Kornimate/medical-research-clean huggingface dataset:
gvhd prophylaxis with methotrexate in haploidentical hct using posttransplant cyclophosphamide

Conditions: Graft Vs Host Disease; Hematopoietic Neoplasm

Summary: allogeneic hematopoietic cell transplantation (hct) is an important therapeutic strategy for many malignant and benign hematologic diseases. haploidentical hct has been increasingly used in patients lacking a hla-matched donor due to its prompt availability, possibly lower cost and results comparable with other donor types. graft-versus-host disease (gvhd) is the main cause of morbidity and mortality after hsct, and prophylactic strategies are routinely used. in the context of haploidentical hct, posttransplant cyclophosphamide plus cyclosporine and mycophenolate mofetil (mmf) is the most common platform used in brazil. data comparing mmf and methotrexate (mtx) as gvhd prophylaxes have proved controversial in other donor types, yet some large studies have showed that mtx is associated with lower risk of gvhd and improved long-term outcomes. moreover, it is known that mmf is a potent inhibitor of natural killer (nk) cells, possibly interfering with the graft-versus-leukemia effect in haploidentical hct. given the possible advantages and the absence of consistent evidence regarding safety, efficacy and ideal dosage of mtx as gvhd prophylaxis in this setting, we propose a phase i / ii study evaluating this drug in adult patients with hematologic malignancies undergoing haploidentical hct with posttransplant cyclophosphamide.


Eligibility criteria:
inclusion criteria: * diagnosis of acute myeloid leukemia and chronic myeloid leukemia in complete morphologic remission, myelodysplastic syndrome with less than 10% in bone marrow or peripheral blood, ph-negative acute lymphoblastic leukemia in complete morphologic remission, chemosensitive hodgkin lymphoma or non-hodgkin lymphoma in at least partial remission * donor type: haploidentical related donor * graft source: bone marrow or peripheral blood * recipients of non-myeloblative or myeloablative intensity conditioning * left ventricle ejection fraction \> 40% * estimated creatinine clearance \> 40 ml/min * adjusted dlco ≥ 40% and fev1 ≥ 40% * total bilirubin \< 2x uln e alt/ast \< 2.5x uln exclusion criteria: * prior allogeneic transplant * ex-vivo graft manipulation (t-cell-depleted or cd34-selected grafts) * use of alemtuzumab or anti-thymocyte globulin * kps \< 70% * patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment * pregnant or lactating women * patients seropositive for human immunodeficiency virus (hiv) or active hepatitis b or c infection by pcr * presence of fluid collection (ascites, pleural or pericardial effusion) that may interfere with methotrexate clearance or make methotrexate use contraindicated * patients with a serious medical or psychiatric illness likely to interfere with participation in this study

Keywords: methotrexate post-transplant cyclophosphamide cyclosporine haploidentical hematopoietic cell transplantation
immune response of visceral leishmaniasis patientstreated with antimonial plus n-acetylcysteine

Conditions: Visceral Leishmaniasis; Immune Response; Treatment

Summary: this study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using n-acetylcysteine (nac) as an adjuvant therapy to pentavalent antimony.

in this study we intend to evaluate the immune and therapeutic responses of patients with visceral leishmaniasis n-acetylcysteine (nac) as an adjuvant to standard treatment with pentavalent antimony, compared to treatment with antimonial only through a blind randomized clinical trial. our hypothesis is that patients treated with nac associated with pentavalent atimonial have a rapid changing of the immune responses, towards th1, and clinical improvement when compared to patients who will use only the standard treatment

Eligibility criteria:
inclusion criteria: * age 2 to 50 years * diagnosis of visceral leishmaniasis exclusion criteria: * other acute or chronic diseases * use of immunosuppressive drugs * aids * history of allergy to nac and/or pentavalent antimony

Keywords: visceral leishmaniasis n-acetylcysteine antimony immune response
omitting gnrh-antagonist dose on the day of ovulation trigger

Conditions: Pituitary Downregulation

Summary: omitting the gnrh antagonist on the day of the trigger can be cost effective and more convenient to the women. we will study the impact of omitting the antagonist dose in a prospective randomized trial


Eligibility criteria:
inclusion criteria: * all antagonist cycle ivf who agree to participate exclusion criteria: * expected poor responders.

