Kornimate/medical-research-clean huggingface dataset:
immunotherapy for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Immunotherapy

Summary: this study is an observational real-world research conducted on chinese hepatocellular carcinoma (hcc) patients. its primary objective is to evaluate the safety and efficacy of immunotherapy-based combination therapies in chinese hcc patients within the practical context of real-world conditions.

hepatocellular carcinoma exhibits a significantly elevated incidence and mortality rate in china. despite the chinese population representing a mere 18.4% of the global population, the annual incidence of new liver cancer cases reaches a staggering 466,000 (55.4% of the global total), with 422,000 deaths (53.9% of the global total). immunotherapy, particularly the implementation of immunotherapy-based combination treatment regimens, holds substantial therapeutic value in the management of hepatocellular carcinoma (hcc), leading to notable breakthroughs and advancements in the comprehensive treatment of liver cancer. the aim of this study is to evaluate the safety and efficacy of immunotherapy-based combination treatment regimens in chinese hepatocellular carcinoma (hcc) patients under real-world clinical conditions. by collecting and analyzing data on the etiology, clinical characteristics, treatment modalities, and treatment outcomes of hcc patients receiving immunotherapy-based combination treatments in the clinical healthcare setting, the study seeks to provide valuable information regarding treatment patterns and effectiveness for hepatocellular carcinoma patients.

Eligibility criteria:
inclusion criteria: 1. aged after 18 years (18 is included). 2. hepatocellular carcinoma diagnosed by pathology or imaging. 3. patients assessed by researchers as potentially benefiting from receiving immunotherapy-based combination regimens. 4. for participants who have previously received treatment according to this protocol, a comprehensive pre-treatment assessment is required, including demographic information, tumor history, medical history, and baseline imaging examinations. 5. patients voluntarily enroll in this study. exclusion criteria: 1. pregnant or lactating women. 2. other conditions regimented at investigators' discretion.
efficacy of dolasetron in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: this study offers a new treatment, dolasetron or anzemet ®, which will be administered by intravenous way once a day during a 4 days hospitalization. this study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo). randomisation at the beginning of the study will decide whether you receive active treatment or its placebo. this treatment will be renewed after one month, after 2 months and after 3 months. if the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. during these visits, you will undergo routine health exams and complete different kinds of questionnaires. following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 75 * primitive fibromyalgia according to acr criteria * patient no responding to conventional treatment * women of childbearing age using an efficace contraception * signed consent exclusion criteria: * inflammatory rheumatic diseases * diseases of the system: gougerot sjögren, polymyositis, vasculitis, * infectious diseases: hepatitis b and c, lyme disease, hiv, * hypothyroidism, * bone and mineral metabolism disorders * disorders of cardiac conduction * failure of heart, of kidney or liver, * patient allergic to dolasetron * pregnant or nursing women * women without means of contraception, * age \ 75 years.
histocompatibility leukocyte antigen (hla)-a*0201 restricted peptide vaccine therapy in patients with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the safety and time to progression of hla-a\*0201 restricted epitope peptides vegfr1 and vegfr2 emulsified with montanide isa 51 in advanced breast cancer patients.

vegf receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific ctl response in vitro and vivo. according to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. patients will be vaccinated twice a week for 8 weeks. on each vaccination day, vegfr1 peptide (1mg) and vegfr2 peptide (1mg) mixed with montanide isa 51 will be administered by subcutaneous injection. repeated cycles of the vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. in the phase i study, we evaluate the safety and tolerability of these peptide vaccine. in the following phase ii study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: * advanced or recurrent breast cancer * resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s) * resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive * ecog performance status 0-2 * life expectancy \> 3 months * hla-a\*0201 * laboratory values as follows * 2000/mm3\<wbc\<15000/mm3 * platelet count\>100000/mm3 * bilirubin \< 3.0mg/dl * asparate transaminase \< 150iu/l * alanine transaminase \< 150iu/l * creatinine \< 3.0mg/dl * able and willing to give valid written informed consent exclusion criteria: * pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception) * breastfeeding * active or uncontrolled infection * unhealed external wound * concurrent treatment with steroids or immunosuppressing agent * prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks * uncontrolled brain and/or intraspinal lesion(s) * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: hla-a*0201 peptide vaccine vegfr1 vegfr2
role of clinical pharmacists in epilepsy management

