Kornimate/medical-research-clean huggingface dataset:
"quidel reader influenza a + b test 510(k) and clia waiver field study"

Conditions: Influenza

Summary: the objective of this study is to demonstrate the clinical performance of the quidel reader influenza a+b test and quidel reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. clinical performance will be based on comparison of quidel reader influenza a+b results to cell culture at a central reference or alternative laboratory.

a sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. * the 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza a, and 30 fresh positive results for influenza b. * the clia waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza a and influenza b. the nasal swab will be the primary sample type planned for the clia waiver submission. however, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for clia waiver.

Eligibility criteria:
inclusion criteria: 1. male or female, of all ages (assuming appropriate consent is obtained). 2. must currently be exhibiting symptoms characteristic of influenza-like-illness (ili). for example: 1. fever, ≥ 38º c (100º f), either at the time of the visit or onset within the past two (2) days. 2. nasal congestion 3. rhinorrhea 4. sore throat 5. cough 6. headache 7. myalgia 8. malaise exclusion criteria: 1. has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to amantadine, rimantadine, ribavirin, oseltamivir, zanamivir or any other antiviral currently available in these classes. 2. has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days. 3. unable to understand and consent to participation; for minors this includes parent or legal guardian.
fluvoxamine maleate in the treatment of obsessive-compulsive disorder: a post-marketing clinical study in children and adolescents

Conditions: Obsessive Compulsive Disorder

Summary: this study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder


Eligibility criteria:
inclusion criteria have a minimum total score of 16 on the jcy-bocs, weight is within the standard weight ± 2s.d. based on the standard weight for each age in the school health statistical survey exclusion criteria have the following predominant psychiatric diagnosis -schizophrenia have previously been treated with fluvoxamine maleate

Keywords: fluvoxamine maleate ocd children and adolescents
lateral pharyngoplasty outcomes in the treatment of snore and obstructive sleep apnea

Conditions: Snore; Obstructive Sleep Apnea

Summary: the aim of this study is to describe the results of lateral pharyngoplasty in the treatment of snore and osas.


Eligibility criteria:
inclusion criteria: * snore * osas exclusion criteria: * previous pharynx surgery * use of medication that modifies the muscular tonus or the perception of sleepiness before or after the surgery * body mass index (bmi) bigger than 35 kg/m2 * neurological or psychiatric disease.
effect of music on coronary angiography

Conditions: Coronary Angiography; Hemodynamic Parameters; Comfort; Anxiety; Music Intervention

Summary: this study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. the research was conducted with 78 patients (39 intervention and 39 control groups) who were processed in the coronary angiography laboratory of necmettin erbakan training and research hospital between february and june 2024. the intervention group listened to nature sounds based music during the angiography procedure, but no intervention was made to the control group. "introductory information form," "state anxiety scale," "general comfort scale," and "hemodynamic parameters record form" were used to collect the data.


Eligibility criteria:
inclusion criteria: * being 18 years of age or older * being at least literate * having no mental and cognitive competence * understanding and speaking turkish * having a planned coronary angiography * performing for diagnostic purposes exclusion criteria: * having visual and hearing impairment * having a psychiatric diagnosis * using psychiatric medication (tranquilizers, etc.) * using anxiety medication in the last 6 months * having had coronary angiography before * the coronary angiography procedure is being performed for therapeutic purposes (stent, balloon, etc.) * an unexpected complication during coronary angiography (arrhythmia, mi, bleeding, etc.) * coronary angiographyprocedure started for diagnostic purposes and stent and/or balloon procedures were applied during the procedure * data collection forms were not filled out by the participant after coronary angiography

Keywords: anxiety comfort coronary angiography hemodynamic parameters nursing
a phase 2 randomized double-blind, parallel, adaptive-design, clinical trial to evaluate the safety and efficacy of nrct-101sr with nrct-202xr compared to nrct-202xr alone in subjects with attention-deficit/hyperactivity disorder

Conditions: ADHD

Summary: a combination therapy of nrct-101 with nrct-202 is being developed for patients with adhd.

a multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of nrct-101sr and low dose nrct- 202xr compared to low or high dose of nrct-202xr and placebo nrct-101sr over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with adhd. subjects' enrollment will be conducted in two stages. in stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio): arm 1: nrct-101sr and low dose nrct-202xr arm 2: nrct-101sr placebo and high dose nrct-202xr in stage 2, a third study arm will be added (arm 3 - nrct-101sr placebo and low dose nrct-202xr. the study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with adhd.

