Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of 9mw2821 in the treatment of high-risk non-muscle-invasive bladder cancer (nmibc)

Conditions: Bladder Cancer

Summary: assess the safety and efficacy of 9mw2821 in patients with high-risk non-muscle-invasive bladder cancer (nmibc) who have previously failed to intravesical therapy. provide a new treatment option for patients with nmibc recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.


Eligibility criteria:
inclusion criteria: * age≥18 years old before signing the informed consent. * subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to bcg, gemcitabine, etc. * subjects refuse or are intolerant to bcg therapy. * subjects must have completed a standard turbt surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in the surgical field. * tumor tissue samples from turbt must be provided (≥5 slides), along with relevant pathological reports. * histological and pathological diagnosis of urothelial carcinoma (with a major component \>50%) , with the confirmation of no-muscle invasion. * subjects must be categorized as high-risk nmibc * subjects refuse or are intolerant to radical cystectomy. * clinical non-metastatic bladder cancer (n0, m0) determined by ct scan. * adequate function of heart, bone marrow, liver, and kidney. * ecog 0-1 * subjects must be willing to take highly effective contraception during the study and 180 days after the last dose of 9mw2821 (a negative serum pregnancy test result within ≤7 days before enrollment for the female). exclusion criteria: * history of muscle invasive or metastatic bladder cancer. * history of other malignancies within 3 years. * other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug. * surgery (such as turbt) or radiotherapy for bladder lesions within 2 weeks before the first dose. * hypersensitivity reactions to certain components of 9mw2821 or similar drugs. * persistence of adverse reactions caused by prior anti-tumor therapy before the first dose, does not recover to grade 1 and below, according to nci-ctcae v5.0. * active systemic infections that require treatments within 7 days before the first dose. * severe cardiovascular diseases within 6 months before the first dose. * history of allogeneic hematopoietic stem cell transplantation or organ transplantation. * history of autoimmune diseases. * serum virology tests: positive results for hbsag or hbcab, with positive hbv-dna copies (≥500iu/ml); positive hcv-ab results, with positive hcv-rna results; positive hiv-ab results. * prior treatment with drugs targeted nectin-4 or mmae-conjugated adc.
staccato apomorphine multi-dose pk and pd in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: this study will be conducted in subjects with established parkinson's disease in 2 parts. part a will examine the tolerability, safety, and pharmacokinetics of az-009 dose escalation ; and part b will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of az-009 compared with placebo in a crossover design

this study will be conducted in subjects with established parkinson's disease in 2 parts. part a will examine the tolerability, safety, and pharmacokinetics of daily doses of az-009 for 5 days followed by 3 doses on each of days 6 and 7 in dose escalation through 3 cohorts part b will assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of az-009 compared with placebo in subjects with established parkinson's disease experiencing regular off episodes

Eligibility criteria:
inclusion criteria: * healthy adult males and females between 30 and 85 years of age, inclusive at the time of signing the informed consent document with a clinical diagnosis of parkinson's disease * body weight ≥ 50 kg and bmi within the range of 18 to 32 kg/m2. * willing and able to be confined at the clinical research center for the study period and adhere to overall study visit schedule, procedures and other protocol requirements. * understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. exclusion criteria: * any significant medical condition, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol. * history of clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions including gastric bypass or other weight loss
effects of interleukin (il)- 4r-alpha inhibition on respiratory microbiome and immunologic correlates in severe asthma

Conditions: Asthma

Summary: the overall goal of this study is to understand biological responses related to dupilumab treatment among severe asthma patients. not all asthma is the same, and characteristics of asthma vary from person to person. the study will investigate whether the study drug can help to improve the health of participants lungs, boost immune response, as well as improve quality of life.


