Kornimate/medical-research-clean huggingface dataset:
pemetrexed and gemcitabine in patients with advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: this study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced nsclc. this study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced nsclc. this combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

upon determination of eligibility, patients will be receive: * pemetrexed + gemcitabine

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * histologically confirmed non-small cell bronchogenic carcinoma * newly diagnosed or recurrent unresectable stage iii or stage iv disease * no mixed tumors with small cell anaplastic elements * measurable disease * must not have received any prior antineoplastic chemotherapy for lung cancer * age \> 18 years * able to perform activities of daily living with little or no assistance * adequate bone marrow, liver and kidney * understand the nature of this study and give written informed consent. exclusion criteria: you cannot participate in this study if any of the following apply to you: * female patients who are pregnant or are lactating * history of serious cardiovascular disease within the previous six months * serious active infection at the time of treatment * other serious underlying medical condition please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
phenotypic properties in individuals affected with xlhed

Conditions: X Linked Hypohidrotic Ectodermal Dysplasia

Summary: the current study design incorporates two previously developed, non-invasive approaches to characterize the phenotype of individuals affected with xlhed.

the current study design incorporates two previously developed, non-invasive approaches to characterize the phenotype of individuals affected with xlhed. facial 3-dimensional (3d) imaging will be created from white-field morphometric scanning (hammond, 2004. the 3d facial photographs collected from males (ages 4 years and up) will be used to develop a non-invasive screening tool, which could enable detection of craniofacial signs of xlhed in the newborn period. 3d facial profiling has been reported to be effective in identifying hed (dellavia et al., 2008), but the technology does not yet meet the ease-of-use criteria for a universal screening tool. standard 2-dimensional (2d) frontal and lateral facial photographs will be taken of the same xlhed-affected male subjects as well as of adult females (ages 18-45 yrs) at risk for being xlhed carriers and unaffected adult female controls. the 2d facial photographs will serve a dual purpose; the first being to beta-test a previously developed algorithm to identify males affected with xlhed (automatic phenotype identification of xlhed patients final report, december 25, 2012, unpublished), and the second to adapt the facial recognition algorithm to identify female carriers of xlhed.

Eligibility criteria:
inclusion criteria: 1. females of original gender of age 18-45 years who are registered and attending the 2013 nfed family conference. this will include those at risk for xlhed and controls 2. xlhed-affected males of original gender of age 4 yrs and up who are registered and attending the 2013 nfed family conference 3. provide informed consent/assent exclusion criteria: 1. subjects who are not able or are not willing to comply with the procedures of this protocol 2. subjects with any major medical problem that will prevent them from participating in this study 3. male subjects who participated in the prior study ecp-003 sponsored by edimer pharmaceuticals inc. in may 2011 in san francisco, ca 4. males at risk for xlhed with prior genetic testing that did not reveal an eda mutation

Keywords: xlhed hed hypohidrotic ectodermal dysplasia x linked hypohidrotic ectodermal dysplasia
functional imaging of tumor and normal tissue

Conditions: Head and Neck Cancer

Summary: dynamic contrast-enhanced (dce) - magnetic resonance imaging (mri), diffusion-weighted (dw)-mri, and fludeoxyglucose - positron emission tomography - computed tomography (fdg-pet-ct) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including perfusion, vascular permeability and glucose metabolism. demonstrating that these parameters are associated with clinical outcome, either efficacy or toxicity, could enhance the ability to select patients for different treatment strategies and improve the therapeutic ratio.

patients will undergo functional imaging studies, dce-mri pre-treatment (twice) and after 1 week of radiation therapy (rt) and pet scans - pre-treatment and after 1 week of rt. parotid gland saliva production will also be measured at baseline and at 3, 6, and 12 months of follow-up.

