Kornimate/medical-research-clean huggingface dataset:
a research study to evaluate the safety of nnc4004-0002 when given to participants with asymptomatic hyperuricemia

Conditions: Healthy Volunteers; Hyperuricemia

Summary: this study will evaluate an investigational drug called nnc4004-0002. "investigational" means nnc4004-0002 has not been approved for sale/ for clinical use or for the use described in this study/ by any regulatory authority. its use in this study is experimental. this will be the first time that nnc4004-0002 will be given to human. this study will be testing the ability of the study medicine to lower serum uric acid. the main aim of this study will be to see if the new study medicine is safe and tolerated by the body after a single dose of study medicine in adults with asymptomatic hyperuricemia. participants will either get nnc4004-0002 (the study medicine), or saline. which treatment the participant get will be decided by chance. the participant will get the medicine as an injection under their skin. depending on the dose they will receive, participant may need more than one injection. the study will last for about 19 months in total. the participant will take part in the study for about 7 months. participant will have approximately 14 visits to the clinic and one of them will be a 4 night in-house stay.


Eligibility criteria:
inclusion criteria: * males or females 35 to 75 years of age at the time of signing the informed consent form (icf). * considered to be generally healthy based on medical history, physical examination, and the re-sults of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator. * body mass index (bmi) 20 to 35 kilogram per meter square (kg/m2) (both inclusive) at screening. * serum uric acid levels greater than or equal to (≥) 6.8 miligram per decileter (mg/dl) to less than or equal (≤) 12 mg/dl on 2 consecutive screening samples (the first at the screening visit \[v1\], and the second taken at v2 \[day -1\]; samples at least 7 days apart). exclusion criteria: * female who is pregnant, breastfeeding, or intends to become pregnant or is of childbearing po-tential and not using an adequate contraceptive method. * male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method. * present or prior history of gout, or present or prior use of serum uric acid (sua) lowering medication. * serious cardiovascular or hepatic disease, current or past malignancies, or chronic debilitating neurologic, gastrointestinal, or inflammatory diseases. * history or current diagnosis of chronic history kidney disease. * screening alanine transaminase (alt) or aspartate aminotransferase (ast) values greater than (\>) 2 multiply by (×) upper limit normal (uln) or total bilirubin \>1.5× uln.
a phase i study to estimate the effect of ketoconazole and omeprazole on the pharmacokinetics of dimebon in healthy subjects who are normal or poor cyp2d6 metabolizers

Conditions: Alzheimer's Disease; Huntington's Disease

Summary: this study will evaluate the potential for a drug-drug interaction of dimebon with ketoconazole and omeprazole, potent inhibitors of the drug metabolizing enzymes cyp3a4 and cyp2c19, respectively.


Eligibility criteria:
inclusion criteria: * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * subjects must have either a cyp2d6 em (n=12) or pm (n=12) status based on genotyping at screening. * subjects must have a cyp2c19 em status based on status at screening. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * subjects with any history of a previous seizure or convulsion or significant head trauma. * subjects specifically allergic to imidazole antifungal agents. * subjects specifically allergic to omeprazole or other proton pump inhibitors. * any condition possibly affecting drug absorption (eg, gastrectomy). * subjects with hypersensitivity reactions to dimebon or other antihistamines. * consumption of grapefruit or grapefruit containing products within 7 days prior to the first dose of study medication. * subjects currently taking omeprazole, other proton pump inhibitors, antacids, h2-blockers or cyp2c19 inhibitors. * pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.

Keywords: drug interactions pharmacokinetics cyp2d6 cyp2c19 ketoconazole omeprazole
comminuted proximal humeral fractures. a randomised study of surgical versus conservative treatment

Conditions: Proximal Humeral Fracture; Osteosynthesis or Conservative Treatment

Summary: 1. do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year? 2. do surgical treatment gain more qaly than conservative treatment after one year?


Eligibility criteria:
inclusion criteria: * proximal humerus fracture of ao group b2 or c2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital exclusion criteria: * aged less than 60 year * patients of non-scandinavian ethnicity * previous history of injury or illness of the injured or contralateral shoulder * injury of other part of the humerus or the contralateral upper extremity, * alcohol- or drug abuse * dementia or neurological diseases * severe cardiovascular disease that would contraindicate surgery

Keywords: proximal humerus fracture in elderly
the changes of urine growth factors level

Conditions: Benign Prostatic Hyperplasia

Summary: the changes of urine growth factors level in patients with benigh prostate hyperplasia after medical treatment.