Eligibility criteria:
inclusion criteria: * physician-diagnosed/managed severe asthma patients that are clinically eligible for dupilumab * current treatment with a medium-to-high-dose inhaled glucocorticoid (fluticasone propionate at a total daily dose of greater or equal (≥) 440 μg or equipotent equivalent) plus up to at least one additional controller (e.g., a long-acting β2-agonist or leukotriene receptor antagonist) * eosinophilic asthma phenotype (blood eosinophil level \>300) or asthma requiring daily oral corticosteroids * asthma that is uncontrolled, as defined by a score on the asthma control test of 19 or lower, or a worsening of asthma in the past year that led to an asthma hospitalization, emergency department visit, or 3 days of oral corticosteroids * severity of asthma that, in the opinion of the subject's asthma care specialist, requires dupilumab for control * for women of childbearing age: agree to use birth control or remain abstinent during the duration of the study. exclusion criteria: * patients with diagnosis of other chronic lung diseases (e.g. chronic obstructive pulmonary disease (copd), idiopathic pulmonary fibrosis, churg-strauss syndrome, allergic bronchopulmonary aspergillosis, etc.) * current smoker or reported smoking within 1 month of the screening visit (tobacco or any inhaled recreational product) * greater than 10 total pack-year of cigarette smoking history * treatment with oral corticosteroids for an asthma exacerbation 1 month prior to screening or during the screening period * use of any biologic therapy for asthma within the past 3 months * respiratory or gastrointestinal illness within 1 month prior to screening or during the screening period * treatment with antibiotics for acute infections within six weeks prior to screening or during the screening period. * pregnancy at enrollment or during the study * known hypersensitivity to dupilumab or its excipients

Keywords: inhaled corticosteroids dupilumab
chemotherapy combined with radiotherapy versus radiotherapy alone for solitary plasmacytoma

Conditions: Solitary Plasmacytoma

Summary: solitary plasmacytoma (sp) is characterized by a localized mass of clonal plasma cells with no or minimal bone marrow plasmacytosis. it can present either as emp or sbp. radiotherapy is the first-line treatment with high response rate. however, 65-84% sbp patients and 25-35% emp patients progress at 10 years. we aimed to investigate whether adjuvant bortezomib based chemotherapy with radiotherapy could prolong event-free survival in treatment-naive sp patients compared to that with radiotherapy alone.


Eligibility criteria:
inclusion criteria: * treatment-naïve sp. exclusion criteria: * not appropriate for radiotherapy. * ecog \> 2. * co-morbidity of uncontrolled infection. * co-morbidity of other active malignancy. * patients in pregnancy or lactation. * prior or concurrent pulmonary embolism. * patients not able to tolerate thrombosis prophylaxis, bortezomib, lenalidomide or dexamethasone. * seropositive for human immunodeficiency virus, seropositive for hepatitis c, or hbv-dna \> 1000 copies/ml. * myocardial infarction, nyha class iii or iv heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment. * grade 2 or higher neuropathy according to national cancer institute common terminology criteria for adverse events. * neutrophil \<1×10e9/l，hemoglobin \< 8g/dl，or platelet \< 75×10e9/l. * severely compromised hepatic or renal function: alt or ast \> 3 × uln, total bilirubin \> 1.5 × uln，or egfr \< 40ml/min.
l-arginine for knee osteoarthritis patients

Conditions: Osteoarthritis, Knee

Summary: this study will examine the pain-relief efficacy and safety of l-arginine in knee oa patients.

pain is the dominant symptom of knee osteoarthritis (koa). the main management goal for people with koa is to control pain without increasing treatment-related adverse effects (aes). however, the commonly prescribed systemic analgesics have safety concerns, such as increased risk of cardiovascular and gastrointestinal aes. therefore, it is urgent to develop safe and effective treatment options. l-arginine is one of the most commonly used oral nutritional supplements that has been widely used in patients with peripheral arterial disease, cystic fibrosis, and pregnant women with high risk of pre-eclampsia. the supplement has a high safety profile. previous case-control and cross-sectional studies have found plasma l-arginine levels were lower in patients with knee oa than controls, suggesting that arginine deficiency may increase the risk of oa. the investigators previously observed an inverse dose-response relationship between levels of serum l-arginine and the risk of incident symptomatic koa. additionally, the investigators demonstrated that intra-articular injection of l-arginine solution relieved pain symptoms in a surgical rat model of oa. however, there is a paucity of high-quality clinical evidence on the effect of intake of l-arginine supplement on pain relief among patients with symptomatic koa. the investigators propose to conduct a randomized, double-blind, placebo-controlled trial to examine the efficacy and safety of oral l-arginine in patients with knee oa.

