Kornimate/medical-research-clean huggingface dataset:
a study to investigate the pharmacokinetics of azd2389 in healthy participants when administered alone and in combination with quinidine

Conditions: Advanced Chronic Liver Disease; Healthy Participants

Summary: the purpose of this study is to assess the pharmacokinetics (pk) and safety of azd2389 when administered alone and in combination with quinidine in healthy participants.

this is a 2-way cross-over study to evaluate the effect of quinidine on the pk of azd2389. the study will include 2 treatments - treatment a - azd2389 treatment b - azd2389 + quinidine the study will comprise - 1. a screening period of maximum 28 days. 2. period 1: single dose administration of treatment a or treatment b on day 1. period 2 will start after a washout period of at least 7 days. 3. period 2: single dose of alternate treatment on day 8. 4. a follow-up visit: participants will return for a follow-up visit, 7 to 14 days after the last azd2389 pk sample in period 2. participants will be randomized to one of the 2 treatment sequences - 1. sequence ab: treatment a in period 1, treatment b in period 2. 2. sequence ba: treatment b in period 1, treatment a in period 2.

Eligibility criteria:
inclusion criteria: * healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture. * all females must have a negative pregnancy test at the screening visit and on admission to the clinical unit. * females of non-childbearing potential must be confirmed at the screening visit. * sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods from the time of first administration of study intervention administration until 3 months after the study follow-up visit. * have a body mass index between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg at the screening visit. exclusion criteria: * history of any clinically important disease or disorder. * history or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * any clinically important abnormalities in hematology, clinical chemistry, urinalysis, coagulation results or other laboratory values and vital signs. * any positive result on screening for serum hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab), hepatitis c virus antibody (hcv ab), or human immunodeficiency virus (hiv). * any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ecg) at screening. * known or suspected history of alcohol or drug abuse or excessive intake of alcohol. * current smokers or those who have smoked or used nicotine products within the previous 3 months prior to screening. * positive screen for drugs of abuse, or alcohol or cotinine at screening. * history of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity. * history of hypersensitivity to dipeptidyl peptidase 4 (dpp4) inhibitors.

Keywords: hepatic fibrosis fibroblast activation protein inhibitor
rechallenge, potential drug induced liver injury (kaiser)

Conditions: Drug-induced Liver Injury

Summary: drug re-administration or rechallenge should be avoided after drug-induced liver injury (dili) to avoid recurrent and fatal injury. rechallenge outcomes vary considerably by drug and patient subjects. in order to better predict these outcomes, the objective of this analysis is to assess clinical outcomes of positive drug rechallenge following possible drug-induced liver injury. electronic medical records from kaiser permanente california (kpsc), a managed care organization, will be utilized to identify patients who experience possible drug-induced liver injury following exposure to medications associated with hepatotoxicity, and who are then rechallenged with the medication.


Eligibility criteria:
inclusion criteria: * patients who received at least one prescription for a suspect drug between jan 1, 2003 and june 30, 2009 (drug initiation period) * patients who experienced incident dili event (identified by alt ≥3xuln or ap ≥2xuln within 6 months of suspect drug administration) during the first exposure period that: 1. resolved to within normal limits of alt (for hepatocellular \& mixed) or ap (for cholestatic) within 180 days or 2. resolved to alt \< 3xuln (for hepatocellular \& mixed) within 90 days or ap\<2xuln (for cholestatic) within 180 days or 3. dropped by ≥50% of (peak alt - uln) for hepatocellular or of (peak ap - uln) for cholestatic or mixed within 180 days * patients who were rechallenged with the same suspect drug; rechallenge will include first rechallenge event for the analysis. * patients who had at least of 12 months of continuous membership and drug benefit prior to and on the dispensing index date (inclusive). there is no minimum restriction of continuous membership plus drug benefit after the start date. * patients who were 18 years of age or older at the time of the first drug dispensing (index date) during the drug initiation period jan 1, 2003 and june 30, 2009. each patient's first prescription for the study drugs during the drug initiation period will be identified as index prescription. * patients who had health insurance coverage with full medical, pharmacy and lab benefits at the index date. exclusion criteria: * patients meeting the definition of chronic liver injury and exhibiting persistent alt≥3xuln or ap or bilirubin ≥2xuln within 90 days after initial injury * patients with chronic liver injury diagnostic codes or included in kpsc disease registries preceding the initial or rechallenge liver injury

Keywords: liver injury rechallenge kaiser permanente california
trail evaluating apatinib with imrt for inoperable or iodine refractory thyroid cancer

Conditions: Thyroid Cancer

Summary: to determine the efficacy and safety of intensity modulated radiation therapy combined with apatinib for inoperable or iodine refractory thyroid cancer.


