Kornimate/medical-research-clean huggingface dataset:
cd19/79b bi-specific car-t cell therapy

Conditions: B Cell Malignancies

Summary: the purpose of this study is to assess the feasibility, safety and efficacy of cd19/79b bi-specific car-t cell therapy in patients with cd19 and/or cd79b positive b cell malignancies. another goal of the study is to learn more about the safety and function of the anti-cd19/79b bi-specific car-t cells and their persistency in patients.

patients with refractory and/or recurrent b cell malignancies have poor prognosis despite complex multimodal therapy. despite impressive progress, more than 50% of patients treated with cd19-targeting chimeric antigen receptor t cells (car19) experience progressive disease. further, more than 40% patients with progressive large b cell lymphoma (lbcl) experienced reduced or lost expression of cd19 on the tumor cells after car19 treatment; low surface cd19 density before treatment was associated with progressive disease. therefore, novel curative approaches are needed. the investigation attempts to use genetically modified t cells to express a 4th generation lentiviral anti-cd19/79b bi-specific car (bi-4scar-cd19/79b). the car molecules enable the t cells to recognize and kill tumor cells through the recognition of a surface antigen, cd19 or cd79b, which is expressed at high levels on tumor cells but not at significant levels on normal tissues. cd79b is a b cell surface antigen, which is a component of b cell receptor. cd79b is up-regulated in more than 90% of b-cell lymphomas. recent studies have shown that cd79b car-t cells have potential in targeting b-cell lymphomas. in addition, several immunotherapy drugs based on targeting cd79b have been reported worldwide. the cd79b specific car-t cells with binding moiety of cd79b specific scfv exhibited a high affinity and antitumor effect against cd79b+ tumor cells. a potential strategy to prevent relapse due to antigen escape is to infuse t-cells capable of recognizing multiple antigens. to overcome tumor escape of single target antigen and enhance in vivo car-t efficacy, a novel bi-specific cd19/79b car-t therapy regimen is developed to include booster and consolidation car-t applications to target highly-refractory b cell cancer. the aim is to evaluate safety and long term efficacy of the bi-car-t therapy strategy in cd19 and/or cd79b positive cancer patients.

Eligibility criteria:
inclusion criteria: 1. age older than 6 months. 2. malignant b cell surface expression of cd19 or cd79b molecules. 3. the kps score over 80 points, and survival time is more than 1 month. 4. greater than hgb 80 g/l. 5. no contraindications to blood cell collection. exclusion criteria: 1. accompanied with other active diseases and difficult to assess patient response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with hiv. 4. active hbv or hcv infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed cd19 and cd79b car-t treatment.

Keywords: car-t b cell malignancies cd19 cd79b
the diabetes medication choice cards trial in greece

Conditions: Diabetes Mellitus, Type 2

Summary: a cluster randomized trial to assess the efficacy of the diabetes medication choice decision aid among greek patients with type 2 diabetes mellitus compared with usual care. the tool will serve as a facilitator for the shared decision making process.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus for more than one year * agree to be followed for at least 6 months * willing to respond to survey questions immediately following the visit * hba1c value between 7.5% and 10% * need treatment intensification and there are more than one available treatment options exclusion criteria: * decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment * is to transfer to another practice within the next 6 months * significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid * planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge * enrolled in other studies that require prolonged participation and follow-up * unable to speak greek at a level necessary to complete the patient surveys and ensure involvement in decision making * women known to be pregnant

Keywords: shared decision making decision aids
an efficacy and safety study of hydromorphone hydrochloride (hcl) oral osmotic system (oros) in the reduction of breakthrough pain medication frequency in participants with cancer

Conditions: Cancer; Pain

Summary: the purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (hcl) oral osmotic system (oros) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone hcl oros in korean cancer participants.

