Kornimate/medical-research-clean huggingface dataset:
characterization of the nutritional status in the patient with liver cirrhosis

Conditions: Sarcopenia

Summary: in the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.


Eligibility criteria:
inclusion criteria: * cirrhotic patients with sarcopenia in abdominal ct. exclusion criteria: * chronic renal failure or being on hemodialysis * active hepatitis b or c virus infection * active alcohol abuse * coinfection with human immunodeficiency virus * renal or previous liver transplantation * history of neoplasia requiring chemotherapy or radiotherapy * hepatocellular carcinoma outside of milan criteria * tips * unwillingness to participate in the study.
short term intensified chemo-immunotherapy in hiv-positive patients with burkitt lymphoma

Conditions: HIV; Burkitt's Lymphoma

Summary: this is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in hiv+ patients with burkitt's lymphoma. experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response. until recently, the immuno-compromised state of patients with concomitant hiv/aids and bl was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. however, the advent of highly active antiretroviral therapy (haart) and evidence in diffuse large b-cell lymphomas that hiv-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat hiv-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population.

the activity of feasibility of the proposed program will be assessed in hiv+ patients with burkitt lymphoma with the aim to improve tolerability, minimize source consuming and supporting treatment and redu ce late sequels. available combinations in this setting are really source demanding and toxic combinations showing high rates of septic complication and a treatment-related mortality of near 20%.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of burkitt's lymphoma (who 2008) * hiv sero-positivity * age ≥18 and ≤60 years * ecog-ps ≤3 exclusion criteria: * cns parenchymal involvement * absolute neutrophil count \<1.000 cells/μl and platelets count \<75 × 109/l (burkitt unrelated) * creatinine \>1,5n (burkitt unrelated) * sgot and/or sgtp \>2,5n (burkitt unrelated) * bilirubin \>2n (burkitt unrelated) * severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance * significant cardiac disease or acute myocardial infarction in the last 12 months * severe active infection (except for hbv and/or hcv co-infection)

Keywords: hiv burkitt's lymphoma intensive short term immuno-chemotherapy hiv-positive patients with burkitt's lymphoma
a phase 2 trial of almonertinib with concurrent radiotherapy in the treatment of local advanced egfr-mutant nsclc

Conditions: Non Small Cell Lung Cancer; Stage III NSCLC; EGFR Activating Mutation

Summary: previous clinical studies showed there is a potential value of egfr-tki in local advanced egfr-mutant nsclc, while the risk of radiation pneumonia in combination of egfr-tki with thoracic radiotherapy is unknown. this study aims to explore the safety and efficacy of concurrent almonertinib, a new third-generation egfr-tki drug, with radiotherapy in local advanced egfr-mutant nsclc patients.

doublet platinum-based therapy combined with radiotherapy remains the standard treatment for first-line management of unresectable stage iii nsclc patients, regardless of the egfr mutation status. but the 5-year survival rate is not satisfying. previous clinical studies showed there is a potential value but also a high risk of radiation pneumonia in treatment regimens of combination tki with radiotherapy. this study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation egfr-tki drug, with radiotherapy in egfr-sensitive mutated locally advanced nsclc patients.

Eligibility criteria:
inclusion criteria: * confirmed histologically or pathologically as non-small cell lung cancer; * according to the eighth edition of the 2015 iaslc international lung cancer staging, imaging staging assessed as inoperable stage iii patients (according to the eighth edition of the 2015 iaslc international lung cancer staging); * blood or tissue egfr detection is exon 19 deletion or l858r mutation; * have not received systemic anti-tumor therapy; * fev1\>0.75l; * age ≥ 18 years old; * ecog ps score ≤ 2; * estimated survival period ≥ 6 months; * women must undergo surgical sterilization, post-menopausal, or take contraceptive measures during the treatment period and within 3 months after the end; * sign the informed consent form. exclusion criteria: * previously received other anti-tumor treatment, including almonertinib or other egfr-tki drugs; * contraindications for radiotherapy such as uncontrolled systemic lupus erythematosus, scleroderma or other connective tissue diseases; * other malignant tumors within 5 years (except for non-melanoma skin cancer and cervical cancer); * any medical or non-medical reasons prevent the patient from continuing to participate in the research; * it is expected that the patient will not be able to comply with the research procedures, restrictions and requirements, and researchers determine that the patient is not suitable for participating in the trial; * currently receiving (or unable to stop using it before receiving the first dose of study treatment) drugs or herbal supplements known to be potent inducers of cyp3a4 (at least 3 weeks ago); * the patient is taking any drugs that prolong the qt interval, and the drug cannot be stopped before the treatment of almonertinib; * patients with lung v20 \> 28% even after two-month almonertinib treatment. * pregnancy or breastfeeding.

