Kornimate/medical-research-clean huggingface dataset:
the comparison of stress response to rapid opioid detoxification applying different methods of opioid antagonism

Conditions: Opiate Addiction

Summary: the aim of this study is to investigate which method of naltrexone induction during rapid opioid detoxification causes stronger stress response and has a higher influence on opioid abstinence caused by opioid induction.

study enrolls opiate addicted patients who are motivated for a long term treatment and full opiate abstinence. patient is offered to take part in a study. information is provided regarding protocol, aim and course of study. patients who are eligible and consent for study commit to follow the pre-study recommendations. study consists of: primary assessment - information about study. assessment of patient according to predefined criteria. consent form. allocation of the treatment date. stabilization - buprenorphine. assessment according to sows and ows. total amount of buprenorphine is recorded. repeated evaluation - patient after successful stabilization course undergoes urine test for psychotropic substances, blood alcohol level is recorded. if any test is positive patient is not enrolled to study. correction of opioid withdrawal symptoms - all of the patients receive medicines for opioid detoxification, infusion therapy in predefined doses. antagonist induction - patients receive opioid antagonist (incremental or standard dose). withdrawal symptoms are assessed and correction with lorazepam is given if needed. data collection - data is recorded (demographic, epidemiological, vital signs, opioid withdrawal symptoms, levels of hormones, metabolites, electrolytes).

Eligibility criteria:
inclusion criteria: * opiate addiction * use of short-acting opiate (morphine or heroine) * age \> 18 years * length of opiate addiction \> 1 year * patient can make a decision for detoxification and has a capacity to consent for procedure * written consent for procedure exclusion criteria: * polyvalent addiction * pregnancy or breast feeding * cardiovascular pathology * acute or chronic kidney disease * decompensated liver pathology (jaundice, ascites, hepatic encephalopathy) * infective complications of opiate addiction (pneumonia, phlegmon, abscess, thombophlebitis, sepsis) * malnutrition (nutritional risk screening 2002 score ≥3) * diabetes mellitus * previous history of psychosis * glasgow coma scale \< 15 * abdominal surgical intervention during last 30 days * cumulative buprenorphine dose for stabilization \< 8 mg * positive test for psychoactive substances during treatment * refusal to participate in study at any point of it

Keywords: opioid detoxification opioid antagonist induction conscious sedation
an investigational drug in patients with type 2 diabetes mellitus and chronic renal insufficiency (0431-028)(completed)

Conditions: Diabetes Mellitus, Type 2; Chronic Renal Insufficiency

Summary: the purpose of this study is to determine the safety and tolerability of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes) and chronic renal insufficiency (inadequate kidney function).


Eligibility criteria:
inclusion criteria: * patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus (t2dm) (a specific type of diabetes). * patient has renal (kidney) insufficiency (inadequate kidney function) exclusion criteria: * patient has had heart problems (such as a heart attack or chest pain) or stroke within the past 6 months or any condition or therapy which, in the opinion of the investigator, may not be in the patient's best interest to participate. * pregnant or breast feeding

Keywords: type 2 diabetes mellitus and chronic renal insufficiency
a trial to compare surgery with sorafenib for hepatic celluler cancer with portal vein tumor thrombosis

Conditions: Portal Vein Tumor Thrombus

Summary: according to the guidelines recommended, only a few new targeted therapy drugs treatment, such as sorafenib, is proper. it's 3 year survival rate is only 8% or so. according to our previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3 year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect is obviously better.


Eligibility criteria:
inclusion criteria: * 1. clinical diagnosis of hepatic cellular carcinoma. 2. patients with portal vein tumor thrombus (pvtt) of hepatic cellular carcinoma (hcc) detected by serum alpha fetoprotein (afp) and ct or mri. 3. patients with a solitary tumor or multiple tumor which are resectable. 4. patients without hepatic vein or bile duct invasion and extrahepatic metastasis. 5. patients without surgical contraindication. 6. patients with child a or b liver function and indocyanine green retention rate at 15min (icgr15) \< 10% before treatment. 7. laboratory examination: haemoglobin (hb)\>100g/l, white blood cell (wbc) \> 3000/ml, plt \> 8×10\*10/l before treatment. 8. patients without severe esophagealgastric varices before treatment. 9. patients with hbv，hbv dna≤100, 000 copy/ml. 10. all of the patients has written consent for this research. exclusion criteria: * 1.patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis. 2.patients with surgical contraindication. 3.patients with child c grade liver function before treatment. 4.patients with other malignancy. 5.patients treated with hepatic resection or tace before this treatment. 6.patients with severe esophagealgastric varices or refractory ascites or coagulation dysfunction before treatment.

Keywords: sorafenib, operation
evaluation of the impact of tricuspid regurgitation on patients lives. exploration of experience and impact on a daily basis.

