Kornimate/medical-research-clean huggingface dataset:
development of phy606 as adjunct therapy for anemia patients

Conditions: Anemia; Herbal Interaction

Summary: many reasons can cause anemia, decreased rbc production or increased destruction of circulation rbc. the investigators investigate the danggui buxue tang (phy606) composed of angelicae sinensis radix and astragali radix in the fields of genomic and metabolomics in the healthy people and the patiens with anemia.

many reasons can cause anemia, decreased rbc production or increased destruction of circulating rbc. the reasons of the former are lake of nutrients, bone marrow disorder, low level tropic hormone, inflammation associated with infectious, inflammatory, or malignant disorders and the latter are intravascular hemolysis or blood loss. anemia is characterized by the sign of pallor (reduced oxyhemoglobin in skin or mucous membranes), fatigue, lightheadedness, and weakness associated with low hemoglobin. iron deficiency anemia (ida) is mainly resulted from inadequate iron uptake of food, malabsorption of iron and blood loss. adult female are easy to have ida compared to male because of menstruation, pregnancy, lactation and low caloric uptake leading to iron deficiency. in taiwan, cancer-related and chronic kidney disease also lead to insufficient secretion of erythropoietin (epo). the cost of long-term use epo and its derivative drugs is high. besides, drug resistance, risk of tumor growth and cardiovascular disease are all important issues. however, ferrotherapy will induce gi upset, muscle pain and skin hives. also, iron supplementation can lead to an increase in infectious disease morbidity in areas where bacterial infections or where malaria are common. based on the concept of dietetic invigoration, the investigators investigate the danggui buxue tang (phy606) composed of angelicae sinensis radix and astragali radix in the fields of genomics and metabolomics in the healthy people and the patients with anemia. in the meantime, the investigators will explore whether phy606 activates the immune function, improves anemia and reduces the side effects induced by anemia treatment. furthermore, the novel metabolites from angelicae sinensis radix and astragali radix will be tested from clinic back to the bench including immunological potentiation and hematopoietic function. according to the tcm theory, the investigators integrate with modern medicine and molecular biotechnology to investigate anemia and hope to provide the evidence base for clinical application.

Eligibility criteria:
inclusion criteria: * female: hb\<11 g/dl; male: hb\<13.5 g/dl * has no allergic reaction to tcm exclusion criteria: * below 20 years old * ever drug abuse or still in drug abuse * pregnant or in breast-feeding women * with psychotic disorders * cardiac arrhythmia with pacemaker * dyscoagulation or thrombocytopenia (platelet\ 2 fold normal range) * with severe disease (cardiac arrest, heart failure, copd, gi bleeding, etc.) * under another clinical trials

Keywords: anemia danggui buxue tang phy606 side effects tcm
comparison of the efficacy and safety of rhtsh as an adjunctive diagnostic tool in differentiated thyroid cancer patients who had been thyroidectomized vs. patients who after thyroid hormone withdrawal

Conditions: Differentiated Thyroid Cancer

Summary: this is a non-blinded trial. oral radioiodine was given 24 hours after the second injection of rhtsh, and scanning was done 48 hours after the radioiodine administration. each patient was scanned first following rhtsh and then scanned after thyroid hormone withdrawal.


Eligibility criteria:
inclusion criteria: * subjects voluntarily sign the informed consent form (icf). * age 18-75 years old, either male or female. * patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant,. * patients with a total or near-total thyroidectomy within 6 weeks prior to administered. * low iodine diet for 4 weeks prior to randomized. exclusion criteria: * pregnant or breast feeding women. * patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission) * subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator. * subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
pain procedures and anxiolysis via distraction with virtual reality

Conditions: Virtual Reality; Anxiety; Pain

Summary: the purpose of this study is to evaluate the efficacy of vr distraction on reducing anxiety patients undergoing interventional pain procedures compared to placebo/active placebo or a non vr option.


