Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety and interaction between casopitant and ketoconazole when taken by healthy adults

Conditions: Nausea and Vomiting, Chemotherapy-Induced

Summary: casopitant may affect liver enzymes that metabolize ketoconazole. this study is designed to test the safety and the extent of the casopitant affect on ketoconazole levels in healthy human subjects.


Eligibility criteria:
inclusion criteria: * a female subject who is non-childbearing potential or using acceptable contraceptive methods. * adequate organ system functions. * able to swallow and retain oral medication. * subject is able to understand and comply with protocol requirements and instruction and is likely to complete the study. exclusion criteria: * current clinically relevant abnormality, medical condition, or circumstance that makes the subject unsuitable for the study per the study doctor. * history of drug or other allergy which, in the opinion of the study doctor, contraindicates participation. * use of an investigational drug within 28 days or 5 half-lives. * use of prescription or non-prescription drugs, supplements or vitamins (excluding multivitamins) within 14 days, or 5 half-lives prior to first dose of study medication. * blood donation in excess of 500ml within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit. * iron deficiency. * positive stool for occult blood. * female subject who is pregnant or lactating. * male subject who has a history of hypogonadism. * positive urine drug screen. * positive for hiv antibody, hepatitis c antibody or hepatitis b surface antigen. * use of tobacco-containing products within the past 12 months prior to screening. * history of drug or alcohol abuse or dependence within 6 months of screening. * history or presence of uncontrolled emesis. * presence of active infection. * history of cholecystectomy or biliary tract disease. * active peptic ulcer disease (pud) or a history of pud of unknown etiology. * any degree of heart failure. * consumption of any food or drink containing grapefruit or grapefruit juice, apple juice, seville oranges, kumquats, pommelos or vegetables from the mustard green family within 7 days prior to the first dose unless prior approval is received.

Keywords: gw679769 healthy adult subjects casopitant ketoconazole
pivotal, multicenter, observer-blind, randomized study of influenza a (h1n1)2009 monovalent subunit vaccine with and without adjuvant in children ages 6 to <36 months

Conditions: Influenza

Summary: this study will evaluate the safety and immunogenicity of different combinations of a/h1n1 2009 (swine flu) vaccine in healthy young children


Eligibility criteria:
inclusion criteria: * children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months exclusion criteria: * history of serious disease. * history of serious reaction following administration of vaccine or hypersensitivity to vaccine components. * known or suspected impairment/alteration of immune function. * receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination for additional entry criteria, please refer to protocol

Keywords: swine flu flu vaccine children adjuvant a/h1n1 2009 influenza
effect of oxygenated mouthwash and mouth foam

Conditions: Gingival Diseases; Plaque, Dental; Quality of Life

Summary: the aim of this independent, parallel, twelve-week clinical study is to assess the efficacy of a commercially available oxygenated mouth rinse and mouth foam on both plaque level and gingival status in addition to assessing the oral health related quality of life.

participants in all groups will be examined for gingival inflammation and plaque accumulation. the difference between three trial arms lies in the product used (control, oxygenated mouth wash, oxygenated mouth foam). a comparison against no intervention was disregarded due to ethical concerns (children only examined without informing them about their oral problems). after examination at baseline participants will be assigned to one arm of intervention. all participants will be provided an oral health education and gingival scaling to remove any underlining predisposing factor for gingival inflammation as well as fluoridated toothpaste and a toothbrush. participants within intervention arms will also be provided the product package and informed how to use it (oxygenated mouth wash, oxygenated mouth foam). all three arms will be followed after (1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks) from baseline examination. 1. control group won't receive an oxygenated mouthwash nor oxygenated mouth foam (20 participants) 2. intervention group a: 20 participants - 2 oxygenated mouthwash bottle per individual for 3 months (40 bottles in total). 3. intervention group b: oxygenated mouth foam/ day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).

