Kornimate/medical-research-clean huggingface dataset:
developing and treating a mouse model of acute myeloid leukemia using tissue samples from younger patients with acute myeloid leukemia

Conditions: Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Summary: these laboratory trial studies the development and treatment of a mouse model for acute myeloid leukemia (aml) using samples from younger patients with aml. studying tissue samples from patients with cancer in the laboratory may help doctors learn more about cancer and how well patients will respond to treatment.

primary objectives: i. to determine the rate of engraftment of pediatric fms-like tyrosine kinase-3 (flt3)-internal tandem duplication (itd) acute myeloid leukemia (aml) samples in nod scid gamma (nsg) mice. ii. to determine the efficacy of treatment of flt3-itd xenografts with tyrosine kinase inhibitors. outline: human acute myeloid leukemia cells are injected into nsg mice. mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human cd45+ and cd33+ cells by quantitative flow cytometry.

Eligibility criteria:
inclusion criteria: * cryopreserved human aml samples * flt3-itd samples with high allelic ratios
xpo-1 in combination with rchop for dh/th lymphoma

Conditions: Double Hit Lymphoma; Triple Hit Lymphoma

Summary: the purpose of this study was to evaluate the efficacy and safety of selinexor in combination with rchop in first-line treatment of patients with dh or th lymphoma.

this is a prospective, single-arm, single-center clinical study evaluating the first-line treatment of dh or th lymphoma with selinexor combined with rchop. there are three stages: screening, treatment and follow-up period. the screening period was 28 days before the first dose. treatment period: enrolled subjects were treated with selinexor in combination with rchop every 21 days for a maximum of 6 cycles until the efficacy of sd or pd, drug toxicity became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy deemed unsuitable by the investigator. lugano2014 criteria were used to evaluate the efficacy during treatment. objective effective rate, safety and survival data were observed during the experiment. after stopping treatment or completing 6 cycles of treatment, subjects entered the follow-up period, during which imaging evaluation (enhanced ct at focal site is recommended) was performed at the following intervals: once every 3 months for 2 years, once every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.

Eligibility criteria:
inclusion criteria: 1. volunteer to participate in clinical studies 2. age: 18\~75 (inclusive), male and female. 3. histopathologically confirmed high-grade b-cell lymphoma with myc and bcl2 and/or bcl6 gene rearrangement. 4. no previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy. 5. ecog score is 0-2. 6. there must be at least one evaluable or measurable lesion that meets lugano2014 criteria. 7. adequate organ and bone marrow function. 8. left ventricular ejection fraction (lvef) ≥ 50% in cardiac function examination. 9. serum pregnancy test negative exclusion criteria: 1. left ventricular ejection fraction (lvef) ≥ 50% in cardiac function examination. 1) mixed lymphoma (hodgkin's lymphoma + non-hodgkin's lymphoma), or dlbcl transformed from inert non-hodgkin's lymphoma, or gray zone lymphoma (lymphoma between dlbcl and hodgkin's lymphoma), or inert lymphoma with myc, bcl2, bcl6 gene rearrangement. 2. known central nervous system involvement. 3. received prior anti-tumor therapy 4. is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study 5. had other malignant tumors in the past 5 years 6. major surgery was performed within 28 days prior to study initiation 7. cardiovascular function is unstable 8. active infection

Keywords: double/triple hit lymphoma selinexor rchop
mental health intervention for elderly abuse victims

Conditions: Depression

Summary: there is no current elder abuse service that systematically assesses and provides services to address the mental health needs of older adult abuse victims. the proposed study will investigate the efficacy of a skill-based, mental health intervention to help treat elder abuse victims, bolster mental health outcomes, and improve detection of symptomatology in future screenings.

despite increasing recognition of the epidemic of elder abuse, we continue to face barriers helping abuse victims access and use elder abuse resolution services. in addition, many victims suffer from concurrent mental health problems that prevent them from taking the necessary steps to protect themselves. the proposed study will introduce a tailored intervention, built on an evidence-based approach (problem solving therapy), to be delivered through a sustainable mental health program embedded in elder abuse services. the proposed psychotherapy is a brief 8-session weekly intervention that combines problem-solving therapy, anxiety management, and psycho education developed specifically for this population by this team. the objectives of the project are to: identify the mental health needs of elder abuse victims, provide the mental health treatment, assess the impact of the treatment, and facilitate conditions which will sustain the mental health program.

