Kornimate/medical-research-clean huggingface dataset:
a study about how well tak-279 works and its safety in participants with moderate-to-severe plaque psoriasis during 52 weeks of treatment

Conditions: Plaque Psoriasis

Summary: the main aim of this study is to show how well tak-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. participants will be assigned to one of the 3 study treatments (tak-279, apremilast (an approved treatment), or a placebo). participants will be in the study for up to 61 weeks.

the drug being tested in this study is called tak-279. tak-279 is being tested to treat people with moderate to severe plaque psoriasis. the study will enroll approximately 600 patients. participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups in a ratio of 3:1:1 to receive tak-279, placebo, or apremilast which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): 1. tak-279 2. placebo 3. apremilast this multi-center trial will be conducted worldwide. participants will go through a screening process to make sure they meet the rules for taking part in the study. this will take up to 35 days. if participants meet the study rules, they will be treated for up to 52 weeks (1 year). there will be a safety follow-up visit 4 weeks after their last day of treatment.

Eligibility criteria:
inclusion criteria: 1. plaque psoriasis for at least 6 months. 2. moderate to severe disease. 3. candidate for phototherapy or systemic therapy. exclusion criteria: 1. other forms of psoriasis. 2. history of recent infection. 3. prior exposure to tak-279 or active comparator. other protocol defined inclusion/exclusion criteria apply.

Keywords: drug therapy latitude psoriasis 1, latitude research program
xarelto regulatory post-marketing surveillance

Conditions: Venous Thromboembolism

Summary: this study is to identify the following problems and questions with respect to the safety and effectiveness of xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (vte) in a large sample of patients who undergo elective total hip replacement (thr) or total knee replacement (tkr) in the real-life conditions in its registered indication(s) as required by korean food and drug administration (kfda). 1. known and unknown adverse reactions, especially serious adverse reactions 2. incidence of adverse reactions under the routine drug use 3. factors that may affect the safety of the drug 4. factors that may affect the effectiveness of the drug 5. other safety information related to overuse, drug interaction and laboratory abnormalities 6. other adverse reactions


Eligibility criteria:
inclusion criteria: * female and male patients \>/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive xarelto or other pharmacologic standard of care venous thromboembolism (vte) prophylaxis, and who consent to participate in the study exclusion criteria: * patients with hypersensitivity to any pharmacologic vte prophylaxis treatment * patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding) * patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk * pregnant or lactating women * patients with hereditary problems of lactose or galactose intolerance (e.g., the lapp lactase deficiency or glucose-galactose malabsorption)

Keywords: tkr (total knee replacement) thr (total hip replacement) vte (venous thromboembolism) lmwh (low molecular weight heparin) vka (vitamin k antagonist)
trial of high-dose vitamin d in the treatment of complicated severe acute malnutrition

Conditions: Severe Acute Malnutrition

Summary: this double-blind randomized placebo-controlled controlled trial will test the hypothesis that administration of high-dose oral vitamin d supplementation to children in lahore, pakistan, who are recovering from complicated severe acute malnutrition will safely accelerate weight gain (primary outcome) and enhance neurodevelopment, muscle mass accumulation, resolution of systemic inflammation and antimicrobial immune function (secondary outcomes).


Eligibility criteria:
inclusion criteria: * consent of parent / guardian * age 6-59 months at enrolment * diagnosis of complicated sam at the point of hospital admission as defined by the world health organisation. * medical team managing the child has made the decision to discharge the child from inpatient care exclusion criteria: * ingestion of a dose of vitamin d\>200,000 iu (5 mg) in the last 3 months * known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin d hypersensitivity) * known neurodevelopmental disorder (e.g. cerebral palsy) * hiv infection * taking anti-tuberculosis treatment * inability to assess child's developmental status at baseline using the malawi development assessment tool * signs of rickets * corrected serum calcium concentration \>2.65 mmol/l on blood sample taken during the current hospital admission
effect of probiotics on health-related quality of life in college students with upper respiratory infections

Conditions: Upper Respiratory Infection

Summary: the main purpose of the study is to find out if probiotics (healthy bacteria found in yogurt) can improve the health-related quality of life (hrql) during upper respiratory infections (like the common cold) in college students living in residence hall on-campus at framingham state university (framingham, ma) who are randomized to receive a probiotic or placebo candy daily for 12 weeks. hrql is a subjective measure, defined as the aspects of quality of life (i.e., one's satisfaction with their life) that related specifically to a person's health (for example, ability to carry out normal daily activities). the investigators hypothesize that hrql during uris will be significantly higher in the probiotic groups compared to the placebo group. the proposed study will also seek to address the following secondary objectives: missed school and work days due to a upper respiratory infection.