Eligibility criteria:
inclusion criteria: * patients aged over 18 years old, who are referred to university of california davis pain medicine clinic and require an interventional pain procedure * english speaking * having the ability to understand oral and written instructions * willing to fill out psychometric surveys. exclusion criteria: * pregnant women * prisoners * patients who have high risk of motion sickness, seizure disorder, or visual/hearing impairment
robotic total knee arthroplasty anesthesia management

Conditions: Knee Osteoarthritis; Joint Diseases; Anesthesia

Summary: robotic arthroplasty is increasing in acceptance on a global scale as a result of advancements in orthopedic surgery technology. the investigators aimed to share our anesthesia management experience as well as compare robotic unilateral total knee arthroplasty with conventional surgical technique in this retrospective study.

this study was approved by the ethics committee of a tertiary academic hospital. the following criteria were used to assess inclusion: asa physical status i-iii patients aged 40-85 years, elective unilateral total knee arthroplasty (tkas) performed by a single senior orthopedic surgeon and orthopedic team under combined spinal epidural anesthesia (csea) between january 2021 and january 2023. exclusion criteria included urgent surgery, bilateral surgery, previous surgery, missing data, and being lost to follow-up during the perioperative period. data was collected from the hospital's electronic database records, patient files, and anesthesia charts.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-iii * between 40-85 years * elective unilateral tkas which were performed by a single senior orthopedic surgeon * between january 2021 and january 2023 under csea. exclusion criteria: * urgent surgery * bilateral surgery * previous surgery * missing data and lost to follow-up in the perioperative period
alfasleep: exploring cognitive and biological correlates of sleep quality and their potential links with alzheimer's disease

Conditions: Cognitively Unimpaied

Summary: the main goal of this study is to perform a multimodal characterization of brain structural and functional changes, as well as changes in alzheimer's disease (ad) biomarkers, as a function of sleep quality measures. cross-sectional data will enable us to confirm and expand previous knowledge in a large and well-phenotyped population, while longitudinal data will allow us to test the hypothesis of the existence of a bidirectional relationship between sleep quality and ad.

the main goal of this study is to perform a multimodal characterization of brain structural and functional changes, as well as changes in alzheimer's disease (ad) biomarkers, as a function of sleep quality measures. cross-sectional data will enable us to confirm and expand previous knowledge in a large and well-phenotyped population, while longitudinal data will allow us to test the hypothesis of the existence of a bidirectional relationship between sleep quality and ad.

Eligibility criteria:
inclusion criteria: * subjects that are currently participating in the alfa+ study (cognitively healthy adults aged between 45-65 years at the moment of the inclusion in the 45-65/fpm2012 study). * subjects from whom csf and/or neuroimaging biomarkers have been acquired during the last 36 months prior to their enrollment in the current study. exclusion criteria: * presence of cognitive impairment. * presence of clinically relevant neurological disorder, psychiatric disorder or other medical conditions that may jeopardize the interpretation of the study results according to the investigator criteria * for the psg sub-study, participants currently treated with drugs that may interfere in psg data interpretation (e.g. antidepressants or benzodiazepines).
effects of concomitant administration of bms-986195 on methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin

Conditions: Rheumatoid Arthritis

Summary: drug-drug interaction study in healthy men and women not of childbearing potential. assess the effect of bms-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. collect data on safety of bms-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. collect data on multiple-dose pharmacodynamics of bms-986195.


Eligibility criteria:
inclusion criteria: * healthy male and female (not of childbearing potential) participants as determined by medical and surgical history and assessments * body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive * normal kidney function at screening exclusion criteria: * history of chronic headaches (eg, migraines, cluster headaches), defined as occurring 15 days or more a month, over the previous 3 months * history of headaches related to caffeine withdrawal, including energy drinks * history of syncope, orthostatic instability, or recurrent dizziness other protocol defined inclusion and exclusion criteria could apply
chemoradiotherapy in elderly patients with locally advanced pancreatic cancer (70+).

Conditions: Unresectable Locally Advanced Pancreatic Cancer

Summary: the goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. the main question it aims to answer is: does chemoradiotherapy represent an effective and safe treatment for older participants without radical surgery? participants will sequentially receive combined chemotherapy followed by concurrent chemoradiotherapy and subsequent maintenance therapy.