this is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) study. the total duration of study will be 3 weeks. the study consists of 2 periods and 4 visits: screening period (1 week; visit 1) and treatment period (2 weeks; visit 2, 3 and 4). during screening period at visit 1, potential participants will receive previously administered oral opioid analgesic until the second visit and with immediate-release opioid analgesic whenever breakthrough pain is present. during treatment period, from second visit to the fourth visit, participants will receive the hydromorphone hcl oros once daily for 2 weeks. at investigator's discretion, participants completing 2 weeks of treatment with study drug could be enrolled into the extension phase of 12-weeks. the dose of study drug is flexible and will be increased or decreased based on the frequency of immediate-release opioid analgesic doses needed to manage pain. at second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion tablet (oxycodone 10 milligram \[mg\] twice daily is equal to hydromorphone hcl 8 mg once daily). the investigator will increase a participant's daily dose if more than 3 breakthrough pain episodes require rescue medication within a 24 hours period. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * cancer participants administering only strong oral opioid analgesic for cancer pain control * participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before visit 2 (day 1) * participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the investigators * abstinent or surgically sterile female participants exclusion criteria: * participants with cancer pain who are potentially unresponsive to narcotic analgesics * participants with presence or history of drug or alcohol abuse within the past 6 months * participants with hypersensitivity to hydromorphone hcl * participants with history of colectomy (surgery to remove part or all of the colon) * participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication

Keywords: hydromorphone hydrochloride oral osmotic system jurnista
pharmacogenetics of alcohol: treatment implications

Conditions: Alcohol Related Disorders; Alcoholism; Alcohol Abuse

Summary: this study will explore the hypothesis that effects of alcohol are in part mediated by increased production of neuroactive steroids, which interact with gabaa-receptors. we propose to study non-dependent drinkers using a 4-session within-subjects design in which alcohol / placebo is paired with dutasteride / placebo pretreatment. dutasteride is a 5-alpha steroid reductase (5ar) inhibitor that limits the production of dihydrotestosterone and the 5a-reduced neuroactive steroids allopregnanolone, pregnanolone and 3a,5a-androstanediol.

alcohol has multiple pharmacological effects, though which of these effects relate to the risk of alcohol dependence is not clear. animal studies indicate that the neuroactive steroid allopregnanolone is an alcohol-modulated endogenous agonist at gabaa receptors and that genetic variation in steroid 5a-reductase type i gene which generates neuroactive steroids, may moderate alcohol effects. to better define the role of neuroactive steroids we will conduct a laboratory study of non-alcohol dependent drinkers using a 4-session design in which alcohol/placebo beverage is paired with dutasteride/placebo pretreatment. dutasteride, an inhibitor of both type i and type ii 5a-reductase enzymes, blocks the production of 5a-reduced neuroactive steroids. this study will extend our preliminary findings with finasteride by including a) a placebo control for alcohol, b) a more specific inhibitor of both 5a-reductase isoenzymes, c) a larger group of subjects (including both light and heavy drinkers).

Eligibility criteria:
inclusion criteria: * main study: subjects will be healthy volunteers with or without parental history of alcoholism who are 21-45 years old and who have a bmi \>18.5 and \ 4 drinks. hd subjects will be selected if they report drinking at least 10 drinks per week, with at least one episode per week of heavy drinking. exclusion criteria: * main study: subjects cannot have a current or past dsm-iv diagnosis of alcohol or drug dependence, current or past 24-months diagnosis of alcohol or drug abuse or another major psychiatric disorder, neurological illness, have had a hypersensitivity reaction to dutasteride, evidence of liver dysfunction, currently be using benzodiazepines, other psychotropic medications or medications that are known to influence steroid hormone levels or metabolism or modify the effects of alcohol. nicotine-dependent subjects will be excluded to avoid the confounding effects of nicotine withdrawal during day-long laboratory sessions. women are not allowed to participate. subjects anticipating moving from the area during the period of their planned study participation will be excluded from study entry.

Keywords: steroid 5alpha reductase dutasteride neuroactive steroid
safety and efficacy of ipd1 cd19 ecar t cells in relapsed or refractory b-cell lymphoma

Conditions: Relapsed or Refractory B-cell Lymphoma

Summary: pd1 pathway is critical in determining the response to car t cell therapy. emerging data suggested that inhibition of pd1 could enhance the efficacy of car t cell therapy. ipd1 cd19 ecar t cells is an enhanced version of the classical 2nd generation anti-cd19 4-1bb-costimulatory chimeric antigen receptor engineered t cells with cell-intrinsic pd1 inhibition by incorporation of a pd1 shrna-expressing cassette in the car lentivector. this design will enhance the anti-tumor activities of car t cells by inhibiting pd1 induction after car t cell activation. this pilot, single arm, one center, dose-escalation, open label study is to determine the safety and efficacy of ipd1 cd19 ecar t cells in relapsed or refractory cd19 positive lymphoma. subjects will be given a lymphodepletion chemotherapy comprised of fludarabine and cyclophosphamide prior to car t cell infusion. the chemotherapy is completed 1 to 4 days before the first dost of ipd1 cd19 ecar t cells.