Conditions: Epilepsy

Summary: clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. however, the pharmacy practices of managing epilepsy are still limited in vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. this study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a vietnamese general hospital.

phenytoin, carbamazepine, and valproic acid, which are among the first-generation aeds, are prescribed in many countries around the world, including vietnam. these agents have complicated pharmacokinetics, which may result in alterations in absorption, distribution, and metabolism. this means that, given the same dose, the serum concentration of each drug may vary between patients. the management of epilepsy, as a result, requires inter-professional collaboration to ensure therapeutic optimization. as healthcare professionals, clinical pharmacists play an important role in epilepsy management, which includes establishing a therapeutic drug monitoring (tdm) protocol, adjusting doses, monitoring adrs, etc. however, the clinical pharmacy practices in epilepsy management are quite limited in vietnam. the treatment gap-the proportion of people with epilepsy who are not adequately treated-still remains very high, especially in rural areas (84.7%), which probably results from discontinuing the treatment or refusing to take medications. this shows a need for pharmacist consultations for patients with epilepsy and their family members, as they may be lack information about aeds or motivation in controlling potential seizures. in addition, the adjustments of antiepileptic drugs by pharmacists are not routine procedures, nor are monitored for effectiveness in many vietnamese hospitals. this lack of engagement threatens the patients' safety and decreases their quality of life. to address this issue, certain interventions are needed to enable pharmacists to manage patients with epilepsy more systematically. this study was therefore conducted to evaluate the effectiveness of pharmacist interventions in epilepsy treatment at a general hospital in vietnam.

Eligibility criteria:
inclusion criteria: * were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid. * were treated for more than one month. exclusion criteria: * were pregnant or breastfeeding women. * had a history of alcoholism. * had liver or renal disease. * were using drugs known to have an influence on cytochrome p450 enzymes.

Keywords: epilepsy role of pharmacist adverse drug reaction antiepileptic drug vietnam
a clinical study of ak120 in adolescents with moderate-to-severe atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: this is a a multicenter, open label, phase ii clinical study to evaluate the safety, pharmacokinetics (pk), pharmacodynamics(pd), and preliminary efficacy of ak120 in adolescents with moderate-to-severe atopic dermatitis

this is a a multicenter, open label, phase ii clinical study aimed to evaluate the safety, pk, pd, and preliminary efficacy of ak120 in adolescents with moderate-to-severe ad. the entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). the duration of the study is about 20 weeks.

Eligibility criteria:
inclusion criteria: * male or female subjects aged ≥12 \<18 years old. * weight≥30kg at baseline. * ad diagnosed at least half a year before screening. * subject with easi score ≥16, iga ≥ 3, bsa ≥ 10% at screening and baseline. exclusion criteria: * acute onset of ad in 4 weeks prior to enrollment. * undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment. * previously suffered from vernal keratoconjunctivitis (vkc) or atopic keratoconjunctivitis (akc). * received systemic traditional chinese medicine treatment within the 4 weeks before randomization or topical traditional chinese medicine treatment within 1 week before randomization. * received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer). * have a history of allergies to any component of ak120 and/or severe allergic reactions to monoclonal antibodies.
a clinical trial of csl's 2009 h1n1 influenza vaccine (csl425) in healthy adults in the usa

Conditions: Influenza

Summary: the purpose of this study is to determine whether csl425 is a safe and effective vaccine for eliciting an immune response to h1n1 influenza in healthy adults


Eligibility criteria:
inclusion criteria: * male or female aged 18 and older, inclusive, at the time of providing informed consent. * females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination. exclusion criteria: * known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the study vaccine.
telehealth-clinical advocacy project

Conditions: Substance Use

Summary: the purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program.

participants in a police opioid diversion program will receive information about the research opportunity; those interested will be administered informed consent and randomized to either the (1) diversion program treatment as usual condition or (2) the enhanced condition, receiving the telehealth video call intervention with motivational interviewing and substance use treatment appointment reminders during the 12-week intervention. the study design has been modified to provide the enhanced condition with coaching and the t-cap app to all individuals consented to the study beginning january 1, 2023.

