Kornimate/medical-research-clean huggingface dataset:
anti-cd19 and anti-cd22 immunotoxins in treating patients with refractory or relapsed b-cell acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: immunotoxins, such as anti-cd19 and anti-cd22, can find cancer cells that express cd19 and cd22 and kill them without harming normal cells. this may be an effective treatment for b-cell acute lymphoblastic leukemia. purpose: this phase i trial is studying the side effects and best dose of anti-cd19 and anti-cd22 immunotoxins in treating patients with refractory or relapsed b-cell acute lymphoblastic leukemia.

objectives: * determine the maximum tolerated dose of deglycosylated ricin a chain-conjugated anti-cd19 and anti-cd22 immunotoxins (combotox) in patients with refractory or relapsed b-cell acute lymphoblastic leukemia. * determine the toxicity of combotox in these patients. * determine the pharmacokinetic (pk) profile of combotox in these patients. * determine any antitumor activity of combotox, in terms of the percentage of blasts in bone marrow and peripheral blood. * determine the levels of human antimouse and human anti-dga antibodies in patients treated with combotox. * determine if there is a correlation between pk parameters and toxicity of combotox in these patients. * determine if the expression of the cd19 and cd22 cell surface antigens is affected by combotox. outline: this is a dose-escalation study. patients receive deglycosylated ricin a chain-conjugated anti-cd19 and anti-cd22 immunotoxins (combotox) iv over 4 hours on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. cohorts of patients receive escalating doses of combotox until the maximum tolerated dose is determined. after completion of study treatment, patients are followed periodically. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adult acute lymphoblastic leukemia * b-cell lineage * refractory or relapsed disease based on a bone marrow/peripheral blood examination, cytogenetic studies, or polymerase chain reaction amplification * disease refractory to conventional therapy and other therapies of higher priority * at least 50% of the blasts (in bone marrow or peripheral blood) expressing cd19 and/or cd22 by flow cytometry patient characteristics: * ecog performance status 0-2 * life expectancy \> 2 months * creatinine \< 1.5 times normal * bilirubin \< 1.5 times normal * alt or ast \< 2.5 times normal prior concurrent therapy: * prior chemotherapy, biologic therapy, and/or radiotherapy allowed

Keywords: b-cell adult acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia
ginger capsules for the acute treatment of migraine attacks

Conditions: Migraine

Summary: the main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.

patients with the diagnosis of migraine according to the international headache society (ihs) criteria were enrolled in the study during a migraine attack. patients received two 200 mg capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose) in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine attack.

Eligibility criteria:
* inclusion criteria: * migraine diagnosis for at least one year; * migraine attack with moderate or severe pain intensity; * one to six migraine attacks per month. * exclusion criteria: * patients with headaches not characterized as migraine; * pregnant or lactating women; * fertile and sexually active women who do not use contraception; * abuse of painkillers, alcohol or drugs; * people with hypersensitivity to ginger; * people with other neurological diseases; * people in use of anticoagulant drugs; * people who have started the disease after 50 years old.

Keywords: migraine ginger acute treatment
antiviral treatment of chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: chronic lymphocytic leukemia (cll) is increasingly believed to be closely related to chronic stimulation of healthy b-cells. identification of antigen(s) are relevant for the stimulation of cll precursor cells is therefore of high interest. the investigators found recently evidence that a herpes virus is involved in this process of stimulation. consequently, elimination of the antigenic stimulation of leukemic cells by this herpes virus may be expected to reduce or even inhibit propagation of leukemic cells. the investigators hypothesize that inhibition of cmv replication by a short course of antiviral treatment may reduce significantly proliferation rates of leukemic cells. to test this hypothesis, the investigators will treat 20 cll patients with an antiviral drug for 3 months in a proof-of-concept clinical trial and leukemic cell counts measured before and after antiviral treatment. antiviral treatment has the potential to treat the disease at its origin and therefore more efficiently than conventional chemotherapeutic regimens.