the prevalence of benign prostate hyperplasia, like medical illness such as hypertension, diabetes mellitus and stroke, increase by age. benign prostate hyperplasia will cause bothersome lower urinary tract symptoms in the middle and aged male. previous studies have showed that overactive bladder syndrome (urge, frequency, nocturia or urinary incontinence) has been considered as an important factor to predict successful treatment. urine nerve growth factor level, brain-derived neurotrophic factor and endothelium vascular growth factor have been proved as a simple and noninvasive biomarker for diagnosing overactive bladder. as a result, investigator will investigate the changes of these growth factors level in patients with benign prostate hyperplasia before and after three and six-months medical treatment. in addition, investigator can understand whether overactive bladder will have effects on successful medical treatment in patients with benign prostate hyperplasia.

Eligibility criteria:
inclusion criteria: * men with age 50\~80 years old * ipss\>12 * maximal flowrate 5\~15ml/sec * prostate size\>20ml * urine amount\>150ml * patient/family can sigh the inform concent exclusion criteria: * prostate cancer or suspected prostate cancer(psa\>4ng/ml) * history of prostate surgery * free of active urinary tract infection in past 6 months * patient with any other serious disease considered by investigator not in the condition to enter trials

Keywords: benigh prostate hyperplasia(bph) urine growth factors
effectiveness of sphenopalatine ganglion block for post-dural puncture headache

Conditions: Post-Dural Puncture Headache; Sphenopalatine Ganglion Block

Summary: the objective of the study is to determine the effectiveness of spheno-palatine (sp) ganglion block to alleviate the pain of post-dural puncture headache (pdph).

the primary objectives of the study are to study the effectiveness of sp ganglion block in relieving post-dural puncture headache in terms of : 1. number of subjects who get relief of pain 2. the onset time to pain relief after application of block 3. the duration of pain relief 4. the incidence of recurrence of post-dural puncture headache secondary objectives are to: 1. monitor any complications due to sp ganglion block 2. measure patient satisfaction 3. monitor any residual effects at 1 months after the sp block

Eligibility criteria:
inclusion criteria: 1. complains of symptoms suggestive of post-dural puncture headache 2. has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days 3. fluent in written and spoken english exclusion criteria: 1. those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of glydo 2. those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block 3. those who refuse to consent to participate in the study 4. patients who have had a failed epidural blood patch 5. cognitive impairment 6. prisoner
circuit-based deep brain stimulation for parkinson's disease; udall clinical core

Conditions: Parkinson Disease

Summary: the goal of this project is to provide comprehensive longitudinal assessments of a cohort of pd patients before, during, and after dbs surgery, including neurological, neurophysiological, and neuropsychological data.


Eligibility criteria:
inclusion criteria: * age 21 years and older * diagnosis of parkinson's disease * candidate for dbs exclusion criteria: * diagnosis of dementia * pregnant women

Keywords: parkinson's disease
efficacy and safety of grazoprevir (mk-5172), elbasvir (mk-8742), and sofosbuvir for chronic infection with hepatitis c virus genotypes 1 and 3 (mk-5172-074)

Conditions: Hepatitis C

Summary: this is a study of grazoprevir (mk-5172) + elbasvir (mk-8742) and sofosbuvir (sof) in treatment-naive participants with chronic hepatitis c (hcv) genotype (gt) 1 or gt3. the objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (svr12).

the study is an open-label, single-center, multiple-arm investigation of a fixed-dose combination \[fdc\] of grazoprevir 100mg + elbasvir 50mg, and sof 400mg, in treatment-naive participants with chronic hcv gt1 or gt3. the impact of study treatment regimens of varying duration on svr12 (undetectable hcv ribonucleic acid \[rna\] 12 weeks after ending study treatment) in cirrhotic (c) participants and non-cirrhotic (nc) participants will be determined (part a). any hcv gt1 participant from study arms 1-4 in part a who experienced virologic relapse will be offered retreatment consisting of 12 additional weeks of treatment with mk-5172/mk-8742 + sof + ribavirin and 24 weeks of follow-up in part b.