Keywords: radiotherapy radiation pneumonitis almonertinib lung cancer egfr-tki
study of the involvement of fatty acids in retinopathy of prematurity: relationship between retinopathy of prematurity and the rate of expression of transplacental fatty acid receptors.

Conditions: Prematurity; Retinopathy

Summary: the development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. this late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (rop). among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (pufas) appears to be a crucial element. in a previous project, omega-rop, we showed a difference in the blood bioavailability of omega-3 pufas in infants born at less than 28 weeks of amenorrhea who develop rop compared to healthy newborns with no retinopathy. this study also showed that mothers experienced variations in the blood levels of omega-3 pufas that were contrary to the types of variations observed in their children. this suggests a sequestration of omega-3 pufas in the mothers of children who will develop rop. this new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of rop in newborns.


Eligibility criteria:
inclusion criteria: 1. mothers giving birth to premature babies less than 29 weeks of amenorrhea (wa), after obtaining their non-opposition. 2. mothers giving birth at term between 39 and 41wa+6 days, after obtaining their non-opposition. 3. ≥18 years 4. mothers not under legal protection exclusion criteria: 1. mothers giving birth between 29wa and 38wa+6 days 2. mothers in critical condition. 3. person not affiliated to national health insurance 4. for full-term mothers: patient presenting or having presented a health condition that affected a previous pregnancy (vascular such as pregnant hypertension, preeclampsia; gestational diabetes; intrauterine growth retardation, maternal infection during pregnancy such as toxoplasmosis, cytomegalovirus, rubella, measles, chickenpox).
cognitive behavioral therapy (cbt) for latinos with generalized anxiety disorder in the general medical sector

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this project is to implement culturally adapted cognitive behavioral therapy (cbt) based interventions in general health settings that are delivered to reduce generalized anxiety disorder (gad) symptoms, increase levels of functioning, and improve health-related quality of life.

this project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of cbt based treatments for gad among spanish-speaking latinos, particularly puerto ricans. this area of research is important in light of the limited treatment options currently available for spanish-speakers with gad and the long-term negative consequences of this condition. participants in this study are recruited in general health settings. patients meeting criteria for enrollment will be randomly assigned to receive either cognitive behavior based therapy or treatment as usual. assessments for all participants will be collected at baseline, post-treatment, and at two months follow-up visits.

Eligibility criteria:
inclusion criteria: * diagnosis of gad * 18 to 65 years * spanish speaker * able to read and write * plan to continue receiving services in the health care setting during the next six months exclusion criteria: * severe cognitive impairment, psychoses, history of bipolar disease, alcohol or drug abuse or dependence * clinically judged to have a high acute suicide risk * life-threatening medical condition * currently receiving psychotherapy
haemate hs in patients with severe bleeding undergoing valve replacement due to aortic stenosis

Conditions: Blood Loss, Surgical

Summary: evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of von willebrand factor concentrate f viii (haemate).