Eligibility criteria:
inclusion criteria: * client of the new york city department for the aging's (dfta) elderly crime victims resource center * score of 10 or higher on the patient health questionnaire (phq-9) or generalized anxiety disorder 7-item scale (gad-7) exclusion criteria: * co-morbid psychiatric disorder other than unipolar non-psychotic major depression that prevents participation in depression and anxiety screening * inability to speak or understand english * cognitive impairment that prevents participation in screening, as determined by screening social worker

Keywords: elder abuse intervention treatment detection
comparison between different psychotherapy interventions regarding their effect on substance craving

Conditions: Addiction Opiate

Summary: the study aim is to compare betwenn the effect of mindfulness based relapse prevention and other evidence based psychotherapy interventions regaring substance craving.

in this prospective study, the population included opioid-dependent men (aged 18-50 years), some of them were admitted to el maamora hospital and others were attendees in na. to conduct this research, considering the drop-out rate, the list of 60 persons applying for treatment was prepared based on inclusion and exclusion criteria. then, three groups of 20 were randomly selected and placed in three intervention groups, group one received cbt, group two received mbrp, and group three received twelve-step therapy. the subjects were assigned randomly to the treatment condition via a computer-generated random number with the aid of trained staff at the clinic blindly. all participants completed the measurement scales immediately after detoxification (pre-test) and after the end of therapeutic sessions (post-test).

Eligibility criteria:
inclusion criteria: * age: 15-50 years. * male gender. * patients meet dsm-5(3) criteria of opioid abuse. * had completed detoxification in a treatment center. * willing to give consent they will be randomly assigned to either cbt, mbrp, or twelve-step treatment group. * patients have dual diagnoses. * patients have poly-substance use disorder. exclusion criteria: * participants with significant cognitive disorder. * participants with suicidal thoughts. * participants with any organic condition affecting stress response and so craving such as hypertension, respiratory or cardiovascular disorders. * participants taking any medications (e.g., antipsychotics in high doses) known to affect the stress response. * participants relapsed to drug abuse during therapy.
investigation of immune disorders and deficiencies

Conditions: Primary Immune Deficiencies; Autoimmune Diseases; Inflammatory Diseases; Common Variable Immune Deficiencies; Hypogammaglobulinemia

Summary: the immune system is an intricate system comprised of specialized cells, proteins, tissues and organs. proper functioning is critical to the body's ability to defend itself against harmful pathogens. immunological disorders and deficiencies are defects in the immune system that lead to abnormal immune responses. abnormal immune responses could be derived from immune deficiencies, dysregulations or hypersensitivities. the overall goal of this research study is to identify the mechanisms of primary immune deficiencies and immune disorders at the genetic, cellular and molecular level, using novel analytic techniques to be performed on immune cells derived from blood samples. the knowledge gained from the aims of this study could lead to better diagnostics and identify novel targets for therapeutic interventions.

primary immunodeficiency diseases (pid) represent a class of disorders in which there is an instrinsic defect in the human immune system. the pid could be caused by defects or perturbations in either the innate or adaptive immune cells, such as b cell defects which result in lack of antibodies. research in this topic remains a difficult feat due factors such as genetic heterogeneity and the gene-environment interface. limitations of standard of care testing leads to many patients with immunological problems to be undiagnosed. in addition to the variety of primary immune deficiencies, there are large number of immune system disorders due to various perturbations in the immunological components that cause diseases with much greater prevalence such as autoimmune diseases, lymphoproliferative diseases, chronic inflammation and certain cancers. the causes of these immune disorders are typically more complex than pid but there are also many overlaps in immune hyper-activation and deficiency.

Eligibility criteria:
inclusion criteria: * subject is greater than or equal to 1 day of age and less than or equal to 100years of age * signed informed consent/assent * subject is able and willing to comply with study protocol requirements * from clinical or blood laboratory findings subject has evidence of immune abnormalities (or no immune abnormalities in the case of controls) or immune-mediated disease. exclusion criteria: * risk factors for donating blood (such as anemia or blood clotting disorders)

Keywords: primary immune deficiencies autoimmune diseases inflammatory diseases common variable immune deficiencies primary immunodeficiencies immunoglobulin igg ivig recurrent infections
study of acupuncture on postoperative delirium in patients with diabetes mellitus

Conditions: Acupuncture; Postoperative Delirium (POD); Diabetes Mellitus

Summary: 1. to evaluate the effectiveness and safety of acupuncture on pod in diabetic patients undergoing surgery, to provide effective prevention and treatment measures of integrated traditional chinese and western medicine for reducing the incidence of postoperative delirium in high-risk groups, and to provide clinical basis for further promotion of integrated traditional chinese and western medicine anesthesia in the future. 2. to investigate the relationship between pod and rso2 in diabetic patients undergoing surgery. to clarify the predictive value of intraoperative rso2 monitoring on postoperative cognitive function in patients with diabetes, and to explore the effect of acupuncture on cerebral blood flow perfusion in patients with diabetes.

