Kornimate/medical-research-clean huggingface dataset:
pea in functional dyspepsia

Conditions: Dyspepsia and Other Specified Disorders of Function of Stomach

Summary: the goal of this placebo controlled randomized double blind interventional study is to assess the effect of palmitoylethanolamide supplementation in patients with functional dyspepsia the main questions it aims to answer are: * the efficacy of pea on functional dyspepsia symptoms measured using the lpds questionnaire * the effect of pea on duodenal mucosal permeability. participants will receive an 8-week during treatment with pea 3x400 mg per day or placebo 3 times per day.


Eligibility criteria:
inclusion criteria: * patients with functional dyspepsia as diagnosed by the rome iv criteria. * subjects must provide witnessed written informed consent prior to any study procedures being performed. * subjects aged 18-70 years old. * male or female subjects. * subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements. * women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (iuds), sexual abstinence, or vasectomized partner. women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. exclusion criteria: * presence of a history of gastrointestinal surgery other than appendectomy and cholecystectomy. * organic gastro-intestinal disease * major psychiatric disorder such as major depression * presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease. * patients with eosinophilic esophagitis * presence of diabetes mellitus * active h. pylori infection or \< 6 months after eradication * predominant ibs (based on the rome iv questionnaire) * predominant gerd (based on the rome iv questionnaire) * patients taking prohibited medication * females who are pregnant or lactating * patients not capable to understand or be compliant with the study.
endometrial cancer diet and exercise

Conditions: Early Stage Endometrial Cancer

Summary: this study will evaluate whether the use of the jawbone wristband monitor, in connection with home-based exercise and nutritional counseling can be safely completed and improve cardiorespiratory fitness (heart and lung health) in women with early stage endometrial cancer who have undergone surgery.


Eligibility criteria:
inclusion criteria: * ages \> 18 years. * localized endometrial cancer (stage i and ii); no evidence of stage iii or iv disease. * at least 2 months was passed since the hysterectomy and enrollment. * karnofsky performance status \> 70%. * body mass index of 30.0 - 49.9 and body weight \< 300 pounds. * no plan for adjuvant endometrial cancer therapy. * able to exercise safely on a treadmill. * no absolute contraindications to exercise testing as recommended by the american thoracic society. no recent (\<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection. * the subject is not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting. * able to provide informed consent. * have reliable transportation to the testing facilities. * subjects must be able to speak and understand english to participate in this study. * subjects must have a personal mobile device compatible for the activity monitor compatible devices for the activity monitors are below: * android o activity monitor is compatible with most android devices equipped with bluetooth 4.0 and running android 4.3 (jelly bean) or later. * ios * iphone 4s (or newer) * ipod touch (5th generation or newer) * ipad (3rd generation or newer) * ipad mini (1st generation or newer) * ipad air (1st generation or newer) exclusion criteria: -
clinical trial of aplidin® in patients with primary myelofibrosis

Conditions: Myelofibrosis

Summary: this is an open-label, phase ii clinical trial of aplidin® (plitidepsin) in patients with primary myelofibrosis and post polycythemia vera/essential thrombocythemia (post-pv/et) myelofibrosis.

this trial tries to assess response rate (orr) of plitidepsin in patients with: primary myelofibrosis (pmf), post-polycythemia vera myelofibrosis (post-pv mf), or post-essential thrombocythemia myelofibrosis (post-et mf). besides, the study results will allow to evaluate the effect of plitidepsin on bone marrow (bm) or peripheral blood histology and to determine the quality of life (qol) and symptoms or participant patients.

