Kornimate/medical-research-clean huggingface dataset:
a study of apatinib combined with temozolomide in patients witn advanced melanoma

Conditions: Advanced Melanoma

Summary: 30 patients with advanced melanoma will receive apatinib plus temozolomide as maintenance therapy.

in this study, we plan to enroll 30 patients with advanced melanoma patients who have failed at least one systemic treatment regimen. the therapeutic regimen is temozolomide, 300mg,po, d1-5, apatinib, 500 mg, qd, po, d1-28, every 28 days for 1 cycles, the primary end point was pfs, the secondary end point was os, dcr, orr etc. so we plan to investigate the safety and efficacy of apatinib combined with temozolomide in the treatment of advanced melanoma patients.

Eligibility criteria:
inclusion criteria: * age 18-70 years old； * ecog performance scale 0-1； * life expectancy of more than 3 months； * histologically or cytologic confirmed melanoma； * temozolomide has not been previously treated； * patients who have failed at least one systemic treatment regimen： including but not limited to patients receiving immunotherapeutics such as pd-1 monoclonal antibodies, pdl-1 monoclonal antibodies, ipilimumab, c-kit inhibitors, braf inhibitors, and molecular targeted drugs. * for results of blood routine test and biochemical tests： hgb\>100g/l, anc\>2.0×109/l, plt\>100×109/l, serum total bilirubin ≤ 1.5 x unl, alt and ast ≤ 2.5 x upper normal limit (unl), and ≤ 5 x unl（hematogenous metastases）, serum creatine ≤ 1.5 x unl； * informed consent； * willingness and ability to comply with scheduled visits. exclusion criteria: * hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg)； * with ≥grade 2 coronary heart disease, arrhythmia (including qtc interval prolongation male ≥450 ms, women ≥470 ms)； * imaging studies have shown that the tumor has been infringing on an important perivascular or when the researcher determines that the patient's tumor has a high risk of fatal hemorrhage during treatment； * abnormal coagulation (inr\>1.5, pt\>unl+4 seconds), with tendency of bleed or receiving the therapy of thrombolysis or anticoagulation.； * urine protein ≥++ or confirmed \>1.0 g by the 24h quantity； * pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures； * a history of psychotropic substance abuse and can not be abstinent or mental disorders ； * there are serious concomitant diseases that endanger patient safety or affect the patient in completing the study； * patients participating in other clinical trials simultaneously； * other situations that the researchers considered unsuitable for this study； * confirmed brain metastasis.

Keywords: apatinib temozolomide advanced melanoma
a study to assess efficacy and safety of two different dose regimens of risankizumab administered subcutaneously in japanese subjects with generalized pustular psoriasis or erythrodermic psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for japanese subjects with generalized pustular psoriasis (gpp) or erythrodermic psoriasis (ep).

safety and efficacy data through 14 december 2017 are included in the interim analysis, which was conducted after all participants completed the week 28 visit or discontinued from the study.

Eligibility criteria:
inclusion criteria: for gpp * have a diagnosis of gpp for at least 60 days prior to informed consent based on the diagnostic criteria of the japanese dermatological association (jda). subjects not fulfilling one of the diagnostic criteria i.e., "accompanying systemic symptoms including fever or malaise" at the time of screening can be entered. * subjects with an erythema area with pustules accounting for ≥ 10% of the body surface area (bsa), and with a severity assessment criteria score (jda total score) specified by the jda of less than 14. * must be candidates for systemic therapy or phototherapy for gpp, as assessed by the investigator. for ep * have a diagnosis of ep prior to informed consent. * subjects with an inflammatory erythema area accounting for ≥ 80% of the bsa at screening and at the time of the first administration of the study drug. * must be candidates for systemic therapy or phototherapy for ep, as assessed by the investigator. exclusion criteria: * previous exposure to risankizumab. * currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted). for gpp * subjects with active ongoing inflammatory diseases other than gpp that might confound trial evaluations according to investigator's judgment. for ep * subjects with active ongoing inflammatory diseases other than ep that might confound trial evaluations according to investigator's judgment. * subject diagnosed with medication-induced or medication-exacerbated ep.