Eligibility criteria:
inclusion criteria: * cll confirmed by immunophenotyping and a relative preponderance of leukemic cells of \>70% * anc \>1.500 /µl, thrombocyte count \>100.000 /µl und hemoglobin value \>11 g/dl * cll patients with expression of immunoglobulin heavy chains (ighv) 1-69 or 3-21 * seropositive for cmv-specific igg-antibodies * older than 18 years of age * written informed consent * able to comply with the protocol * if female, should not be pregnant or be breast-feeding. women of child-bearing age must have a negative serum pregnancy test within 28days prior to enrollment into the study, if a serum pregnancy test is not performed within 7 days prior first imp administration; a confirmatory urine test is required. exclusion criteria: * indications for treatment of cll (advanced stages of the disease) * having receiving chemotherapy for cll within 3 months prior to enrollment * having received antiviral drugs or i.v. immunoglobulins within 3 months prior to enrollment * significant thrombocytopenia (\<100.000/µl) or anemia (hb \< 11 g/dl) * women of child bearing age not using effective contraception * pregnant of lactating female (as determined by a positive pregnancy test at screening or within 7 days prior to first imp administration) * known hypersensitivity to drug or its excipients
microarray analysis of gene expression in idiopathic pulmonary fibrosis (ipf)

Conditions: Pulmonary Fibrosis

Summary: this study is investigating the way the lung is damaged in a condition called pulmonary fibrosis. research studies will be conducted on lung tissue obtained from an open lung biopsy performed by the subject's surgeon. the identification of unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.

subjects are being asked to participate in a research study that is investigating the way the lung is damaged in a condition called pulmonary fibrosis. these research studies are conducted in the laboratory on a portion of the tissue from the subject's lung biopsy that was performed by a surgeon. the lung biopsy is to be performed for clinical purposes to diagnose the cause of the subject's lung disease. the tissue used for the research study will in no way interfere with the ability of the pathologist to establish a diagnosis. in addition, the results of your breathing tests, chest x-rays and ct scans, and diagnosis made from the lung biopsy (and slides) will be collected. the goal of the study is to gain an understanding of the causes of pulmonary fibrosis and why it gets worse, which may ultimately lead to new therapies for this disease. once the lung biopsies are obtained, the pathologist will examine the tissue and determine if there is a sufficient amount available to use in the study without compromising their ability to make a diagnosis. if so, the lung biopsy will be divided. one portion will be submitted to the research study and the other processed by the pathologist in the usual manner to make a diagnosis. the decision to use tissue for the research study will be at the complete discretion of the pathologists. the tissue used in the study will be further processed in the laboratory in order to analyze for the presence of genetic markers in the scarred tissue that are not present in normal. the identification of these unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.

Eligibility criteria:
inclusion criteria: * 18 years or age or older * diagnosis of pulmonary fibrosis * undergoing open lung biopsy exclusion criteria: * n/a

Keywords: lung fibrosis idiopathic microarray tissue biopsy
ultrasound guided esp block versus intrathecal morphine for postoperative analgesia in major hpb surgery.

Conditions: Postoperative Pain

Summary: to compare the efficacy of usg-guided bilateral erector spinae plane block (espb) with intrathecal morphine (itm) for postoperative analgesia after major hepatopancreaticobiliary surgery (hpb)


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years with a body mass index (bmi) of 18-35 kg/m2, * patients with the american society of anesthesiologists (asa) physical status i - ii, * patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour. exclusion criteria: * patient's refusal * allergy or contraindications to the study drugs, * infection at the site of injection, * coagulopathy, * psychiatric disorders * severely co-morbid patients, * chronic pain syndromes, * prolonged opioid medication,
elective simultaneous modulated accelerated brain radiation therapy for nsclcs with limited brain metastases

Conditions: Brain Metastases

Summary: brain metastases are the most common intracranial tumors in adults. whole-brain radiation therapy (wbi) increases the median survival of patients with brain metastases up to 3-6 months, but wbi can lead to the decline of cognition and quality of life, with short local control time. the use of sib(simultaneous integrated boost) technology can increase the local control rate. hippocampus avoidance can effectively reduce the cognitive impairment caused by wbi.this study was designed to evaluate the safety and efficacy of selective brain radiotherapy (ebi)(based on sib and hippocampus, inner ear avoidance )in nsclcs with limited brain metastases.

in this prospective phase 1 study evaluating the safety and efficacy of selective brain radiotherapy in nsclcs with limited brain metastases, patients will received selective brain radiotherapy based on sib and hippocampus, inner ear avoidance. prescription dose: gross tumor (pgtv) 40-50 gy/10 fractions/2 weeks + ebi (pctv) 30 gy/10 fractions/2 weeks. oars dose limits: hippocampus d100%≤10gy, dmax≤17gy,inner ear: dmean ≤15gy. all patients were observed and recorded daily for acute radiation impairment during radiotherapy. follow-up every 2 months will be performed after radiotherapy. the primary endpoint:acute and chronic radiation response, qol in patients, vestibular function,neurocognitive function based on mini-mental state examination(mmse) questionnaires, hearing. the secondary endpoint included:objective response rate (orr);intracranial progression-free survival (ipfs); os (defined as the time from study beginning to death from any cause).