Eligibility criteria:
inclusion criteria: individuals interested in joining the study will be * enrolled in the a way out opioid diversion program (odp), * at least 18 years of age, * able to speak and understand english, * have a history of opioid, alcohol, or other substance use within last 12 months, * be willing to provide the research team with access to treatment records, * have access to a phone, tablet or computer for the informed consent activity, and * have a mailing address to receive a study phone issued to consented participants exclusion criteria: individuals not eligible for the study are * not currently enrolled in the a way out opioid diversion program on the day of consent, * under the age of 18 on the day of consent, * unable to speak and understand english, * have a history of past opioid, alcohol, or other substance use longer than 12 months ago with no use of opioids in the last 12 months, * unwilling to authorize the research team to access treatment records, * without access to a phone, tablet or computer to complete the informed consent activity, * without a mailing address

Keywords: opioids telehealth police diversion program
study of breast cancer prevention by letrozole in high risk women

Conditions: Breast Cancer

Summary: this is a multi-institution double-blind placebo-controlled trial whose main objective is to determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have random periareolar fine needle aspiration (rpfna) evidence of hyperplasia with atypia or borderline atypia, and a minimum ki-67 of \>1.5%. the primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life.

subsequent to the 6 month rpfna for assessment of biomarkers, toxicity and quality of life assessments, all women may receive optional open-label letrozole for an additional 6 months, followed by a third rpfna and biomarker

Eligibility criteria:
inclusion criteria: * post-menopausal women at high risk for development of breast cancer * stable dose of hormone replacement therapy * have cytomorphologic evidence of hyperplasia +/- atypia and ki-67 expression \>1.5% in benign breast epithelial cells acquired by rpfna * serum level of 25-hydroxyvitamin d of at least 30 ng/ml prior to study entry * willing to have a repeat random periareolar fine needle aspiration (rpfna) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug exclusion criteria: * prior history of osteoporosis or osteoporotic fracture. * prior history of invasive breast cancer or other invasive cancer within five years from date of study entry. * current and chronic use of cyclooxygenase-2 (cox-2) specific inhibitors or nsaids * receiving treatment for rheumatoid arthritis or fibromyalgia * current history of poorly controlled migraines or perimenopausal symptoms * currently receiving other investigational agents. * receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past.
monitoring of circulating tumor dna and its aberrant methylation in the surveillance of surgical lung cancer patients (medal, methylation based dynamic analysis for lung cancer).

Conditions: Carcinoma; Lung Cancer; NSCLC; Lung Neoplasm

Summary: conduct a prospective study to confirm the value of circulating tumor dna and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients.

studies have already demonstrated the feasibility of circulating tumor dna as a surrogate to reveal tumor mutation status in lung cancer patients and a few researches have shown the potential ability of using circulating tumor dna in surveillance. however, no study focused on the value of methylation status of circulating tumor dna in the surveillance and no strict prospective study has been performed in surgical lung cancer patients. the investigators plan to analyze the dynamic change of circulating tumor dna and its methylation status longitudinally from preoperation to long term follow-up in surgical lung cancer patients, and compare assessment value between circulating tumor dna detection with methylation , traditional imaging examinations and traditional blood tumor markers in the monitoring process.