Eligibility criteria:
inclusion criteria: * students and employees at college of applied medical science over 19 years old * both saudis and non-saudis. * students and employees consenting to participate. exclusion criteria: * intern students or students in their 1st year. * students and employees with medically compromised condition (including congenital heart disease, hematological condition, immune deficiency condition and end stage renal disease or those with organ transplant within the previous 5 year. * students and employees not consenting to participate.
short and long-term safety of micafungin and other parenteral antifungal agents

Conditions: Systemic Fungal Infections

Summary: this multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2017.

all eligible patients treated with a parenteral antifungal agent at any time during the years 2005-2012 in each of the participating hospitals, will be included in the study.

Eligibility criteria:
inclusion criteria: * hospitalized and treated with parenteral antifungal medication * first time treatment of the patient with parenteral antifungal in the medical center was anytime from 2005 through 2012 exclusion criteria: * prior diagnosis of hepatocellular carcinoma * had received parenteral antifungal therapy during the 6 months prior to index hospitalization

Keywords: hepatic toxicity renal toxicity micafungin hepatocellular carcinoma antifungals (parenteral)
comparison of remimazolam and dexmedetomidine for intraoperative sedation

Conditions: Orthopedic Disorder

Summary: the purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.


Eligibility criteria:
inclusion criteria: * patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of asa class i or ii. exclusion criteria: * patient refusal * contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy) * contraindications to dexmedetomidine or remimazolam administration * allergy to dexmedetomidine or remimazolam * baseline moaa/s score of 4 or less * pregnancy * other conditions considered unsuitable by the investigators
prestige: prevention of stent thrombosis by an interdisciplinary global european effort

Conditions: Coronary Artery Stent Thrombosis

Summary: the prestige-registry is a joint effort at 9 european heart centers to collect data regarding patients presenting with stent thrombosis in a dedicated database. there will be extensive clinical and procedural characterization, furthermore blood platelet function testing, intracoronary imaging, dna-sampling and analysis of thrombus aspiration will be performed.

rationale: stent thrombosis (st) is a serious complication of percutaneous coronary intervention (pci) with stent implantation. previous studies have been hampered by small sample size, in particular regarding the number of patients with late and very late st and patients with des thrombosis, and by incomplete patient characterisation, particularly concerning intracoronary imaging and blood platelet function data. objective: to identify novel predictors and to observe clinical outcome after an episode of st, with the use of state-of-the-art new techniques such as oct/ivus, platelet function testing, genetic analysis. study design: multicenter matched case control study study population: cases: all patients presenting with definite st. expected number of patients to be included: 2000 controls: patients undergoing pci will be matched based on the following criteria: expected number of patients to be matched: 2000 1. who underwent a pci for the same indication 2. who underwent a pci on the same date (±5 days) 3. who underwent a pci in the same interventional centre main study parameters/endpoints: clinical, ecg, biochemical, angiographic, procedural, haematological, histopathological, genetic, oct/ivus-imaging, and follow-up characteristics nature and extent of the burden and risks associated with participation, benefit and group relatedness: prior to pci, 50 ml of whole blood will be drawn from all patients. primary pci for st will be performed according to institutional best practise. during pci, performance of optical coherence tomography and/or intravascular ultrasound is encouraged. thrombus aspiration is performed when indicated. during hospitalisation, all patients will be asked to fulfil a questionnaire regarding possible triggering mechanisms that might have provoked the st. patients will be asked to visit the patient clinic for platelet function 30 days after the acute phase of the st. finally, patients will be contacted for follow-up details.

Eligibility criteria:
inclusion criteria: * patients presenting with stent thrombosis exclusion criteria: * patients refusing informed consent

Keywords: stent thrombosis intra coronary imaging blood platelet function testing
study of treatment and metabolism in patients with urea cycle disorders

Conditions: Amino Acid Metabolism, Inborn Errors

Summary: rationale: the urea cycle is the process in which nitrogen is removed from the blood and converted into urea, a waste product found in urine . urea cycle disorders are inherited disorders caused by the lack of an enzyme that removes ammonia from the bloodstream. gene therapy is treatment given to change a gene so that it functions normally. studying the treatment and metabolism of patients with urea cycle disorders may be helpful in developing new treatments for these disorders. purpose: two-part clinical trial to study the treatment and metabolism of patients who have urea cycle disorders.

protocol outline: this protocol involves 2 clinical studies. part a is a metabolic study of glutamine conversion to urea at different levels of protein intake, while on and off medications. part b is a dose escalation study of a first-generation adenoviral vector with an e1 deletion and an e3 deletion substitution (d1309) expressing ornithine transcarbamylase (otc). in part a, diet is controlled for protein and calories. intravenous glutamine and urea are administered. controls are given intravenous arginine, phenylacetate, and benzoate. in part b, groups of 3 patients are given a single low, intermediate, or high dose of intravenous otc vector. allopurinol is administered every 12 hours for 12 days. as of 12/10/1999, part b of the study is closed.