Eligibility criteria:
inclusion criteria: * patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement * caucasian * written informed consent (classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.classification as excessive leads to recruitment) exclusion criteria: * active endocarditis * history suggestive for inherited oe acquired bleeding disorder * concomitant coronary heart disease * agents impairing platelet function up to 14 days before surgery * pregnancy * inherited platelet function * known intolerance against haemate hs * previous thromboembolic complications * hepatitis b, c or hiv infection * previous chemotherapy * emergency surgery within the last 7 days * weight \ 100 kg

Keywords: intraoperative bleeding aortic-valve replacement aortic stenosis von willebrand heamate
"twelve-week study of the safety and efficacy of jzp-110 in the treatment of excessive sleepiness in narcolepsy"

Conditions: Narcolepsy

Summary: this trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of jzp-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.


Eligibility criteria:
major inclusion criteria: 1. males and females between 18 and 75 years of age, inclusive 2. diagnosis of narcolepsy according to icsd-3 or dsm-5 criteria 3. body mass index from 18 to \<45 kg/m2 4. consent to use a medically acceptable method of contraception 5. willing and able to provide written informed consent major exclusion criteria: 1. female subjects who are pregnant, nursing, or lactating 2. moderate or severe sleep apnea on the baseline psg. 3. any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness 4. history or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to dsm-5 criteria 5. history or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, pk assessments, or the ability of the subject to complete the trial per the judgment of the investigator 6. history of bariatric surgery within the past year or a history of any gastic bypass procedure 7. presence or history of significant cardiovascular disease 8. use of any over-the-counter (otc) or prescription medications that could affect the evaluation of excessive sleepiness 9. use of any medications that could affect the evaluation of cataplexy 10. received an investigational drug in the past 30 days or five half-lives (whichever is longer) 11. previous exposure to or participation in a previous clinical trial of jzp-110 (adx-n05, r228060, ykp10a) 12. history of phenylketonuria (pku) or history of hypersensitivity to phenylalanine-derived products
the effect and mechanism of electroacupuncture on acute chemotherapy-induced nausea and vomiting

Conditions: Lung Neoplasms

Summary: the purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional magnetic resonance imaging (fmri).


Eligibility criteria:
inclusion criteria: * first diagnosed stage ⅲ-ⅳ lung cancer patients on cisplatin chemotherapy; * right-handed and aged 18 to 75 years; * karnosky performance status (kps) ≥ 70; * life expectancy ≥ 6 months. exclusion criteria: * had brain metastases or other concurrent life-threatening diseases; * nausea and/or vomiting were present 24h before chemotherapy treatment; * suffered from or had a history of gastrointestinal diseases; * had a history of head trauma, serious neurological or psychiatric disorders; * participating in other clinical trials currently; * had any contraindication to exposure to a high magnetic field or receive acupuncture
angioplasty + sbcv vs. angioplasty alone for femoropopliteal artery stenosis

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to compare balloon angioplasty plus sbcv against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.

this first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, sbcv, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.

Eligibility criteria:
inclusion criteria: * scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s) * rutherford clinical category 1-4 (claudication or critical limb ischemia) * lesions are ≥70% stenosis by visual estimate * a patent inflow artery free from significant lesion * at least one patent native outflow artery to the ankle exclusion criteria: * history of haemorrhagic stroke within 3 months of screening * history of myocardial infarction, thrombolysis or angina within 2 weeks of screening * renal failure or chronic kidney disease * severe calcification that renders the lesion undilatable
a phase ii study of epstein-barr virus-specific immunotherapy for nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this research study is to determine how effective and how safe it is to give an epstein-barr virus (ebv) immunotherapy product to participants with nasopharyngeal carcinoma (npc) associated with ebv that has come back or spread to other parts of the participant's body. this is phase ii study with the aim of establishing a baseline of efficacy.