Eligibility criteria:
inclusion criteria: 1. cd19+ b cell lymphoma,verified by ihc or flow cytometry. 2. a prior history of at least one standard care of medication. 3. ineligible for allogeneic transplantation or relapsed after transplantation. 4. patients are 18 years older. 5. life expectancy \> 3months. 6. ecog ≤ 2. 7. satisfactory major organ functions: adequate heart function with lvef≥50%; pulse oximetry of ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤3uln; bilirubin ≤2.0 mg/dl . 8. blood: hgb ≥ 80 g/l, anc ≥ 1×10\^9/l, plt ≥ 50×10\^9/l. 9. women of reproductive potential must have a negative pregnancy test. male and female of reproductive potential must agree to use birth control during the study and one year post study. 10. measurable tumors. exclusion criteria: 1. using immunosuppressive drugs or systemic steroids within one week of enrollment. 2. active infection. 3. hiv positive. 4. active hepatitis b virus infection or hepatitis c virus infection. 5. breastfeeding or pregnant women. 6. patients refuse to practice birth control during study and one year post study. 7. patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study. 8. currently enrolled in other study. 9. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
characterization and management of metabolic dysfunction-associated fatty liver disease (mafld)

Conditions: Metabolic Associated Fatty Liver Disease; Metabolic Associated-dysfunction Steatohepatitis (MASH); Obesity

Summary: the goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. the main question it aims to answer is: does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity? participants will either participate in one of three groups: * nutrition: participant will only have a regular follow-up with a registered dietician; * nutrition + semaglutide: participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician; * semaglutide: participants will start a new medication targeting obesity.

participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint. the nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.

Eligibility criteria:
inclusion criteria: * body mass index between 30 and 50 kg/m2; * stade 2 or 3 (s2 or s3) hepatic steatosis with or without liver fibrosis. exclusion criteria: * type 1 diabetes diagnosis; * alcohol consumption exceeding recommendations \[\>140 g/week (women) and \>210 g/week (men)\]; * known chronic hepatic disease non-steatotic at the entry of the study (wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.); * pharmacological treatment targeting obesity active or ended in the last 3 months; * bariatric surgery; * gastro-intestinal pathologies (gi cancers, ibd, etc.); * capsulated probiotics consumption; * antibiotic treatment in the last 3 months; * pregnancy; * cirrhosis diagnosis (hepatic decompensation).

Keywords: obesity metabolic associated fatty liver disease glp-1 receptor analogs pharmacotherapy nutrition transient elastography semaglutide microbiome lipidomics
bioequivalence of two formulations of biphasic insulin aspart 70 in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history and physical examination, as judged by the investigator * body mass index (bmi) between 19.0-30.0 kg/m\^2 * glycohemoglobin (hba1c) within laboratory normal range * non-smokers exclusion criteria: * clinically significant abnormal haematology, biochemistry, urinalysis or ecg (electrocardiogram) screening tests, as judged by the investigator * liver enzyme values (alat and asat) exceeding 2 times the upper reference limit according to the local laboratory * a history of any illness that, in the opinion of the investigator and/or sponsor, might confound the results of the trial or pose additional risk in administering the investigational product to the subject * history of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen) * hiv (human immunodeficiency virus), hepatitis b or c positive * subjects with a first-degree relative with diabetes mellitus * a history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions * known or suspected allergy to trial product or related products * smoking during the past three months
a study to evaluate the efficacy and tolerability of rizatriptan for treatment of acute migraine (0462-087)

Conditions: Acute Migraine

Summary: a study to provide evidence supporting the benefit of rizatriptan in patients who have an inadequate response to sumatriptan.