Conditions: Severe Tricuspid Regurgitation Medically Treated and Not Operated (Without Valve Replacement or Repair)

Summary: the purpose of this study is to objectively assess the impact of the pathology on the patient's life so as to best inform the choices of evaluators "the french national authority for health" (has) and decision makers "the economics committee for health products" (ceps) through the expression of the patients' feelings themselves. for this, the study will assess the impact of severe tricuspid insufficiency and its symptoms on the quality of life of patients from a physical, psychological and social point of view.

patients eligible for this study are selected by their cardiologist to participate in one of two interviews: * individual semi-structured interview lasting 45 minutes to 1.5 hours conducted by a psychologist these interviews are recorded (voice recording by dictaphone). they address the experience of patients with different degrees of severity of the pathology (severe, massive or torrential regurgitation), questioning the different dimensions of the impact of tricuspid regurgitation on their life, as well as the hierarchy of consequences for their lives and their daily lives. * collective interview lasting 1.5 hours to 2 hours which allows to consolidate the information obtained during the individual interviews in order to best assess the impact of the tricuspid regurgitation on the daily life and the patient experience.

Eligibility criteria:
inclusion criteria: * subject, male or female, at least 60 years old, * suffering from isolated severe tricuspid insufficiency, * symptomatic despite medical treatment, * without tricuspid surgery or transcatheter tricuspid surgery, and/or not eligible for surgery, * potentially eligible for tricuspid transcatheter therapy (repair or replacement), without considering purely anatomical criteria related to the valve, * not suffering from refractory heart failure (stage d) requiring heart transplant or dmca (mechanical circulatory assist device), * without cognitive impairment, * not suffering from severe deafness, * speaking and understanding french, * person not under legal protection and not deprived of liberty

Keywords: severe tricuspid regurgitation
effects of customized insoles for individuals with symptomatic hallux valgus

Conditions: Hallux Valgus; Foot Diseases; Foot Deformities

Summary: hallux valgus is one of the most common forefoot deformities. its prevalence increases with age, representing approximately 23% in adulthood, being more common in females. some studies indicate that the use of the insole associated with the finger separator promotes pain relief and that this may be related to better alignment of the hallux. however, there is still no consensus about the ideal insole or how long it should be used to relieve pain or improve function in patients with hallux valgus. therefore, the objective of this study will be to evaluate the effect of the customized insole on pain and function of individuals with symptomatic hallux valgus.

this is a protocol for a randomized, controlled, blinded clinical trial. eighty participants with hallux valgus pain will be evaluated and randomized into two intervention groups (40 per group): customized insole group or sham insole group. assessments will be performed at baseline (t0), after six weeks (t6) and twelve weeks (t12) of insoles use, in addition to the follow-up that will be performed four weeks after the end of the intervention (t16). the primary outcome will be pain, assessed by the numerical pain scale and the secondary outcome will be foot functionality, assessed by the foot function index questionnaire. statistical analysis: for normal data, analysis of variance with a mixed design will be considered, and for non-normal data, the friedman test will be used, in addition to the interaction of time per group and intergroup and intragroup differences. the bonferroni test will be performed in post hoc analyses. intent-to-treat analysis will be used. a significance level of 5% and ci 95% will be adopted for all statistical analyses.

Eligibility criteria:
inclusion criteria: * individuals of both sexes aged over 18 years; * presence of mild to moderate hallux valgus, according to the manchester scale; * presenting no hallux with intensity greater than or equal to 3 points up to 8 points, according to the numerical pain scale (end); * be available to actively use the insole for at least 4 hours/day; * commitment to wear closed shoes, for example (sneakers, shoes used by the patient, due to: wide toe cap and heel height of 2 to 3 cm) during the study. exclusion criteria: * being in physical therapy treatment for hallux valgus concomitantly with the research; * previous hallux valgus surgeries performed in the last 5 years; * presence of foot wounds and wounds, dislocations or metatarsophalangeal fractures in the foot with hv, in the last 5 years * presence of diseases such as rheumatoid arthritis, decompensated diabetes, gout, neurodegenerative diseases; * cognitive and mental disorder being unable to respond; those related to the study

Keywords: hallux valgus insoles pain
a within subject comparison of opioid withdrawal in opioid dependent individuals

Conditions: Opioid Abuse; Opioid Dependence

Summary: buprenorphine is an approved medication for the treatment of opioid dependence. it is typically administered once daily as a sublingual tablet combined with naloxone (i.e., suboxone). evidence suggests buprenorphine produces relatively low levels of physical dependence. in addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. this study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. this study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.