Eligibility criteria:
1. male or female, 13-17 years of age at screening. 2. has a prior primary diagnosis of adhd according to the dsm-5 classification evident by a medical record and confirmed with mini using dsm-5 probes. 3. is taking adhd medication 4-7 days/week, for at least 4 weeks at screening and at least 6 weeks at baseline. 4. has side effects identified using sdse-rs at screening and baseline. 5. cgi-s ≥ x (blinded) at screening and baseline. 6. must be fluent in english and communicate effectively with others. 7. both subject and parent/guardian willing and able to give informed assent/consent. 8. parent/guardian willing to serve as informant.
neurobiological changes when treating depression with electroconvulsive therapy - a longitudinal observational study

Conditions: Depression

Summary: the purpose of this study is to determine functional and structural changes in brain following treatment of severe depression with electroconvulsive therapy with correlation to clinical outcome. our hypothesis is that there are state-dependent changes in functional connectivity within specific neurocircuits systems, as well as structural plasticity changes in hippocampus, when recovering from depression.

the study is a prospective, within-subject, observational follow-up study in individuals with depression who receive electroconvulsive therapy (ect)at a psychiatric clinic. we will use a consecutive sampling method and patient referred for ect by their psychiatrist will be screened for inclusion and asked for participation. both in - and outpatients can be included. at three occasions (before treatment, after four week and after three months) patients will be assessed with clinical ratings, cognitive tests, functional and structural magnetic resonance imaging and biomarkers for cell proliferation.

Eligibility criteria:
inclusion criteria: * major depressive disorder * depressive episode in bipolar disorder * age 18 - 65 years exclusion criteria: * alcohol- and/or drug dependence or abuse in the past 3 months * severe/life-threatening medical disease * pregnancy * type i diabetes * neurodegenerative disorder * inability to give written informed consent to participation in the study * contradiction to mri scanning.
rascals: rapid assay for sick children with acute lung infection study

Conditions: Lower Respiratory Tract Infection; Ventilator Associated Pneumonia; COVID19

Summary: lower respiratory tract infections are a common cause of admission to the intensive care unit. children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. the exclusion of bacterial infection may take 48 hours or longer for culture tests on biological samples to be completed. in many cases, the results may be inconclusive or negative if the patient has already received antibiotics prior to the sample being taken. a rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed. this study aims to assess whether a new genetic testing kit which can identify the presence of bacteria and viruses within hours rather than days is a feasible tool in improving antibiotic prescribing and rationalisation of therapy in critically ill children with suspected lower respiratory tract infection.


Eligibility criteria:
inclusion criteria: 1. aged \>37 weeks corrected gestation and ≤16 years old 2. receiving mechanical ventilation 3. commencing or already receiving antibiotic treatment for lower respiratory tract infection exclusion criteria: 1. survival not expected/active medical treatment expected to be withdrawn/palliative care only
efficacy trial of the implantation of mouse renal adenocarcinoma macrobeads in subjects with castration-resistant prostate cancer resistant to taxanes (docetaxel, cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or immunotherapy in the form of sipuleucel-t

Conditions: Prostate Cancer

Summary: this is a clinical research study of an investigational (fda ind-bb 10091) treatment of subjects with castration-resistant prostate cancer resistant to taxanes (docetaxel, cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or immunotherapy in the form of sipuleucel-t. the treatment is being evaluated for its effect on tumor growth. it consists of the placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (renca macrobeads). the cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients. it has been tested in 31 human subjects with different types of cancers in a phase i safety trial. phase ii studies in patients with colorectal, pancreatic or prostate cancers are in progress.