Eligibility criteria:
inclusion criteria: * has hcv rna ≥10,000 iu/ml in peripheral blood at the time of screening * has documented chronic hcv gt1 or gt3 infection * has either negative or positive history of liver cirrhosis based on liver biopsy, fibroscan, or fibrosure ® (fibrotest®) * is treatment naïve to all anti-hcv treatment exclusion criteria: * has evidence of decompensated liver disease * is coinfected with hepatitis b virus (e.g. hepatitis b surface antigen positive) or human immunodeficiency virus * has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy * has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc * has clinically-relevant drug or alcohol abuse within 12 months of screening * has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial * has a history of chronic hepatitis not caused by hcv
severity over time of early forms of spondyloarthritis

Conditions: Spondyloarthritis; Spondyloarthritis, Axial

Summary: spondyloarthritis (spa) is a group of chronic inflammatory pathologies whose progression over time is poorly defined, and in particular the clinical and instrumental elements that can predispose to a condition of disease severity are not completely known. it would be important to have an idea of what the predisposing factors are, possibly already at baseline, and possibly also at follow up, of severe disease, so as to be able to act early with more aggressive and targeted therapies on these patients, so as to achieve remission.


Eligibility criteria:
inclusion criteria: * age \&gt;18 years; * diagnosis of spa confirmed by the rheumatologist with duration of symptoms \&lt; * 2 years; * signature of the written informed consent to the study exclusion criteria: * age \&lt; 18 years; * patients suffering from other rheumatic pathologies (even in overlap), or genetic diseases such as marfan syndrome, ehlers danlos syndrome * any medical or psychiatric condition that in the judgment of the investigator would prevent the participant from complying with the protocol or completing the study according to the protocol. * refusal to sign the informed consent to the study.
buprenorphine detoxification with two types of treatment. bbd iv - 13

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to evaluate buprenorphine and behavioral treatment with and without contingent payment on compliance with pro-social activities. in addition, we will examine whether blind naltrexone dosing is effective in indicating naltrexone consumption.


Eligibility criteria:
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positive assurance and mtbi

Conditions: MTBI - Mild Traumatic Brain Injury; Concussion, Mild Traumatic Brain Injury

Summary: this study will develop and validate a new ed/urgent care discharge educational video that provides positive assurance about mild traumatic brain injury (mtbi) recovery for patients with mtbi.

the research team will investigate the effect of this new ed/urgent care positive assurance discharge intervention video on state anxiety and clinical recovery outcomes in pediatric patients with mtbi. a sample of adolescent and young adult patients (13-21yrs) will be recruited for participation that present to the ifh pediatrics ed (ped) and/or inova gohealth urgent care sites with confirmed mtbi diagnosis and receive specialty referral to the inova sports medicine concussion program for follow-up care. investigators will employ a randomized controlled trial (rct) to enroll two groups of mtbi patients: 1) a group that receives the video intervention (educ), and 2) a group that receives standard discharge instructions (i.e., treatment as usual: tau).

Eligibility criteria:
inclusion criteria: 1. 13-21 years 2. has sustained an external force to head or body resulting in neurological symptoms and at least one reported symptom is attributed to the mtbi (e.g., dizziness, confusion, headache, postural instability, light/noise sensitivity, nausea) 3. has receive a medical diagnosis of mtbi from an emergency physical at the ifh pediatrics ed or inova gohealth urgent care clinic within 72 hours of injury 4. is able to provide informed written consent (parent) and assent exclusion criteria: 1. loss of consciousness \&gt; 30 minutes in conjunction with the injury 2. glasgow coma scale (gcs) score \&lt; 13 3. has sustained a previous mtbi within the past 6 months 4. has a neurological disorder (e.g., epilepsy) 5. has a positive finding on brain imaging (e.g., ct, mri) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma) 6. has a previous history of neurosurgery 7. does not speak english as a primary language 8. requires admission to the hospital 9. has developmental delays 10. prisoner 11. pregnant\* 12. has been previously enrolled in the study 13. members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.
the cytogenetic constitution of embryos resulting from immature oocytes (m1)

Conditions: Infertility

Summary: to examine the chromosomal number content in the blastomeres of embryos achieved from fertilization of immature oocytes at mi stage recruited following coh for ivf. comparison of the genetic number content of embryos and their quality in terms of cleavage rate and morphological score reached after fertilization of immature oocytes at mi stage whether arrested at the mi stage or extruded the polar body, after in vitro maturation for a variable length of time.

patients undergoing routine ivf, following informed consent, donated some of their unusable, immature- mi stage oocytes for our research. following in vitro maturation for up to 2, 4, 8 and 24 hours after harvest, all immature oocytes in these 4 study groups underwent intracytoplasmic donor sperm injection (icsi), whether they extruded their polar body (mi-pb or rescued mi) or not (arrested mi). oocyte fertilization rate after 24 hours and embryonic development in terms of cleavage rate and morphology were assessed, for another 48 hours. then the whole embryo was prepared for molecular cytogenetic evaluation using fish (fluorescence in situ hybridization) analysis of chromosomes x, y and 18.

