Kornimate/medical-research-clean huggingface dataset:
safety study of a monoclonal antibody to respiratory syncytial virus (rsv) in children hospitalized with rsv infection

Conditions: Respiratory Syncytial Virus Prophylaxis

Summary: the purpose of this study is to determine the safety of motavizumab (medi-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (rsv).

this study was designed as a phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (medi-524) and the effect on the amount of respirtory syncytial virus (rsv) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with rsv infection.

Eligibility criteria:
inclusion criteria: * previously healthy * age 24 months and younger at the time of randomization * gestational age of 36 weeks gestation and older * randomization within 24 hours after hospitalization * hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (rsv) bronchiolitis and/or pneumonia) documented by positive rsv antigen detection or culture in respiratory secretions within 72 hours before randomization exclusion criteria: * already received or would receive ribavirin or other anti-viral treatment for the current episode of rsv infection prior to randomization * required intubation for ventilatory support * any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than rsv infection * known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency * requirement for supplemental oxygen at any time prior to the current rsv infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed) * mechanical ventilation at any time prior to the onset of the current rsv infection * congenital heart disease (children with medically or surgically corrected patent ductus arteriosus \[pda\], small atrial septal defect \[asd\] or ventricular septal defect \[vsd\] were allowed) * previous reaction to intravneous immunoglobulin (ivig), blood products, or other foreign proteins * prior use of ivig, rsv-igiv (respigam), palivizumab (synagis), or other immunoglobulin products within the past 2 months * currently receiving other investigational agents or have received any other investigational agents within the last 3 months * prior or current participation in any investigational study with a therapeutic agent or vaccine for rsv

Keywords: medi-524 motavizumab respiratory syncytial virus children intravenous rezield
computer planned radiation therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. purpose: this phase ii trial is studying how well radiation therapy that has been planned with a computer works in treating patients with prostate cancer.

objectives: * establish the efficacy of high-dose three-dimensional conformal radiotherapy in patients with intermediate prognostic risk adenocarcinoma of the prostate. * determine the psa relapse-free survival rate of this patient population. outline: patients receive high-dose three-dimensional conformal radiotherapy 4-5 days per week for at least 9 weeks. patients are evaluated at least weekly during radiotherapy and at 2 and 4 months after treatment completion. thereafter, patients are followed every 6 months for a total of 3 years. projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven intermediate prognostic risk (t1-t2) adenocarcinoma of the prostate * previously untreated (except for hormonal therapy) * psa levels greater than 10 ng/ml and gleason scores no greater than 6 or * psa levels no greater than 10 ng/ml and gleason scores at least 7 * patients requiring volume reduction of prostate prior to radiotherapy continue to be treated at least 3 months on neoadjuvant hormonal therapy prior to radiation * no evidence of distant metastases * no regional lymph node involvement patient characteristics: age: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no major medical illness * no psychosis * no metallic pelvic prosthesis prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * see disease characteristics * prior neoadjuvant antiandrogen therapy allowed radiotherapy: * no prior radiotherapy * no prior pelvic irradiation surgery: * no prior radical surgery for carcinoma of the prostate

Keywords: adenocarcinoma of the prostate stage iib prostate cancer stage iia prostate cancer
attentin® in children and adolescents with adhd - a non-interventional study

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the practicality of most adhd medications is not or only moderately examined under long term routine conditions. therefore, in this multi-centre, multi-national prospective non-interventional study, a recommended follow-up time of 12 months will investigate the course of the therapy in children and adolescents with adhd with prior mph treatment and their medication change to dexamfetamine in several european countries under daily routine. it consists of a baseline visit under mph or another adhd drug therapy, a change to dexamfetamine, the prospective description of the titration phase and a 12 month maintenance phase. data on the use of dexamfetamine in routine clinical practice will be collected to describe how dexamfetamine is prescribed, titrated and used in the population of adhd patients and how these factors influence the general intensity of adhd and safety events. this study will collect real world data of dexamfetamine and compare descriptively the general intensity of adhd according to adhd classification and the impairment due to adhd under therapy with dexamfetamine to the general intensity of adhd according to adhd classification and the impairment due to adhd under the prior therapy with mph. furthermore the utilization of dexamfetamine will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation. due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period.