Keywords: generalized pustular psoriasis erythrodermic psoriasis risankizumab japanese
intraoperative neuromonitoring of the recurrent laryngeal nerve versus neurostimulation

Conditions: Thyroidectomy

Summary: the purpose of this study is to evaluate if intraoperative neuromonitoring associated to neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy respect to neurostimulation alone.

anatomic and functional preservation of the recurrent laryngeal nerve is a key element of thyroid surgery. surgical exposure and visual identification of the nerve during thyroid surgery has been shown to provide the best rates of normal postoperative vocal fold function. nevertheless, identification of the nerve sometimes can be difficult in patients who are heavily scarred or who have undergone previous surgery. moreover, an anatomical intact nerve does not always correlate with normal vocal fold function. so it is mandatory to identify the nerve and to establish its function. two techniques are described to facilitate identification of the nerve and to test its function. one is the neurostimulation with laryngeal palpation which is an intermittent monitoring techniques that permits to evaluate the contraction of cricoarytenoid muscle (laryngeal twitch ) after stimulation of rln or vagal nerve with an electric stimulator probe. more recently some authors have suggested a continuous intraoperative neuromonitoring which provide audio and visual feed back when the nerve is electrically or mechanically stimulated during thyroidectomy. however controversy remains as to whether intraoperative neuromonitoring confers any significant benefit in injury prevention of recurrent laryngeal nerve.

Eligibility criteria:
inclusion criteria: * mono or bilateral thyroid surgery exclusion criteria: * previous thyroid and parathyroid surgery * thyroidectomy with mono or bilateral neck dissection * extended thyroidectomy for locally advanced thyroid carcinoma * retrosternal goitre * minimally invasive thyroid surgery * preoperative palsy

Keywords: neurostimulation intraoperative neuromonitoring recurrent laryngeal nerve palsy of recurrent laryngeal nerve rct
a study evaluating the safety and efficacy of the gmcn-508a drug product in transfusion-dependent α-thalassemia participants

Conditions: Transfusion-dependent α-Thalassemia

Summary: this is a non-randomized, open label, single-site, single-dose, phase 1 study in up to 5 participants (between 5 and 35 years of age, inclusive) with transfusion-dependent α-thalassemia. the study will evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (hsct) using gmcn-508a drug product \[autologous cd34+ hematopoietic stem cells transduced with gmcn-508a lentiviral vector encoding the human α-globin gene\].

subject participation for this study will be 5 years.

Eligibility criteria:
inclusion criteria: 1. the subject himself/herself or one legal guardian/agent of the subject is required to fully understand the study and voluntarily sign a written informed consent. 2. ages 5 to 35, no gender limitation. 3. the clinical diagnosis of transfusion-dependent α-thalassemia.transfusion dependence was defined as ≥6 units of transfusions of prbcs for the prior 24 weeks without \>56 days of non-transfusion. 4. karnofsky level of performance (kps) score or lansky level of performance (lps) score ≥70. 5. subjects were determined to undergo autologous hematopoietic stem cell transplantation and conditioning procedure by the principle investigator. 6. subjects were willing to comply with the protocol. 7. fertile subjects are willing to take effective contraceptive measures during the study. exclusion criteria: 1. diagnosed with mild α-thalassemia, hb bart's edema, atrx α-thalassemia, hemoglobin s/β-thalassemia, myelodysplastic subtype anemia, or with hbe homozygous β gene mutation, or with any type of β-thalassemia thalassemia. 2. uncorreted bleeding disorders with frequent bleeding (eg, menorrhagia, epistaxis, coagulation disorders). 3. bacterial, fungal, parasitic or viral infection as determined by the investigator to be clinically significant. 4. presence of severe iron overload. 5. any prior or current malignancy, myeloproliferative disorders or immunodeficiency disorders. 6. any major medical disease, laboratory test abnormality or mental illness that would render the participant ineligible for the study. 7. immediate family member with a known familial cancer syndrome. 8. prior receipt of gene therapy, allogeneic bone marrow transplantation or allogeneic hematopoietic stem cell transplantation. 9. participation in another clinical study with an investigational drug 3 months prior to screening. 10. pregnancy, plan to be pregnant during study or breastfeeding in a postpartum female. 11. known hypersensitivity to any ingredients or excipients of the test drug. 12. eligible for allogeneic bone marrow transplantation or allogeneic hematopoietic stem cell transplantation with a known and available donor. 13. any other condition that would render the participant ineligible for the study, as determined by the investigator.

Keywords: gmcn-508a gene therapy transfusion-dependent α-thalassemia human hematopoietic stem cell
does omega-3 polyunsaturated fatty acids (pufas) pretreatment improve outcomes in patients undergoing percutaneous coronary intervention (pci)?

