Kornimate/medical-research-clean huggingface dataset:
study on liprimar (atorvastatin) in patients with coronary heart disease (chd) and high risk of cardiovascular complications

Conditions: Cardiovascular Diseases; Coronary Artery Disease

Summary: in which chd patients with high risk of cv complications are different doses of liprimar used? for this purpose, data on hyperlipidemia will be elicited over and above the basic nosographic and demographic data, concomitant diseases and cardiovascular risk factor.


Eligibility criteria:
inclusion criteria: * patients, who eligible to sign informed consent; * patients with indications to lipid lowing therapy, according to local product document. * patients with chd and high risk of cv complications (diabetes mellitus ii, myocardial infarction, heart failure, arterial hypertension, ets) will be included into study; * patients with ldl levels: \> 3,5 mmol/l exclusion criteria: * individual intolerance of atorvastatin, in accordance to local product document.

Keywords: coronary artery disease hyperlipidemia atorvastatin
a trial comparing adjuvant oral uft/lv to 5-fu/l-lv in stage iii colorectal cancer (jcog-0205-mf)

Conditions: Colorectal Neoplasms

Summary: to evaluate the clinical effectiveness of oral uft/lv comparing 5-fu/l-lv as adjuvant therapy for stage iii colorectal cancer.

oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in japan. in order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, uft+lv, to the standard intravenous combination chemotherapy, 5-fu+l-lv, in stage iii colorectal cancer. uft+lv: uft 300mg/m2/day and lv 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks. 5-fu+l-lv: 5-fu 500mg/m2, l-lv 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks. primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.

Eligibility criteria:
inclusion criteria: 1. pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma). 2. tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum. 3. stage iii cancer by general rules for clinical and pathological studies on cancer of the colon, rectum and anus (6th ed.), excluding si(ai), n(-), m(-). 4. no synchronous colorectal cancer which invade muscularis propria or deeper. 5. tumor resection with d2 or d3 lymph node dissection was performed. 6. pathological determination of curability of tumor resection is cur a. 7. age at registration is above 20 and below 75 years old. 8. ecog performance status is 0 or 1. 9. no prior chemotherapy or radiation therapy. 10. intake of normal diet and oral drugs is possible. 11. major organ function is preserved. wbc\>=3,000/mcl, plt\>=100,000/mcl, got\<=100 iu/l, gpt\<=100 iu/l, t.bil \<=2.0 mg/dl, cr\<=1.5 mg/dl 12. adjuvant chemotherapy can be started within 9 weeks after surgery. 13. written informed consent is taken. exclusion criteria: 1. active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). carcinoma in situ is eligible. 2. severe postoperative complications which do not resolve until registration. 3. there is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema 4. pregnant or breast-feeding woman. 5. difficult to participate with the trial, having mental disorder or psychiatric symptoms. 6. judged to be inappropriate to register.

Keywords: adjuvant chemotherapy stage iii colorectal cancer 5-fu+l-lv uft+lv randomized controlled trial
covid-19 aerosol in egd using a droplet reduction mouthpiece

Conditions: Droplet Spread; Covid19

Summary: measurement of aerosolisation during esophagogastroduodenoscopy (egd) to compare two types of mouthpieces, conventional versus a new and commercially available one 'the droplet reduction mouthpiece b1'. this new mouthpiece is considered to reduce droplet spreading during egd and therefore could be a good option for use in covid-19 positive patients.

during esophagogastroduodenoscopy (egd), a hard-plastic mouthpiece is used to protect the endoscope from being bitten and to enable its smooth insertion. in september 2020, the droplet reduction mouthpiece "b1" (mouthpiece mpc-st gmdn:62534 generic name: endoscopic bite block, basic, reusable) was launched by fujifilm corporation, tokyo, japan and imported to europe by fujifilm europe. the droplet reduction mouthpiece is used in the same way as the conventional mouthpiece but differs from current mouthpieces by the inclusion of a sponge rubber incorporated into the mouthpiece orifice, and a drape shield specifically created to catch and reduce the droplets emitted by the patient during upper gastrointestinal endoscopy. this newly developed mouthpiece is considered for application during routine endoscopy at our facility during the covid-19 pandemic, helping to minimize the risk to health care workers and patients from becoming infected with covid-19 and various other pathogens. however, there is a lack of scientific evidence on the amount of aerosol reduction with the modified mouthpiece when upper gastrointestinal (gi) endoscopy is being performed. the aim of the present study is to quantify the generation of aerosols when performing upper gi endoscopy with the modified mouthpiece. the investigators intend to quantify the number of particles in the air near the patient. the duration of therapeutic upper gastrointestinal endoscopies can vary extremely. to avoid risk of imbalance in procedure durations, the investigational team is limiting the protocol to standard diagnostic egds. the investigators assume that aerosol generations during short procedures can be extrapolated to longer procedures and hence this should not invalidate the findings

Eligibility criteria:
inclusion criteria: * aged \>18 years old; * male or female patients; * patients undergoing elective standard diagnostic egd; * negative polymerase chain reaction (pcr) test on nasopharyngeal swab 24 or 48 hours prior to the test; * no anatomical deformity of nose and throat, no known diseases of nose and throat; * signed informed consent exclusion criteria: * females who are pregnant or lactating.