postoperative delirium (pod) increases the risk of postoperative dementia and mortality. cognitive decline is common in patients with diabetes mellitus. as an independent risk factor for pod, diabetes significantly increases postoperative dementia and mortality. our team found that acupuncture can reduce the incidence of pod in elderly patients, increase regional cerebral oxygen saturation (rso2), and increase cerebral blood flow perfusion in diabetic patients. in this study, a prospective randomized controlled study with placebo acupuncture will be conducted. diabetic patients undergoing elective surgery will be divided into acupuncture group, placebo acupuncture group and control group. acupuncture will be used as the intervention method, and the incidence of pod will be the main therapeutic effect evaluation index to explore the efficacy of acupuncture in the prevention and treatment of pod in diabetic patients undergoing surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing general anesthesia in our hospital * expected duration of operation \>2h * ages 18-60 * with type 2 diabetes * american society of anesthesiologists (asa) grade 2-3 , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities; * expected postoperative hospital stay \>3 days * no history of cerebrovascular accident in the past six months * the informed consent signed exclusion criteria: * unable or unwilling to cooperate with cognitive function scale tests * mmse score \<24 * refuse acupuncture treatment or have a history of needle sickness * with skin damage at the acupuncture sites * coagulation dysfunction * participated in other clinical studies

Keywords: acupuncture postoperative delirium (pod) diabetes mellitus regional cerebral oxygen saturation (rso2)
dynamic pet ct as a tool for treatment efficacy monitoring in lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the use of dynamic pet/ct as a tool to assess disease response to anti-cancer therapy in lung cancer patients.

background: lung cancer is a devastating disease in which the response for first line therapy is only 30%. evaluating response is performed normally by a ct or pet-ct scans after 2-3 cycles of therapy, thus, lack of response is been evaluated only after the patient has been treated following significant amount of therapy, which is inefficient in 70% of cases. therefore, there is an urgent need to develop tools that might predict response to therapy during the early course of therapy; most valuable will be before or after the first cycle of therapy. for that reason, the investigators aim in this study to evaluate the use of dynamic pet-ct as a tool to assess disease response to anti-cancer therapy in lung cancer patients. objectives: 1. to assess the feasibility of baseline dynamic pet-ct as a tool for assessing response for anti-cancer therapy in lung cancer patients. 2. to predict early response to treatment as soon as after 1 cycle of therapy by dynamic and static pet-ct. 3. to correlate dynamic pet-ct with survival/disease free survival method: 200 advanced lung cancer patients will be enrolled over 3 years in a single institute, single arm study at rabin medical center, beilinson hospital. patients will be evaluated by a dynamic pet-ct protocol: before initiation of therapy, 7-14 days after the first therapy cycle, 3 months after initiation of therapy and 6 months after the first therapy cycle. in addition, non-invasive biomarkers that are routinely measured including protein markers (cea- carcinoembryonic antigen, cyfra21- cytokeratin 19 fragment, nse- neuron specific enolase) will be assessed in this trial. disease response will be evaluated by response evaluation criteria in solid tumors (recist criteria). additional pet-ct will not increase radiation dose significantly. the mean estimated radiation dose for a limited ct of the chest is about 14 msv (i.e., 7msv for limited diagnostic ct and fdg (\[18f\]-fluorodeoxyglucose), each). the dynamic stage will add radiation dose of about 0.3msv. of note, the significance of adding radiation dose is less of importance with regard to treatment of patients with aggressive cancer.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * lung cancer, stage 4 * patients are planned to be treated by a systemic anti-cancer therapy. * a define lesion for imaging. * able and willing to sign an informed consent form. * first line therapy or at least 6 weeks after previous line of therapy exclusion criteria: * pregnant or lactating women. * anti cancer therapy within the last 6 weeks before enrollment.

Keywords: lung cancer biomarkers pet-ct early detection
does optimal control of pre-operative chronic and acute pain predict improved function after orthopedic surgery?