Eligibility criteria:
inclusion criteria: * histologically documented squamous cell carcinoma of the head and neck (ajcc stages ii-iv, m0) * eligible anatomic sites: oral cavity, oropharynx, hypopharynx, supraglottic and glottic larynx, or nasopharynx * curative intent concurrent chemoradiation * age \> 18 years * karnofsky performance status \> 60 * able to undergo mri with contrast (gadolinium) and/or fdg pet scan exclusion criteria: * diabetes other than diet controlled * mri absolute contraindications including: * glomerular filtration rate \< 60 ml/min * weight \< 350 lb or current device limitations * metallic foreign bodies in the eye * cardiac pacemakers * clips in the central nervous system (ferromagnetic haemostatic) * automatic internal cardiac defibrillators * cochlear implants * shrapnel in vital locations * pregnant (positive pregnancy test) or lactating

Keywords: dce mri pet perfusion permeability cancer of the head and neck head, neck neoplasms
validation of the ellume® respirio flu test and the ellume® elab flu test for the rapid identification of influenza a/b

Conditions: Influenza A; Influenza B

Summary: the primary purpose of this study is to validate the sensitivity and specificity of the respirio flu test and the elab flu test in detecting influenza a as compared to the gold standard for detection, reverse transcriptase polymerase chain reaction (rt-pcr). the secondary aims are to: validate the sensitivity and specificity of the respirio flu test and the elab flu test in detecting influenza b as compared to the gold standard for detection, reverse transcriptase polymerase chain reaction (rt-pcr); evaluate the correct interpretation of the respirio flu test by subjects with influenza-like symptoms; evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the respirio flu test.


Eligibility criteria:
inclusion criteria: * male and female subjects aged ≥ 1 year; * rhinorrhea; * ≤ 5 days from onset of influenza-like illness symptoms; * subject (or parent/legal guardian) capable and willing to give informed consent/assent; * subject (or parent/legal guardian) able to read and write english. exclusion criteria: * has undergone treatment with antivirals within the previous 7 days; * has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days; * recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months; * currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent; * has had prior exposure to the respirio flu test or elab flu test.
different approaches for the management of post-dural puncture headache

Conditions: Post-Dural Puncture Headache

Summary: detecting the efficacy and safety of trans-nasal sphenopalatine ganglion block using either lidocaine 2% or bupivacaine 0.5 % as a treatment line for post-dural puncture headache


Eligibility criteria:
inclusion criteria: * the asa physical condition і-п * the patient underwent cs under spinal anesthesia * the headache developed within 5 days after the dural puncture * there is no different explanation for the headache exclusion criteria: * coagulopathy * history of nasal bleeding * nasal polyp * septal deviation * local anesthetics reaction
pilot study evaluating the efficacy of a topical pde4 inhibitor for morphea

Conditions: Morphea

Summary: this is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.

a phase 2, pilot, proof-of-concept, open label, single arm prospective study to assess the safety, tolerability and efficacy of using crisaborole 2% ointment for adult morphea. patients identified by their physician, nurse, or other member of their clinical care team as meeting criteria for the study will be asked to apply crisaborole 2% ointment, twice daily, on affected plaques for 12 weeks. a 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. dermal thickness will be measured and compared before and at the end of treatment. patients will have a clinical assessment at baseline and at weeks 4, 8 and 12. after week 12, patients who need further treatment will undergo standard of care treatment as determined by their primary dermatologist. physician and patient reported assessment and skin imaging will be performed at baseline, week 4, 8 and 12, and at week 20. photography will also be performed at baseline and week 12. an optional post treatment follow-up will be performed at week 20. medication will be provided free of charge by pfizer, as part of the grant that is funding this study. these will be dispensed by the study group at baseline and during the subsequent clinic visits.

Eligibility criteria:
inclusion criteria: 1. \>= 18 years of age 2. clinical diagnosis of morphea. 3. \<20% total body surface area involvement. 4. does not require systemic immunosuppressive therapy for morphea. 5. no immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone \>=10 mg po daily). 6. no immunomodulating topical therapy (topical steroids or topical calcineurin inhibitor), and no topical vitamin d analogue, 2 weeks prior to starting study. 7. no allergy to crisaborole or vehicle. 8. no known renal disease 9. able to give informed consent. exclusion criteria:subjects fulfilling any of the following criteria are not eligible for inclusion in this study. 1. clinical diagnosis of depression or history of suicidal ideation. 2. pregnant or breastfeeding women, with pregnant women being defined as the state of a female after conception until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hcg) laboratory test. women with a positive urine hcg at any time during the study will be withdrawn from the study.

