Kornimate/medical-research-clean huggingface dataset:
evaluation of full versus fractional dose of covid-19 vaccine given as a booster for the prevention of covid-19 in adults in mongolia.

Conditions: COVID-19

Summary: this clinical trial is a single-blind, randomised study to determine the reactogenicity and immunogenicity of severe acute respiratory syndrome-coronavirus-2 (sars-cov-2) vaccine (pfizer-biontech) as booster dose in adults, who have previously received either sinopharm (bbibp-corv®), astrazeneca (chadox1-s, or vaxzevria®) or sputnik v (gam-covid-vac®) as their primary doses 6 to 9 months earlier. both standard and fractional doses will be tested. participants are healthy adults aged 18 years or older, with no upper age limit. procedures will be implemented to ensure participants of all ages (aged 18 and above) are included and that there is an even age distribution (\<50 and ≥50 years) in each group. there will be a total of 6 groups (sinopharm-standard dose pfizer, sinopharm-fractional dose pfizer, astrazeneca-standard dose pfizer, astrazeneca-fractional dose pfizer, sputnik - standard dose pfizer, sputnik - fractional dose pfizer), with 200 participants per group for sinopharm and 100 for astrazeneca and sputnik.

as per brief summary

Eligibility criteria:
inclusion criteria: 1. have completed two doses of sinopharm, astrazeneca or sputnik vaccines with the recommended schedule 6 months prior to the date of enrolment 2. willing and able to give written informed consent 3. aged 18 years or above 4. willing to complete the follow-up requirements of the study exclusion criteria: 1. received 3 doses of covid-19 vaccine 2. received 2 doses of covid-19 less than 6 months prior to the start of the trial 3. currently on immunosuppressive medication or anti-cancer chemotherapy 4. hiv infection 5. congenital immune deficiency syndrome 6. has received immunoglobulin or other blood products in the 3 months prior to vaccination 7. study staff and their relatives 8. have a history of a severe allergic reaction to any covid-19 vaccines or have a medical exception to receiving further covid-19 vaccines

Keywords: booster dose pfizer fractional and standard doses covid-19 vaccination mrna vaccine
a comparison of two behavioral sleep interventions among college students (projecttech)

Conditions: Sleep Disturbance; Sleep Hygiene

Summary: the study was a randomized controlled trial designed to examine whether augmenting traditional sleep hygiene and stimulus control procedures with technology use reduction stimulus control procedures would produce better sleep and technology usage outcomes.

sixty college students were randomized to a 4-week sleep hygiene and stimulus control intervention (aci) or an enhanced intervention including technology stimulus control instructions (ti).

Eligibility criteria:
inclusion criteria: * participants must be at least 18 years old, enrolled at oakland university, and reside in an on-campus dormitory to participate. exclusion criteria: * none
to assess the safety, efficacy and tolerability of ckd-519, administered with hmg-coa reductase inhibitors

Conditions: Dyslipidemias

Summary: a multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess the safety and efficacy of the novel cholesteryl ester transfer protein (cetp) inhibitor ckd-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.

the purpose of this study is to assess the safety, efficacy, and tolerability of ckd-519, administered with hmg-coa reductase inhibitors in subjects with dyslipidemia

Eligibility criteria:
inclusion criteria: 1. age 18 to 80 years. 2. dyslipidemia with ldl-c * at screening if untreated: 100 to 190 mg/dl * at screening if treated with statins or other lipid-lowering drugs: 100 to 170 mg/dl * at start of double-blind treatment: 100 to 190 mg/dl. 3. hdl-c \<45 mg/dl (males) or \<50 mg/dl (females). 4. fasting tg \<400 mg/dl. 5. presence of the following conditions is permitted but not mandatory, at the discretion of the investigator: * treated and stable coronary heart disease without acute events in the past 3 months and stable, state-of-the-art medication. * treated and stable carotid artery disease or peripheral arterial disease on stable, standard medication for the past 3 months * treated and stable type 2 diabetes mellitus with glycosylated hemoglobin (hba1c) ≤9.5%. 6. willing and able to sign the informed consent form (icf). exclusion criteria: 1. chronic heart failure as defined by new york heart association classes iii and iv. 2. uncontrolled cardiac arrhythmias. 3. myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before visit 1. 4. stroke or transient ischemic attack within 3 months before visit 1. 5. uncontrolled hypertension. 6. clinically significant laboratory abnormalities * aspartate aminotransferase or alanine aminotransferase \>2 times upper limit of normal range * bilirubin \>1.5 times upper limit of normal range * creatine kinase \>2 times upper limit of normal range. 7. any active nephropathy or estimated glomerular filtration rate \<60 ml/min/1.73m2 or on kidney dialysis. 8. poorly controlled (thyroid-stimulating hormone \[tsh\] \>2 times upper limit of normal) hyperthyroidism. 9. homozygous familial hypercholesterolemia. 10. intolerance or hypersensitivity to atorvastatin or rosuvastatin. 11. prior treatment with any cetp inhibitor. 12. positive for human immunodeficiency virus (hiv) positive, hepatitis b or hepatitis c.