Eligibility criteria:
protocol entry criteria: part a. patients at least 6 months old with ornithine transcarbamylase deficiency (otc), i.e.: hemizygous otc or homozygous autosomal recessive disorder with evidence of complete enzyme deficiency hemizygous otc male with late presentation and presumed evidence for residual enzyme activity otc heterozygotes (molecular diagnosis) with severely symptomatic to asymptomatic disease obligate heterozygotes for autosomal recessive disorder (parent or genotyped sibling) normal adult volunteers and genotyped siblings entered as controls part b. metabolically stable heterozygous otc females aged 18 to under 65 orotic acid level at least 5 times normal on allopurinol symptoms ranging from severe to asymptomatic acceptable no prior hospitalization for hyperammonemia exclusion criteria (parts a and b): acute or chronic intercurrent illness pregnancy acute hyperammonemia

Keywords: inborn errors of metabolism rare disease urea cycle disorder
study of 5 and 10 days treatment with penicillin against sore throat caused by streptococci

Conditions: Tonsillitis

Summary: the primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (pcv) in adults, adolescents and children with streptococcal tonsillitis. patients are recruited from 17 primary health care centres in the south of sweden. adult men and women, youth and children ≥ 6 years of age who are visiting the primary health care for sore throat with suspected tonsillitis and meeting the criteria in accordance with current treatment recommendations for pharyngotonsillitis, ie 3-4 centor criteria (fever≥ 38.5, tender lymph nodes, coatings of the tonsils and absence of cough) and a positive rapid antigen detection test (radt) for group a streptococcus (gas) will be included in the study. patients will be randomized to be prescribed pcv of 5 and 10 days. each patient or guardian fills daily in a short diary including aches, fever, pcv doses, pain relievers, adverse events etc. five to seven days after last intake of pcv the general practioner make a clinical judgement if the patient has recovered from the pharyngotonsillitis. questions to be asked are if remaining symptoms or new symptoms of sore throat is present, if adverse events have been noted or of any extra physician visits have been made. throat swab for semi quantitative cultures of streptococcus group a, c and g are made at randomization and five to seven days after last intake of pcv. a study nurse will contact the patients one month and three months after the last treatment day for follow-up. if the patient has reconsulted or been hospitalised for a sore throat or possible complication, those patient records will be examined.


Eligibility criteria:
inclusion criteria: * adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis. exclusion criteria: * signs of serious infection. * known hypersensitivity against penicillin. * chronic disease with effect on the immune response. * immunosuppressive treatment. * streptococcal tonsillitis within one month (relapse).
video recording in the delivery room in very preterm infants (video apgar trial)

Conditions: Premature Birth

Summary: a video of the delivery room management will be taken using standardized conditions. the video will be evaluated either locally by those directly involved in the delivery room care of this specific infant or anonymously at the main study center. using a standardized evaluation form a set of predefined interventions is rated regarding at what time they took place and at what time they should have taken place. the difference in time for all interventions is summed up to a score. this score should allow to assess the delivery room management in comparison to the desired standard as well as between hospitals. the evaluation forms of all centers will be analyzed at the main study center to define correlations between certain delivery room interventions and short term outcome. aim of the study is to * gather data on how delivery room care is currently done, * come closer to an agreement between different nicus towards what should be done in the delivery room under what circumstances in which way, * find those interventions with potential influence on short term outcome. those aspects of management that are different between centers and show correlation with short term outcome will be the focus of future prospective intervention trials in order to find the best way how to take care of preterm infants in the delivery room. hypothesis: in preterm infants \<32;0 weeks of gestational age a correlation exists between specific delivery room interventions and short term outcome.

