up.


Eligibility criteria:
inclusion criteria: 1. suffered an mi (st elevation mi (stemi) or non-st elevation mi (nstemi) with creatine kinase mb fraction elevation 3 times the upper limits of normal and with ischemic ecg changes within 12 months of baseline testing; 2. an ef less than 50% on echocardiogram; 3. clinically stable defined as, no active arrhythmia, no residual ischemia; 4. able to perform light to moderate exercise; 5. able to give informed consent in english; 6. medical clearance by their cardiologist; 7. \> 35 years of age. exclusion criteria: 1. unstable angina; 2. severe valvular disease; 3. oxygen-dependent copd; 4. recent stroke or significant cerebral neurologic impairment; 5. suicidality with intent or plan; 6. current cancer; 7. currently taking mood stabilizers, benzodiazepines or antipsychotics; 8. medications (e.g., systemic steroids) and conditions affecting immune status (e.g., rheumatoid arthritis, hepatitis c, hiv) (anti-depressant medication is allowed); 9. currently enrolled in another clinical trial.
frequency of common medical conditions in people with and without hht

Conditions: Hereditary Hemorrhagic Telangiectasia (HHT)

Summary: hereditary hemorrhagic telangiectasia (hht) affects 1 in 5,000 people. the purpose of this study is to provide data regarding the frequency of common health conditions and the tolerability of therapies in hht by using a questionnaire. this will be filled in by both people with hht, and controls who will be members of the general population without hht. the questionnaire has been designed primarily for web based entry, but can also be circulated in paper format on request

hereditary hemorrhagic telangiectasia (hht) affects 1 in 5,000 people, usually causing nosebleeds, skin blood spots, and/or anemia as a result of bleeding from the nose or gut. the majority of people with hht also have abnormal blood vessels (arteriovenous malformations) in internal organs such as the lungs, liver and brain. management of this multisystem disorder is highly challenging. the lead applicant has spent 20 years working on this rare disease, and identified multiple areas where more evidence is required to assist clinicians and patients with this lifelong condition. a particular issue is what happens when people with hht have other common medical conditions such as asthma, cancer, diabetes, or heart disease. do they have the same pattern of problems as the general population? can they use the same drugs? are further safeguards needed? for these important questions, current advice can only be based on theoretical considerations and anecdotal data. the ultimate goal of this study is to use information derived from a questionnaire to provide evidence to assist clinicians treating people with hht. data will be entered from april 2012. data will be analysed on average 6-8 months after entry.

Eligibility criteria:
inclusion criteria: * aged 18 or over. * capacity to fill in a questionnaire. exclusion criteria: * age under 18 * unable to fill in a questionnaire

Keywords: on-line questionnaire no travel health medicines drugs lifestyle family help for others rare condition general population
target-metabolic effects

Conditions: Critical Illness; Enteral Nutrition

Summary: the estimation of calorie needs during routine practice in critically ill patients is highly variable and the thermogenic effect of continuous delivery of enteral nutrition (en) on overall calorie utilisation in critically ill adults is unknown. the target-me study is a substudy of the target trial (nct02306746). the target trial provides the perfect opportunity to measure calorie utilisation via indirect calorimetry (ic) and ventilator-derived carbon dioxide production (vco2) to compare measured calorie utilisation to estimation methods, determine the potential thermic effect of en solutions with different energy concentrations and investigate any associations with outcome.


Eligibility criteria:
inclusion criteria: patients must first meet the inclusion and none of the exclusion criteria for the target main trail (nct02306746). the following additional criteria applies for this study when indirect calorimetry is being used: * within 48 hours of randomisation to target (first measurement only) * fi02 \< 50% for the past 1 hour * positive end expiratory pressure (peep) \< 12 mmhg for the past 1 hour * the ic test can be conducted within 48 hours of randomisation to target * the patient is not considered agitated using the usual site assessment * there is a clinician available to complete the test exclusion criteria: * there is an air leak in the ventilation circuit (ie bubbling inter-costal catheters, cuff leak at the endotracheal tube * the patient is receiving renal replacement therapy or extracorporeal membrane oxygenation at the time of measurement * has had surgery in the last 6 hours (if enough time within the 48 hour window, consider waiting until this criteria is less than 6 hours) * if the patient has a traumatic brain injury, for the previous 6 hours, their intracranial pressures have been unstable and in the opinion of the treating intensivist are not controlled * the treating clinician believes that the ic test will pose risk to the patient
bioavailability of carotenoids and flavonoids from fresh oranges and orange juice.

Conditions: Healthy

Summary: the study was designed as a randomized 2-way cross-over study to assess the bioavailability of carotenoids and flavonoids from sweet oranges and orange juice. volunteers followed a wash-out period for 2 weeks prior to eating either 400 g of fresh oranges or 719 g of orange juice. the amount of test food was adjusted to deliver an equal amount of β-cryptoxanthin (740 µg). after a consecutive wash-out period of 2 weeks, the procedure was repeated and the volunteers ingested the complementary test food. blood samples were collected at 8 time points up to 9.5 h after test meal consumption. additionally, 24 h-urine was collected to evaluate flavonoid recovery.


