Kornimate/medical-research-clean huggingface dataset:
trastuzumab in treating patients with stage iiib or stage iv non-small cell lung cancer that overexpresses her2

Conditions: Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Summary: phase ii trial to study the effectiveness of trastuzumab in treating patients who have stage iiib or stage iv non-small cell lung cancer that overexpresses her2. monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells

primary objectives: i. determine the activity of trastuzumab (herceptin) in patients with stage iiib or iv her2-overexpressing non-small cell lung cancer. secondary objectives: i. determine the duration of response in patients treated with this regimen. ii. determine the toxicity of this treatment regimen in this patient population. iii. assess levels of circulating her2 and correlate with her2 expression in this patient population. v. correlate circulating her2 levels with non-small cell lung cancer tissue her2 expression. outline: patients receive trastuzumab (herceptin) iv over 30-90 minutes on day 1. treatment continues once a week in the absence of disease progression or unacceptable toxicity. patients are followed every 8 weeks until disease progression or death. projected accrual: approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed stage iiib or iv non-small cell lung cancer * supraclavicular node involvement allowed * malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative) * no stage iiib patients eligible for clb protocols comprising combined chemotherapy and chest radiotherapy * recurrent disease allowed * her2 overexpression (2-3+) * at least 1 unidimensionally measurable lesion * at least 20 mm by conventional techniques * at least 10 mm by spiral ct scan * the following are not considered measurable: * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * abdominal masses not confirmed and followed by imaging * cystic lesions * no cns metastases * performance status - ecog 0-2 * granulocyte count at least 1,500/mm3 * platelet count at least 100,000/mm3 * bilirubin no greater than 1.5 times upper limit of normal (uln) * creatinine no greater than 1.5 times uln * lvef at least 45% (by echocardiogram or muga) * not pregnant or nursing * fertile patients must use effective contraception * hiv negative * no concurrent immunologic disease (e.g., autoimmune disease) * no history of allergy to murine products * no prior murine antibodies * no prior anthracyclines * no more than 1 prior chemotherapy regimen for lung cancer * at least 4 weeks since prior chemotherapy * no concurrent chemotherapy * no concurrent steroids except for adrenal failure or dexamethasone as an antiemetic * no concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes) * at least 6 months since prior radiotherapy * no concurrent palliative radiotherapy * at least 4 weeks since prior major surgery
intrathecal bolus doses of ziconotide

Conditions: Peripheral Neuropathy

Summary: the purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.

the intrathecal route for administration of analgesia has been in use in clinical practice for the last 3 decades. it is recommended to trial the patient with intrathecal drug therapy prior to implanting an intrathecal drug delivery device. trials can be performed using a single bolus injection or by a continuous intrathecal infusion administered through an external catheter. ziconotide has been approved by ema for the treatment of chronic severe pain in 2005. so far trials of ziconotide have largely been conducted using external catheters with the drug administered by intrathecal infusion over a number of weeks. infusions trials have been shown to be expensive, associated with a risk of meningitis and inconvenient to both patient and physician. the option of conducting a trial of intrathecal ziconotide therapy by bolus injection remains unexplored. this study aims to evaluate the efficacy and safety of a bolus dose of ziconotide (prialt®) to evaluate the option of continuous administration of the drug via implanted pump in the event of a successful trial.

Eligibility criteria:
inclusion criteria: * patient, at least 18 years of age * suffering from severe chronic (≥ 6 months) pain, who has failed on conventional pharmacological treatment * only patients with peripheral neuropathic pain or central neuropathic pain, due to trauma or surgery, will be included * average usual vaspi last week ≥ 40 mm * patient capable of judgment, i.e. able to understand information regarding the drug, the mode of administration and evaluation of efficacy and side effects signed informed consent exclusion criteria: * limited life expectancy (investigator's judgement) * intrathecal chemotherapy * known or suspected intracranial hypertension * known liver or kidney disease, defined as asat, alat, total bilirubin, alp or s- creatinine \> 1.2 x uln * advanced cardio-pulmonary disease (investigator's judgment) * ongoing infection, whether systemically or locally in the lumbar area * coagulopathy (including medication with warfarin, clopidogrel and heparin) * allergy to ziconotide or any of the excipients in the ziconotide vial * history of psychiatric disorders which in the investigator's opinion would put the patient at risk * pregnant or lactating woman. * menstruating women must use an effective contraceptive method (contraceptive pill or intrauterine spiral) during the trial period

Keywords: neuropathic pain intrathecal analgesia ziconotide bolus trauma central severe chronic
cerebellar transcranial direct current stimulation (tdcs) in children with autism spectrum disorder: raynor cerebellum project