the study follows a pilot study optimizing and refining the manufacturing process, streamlining logistics (eg infusion protocol, enrolling out-of-town patients), increasing the cell dose, defining optimal patient eligibility, and improving monitoring for patients. eligible participants will undergo a blood draw to obtain peripheral blood mononuclear cells (pbmcs) used for preparation of the immunotherapy product \[estimated time 14-16 weeks\]. participants' pbmcs will be isolated by density centrifugation from peripheral blood and then infected with ebv to generate ebv-transformed b-lymphoblastoid cell lines (lcls). lcls will be irradiated and then used to stimulate autologous t cells, yielding an ebv-specific, autologous t cell product.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven npc of an who grade, associated with ebv infection documented by the presence of eber expression by in situ hybridization in the tumor. positive eber staining from another institution must be confirmed by pathology review at brigham and women's hospital. other confirmation of ebv-associated disease is acceptable, such as ebv dna in situ hybridization, if eber analysis is not adequate * incurable npc * recovery from toxicity from any prior npc therapy to grade 1 or better * 18 years of age or older * evaluable or measurable disease, according to modified recist * ecog performance status of 0 or 1 * adequate bone marrow, liver and renal function as outlined in protocol exclusion criteria: * radiotherapy for primary npc within 8 weeks of enrollment, or radiotherapy for any other reason within 6 weeks * chemotherapy for npc within 2 weeks of enrollment * other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer * uncontrolled central nervous system metastases * active hepatitis, known hiv, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids * autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy * active uncontrolled serious infection * women of child-bearing potential who have a positive pregnancy test or are breast-feeding

Keywords: epstein-barr virus npc ebv immunotherapy
margetuximab plus chemotherapy vs trastuzumab plus chemotherapy in the treatment of her2+ metastatic breast cancer

Conditions: HER-2 Positive Breast Cancer; Metastatic Neoplasm

Summary: the purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (pfs) and overall survival (os) than patients treated with trastuzumab plus chemotherapy. a non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically-proven metastatic or locally-advanced relapsed/refractory her2+ breast cancer based on the most recently available tumor biopsy collected from the patient. tumors may be estrogen receptor (er)/progesterone receptor (pgr) positive or negative. * have received at least 2 prior lines of anti-her2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-her2 directed therapy in the metastatic setting. in either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. prior radiotherapy, hormonal therapies, and other anti-her2 therapies are allowed. * prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. patients must have progressed on or following, the most recent line of therapy. * resolution of all chemotherapy or radiation-related toxicities to ≤ grade 1 * life expectancy ≥ 12 weeks * acceptable laboratory parameters * women of childbearing potential must have negative pregnancy test performed within 14 days of randomization and on the first day of treatment. all subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug. infusion sub-study prior therapy requirements: same as above, except: * must have received 4 or more prior lines or therapy in the metastatic setting * must have received prior trastuzumab, pertuzumab, and t-dm1 exclusion criteria: * known, untreated brain metastasis. patients with signs or symptoms of brain metastasis must have a ct or mri performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases * history of uncontrolled seizures within 6 months of randomization * history of prior allogeneic bone marrow, stem-cell, or solid organ transplantation * history of clinically significant cardiovascular disease * clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation * any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapy
alx-0171 phase i study, evaluating single ascending dose and multiple dose in healthy male volunteers

Conditions: RSV Infection

Summary: alx-0171 is a nanobody directed against the human respiratory syncytial virus (rsv). the purpose of this first-in-man study is to determine the safety, tolerability and pharmacokinetics (pk) of alx-0171 after single and multiple pulmonary administrations in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * non-smoking healthy male volunteers, aged 18-55 years * good health condition, as determined by medical history, physical examination and clinical laboratory testing * forced expiratory volume in 1 second (fev1) ≥ 90% of predicted value * diffusing capacity of the lung for co (dlco) ≥ 85% of predicted value * normal chest x-ray (anteroposterior and lateral view) * minimum weight of 70.0 kg, minimum height of 1m70, body mass index between 18.0 and 30.0 kg/m² exclusion criteria: * current smokers, or ex-smokers abstinent from tobacco for less than one year * history or presence of atopy or pulmonary non-specific hyperreactivity * positive bronchial challenge test * symptomatic viral infection, or suspicion thereof (including rhinitis) in last 14 days prior to dosing * signs of active pulmonary infection or other inflammatory conditions, even in the absence of febrile episodes, in the last 14 days prior to dosing