Eligibility criteria:
inclusion criteria: * be adults ranging in age from 21-55 years old. * be dependent on opioids. * be willing to accept or desiring of opioid detoxification. * he healthy as determined by medical screen, history, and vitals. * be without significant psychiatric illness besides drug dependence. * be without chronic pain. * fluent in english (speaking, writing, and reading). * be willing and able to participate. exclusion criteria: * previous documented allergy to buprenorphine or morphine. * are dependent on other drugs besides opioids and tobacco. * have current history of significant use of alcohol or sedative/hypnotics. * have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness. * are pregnant (female volunteers will receive a pregnancy test before participation in the study and routinely during the study). * have an abnormal or prolongation of the corrected qt interval (qtc) on a baseline electrocardiogram (ecg). * are seeking treatment for their substance dependence.

Keywords: opioid pharmacology buprenorphine morphine withdrawal human research
evaluate the effect of tirazamine on primary liver cancer.

Conditions: Hepato Cellular Carcinoma (HCC)

Summary: this phase i/ii trial aims to evaluate the pharmacokinetics, efficacy, and safety of tirapazamine administered via hepatic artery injection followed by tace in patients with intermediate-stage hcc. the trial will compare the outcomes of tate with standard tace.

the clinical trial is bifurcated into two distinct strata. phase one: this stratum is designed to elucidate the pharmacokinetics of tirapazamine, specifically its concentration in peripheral blood, in patients with hepatocellular carcinoma (hcc) subsequent to hepatic arterial infusion of tirapazamine at dosages of 5, 10, and 20 mg/m², culminating in hepatic arterial embolization. a total of approximately 12 patients are slated for enrollment, with 3 to 6 patients allocated to each dosage tier. this constitutes a multicenter, open-label, dose-escalation study. initiation occurs at a tirapazamine dosage of 5 mg/m² (administered to 3 patients), followed by escalation to 10 mg/m² (administered to 3 patients), and culminating at 20 mg/m² (administered to 6 patients). all subjects undergo hepatic arterial infusion of tirapazamine directed towards the tumor vasculature, followed by embolization utilizing a formulation comprising iodized oil, gelatin sponge, and contrast agent (the preparation and application of the embolic agent are delineated in appendix e). phase two: phase two is delineated as a phase ii open-label, randomized, controlled trial that compares the therapeutic outcomes of tate (transarterial tirapazamine embolization) and tace (transarterial chemoembolization) in patients with intermediate-stage primary hepatocellular carcinoma who are candidates for hepatic arterial embolization. this phase may be conducted contemporaneously with phase one. approximately 200 patients will be randomized in a 1:1 ratio to either the experimental arm (group a, tate ) or the control arm (group b, tace ). inter-arm crossover is proscribed.

Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed * age 18-80 years * patient is eligible to do tae or tace treatment. * ecog performance status score 0-1. * child-pugh score 5 - 7 . * no portal vein tumor thrombus, lymph node metastasis, peritoneal tumor seeding, or extrahepatic metastasis. exclusion criteria: * prior liver transplantation * history of liver tumor embolization or radioembolization * uncontrolled hbv or hcv infection * significant cardiovascular, pulmonary, or renal disease * qtc prolongation or use of qtc-prolonging medications

Keywords: tate tace pharmacokinetics hepatocellular carcinoma
ivig treatment in systemic sclerosis

Conditions: Systemic Sclerosis; Diffuse Scleroderma

Summary: the purpose of this research is to study the effects of privigen (intravenous immunoglobulin) on the skin in patients with scleroderma. approximately 24 subjects will take part in this investigator-initiated study at georgetown university hospital and johns hopkins hospital. this study will last for one year (12 months). this research is being done because systemic sclerosis can cause severe, progressive organ involvement. the investigators hope this study treatment will improve the outcomes in this disease, including skin, muscle, joint, gastrointestinal, and lung involvement.

the investigators propose a double-blind controlled trial of 24 patients with privigen® (immune globulin intravenous (human), 10% liquid treatment) with 3:1 randomization. subjects with scleroderma will be given 2 g/kg/mo of privigen® or placebo (albuminar®-5) for 6 months. scleroderma is generally a progressive disease, and while the skin does improve with time in some patients, others have progressive disease in spite of aggressive treatment. also, spontaneous improvement in other organ systems is even less likely. patients entered into the trial will have failed to respond to standard of care treatment over the past 4 months. thus, the investigators feel that any actual improvement observed can be attributed to the ivig treatment. since this is a pilot study, future larger controlled trials will be necessary to clearly demonstrate the effectiveness, but the investigators are hoping that this study will give us signals that will guide the future clinical trial.