Conditions: Autism Spectrum Disorder

Summary: the purpose of this research study is to investigate the effects of transcranial direct current stimulation (tdcs) on some of the challenges faced by children with autism spectrum disorder (asd).

the study will be randomized, double-blind, within subject crossover design. it will involve a group of 30-40 children and young adults with autism spectrum disorder (asd). we may recruit up to 60 subjects. diagnosis of asd will be confirmed with the autism diagnostic interview-revised (adi-r) or autism diagnostic observation schedule-2 (ados-2) by a research-reliable clinician. each participant will undergo a sham condition and a transcranial direct current stimulation (tdcs) condition, the order of sham and tdcs conditions will be randomly assigned to each participant during baseline testing. sham refers to participants only receiving 1 milliamp of tdcs stimulation for 1 minute, and tdcs stimulation refers to 20 minutes of tdcs stimulation. the study involves an initial screening visit followed by two sessions with three months between each session period. each session includes the following: pre-testing and imaging, tdcs 3-week session, post-testing and imaging. participants will complete an initial screening to confirm clinical diagnosis of asd, determine baseline cognitive functioning, and complete a practice magnetic resonance imaging (mri) and magnetoencephalography (meg) session. at pre-testing, they will complete a psychometric battery, as well as undergo safety screening, and an mri and/or meg. each 3-week tdcs sessions will be randomized, and each participant will undergo three weeks of sham stimulation and three weeks of 20-minute tdcs stimulation. neither the researchers nor the participants will know which group they are assigned during each three-week session.

Eligibility criteria:
inclusion criteria: * ages 5 to 21, male and female, with known autism spectrum disorder as diagnosed by a clinician exclusion criteria: * pregnancy * brain implants * pacemakers * any biomedical or metal implants in any part of body * hearing or visual impairment * history of brain injury * known brain or skull abnormality other than those that may be associated with asd

Keywords: children young adults autism spectrum disorder transcranial direct current stimulation tdcs
pulsed radiofrequency of lateral femoral cutaneous nerve

Conditions: Meralgia Paresthetica

Summary: in the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of prf of lfcn in refractory mp for 6 months. secondary outcomes were to identify the clinical and diagnostic features of the mp.

in the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of prf of lfcn in refractory mp for 6 months. secondary outcomes were to identify the clinical and diagnostic features of the mp.

Eligibility criteria:
inclusion criteria: * older than 18 years treated with prf neuromodulation of lfcn for mp * followed up at least 6 months in the pain clinic of the tertiary hospital between january 2020 and august 2023. exclusion criteria: * inadequate follow-up or missing documentation * if a new analgesic drug was prescribed during the follow-up period that could affect the evaluation of outcomes, the patients were also excluded. * patients who missed appointments, or were unable to communicate with; were not included in the study. * patients with secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism), malignancy, pregnancy, skin infection in the inguinal region or dermatitis, lumbar radiculopathy, polyneuropathy, and cardiac pacemakers were excluded. * in the ssep analysis, when the latency of lfcn was not evaluated in both sides, these patients were not also included in the study.

Keywords: meralgia parestetica pulsed radiofrequency obesity dn4 neuropathic pain
a study of aav5-hrkp.rpgr for the treatment of japanese participants with x-linked retinitis pigmentosa

Conditions: X-Linked Retinitis Pigmentosa

Summary: the purpose of the study is to assess the safety and tolerability of bilateral subretinal delivery of adeno-associated virus vector with a serotype 5 capsid human rhodopsin kinase promoter. retinitis pigmentosa guanosine triphosphatase regulator (aav5-hrkp.rpgr).


Eligibility criteria:
inclusion criteria: * participants who are japanese male or female aged 5 years or older * participants diagnosed as x-linked retinitis pigmentosa (xlrp) (generalized rod-cone dystrophy) associated with pathogenic or likely pathogenic variants in the retinitis pigmentosa guanosine triphosphatase regulator(rpgr) gene * has evidence of preserved retinal function as defined by a mean retinal sensitivity of greater than or equal to (\>=) 2 decibel (db) by octopus static perimetry and evidence of preserved outer retinal structure (namely the presence of discernible ellipsoid zone) as determined by spectral domain-optical coherence tomography (sd-oct) in both eyes * otherwise, healthy participant on the basis of clinical laboratory tests performed at screening. if the results of the serum chemistry panel or hematology outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. this determination must be recorded in the participant's source documents and initialed by the investigator exclusion criteria: * has had ocular surgery within 3 months prior to screening or is anticipated to require ocular surgery within 6 months after the aav5-hrkp.rpgr administration * is unable to perform the imaging assessments as required (for example: reliable static perimetry \[reliability factor less than or equal to {\<=}19\], optical coherence tomography \[oct\], or fundus autofluorescence \[faf\]). * any investigational ocular treatment or any other ocular treatment that could confound the interpretation of the efficacy results or affect participant compliance with the visit schedule
impact of hydrocortisone administration on white blood cell gene expression in patients with severe sepsis