Eligibility criteria:
inclusion criteria: histologically or cytologically confirmed nsclc with mri confirmed new brain metastases a life expectancy of at least 3 months; adequate organ function according to the national cancer institute common terminology criteria for adverse events (nci-ctcae) version 4.0. exclusion criteria: radiologically or pathologically confirmed metastases in the spinal cord or meninges obvious hernia formation risk previously received brain surgery or radiotherapy a history or presence of poorly controlled systemic diseases pregnant patients

Keywords: non-small cell lung cancer brain metastases sib hippocampus avoidance inner ear avoidance
effect of esketamine on conscious state in patients with pdoc

Conditions: Esketamine; Consciousness Disorders

Summary: the goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia. participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at beijing tiantan hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. coma recovery scale-revised, glasgow coma scale, full outline of unresponsiveness scores, sedline multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated.


Eligibility criteria:
inclusion criteria: 1.16-65 years old 2.native chinese language 3.pdoc after acquired brain injury 4.scheduled to undergo surgery 5.signed informed consent exclusion criteria: 1. continuous sedation treatment was carried out within 72 hours before the study 2. airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons 3. known or suspected to have serious cardiac, pulmonary and renal dysfunction 1)severe cardiac dysfunction: a. unstable coronary syndrome b. congestive heart failure: left ventricular ejection fraction less than 50%, elevated bnp c.severe arrhythmia d. history of severe valvular disease 2)severe pulmonary dysfunction: a. history of pulmonary heart disease b. history of chronic obstructive pulmonary disease 3)severe renal dysfunction: a. endogenous creatinine clearance (ccr) less than 30ml/min b. the glomerular filtration rate (gfr) was less than 30ml/min•1.73m2 4. allergic history of sedative drugs 5. combined with other mental or nervous system diseases 6. other reasons are not suitable for this study.
keep intervention for people newly diagnosed with parkinson's

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is a progressive neurological condition that affects movement, balance and cognition, resulting in loss of independence and compromised quality of life over the course of the condition. research suggests that those detrimental outcomes can be reduced through physical activity (pa) and exercise, especially when those are started early. educating people with parkinson's (pwp) on the role of pa and exercise in pd progression can boost pa engagement by increasing enablers such as exercise self-efficacy and removing barriers such as misinformation about exercise and exercise outcomes. working closely with pwp and healthcare professionals, a physical health education programme was co-designed to address the needs and preferences of pwp around exercise and pa education. the process was supervised by the patient and public involvement group attended by pwp, academics, researchers and clinicians working with pwp. the study will utilise an assessor blinded randomised controlled design to investigate the acceptability and feasibility of delivering an online physical health education programme for pwp who are newly diagnosed. thirty pwp, diagnosed in the last 12-months, will be randomly allocated into two groups: 1) the intervention group in which participants will receive online education modules and will be invited to attend virtual group sessions with a specialist neuro-physiotherapist; 2) the control group which will follow the usual care pathway and participants will receive parkinson's uk booklets. the aim of the study is to explore an alternative approach to standard care regarding patient education in pd and evaluate the feasibility and acceptability of a co-designed education intervention for newly diagnosed pwp delivered online. feasibility data will be collected during the study and acceptability data will be assessed via a questionnaire at the end. outcomes including pa levels, exercise knowledge, exercise efficacy, and participation will be assessed at baseline, post-intervention and at 6 months.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic parkinson's disease * within 12 months since diagnosis * stable medication regime for four weeks prior to initiation of trial * ability to understand written english exclusion criteria: * acute illness * history of neurological disorder other than parkinson disease * diagnosis of dementia or significant cognitive impairments * participation in nhs structured pd-specific education program with or without exercise classes in the last year * unable to understand written english

Keywords: physical activity education exercise self-efficacy
study of circulating tumor dna (ctdna) kinetics in immuno-oncology (io-kin)

Conditions: Head and Neck Cancer; Advanced Cancer; Metastatic Cancer; HNSCC; Squamous Cell Carcinoma

Summary: this study aims to study the kinetics of ctdna levels after the first dose of immune checkpoint inhibitor in patients with recurrent or metastatic head and neck cancer. this is an important study to understand the optimal timing for ctdna quantitation for future studies in immunotherapy, though further validation would be needed in other tumor types. it may help standardize the most relevant blood collection time points so that patients will not be subjected to multiple blood draws at random time points in future liquid biopsy trials.