Keywords: dyslipidemia cetp inhibitors hyperlipidemia
a study evaluating the effect of briumvi® (ublituximab) on pregnancy and infant outcomes in participants with multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to compare the prevalence rate of major congenital malformations (mcm) between 2 cohorts of pregnant participants with ms who are exposed to briumvi® and who are unexposed to briumvi®.


Eligibility criteria:
inclusion criteria: 1. for exposed cohort: participant exposed to at least 1 dose of briumvi®. 2. for unexposed cohort: participants not exposed to briumvi® at any time during the pregnancy. 3. diagnosis of ms. 4. currently or recently (within 1 year of pregnancy outcome) pregnant. 5. authorization from healthcare provider to provide data to registry. exclusion criteria: 1. prior to enrollment, participant has exposure to anti-cd20 monoclonal antibodies at any time during pregnancy. 2. occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (vrcc) (retrospectively enrolled). 3. exposure to known teratogens and/or investigational medications during pregnancy.
enhanced recovery after laparoscopic colorectal surgery

Conditions: Rectal Cancer; Postoperative Pain

Summary: investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. investigators hypothesize that spinal anesthesia as an adjunct to general anesthesia will reduce postoperative pain and opioid requirements.

effective pain management after laparoscopic rectal surgery is a fundamental requirement in an enhanced recovery after surgery program (eras). opioids remain the mainstay for postsurgical pain despite well documented side effects including sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression. spinal analgesia as an adjunct to general anesthesia has not been studied in laparoscopic rectal surgery, but data from studies of patients undergoing colon cancer resection indicate a positive analgesic effect of spinal anesthesia as an adjunct to general anesthesia. when an eras program was used for laparoscopic colonic resection, it has been showed that an intrathecal mixture of bupivacaine and morphine was associated with less postoperative opioid consumption. in a more recent paper intrathecal morphine was a more effective method for treating postoperative pain in laparoscopic colon surgery than intravenous opioids within an eras program. in the present proposal the investigators would like to test the effects of spinal anesthesia as an adjunct to general anesthesia in patients undergoing laparoscopic abdominoperineal rectal amputation. it was hypothesized that spinal anesthesia as an adjunct to general anesthesia would reduce postoperative pain and opioid requirements.

Eligibility criteria:
inclusion criteria \*all patients undergoing laparoscopic abdominoperineal rectal amputation for rectal cancer \* age 18-100 years are eligible for enrollment in the study. exclusion criteria * asa iv, * bmi\>35, * contraindication to spinal analgesia * allergy to any of the drugs used in this study protocol, * chronic use of opioids or steroids, * liver or renal impairment, * patients scheduled for synchronous laparoscopic liver metastatic surgery * inability to communicate in norwegian.
a study of erlotinib (tarceva) versus gemcitabine/cisplatin as first-line treatment in patients with non-small cell lung cancer with egfr mutations

Conditions: Non-Small Cell Lung Cancer

Summary: this open-label, randomized, parallel arm study assessed the efficacy and safety of tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage iiib/iv non-small cell lung cancer with epidermal growth factor receptor (egfr) mutations in their tumours. patients were randomized to receive either tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m\^2 intravenously (iv) on days 1 and 8 plus cisplatin 75 mg/m\^2 iv on day 1.


Eligibility criteria:
inclusion criteria: * adult participants, ≥ 18 years of age. * locally advanced or recurrent (stage iiib) or metastatic (stage iv) non-small cell lung cancer. * presence of epidermal growth factor receptor (egfr) mutations in tumours. * measurable disease according to response evaluation criteria in solid tumors (recist) version 1.1 criteria. * european cooperative oncology group (ecog) performance status ≤ 2. exclusion criteria: * prior exposure to agents directed at the human epidermal receptor (her) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab). * prior chemotherapy or systemic anti-neoplastic therapy for advanced disease. * lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease. * any inflammatory changes of the surface of the eye. * ≥ grade 2 peripheral neuropathy. * history of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer. * brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months. * human immunodeficiency virus (hiv) infection. * pregnant, nursing, or lactating women.
effects of modified precision functional sphincter-preserving surgery (pps) on ultralow rectal cancer

Conditions: Rectum Cancer; Stoma Colostomy; Faecal Incontinence; Leakage, Anastomotic

Summary: rationale: colorectal cancer is one of the most common cancers. however, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer. purpose: this one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified pps and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified pps surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.


