Kornimate/medical-research-clean huggingface dataset:
efficacy and safety eval of guanfacine hydrochloride in combination with psychostimulants in adults (18-65).

Conditions: Adult Attention-Deficit Hyperactivity Disorder

Summary: this is considered an investigator-initiated clinical research trial, which means that your study doctor is researching a particular medication (in this case a medication that is currently fda- approved) for the treatment of ad/hd in individuals ages 6-17. the medication is guanfacine hydrochloride. the hypothesis is that this medication could be used in adults with attention deficit/hyperactivity disorder who have not received satisfactory results with their current stimulant adhd medication. the study drug is investigational for use in adults. investigational means it has not been approved by the u.s. food and drug administration (fda) for use in adults.

the purpose of this study is to determine whether guanfacine hydrochloride used as an adjunct therapy (to subjects' current stimulant medication) would bring about a statistically significant improvement in ad/hd symptoms.

Eligibility criteria:
inclusion: * male and females (non pregnant) ages 18-65 * current diagnosis of adhd and have met the dsm-iv-tr criteria for adhd * currently taking an adequate dose stimulant to treat their adhd (with a sub-optimal response). a suboptimal response is determined by a baseline score of 28 or greater on the adhd-rs or a cgi score of 4 or greater. * subjects must be of normal intelligence * english speaking * able to swallow pills. exclusion: * non pregnant or lactating females * severe axis i and axis ii disorders * suicidal * tourette's * heart disease or any other serious chronic or acute unstable medical conditions/illnesses that would compromise participation or likely lead to hospitalization during the duration of the study. * a known history or presence of cardiovascular, hepatic, renal, respiratory, or hematologic abnormalities, narrow angle glaucoma, or any other unstable medical or psychiatric conditions (as judged by the primary investigator) * a current or recent history (within the past 6 months) of suspected substance abuse and/or drug dependence as defined by dsm-iv-tr criteria * healthy weight (not under or over as judged by investigator) * no immediate family member of the investigator or research staff no involvement in a research study in the last 30 days.
optimized pgt-m strategy for patients with no proband

Conditions: De Novo Mutation; Preimplantation Genetic Testing; Without Proband

Summary: the clinical practice of pgt-m for monogenetic disease usually adopted a double-checking strategy, which detect the mutation by sanger sequencing and meantime construct haplotypes using the dna sample of the proband so as to avoid the risks of misdiagnosis due to recombination and allele drop out (ado). when there is no affected parent or offspring to serve as the proband, embryo carriers identified through direct mutation detection can be preferentially taken as probands for subsequent linkage analysis. in cases where none of the embryos are detected as mutant carrier, single sperm or the second polar body (pb2) can be complementally collected in the work-up of haplotype establishment. our study aims to develop an optimized strategy of haplotype construction using gametes or arrested embryos for pgt-m in pedigrees with single gene diseases and no proband in the setting of difficult cases, which takes into account the expected number of oocytes acquired and the gonadal mosaicism.


Eligibility criteria:
inclusion criteria: * the couples intended for pgt-m without proband were recruited from shanghai jiai genetics and ivf institute, obstetrics and gynecology hospital of fudan university between january 2023 and december 2024, and were included in the study if they were expected to have difficulties in the identification of an eap, typically meeting one of the following criteria: 1. the carrier of the pathogenic variant was without typical clinical symptoms or detected as gonadosomal mosaic; 2. the asymptomatic parents, who had one or more children affected with the same disorder, did not possess the genomic alterations carried by the children as per sanger sequencing or targeted deep sequencing; 3. female partner with diminished ovarian reserve and therefore a low yield of embryos; 4. the variants are x-linked and the karyotype of the variant carrier is 47, xxx or 47, xxy etc. exclusion criteria: * (1) non-pgt-m families; (2) pedigree of other proband samples can be obtained; (3) patients seeking for pgt-m who strongly request no haplotype analysis in embryos and only require sanger testing after being fully informed of the risk.

Keywords: preimplantation genetic testing without proband de novo mutation
safety and tolerability of ertapenem sodium in the treatment of complicated urinary tract infections (0826-055)

Conditions: Urinary Tract Infection

Summary: the purpose of this study is to determine the efficacy of ertapenem sodium (invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.