Eligibility criteria:
inclusion criteria: 1. age between 40 and 80 years. 2. knee oa according to the american college of rheumatology (acr) clinical criteria. 3. knee pain lasting 3 months or longer and a score of 7 or greater on the western ontario and mcmaster universities osteoarthritis index (womac) pain subscale (standardized to range from 0-20). 4. kellgren-lawrence (kl) grade 2 or 3. 5. willing to and able to provide written informed consent. exclusion criteria: 1. any use of nsaids or other analgesics in the past two weeks. 2. history of injections of corticosteroids in the past three months or hyaluronic acid in the past 6 months in the index knee. 3. history of arthroscopy or open surgery in the index knee in the past 12 months. 4. history of a knee replacement in the index knee or planning to receive such a procedure within 3 months. 5. history of a severe injury in the index knee. 6. pain in the index knee caused by inflammatory, autoimmune, neoplastic diseases or other diseases. 7. abnormal liver or kidney functions, as defined by alanine transaminase or aspartate aminotransferase \>two times the upper limit of normal, or blood urea nitrogen or serum creatinine \>two times the upper limit of normal. 8. severe respiratory diseases. 9. history of coronary artery disease and heart failure. 10. uncontrolled hypertension or diabetes mellitus. 11. diagnosis of malignant tumors. 12. pregnant or contemplating pregnancy or breast-feeding.

Keywords: osteoarthritis l-arginine pain
effects of electroconvulsive therapy (ect) in bipolar depression

Conditions: Bipolar Disorder

Summary: the primary purpose of this study is to use magnetic resonance spectroscopy (mrs) to measure the levels of several brain chemicals including, but not limited to, glutamate, glutamine, and n-acetylaspartate, before and after treatment with ect. in addition to mrs, the investigators will use several other mri techniques including structural mri, resting state functional mri (fmri), and diffusion tensor imaging (dti) to measure how the structure and function of the brain changes with ect. the investigators hypothesize that the gln/glu ratio is increased in the anterior cingulate cortex (acc), but not the parieto-occipital cortex (poc), following the first ect treatment.


Eligibility criteria:
inclusion criteria: * male or female age 18-55 * meets dsm-iv criteria for bipolar disorder type i, ii, or nos with current episode depressed * has been scheduled to be evaluated by an ect consultant from the mclean hospital ect service * current score of greater than or equal to 24 on the montgomery-asberg depression rating scale (madrs) exclusion criteria: * unwillingness or inability to provide informed consent * lifetime history of schizophrenia * dsm-iv diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening * positive urine toxicology screen at screening (note: participants with a positive urine toxicology screen who are prescribed benzodiazepine, stimulant, or opiate medications by their physician will be permitted to enroll in the study as long as they do not meet abuse or dependence criteria for these substances) * female participants with a positive urine pregnancy test at screening * pregnancy. females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, mri-safe intrauterine device, double-barrier method, male partner sterilization) * any contraindications to having an mri scan, including cardiac pacemakers, metal vascular clips or stents, artificial heart valves, certain kinds of prostheses, brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings (wounded in military combat, sheetmetal workers, welders, and others), transdermal drug delivery systems, and certain tattoos with metallic ink. note: participants will be screened for these conditions at screening, and will be required to fill out a standard mri screening form at the brain imaging center, which will be reviewed by an mri technician prior to each mri scan * scheduled to receive first ect treatment on a friday

Keywords: ect bipolar disorder
fmri and opioid abstinence

Conditions: Drug Use Disorder; Opioid Dependence; Opioid-Related Disorders; Opioid Use; Opioid Abuse

Summary: this project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for oud.


Eligibility criteria:
inclusion criteria: * recent initiation of methadone or buprenorphine at apt foundation within the last year (i.e., period of time during which treatment drop-out and risk for relapse is highest); * eligibility for mri scanning; * ability to commit to study visits. exclusion criteria: * current acute psychosis, mania, or suicidal ideation with intent, as assessed during screening with the scid-5; * current intoxication or acute withdrawal at time of study visit sufficient to prevent participation based on: behavioral observation, breathalyzer, and sows assessment; * severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a promis cognitive function tscore \<30 (i.e., severe impairment) * past or present history of intellectual disability, developmental disorder, or neurological disease; * head trauma with loss of consciousness \>30 min; * organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.

Keywords: relapse
astym® compared eccentric exercise for chronic mid-substance achilles tendinopathy

Conditions: Achilles Tendon Pain

Summary: the purpose of this study is to compare the changes in pain and self-perceived function between two different treatments for achilles tendinopathy: the astym® protocol (a form of soft tissue mobilization using instruments) and a specific exercise protocol that involves strengthening the calf and achilles tendon. astym® (a-stim) is not an acronym, but rather stands for "a stimulation" of the body's healing response, describing the physiologic process which occurs with astym treatment. astym is the trademark name of a non-invasive treatment where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild to moderate pressure to the underlying soft tissue structures. the aim of astym treatment is to eliminate scar tissue and stimulate tissue regeneration. both the principal investigator and co-investigator have been trained and certified in administering the astym treatment. the specific exercise protocol will involve exercises that strengthen the achilles and calf through eccentric exercise. eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.