Eligibility criteria:
inclusion criteria: 1. histological proof of newly diagnosed primary adenocarcinoma of the rectum 2. the lower edge of tumor \< 3 cm from the dentate line 3. clinical t stage ≤ t3 exclusion criteria: 1. the lower edge of tumor \< 1 cm from the dentate line 2. locally advanced stage of tumor 3. presence of metastatic disease or recurrent rectal tumor 4. concomitant malignancies 5. concurrent uncontrolled medical conditions 6. impaired anal function before surgery 7. presence of acute bowel obstruction or bowel perforation caused by cancer 8. pregnancy or breast feeding
long-term treatment of collagenous colitis with budesonide

Conditions: Collagenous Colitis

Summary: the aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. all patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. the end poit is effect on clinical symptoms (number of daily stools)


Eligibility criteria:
inclusion criteria: * histological criteria of collagenous colitis * clinical activity (\> 3 stools/day) exclusion criteria: * treatment of collagenous colitis within the last 3 months

Keywords: collagenous colitis budesonide treatment diarrhea
study of int-747 as monotherapy in participants with primary biliary cirrhosis (pbc)

Conditions: Liver Cirrhosis, Biliary

Summary: the primary hypothesis was that obeticholic acid (oca) will cause a reduction in alkaline phosphatase levels in pbc participants, over a 12-week treatment period, as compared to placebo.

the study included 2 phases: a 3-month randomized, double-blind (db), placebo-controlled, parallel group phase, followed by a long-term safety extension (ltse). the planned duration of the ltse phase was country-specific, ranging from 108 months to indefinitely. on-site visits occurred at least every 6 months. following completion of the 3-month db phase, participants who continued to meet protocol requirements were given the opportunity to enroll in the ltse phase of the study at selected study sites. the participants who enrolled in the ltse phase started oca administration, from a starting dose (10 or 50 milligrams \[mg\]) based on the dose of oca or placebo received in the db phase or on the timing of entry into the ltse phase. because the ltse phase was not planned in the original study design, participants had varied gaps between the end of the db phase and the start of the ltse phase. moreover, some participants initiated ursodeoxycholic acid during the course of that break.

Eligibility criteria:
inclusion criteria: * female participants must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use 1 effective method of contraception with all sexual partners during the study and for 14 days after the end of dosing. * male participants must be prepared to use 1 effective method of contraception with all sexual partners during the study during the study unless they had a prior vasectomy. * proven or likely pbc, as demonstrated by the participant presenting with at least 2 of the following 3 diagnostic factors: * history of increased alkaline phosphatase (alp) levels for at least 6 months; * positive antimitochondrial antibody titer (\>1:40 titer on immunofluorescence or m2 positive by enzyme-linked immunosorbent assay) or pbc-specific antinuclear antibodies (antinuclear dot and nuclear rim positive); * liver biopsy consistent with pbc * screening alp level between 1.5 and 10 × upper limit of normal (uln). exclusion criteria: * administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid, colchicine, methotrexate, azathioprine, or systemic corticosteroids. * screening conjugated (direct) bilirubin \>2 × uln. * screening alanine aminotransferase or aspartate aminotransferase \>5 × uln. * screening serum creatinine \>133 micromoles/liter (1.5 mg/deciliter). history or presence of hepatic decompensation (for example, variceal bleeds, encephalopathy, or poorly controlled ascites). * history or presence of other concomitant liver diseases including hepatitis due to hepatitis b or c virus infection, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis. * pregnancy.
complications related to transpulmonary thermodilution

Conditions: Critical Illness; Hemodynamic Instability; Septic Shock; Acute Respiratory Distress Syndrome

Summary: the transpulmonary thermodilution is commonly used in patients with acute circulatory failure in the intensive care unit and for monitoring surgical patients at high risk. however, the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution has not been completely reported yet.