Eligibility criteria:
inclusion criteria: * adult patients with a suspected or documented complicated urinary tract infection * female patients must test negative for pregnancy and agree to use adequate birth control measures * nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy exclusion criteria: * patients with complete obstruction of any portion of the urinary tract * patients with rapidly progressive or terminal illness * renal transplant patients
prophylactic post-cesarean incisional negative-pressure wound therapy in morbidly obese patients

Conditions: Negative-pressure Wound Therapy; Morbid Obesity; Cesarean Section; Wound Infection

Summary: to evaluate the effectiveness of negative-pressure wound therapy in decreasing wound complications in morbidly obese patients (bmi greater than of equal to 40) at albany medical center hospital. retrospective data will be collected regarding morbidly obese patients who have undergone cesarean section and patients will be recruited to have the intervention (negative-pressure wound therapy) applied and outcomes will be evaluated.


Eligibility criteria:
inclusion criteria: * women undergoing cesarean section at albany medical center hospital * current bmi greater than or equal to 40 exclusion criteria: * current bmi less than 40 * current skin or soft tissue infection * skin or soft tissue disorder * allergy to silver
treating heart failure with enhanced external counterpulsation (eecp)

Conditions: Heart Failure

Summary: enhanced external counterpulsation (eecp) is an outpatient coronary artery disease (cad) therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower extremities. however, the possible benefits of eecp in patients with heart failure (hf) (new york heart association \[nyha\] classes ii to iv) and cardiomyopathy are unclear.


Eligibility criteria:
inclusion criteria: * patients with heart failure (nyha ii-iv) 1. with optimal medical therapy 2. caused by ischemic or non-ischemic cardiomyopathy * eecp-therapy and treatment in the cardio centrum berlin or charité - university medicine berlin * aged 18 to 100 years * offered patient information and written informed consent exclusion criteria: * participation in another interventional trial * acute coronary syndrome \< 4 weeks prior to enrollment * operation \< 4 weeks prior to enrollment * stroke \< 4 weeks prior to enrollment * clinically significant disease with hospitalization * aortic valvular heart disease ≥ moderate * aortic aneurysm * clinically relevant severe cardiopulmonal diseases * resting rr \> 160/90mmhg * thrombose, thrombophlebitis \< 8 weeks prior to enrollment * peripheral artery occlusive disease ≥ stadium ii * acute heart failure * pathological bleeding tendency * arrhythmias, which interfere with triggering of the eecp * other diseases, that inhibit eecp-treatment (e.g. spinal disc herniation) * accommodation in an institution due to an official or judicial order * women: pregnancy or lactation
prospective study to measure the impact of mammaprint on adjuvant treatment in hormone receptor-positive her2-negative breast cancer patients (prime)

Conditions: Breast Cancer

Summary: prime is a prospective, case-only trial designed to measure the impact of mammaprint on physician chemotherapy intention in the two discordant groups (et/poor, ct/good) in stage 1 and 2 hr-positive her2-negative breast cancer patients. the design also provides for assessment of several important secondary indicators. eligible patients will have their tumor sample analyzed for mammaprint, blueprint and targetprint. patients cannot start treatment before the mammaprint result is received and taken into consideration for the adjuvant treatment plan.


Eligibility criteria:
inclusion criteria: * women with histologically proven invasive stage 1 and 2 breast cancer * hormone receptor positive according to local standards * her2 negative - i.e. ihc 0-1+, or fish or other ish non-amplified (locally assessed) * axillary lymph node status: 0-3 involved (macro metastases i.e. \>2mm or micro metastases i.e. \>0.2-2mm) * ≥ 18 years of age at time of consent * patients must be eligible to receive adjuvant chemotherapy and endocrine therapy as defined by a good karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity * written informed consent exclusion criteria: * ≥4 involved axillary nodes * multi-centric disease with more than 2 clinically relevant lesions * hr negative or her2 positive/amplified (locally assessed) * previous diagnosis of malignancy unless disease free for 10 years * metastatic disease * tumor sample shipped to agendia with ≤ 30% tumor cells or that fails qa or qc criteria * women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer

Keywords: mammaprint blueprint targetprint
ckit, braf/nras mutations in advanced melanoma : clinical outcome in response to tyrosine-kinase inhibitors - kitmel project