Keywords: gnrh antagonist pituitary downregulation ivf icsi
chinese exercise modalities in parkinson's disease

Conditions: Parkinson Disease

Summary: this study will compare the effects of two chinese and one western exercise modalities on the signs and symptoms of parkinson's disease.

the long-term goal of this project is to study the effects of different exercise modalities on parkinson's disease (pd). pd is a disorder whose primary disability stems from motor dysfunction including balance. recent studies have shown that the risk of falling in the elderly can be reduced through the practice of the chinese complementary and alternative medicine (cam) such as t'ai chi chuan (tcc). this finding may be highly significant to pd. although a recent report from emory suggests pd patients can do well with aerobic (walk-run) exercise training (aet), it is still unclear whether the potential anti-parkinsonian effect of such modalities is secondary to improved physical fitness (crf), motor control or both. cam interventions such as tcc may offer a unique opportunity to examine these fundamental questions. in pd we hypothesize that exercise training will reduce primary and secondary disability and that some of these changes represent adaptive reprogramming of central motor pathways. we will conduct a controlled double-blind, 16-week dose-response study of exercise based on caloric expenditure and thus on the cardiorespiratory fitness effects of exercise (crf). the treatments will be qi gong (minimal caloric expenditure), tcc (low expenditure), and walk-cycle aet (moderate expenditure). we will examine exercise-induced change in motor control using quantitative measures of motor disability, including dynamic gait stability measures. we will also examine exercise effects on central and peripheral indices of parkinsonian motor disability. a caloric "dose-response" effect of exercise would suggest crf is a major determinant of the anti-parkinsonian effects of exercise. if the chinese modalities are as effective or superior to aet however, this would suggest that other mechanisms such as change in central motor programming may be playing a role (e.g. relaxation effects, reinforcement of central motor programs?). a better understanding of exercise-induced neural plasticity and motor control would offer a significant, and heretofore unexploited rehabilitative potential in pd.

Eligibility criteria:
inclusion criteria: * ambulatory patients with parkinson's disease, defined as a clinical state in which at least two of these four cardinal features are present- 1) slowness of movement, 2) tremor at rest, 3) muscular rigidity, 4) gait disturbance or posture imbalance. * ambulatory patients with parkinson's disease not exercising regularly more than 2x per week. willing to be randomly assigned to 1 of the 3 exercise modalities: tai chi, qi gong and aerobic exercise. note that participation in the study requires bi-weekly participation in a 16-week supervised exercise program plus related evaluations at emory. accordingly, recruitment is limited to local patients.

Keywords: parkinsons disease chinese exercise
determination of the effect of cold needle on invasive pain cannulation

Conditions: Hemodialysis Complication; Pain

Summary: in studies evaluating the methods used to reduce invasive pain associated with cannulation, it is seen that pharmacological and non-pharmacological methods are used. pharmacological treatment is considered risky as it may cause drug addiction in the patient and may cause side effects and complications. on the other hand, the use of non-pharmacological methods is preferred because they are cheaper and cause fewer side effects and complications.

cold application, one of the non-pharmacological methods used, is effective in relieving pain by slowing down or blocking the conduction of peripheral nerves. apart from this effect, it stimulates touch receptors by activating the door-control mechanism; it increases the release of endogenous opioids and stops pain by ensuring the nerve impulses caused by cold are transmitted to delta fibers. although studies conducted on hemodialysis patients have shown that cold application is effective in reducing pain; due to the small number of sample groups and deficiencies in the methodology, it was suggested that further studies be conducted. in these studies, cold application; it was applied to the area one cm above the fistula or between the thumb and index finger of the opposite arm, using an ice pack and an ice-filled glove for 2-10 minutes.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older * had been treated with hd for at least 3 months, thrice a week, and for 4 hours per session * did not have a psychiatric disorder that would prevent communication * volunteered to participate in the study exclusion criteria: * patients who were known to present difficulties when entering the fistula (requiring multiple cannulations) * had a history of hematoma or stenosis in the avf * had an infection at the fistula site * took painkillers within 3 hours of treatment * did not want to participate in the study
the evolutionary model of mild-to-moderate myopia in china

Conditions: Refractive Error

Summary: myopia has emerged as a major health issue in east asia, because of its increasingly high prevalence in the past few decades (now 80-90% in school-leavers), and because of the sight-threatening pathologies associated with high myopia, which now aff ects 10-20% of those completing secondary schooling in this part of the world. similar, but less marked, changes are occurring in other parts of the world. the higher prevalence of myopia in east asian cities seems to be associated with increasing educational pressures, combined with life-style changes, which have reduced the time children spend outside.

myopia has emerged as a major health issue in east asia, because of its increasingly high prevalence in the past few decades (now 80-90% in school-leavers), and because of the sight-threatening pathologies associated with high myopia, which now aff ects 10-20% of those completing secondary schooling in this part of the world. similar, but less marked, changes are occurring in other parts of the world. the higher prevalence of myopia in east asian cities seems to be associated with increasing educational pressures, combined with life-style changes, which have reduced the time children spend outside. in this trial, the investigators aim to study the evolutionary model of myopia in china, which could provide new insight into the social development and human adaptation.