Eligibility criteria:
inclusion criteria: * cancer of prostate * evidence of metastasis * failed available therapies * resolution of any toxic effects of previous therapies * performance status (ecog ps) 0-2 * adequate hematologic, coagulation (inr 2-3max), hepatic and renal function * life expectancy of 12 months * agrees to contraceptive use while on study if sexually active * sign informed consent document exclusion criteria: * any condition presenting an unacceptably high anesthetic or surgical risk * hiv positive * cognitive impairment such as to preclude informed consent * other surgical treatment, chemotherapy and radiation within four weeks of baseline * inadequate hematologic, coagulation (inr \>3), hepatic, renal function * hepatic blood flow abnormalities and/or large-volume ascites * concurrent cancer of any other type except skin cancer (excluding melanoma) * history of allergic reactions to mouse antigens * active infection, congestive heart failure, unstable angina, serious cardiac arrhythmias, psychiatric illness, difficult social situations not permitting reliable participation, active bleeding
comparison of coronary lithoplasty and rotablation

Conditions: Coronary Artery Disease; Calcified Atheroma

Summary: this study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.

severe coronary calcification is still a challenge for percutaneous coronary intervention (pci). reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. it provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (oct) before and after debulking, as well as after stent implantation.

Eligibility criteria:
inclusion criteria: * age\>18 yrs * stable coronary heart disease or acute coronary syndromes * single or multi vessel disease. vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. any branch within the vessel is considered part of the vessel. * written informed consent was obtained before the procedure * severely calcified coronary lesion with indication for rotablation exclusion criteria: * known renal insufficiency (serum creatinine clearance \<30ml/min/1.73m² or receiving dialysis) * known allergy against protocol-required medications including ass, prasugrel, ticagrelor, clopidogrel, heparin. history of bleeding diathesis or known coagulopathy * cardiogenic shock * lesion length \> 32mm * bifurcation lesions requiring 2-stent-strategies

Keywords: percutaneous coronary intervention rotablation coronary lithoplasty optical coherence tomography
pharmacokinetics and safety of panobinostat in patients with advanced solid tumors and various degrees of hepatic function

Conditions: Advanced Solid Tumors

Summary: panobinostat (lbh589) is a deacetylase inhibitor (daci) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. it is one of the most potent class i/ii pan-dac inhibitor (pan-daci) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological malignancies. to date, the pharmacokinetics (pk) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase i/ii clinical studies. panobinostat pk does not appear to be different in patients with solid tumors and hematological malignancies. however, the effect of organ dysfunction on pk of panobinostat is yet to be elucidated. kidney and liver are involved in the elimination and metabolism of panobinostat. the current study is designed to evaluate the impact of hepatic function status on panobinostat pk.


Eligibility criteria:
inclusion criteria: 1. patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists 2. patient has normal or abnormal hepatic organ function 3. patient has provided written informed consent prior to any screening procedures exclusion criteria: 1. patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose 2. patient received prior treatment with dac inhibitors including panobinostat 3. patient requires treatment with warfarin that cannot be switched to another anticoagulant treatment prior to starting study drug 4. patient has encephalopathy 5. patient has ascites requiring intervention 6. female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: solid tumors hepatic function advanced panobinostat
the effect of a pre- and postoperative orthogeriatric service

Conditions: Dementia; Delirium

Summary: the investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study. the investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome.