Conditions: Coronary Arteriosclerosis

Summary: percutaneous coronary intervention (pci) has become the most common form of coronary revascularization worldwide. although pci is a safe procedure, it may have multiple risks including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. it is estimated that approximately 25% of patients undergoing pci have significant postprocedural creatinine kinase (ck)/creatinine kinase myocardial band (ck-mb) elevations and approximately 50% of patients have significant post-procedural troponin elevations. initially, it was felt these elevations were simple enzyme leaks with no long-term implications. now, several studies have demonstrated that periprocedural infarction is associated with short-, intermediate-, and long-term adverse outcomes, most notably mortality. pretreatment with antiplatelets such as aspirin and clopidogrel play an important role in reducing cardiovascular events (cv events) following pci. omega -3 polyunsaturated fatty acids (pufas) have antiplatelet effect. it may also improve response to aspirin and clopidogrel in low-response patients. this study is a randomized clinical trial (rct) evaluating the effect of omega 3 supplement \[with 400mg eicosapentaenoic acid (epa) and 200mg docosahexanoic acid (dha)\] on short-term (within 30 days) and long-term (after one year) major adverse cardiac events (mace) in patients undergoing elective pci. eighty patients planed to do elective pci will be categorized into two groups. the first group will be received standard regimen for pci (aspirin, clopidogrel, and heparin) and the second group will be treated with standard regimen in addition to 3 gram omega 3 (12 hours before pci). the main end point of the trial was short-term (within 30-days) and long-term (after one year) incidence of mace (death, myocardial infarction, or unplanned revascularization).


Eligibility criteria:
inclusion criteria: * candidate of elective pci * treatment with aspirin at least 5 days before pci exclusion criteria: * high ckmb and troponin i level * cardiac bypass in recent 3 months * platelet count \< 70×10 9/l * sever chronic renal failure * active bleeding * treatment with glycoprotein iib/iiia inhibitors during pci * treatment with bivalirudin during pci * sensitivity to aspirin and clopidogrel

Keywords: elective percutaneous coronary intervention omega 3 polyunsaturated fatty acids (pufas) short-term mace long-term mace
an extension to viral kinetics study of telbivudine and entecavir in adults with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis b who have completed the cldt600a2407 trial. patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.


Eligibility criteria:
inclusion criteria: * the patient has completed the previous cldt600a2407 study and is able to immediately enter this extension study with no study drug discontinuation * patient is willing and able to comply with the study drug regimen and all other study requirements * the patient is willing and able to provide written informed consent to participate in the extension study. exclusion criteria: * patient is pregnant or breastfeeding. * patient is co-infected with hcv, hdv, or hiv. * history of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hbeag-positive chronic hepatitis b telbivudine
effects of psaps on speech processing

Conditions: Hearing Loss, Age-Related

Summary: mild to moderate hearing loss remains undertreated, largely because of the high cost of hearing aids. a promising and much less expensive alternative is the use of personal sound amplification products (psaps), which are electronic, portable, over-the-counter devices that amplify sound. studies have shown that the use of psaps provides significant hearing benefits and improves the quality of life for older adults with mild to moderate hearing loss. however, there is insufficient data to determine the impact of psaps use on speech processing in the brain. the purpose of this study is to use electroencephalography (eeg) measurements to assess the neurobiological and behavioral effects of psaps on speech perception in noise in individuals with mild to moderate hearing loss. the investigators expect that the psaps use will result in an immediate improvement in the ability to perceive speech-in-noise, supporting that these hearing devices may be a means of restoring communication skills in people with mild to moderate hearing loss. behavioral benefits will be associated with increased brain activity in auditory regions and connectivity between auditory and speech regions in the brain.

this study will consist of two sessions of 3 hours each. on one session, participants will perform the speech-in-noise task without hearing devices and on the other session, participants will perform the speech-in-noise task while wearing personal sound amplification products. the order of the sessions will be counterbalanced across participants. the speech-in-noise task consists in a word discrimination task in babble noise at three signal-to-noise ratios. on each trial, the task is to determine whether two words are identical or different.