Conditions: Melanoma

Summary: background: metastatic melanoma has a devastating prognosis and is one of the top causes of cancer death in young patients. until now, available therapies were few and unreliable, but recent understanding of melanomas' molecular pathways has improve their classification and new clinical strategies have been proposed. initial studies showed that b-raf/n-ras mutations (respectively v600e and q61) are the most frequent alteration being present in 70 to 80% of melanomas, characterizing non chronic sun-induced damage skins (csd). these include superficial spreading melanomas (ssm) and nodular melanomas (nm). other studies showed that c-kit mutations are presently the predominant activating mutation (20 - 40 %) in acro-lentiginous melanomas (alm), mucous melanomas (mm) and in melanomas arising on csd skin. c-kit mutation pattern is more complex with four exons being affected leading to different mutations, which incidence and biological impact are less documented. braf/nras genetics alterations drive constantly cell growth, being thus attractive targets. spectacular results have indeed been obtained with the braf inhibitor that targets the v600e braf-mutated form. data from gist disease revealed that the different c-kit mutations modulate differently c-kit function and the response to targeted therapies. because c-kit targeted therapy is a critical clinical issue, the investigators aimed to identify the most frequent mutations present in our population to propose appropriate screening test and adapt the therapy. methods: 250 melanoma samples corresponding to an homogeneous white-caucasian population (brittany, france) will be screened. c-kit exons 11, 13, 17 and 18 will be sequenced (direct sequencing and pyrosequencing when possible). c-kit copy number will be quantified by q-pcr and level of c-kit determined by immunohistochemistry (ihc, cd117). samples will also be analyzed for b-raf mutations in codon 464, 466, 469 and 600, and for n-ras mutations in codon 12, 13 and 61 (pyrosequencing). expected results: taken together, the investigators anticipate that the present genetic analysis of the tumours from patients with advanced melanoma will first document the type and frequency of ckit mutations, will confirm or not that braf, nras and ckit mutations are mutually exclusive and document their repartition in the melanomas sub-types. finally this study will clue researchers in to how well patients will respond to a therapy that targets the growth-promoting proteins braf/nras and ckit.


Eligibility criteria:
inclusion criteria: * melanoma * white caucasian population

Keywords: melanoma white-caucasian population
quality of life and treatment satisfaction of people with type 2 diabetes: a european survey

Conditions: Diabetes

Summary: the present european survey seeks to assess quality of life and satisfaction with treatment in people with t2dm and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. it will also provide relevant information on other important aspects such as the level of correlation of objective measures such as hba1c with health status, qol and satisfaction with current treatment. overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. the study will entail a single patient visit. patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review \& an hba1c test, will allow patient, disease and treatment variables to be collected. an hba1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.


Eligibility criteria:
inclusion criteria: * with t2dm, diagnosed at least 1 year prior to entry in the study * currently treated with diet, oad(s) and/or insulin with no change in the type of oad(s) or insulin in the previous three months exclusion criteria: * type 1 diabetes and/or history of diabetic ketoacidosis * secondary diabetes (including disease of the exocrine pancreas, endocrinopathies or drug-induced) * treatment with systemic glucocorticoids other than replacement therapy. inhaled, local injected and topical use of glucocorticoids is allowed

Keywords: diabetes treatment satisfaction quality of life hba1c levels and goals healthcare resources consumption
exhaled breath aerosol for the etiological diagnosis of respiratory tract infections: a pilot study

Conditions: Respiratory Diseases

Summary: pilot study for the evaluation of the feasibility of pathogen detection in exhaled breath aerosols (xbas) samples using the avelocollect device. the aim of the study is to evaluate the feasibility of xba collection and molecular detection of respiratory pathogens using the avelocollect blowtube device (index test) in subjects with a clinical presentation consistent with a respiratory infectious disease, compared to the same molecular assays performed on nasopharyngeal secretions (using commercially available swabs) and sputum (comparator tests).

respiratory infections have a significant impact in terms of morbidity and mortality, both in the eu and globally and were responsible for the majority of pandemics in the last centuries. human breath is an attractive sample type, given the ease of sample collection via non-invasive methods, its direct link to the route of transmission, and its potential role as an indicator of infectiousness. in particular, recent studies have focused on the exhaled breath aerosols (xbas). aerosol transmission was demonstrated for many respiratory infections, including pandemic influenza, respiratory syncytial virus (rsv), tuberculosis (tb) and covid-19. pathogen detection in xba samples has shown a good sensitivity, but currently available research tools are highly technical and resource demanding. new and simplified xba collection devices (face masks, avelocollect blow tube device) are currently under evaluation, and further clinical studies are needed in order to assess their feasibility for pathogen detection in clinical practice, especially for etiological diagnosis in patients with unspecific respiratory symptoms. the objective of this study is to evaluate the feasibility of xbas collection and analysis (index test) using the molecular tests currently in use at san raffaele hospital for the detection of respiratory pathogens in clinical samples, compared to upper respiratory secretion and sputum samples, that will be collected using standard procedures and analysed using the same kits (comparator tests).