Eligibility criteria:
inclusion criteria: 1. student at framingham state university (framingham, ma) 2. live in on-campus housing exclusion criteria: 1. their driver's license or state identification card indicated that they were under 18 years of age or over 25 years of age; 2. they experienced chronic perennial allergies (such as, allergies to dust or 3) they were pregnant 4) they had been diagnosed with medical conditions affecting immune function (for example, asthma, chronic fatigue syndrome and human immunodeficiency virus) 5) they had acute pancreatitis, were undergoing treatment for cancer; or, were taking immunosuppressive drugs for an autoimmune disease or post-transplant.

Keywords: health related quality of life functional status
king's invasive aspergillosis study ii

Conditions: Aplastic Anemia; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Bone Marrow Transplantation

Summary: invasive fungal disease (ifd) is an important cause of mortality and morbidity in patients undergoing intensive chemotherapy or transplantation. this current study aims to assess the impact of prophylactically using the broad-spectrum anti-fungal agent posaconazole on the incidence of ifd in high risk patients with aplastic anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia, and allogeneic stem cell transplantation.


Eligibility criteria:
inclusion criteria 1. adult ≥ 18 years 2. patients with aplastic anaemia, mds or aml undergoing: ist; or intensive chemotherapy such as induction chemotherapy; or ric allogeneic hsct 3. able to swallow and retain orally administered medication exclusion criteria 1. refusal or inability to consent 2. autologous hsct 3. contraindicated medications 4. current evidence of ifd diagnosis or treatment 5. enrolled in another study requiring alternative antifungal prophylaxis or treatment 6. women who are pregnant or lactating 7. women who are unable to use and apply with effective contraception without interruption throughout the duration of study drug therapy and not willing to have further pregnancy tests during the course of the study
resistance under the microscope

Conditions: Anxiety

Summary: the purpose of this study is to determine whether lorazepam, which is used to lower preoperative anxiety, also improves postoperative recovery. this study data will also be used for further research aiming to identify vulnerable patients in the day-case surgery setting.

since the early 1980s, the investigators have seen a shift towards day-case surgery. before surgery, many patients have negative feelings about the surgical procedure. these anxieties have various negative effects. to reduce this resistance preoperative administration of an anxiolytic drug is administered, typically a benzodiazepine. the investigators know that benzodiazepines are effective in reducing anxiety, but up to now there is nog good scientific evidence about the effectiveness of lorazepam on the quality of recovery in day-case surgery patients. the ultimate goal of our research project is to identify patients who would benefit from preoperative benzodiazepine administration and who not. identification would substantially contribute to optimal medical decision making.

Eligibility criteria:
inclusion criteria: * patients \> 18 years admitted to the day-case surgery department erasmus mc exclusion criteria: * insufficient command of the dutch language * ophthalmology surgery * extracorporeal shock wave lithotripsy (eswl)-, gastrointestinal endoscopic intervention, botox-, abortion and pain treatment * use of psychopharmaceuticals * contra-indication of lorazepam use

Keywords: quality of life lorazepam anxiety premedication surgery adult patients ambulatory surgical procedures postoperative period
circular polyethylene drape in prevention of surgical site infection: a randomized controlled trial

Conditions: Surgical Wound Infection

Summary: this study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the rate of surgical site infection in patients who undergo open abdomen surgery for gastrointestinal tract.

participants who are determined to undergo open abdomen surgery will be screening for the eligibility first. if eligible and agreed to participate, each participant will be assigned to either the experimental group or control group based on the electronic randomization. the experimental group will use the plastic ring wound retractor, while the control group will use a conventional surgical pad for wound protection method. each participant will be blind to the randomization result because he/she will be under general anesthesia. once the surgery is finished, the patient will be assessed on the surgical wound at postoperative day 1, 7, 14, 30. two groups will be compared for the surgical wound infection rate.