Conditions: Osteoarthritis

Summary: despite the development of new pain medications, the prevalence of persistent postoperative pain (for more than three to six months) remains alarmingly high. chronic pain and reduced function after surgery are of great concern since they have a significant impact on a patient's quality of life and are costly to society in terms of longer hospital stays and lost work days. an important risk factor for chronic pain and reduced function after surgery is the amount of pain patients experience immediately after surgery which is highly influenced by the amount of pain patients have preoperatively. for many patients, longstanding pain prior to surgery is common and thus can compromise the outcome of the procedure. therefore, the aim of this study is to reduce the amount of pain patients have before they undergo surgery by administering a novel pain-relieving regimen in the weeks before surgery. crucially, this treatment will be continued for three weeks after surgery to reduce pain that arises from the surgical trauma. the novel regimen will include a non-steroidal anti-inflammatory (celecoxib) and the alpha2 delta ligand, pregabalin. this drug combination will provide the best opportunity to target several key sites in the pain pathway. this regimen will be tested in patients with pain related to osteoarthritis and who are undergoing orthopedic (hip) surgery because chronic preoperative pain is common in these patients and is the main reason for undergoing surgery. the goal of this research proposal is to adequately manage pain before and after surgery in order to improve function weeks after surgery. if controlling pain in this way does lead to improved long term postoperative function the findings from this study may lead to the development of a standardized regimen. this is highly relevant not only for orthopedic procedures but following other common surgical procedures which would be of great benefit to patients and the entire healthcare system.


Eligibility criteria:
inclusion criteria: * provision of informed consent * american society of anesthesiologists physical status i-iii * average daily vas ≥ 4 * aged 18 - 75 years * male or female * scheduled for total hip arthroplasty (tha). exclusion criteria: * allergy to study medications or local anesthetics * history of drug or alcohol abuse * patients with chronic pain on slow-release preparations of opioid (\>30mg morphine equivalent per day) * patients with rheumatoid arthritis * patients with psychiatric disorders * patients unable or unwilling to use patient controlled analgesia (pca). * diabetic patients or those with impaired renal function (creatinine \> 55) * obese patients (i.e. bmi \> 40).

Keywords: chronic pain preemptive analgesia pregabalin celecoxib hip arthroplasty osteoarthritis
treatment for insomnia during pregnancy

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.


Eligibility criteria:
inclusion criteria: * meets diagnostic and statistical manual (iv-tr edition) criteria for insomnia (duration criterion - 1 month) * pregnant with gestational age between 18-32 weeks. * adequately fluent in english or spanish. exclusion criteria: * some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea) * co-morbid psychiatric disorder * use of medications, herbs or other drugs with known effects on sleep * unstable medical conditions * currently engaged in psychotherapy or other treatments for insomnia
baclofen for the treatment of cocaine dependence - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.

double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence

Eligibility criteria:
inclusion criteria: * subject must have dsm-iv diagnosis of cocaine dependence. * subject must be seeking treatment for cocaine dependence. * be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures. exclusion criteria: * please contact site for more information.

Keywords: cocaine dependence
an observational study to assess treatment & outcomes data in patients receiving long-acting injectable risperidone

Conditions: Schizophrenia

Summary: the purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone.

this is an observational (study in which patients/participants are observed) and multicentre (at multiple sites) study. this is one-country arm of a multinational study. this study consists of 2 years of retrospective (a study in which the patients are identified and then documented backward in time and 2 years of prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) study periods during which medication utilization review will be done, determining medication usage patterns and outcomes associated with the use of risperidone long acting, in clinical practice. usage of risperidone according to label was recommended during the study. the planned recruitment period will be 6 months. retrospective observation will be 2 years for hospitalization history and at least 1 year for medication usage. total duration of prospective observation for each patient with a complete follow-up will be 24 months. data collection during the follow up period will be scheduled every 3 months ± 2 weeks. in addition, this study is proposed in belgium to satisfy the demand from belgian reimbursement authorities to collect clinical data on the impact of risperidone long acting on treatment compliance, number of hospitalizations and potential prevention of relapses. also, this data will provide documentation on switch from oral to parenteral treatment. data will be pooled from different physicians and/or countries. the objectives of this study are: collect clinical outcome data at the request of the belgian reimbursement authorities; prospectively assess medication usage patterns to document clinical efficacy and long-term treatment outcomes of risperidone long acting, in a naturalistic setting; collect retrospective data, to compare with risperidone long acting; document reasons for initiating risperidone; collect data on switch of treatment to risperidone long acting.

Eligibility criteria:
inclusion criteria: * patient who started long-acting injectable risperidone treatment after agreement between doctor and patient * ambulatory patient or not chronically full-time hospitalized patient. full-time hospitalization at the moment of inclusion for maximal 6 months * the treatment and treated indication according to local label * patient had given informed consent in agreement with local legislation exclusion criteria: * patient participating in another medication related study, chronically full-time hospitalized patient, who according to the treating physician had no perspective of being discharged within the planned observation period * patient suffering from treatment resistant schizophrenia * pregnant or breastfeeding females or females with planned pregnancy within two years

Keywords: schizophrenia risperidone risperdal consta propective retrospective mental disorders observational