Eligibility criteria:
inclusion criteria: * right-handed exclusion criteria: * mother tongue not english * language impairment * dementia * cerebrovascular diseases * untreated vision impairment; * tinnitus and otologic disorders * cochlear implant * history of prior hearing aid use * diagnosed addiction (alcohol or drugs) * significant medical or neurocognitive conditions or interventions likely to significantly impact cognitive function (e.g., epilepsy, stroke, traumatic brain injury with loss of consciousness \> 5 minutes, brain tumor, multiple sclerosis, hepatitis c, developmental delay, electroconvulsive therapy) * a diagnosis (based on the diagnostic and statistical manual of mental disorders (dsm-5)) of major depressive disorder with active symptoms within 90 days of study entry, past or present psychosis, or other psychiatric disorders such as obsessive-compulsive disorder, generalized anxiety disorder, and bipolar disorder

Keywords: hearing loss speech processing speech-in-noise aging
comparison of two tablet formulations of sb-568859

Conditions: Atherosclerosis

Summary: sb-568859 is a medication that is being developed for the treatment of atherosclerosis (hardening of the arteries). the purpose of this study is to see if there is a difference in how the human body takes up the study drug depending on how the study drug is made. this study will compare sb-568859 tablets that are made in 2 different ways. this is not a treatment study.


Eligibility criteria:
inclusion criteria: * healthy men and sterile women between 18 and 50 years old * body weight greater than 50 pounds and a body mass index between 19 and 31 * normal electrocardiogram exclusion criteria: * no history of asthma or severe allergic reactions * no history of or current drug use * no hepatitis or hiv/aids * no excessive alcohol use * no smoking or tobacco use * no use of prescription drugs, over-the-counter drugs or vitamins within 7 days * no use of herbal supplements within 14 days * no treatment with an investigational drug within 30 days. * no treatment with 4 or more investigational drugs in the last 12 months * no grapefruit or grapefruit juice in the last 7 days * no donation of blood in the last 8 weeks * no history of allergy to heparin * no history of liver or gall bladder disease * unwillingness to use contraception

Keywords: unmilled formulation, micronised formulation relative bioavailability,
eeg in in-hospital patients with seizure or altered mental state

Conditions: Status Epilepticus; Seizure; Altered Mental Status

Summary: in kuopio university department of clinical neurophysiology there have been designed a fast eeg electrode, that is suitable for acute emergency use. it is easy to set up, records high quality eeg and can detect the most important eeg abnormalities comparable to conventional eeg. this study will address the clinical use of acute eeg with fast electrode set in in-hospital patients who have been consulted by medical emergency team because of seizure or altered mental state of uncertain etiology. patients are going to be treated in icu and eeg monitoring will continue for 24 hours.


Eligibility criteria:
inclusion criteria: * in-hospital patients who have a seizure or altered mental state and are going to be treated in icu exclusion criteria: * patiets that are not going to be treated in icu * patients with a do not attempt to resuscitate - decision

Keywords: acute eeg status epilepticus seizure
mri-mapped dose-escalated salvage radiotherapy post-prostatectomy: the maps trial

Conditions: Prostate Cancer; Prostate Adenocarcinoma

Summary: 1. the investigators hypothesize that increasing radiation dose to the functional mri-defined lesion in the prostate bed will result in an improved initial complete response (reduction in prostate-specific antigen (psa) to \< 0.1 ng/ml), which is related to long-term outcome biochemically. 2. biomarker expression levels differ in the dce-mri enhancing and non-enhancing tumor regions (when applicable). 3. 10-15% of men undergoing rt have free circulating dna (fcdna) or tumor cells (ctc) that are related to an adverse treatment outcome. 4. prostate cancer-related anxiety will be reduced in the mri targeted srt arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose (compared to those pts who were treated on standard arm prior to its closure).

phase 3 arms i (ssrt) and ii (mtsrt) were closed. study recruitment was suspended until re-opening as a single-arm phase 2 (mtsrt) study.

Eligibility criteria:
inclusion criteria: 1. prostate cancer patients with a psa after prostatectomy of at least 0.1 ng/ml and up to 4.0 ng/ml within 3 months prior to enrollment. 2. patients with or without palpable abnormalities on digital rectal exam (dre) are eligible. 3. minimum of 3 months since prostatectomy to allow for return of urinary continence and healing. 4. imaging detectable lesion or lesions in prostate bed or regional lymph node (ln). each lesion should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to protocol entry or enrollment. 5. no evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac). 6. negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment. 7. no previous pelvic radiotherapy. 8. serum total testosterone taken within 3 months prior to enrollment. 9. no concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). if a prior malignancy is in remission for ≥ 3 years then the patient is eligible. 10. ability to understand and the willingness to sign a written informed consent document. 11. zubrod performance status \< 2. 12. patients must agree to fill out quality of life/psychosocial questionnaires. 13. age ≥ 35 and ≤ 85 years. exclusion criteria: a. prior androgen deprivation therapy is not permitted if it was within 6 months previous to signing consent form. (note: therapy given as part of the planned course of radiation is allowed).