Keywords: morphea, localized scleroderma
three mirna signatures in glioma: from molecular mechanisms to potential clinical application

Conditions: Glioma

Summary: individual overexpression of the three mirnas negatively affects cell viability and proliferation mainly in grade iii idh-wild type cells, while in higher grade cells, the effect is more pronounced when the entire signature is overexpressed, individual and combined overexpression of the signature members is able to determine a significant reduction in both migration and invasion. therefore, ectopic expression of the mirnas identified by us has a negative impact on cell viability, proliferation and apoptosis, but above all on migration and invasion.

decipher the impact and functional role of the signature formed by mir-1-3p, mir-26a-1-3p and mir-487b-3p on glioma biology. the functional role of the mirnas of the signature will be assessed with gain/loss of function strategies, using primary glioma cells derived from patients with native idh-wild type or mutated status. to set up the system we will start the study using glioma cell lines derived from patients already well characterized from a molecular and immunohistochemical point of view following the criteria reported by the new update of the 2016 who classification of tumors of the central nervous system. furthermore, the involvement of the signature in the response to treatment will be evaluated. despite the application of the most recent treatment protocols, the prognosis of patients with glioma remains unfavorable especially for patients with grade 4 glioma idh-wild type in which resistance to radiotherapy and temozolamide contributes significantly to the negative outcome. since it has been reported that some mirnas can promote chemosensitization on a wide variety of tumors, including gliomas, the involvement of the mirna signature in the response to treatment of these tumors will be studied. cellular sensitivity to radiotherapy and temozolamide will be evaluated by dose-response curves in cell lines and primary cells derived from both idh-wild type and idh-mutated patients.

Eligibility criteria:
inclusion criteria: * histological diagnosis of glioma; * no concomitant primary tumor; * no metastatic disease; * availability of surgical material/tissue; * written informed consent. exclusion criteria: * histological diagnosis of non-glial tumor; * patients with concomitant other solid tumors; * metastatic disease; * no surgical material/tissue available; * hiv seropositivity.
genes, intermediate phenotypes and response to quetiapine rx

Conditions: Schizophrenia

Summary: pharmacological treatment of schizophrenia is still characterized by a certain proportion of patients who are resistant to common antipsychotics. variability in individual response ranges from patients who experience complete or near complete symptom remission to a subset of patients who remain treatment-refractory despite extensive drug trials over years. the investigators propose to take advantage of the simultaneous acquisition of clinical and of intermediate phenotypes to ascertain the possible contribution of snps within putative causative genes to response to treatment with quetiapine xr.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * diagnosis of schizophrenia using the structured clinical interview for diagnosis for the diagnostic and statistical manual of mental disorders-fourth edition * male or female patients aged between 18 and 65 years * female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin test at enrollment * able to understand and comply with the requirements of the study * patients with a cut off value for panss more than 75 exclusion criteria: * pregnancy or lactation * any dsm-iv axis i disorder not defined in the inclusion criteria * patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others * known intolerance or lack of response to quetiapine fumarate, as judged by the investigator * use of any of the following cytochrome p450 3a4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir * use of any of the following cytochrome p450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, st. john's wort, and glucocorticoids * administration of a depot antipsychotic injection within one dosing interval before randomization * patients treated with clozapine within 28 days before the enrollment * substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence) * opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by dsm-iv criteria within 4 weeks prior to enrollment * medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment * unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator * involvement in the planning and conduct of the study * previous enrollment or randomization of treatment in the present study * participation in another drug trial within 4 weeks prior to enrollment into this study or longer in accordance with local requirements * a patient with diabetes mellitus * an absolute neutrophil count of ¬1.5 x 109 per liter * pre-existing organic mental disorder or mental retardation.
optimised nutritional therapy and early physiotherapy in long term icu patients (nutriphyt trial)