Conditions: Sepsis; Relative Adrenal Insufficiency

Summary: the purpose of this pilot study is to (1) examine the changes in gene expression in patients who suffer from severe sepsis and whose shock (inadequate oxygen delivery to vital organs) state does not respond to fluid and vasopressor administration, (2) to show that our sampling method of isolating rna provides reliable and consistent data, (3) provide a basis for future gene expression studies in critically ill patients

severe sepsis is characterized by inadequate perfusion of vital organs due to infection. more than 750,000 cases of severe sepsis occur each year in the united states. mortality among patients with severe sepsis ranges from 7% to 50%. initiation of antibiotic therapy within the first hour of diagnosis as well as fluid resuscitation and hemodynamic stabilization are primary goals of therapy. steroid administration has been shown to improve outcome in the subset of severe sepsis patients suffering from relative adrenal insufficiency. although initial studies using high dose short course steroid therapy did not demonstrate efficacy, more recent studies of low dose longer duration hydrocortisone administration demonstrated a significant reduction in mortality at 28 days. the mechanism by which steroid administration affords protection is unclear. we hypothesize that steroid administration changes white blood cell gene and protein expression in severe sepsis patients from an immuno-inflammatory profile to a pattern consistent with healing. our first specific aim is to obtain plasma and total cellular rna from leukocytes in the blood of ten patients admitted to stanford medical center with the diagnosis of severe sepsis and adrenal insufficiency. significant and distinct variations in whole blood leukocyte gene expression patterns occur depending upon the method of rna isolation. we will attempt to demonstrate that our sampling method provides reliable and consistent data. our second specific aim is to begin an analysis of gene expression patterns in white blood cells before and after steroid administration in patients suffering from severe sepsis with relative adrenal insufficiency. we will use a protocol for assessment of gene expression that was developed by members of our research team.

Eligibility criteria:
inclusion criteria: * admission diagnosis of sepsis * evidence of relative adrenal insufficiency * hypotension (mean arterial pressure less than 60 mm hg) refractory to a. fluid resuscitation b. dopamine infusion (greater than 5 micrograms/kg/min) c. phenylephrine infusion (greater than 1 microgram/kg/min) exclusion criteria: * use of immunosuppressant medications * immune compromised due to disease (e.g., hiv infection) * transfusion of blood products within the past 7 days * use of cytokine therapy (i.e., g-csf) * history of bone marrow transplantation

Keywords: sepsis adrenal insufficiency hydrocortisone gene expression microarray rna critically ill
speech rehabilitation based on mobile applications

Conditions: Stroke; Motor Speech Disorder

Summary: this study evaluates the efficacy of smartphone-based speech therapy administered at home compared with usual care. participants will be randomized into the treatment and waitlist control groups with an allocation ratio of 1:1.

despite the importance of dysarthria intervention in post-stroke rehabilitation, further research in this area remains underexplored. this study builds on previous research on the use of smartphone-based dysarthria interventions based on motor learning principles, such as repetitive training and feedback and neuroplasticity through repetition, motivation, and reward. the treatment duration of 1h, 5 times a week for 4 weeks, is consistent with previous behavioral interventions for post-stroke dysarthria. this study aimed to determine whether the condition of patients with stroke can be improved through the use of smartphone-based interventions. this is a single-center, investigator-blinded, randomized, crossover effectiveness study. in this study, both the objective and subjective measurements will be performed three times: at baseline, post-phase 1 study (week 4), and post-phase 2 study (week 8). the study includes three intervention cycles, and for each research cycle, 12 subjects will be recruited to participate (6 per each group × 3 cycles).