Eligibility criteria:
inclusion criteria: * histologically or cytological confirmed recurrent, metastatic or advanced hnscc of the oral cavity, oropharynx, hypopharynx, larynx or unknown origin (but being treated as hnscc). * availability of tumor sample. * patients who are going to receive at least one dose of anti-pd1antibody (nivolumab or pembrolizumab). exclusion criteria: * nasopharynx, maxillary sinus, nasal/nasal vestibule squamous tumors * patients who are receiving concomitantly any other tumor-specific treatment (chemotherapy, radiotherapy, any monoclonal antibodies different from anti- pd-1 antibodies).

Keywords: head and neck immune checkpoint inhibitors immuno-oncology liquid biopsy advanced cancer metestatic cancer
expanded access program of amtagvi that is out of specification for commercial release

Conditions: Unresectable Melanoma; Metastatic Melanoma

Summary: the objective of this expanded access protocol is to provide access to out of specification (oos) amtagvi treatment to patients.

this program provides access to oos amtagvi (lifileucel) that does not meet commercial release criteria but does meet iovance clinical trial release criteria. patients will be followed for safety and efficacy.

Eligibility criteria:
inclusion criteria: 1. eligible for treatment with amtagvi per united states prescribing information (uspi) 2. have an amtagvi product manufactured for commercial treatment; however, the final manufactured product did not meet commercial release criteria but was deemed safe and acceptable for release after risk/benefit assessment 3. patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after receiving the last protocol-related therapy exclusion criteria: 1. history of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium 2. ongoing systemic infection 3. cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or il-2, at the discretion of the treating physician 4. experience a significant worsening in clinical status that would, in the opinion of the treating physician, increase the risk of toxicities from treatment with lymphodepleting chemotherapy, amtagvi product that is out of specification, or il-2 5. any other condition, laboratory abnormality and/or pre-treatment assessment that places patient at unacceptable risk if they were to participate in the eap based on the treating physician's judgment 6. pregnant or breastfeeding

Keywords: ln-144 lifileucel adoptive cell therapy cell therapy tumor infiltrating lymphocytes til immunotherapy
closed suction drainage after revision hip arthroplasty

Conditions: Hip Osteoarthritis; Bleeding

Summary: prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided in to two groups with or without drainage. all patients was assessed with ultrasonography on 3rd day after surgery. bleeding, need for blood transfusion and laboratory test was analyzed after surgery. patients was assessed with harris hips score and visual analog scale after surgery.

inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. exclusion criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure, thromboembolism in past history. at the end of operation information of drainage was get out from the envelope. on 3rd day all patient get ultrasonography with level of fluid in the joint and hematoma in soft tissue measurement. we analyzed hemoglobin, c-reactive protein, erythrocyte sedimentation rate on 1st and 3rd day after surgery. visual analog scale was taken on 3rd day after surgery and harris hip score 6 weeks after.

Eligibility criteria:
inclusion criteria: * aseptic loosening, * head or insert damage, * girdlestone hip exclusion criteria: * septic loosening, * primary or secondary coagulopathy, * renal or hepatic failure, * thromboembolism in past history

Keywords: hip revision arthroplasty drainage
isocaloric dietary restriction vs. bariatric surgery for obesity treatment

Conditions: Obesity

Summary: this is a prospective, randomized, two-armed study to assess the efficacy and safety of isocaloric dietary restriction in the treatment of obese without diabetic for a period of 4 weeks.

this is a randomized, open-label, two arms trial. based on inclusion and exclusion criteria, 72 eligible patients, who are 18-45 years old, with bmi between 35 to 45kg/m2 are assigned to one of two intervention groups: isocaloric dietary restriction; bariatric surgery. both groups were given a dietary intervention for a period of 4 weeks (in rigorous supervision confined in inpatient department). the main purpose of this study is to clarify the efficacy of isocaloric dietary restriction, compared to bariatric surgery, in losing weight and improving metabolic factors. this is an investigator-initiated study performed by department of endocrinology and metabolic disease, ruijin hospital affiliated with shanghai jiaotong university school of medicine.

Eligibility criteria:
inclusion criteria: * age between 18 to 45 years old * 35 ≤ bmi ≤ 45 kg/m2 exclusion criteria: * obesity induced by other endocrinologic disorders * severe gastrointestinal diseases or contraindication for surgery * history or newly known of diabetes * use of hypoglycemic medications, antibiotic in the preceding 2 months, or yogurt within 5 days * weight change more than 5% of body weight within the past 3 months * severe or unstable cardiovascular, liver or renal diseases or known cancer * history of drug or alcohol abuse or other substance abuse * any mental disorders or current use of antidepressantspregnancy or lactation or consideration of pregnancy * allergies to specific food ingredients in the intervention