Eligibility criteria:
inclusion criteria: aged 18 to 80 years * lung cancer was suspected preoperatively. * received curative surgical therapy * no malignant tumor history within the past 5 years * no being received any treatment prior to resection * patients must have given written informed consent exclusion criteria: * the pulmonary nodule is pure ground glass opacity * unable to comply with the study procedure * the postoperative pathology is not nsclc. * unqualified blood samples

Keywords: circulating tumor dna ctdna methylation lung cancer surveillance
effects of hipopressive exercises in nonspecific low back pain

Conditions: Low Back Pain

Summary: introduction non-specific low back pain is very prevalent in our society. different effective physiotherapy treatments have been performed in the reduction of pain and improvement of quality of life, however there are few studies that exist on the effectiveness of these treatments in protocol format based on manual therapy. on the other hand, there are no studies that implement a protocol of therapeutic exercises called abdominal hypopressives. the aim of the study is to study the effect of a manual therapy protocol on non-specific low back pain and the implementation of hypopressive exercises in different areas such as disability, pain, flexibility and quality of life. material and methods participants the sample will consist of subjects with non-specific low back pain. inclusion criteria -participants with nonspecific lumbar pain of at least 4 pain crises a month with recurrent low back pain. exclusion criteria * light acute. * lumbalgia after trauma. * presenting sciatica or musculoskeletal disorders or injuries within three months prior to the study. * contraindication of one of the two treatments. * participate in this period of no functional recovery program or physiotherapy treatment. study design a randomized clinical trial will be conducted. the sample will be divided into 2 groups: group 1 will receive a manual therapy protocol that has previously shown its effectiveness in non-specific low back pain being 1 session a week, while group 2 will receive a protocol of hypopressive therapeutic exercises. evaluations at the beginning of the study, a clinical interview will be carried out and, in addition, 3 evaluations will be carried out: at the beginning, at the end of the treatment and one follow-up per month. the investigators will use the following evaluation tools: * pain, through the visual analog scale. * oswestry low back pain disability scale. * sf-36 quality of life scale. * visual analog scale. * algometry of spinous processes and lumbar muscles. * lumbar flexion with inclinometer and fingers test - floor.


Eligibility criteria:
inclusion criteria: * man between 18 and 40 years old * recurrent episodes of low back pain at least 4 times a month * at least 3 months of evolution * non-specific low back pain * not having undergone surgery exclusion criteria: * acute low back pain * lumbalgia operated surgically * low back pain after traumatism * episodes of sciatica * contraindication to any of the treatments * attend, during the study period, rehabilitation programs * serious injuries in the 3 months prior to the study * root pain * any breach of the inclusion criteria

Keywords: low back pain manual therapy hypopressive therapeutic exercises
breech external cephalic version intervention trial

Conditions: Breech Presentation

Summary: a prospective study assessing the use of external cephalic version for the management of breech presentation in pregnancy.

the primary aim of the study is to determine the success rate of external cephalic version for breech presentation from 36 gestational weeks.

Eligibility criteria:
inclusion criteria: * presence of the written consent of the patients. * the patients must be over 18 years old . * no limit in the ability to consent. exclusion criteria: * age under 18 * limited ability to consent * placenta previa * fetal abnormalities
target-specific immunopet imaging of breast cancer

Conditions: Breast Cancer; Breast Neoplasms; Breast Cancer Metastatic

Summary: the aim of this study is to establish and optimize the trop2/her2-targeted pet/ct imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.

enrolled patients will undergo whole-body \[68ga\]ga-nota-t4/\[18f\]f-resca-t4(trop2-targeted imaging probes ) or \[68ga\]ga-dota-h2d3/\[18f\]f-resca-rb14(her2-targeted imaging probes) pet/ct scans at 1 hours after tracer injection(0.05-0.1 mci/kg). uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively. tumor uptake will be quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv), and accuracy will be calculated to evaluate the diagnostic efficacy. the correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. the exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Eligibility criteria:
inclusion criteria: 1. aged 18-75 years old and of female gender； 2. histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging; 3. capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (icf) and this protocol. exclusion criteria: 1. pregnancy； 2. severe hepatic and renal insufficiency; 3. history of serious surgery in the last month; 4. allergic to antibody or single-domain antibody radiopharmaceuticals.

Keywords: trop2 her2 breast cancer immunopet