Eligibility criteria:
inclusion criteria: * patients must be able to use a smartphone-based speech therapy application, as determined by self-reporting cognitive abilities. * speaks english as a native language. exclusion criteria: * unable to use smartphone application or conduct speech assessment due to severe speech impairment. * self-reported co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, pick's disease, huntington's disease, parkinson's disease, or parkinsonism). * patient with severe mental disorders as self-reported (e.g., depression, schizophrenia, alcohol addiction, or drug addiction). * illiterate patients.
observational study with prospective and/or retrospective follow-up, without modifying patient treatment and follow-up practices for the initial treatment of hypothyroidism in france

Conditions: Hypothyroidism

Summary: this observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in france without modifying subject treatment.

thyroid disorder can be central, caused by a deficiency in thyroid stimulating hormone (tsh) production; or peripheral, caused by the decrease in the plasma concentration of thyroid hormones, more specifically of free thyroxine (free t4). peripheral hypothyroidism is caused by the decrease in the production capacities of the thyroid gland. the treatment of hypothyroidism is based on the restoration and maintenance of biological (judged on the basis of the standardised tsh and t4 values) and clinical euthyroidism. a number of forms of thyroid hormones are available in the french market (euthyral®, cynomel®, l-thyroxine drops®), of which, levothyrox® is the most frequently prescribed drug in this category. the treatment of peripheral hypothyroidism, in particular, is well codified and almost consensual. in france, there is no published observational study, based on which one can document the manner in which subjects are treated. this observational study is set up to document these practices. objectives the principal objectives of this survey is to to get information on the use of levothyrox in france * circumstances of diagnosis * record realised * terms and conditions of treatment by the general practitioner and/or the endocrinologist the secondary objective is to evaluate the inclusion criteria for levothyroxine treatment. for each subject the participating doctor will complete a follow up questionnaire form until the first control level of tsh after the diagnosis of hypothyroidism.

Eligibility criteria:
inclusion criteria: * recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor * subject, who has given his/her oral consent for participation exclusion criteria: * subject included in clinical trial or having participated in a clinical trial during the last 3 months * subject presenting a major and objectifiable risk of not being able to follow-up until the next tsh level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) * all contraindications to lévothyrox

Keywords: hypothyroidism thyroid hormones
study of oglemilast for the prevention of asthma.

Conditions: Exercise-Induced Asthma

Summary: the purpose of this study is to determine whether it is effective in the treatment of exercise-induced asthma and investigate the safety of oglemilast.


Eligibility criteria:
inclusion criteria: * stable mild asthma patients who exhibit at least a 20% decrease in fev1 following exercise. exclusion criteria: * pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.

Keywords: oglemilast asthma exercise prevention prophylaxis
the effect of analgesia based sedation protocol on brain function of critical care patients

Conditions: Delirium

Summary: benzodiazepines is a commonly uesd sedative medication,there are many reports that benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .the purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium.


Eligibility criteria:
inclusion criteria: * signing a consent form * postoperative patient * requirement for mechanical ventilation and anticipate time of mechanical ventilation more than 24 hours * requirement for sedation * age more than 18 and less than 85 years old exclusion criteria: * unstable blood circulation * heart rate less than 50 beats per minute * ii ° ～ iii ° atrioventricular conduct block * intracranial lesions 、neurosurgical intervention and mental disability inability to cooperate; * receipt of antipsychotics 、hypnotic drugs before surgery ; * alcohol abuse; * liver failure class child-pugh c; * acute respiratory distress syndrome; * acute or chronic renal failure; * other severe diseases ,septic shock; * receipt of neuromuscular blocking drug; * pregnancy and nursing woman; * allergy to investigational drug or other contraindication.
plasticity of deep brain structures in mild cognitive impairment and healthy aging

Conditions: Traumatic Brain Injury

Summary: acute and chronic cognitive impairment (tbi and mci) is one of the most common problems in the growing and aging society of the 21st century. at an individual level, not all brain structures are affected with the same rate. there are subcortical structures less involved (e.g., the cerebellum), and other more involved (e.g., the hippocampus) in the cognitive decline with age or following a traumatism. to pave the way for personalized precision medicine in the field of cognitive preservation and recovery, there is a need for testing the impact of individually tailored innovative non-invasive neuro-technologies. in this project, we aim at testing the benefit of non-invasively stimulating subcortical structures to boost resilience in supporting motor and non-motor memory.


Eligibility criteria:
inclusion criteria: tbi patients: * age ≥ 18 years * clinical diagnosis of tbi * no history of other severe neurological or psychiatric disorders exclusion criteria: * unable to consent * severe neuropsychiatric (e.g., major depression, severe dementia) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life threatening infectious diseases) * severe sensory or cognitive impairment or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the experimental tasks * inability to follow or non-compliance with the procedures of the study * contraindications for nibs or mri (1): * electronic or ferromagnetic medical implants/device, non-mri compatible metal implant * history of seizures * medication that significantly interacts with nibs being benzodiazepines, tricyclic antidepressants and antipsychotics * regular use of narcotic drugs * pregnancy * request of not being informed in case of incidental findings * concomitant participation in another trial involving probing of neuronal plasticity

Keywords: non-invasive brain stimulation deep brain stimulation subcortical memory neuro-imaging transcranial temporal interference stimulation motor learning