Eligibility criteria:
inclusion criteria: * patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month * patient generally does not respond to treatment with sumatriptan * patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. iud, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study * patient is able to complete paper diary exclusion criteria: * patient is pregnant or breast feeding or excepts to become pregnant during the study * patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours * patient has basilar or hemiplegic migraines * patient is unable to distinguish between migraine attacks from other types of headaches * patient has more than 15 headache-days per month * patient was greater than 50 years old at age of migraine onset * patient has failed to respond to 3 or more triptans * patient has a repeated history of failing to respond to or tolerate rizatriptan * patient uses opioids as primary migraine therapy * patient uses daily opioids * patient has a history of cerebrovascular accident (cva) or other significant cardiovascular disease * patient has uncontrolled hypertension * patient has a history of neoplastic disease * patient is taking a serotonin reuptake inhibitor (ssri or snri) where the dose has changed 3 months prior to screening * patient has a history of drug or alcohol abuse

Keywords: treatment of acute migraine with or without aura in adults
feasibility rct of act self-help for depression in haemodialysis

Conditions: End-stage Renal Disease; Depression

Summary: the purpose of this study is to assess the feasibility of conducting a trial to evaluate a self-help treatment for depression in people with end-stage renal disease.

chronic kidney disease (ckd) is a long-term condition in which the function of the kidneys - to filter out waste products from the blood - slowly declines. when renal function becomes sufficiently low it is described as end stage renal disease (esrd) and renal replacement therapy (rrt) is likely to be needed to prolong life. the most common type of rrt is haemodialysis, in which the patient's blood is filtered through a machine. it is estimated that depression is experienced by 20-40% of people with esrd. depression not only affects the quality of life of individuals with esrd but is also associated with higher rates of hospitalisation and poorer physical health outcomes. acceptance and commitment therapy (act) has been found to be an effective treatment for depression and has been used successfully as a self-help treatment. however, no study has examined the effectiveness of an act self-help treatment for depression in esrd. this study aims to assess the feasibility of conducting such a study and will look at suitability of recruitment, assessment methods and the acceptability of the self-help treatment, as well as helping to calculate the number of people needed for a definitive study. haemodialysis patients receiving dialysis through an nhs renal service will be invited to participate. to participate they will be consenting, over 18 years of age and experiencing depressive symptoms at a clinical level. those eligible will be randomly assigned into one of two conditions; a control condition receiving treatment as usual (tau), and an intervention condition receiving tau alongside an act self-help manual with weekly telephone support. the manual will be completed over six weeks. both groups will be asked to complete questionnaires prior to intervention and 2 and 4 months post-intervention. participants from each condition will be asked to participate in interviews to explore their experiences of taking part.

Eligibility criteria:
inclusion criteria: * undergoing haemodialysis treatment at one of three identified units * receiving haemodialysis treatment for more than 6 months * moderate depression (as indicated by the phq-9) exclusion criteria: * receiving concurrent psychological treatment * lacking mental capacity to consent due to cognitive impairment * inadequate reading ability (indicated by inability to complete phq-9 screening measure) * visual or hearing impairment that would prevent completion of the self-help book or engagement in telephone calls

Keywords: acceptance and commitment therapy
screening for lung health by a mobile device

Conditions: Lung Diseases; COPD

Summary: respiratory diseases are a common cause of mortality and disability at the worldwide and national levels. many of them are characterized by underdiagnosis and diagnosis in advanced stages of the disease, and in most of them, forced spirometry is one of the fundamental tools to assess the diagnosis and seriousness of the disease. to help in improving the detection of respiratory diseases and the understanding of the respiratory health of the general population, one possible solution would be to develop a mobile application that could assess respiratory health by using the sound signal of exhaled air recorded by a mobile microphone. this project will aim to validate a mobile application (webapp) for the detection of pulmonary function disorders. it is planned to recruit 267 subjects, with and without respiratory disease, who are attended in pulmonary function laboratories of 10 spanish hospitals, to compare the sensitivity of this application in the diagnosis of pulmonary function disorders (either obstructive patterns or prism) versus the gold standard (spirometry). ease of use and user satisfaction with the application will also be assessed.


Eligibility criteria:
inclusion criteria: * adult subjects with age range between 18 and 80 years old * signing the informed consent form * subjects scheduled for respiratory function tests at the pulmonary function laboratory for clinical reasons * having a cell phone and be willing to install the application exclusion criteria: * contraindication to perform any of the protocol procedures * inability to answer the study questionnaires.

Keywords: spirometry