Eligibility criteria:
inclusion criteria: * age older than 18 years or less than 75 years * either elective or emergent surgery for upper gi, small intestine, or colorectal disease * open laparotomy * the patient who agrees to participate in this trial exclusion criteria: * concurrent abdominal wall infection * open conversion from laparoscopy * poor nutritional status, nrs 2002 score 3 * combined hepatobiliary operation * pregnant or breast-feeding state * severe immunosuppression
intraoperative cell salvage and postoperative acidosis

Conditions: Metabolic Acidosis

Summary: metabolic acidosis is a common complication that patients experience in the early postoperative period following cardiac surgery. increasingly, the composition and volume of intravenous fluids administered during surgery have been implicated in the development of postoperative acidosis. intraoperative cell salvage (ics), an autologous blood transfusion technique employed by cardiac/perfusion units to minimize blood loss during surgery, involves the infusion of of one such fluid, 0.9% sodium chloride. the rapid infusion of large volumes of 0.9% sodium chloride has previously been linked with the development of hyperchloraemic acidosis. it was therefore hypothesized that the volume of mechanically salvaged of red blood cells re-infused into patients undergoing heart surgery contributes to the acidosis that occurs in the early postoperative period. to test this, the investigators have designed an observational cohort study to check for correlation between the volume of cell salvaged blood infused during surgery and the severity of postoperative acidosis (which will be assessed using data from routine arterial blood gas samples).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients scheduled for cardiac surgery including both on- and off-pump coronary artery bypass grafting surgery, heart valve surgery, septal surgery, and aortic surgery) * patients must have consented to participate exclusion criteria: * patients under 18 years of age * patients who are unable or unwilling to provide informed consent
patient profiling and provider feedback to reduce adverse drug events

Conditions: Adverse Drug Events

Summary: adverse drug events (ade) present a unique focus for error reduction. computerized provider order entry, with embedded clinical decision support, has great promise in reducing medication errors but preventable adverse drug events may still occur despite such systems.

background: adverse drug events (ade) present a unique focus for error reduction. computerized provider order entry, with embedded clinical decision support, has great promise in reducing medication errors but preventable adverse drug events may still occur despite such systems. objectives: the purpose of the study was to evaluate whether adding medication profiling (by using a retrospective drug utilization review program) to computerized provider order entry with embedded order checks (drug alerts) reduces the incidence of adverse drug events. methods: medication profiles mainly focused on possible drug-drug and drug-disease interactions, with some drug duplications. to do the medication profiles we licensed a proprietary computerized retrospective drug utilization review system. we randomly assigned over 900 patients to usual care or provider feedback. for patients in the latter group, selected providers were contacted by letter with pertinent information; electronic mail was used for follow-up contact. clinical and other relevant data was retrospectively abstracted from the medical records for up to one year from the last medication profile for all patients. this was done by a pharmacist reviewer, using a study-derived instrument, and blinded to patient assignment. ade incidence is the primary outcome of interest, with other outcomes such as ade severity and preventability also assessed. we also developed and implemented provider surveys in pre- and post-profiling periods. status: pre and post survey results published. adjunct study on clinical actions as a result of drug alerts published. main study (profiling): manuscript in proces.

Eligibility criteria:
inclusion criteria: * patient must be alive * patient must be currently active in gla system * medication for which alert was generated must be currently active * patient provider must not be peter glassman exclusion criteria:
x-ray follow-up in proximal humeral fractures conservatively treated

Conditions: Shoulder Fractures

Summary: randomly assign patients with fractures of the proximal humerus to conservative treatment to a group in which a control radiological study will be carried out after a week of evolution of the fracture and to another group in which this control radiology will not be carried out. in the evolutionary controls, it will be determined whether there are differences between the two groups in the final functional result, in the perception of quality of life, and in the number of complications derived from the fracture.


Eligibility criteria:
inclusion criteria: * patients\> 18 yo and \< 85 yo * fractures of the proximal humerus \<3 weeks of evolution. * fractures treated conservatively. * no previous pathology of the affected shoulder. exclusion criteria: * dementia * impossibility of carrying out a rehabilitation guideline.

Keywords: proximal humeral fractures conservative treatment outcomes
observational sir-spheres study for the treatment of unresectable liver tumors (sirtain registry)

Conditions: Unresectable Hepatocellular Carcinoma (HCC); Liver Metastases From Colorectal Cancer (mCRC)

Summary: this registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of sir-spheres in patients diagnosed with unresectable hcc or unresectable liver metastases from mcrc refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of sir-spheres

this is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable hcc or unresectable liver metastases from mcrc refractory to or intolerant to chemotherapy who have been prescribed sirt with sir-spheres per medical decision. the study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.

Eligibility criteria:
inclusion criteria: * age 18 years or older * confirmed diagnosis of: * unresectable hepatocellular carcinoma (hcc) or * unresectable liver metastases from colorectal cancer (mcrc) refractory to or intolerant to chemotherapy * identified as a candidate for sir-spheres treatment as deemed appropriate during the normal course of practice * planned to receive sir-spheres treatment to the liver for the first time * provision of signed patient informed consent exclusion criteria: * prior radiation treatment to the liver caveat: sequential selective internal radiation therapy (sirt) treatment is allowed * patients participating in any interventional clinical trial with an investigational product, device, or procedure * need for surrogate consent. patients who are not able to consent on behalf of themselves are not eligible.