Keywords: droplet reduction mask covid-19 upper gi endoscopy
echinacea versus placebo effect in common cold (physician echinacea placebo)

Conditions: Common Cold

Summary: the design and interpretation of randomized trials is intimately connected to the use of "placebo". the nature and magnitude of placebo effects, however, is very poorly understood. this study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. the goal of this study is to assess two kinds of placebo affects and how physician interaction effects; 1. the effect of receiving blinded placebo, compared to no treatment; and 2. the effect of receiving open-label active echinacea treatment compared to blinded active treatment.

as per brief summary

Eligibility criteria:
inclusion criteria: * suspected or known cold * at least one of the following cold symptoms: nasal discharge, nasal congestion, sneezing, or sore throat * enrolled in school, for children 12 to 17 years of age exclusion criteria: * pregnancy; * symptom duration \> 36 hrs * concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines; * anticipated need for symptom-relieving meds during cold * autoimmune/deficiency disease * history of allergic rhinitis with current eye itching/sneezing * history of asthma w/current cough/sob * prior study entry * allergy to echinacea

Keywords: head cold common cold echinacea placebo
propofol vs. nasal dexmedetomidine in pediatric agitation and delirium

Conditions: Comparison of the Effects of Propofol and Nasal Dexmedetomidine

Summary: dental pain and anxiety are quite common in pediatric patients. however, due to children's inability to express their fears and lack of knowledge about the procedures to be performed, these symptoms have often been misunderstood and inadequately treated in pediatric settings. children have consistently experienced high rates of emergence anxiety during the recovery process after general anesthesia. emergence anxiety can be harmful to the patient, leading to bleeding at the surgical site, displacement of intravenous catheters, parental anxiety, additional care needs, and delays in hospital discharge. inhalation anesthetics are preferred for pediatric surgeries because they promote faster recovery. however, inhalation anesthetics often lead to a high rate of emergence anxiety, ranging from 25% to 80% depending on the scoring scale used, the child's age, and the type of surgery performed. additional sedative or analgesic drugs, such as midazolam, dexmedetomidine, or propofol, have been used to prevent emergence anxiety. dexmedetomidine is a selective α2-agonist with sedative and analgesic effects, but it can cause mild respiratory depression. numerous studies have shown that intranasal dexmedetomidine is more effective than other adjunctive drugs. it has been found to be beneficial in reducing emergence anxiety during pediatric anesthesia with minimal blood pressure or respiratory depression. however, although intranasal dexmedetomidine initially has relatively rapid absorption, the absorption process may take longer compared to intravenous administration, implying that the child's hemodynamic status is more stable and a longer effective absorption time may have a clinical advantage in preventing emergence anxiety. the aim of this study is to compare and investigate the effectiveness of nasal dexmedetomidine and intravenous propofol applications used to reduce agitation in pediatric cases following extubation in clinical practice.


Eligibility criteria:
inclusion criteria: * asa 1-2 exclusion criteria: * cardiac disease, * psychiatric disease, * coronary artery disease, * long-term sedative drug use, * pulmonary disease, * known allergy to planned drugs
duration of antibiotic treatment of erythema migrans

Conditions: Erythema Chronicum Migrans

Summary: the purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.


Eligibility criteria:
inclusion criteria: * solitary erythema migrans in patients \> 15 years exclusion criteria: * a history of lyme borreliosis in the past * pregnancy or lactation * immunocompromised status * serious adverse event to doxycycline * taking antibiotic with antiborrelial activity within 10 days * multiple erythema migrans or extracutaneous manifestations of lyme borreliosis

Keywords: erythema migrans lyme borreliosis doxycycline treatment outcome subjective symptoms
posterior tibial nerve stimulation's effectiveness in ui frequency in overactive patients in home

Conditions: Overactive Bladder

Summary: this pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with ui. subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of ui episodes and oab quality of life.