Eligibility criteria:
inclusion criteria: * age ≥ 6 to 17.11 years * current mph therapy insufficient * adhd was classified according to a validated classification system (e.g. dsm or icd-10) * no contraindication against dexamfetamine exclusion criteria: * contraindication against dexamfetamine
the recovery time of quadriceps strength after total knee arthroplasty (tka): the effect of quadriceps incision length

Conditions: Osteoarthritis of Knee

Summary: minimally invasive total knee arthroplasty (mis-tka) became the popular technique. it had the less postoperative pain and shorter recovery time compared to the conventional technique. with using mis technique, less cut of quadriceps tendon was the key. it related to keep more quadriceps strength and improve functional performance after tka. however, there was no previous studies about the effect of quadriceps incision length in the recovery time of the quadriceps strength. the investigators hypothesized that longer quadriceps incision affected the longer recovery time of quadriceps strength in mis-tka.


Eligibility criteria:
inclusion criteria: * the patients who diagnosed primary osteoarthritis of knee with 1. varus or valgus deformity \< 20 degrees 2. preoperative range of motion \> 90 degrees 3. extension lag \< 10 degrees 4. flexion contracture \< 30 degrees exclusion criteria: * bilateral simultaneous total knee arthroplasty * previous knee surgery * inadequate exposure during the surgery
a randomized controlled study comparing priming solution containing crystalloid or packed red blood cells in patients treated with isolated limb perfusion.

Conditions: Melanoma; Sarcoma

Summary: the primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution.


Eligibility criteria:
inclusion criteria: 1. the patient scheduled for treatment with isolated hyperthermic perfusion 2. age over 18 years. 3. signed informed consent

Keywords: isolated limb perfusion
cutaneous silent period assessment in primary sjögren's syndrome

Conditions: Small Fiber Neuropathy; Primary Sjögren Syndrome

Summary: primary sjögren's syndrome (pss) is a chronic, immune-mediated inflammatory disease mainly characterized by exocrine gland involvement. beyond the wide heterogeneity in clinical presentation, neurological manifestation is one of the important systemic involvement of pss. the prevalence of neurological involvement varies widely from 10% to 60% in different series. small fiber neuropathy (sfn) as a popular clinical entity in recent years targets nociceptive thinly myelinated a-delta and unmyelinated c-fiber nerves and is frequently associated with burning and allodynic pain. previous studies have demonstrated that sfn is frequently seen in patients with pss and has an important clinical importance because it cannot be detected by routine electrophysiological studies. various methods can be used in the detection of sfn, and cutaneous silent period (csp) measurement is gaining popularity recently due to its non-invasiveness and practical fashion. in this study, the investigators aimed to compare csp parameters as an indicator of sfn in patients with pss and in the healthy population and to reveal its relationship with clinical parameters.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * for the patient group, patients followed up in accordance with the 2016 acr/eular primary sjögren's syndrome classification criteria exclusion criteria: * any comorbidities that may cause neuropathy * any drugs that may cause neuropathy * chronic alcohol consumption * a history of disease that may affect the central nervous system

Keywords: small fiber neuropathy primary sjögren syndrome neuropathic pain
methods for managing intrusive thoughts

Conditions: Obsessive-Compulsive Disorder

Summary: the current study sought to translate laboratory research on learning and memory to better understand the mechanisms and methods for implementing exposure therapy for unwanted obsessional thoughts. specifically, we compared the processes and the short- and long-term outcomes of: (a) gradual exposure (exp-g), emphasizing hierarchical exposure completion, versus (b) variable exposure (exp-v), emphasizing variability in exposure intensity.

although preliminary research suggests that learning to tolerate varying levels of fear during exposure enhances outcomes for some anxiety-related problems, no previous study has examined this possibility in the context of unwanted obsessions. adults with a moderately distressing obsessional thought were randomly assigned to four twice-weekly sessions of either: (a) gradual exposure (exp-g), emphasizing hierarchical exposure completion, or (b) variable exposure (exp-v), emphasizing variability in exposure intensity.