Conditions: Critical Illness; ICU Acquired Weakness; Malnutrition

Summary: due to medical advances and quality of care, mortality in adult intensive care units (icus) has decreased significantly in recent years, leading to a significant increase in the number of patients with high rehabilitation needs on discharge from the icu. a specific management by a multidisciplinary team has been set up since 2017 at the geneva-icu for long-stay patients (hospitalised ≥ 7 days). this study aim to assess whether an optimization of the nutritional therapy coupled with an early mobility during and after the icu stay allows an improvement in the muscle function at hospital discharge compared to patients receiving the standard care.

due to medical advances and quality of care, mortality in adult intensive care units (icus) has decreased significantly in recent years, leading to a significant increase in the number of patients with high rehabilitation needs on discharge from the icu. indeed, these patients are at high risk of complications related to their icu stay (cognitive impairment, icu acquired weakness, diaphragm dysfunction, icu polyneuropathy, post-traumatic stress, malnutrition, etc.). despite prolonged periods of rehabilitation, there is a significant decrease in functional status and quality of life compared to the previous status of these patient. a specific management by a multidisciplinary team has been set up since 2017 at the geneva-icu for long-stay patients (hospitalised ≥ 7 days) including special attention to weaning from ventilation, nutrition, mobilisation, anxiety, pain, skin condition etc. the culture of nutritional therapy and early mobilisation is already well established at the geneva-icu. however, a comprehensive approach to nutrition and mobilisation during and after the icu stay could be optimised. the objective of the study is to determine whether optimization of nutritional therapy combined with early mobilization for patients with long icu stay will improve muscle function at discharge compared with patients receiving standard care.

Eligibility criteria:
inclusion criteria: any patient admitted to the adult icu : * ≥18 years old * on mechanical ventilation with an expected length of stay ≥ 7 days * requiring artificial nutrition (enteral and/or parenteral nutrition) exclusion criteria: therapeutic withdrawal pregnant or breastfeeding patients neurological disorders with motor deficits: * new or pre-existing neuromuscular or nervous system disease * spinal cord injury severe polytrauma of the lower limbs (amputation etc.) non-independent ambulation (including walking aids) before icu admission for organizational reasons not allowing follow-up : * transfer to another icu * patient living abroad from switzerland * patient living in nursing homes preceding to icu admission * incarcerated patients * intellectual/cognitive disabilities or language barrier, limiting ability to follow the instructions

Keywords: early nutrition therapy early mobilisation long stay icu patient physiotherapy
platelet count（pc）/spleen diameter(sd) ratio to predict the variceal haemorrhage in hbv cirrhotic patients in china

Conditions: Platelet Count/Spleen Diameter Ratio; Child-Pugh Classification

Summary: to validate the pc/sd ratio to be used to predict the variceal haemorrhage in chinese patients with hepatitis b virus (hbv)-associated hepatic cirrhosis.

esophageal variceal bleeding remains the leading cause of acute mortality in patients with cirrhosis. using noninvasive parameters for high-risk variceal haemorrhage may reduce the need for endoscopies. the ratio of platelet count/diameter of the spleen (pc/sd ratio) is the principal noninvasive predictor of esophageal varices. this was an analytical cross-sectional study to validate the diagnostic test for hbv hepatic cirrhosis and was performed between january 2013 and august 2015. this study is to validate the pc/sd ratio to identification of those patients with high bleeding risk and selection for prophylactic treatment.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of hbv hepatic cirrhosis exclusion criteria: * patients with hepatocellular carcinoma, * use of medications for the primary prophylaxis of variceal bleeding, * history of esophageal variceal bleeding, * alcohol consumption within the admission and a history of ligation, * sclerotherapy, and/or * portal hypertension surgery

Keywords: platelet count/spleen diameter ratio china