Eligibility criteria:
inclusion criteria: 1. diagnosis of primary myelofibrosis (pmf) or post polycythemia vera/essential thrombocythemia myelofibrosis(post-et/pv mf) as per revised world health organization (who) criteria. 2. high-risk or intermediate-2 risk myelofibrosis (mf) as defined by the international prognostic scoring system (ipss); or intermediate-i risk mf associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy. 3. at least 18 years of age, with life expectancy of ≥12 weeks. 4. able to provide informed consent and being willing to sign an informed consent form (icf). 5. eastern cooperative oncology group (ecog) performance status ≤2. 6. evidence of acceptable organ function within seven days of initiating study drug exclusion criteria: 1. previous treatment with plitidepsin. 2. any of the following therapies within two weeks prior to initiation of study drug: * chemotherapy (e.g., hydroxyurea), * immunomodulatory drug therapy (e.g., thalidomide), * immunosuppressive therapy, * corticosteroids \>10 mg/day prednisone or equivalent, or * erythropoietin. 3. incomplete recovery from major surgery within four weeks of study entry. 4. radiation therapy within four weeks of study entry. 5. women of childbearing potential 6. women who are pregnant or are currently breastfeeding. 7. myopathy grade \> 2 8. known positive status for human immunodeficiency virus (hiv). 9. active hepatitis b or c virus (hbv or hcv) infection 10. diagnosis of another invasive malignancy 11. any acute active infection. 12. known hypersensitivity to the study drug or any of its formulation components (e.g., cremophor®). 13. treatment with any investigational product in the 30 days before inclusion in the study.

Keywords: aplidin plitidepsin myelofibrosis pharma mar
ultrasound and cytological evaluation 3 years after radiofrequency thermal ablation of benign thyroid nodules : a prospective exploratory cohort of 180 nodules

Conditions: Thermal Ablation; Fine Needle Aspiration Biopsy; Thyroid Nodules

Summary: there is no scientific data on post-thermal ablation cytological aspects, but treated nodules that grow back significantly after a procedure justify a new cytology in order not to ignore a neoplastic process. the eu-tirads classification usually used to stratify the risk of cancer (and to justify a fine needle aspiration biopsy) of thyroid nodules is not validated for nodules treated by thermal ablation (ta) (post-rf nodules). however, these nodules often acquire ultrasound criteria of suspicion making it necessary to develop an ultrasound stratification of the risk of malignancy specific to nodules treated by ta. the objective of this work is to describe the ultrasound and cytological aspects of these treated nodules by performing a systematic assessment at 3 years after thermal ablation including systematic neck ultrasound and fine needle aspiration biopsy. thus, an ultrasound and cytological atlas (bethesda classification 2017) of nodules treated by thermal ablation will be constituted.


Eligibility criteria:
inclusion criteria: 1. patients \> 18 years old 2. carrier of a benign thyroid nodule that has undergone radiofrequency thermoablation 36 months previously ± 12 months, whether the nodule is stable, progressing or decreasing in volume during the screening period and/or on the day of inclusion. 3. obtaining written informed consent 4. affiliation to a social security system (excluding ame) exclusion criteria: 1. pregnant or breastfeeding women 2. previous alcohol use 3. patients on anti-vitamin k anticoagulants 4. patients on direct oral anticoagulants 5. persons deprived of liberty by judicial or administrative decision 6. persons under forced psychiatric care 7. persons admitted to a health or social institution for purposes other than research 8. persons of full age who are under legal protection (guardianship or curatorship) 9. persons unable to express their consent 10. persons under a legal protection measure (there can be no derogation for this category)
use of the amniotic membrane in large wound epithelialization

Conditions: Wounds

Summary: the purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.


Eligibility criteria:
inclusion criteria: * acute wounds in granulation phase with a minimum area of 100 cm2. * patients 18 or more years. * patients offering sufficient guarantees of adherence to protocol. * sign the written informed consent. * meet all inclusion criteria. exclusion criteria: * patients with symptomatic chronic arterial insufficiency. * patients who are pregnant * patients in active lactation * patients physically fertile, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, unless they are using reliable contraception. this method of contraception can be: * complete abstinence from sexual intercourse * surgical sterilization (tubal ligation) * surgical sterilization of the partner (vasectomy) * implanted or injectable hormonal contraceptives, oral \* * because hormonal contraceptives have a risk of thrombosis, should consider other methods of birth control. these reliable contraception must be maintained during their participation in the study. * patients with heart, kidney, liver, systemic immune may influence the survival of the patient during the test. * participation in other clinical trials. * inability to understand informed consent.