Eligibility criteria:
inclusion criteria: * healthy adult men and women * bmi: 17-60 * age: 18-65 exclusion criteria: * women who are lactating or pregnant or plan to be pregnant * individuals using tobacco products * individuals with metabolic or malabsorption disorders * individuals with a history of cancer * individuals with a history of liver insufficiency * individuals with a history of chronic and lipid metabolism-related diseases * individuals with an allergy to oranges * obese individuals (bmi \> 30)

Keywords: carotenoid bioavailability beta-cryptoxanthin flavonoid hesperidin narirutin randomized cross-over pharmacokinetics micronutrients oranges/orange juice
belotecan (ckd-602) in recurrent or progressive carcinoma of uterine cervix

Conditions: Cervical Cancer

Summary: -list item one, the purpose of this study is to evaluate the overall response rate of belotecan (ckd-602) in recurrent or progressive carcinoma of uterine cervix

* list item one, to evaluate toxicities of belotecan * list item two, to evaluate duration of primary response for responding patients * list item three, to evaluate time to disease progression * list item four, to evaluate progression free survival and overall survival.

Eligibility criteria:
inclusion criteria: * histologically confirmed, patients with recurrent uterine cervical carcinoma who were unsuitable candidates for curative treatment with surgery and/or radiotherapy. * one of the following histologic types * squamous cell carcinoma * adenocarcinoma * adenosquamous carcinoma * clinically measurable disease * performance status of 0, 1, 2 on the ecog criteria exclusion criteria: * histology of neuroendocrine tumors * patient previously treated with topoisomerase-i inhibitor
a phase 2a of rslv-132 in subjects with systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: this study evaluates the impact of 13 bi-weekly intravenous infusions of rslv-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.


Eligibility criteria:
inclusion criteria: * clasi score greater than or equal to 10 at baseline * positive for one or more rna autoantibodies exclusion criteria: 1. severe, active central nervous system (cns) involvement at screening; 2. severe renal involvement at screening (urine protein/creatinine ratio of \>200 mg/mmol, or an estimated creatinine clearance of \<30 ml/min); 3. use of cyclophosphamide within 3 months of the baseline visit; 4. use of rituximab within 6 months of the baseline visit; 5. use of belimumab within 3 months of the baseline visit; 6. use of background medications within 1 month of baseline in excess of: i. mycophenolate mofetil \> 3 g/day; ii. azathioprine \> 200 mg/day; iii. methotrexate \> 25 mg/day; iv. hydroxychloroquine \> 400 mg/day; v. prednisone (or equivalent) \> 15 mg/day; 7. use of an intravenous steroid "pulse" within 2 months of baseline; 8. use of an intramuscular steroid injection within 1 month of baseline; 9. change in sle medications within 1 month of baseline; 10. the presence of a clinically significant infection in the judgement of the investigator within seven days prior to the receipt of the first dose of study drug; 11. positive viral load test for hepatitis b, c, or hiv at screening; 12. participation in another clinical trial with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from baseline; 13. positive pregnancy test at screening or at baseline; 14. female subjects currently breast feeding at baseline; 15. inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the investigator, would make the subject unsuitable for study participation.
the molecular basis for a broad range of phenotypes related to htas2r38

Conditions: Healthy

Summary: this single-site, within-subject, experimental study is designed to test the hypothesis that individuals express taste receptors differently and have different sensitivities to bitter taste samples, which results from uneven expression. subjects will include 100 racially and ethnically diverse, healthy adults. all subjects will provide saliva samples for genetic analysis and undergo taste testing with common psychophysical stimuli. from the pool of 100 subjects, 36 subjects from the common heterozygous group (pav/avi) and two from each homozygous group (avi/avi, nontaster and pav/pav, taster) will be invited to return for two additional sessions. during both sessions the investigators will 1) measure bitterness thresholds for prop, a common psychophysical stimulus; 2) measure bitterness perception of several vegetables; 3) obtain a saliva sample and 4) collect taste papillae. the investigators will then isolate dna and rna from the taste papillae and isolate dna from saliva to evaluate molecular differences over time and between individuals and how it relates to taste psychophysics. all psychophysical and cellular measurements will be done during both sessions so that the investigators can determine how much variation is observed over a one-week time period in both cellular phenotype and psychophysical phenotype.


Eligibility criteria:
inclusion criteria: * key inclusion criteria include age 18-40 years; english speaking, and good health at the time of study participation. exclusion criteria: * key exclusion criteria include cigarette smoking, which alters taste perception, oral disease and subjects undergoing coumadin therapy. subjects showing signs of oral disease, including tongue lesions or xerostomia will be excluded from tongue biopsy and therefore excluded from the study. subjects undergoing coumadin therapy will be excluded from tongue biopsy due to the risk of bleeding, and therefore excluded from the study. subjects will not be excluded because of economic status, gender, race or ethnicity.

Keywords: bitter taste psychophysics genetics epigenetics bitterness sensitivity
probiotics for preterm infants

Conditions: Preterm Infant Feeding Outcomes; Probiotic

Summary: probiotics will be used for preterm infants under 32 weeks of gestation and under 1500 g birthweight. our aim was to investigate the effects of probiotics for stable preterm infants after extubation and who reached full enteral feeding. there are some hesitations among care-givers to start probiotics early due to safety issues although there are many positive effects of these products reported int the literature.

our study included premature babies with a birth weight of less than 1500 grams, born at less than 32 weeks of gestation, and without congenital anomalies. approval was obtained from the hospital's clinical research ethics committee before starting the study. the decision to start probiotics was made when these premature babies were fully enteral fed. the study design was created as a cohort and case-control study (no randomisation). when clinicians decided to start probiotic support for premature babies with good general health and no additional problems, probiotics were added to the baby's order.

Eligibility criteria:
inclusion criteria: \<32 weeks, \<1500 g birthweight - exclusion criteria: congential anomalies, still parenteral feeding, bw\<800 gr and \<23 weeks of ga -