Eligibility criteria:
inclusion criteria: * diffuse systemic sclerosis with active skin involvement as defined as a mrss \>12, with no improvement or worsening in the previous 4 months in spite of treatment with methotrexate, cellcept, imuran, or anti-tnf agent; * 18 years of age or older; * disease duration of less than 5 years from the first non-raynaud's symptom of scleroderma. exclusion criteria: * use of more than 10 mg of prednisone, or any dose of cytoxan, d-penicillamine, or rituximab in the last 3 months; * history of deep vein thrombosis (dvt), stroke, or other thromboembolic phenomenon; * history of anaphylaxis or other serious reaction to human blood or blood products. * absolute iga deficiency * a prior receipt of ivig treatment

Keywords: systemic sclerosis diffuse scleroderma ssc
the v-tachogram:decreasing ventricular arrythmias when injecting contrast in the left ventricle

Conditions: Ventricular Arrythmias

Summary: the purpose of this study is to determine if increasing the linear rise rate of injection of x-ray contrast in the heart during left ventriculograms(part of a cardiac catheterization procedure) will decrease the incidence of arrythmias and improve image quality?

the lv angiogram is performed frequently as part of the cardiac catheterization procedure. it is done by injecting a bolus of x-ray contrast into the ventricle through a pigtail catheter over a short period of time and observing the heart as it is pumped out. this provides information on regional wall motion abnormalities, ejection fraction, and mitral regurgitation. a common occurrence when performing a lv angio is frequent pvc's or v-tach during the injection, it has been suggested that ectopic's occurs about 54% of the time and that interpretability was limited 30% of the time(3) this is rarely serious and subsides at the end of the injection but the irregularity of the contractions does affect the diagnostic quality of the exam. in an attempt to decrease the incidence of ventricular ectopic's during the lv angiogram contrast injections with a greater linear rise increasing the injection duration to at least ½ the flow rate, greater than previous settings should decrease the tension and the contrast jets coming out of the catheter, decreasing the fling of the catheter at the initiation of the injection. whether this affects the quality of the angiogram with a pig tail vs. a straight catheter will also need to be considered?

Eligibility criteria:
inclusion criteria: * only ventriculograms that the operator deems necessary for the booked procedure will be considered. only operators agreeing to the for mentioned settings will participate in the study. patients will be randomized consecutively and should conclude in 3 to 4 weeks. exclusion criteria: * patients with aortic valve disease, a-fib, and frequent benign ectopic beats and patients unable to follow instructions to stop breathing will be excluded.

Keywords: arrythmias
effects of peanuts on immunity and cardiometabolic risk factors

Conditions: Immune Response; Cardiometabolic Risk Factors

Summary: the aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors.

the aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors . to accomplish this objective, a human dietary intervention trial (rct) with peanuts is proposed. the proposed study is a 12-week parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial. this study will examine the effects of peanuts on markers of immune function, cardiometabolic markers and risk factors and upper respiratory tract infections, in 80 adult male and female volunteers.

Eligibility criteria:
inclusion criteria: * adults between the ages of 18-70 years exclusion criteria: * known intolerance or allergy to peanuts * bad dentures unable to chew peanuts * regular intake of peanuts and/or other nuts (\>3 ounces/week) * use of immune-boosting supplements * exposure to antibiotics and corticoids immediately prior to the study * use of other medications or supplements that can interfere with the immune functions * individuals that received any vaccination (i.e flu or covid 19) 6 months prior to the start of the study

Keywords: peanuts immunity heart disease
the effect of probiotics on aging population

Conditions: Debility

Summary: this study intends to recruit aging population (over 65 years old). the investigators use 16 srdna sequencing technology, genome sequencing technology, metabonomics, random forest forecast model, analysing and selecting specific age-related intestinal flora. the investigators select probiotics slowing down senility. then the investigators use the probiotics to intervene in the aging population. finally the investigators observe whether the probiotics can delay aging.

this project plans to recruit the aging population (aged over 65 years old) and comprehensively analyze the public database and self-sequencing clinical big data by using 16 srdna sequencing technology, metagenomic sequencing technology, metabonomics methods and random forest (r) prediction model to judge the key bacterial communities and related functional pathways related to aging.based on the analysis results, the probiotics with the potential to alleviate aging were selected for intervention evaluation of aging population. this topic aims to explore the change process of intestinal flora structure and composition related to aging process.identify the key intestinal bacteria genera/species/strains associated with aging, and target the pathway and metabolic characteristic spectrum of the key bacterial communities associated with aging;and select and breed specific intestinal bacterial strains related to aging.the aim is to reduce the age-related metabolic abnormalities and chronic inflammation, reduce medical treatment, rationally allocate medical resources, reduce medical costs and improve the quality of life.

Eligibility criteria:
inclusion criteria: 1. over 65 years old 2. frail scale score above 3 points exclusion criteria: 1. severe impairment of liver and kidney function 2. the tumor is advanced and life expectancy is less than 2 years 3. severe cognitive impairment and inability to cooperate 4. unable to give informed consent 5. have participated in other study before

Keywords: intestinal flora