Eligibility criteria:
inclusion criteria: * patients complete the examination of refractive error from 2005 to 2015 year. exclusion criteria: * patients could not complete the examination of refractive error

Keywords: evolutionary model
efficacy of mobilization with post- isometric relaxation in neck pain associated with myofascial trigger points

Conditions: Mechanical Neck Pain

Summary: purpose of the study: to determine the effectiveness of cervical mobilization with pir in reducing pain and improving neck rom and function in people with mechanical neck pain associated with mtrps

this study will be based on a randomized controlled design which will be comparative in nature. participants will be recruited using the convenience sampling method and will be randomly divided into two groups a and b respectively. thirty participants of mechanical neck pain associated with upper trapezius trigger point pain will be recruited from the physiotherapy department, at the najran university, saudi arabia. study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. all the participants will be randomly assigned into two equal groups a and b. group a will be receiving the hot pack, active stretching, isometric exercise intervention, and pir technique while group b will receive the hot pack, active stretching, isometric exercise intervention, and cervical mobilization.

Eligibility criteria:
inclusion criteria: * age 20-40 years, * having mechanical neck pain located in the neck or scapular regions along with 1-2 mtrps which, * on palpation replicated their chief complaints in the upper trapezius muscle (unilateral). exclusion criteria: * known cases of fibromyalgia syndrome, * cervical radiculopathy or myelopathy, * history of cervical spine surgery, * congenital or acquired postural deformity, presence of mtrps in bilateral upper trapezius muscles, * patients who received any treatment for their pain one month prior to the study.
prolonged emend in a study (nyu 03-67) of oxaliplatin and topotecan in previously treated ovarian cancer

Conditions: Ovarian Cancer

Summary: the investigators propose to totally abolish the emesis (vomiting) associated with the regimen of oxaliplatin + topotecan by adding a daily administration of aprepitant (emend) for 17 days to the ht3 blocker routinely given on days 1 and 15.

patients enrolled in nct0031361, nyu 03-67 (a phase ii study of oxaliplatin combined with continuous infusion topotecan as chemotherapy for patients with previously treated ovarian cancer nci #6317) will receive oxaliplatin 85mg/m2 as a 2-hr iv infusion on d1, 15 and topotecan 0.4mg/m2/day as a continuous infusion for 14 days beginning on d1 (d1-15) on a 4 week cycle. on days 1 and 15 of the first cycle, patients will also receive iv ondansetron 32 mg and 10mg of dexamethasone. emend 125 mg will be given on day 1; on days 2-17, patients will be given daily oral 80mg emend without dexamethasone. on cycles 2-6 patients opting to continue to receive emend as above: emend 125 mg will be given on day 1; on days 2-17, patients will be given daily oral 80mg emend without dexamethasone. following cycle 1, emend will be given in its conventional schedule (i.e., d 1-3, and d 15-17) unless after discussion with the principal investigator, the patient's request to receive drug as in cycle 1 is deemed desirable and safe to enter the optional extension arm.

Eligibility criteria:
inclusion criteria: * all patients fulfilling the requirement for entering the study nyu 03-67 will be eligible to enter the supplementary protocol with emend. please see nct0031361 for eligibility. exclusion criteria: * patients not enrolled on nyu 03-67(nct0031361).

Keywords: ovarian chemotherapy nausea
discrepancies in management of hepatocellualr carcinoma between practice and recommendations