delivery room interventions measured are: stimulation, ventilation, oxygen, cardiac massage, suctioning, ven / art access, fluid and drugs given short term outcome measurements are: ivh, pvl, pneumothorax, bpd, dol when first time 120ml/kg oral feeds, nec, rop, death, head circumference at discharge

Eligibility criteria:
inclusion criteria: * preterm infants \<32;0 weeks of gestational age exclusion criteria: * infants in whom no life support is being planned - e.g. those with lethal malformations

Keywords: infant, premature delivery rooms video recording outcome assessment (health care)
a study of cm313 injection in subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: a study of cm313 in subjects with systemic lupus erythematosus

this is a multi-center, randomed, open-label, dose escalation and dose expansion, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity. about 40 patients who meet eligibility criteria will be randomized 4:1 to receive either cm313 or matched placebo, intravenous infusion. the treatment period includes single dosing and multiple dosing period, in which cm313 and placebo will be adminitrated intravenously, once every 1 week.

Eligibility criteria:
inclusion criteria: * 18 years old ≤ age ≤ 65 years old. * positive autoantibody serology test at screening. * contraception. * voluntarily sign the icf. exclusion criteria: * with central nervous system disease caused by or not caused by sle within 8 weeks before the first dose of study drug. * possibly active mycobacterium tuberculosis infection. * with the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation. * heavy drinking in the 3 months prior to screening. * with depression or suicidal thoughts.
driving inclusivity, validity, and equity in research through strategic engagement (diverse)

Conditions: Blood Cancer; Leukemia

Summary: the purpose of this research study is to enhance inclusion and diversity in clinical trial enrollment by training participants to perform and provide feedback through a community-based protocol review process, called diverse.

this research study aims to pilot a protocol review process, called diverse, assessing its feasibility, acceptability, and preliminary efficacy to enhance inclusion and diversity in clinical trial enrollment. patients and community participants will complete specialized training and provide feedback on clinical trials in development through the diverse process; they will also provide feedback on the process itself. investigator participants will request review and provide feedback on the diverse process. the study is based on community-based participatory research. participation in this research is expected to last about 18 months. it is expected that about 20 patient and community participants and 20 investigators will participate in this research study. the national cancer institute and american society of clinical oncology are providing funding for this research study.

Eligibility criteria:
cab participant inclusion criteria: * age 18 or older * english speaking * ability to understand and willingness to provide oral consent * dfci patient who are in remission from a blood cancer \>1 year will be preferred. cab participant exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers \<18 years old) * prisoners. * unwilling/unable to agree to maintaining the confidentiality of reviews and clinical trial materials, as outlined in section 9.1 * note 1: patients and non-patient community members who are pregnant are eligible. this is a non-interventional study that meets the definition of minimal risk and poses no greater risk to pregnant individuals or fetuses. pregnancy status will not be assessed. * note 2: english fluency is necessary as protocols being reviewed are written in english and cannot be feasibly translated to other languages within the time period necessary to complete timely reviews. investigator participant inclusion criteria: * age 18 older * english speaking * site or principal investigator * not a member of the research team

Keywords: blood cancer leukemia
comparison of a prophylactic intraligamentary injection of piroxicam versus mepecaine of post-endodontic pain

Conditions: Pulpitis - Irreversible

Summary: to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.

the pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment it appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and nsaids before the onset of postoperative pain. administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process

Eligibility criteria:
inclusion criteria: * • medically free patients * patient's age between 25-50 years. * molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis. * positive patient's acceptance for participation in the study. * sex include both male and female. * patients who can understand numerical rating scale (nrs) * patients able to sign informed consent. exclusion criteria: * • pregnancy or lactation in female patients * medically compromised patients. * patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral. * patient with fracture or mobile or mutilated teeth.

Keywords: irreversible pulpitis post endodontic pain symptomatic pulpitis pain single visit rct pain root canal treatment flare up single dose piroxicam intraligamentary piroxicam intraligamentary mepecaine