Eligibility criteria:
inclusion criteria: * ability to understand character and individual consequences of the clinical trial. willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial; * aged ≥ 18 years old; * pathologically confirmed inoperable or iodine refractory thyroid cancer, or postoperative residual disease detected by imaging studies, or progression disease within 12 months before enrollment. (all with measurable disease ≥10mm according to recist 1.1); * ecog0-2; * adequate laboratory values within 14 dyas of enrollment to study defined as follows: n ≥ 1500/mm\^3; plt ≥ 80,000/mm\^3; hb≥90g/l;total bilirubin \ 50ml/min; * the survival period is expected to be greater than 3 months; * willing to accept adequate contraception for patients with childbearing potential. exclusion criteria: * take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments; * take vegfr-tki within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib; * allergic to apainib; * uncontrolled high blood pressure and heart disease; * patients with gastrointestinal bleeding risk; * coagulation disorders(inr\>1.5×ulnaptt\>1.5×uln); * uroprotein positive (uroprotein≥2+ or 24-hour urinary protein quantity \>1.0g); * pregnant or lactating women.

Keywords: thyroid cancer apatinib intensity modulated radiation therapy
a study to compare nivolumab administered subcutaneously vs intravenous in melanoma participants following complete resection

Conditions: Melanoma

Summary: the purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected stage iiia/b/c/d or stage iv melanoma.


Eligibility criteria:
inclusion criteria: * stage iiia/b/c/d or stage iv melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins * complete resection performed within 12 weeks prior to randomization or treatment assignment * eastern cooperative oncology group (ecog) performance status of ≤ 1 exclusion criteria: * history of uveal or mucosal melanoma * untreated/unresected cns metastases or leptomeningeal metastases * active, known or suspected autoimmune disease * serious or uncontrolled medical disorder 4 weeks prior to screening * concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible * prior immunotherapy treatments for any prior malignancies are not permitted other protocol-defined inclusion/exclusion criteria apply

Keywords: skin cancer rhuph20 opdivo®
neural operant conditioning

Conditions: Stroke; Chronic Stroke; Gait, Hemiplegic; Gait, Spastic; Walking, Difficulty

Summary: the goal of this clinical trial is to learn if operant conditioning can reduce spasticity in order to improve walking in stroke patient. the main questions it aims to answer are: * can participants self-regulate reflex excitability * can participants self-regulate reflex, reduce spasticity and improve walking participants will undergo surface stimulation to evoke spinal reflexes and will be asked to control these reflexes therefore reducing spasticity. researchers will compare result to able bodied participants to see if \[insert effects\]

the study purpose is to investigate the possibility and later effect of spinal reflex self-regulation in post-stroke stiff-knee gait. the intervention will consist of direct current surface stimulation of the peripheral nerves using electrical stimulation. stimulation will evoke a motor response that will be collected through surface emg electrodes and processed to depict a measure of the response as feedback to the participant to complete the loop of operant conditioning. the participant will attempt to modulate their responses over multiple sessions to cause this depiction to either increase or decrease its value depending on an established target. .

Eligibility criteria:
inclusion criteria: 1. sign and date consent form 2. at least 3 months since stroke event 3. over 18 years of age at time of eligibility 4. ability to stand upright and walk for at least 5 minutes 5. premorbidly independent 6. mild to moderate gait impairment 7. reduced knee flexion during walking relative to the unimpaired side 8. unilateral hemiparesis of the lower limbs 9. ability to evoke muscle responses through peripheral nerve stimulation, spinal cord stimulation, and transcranial magnetic stimulation 10. medically stable 11. skin intact on hemiparetic leg, abdomen, and scalp 12. ability to evoke muscle responses and/or reflex responses through peripheral nerve stimulation, spinal cord stimulation, and/or transcranial magnetic stimulation exclusion criteria: 1. co-existing neurological condition other than prior stroke involving the hemiparetic lower limb (e.g., peripheral nerve injury, pd, sci, tbi, ms). 2. history of lower limb musculoskeletal injury 3. functionally relevant osteoarthritis and weight bearing restriction 4. functionally relevant polyneuropathy resulting in lack of sensation in the lower leg 5. functionally relevant cognitive impairment 6. functionally relevant vision impairment 7. pregnant 8. botox injection to the ipsilateral leg in the last 12 weeks or taking oral anti-spasticity medications 9. taking part in physical therapy for any walking-related impairment 10. cardiac pacemaker or other implanted electronic systems 11. uncontrolled seizure disorder 12. use of seizure lowering threshold medications and the discretion of the study physician 13. deficits in communication that interfere with reasonable study participation 14. severely impaired cognition and communication 15. severe lower limb pain
the effect of jin si herbal tea on cancer-related fatigue of gynecological cancer patients