Eligibility criteria:
inclusion criteria * pain for 3 months or longer in the mid portion of only one achilles tendon. * must read, speak and understand english exclusion criteria * previous surgery to the achilles tendon that is currently painful * an injection into the achilles tendon in the previous 4 weeks * have symptoms in both achilles tendons concurrently * have taken fluoroquinolone antibiotics in the past 6 months
impact of neutrophil activation in acute ischemic stroke patients treated with endovascular therapy

Conditions: Acute Stroke

Summary: clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (ais) involving an increased risk of unfavorable outcome and hemorrhagic transformation (ht). however, clinical trials targeting neutrophil recruitment in ais patients were negative. recently, an experimental study has shown that neutrophil activation and transmigration begin immediately after the occlusion. inhibition of neutrophil recruitment several hours after the start of ischemia appears therefore too late to have a clinical relevance. the objective is to study the time dependent impact of neutrophils in ais and the predominant mediators in each time point to identify the appropriate therapeutic target and time window.


Eligibility criteria:
inclusion criteria: * age \>= 18 years old * acute ischemic stroke secondary to a large vessel occlusion. * patients hospitalized for endovascular therapy. exclusion criteria: * pregnant or breast feeding patient * patient under legal protection * patient opposition to participate in this study
min plan vs cbt for suicide prevention

Conditions: Suicide Risk

Summary: 1. to investigate the effectiveness of young adults culturally adapted manual assisted psychological therapy (ya-cmap) in university students with suicide risk 2. to compare the effectiveness of young adults culturally adapted manual assisted psychological therapy (ya-cmap) against minplan tool in university students with suicide risk


Eligibility criteria:
inclusion criteria: * participants who are not taking any psychological help or psychotherapy in the past and present. * participants who are at risk of suicide without a history of suicidal attempts but with a history of suicidal ideation in the past two months will be included. exclusion criteria: * participants with a history of substance misuse/drug dependence/alcohol dependence and psychosis. * participants diagnosed with dementia, schizophrenia, delirium, bipolar disorder, and learning disability. * participants with a diagnosis of dsm-v mental disorders due to general medical condition. * participants who are taking any psychiatric medication. * participants residing on a temporary basis in the study area.

Keywords: suicidal ideation suicide probability depression cbt self help tool minplan
preoperative radiotherapy in patients at high risk of postoperative pancreatic fistula after pancreatoduodenectomy

Conditions: Neuroendocrine Carcinoma of Pancreas; Duodenum Carcinoma; Pancreas Neoplasm; Distal Cholangiocarcinoma; GIST; Pancreas Fibrosis; Pancreatic Fistula

Summary: the fibropanc-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (\>25%) of developing post operative pancreatic fistula (popf). a single course of 12gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade b and c popf.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma. * pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic ct scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site). * who-ecog performance status 0,1 or 2. * ability to undergo stereotactic radiotherapy and surgery. * age ≥ 18 years. * good understanding of the oral and written patient information provided. * written informed consent. exclusion criteria: * patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region. * patients with (a history of) chronic pancreatitis

Keywords: post operative pancreatic fistula stereotactic radiotherapy pancreatic fibrosis pancreatoduodenectomy
safety and tolerability of wve-120101 in patients with huntington's disease

Conditions: Huntington's Disease

Summary: precision-hd1 is a phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of single and multiple doses of wve-120101 in adult patients with early manifest huntington's disease (hd) who carry a targeted single nucleotide polymorphism (snp) rs362307 (snp1).


Eligibility criteria:
key inclusion criteria: * prescreened with targeted snp on the same allele as the pathogenic cag expansion * ambulatory, male or female patients aged ≥25 - ≤65 years * clinical diagnostic motor features of hd, defined as unified huntington's disease rating scale (uhdrs) diagnostic confidence score = 4 * early manifest hd, stage i or stage ii based on uhdrs total functional capacity scores ≥7 and ≤13 key exclusion criteria: * malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years. * received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 half-lives of the oligonucleotide, whichever is longer * clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy * inability to undergo brain mri * bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture