Kornimate/medical-research-clean huggingface dataset:
clinical pharmacokinetics and pharmacodynamics study of different doses of zoledronic acid

Conditions: Postmenopausal Osteoporosis

Summary: the recommended dosing regimen of zoledronic acid in chinese osteoporosis patients is completely in accordance with the one of 5 mg per year abroad that based on the dosing regimen in paget's disease. this dosing regimen lacks the actual supportive clinical data of chinese patients. in addition, the overall incidence of acute phase response, the main adverse event after the first infusion, in chinese patients is higher than that in caucasian patients population. moreover, the results of the similar drug clinical study in the japanese patients shown that the purpose of effective treatment for osteoporosis could be achieved with half of the dosage in caucasian population. thus, it could be inferred from these that the dosing regimen of zoledronic acid might be inappropriate in chinese osteoporosis patients. therefore, the main purpose of this clinical trail is to compare the zoledronic acid pharmacokinetic and pharmacodynamic characteristic of different doses in chinese postmenopausal subjects with low bone mass or osteoporosis and explore the best dosing regimen in chinese patients.


Eligibility criteria:
inclusion criteria: 1. chinese postmenopausal women 2. aged between 60 and 70. 3. bone mineral density (bmd) values of less than 1 standard deviations (sd) below the normal adult mean. 4. willing to participate in this study. exclusion criteria: 1. hypersensitivity to zoledronic acid or other bisphosphonate or zoledronic acid formulation (excipients). 2. secondary osteoporosis. 3. receiving the following drugs that affect bone metabolism prior to randomization: (1) intravenous biphosphonates or denosumab. (2) oral biphosphonates, parathyroid hormone or its analogues, strontium, or fluoride within 12 months. (3) glucocorticoid, steroids, immunosuppressive agents, calcitonin, calcitriol or its analogues, thiazides diuretics, long-acting estrogen/progesterone, or statins within 3 months. 4. combine other diseases affect bone metabolism: osteogenesis imperfecta, hyperthyroidism, malignant tumors, paget's disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, liver failure, or renal failure. 5. hyperthyroidism or hypothyroidism during screening. 6. treatment with any investigational drug within the past 3 months. 7. creatinine clearance \< 35 ml/min. 8. 25(oh)d level\< 20 ng/ml. 9. serum calcium level \ 2.8 mmol/l (11.0 mg/dl). 10. fever, severe infections, severe injuries, or major surgical operation within 30 days. 11. ecg corrected qt interval (qtc) \> 480 ms. 12. pending invasive dental procedure or in progress. 13. history of smoking within 6 months. 14. diabetes with fasting blood glucose ≥ 7.0 mmol/l, or glycated hemoglobin (hba1c) \>6.3%. 15. history of drug or alcohol abuse. 16. history of stroke, cerebral ischemic stroke, or cerebral hemorrhage. 17. any physiological or medical condition which, in the opinion of the investigator, would preclude the participant from this trail.

Keywords: zoledronic acid pharmacokinetic pharmacodynamic chinese osteoporosis
risk scoring systems in upper gi-haemorrhage

Conditions: Upper Gastrointestinal Hemorrhage

Summary: use of risk scoring systems in the assessment of patients presenting with upper gastrointestinal haemorrhage is increasing. comparative studies have intended to identify the system of choice, but the majority of these are characterized by retrospective designs, small sample sizes, low rate of severe bleeding, or low mortality. the main aim of this study was to identify the optimal scoring system.


Eligibility criteria:
inclusion criteria: one of the following: * haematemesis * melaena * coffee-ground vomit
valemetostat tosylate (ds-3201b) phase 2 study in relapsed or refractory adult t-cell leukemia/lymphoma

Conditions: Adult T-cell Leukemia/Lymphoma

Summary: this phase 2 study will be conducted to assess the efficacy and safety of valemetostat tosylate (ds-3201b) in participants with relapsed or refractory adult t-cell leukemia/lymphoma (r/r atl).


Eligibility criteria:
inclusion criteria: * participants with relapsed or refractory adult t-cell leukemia/lymphoma (atl) who have history of treatment with mogamulizumab or are mogamulizumab intolerant, contraindication after treatment with at least 1 medication regimen * aged ≥20 years or older at the time of signing the informed consent * eastern cooperative oncology group (ecog) performance status (ps) of 0-2 * at least 1 evaluable lesion * participants who have defined laboratory criteria * life expectancy ≥ 3 months exclusion criteria: * a presence of central nervous system involvement at the time of screening tests * have poorly controlled complication (eg. chronic congestive heart failure, unstable angina * ≥ grade 3 neuropathy * qt interval corrected using fridericia's method (qtcf) \>470 ms * has an uncontrolled infection * participants who use corticosteroids over 10 mg/day * receipt of allogeneic hematopoietic stem cell transplantation * history of, or concurrent, malignant tumors
telephone support program for lung cancer patients and their family caregivers

Conditions: Lung Cancer

Summary: the goal of this project is to examine the physical and psychological health benefits of a novel, telephone-delivered symptom management intervention for advanced lung cancer patients and their family caregivers.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of lung cancer * must be able to speak and read english exclusion criteria: * no working phone service * does not have a family caregiver

Keywords: lung cancer family caregiving behavioral intervention counseling symptom management
stratification of oral ulcers in rheumatoid arthritis patients kept on methotrexate

Conditions: Methotrexate Adverse Reaction; Oral Mucositis

Summary: this study included rheumatoid arthritis patients receiving methotrexate as monotherapy. all eligible patients were subjected to thorough clinical examination and full history to identify oral events. drug history, current dose and duration of mtx were recorded.

the current study was conducted in the clinics of oral medicine, faculty of dentistry and rheumatology, faculty of medicine - cairo university from 2017 to 2019. this study followed the principles of the helsinki declaration and was approved by the research ethics committee of faculty of dentistry, cairo university. ra patients receiving mtx as monotherapy were included in the study. patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded. all eligible patients were subjected to thorough clinical examination for the whole oral cavity. medical history and history of any oral manifestation were recorded. drug history, dose, and duration of mtx were recorded. categorical data was presented as frequencies and percentages. continuous data was described as means and standard deviations. means were compared by one-way annova and student-t-test. the significance level was set at p ≤0.05. statistical analysis was performed with ibm® spss® statistics version 25 for windows.

Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis using methotrexate as sole treatment exclusion criteria: * patients with rheumatoid arthritis using any other treatments for rheumatoid arthritis
effects of functional ingredients in an acute metabolic challenge context

Conditions: Metabolic Syndrome

Summary: after an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary increase, triggering a wave of oxidative stress due to the appearance of excess free radicals in adipose and muscle tissues. elevated postprandial hypertriglyceridemia has been associated with increased risk of cardiovascular disease and type 2 diabetes. hence, postprandial changes in different circulating biomarkers are potential predictors of cardiometabolic risk. in addition to the possibility of evaluating acute variations in metabolic risk markers in response to different types of fat, the metabolic challenge approach may serve as a challenge-meal background in order to reveal possible beneficial effects of specific food ingredients. in this study, circulating cardiometabolic disease-related biomarkers, including endotoxemia, will be assessed postprandially in search for beneficial actions of particular functional food ingredients consumed in combination with a high-fat meal.

the study will be carried out in a group of healthy mature subjects with overweight and normal fasting blood glucose values. a randomized crossover design will be followed, in which the postprandial metabolic responses to a high fat breakfast (hf) will be compared with those registered after an identical breakfast containing a functional ("active") ingredient. each meal will be tested in an independent experimental session. experimental sessions will take place with1 week interval. the study will be carried out at the food for health laboratory, food for health science centre - lund university (medicon village, lund). the volunteers will consume the challenge hf alone and with 4 active ingredients, i.e. each volunteer will undergo five experimental sessions. additionally, the plan contemplates an initial information visit that includes the screening of fasting blood glucose. in total, each volunteer completing the study will pay six visits to the food for health laboratory. based on the results from the above-described phase, a second step of the study will focus on the impact of the order of consumption -i.e. "active ingredient" before hf and vice versa on cardiometabolic risk outcomes, as a way to optimize putative protective actions.

Eligibility criteria:
inclusion criteria: * overweight (bmi between 25 and 30) * fasting blood glucose value ≤ 6.1 mmol/l. exclusion criteria: * treatment for dyslipidemia * treatment for hypertension

Keywords: type 2 diabetes risk cardiovascular disease risk
intraperitoneal chemotherapy and systemic chemotherapy versus systemic chemotherapy after curative resection of serosa-positive gastric cancer

Conditions: Advanced Gastric Cancer With Serosal Invasion

Summary: intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published. in this study, we review the clinicopathological characteristics of patients and effects of early postoperative intraperitoneal chemotherapy (epic) on overall and gastric cancer-specific survival and patterns of recurrence of gastric cancer patients with macroscopic serosal invasion. the aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall and disease free survival of advanced gastric cancer patients with serosal invasion after potentially curative surgery.


Eligibility criteria:
inclusion criteria: 1. histologically proven adenocarcinoma of the stomach 2. preoperative suspicion of serosal invasion on the radiological examination 3. candidate for curative resection of the stomach with d2 4. age from 19 to 70 year old 5. eastern cooperative oncology group performance status :0, 1, or 2 6. absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dl, and platelet≥100,000/microliter 7. serum creatinine\<1.5mg/dl 8. total bilirubin \<2 x upper normal limit, transaminase\<3 x upper normal limit 9. patients without previous administration of chemotherapeutic agent 10. patients who agreed and signed to the informed consent form exclusion criteria: 1. malignancy of the stomach except for adenocarcinoma 2. history of hypersensitivity to 5-fluorouracil or mitomycin 3. concomitant infectious disease 4. active hepatitis or chronic liver disease 5. history of psychotic disorders 6. patients with disorders in the central nervous system 7. history of other malignancy within 5 years 8. history of clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, symptomatic arrhythmia, myocardial infarction) 9. patients with increased bleeding tendency 10. pregnant or lactating female patients 11. patient who did not agreed and signed to the informed consent form

Keywords: advanced gastric cancer serosal invasion peritoneal recurrence intraperitoneal chemotherapy
pain neuroscience education and exercise in institutionalized older adults with pain

Conditions: Chronic Pain

Summary: the primary objectives of this study are to: * evaluate recruitment procedures and adherence rates; * evaluate the ability to understand the concepts of pain neurophysiology; * evaluate the acceptability of an intervention program based on pain neuroscience education and exercise by institutionalized older adults and the institutions where they are.

participants will be older adults with pain that are institutionalized and assess the feasibility of implementing an intervention consisting of pain neuroscience education in addition to exercise. it is antecipated that the intervention will consist of 1 to 2 sessions per week during 8 weeks and will be delivered in small groups. participants will be assessed for pain intensity, duration, catastrophizing, fear of movement, knowledge of pain neuroscience, depression and performance.

Eligibility criteria:
inclusion criteria: * be institutionalized in any type of response (nursing home, day care, ...), be able to read and write, have chronic pain (defined as pain lasting 3 months or more and felt at least once a week during these 3 months ) anywhere in the body, and have a statement from the institution's physician authorizing participation in the exercise sessions. exclusion criteria: * have any contra-indication to exercise and have cognitive limitations (evaluated through the montreal cognitive assessment questionnaire).
sleep and maximal fat oxidation

Conditions: Sleep Deprivation

Summary: introduction: despite the awareness of the importance of sleep in our lives, especially for athletes, the consequences of poor rest on sports performance are not well understood. furthermore, the interaction between complete and partial sleep deprivation over one night and sleeping the usual hours for each person remains unclear. objectives: the aim of this study is to evaluate the effects of sleep deprivation on maximal fat oxidation (mfo) in male and female participants.


Eligibility criteria:
inclusion criteria: * inclusion criteria: * age between 18 and 35 years. * body mass index (bmi) \&lt; 25 kg/m². * resistance-trained individuals (more than 2 years of structured training). * healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising. * participants must be able to perform the tests described in the following section. exclusion criteria: * history of neuromuscular diseases, heart disease, or conditions that may affect liver or muscle metabolism. * use of drugs, stimulants, or sports supplements that could interfere with the dietary supplement used in the study. * sedentary habits (less than 150 minutes/week of moderate exercise). * having undergone prolonged periods of physical inactivity in the 6 months prior to the study. * engaging in strenuous exercise within 48 hours prior to the tests. * failure to replicate the same food intake on both experimental days. * consumption of caffeine or any other stimulant the day before the tests.
vinflunine in patients with locally advanced or metastatic transitional cell carcinoma of the urothelium

Conditions: Transitional Cell Carcinoma; Bladder Neoplasms; Kidney Neoplasms; Ureter Neoplasms; Bladder Cancer; Neoplasm, Bladder

Summary: the purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease). * relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen. * adequate performance status (karnofsky greater or equal to 80). exclusion criteria: * receipt of more than 1 prior chemotherapy regimen in any setting. * prior discontinuation of platinum due solely to toxicity. * current neuropathy greater or equal to ctc grade 2. * prior radiation to greater or equal to 30% of bone marrow. * inadequate hematologic function: anc \<1,500 cells/mm3, platelet\<100,000 cells/mm3. * inadequate hepatic function: total bilirubin \> 1.5 times uln, alt/ast \> 2.5 times uln or \> 5 times uln in case of liver metastasis. * inadequate renal function: creatinine clearance \<20 ml/min. * prior allergy to any vinca-alkaloid.