Eligibility criteria:
inclusion criteria: * voluntarily participate and sign the informed consent form * age 70-85 years old, life expectancy \> 1 year and gender is not limited * eastern cooperative oncology group physical status score (ecog) physical state score\<=1 point * pathological or cytological confirmation of pancreatic ductal adenocarcinoma (including ipmn malignant transformation, acinar carcinoma, etc., excluding adenosquamous cell carcinoma and neuroendocrine carcinoma) * the clinical stage is stage iii (locally advanced pancreatic cancer), and no radical surgery has been performed (bypass surgery is acceptable), or the patient has resectable pancreatic cancer, but cannot accept surgery or refuse surgery due to physical strength or concomitant diseases * have not received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional chinese medicine therapy * no serious hematological, cardiological, pulmonary function abnormalities and autoimmune deficiencies (refer to their respective diagnostic criteria) * blood routine index: white blood cell (wbc) \>=3.0 × 109/l; absolute neutrophil count (anc) \>=1.5 × 109/l; platelets (plt) \>=100 × 109/l; hemoglobin (hgb) \>=90 g/l * blood biochemical indexes: ast (sgot), alt (sgpt) \<=2.5 × upper limit of normal value (uln); total bilirubin (tbil) \< = uln; serum creatinine (cre) \<=1.5 × uln * coagulation function: prothrombin time (pt), international normalized ratio (inr) \<=1.5 × uln * able to comply with the requirements of the study visit plan and other programs. exclusion criteria: * accompanied by malignant tumors of other systems * received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional chinese medicine therapy * have used any other non-anti-tumor research drugs within 4 weeks before treatment * combined with uncontrollable hypertension, diabetes, infection, etc. * poor compliance, unable or unwilling to sign informed consent * patients who are expected to be out of the observation period for 14 days or more during the treatment period.
etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma

Conditions: Brain Tumors; Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy with chemotherapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma.

objectives: * assess the response rate and toxicity of oral etoposide and radiotherapy in children with newly diagnosed high stage medulloblastoma. * compare the response rate and toxicity of these patients to historical control patients registered on pog #9031. * estimate the 2-year event-free survival and overall survival of these patients. * evaluate the toxicity of dose intensive chemotherapy with oral etoposide, cisplatin, cyclophosphamide, and vincristine following craniospinal irradiation in these patients. outline: patients begin treatment within 1 month of surgery. patients receive 6 weeks of radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7). patients then receive adjuvant chemotherapy consisting of cisplatin iv once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide iv on days 1 and 2 with filgrastim (g-csf) sq daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine iv on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51). patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually thereafter. projected accrual: a total of 48 patients will be accrued for this study within about 2 years.

Eligibility criteria:
disease characteristics: * histologically diagnosed advanced (high grade) childhood medulloblastoma * residual disease of at least 1.5 cm2 in size on mri or ct scan or * evidence of cns or extraneural metastases patient characteristics: age: * 3 to 21 performance status: * not specified life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * sgpt less than 5 times normal * bilirubin less than 1.5 mg/dl renal: * creatinine less than 1.7 mg/dl or * creatinine clearance greater than 70 ml/min other: * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * prior corticosteroids allowed radiotherapy: * no prior radiotherapy surgery: * not specified

Keywords: untreated childhood medulloblastoma
a study of safety and immunogenicity of a malaria vaccine candidate

Conditions: Prophylaxis Against Plasmodium Falciparum Malaria

Summary: shanghai wanxing bio-pharmaceuticals is currently evaluating one malaria vaccine candidate, pfcp2.9 adjuvanted with montanide isa 720. this trial is designed to test the safety and immunogenicity of 3 doses and 2 vaccination schedules. this blood stage candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas.

this is a double blind, randomized, controlled phase i study of pfcp2.9, an experimental malaria vaccine candidate, adjuvanted with montanide isa 720. the primary objective of this study is to assess the safety and reactogenicity of the vaccine in healthy chinese adult volunteers.

Eligibility criteria:
inclusion criteria: * healthy male or female ≥ 18 and ≤ 45 years of age * agrees not to donate blood during the course of the trial. * signed written informed consent provided. * available to participate for the study duration. exclusion criteria: * history of allergic reactions following any vaccination. * involvement in drug or other vaccine trial within four weeks prior to the trial. * acute illness within four weeks prior to the trial. * presence of fever at the time of vaccination, i.e. body temperature (by axillary) \> 37.5 c. * presence of any chronic illness/disease including diabetes mellitus, tuberculosis, leprosy, epilepsy and hypertension determined by medical history or examination. * persons on systemic corticosteroids, immunomodulators or anticoagulants within four weeks prior to vaccination. * persons with a history of allergic manifestations requiring treatment with injectable antihistamines, adrenaline or steroids. * pregnancy. women should not be pregnant, lactating, or planning pregnancy throughout the study period. a urinary pregnancy test (immuno-chromatography) will be performed for all women of child-bearing potential at entry and prior to each vaccination. adequate contraception throughout the study should be used if applicable. * sexually active woman not using contraceptives. * current smoker ( ≥ 20 cigarettes/day). * history of malaria: persons with a known history of malaria or with positive markers for antibodies to malaria parasite by ifa and/or elisa. * history of residing in a malaria endemic region or malaria exposure (travel) within last two years. * abnormal hematology and clinical chemistry considered to be clinically significant. * abnormal urine routine test considered to be clinically significant * persons with positive markers for hbv (hbsag) and/or hcv (anti-hcv) infection.