Keywords: extensive wounds amniotic membrane healing patients phase granulation
spinal cord injury neuroprotection with glyburide

Conditions: Acute Spinal Cord Injury

Summary: to assess the safety and efficacy of using oral glyburide (diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury.

this study will include subjects between 18 and 80 years who have experienced acute traumatic cervical or thoracic spinal cord injury. subjects will begin an oral drug regimen of glyburide with the initial dose being within 8 hours of the injury and again every 6 hours after for 72 total hours of treatment. the daily dose of 3.125mg on day one and 2.5 mg on days 2 and 3 will be used to determine if the investigational drug provides any neuroprotection when given soon after injury. if indicated, the subject will also have surgical intervention for spinal cord decompression surgery and spinal stabilization. participants will have labs drawn regularly, and ecgs done throughout their hospital stay. adverse events will be monitored daily through day 14 of participation or hospital discharge (whichever is earlier). study participation will last for 365 days (+/- 30 days), with post-hospitalization follow-up occurring on days 28, 42, 84, 182, and 365.

Eligibility criteria:
inclusion criteria: * no life threatening injuries resulting from the traumatic accident * no evidence of sepsis * acute cervical or thoracic sci with asia impairment scale grade a, b, or c od admission. * non-penetrating sci at neurologic level from c2 to c8 or t1 to t12 exclusion criteria: * unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours * acute sci with asia impairment scale grade d or e * currently involved in another non-observational sci research study or receiving another investigational drug * history of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components * any condition likely to result in the patient's death within the next 12 months * severe renal disorder from the patient's history (e.g. dialysis) or baseline egfr of \< 30 ml/min/1.73 m2 * known severe liver disease, or alt \> 3 times upper limit of normal or bilirubin * blood glucose \<55 mg/dl at enrollment or immediately prior to administration of diabeta, or a clinically significant history of hypoglycemia * acute st elevation myocardial infarction, and/or acute decompensated heart failure, and/or qtc \> 520 ms, and/or known history of cardiac arrest (pea, vt, vf, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months * known g6pd enzyme deficiency
sildenafil citrate to improve maternal and neonatal outcomes in low-resource settings

Conditions: Fetal Distress; Perinatal Asphyxia; Birth Asphyxia; Stillbirth

Summary: the prism pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of the intervention and expected enrollment rates, and estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource settings in preparation for the main rct.

the primary objectives of the prism pilot study relate to feasibility of a large randomized controlled trial of intrapartum sildenafil citrate and will aid in design of a definitive trial among pregnant women to day 42 postpartum (pp) and their newborns to day 28 pp. the pilot will help prepare for the main trial by allowing the investigators to: * determine the rate and indication for fetal heart rate monitoring practices; * determine the rate and indications for operative delivery; * inform the rates of relevant primary and secondary outcomes to possibly target in a large randomized controlled trial of intrapartum sildenafil citrate; * assess the feasibility and acceptability of the intervention and expected enrollment rates; * estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource setting.

Eligibility criteria:
inclusion criteria: * admission to facility with plan for spontaneous or induced vaginal delivery * early stage of labor (≤ 6 cm cervical dilation per local standard) at ≥ 37 weeks gestation * age ≥ 18 years of age * presence of single live fetus confirmed via a fetal heart rate by doptone in cephalic position * provision of written informed consent \[note: if written consent is obtained at an early time, verbal re-confirmation is required at time of enrollment\] exclusion criteria: * non-emancipated minors (as per local regulations) * plan for cesarean delivery or history of cesarean section prior to enrollment\* * unknown gestational age * advanced stage of labor (\>6 cm or 10 cm cervical dilation per local standards) and pushing or too distressed to understand, confirm, or give informed consent regardless of cervical dilation * not capable of giving consent due to other health problems such as obstetric emergencies (for example, antepartum hemorrhage) or mental disorder; * any medical condition considered a contraindication, including contraindication to sildenafil therapy, per the judgement of site investigators * any maternal medical condition or status that precludes informed consent * recognized fetal anomaly

Keywords: fetal distress perinatal asphyxia sildenafil citrate fetal heart rate monitoring zambia
radiotherapy of head and neck cancer using an intraoral stent