Eligibility criteria:
inclusion criteria: * at least 18 years old * willing to attend and audiotape all study sessions * fluent in english * presence of one or more obsessional thoughts that cause marked distress * if on a psychiatric medication (e.g., ssri), willing to remain at a fixed dose while participating in the study (and stabilized on medication for 30 days before beginning the intervention). exclusion criteria: * previous cognitive behavioral therapy (cbt) for anxiety * current suicidal ideation * current substance use disorder * current mania or psychosis * currently taking an anxiolytic (e.g., ativan) or stimulant (e.g., ritalin) medication * heart, respiratory, or neurological condition * current pregnancy

Keywords: ocd
comparison of spect/ct perfusion and volumetric ct volume

Conditions: Lung Cancer (NSCLC)

Summary: the main aim of this study is to show that single photon emission tomography/computer tomography (spect/ct) is a reliable examination to predict postoperative pulmonary function after segmentectomy, by comparing this predicted function to that measured at 1 and 6 months.

lung cancer has a high prevalence, incidence and mortality in france and worldwide. surgical treatment, possible only at an early stage, improves the prognosis of patients. in addition, the increasing accessibility of chest ct scans allows early detection and monitoring of small pulmonary nodules. as a result, more conservative surgical techniques are becoming increasingly important, including segmentectomy. among patients for whom it is indicated, the preoperative assessment involves the evaluation of pulmonary function and the prediction of postoperative pulmonary function in order to validate the feasibility of surgery. to do this, several methods have been described: anatomical methods (segment counting), radiological imaging methods (ct, dect, perfusion mri), and nuclear imaging methods (planar perfusion and/or ventilation pulmonary scintigraphy, spect pulmonary perfusion scintigraphy), some of which are hybrid (spect/ct). the use of spect/ct to predict postoperative pulmonary function is routinely practiced, and its reliability, accuracy, and concordance with measured postoperative pulmonary function are well demonstrated for pneumectomy and lobectomy. for more conservative surgeries, the data in the literature remain uncertain. however, being able to predict pulmonary function is essential, both to justify the feasibility of the intervention, but also to target the most fragile patients and intensify their postoperative respiratory rehabilitation.

Eligibility criteria:
inclusion criteria: * person having received full information on the organization of the research and not having opposed the exploitation of this data * patients having benefited from a single or multiple segmentectomy within the thoracic surgery department of the chru of nancy during the period april 2021 to june 2023 * patients having a complete pre-operative assessment (spect/ct, volumetric ct and efr) * patients having 2 post-operative assessments (respiratory functional exploration (efr) at approximately 1 month post-operatively and 6 months post-operatively). exclusion criteria: * patients who underwent more extensive surgery (lobectomy, pneumectomy) or less extensive surgery (wedge). * patient who did not have a complete preoperative assessment (spect/ct or volumetric ct or missing respiratory functional exploration efr). * patient who did not have a complete postoperative assessment (missing respiratory functional exploration efr at 6 months). nb: the absence of respiratory functional exploration efr at 1 month postoperatively is not an exclusion criterion
atorvastatin versus rosuvastatin on contrast induced acute kidney injury (prato-acs 2)

Conditions: Acute Coronary Syndrome

Summary: the aim of the project is to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of contrast induced-acute kidney injury in patients with non-st-elevation acute coronary syndromes scheduled for early invasive strategy.