Keywords: malaria
a trial of wellbutrin for crohn's disease

Conditions: Crohn Disease

Summary: the investigators are testing the hypothesis that wellbutrin (bupropion) can give a clinical remission in crohn's disease.

wellbutrin (bupropion) is approved for use as an antidepressant. there have been some cases in which people on wellbutrin had significant improvement clinically in their crohn's disease. in this trial, the hypothesis that wellbutrin can induce clinical remission in crohn's disease will be tested. the investigators will also be looking to see if wellbutrin can lower levels of the inflammatory cytokine tumor necrosis factor-alpha (tnf).

Eligibility criteria:
inclusion criteria: * moderate to severe crohn's disease with 220 \< cdai \< 400. * all patients in the study must have not had any anti-tnf antibodies for at least eight weeks. exclusion criteria: * patients will be excluded from the study if they have fulminant crohn's disease requiring parenteral steroid treatment, hospitalization, or need of surgery imminently. * patients with serious infections in the preceding three months, opportunistic infections within one month, or current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological, or cerebral disease will be excluded. * patients will also be excluded from the study if they have a history of a seizure, epilepsy, presumed current central nervous system tumor, have or have had anorexia nervosa or bulimia, are currently taking or have taken in the last four weeks any drug in the monoamine oxidase inhibitor class, or are allergic to wellbutrin. * patients with active major depression or suicidal ideation will be excluded, as will patients with a score of 19 or higher on the beck depression inventory. * patients will be excluded if they are currently or have taken a medicine in the selective serotonin reuptake class, mirtazapine, venlafaxine, a tricyclic antidepressant, a mood stabilizing, or antipsychotic medication in the previous two weeks. * patients will be excluded if they are currently abusing alcohol or have alcohol dependence. * patients will be excluded from the study if their baseline liver function tests are greater than twice the upper limit of normal, or if a clinical investigator believes that their baseline chemistry, liver function tests or complete blood count contraindicates entry into the study. * pregnant or lactating females are excluded.

Keywords: crohn disease tnf-alpha
functional change and efficacy of duloxetine in patients with co-morbid depression & soft tissue discomfort syndrome

Conditions: Major Depressive Disorder; Soft Tissue Discomfort Syndrome; Pain

Summary: the objective of this study is to determine the time course of duloxetine efficacy on the symptoms of major depressive disorder (mdd)and on the symptoms of soft tissue discomfort syndrome(stds) via use of 24-hour actigraph™ measures. we hypothesize that there will be a reduction in both mdd and stds symptoms in mdd patients with co-morbid stds symptoms. we further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in mdd patients with co-morbid stds symptoms which may occur even before the antidepressant effect is observed.


Eligibility criteria:
inclusion criteria: * \> 17 years old * all races and ethnicity * dsm iv-tr axis i diagnosis of mdd * co-morbid stds * baseline 17-item hamilton depression rating \> 13 exclusion criteria: * primary axis i disorder other than mdd * history of mania or psychosis * actively suicidal * required hospitalization * a alcohol or substance abuse or dependence within the preceding 3 months * pregnant or nursing * unstable medical condition (other than stds) * narrow-angle glaucoma * sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use * hepatic or renal insufficiency
aprepitant for postoperative nausea and vomiting in laparoscopic hysterectomy

Conditions: Postoperative Nausea and Vomiting

Summary: * gynecological surgery is associated with a high incidence of postoperative nausea and vomiting. * nk1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited. * we performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.

123 female patients (ages 21-60) undergoing laparoscopic hysterectomy 1. 80mg aprepitant 2. 125mg aprepitant 3. placebo incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.

Eligibility criteria:
inclusion criteria: * female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use exclusion criteria: * liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications

Keywords: postoperative nausea and vomiting