Conditions: Oral Cavity Cancer; Sinonasal Cancer

Summary: radiotherapy of oral cavity cancer and sinonasal cancer is associated with acute and late morbidity. use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. the aim of the present study is to confirm that an intraoral stent is not a significant bother to the patients.

the investigators have previously performed a pilot study on the feasibility of the intraoral stent in patients receiving radiotherapy for tongue cancer. it was found that most of the patients tolerated the stent. the mean radiation dose to the hard palate was reduced by 61% (absolute percentage) as compared with a control group not using the stent. based on these results, the investigators wish to perform a study on a larger cohort to confirm that the intraoral stent will not lead to increased symptoms towards the end of the radiotherapy period.

Eligibility criteria:
inclusion criteria: * radiation dose 30 gy or higher * cancer in the inferior part of the oral cavity (e.g. tongue or floor of mouth cancer) or superior part of the oral cavity (e.g. hard palate) or sinonasal cancer * eastern cooperative oncology group (ecog) performance status 0-3 * ability to understand and answer questionnaire exclusion criteria: none

Keywords: radiotherapy intraoral stent head and neck cancer patient-reported outcome
studying tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy

Conditions: Melanoma (Skin)

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help the study of cancer in the future. purpose: this laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.

objectives: * develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy. * develop a survival model for relapse based on sentinel lymph node biopsy positivity. * assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma. outline: this is a retrospective, case-controlled, multicenter study. patients are stratified according to breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs \> 4 mm) and gender. archived tumor tissue is analyzed by immunohistochemistry (ihc) for ap2, vascular endothelial growth factor, mmp 2, mcm4, and others, if feasible. sentinel node biopsies are analyzed by ihc for cd31, lyve-1, and d2-40 expression. rna and dna are also extracted for genetic expression studies and mutation analysis (e.g., braf, nras, pten, cdkn2a). patient data related to relapse and recurrence is collected, if available. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 1,000 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of cutaneous melanoma * breslow thickness \> 0.75 mm * has undergone sentinel lymph node biopsy * no primary melanoma that has not originated in the skin * no multiple primary melanomas * currently under clinical followup or discharged from follow up within the past 3 months patient characteristics: * no other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ prior concurrent therapy: * see disease characteristics

Keywords: stage iv melanoma recurrent melanoma stage ia melanoma stage ib melanoma stage iia melanoma stage iib melanoma stage iic melanoma stage iiia melanoma stage iiib melanoma stage iiic melanoma
study to evaluate spi-1005 in adults with meniere's disease

Conditions: Meniere's Disease

Summary: this study will evaluate the safety and efficacy of three dose levels of spi-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with meniere's disease.

randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral spi-1005 in adults with meniere's disease. all subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with spi-1005 or placebo. during treatment with spi-1005, and 7 days and 28 days following the cessation of spi-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. additional testing including electrocochleography will be performed at baseline, at the end of spi-1005 treatment, and 28 days after the spi-1005 treatment has stopped. six outpatient visits will be performed over a 7-week period.

Eligibility criteria:
inclusion criteria: * diagnosis of probable or definite meniere's disease by aao-hns 1995 criteria within 12 months of study enrollment; * voluntarily consent to participate in the study; * females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: * sexual abstinence (inactivity) for 14 days prior to screening through study completion; or * iud in place for at least 3 months prior to study through study completion; or * barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or * stable hormonal contraceptive for at least 3 months prior to study through study completion; or * surgical sterilization (vasectomy) of partner at least 6 months prior to study. * females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses. exclusion criteria: * current use or within 90 days prior to study of ototoxic medications such as aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide); * history of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma; * history of middle ear or inner ear surgery; * current conductive hearing loss or middle ear effusion; * significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease; * history of hypersensitivity or idiosyncratic reaction to compounds related to ebselen; * current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome p450 enzymes; * participation in another investigational drug or device study within 90 days prior to study enrollment; * female patients who are pregnant or breastfeeding.

Keywords: meniere's hearing loss vertigo tinnitus ebselen