transpulmonary thermodilution (tptd) is a technique used for haemodynamic monitoring. it consists of a monitor device which is connected to two catheters. one is a catheter inserted into the superior vena cava (internal jugular or subclavian), which is a standard catheter commonly used in patients with acute circulatory failure. the other one is a thermistor-tipped arterial catheter, which is inserted through the femoral route (the tip stands in the iliac artery), which allows the measurement of blood temperature. catheters designed for the radial, brachial and humeral arteries also exist. tptd allows the computation of cardiac output from the thermodilution curve recorded by the thermistor-tipped femoral arterial catheter. as an advanced cardiac output monitoring technique, it provides several important haemodynamic variables. it can be used in the intensive care unit (icu) and in the operating room (or). two tptd systems are now on the market. the picco2 system (pulsion medical systems, member of the getinge group, feldkirchen, germany) and the volumeview/ev1000 system (edwards lifesciences, irvine, united states of america). this study is designed to investigate the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * monitoring by a tptd system (picco2 or volumeview/ev1000) already planned or set up exclusion criteria: * none

Keywords: hemodynamic monitoring transpulmonary thermodilution intensive care unite operating room complications of catheters
comparison of tiva (total intravenous anesthesia) and tiva plus palonosetron in preventing postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: a total intravenous anesthesia (tiva) is a useful anesthetic technique that reduces the incidence of postoperative nausea and vomiting (ponv). investigator hypothesized the incidence of ponv can be further reduced when palonosetron is added to tiva.


Eligibility criteria:
inclusion criteria: * asa physical status 1 or 2 * elective gynaecological laparoscopic surgery of ≥ 1h duration exclusion criteria: * anti-emetics, steroids, or psychoactive medications within 24 h of study initiation * vomiting or retching in the 24 h preceding surgery * cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry * ongoing vomiting from gastrointestinal disease

Keywords: palonosetron ponv(postoperative nausea and vomiting) tiva(total intravenous anesthesia)
digital sleep optimization for brain health outcomes in older surgical patients

Conditions: Insomnia; Postoperative Delirium; Delayed Neurocognitive Recovery; Postoperative Neurocognitive Disorder

Summary: the sleep optimization for brain health outcomes in older surgical patients (sleep-boost) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (cbt-i) mobile application paired with a wearable device (wrist actigraphy).

cbt-i is the frontline treatment for insomnia but is not considered for preoperative care of older surgical patients with insomnia who are at risk of perioperative neurocognitive disorders associated with sleep/circadian dysfunction. we propose to determine if digital cbt-i (dcbt-i) is feasible for treating older surgical patients with insomnia symptoms and to examine the effects of dcbt-i on sleep, cognitive trajectory, mood, pain, activity, and function after surgery. the sleep optimization for brain health outcomes in older surgical patients (sleep-boost) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cbt-i mobile application paired with a wearable device (wrist actigraphy).

Eligibility criteria:
inclusion criteria: 1. adults ≥ 65 years old 2. scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours 3. at least mild insomnia (isi score of ≥10 on telephone screening) 4. stable sleep-affecting medications in the prior month (by clinical review) 5. own a smart phone 6. willingness to use the dcbt-i app and actigraphy. exclusion criteria: 1. current or previous cbt-i 2. rapidly progressive illnesses/life expectancy \<6 months 3. active psychosis/suicidal ideation 4. irregular shift work/sleep patterns 5. moderate-severe sleep apnea (apnea/hypopnea index ≥15) without cpap compliance per chart review 6. sleep disorders other than insomnia or apnea 7. cognitive impairment (diagnosis of dementia)
quadratus lumborum type 2 as chronic hip pain treatment

Conditions: Hip Arthropathy; Chronic Hip Pain; Ultrasound Therapy; Complications

Summary: the main objective of the study is to assess whether the performance of type 2 quadratus lumborum block produces an improvement in the quality of life of the patient with osteoarthritis of the hip.

the quadratus lumborum block is an interfascial block of the posterior wall of the abdomen, initially described for the management of postoperative pain in abdominal surgery due to its suggested effect on the t7-11 roots. the analgesic efficacy of type 1 quadratus lumborum block (ql1) in hip surgery was subsequently published. regarding chronic pain, ql2 has been successfully performed in posttherniorrhaphy pain or pancreatic cancer. this quadratus lumborum type 2 or posterior, is performed in the patients with hip joint based on the innervation of the hip and taking the role of thoraco-lumbar fascia in the analgesia of these patients as a reference. the good results obtained in the first 5 patients have led us to evaluate whether this blockade can indeed be an analgesic alternative in patients with coxarthrosis.

Eligibility criteria:
inclusion criteria: * sign informed consent (annex 2) * age 18-85 years * cartilage injury (coxarthrosis) hip * illness \<1 year of evolution * patients with pain after treatment with physical therapy, exercises, nsaids. * evn\> 5 exclusion criteria: * refusal of the patient * allergy to the drugs used * contraindication for performing the technique * intraarticular treatment in the previous 3 months * pregnancy

Keywords: chronic hip pain ultrasound therapy