Conditions: Cancer-related Fatigue; Gynecologic Cancer

Summary: cancer-related fatigue caused by cancer and treatment reduces patients' compliance with treatment. fatigue caused by chemotherapy usually has multifaceted symptoms, such as being very tired, feeling weak, desperate for rest, or decreased activity. cancer-related fatigue is often the main reason why patients are reluctant to continue treatment. even after finished chemotherapy, most patients still feel fatigued. therefore, how to solve the patient's fatigue caused by cancer and treatment is a very important issue, and there is no effective treatment at present. this project plans to use the jin si herbal tea developed by our hospital to improve cancer-related fatigue.

cancer-related fatigue caused by cancer and treatment reduces patients' compliance with treatment. fatigue caused by chemotherapy usually has multifaceted symptoms, such as being very tired, feeling weak, desperate for rest, or decreased activity. cancer-related fatigue is often the main reason why patients are reluctant to continue treatment. even after finished chemotherapy, most patients still feel fatigued. therefore, how to solve the patient's fatigue caused by cancer and treatment is a very important issue, and there is no effective treatment at present. this project plans to use the jin si herbal tea developed by our hospital to improve cancer-related fatigue. jin si herbal tea brief mechanism of action: it contains eight kinds of traditional chinese medicines, mainly including wormwood, fish needle grass, ophiopogon japonicas, houttuynia cordata, platycodon, licorice, perilla leaves, and chrysanthemum, which promote lung health including dampness and clean lung heat, diuresis, generate body heat, anti-cold, clean blood, and reduce phlegm.

Eligibility criteria:
inclusion criteria: * patients who received chemotherapy * patients who understand the experimental process exclusion criteria: * unconscious * severe disease, not well-controlled patients judged by pi * pregnancy, breastfeeding, menstruation during screening phase * weakness, allergy to herbal tea, frequently felt cold
neurocognitive and neuroimaging outcomes in older patients with multiple myeloma treated with autologous stem cell transplantation

Conditions: Multiple Myeloma

Summary: the purpose of this study is to learn about possible changes in thinking (cognitive) abilities, such as memory skills, and in brain anatomy and function, in adults with multiple myeloma who are treated with high-dose chemotherapy followed by asct.


Eligibility criteria:
inclusion criteria: * diagnosed with multiple myeloma and in complete, partial or very good partial remission at enrollment as per standard international myeloma working group criteria * scheduled to have high-dose chemotherapy and asct * age 60 - 75 years at study entry * in the judgment of the consenting professional, fluent and able to communicate well enough in english to complete the study assessments and provide informed consent. * patients who report that english is not their primary language will be asked the us census english proficiency question "how well do you speak english" and the answer "very well" will be required exclusion criteria: * with signs and/or symptoms of central nervous system cancers (e.g., tumors, metastases, leptomeningial disease) as determined by their physician, medical records, or by a brain mri, either at the time of enrollment or during the study period * with current diagnosis of major axis i psychiatric disorder (dsm-iv), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report * as per patient report or as confirmed by the medical record, if the patient is taking anti-depression or anti-anxiety medication, \< 2 months on these medications or a change in the prescribed dose in the past 2 months * with history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report * with a history of another cancer, except for non-melanoma skin cancer, as per medical records or patient report * with current substance abuse and/or history of substance abuse, as per medical records or patient report * with evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report * with contraindications to mri examinations as per standard screening guidelines used in the department of radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)

Keywords: asct memorial sloan kettering cancer center 18-154
effectiveness study of integrative treatment for pediatric pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to evaluate the effectiveness of traditional chinese medicine for treatment of pediatric pneumonia. it is a multicenter randomized controlled trial.

the retrospective case study has been finished at the national clinical research base of traditional chinese medicine for major disease pediatric pneumonia, and the research center organized the field training of prospective-study to coordinated units. based on the primary statistical outcomes of retrospective case study and the discussion around prospective-study during the training, investigators found it difficult to include simplex viral infection, therefore, investigators revised the inclusion criteria and treatment protocol of the pragmatic randomized controlled trial. the block randomization is used in this trial. random numbers are generated by spss software. statistical analysis staff and those who perform the follow-up are blinded. sample size calculation was performed, which was 369, and considering drop-out or withdrawal, investigators plan to enroll 450 patients (300 in experimental group, 150 in control).