Conditions: Hepatocellular Carcinoma

Summary: the complex management of hepatocellular carcinoma has prompted many learned societies to issue their management recommendations or decision-making algorithms to best assist in the therapeutic decision-making of patients with hcc. over time, the use of the bclc algorithm (for barcelona clinic liver cancer) has become essential, at least in the west, thanks to a relatively simple and applicable classification system, and the clinical validation of numerous studies. the bclc algorithm thus relies on the general condition of the patient, the child-pugh score reflecting hepatic function, and the tumor extension to propose one or more therapeutic solutions according to the level of scientific evidence, associating with each one. subgroups the expected survival. while this bclc classification has the merit of having the protocol for the management of hcc, thus avoiding many drifts related to possible local preferences, it also has many defects. for example, this classification is only rarely updated, which limits the integration of innovative therapies. then, its design and updates were supported by the recommendations of a limited group of experts that is not necessarily representative of all the key players present daily in the management of chc. finally, some studies have begun to point out that this classification was interesting from a theoretical point of view, but that in practice the diversity of complex situations meant that its care recommendations were not applicable in a significant number of cases. the objective of our study is to analyze the applicability of the bclc classification in real-life situations. to overcome possible "center effects", the investigators analyzed in an exhaustive way the therapeutic decisions taken during the multi-disciplinary consultation meetings of 2018 and 2019 at the level of a large french region, by relying on the regional network of oncooccitanie oncology record. in a second step, the investigators will analyze the causes of the discrepancies to finally propose an improvement of this bclc classification.


Eligibility criteria:
inclusion criteria: - any patient presented at a multidisciplinary meeting within the oncooccitanie network during the years 2018 and 2019 for the management of hepatocellular carcinoma exclusion criteria: * histological type other than chc * multidisciplinary meeting that does not lead to a therapeutic decision (such as the continuation of further investigations, biopsy sampling, or active surveillance)

Keywords: hcc chronic liver diseases interventional radiology surgical therapy resection
a study evaluating the safety, pharmacokinetics and anti-tumor activity of abbv-176 in subjects with advanced solid tumors likely to express prolactin receptor (prlr)

Conditions: Advanced Solid Tumors Cancer

Summary: this is an open-label, phase i, dose-escalation study to determine the maximum tolerated dose (mtd) and the recommended phase two dose (rptd), and to assess the safety, preliminary efficacy, and pharmacokinetic (pk) profile of abbv-176 for participants with advanced solid tumors likely to express prolactin receptor (prlr). the study will consist of 2 cohorts: dose escalation and expanded recommended phase 2 dose.


Eligibility criteria:
inclusion criteria: * participant has histological confirmation of a locally advanced or metastatic solid tumor of a type associated with prolactin receptor (prlr) expression that has progressed on prior treatment, is not amenable to treatment with curative intent, and has no other therapy options known to provide clinical benefit or the subject is ineligible for such therapies. * dose escalation cohort: must have breast cancer, colorectal cancer, adrenocortical carcinoma, chromophobe renal cell carcinoma. * expanded cohort: must have breast cancer. * participant must consent to provide the following for biomarker analyses: * dose escalation cohort: archived tumor tissue or fresh tumor biopsy. * expanded cohort: archived tumor tissue and fresh tumor biopsy. * participant has eastern cooperative oncology group (ecog) performance status 0-1. * participant has adequate bone marrow, renal, and hepatic function. exclusion criteria: * participant received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic, or any investigational therapy within 21 days before study day 1; participant received palliative radiotherapy or small molecule targeted anti-cancer agents within 14 days of study day 1. * participant has prior exposure to any pyrrolobenzodiazopine-containing agent * participant has unresolved, clinically significant toxicities from prior anticancer therapy, defined as greater than grade 1 on common terminology for adverse events. * participant has clinically significant uncontrolled conditions. * participant has a history of major immunologic reaction to any immunoglobulin g (igg). * participant has received more than 4 prior lines of systemic cytotoxic therapy (not including neo-adjuvant or adjuvant therapy). * for prior cytotoxic therapy, treatment for 1 full cycle or less will not be considered as prior therapy unless the patient experienced progression of disease while on that therapy. * participant has a history of \>= grade 3 ast, alt, or bilirubin increase or has extensive liver resection (i.e., left lobe resection). * participant has a history of cholecystitis (subject with history of cholecystectomy will not be excluded), or has active gallbladder disease.

Keywords: cancer metastatic prolactin receptor (prlr) breast cancer colorectal cancer adrenocortical carcinoma, chromophobe renal cell carcinoma hepatocellular carcinoma
a rollover study for continued study treatment and ongoing safety monitoring

Conditions: Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Neoplasms; Solid Tumor, Adult; Metastatic Castration-resistant Prostate Cancer (mCRPC)

Summary: the purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mcrpc).


Eligibility criteria:
inclusion criteria: * have participated in a parent study, with a linked intervention specific appendix (isa) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study * satisfy all isa specific inclusion criteria * sign an informed consent form (icf) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant isa * be willing and able to adhere to the lifestyle restrictions specified in the relevant isa exclusion criteria: * have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study * have unacceptable toxicities or overt disease progression observed at time of rollover to the respective isa * meets any exclusion criteria within the pertinent isa