Keywords: urothelium
duloxetine compassionate use in patients who have completed a previous neuroscience duloxetine clinical trial

Conditions: Major Depressive Disorder; Fibromyalgia; Diabetic Peripheral Neuropathic Pain; Generalized Anxiety Disorder

Summary: the primary objective of this study is to provide duloxetine to investigators for the treatment of patients who have previously participated in neuroscience duloxetine clinical trials and for whom effective alternative therapy is not available.


Eligibility criteria:
inclusion criteria: * male and female outpatients at least 18 years of age who have previously participated in a lilly sponsored neuroscience duloxetine clinical trial * all females must have a negative urine pregnancy test at visit 1. females of childbearing potential must agree to utilize medically acceptable and reliable means of birth control. * must sign the informed consent document exclusion criteria: * have received treatment within the last 30 days with a drug except for duloxetine that has not received regulatory approval for any indication at the time of study entry * in the opinion of the investigator, patient judged to be at serious suicidal risk. * serious or unstable hepatic or renal function or unstable narrow angle glaucoma. * treatment with a monoamine oxidase inhibitor (maoi) within 14 days prior to visit 1 or potential to use a maoi during the study or within 5 days of discontinuation of study drug. * any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the lilly physician
early oral intake following cesarean surgery

Conditions: Obstetrics; Surgery

Summary: in this study we are trying to compare the safety and financial benefit of starting the realimentation early versus conventional oral intake following the cesarean surgery in iran.

cesarean delivery is announced to constitute 50% of deliveries in the capital and 39% of all the deliveries nationwide, which is far beyond the acceptable international normal range, according to the official site of the ministry of health and medical education of the islamic republic of iran \[http://www.mohme.gov.ir/hndc/indicators/simaye_salamt/simaye_salamat.htm\]. this high rate of elective cesarean deliveries might be due to several reasons which are far beyond the scope of this study. here we tried to see whether the reduction in the time of hospitalization for these patients is safe at the expense of earlier oral realimentation and to see whether this strategy increases the patients' satisfaction or not.

Eligibility criteria:
inclusion criteria: women who had elective cesarean deliveries under regional anesthesia exclusion criteria: 1. receiving general anesthesia, magnesium sulfate or insulin. 2. coming across an intraoperative bowel injury. 3. having any medical or gastrointestinal problem that prohibits early feeding

Keywords: cesarean oral intake
trial to assess the safety and clinical performance of contino® in preventing urinary incontinence

Conditions: Urinary Incontinence

Summary: this trial is to assess the safety and clinical performance of contino device is preventing urinary incontinence in male subjects with sphincteric incompetence

sphincteric incompetence is most commonly found in men who have had radical prostatectomy (rp). rp is the most common treatment for localized high-risk prostate cancer in north america. the contino®, a urethral insert, was conceived by a prostate cancer survivor and worn for 10+ years without incident, and a first in human clinical trial was completed without serious adverse event. the basis for this clinical trial is a post market clinical follow-up study. no drug treatment will be administered.

Eligibility criteria:
inclusion criteria: 1. male 18 years of age or older 2. evidence of sphincteric incompetence as assessed by the investigator 3. ecog 0 or 1 performance status 4. evidence of moderate to severe urinary incontinence as assessed by the investigator, typically 2 or more protective garments or pads per day exclusion criteria: 1. inability to consistently insert the contino® into his own urethra and remove it 2. less than 2 months post radical prostatectomy for localized prostate cancer 3. history of significant incontinence that is other than stress incontinence 4. evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions 5. untreated urethral stricture disease 6. use of anticoagulant or antiplatelet medications excluding low-dose asa (in the opinion of the investigator) 7. any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve (in the opinion of the investigator) 8. body mass index (bmi) greater than 32 kg/m2 (in the opinion of the investigator provided the subject is able to insert \& remove the device) 9. known immune deficiency either due to disease or medications (in the opinion of the investigator) 10. uncontrolled diabetes (in the opinion of the investigator) 11. an uti (in the opinion of the investigator)