Eligibility criteria:
inclusion criteria: 1. females 2. 55-100 years old 3. have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary) 4. have self-reported bladder symptoms of more than 3 months 5. are ambulatory and able to use the toilet independently 6. have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment or on a stable dose for the prior 3 months 7. patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe) 8. able to provide informed consent 9. capable and willing to follow all study-related procedures exclusion criteria: 1. have primary complaint of stress urinary incontinence 2. have a pacemaker or implantable defibrillator 3. had botox injections in the bladder or pelvic floor muscles in the past 12 months 4. have a current urinary tract or vaginal infection 5. have an active implantable sns device (interstim \& bion) 6. have been diagnosed with peripheral neuropathy or nerve damage 7. currently pregnant 8. deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Keywords: tens
gene therapy for x linked severe combined immunodeficiency

Conditions: Gene Therapy

Summary: a safety and efficacy clinical study of a lentiviral vector to transfer il2rg complementary dna to bone marrow stem cells in ten children with genetic diagnosed x-scid（severe combined immune deficiency ）.the ten children will be followed for 3-5 years and be evaluated by clinical characteristics, vector marking (vector copy number per cell) in blood and bone marrow cells, immune reconstitution vector insertion-site patterns and so on.


Eligibility criteria:
inclusion criteria: 1. x-scid patients diagnosed by il2rg single gene mutation 2. no hla（human leukocyte antigen） matching donor 3. hematopoietic stem cell transplantation failed and the time from transplantation was more than 18 months 4. severe and persistent refractory infections 5. life expectancy of \> : 4 months 6. hiv pcr in peripheral blood was negative 7. the children and their families signed informed consent and were willing to enter the clinical trial and complete follow-up exclusion criteria: 1. the patient has diagnosed with hematological malignant diseases 2. received chemotherapy within 3 months 3. hiv infection or hbv（hepatitis b virus） infection 4. the patient or his first-degree relative has developed a malignant tumor within the age of 18 or has been diagnosed with malignant tumor prone genes 5. although the patient with x-scid was diagnosed as il2rg single gene mutation , the clinical phenotype was not severe, so they could continue to wait for the donor search; 6. patients whose family members have no intention to continue the follow-up treatment in any link

Keywords: gene therapy x linked severe combined immunodeficiency lentiviral vector
validation of new type radiopaque marker in the evaluation of colonic transit time

Conditions: Slow Transit Constipation; Colonic Transit; Chronic Constipation; Colonic Transit Capsule; Radiopaque Marker

Summary: the goal of this clinical trial is to learn if the local made colonic transit capsule can be use to diagnose slow transit constipation. the main questions it aims to answer are: * does the local made colonic transit capsule correlate with the standard colonic capsule in the diagnosis of slow transit constipation? * does the number of remained radiopaque marker similar between the two test after five days of ingestion? researchers will compare the local made colonic capsule with the standard sitzmark colonic capsule to see the correlation. participants will: * take both local made colonic capsule and sitzmark colonic capsule at the same time. * obtain abdominal x-ray 5 days after capsule ingestion. * keep a diary of their symptoms and medication used during investigation.

the accurate diagnosis of constipation subtype is crucial especially in patients refractory to treatment. the current methods are expensive and not widely available. thus, the investigators design the clinical study to evaluate the correlation and diagnostic accuracy of local made colonic transit capsule (siriraj gastrointestinal transit capsule) compare with standard colonic capsule. the patients with constipation and healthy volunteers will be enrolled. participants will be asked to take both sitzmark colonic capsule and siriraj gastrointestinal transit capsule. the two capsules have different shape of radiopaque marker. the abdominal x-ray will be taken 5 days later. the number of radiopaque marker left will be counted separately between the two type of markers. slow transit constipation is defined with retained more than 20% of radiopaque marker at 5 days after ingestion. primary outcome is the correlation in the diagnosis of slow transit constipation and number of remained radiopaque markers between sitzmark colonic capsule and siriraj gastrointestinal transit capsule and the secondary outcome is the diagnostic performance of siriraj gastrointestinal transit capsule in detecting slow transit constipation with sitzmark colonic capsule as standard reference.

Eligibility criteria:
inclusion criteria: * healthy volunteers with normal bowel habit not meet the criteria for functional constipation and irritable bowel syndrome with constipation according to rome iv criteria * participants with constipation according to rome iv criteria exclusion criteria: * previous abdominal surgery * participants at risk for intestinal obstruction such as endometriosis, history of intra-abdominal infection * receive medication which affect colonic transit such as opioids * pregnancy

Keywords: chronic constipation slow transit constipation colonic transit colonic transit capsule radiopaque marker diagnostic accuracy
acute hyperbaric oxygen treatment increases hepatic insulin sensitivity and muscle reactive oxygen species in t2d