this is a prospective, single-centre, randomized study, designed to compare the nephro-protective effects of high-dose atorvastatin and high-dose rosuvastatin on the incidence of contrast induced-acute kidney injury (ci-aki). consecutive statin-naïve patients admitted in the investigators institution for non-st elevation acute coronary syndrome (nste-acs) and scheduled for early invasive strategy will be eligible. patients are randomized into two groups: 1) high-dose rosuvastatin (40 mg on-admission followed by 20 mg/day); 2) high-dose atorvastatin (80 mg on-admission followed by 40 mg/day). randomization will be performed on-admission by computerized open-label assignment in blinded envelopes used in a consecutive fashion. all patients receive the standard pre-procedural hydration. the primary end-point is the proportion of patients with an increase in serum creatinine of ≥ 0.5 mg/dl or ≥ 25% above baseline within 72 hours after contrast medium administration. the secondary end-points are persistent worsening of renal damage (egfr reduction \>= 25% at 30 days) and cumulative adverse clinical events at follow-up. specifically: death, myocardial infarction, dialysis, stroke or persistent renal damage at 30 days; death or myocardial infarction at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * all consecutive statin-naive patients with non st-elevation acute coronary syndrome admitted to our institution and scheduled for early invasive strategy are considered for enrollment exclusion criteria: * current statin treatment * high-risk features warranting emergency coronary angiography (within 2 hours) * acute renal failure or end-stage renal failure requiring dialysis or serum creatinine ≥ 3 mg/dl * severe comorbidities which precluded early invasive strategy * contraindications to statin treatment * contrast media administration within the last 10 days * pregnancy * refusal of consent

Keywords: statins contrast-induced acute kidney injury periprocedural myocardial damage
aspirin response in high risk patients with coronary artery disease

Conditions: Coronary Artery Disease; Myocardial Infarction; Diabetes Mellitus; Renal Insufficiency, Chronic

Summary: previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. despite treatment with aspirin a large number of patients suffer a myocardial infarction. this has given rise to the phenomenon "aspirin low-responsiveness". laboratory aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet production of thromboxane a2 or inhibit thromboxane-dependent platelet aggregation. whether a low platelet response to aspirin results in an increased risk of future thrombotic events is of great clinical significance, but is still unknown. the investigators hypothesize that patients with a reduced response to aspirin, determined by platelet aggregation using the apparatus verify now aspirin and multiplate, have a higher risk of thrombosis. the purpose of this study is to investigate whether a higher incidence of cardiovascular events is found in patients with coronary artery disease (cad) having a reduced biochemical response to aspirin compared with cad patients having a normal biochemical response to aspirin. in addition to cad, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.


Eligibility criteria:
inclusion criteria: * coronary artery disease verified by coronary angiogram * treatment with aspirin 75 mg/d for at least the previous 7 days * previous myocardial infarction more than one year ago (groups with previous myocardial infarction) * type 2 diabetes mellitus treated with oral antidiabetics and/or insulin (groups with type 2 diabetes mellitus) * renal insufficiency; glomerular filtration rate \<60 ml/min at the time of blood sampling (groups with renal insufficiency) exclusion criteria: * treatment with nsaids, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function * ischemic vascular event within the previous 12 months * revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months * platelet count \ 450 x 10\^9/l * for patients without diabetes: fast glucose \>7 mmol/l * unable to give informed consent

Keywords: platelet aggregation aspirin drug resistance thromboxane b2 pharmacologic actions platelet aggregation inhibitors
a study for optimization of 6% hydroxyethyl starch based indocyanine green near-infrared fluorescence navigated sentinel lymph node biopsy for breast cancer patients

Conditions: Breast Cancer; Sentinel Lymph Node

Summary: a study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.

pre-clinical experiment has shown using 6% hydroxyethyl starch (voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. this study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.

Eligibility criteria:
inclusion criteria: * breast cancer, adults exclusion criteria: * patient aged \< 20 years old * primary lesion without indication of sentinel lymph node biopsy in current guidelines (low-risk ductal carcinoma in situ or metastatic breast cancer) * patient who is allergic to primary tracers (including tc99m and blue dye) * patient who is allergic to indocyanine green

Keywords: indocyanine green sentinel lymph node biopsy axillary lymph node dissection