Eligibility criteria:
inclusion criteria: * children, aged 6 months to 59 months old, diagnosed as pneumonia according to western medicine diagnostic criteria; * diagnosed as tcm pneumonia with gasp-cough, meeting wind-heat blocking lungs pattern (feng re bi fei zheng), and phlegm-heat blocking lungs pattern (tan re bi fei zheng); * disease progression within 72 hours; * those whose guardians understood and assigned the informed consent; exclusion criteria: * emergency pneumonia; * complicated with other pulmonary disorders attack other than pneumonia; * complicated with primary disease of heart (congenital heart disease, myocarditis, et al), liver (alt, and ast ≥ 1.5 times of normal value ceiling), kidney (bun \> 8.2mmol/l, or serum cr \> 104 µmol/l, et al) and blood system (anemia), and those with psychopathy; * allergic to interventional medications; * those who are participating or have participated in other clinical trials in 3 months.

Keywords: pneumonia pediatrics viral
bloodstream infection of carbapenem-resistant proteus mirabilis

Conditions: Proteus Mirabilis Infection; Bacteremia; Carbapenem Resistant Bacterial Infection

Summary: this study aims to determine the clinical characteristics, risk factors, and resistance mechanisms of patients with carbapenem-resistant p. mirabilis bacteremia.patients with p. mirabilis growth in blood culture samples sent to bacteriology laboratory between 2018 and 2021 were retrospectively analyzed. patients meeting the inclusion criteria were divided into carbapenem-resistant and carbapenem- susceptible groups. the investigators recorded demographic data, clinical features, and laboratory findings. resistance genes were investigated in carbapenem-resistant isolates using pcr.

patients with p. mirabilis growth in blood culture who met the study criteria were divided into two groups as carbapenem susceptible and resistant according to carbapenem antibiogram results. patients with carbapenem-resistant p. mirabilis (crpm) growth in blood culture were included in the case group and patients with carbapenem- susceptible p. mirabilis (cspm) growth in blood culture were included in the control group. demographic characteristics of the patients, concomitant chronic diseases, charlson comorbidity index (cci), hospital and intensive care unit (icu) hospitalization and number of days in the last year, history and type of invasive intervention in the last three months (surgical-invasive), history of antibiotic use in the last three months and types of antibiotics used (penicillin, cephalosporin, quinolone, carbapenem, tigecycline, colistin, aminoglycoside), hospitalization unit, total length of hospitalization, sample collection unit, growth result and antibiogram, clinical and laboratory data of the day of growth, sepsis and septic shock evaluated according to systemic inflammatory response syndrome (sirs) criteria, 30-day mortality and patient outcome information were recorded. carbapenemase-producing gene regions were investigated by polymerase chain reaction (pcr) in accessible samples of patients with carbapenem-resistant p. mirabilis growth in blood cultures.

Eligibility criteria:
inclusion criteria: * inpatients aged 18 years and older * p. mirabilis growth in blood cultures exclusion criteria: * samples taken in emergency departments, outpatient clinics, day treatment units * recurrent growths of the same patient

Keywords: proteus mirabilis bacteremia carbapenem resistance resistance mechanisms pcr
lifemel honey to reduce leucopenia during chemotherapy

Conditions: Breast Cancer

Summary: this study will include 60 patients with early breast cancer referred to receive adjuvant chemotherapy with ac ( adriamycin- cyclophosphamide) or caf ( adriamycin- cyclophosphamide- 5- fluorouracil ) combinations. these patients will receive every day one spoon of lifemel honey or regular honey ( double blind)- during the adjuvant chemotherapy .every week a wbc count will be performed in order to record the influence of lifemel on myelotoxicity.


Eligibility criteria:
inclusion criteria: * breast cancer patient treated with adjuvant chemotherapy * ps = 2 or less exclusion criteria: * none

Keywords: breast cancer honey myelosuppression chemotherapy