Conditions: Type 2-diabetes

Summary: diabetes mellitus type 2 (t2d) is characterized by insulin resistance of liver and skeletal muscle, which is at least partly due to impaired muscle mitochondrial function. long-term hbo therapy, as applied for treating the diabetic foot syndrome, has been shown to improve blood glucose concentrations. to study the underlying mechanisms, we want to examin the short-term effect of hbo treatment on insulin sensitivity and mitochondrial oxidative capacity and production of reactive oxygen species (ros) in a randomized, double blinded, placebo-controlled cross-over trial.

in total 14 patients are planned. each participant participates in both experimental parts (100% o2 and ambient air). they are examined immediately after each hbo/ ambient air therapy. the allocation is randomized treated every three weeks with 2-hour therapies using pure o2 or indoor air. randomized and double-blinded in a cross-over setting, one group of patients with type 2 diabetes is first treated with hbo therapy and the other group is first treated with room air. here, an ambient pressure of 2.4 atm is built up and then administered for respiration over a total of 90 minutes of pure o2. patients are examined on two consecutive days for each part of the study.on the first day serum samples are taken and a sample is taken from the vastus lateralis muscle. a magnetic resonance spectroscopic examination (mrs) is performed on the patient subsequently. in this case, phosphorus metabolites (absolute quantification of atp, pi) and the atp synthase flow rate (fatp) are determined non-invasively by means of 31p mrs and tg storage (hcl) by means of 1h-mrs. on the next day of the trial patients are treated with hbo therapy or room air. a hyperinsulinemic-euglycemic clamp test (120-300 min) with administration of deuterated glucose (d- \[6,6-2h2\] glucose) (0-120 min) to measure muscular and hepatic insulin resistance will be performed after the end of hbo therapy or room air treatment performed. indirect calorimetry determines energy consumption and substrate selection (lipid and glucose oxidation) in hyperinsulinaemia. after the end of the hbo therapy or room air treatment and 30 minutes after the start of the clamp test, a sample is taken from the vastus lateralis muscle again.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 75 years * type 2 diabetes * hba1c ≥ 6 and ≤ 9% * bmi ≤ 35 kg / m2 exclusion criteria: * treatment with thiazolidinedione in the last 6 months * uncontrolled hyperglycemia (fpg ≥ 240 mg / dl) * vitamin supplement (washing out at least 4 weeks) * patients requiring revascularization * serum crp ≥ 5 mg / dl * previous treatment for hbo therapy * secondary diabets according to ada criteria (type 3 b-h, eg pancreopriver diabetes) * type 4 diabetes (gestational diabetes), pregnancy * poor glycemic control (hba1c\> 9.0%) * hyperlipidemia (low density triglycerides and lipoproteins ≥ double upper reference limit)
voice activated personal assistant for depression among older adults

Conditions: Depression, Anxiety

Summary: participants will use amazon alexa to test a new voice-assisted program for mental health management. the participant will use this program to help with goal setting, reminders, and various other services. the participant may be supported by a caregiver, if available, or by research team member who will serve as a coach for the duration of the study to guide them with using the program. participants will be asked to complete surveys and assessments about their experiences during the 12-week study period. participants will be randomized into two groups: those who receive a guide to help them with utilization of the program to its fullest potential and those who do not receive that guide.

older adults have often been on the fringe of benefiting from technology. however, voice-controlled intelligent personal assistants (vipas; e.g. google home, amazon echo), with their natural interaction style and ease of use, are a simple interface technology that may be useful to older adults with depression in the home setting. the caregiver or coach will be able to schedule and follow the interactions between the older adult and the vipa. the vipas would potentially be able to provide functional, cognitive, and social stimulation as well as improve anti-depressant medication adherence through reminders to older adults. the aim is to evaluate a vipa that was designed to deliver behavioral activation prompts to older adults with depression. through user centered design (ucd), the investigators have adapted the model for remote support with the aid of vipas that provide psychoeducation, as well as features that support social, cognitive, and functional stimulation and reminders. the intervention will be 8 weeks, with a 4-week follow-up. during 8-week intervention, participants will be able to use amazon echo show 8 and the study's vipa program to set goals, reminders, and the like to help with their mood. participants will also be asked to completed associated assessments. if caregivers are involved, they will also be asked to complete assessments.

Eligibility criteria:
inclusion criteria: * adults 65 years or older * english-speaking * elevated depressive symptoms (phq-9 ≥ 10) * have wi-fi access * cognitively intact (montreal cognitive assessment (moca) score ≥17) or inclusion criteria: * adults 18 years or older * english-speaking * provide support to an older adult (65 or older) * have access to wi-fi * demonstrating capacity to consent * cognitively intact (montreal cognitive assessment (moca) score ≥17 if 65 years or older)