Eligibility criteria:
inclusion criteria: * patients with presence of immature oocytes after art stimulation exclusion criteria: * patients with less than total 7 oocytes

Keywords: mi oocytes, fish,chromosomal aberrations
continuous versus cyclic oral contraceptives for endometriosis

Conditions: Dysmenorrhea; Pelvic Pain; Dyspareunia; Endometrioma

Summary: to evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery.

oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. one tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or one tablet a day in a continuous fashion.

Eligibility criteria:
inclusion criteria: women of reproductive age with symptomatic endometriosis following fertility sparing surgery exclusion criteria: contraindications of use of oral contraceptives

Keywords: endometriosis oral contraceptives laparoscopy
endoscopic ultrasound (eus) processor comparison

Conditions: Pancreatitis; Pancreatic Carcinoma

Summary: the primary objective for this study is to compare the image quality of two endoscopic ultrasound (eus) processors used for imaging of the pancreas. processor images are used to make a correct clinical diagnosis and higher quality imaging is related to more accurate results. patient care may be improved due to the information collected as part of this study. the quality of imaging is of utmost importance for diagnosing early neoplasms in the pancreas and diseases such as chronic pancreatitis. image quality is dictated by two factors: image resolution and depth of penetration. good imaging enables diagnosis of early stage disease and thereby facilitates early treatment.

the endoscope is usually connected to a processor that generates an image which is viewed on a monitor. at fh, we use a processor called aloka 10. a new processor is being developed by olympus corporation called eu-me 2. this new processor is fda approved, but has not been launched commercially yet. it has been loaned to fh for evaluation. we would like to evaluate this processor in an objective manner and hence the request for study approval. in this study, the endoscopy during the procedure will be attached to two different processors and images will be generated. the choice of which processor will be used first will be at the discretion of the endoscopist. this does not require removal and reintroduction of the endoscope into the patient at two occasions. only the connector will be switched to a different processor. so there is negligible risk to the patient. the time required for research activities will be between 5-10 minutes. both processors will be set up in the procedure room for the duration of this study. the physician will then document the depth of penetration of the image (the farthest structure seen) and image resolution (evaluating the pancreas for subtle abnormalities). both processors will be used for each patient. the scores for each processor will be documented to a procedure log, using the primary endpoint described above. the crf will not have any patient information. images viewed by the physician at the time of procedure will not be saved or recorded as part of this study.. eus will be performed in the standard fashion by one of the experienced endosonographers in the unit. once the eus is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient. patients will then be transported to the recovery area for observation as per standard policy. after appropriate observations are deemed satisfactory, patients will be discharged as per unit policy.

Eligibility criteria:
inclusion criteria: all patients referred to florida hospital endoscopy unit for assessment of pancreas will be included. exclusion criteria: age \<19 years unable to safely undergo eus for any reason
effect of multimedia protocol about asthma control

Conditions: Bronchial Asthma; Childhood Asthma; Climate Change; Multimedia Learning Education

Summary: this study aims to evaluate the effect of multimedia protocol about asthma control on asthmatic children's adaptation in the era of climate changes.

in fact, asthma has evolved into a global public health crisis affecting millions of people worldwide . it is one of the most prevalent chronic diseases, with a substantial burden on individuals, families, healthcare systems, and societies as a whole . asthma not only leads to missed school and work but can also result in severe health emergencies and even death, especially in children . this burden is on the rise, with millions already affected and projections of millions more to come . furthermore, the complex interplay of genetic, environmental, and lifestyle factors contributing to asthma's development adds to the urgency of addressing this issue . importantly, the impact of global climate change, with its extreme weather events and increased air pollution, poses an additional threat to asthma sufferers, making it imperative to implement climate change and asthma adaptation measures . the problem's significance is compounded by the vulnerability of children to these environmental changes and the need for innovative strategies like educational multimedia to raise awareness and provide effective interventions. addressing this multifaceted problem is essential for the well-being of individuals and communities worldwide. therefore, this study aims to evaluate the effect of multimedia protocol about asthma control on asthmatic children's adaptation in the era of climate.

Eligibility criteria:
inclusion criteria: * chronic asthmatic children (aged 7-11 years). * both urban and rural asthmatic children. * children and their mothers who have not received current or prior guidance about asthma control with the repercussions of climate changes. * children whose mothers is educated. exclusion criteria: * - children with severe or acute asthma attacks as confirmed by a medical practitioner. * any child suffering from other chronic disease or disability, as confirmed by a medical practitioner.