Eligibility criteria:
inclusion criteria: * adult age (≥18 years) * subjects with one or more symptoms of respiratory tract infection (fever, cough, sore throat, dyspnea, conjunctivitis and/or rhinitis). * samples collected within 3 days from symptom onset. * no antibiotic drug taken during the previous 3 days exclusion criteria: * pregnancy * samples collected after 3 days from symptom onset. * antibiotic drug taken during the previous 3 days

Keywords: respiratory infection exhaled breath aerosols (xbas) xba collection devices
urinary mirna in endometrial cancer study

Conditions: Endometrial Cancer

Summary: this study is a prospective feasibility study with the addition of a retrospective cohort study on the the expression of microrna in urine in endometrial cancer patients.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of endometrial cancer * age: 18 years or older exclusion criteria: * prior or coexisting other malignancies * autoimmune disorders (other than diabetes mellitus)
phase 1 study of vorinostat and bortezomib in multiple myeloma (mk-0683-015 ext 1 (am1))

Conditions: Multiple Myeloma

Summary: the purposes of this study are: * to determine the maximum tolerated dose (mtd) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma * to assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.


Eligibility criteria:
inclusion criteria: * adults with refractory or relapsed multiple myeloma * eastern cooperative oncology group (ecog) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities) * adequate bone marrow reserve * adequate hepatic and renal function * ability to swallow capsules * 3 weeks or more since prior chemotherapy and have recovered from prior toxicities exclusion criteria: * participants who plan to have a bone marrow transplant within 4 weeks of start of treatment * participants with prior treatment with other investigational agents with a similar anti-tumor mechanism * participants with other active/uncontrolled clinically significant illness * pregnant or nursing female participants * participants who received bortezomib within 3 months of start of this trial
randomised study between intramedullary locking nails and locking plates for treatment of proximal humerus fractures

Conditions: Proximal Humerus Fractures

Summary: primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates. the hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate.

: proximal humerus fractures have a higher occurrence in elderly patients and therefore represent a public health problem. prognosis depends on greater and lesser tuberosity status, where rotator tendons of the shoulder have their insertion site. surgical treatment is recommended in case of tuberosities displacement. goals are their anatomic reduction and stable primary fixation that will allow good bone healing and early mobilization. it has been demonstrated that an extended immobilization can result in stiffness by capsular retraction. on the contrary a too early mobilization can lead to secondary displacement of tuberosities and malunion. these sequelae can be responsible for real disability when occuring in active patients, in particular when dominant limb is affected. internal fixation by locking intramedullary nails is currently the first choice technique because less invasive. however it doesn't always provide a good bone fixation, leading to tuberosities displacement or longer immobilization that decrease shoulder function prognosis. locking plates represent a good alternative to avoid these complications by offering a better fixation of tuberosities in osteoporotic bone. though there is no existing randomised study comparing these techniques regarding functional outcomes, complications rates, and patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients between 40 and 85-years-old, who didn't expressed opposition to inclusion, with type iii or iv displaced cephalotuberosity fracture( classification of neer and duparc). exclusion criteria: * cephalotuberosity fractures type iv - ct4 will not be included because it can correspond to posterior or anterior fracture-dislocation of humeral head and therefore be associated to very high risk level of avascular necrosis . in this case a surgical treatment by arthroplasty is recommended. dislocated fracture patient who express opposition to inclusion polytrauma

Keywords: humerus fracture nail plate tuberosity
a comparative study between pf-06410293 and humira® in combination with methotrexate in participants with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the study will assess the impact of pharmacokinetics (pk), safety and immunogenicity after switches between pf-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * diagnosis of ra based on 2010 acr/eular for ra for at least a 4 month duration. * moderately to severely active ra based on local standard of care. exclusion criteria: -evidence of untreated or inadequately treated latent or active tb.