the study will be carried out in close cooperation between the orthopaedic centre and the department of geriatric medicine. the patients will be randomized in the emergency department in accordance with procedures already established for a recently finished trial. the intervention group will be transferred as soon as possible to the orthogeriatric ward, stabilised there preoperatively, and transferred back to the same ward postoperatively for further treatment and rehabilitation, while the control group will be treated in a traditional orthopaedic ward. operative and anaesthesiologic procedures will be the same in the two groups. the primary endpoint is chosen in order to optimize clinical relevance as well as sensitivity to change within a wide range of functional performance, and will be recorded four months after the fracture. our main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome. accordingly, we will use a composite endpoint tapping cognitive functioning in the lower as well as the higher spectre of performance by these two instruments: * clinical dementia rating scale (cdr), proxy-based scale for severity of dementia, that is able to detect differences also between patients with severe dementia. the scale consists of six questions, each rated 0-3, adding up to a sumscore of 0-18 ("sum of boxes"). the scale is frequently used in dementia treatment trials, and is shown to be valid and reliable. cdr will be scored based on the best available source (relative, staff in nursing home or home nursing service) * the 10 words memory task from the consortium to establish a registry for alzheimer's disease battery (cerad). this test is shown to be sensitive for memory changes in persons that have a good or fairly good cognitive functioning. we will use the immediate recall and the delayed recall parts of this task, i.e. two scales. the primary endpoint will be assessed after four months, by a specially trained research assistant blinded to allocation. the patients will be re-assessed after 12 months.

Eligibility criteria:
inclusion criteria: • eligible patients will be admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture. exclusion criteria: * hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a higher level than 1 metre). one recent fracture in addition to the hip fracture (e.g. radius or shoulder) is acceptable. * regarded as moribund at admittance. * absence of a valid informed consent or assent.
validation of a predictive nomogram of response or resistance to targeted therapies in metastatic clear cell renal cell carcinoma

Conditions: Metastatic Clear Cell Renal Cell Carcinoma

Summary: the purpose of this study is to validate of a predictive nomogram of response or resistance to targeted therapies in metastatic clear cell renal cell carcinoma


Eligibility criteria:
inclusion criteria: * patients with metastatic ccrcc * underwent nephrectomy at the university hospital of rennes * treated by sunitinib first line treatment exclusion criteria: * translocation renal cell carcinoma * other targeted therapies before the sunitinib
quality of life in schizophrenic patients

Conditions: Schizophrenia

Summary: this is a non-interventional study evaluating quality of life in schizophrenic patients treated with atypical antipsychotics, in the ambulatory setting. this is a 9-month, observational, multicentric prospective study.


Eligibility criteria:
inclusion criteria: * patients diagnosed with schizophrenia treated with atypical antipsychotics (ambulatory patients).

Keywords: schizophrenia atypical antipsychotic quality of life ambulatory setting
treatment of sub-capital fractures of hip joint by using tribofit™ acetabular buffer

Conditions: Hip Fractures

Summary: the purpose of this study is to determine the performance and efficacy during 6 and 12 month post operation. 1. determine changes in patient pain level 2. determine changes in patient functionality 3. determine changes in patient life quality


Eligibility criteria:
inclusion criteria: * female or male that is not younger than 60 years old. * patient suffers from hip fracture that will need hip arthroplasty. * patient that weight less than 150kg * patient femur head diameter between 40mm - 50mm * mentally normal * patient that could walk before suffering from hip fracture * patient that willing to cooperate with the doctor * patient that signed on the acceptance form exclusion criteria: * patient that does not willing to cooperate with the doctor * patient that is legally rejected * patient that suffer from cancer * patient that had passed amputation in is limbs * patient that is paralysis * patient that passed cva or tia * patient that still recovering from hard wounds or surgery * patient that suffer from infection in the hip joint

Keywords: determine changes in patient pain level determine changes in patient functionality determine changes in patient life quality
the fate of aortic valve after sas surgery in children

Conditions: Subaortic Stenosis; Congenital Heart Disease; Aortic Regurgitation

Summary: aortic valve regurgitation (ar) is a common complication following surgery for subaortic stenosis (sas), yet the long-term outcomes and risk factors for postoperative significant ar (sar) remain poorly understood. this study aims to investigate the incidence and risk factors of sar in sas patients and evaluate the long-term postoperative outcomes.


Eligibility criteria:
inclusion criteria: * age from 0-18 * clinical diagnosis of subaortic stenosis and underwent surgery exclusion criteria: * diagnosed with hypertrophic cardiomyopathy * underwent concomitant previous surgical repair for aortic valve or sas * follow-up time less than 1 year or lack of detailed information.