Keywords: liver metastases from colorectal cancer (mcrc) unresectable hepatocellular carcinoma (hcc) sir-spheres microspheres y-90 resin microspheres sirt
evaluation of the relationship between healthy eating and intrinsic capacity in elderly individuals

Conditions: Healthy Eating Index; Muscle Strain; Frailty

Summary: the aim of this study is to evaluate the relationship between intrinsic capacity and healthy eating in elderly individuals.

the relationship between the healthy eating index and intrinsic capacity in elderly individuals is unknown. the aim of this study is to evaluate the relationship between intrinsic capacity and healthy eating in elderly individuals.

Eligibility criteria:
inclusion criteria: * 65 years and older * those who agreed to participate in the study * orally fed exclusion criteria: * not voluntarily participating in the research * having a serious life-threatening condition (critical illness, hospitalization in the intensive care unit, acute complication) * those who do not have a mental disability that cannot answer the questions (mental retardation, alzheimer's, etc.) * major psychiatric illness * congenital or acquired muscle disease

Keywords: healthy eating intrinsic capacity elderly
the role of immune semaphorins in nafld

Conditions: Non-Alcoholic Fatty Liver Disease; Immune Response; Biomarkers; Liver Fibrosis; Non Alcoholic Steatohepatitis

Summary: to goal is to identify semaphorins that are associated with nafld and to investigate their relationship with variable degrees of steatosis and fibrosis.

nonalcoholic fatty liver disease (nafld) is the most common chronic liver disease associated with systemic changes in immune response. semaphorins were recently recognized as one of the key regulators of immune responses; while some suppress immune cells activation, proliferation, and production of inflammatory cytokines, others stimulate immune responses. we have previously shown that semaphorins are associated with pathogenesis of viral hepatitis and progression of fibrosis. however, their role in nafld is unknown. the hypothesis of this project is that semaphorins are regulators of inflammation in patients with nafld. this study is designed as a prospective, non-interventional study. the main aims are: (1) to analyze serum concentration of semaphorins in patients with nafld; (2) to analyze tissue expression of semaphorins in patients with nafld; (3) to analyze semaphorin gene polymorphisms associated with nafld. semaphorins could be a novel diagnostic and prognostic biomarker as well as targets for immune modulation.

Eligibility criteria:
inclusion criteria: * patients diagnosed with nafld according to current guidelines (aasld, easl) exclusion criteria: * immunosuppression * malignancies * autoimmune diseases * pregnancy * hiv * chronic viral hepatitis * presence of other chronic liver disease (hemochromatosis, wilson's disease, toxic hepatitis, deficiency of alpha-1-antitrypsin, liver autoimmune disease) * consumption of alcohol \> 20 g/day
i vaccin hospitalization of covid-19 patients

Conditions: SARS CoV 2 Infection; COVID-19

Summary: a reallife evaluation of rate of hospitalized patients in intensive care units and in medical units of non -vaccinated patients vs vaccinated patients

transversal national multicenter non interventional on the covid-19 vaccines * period of hospitalization: from january 1st to march 3rd, 2022 * recruitment duration: 37 days * total study duration: 44 days

Eligibility criteria:
inclusion criteria: * male and female ≥ 18 years * confirmed covid-19 patients hospitalized in icu and medical units during the period of the study from january 1st to march 3rd. exclusion criteria: * subjects vaccinated outside tunisia * subjects \<18 years * not confirmed covid-19 * not hospitalized patients

Keywords: covid-19 vaccination hospitalization
the risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users

Conditions: Uncomplicated Peptic Ulcer

Summary: this study is conducted in a cohort of low dose aspirin (asa) users previously ascertained. the aims of the post hoc analyses are: to estimate the incidence of uncomplicated peptic ulcer (upu) in a cohort of low-dose asa for secondary prevention of vascular disease and the relative risk of upu associated with use and discontinuation of use of low dose asa. to estimate the effect of proton pump inhibitors (ppi) on the occurrence of upu among users of low-dose asa for secondary prevention of vascular disease to evaluate the effect of other risk factors on the occurrence of upu among users of low-dose asa for secondary prevention of vascular disease.

the risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users

Eligibility criteria:
inclusion criteria: - patients aged 50-84 years in 2000-2007 with a first prescription of low dose asa ( see study population description) exclusion criteria: - patients aged below age 50 and 85 years and above ( see study population description)

Keywords: uncomplicated peptic ulcer acid-suppressing drugs epidemiology