Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of trivalent influenza vaccine in non-pregnant hiv-infected women

Conditions: Influenza; Human Immunodeficiency Virus

Summary: the overall aim of this project is to evaluate the immunogenicity of tiv vaccination in hiv-infected non-pregnant women in 2013. safety data including solicited local and systemic reactions to the vaccine will also be assessed.

schedule of events visit 1 (enrollment) informed consent form (icf) signed inclusion/ exclusion/ withdrawal criteria medical history targeted physical exam blood draw tiv administered diary card dispensed local/ systematic reactions visit 2: 1 month post enrolment (28-35 days) inclusion/ exclusion/ withdrawal criteria medical history targeted physical exam blood draw diary card collected local/ systematic reactions reviewed

Eligibility criteria:
inclusion criteria: (i) documented to be hiv-1 infected on one assay used in the prevention of mother to child transmission (pmtct)/ other program undertaken within 12 weeks of study enrolment. * able to understand and comply with planned study procedures. * provides written informed consent prior to initiation of study. * not pregnant at time of enrolment (confirmed by urine testing). if pregnant in past year, participant must be at least 6 months post delivery at time of enrolment. * women age ≥ 18 years to \< 39 years. exclusion criteria: * receipt of tiv, other than through the study, during the current and previous two influenza seasons, documented by medical history or record. * receipt of any live licensed vaccine ≤ 28 days or any other vaccine (except for tetanus toxoid vaccine) ≤ 14 days prior to study-vaccine. * receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, unless study approval is obtained. * any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 38 degrees c ≤ 24 hours prior to study entry. * use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or has immunosuppression as a result of an underlying illness or treatment. * long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤ 12 weeks of study entry, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) ≤ 12 weeks before study entry (nasal and topical steroids are allowed). * receipt of immunoglobulin or other blood products (with exception of rho d immune globulin) ≤ 12 weeks prior to enrollment in this study or is scheduled to receive immunoglobulin or other blood products. * receipt of interleukin 2, ifn, gmcsf or other immune mediators ≤ 12 weeks before enrollment. * uncontrolled major psychiatric disorder. * history of a severe adverse reaction to previous tiv. * any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Keywords: influenza human immunodeficiency virus
effect of type-a botulinum toxin in the post-radiosurgical neck contractures

Conditions: Cervical Spasm; Radiotherapy Side Effect; Botulinum Toxin

Summary: the main objective of the study is to estimate the efficiency and to determine the optimal dose of botulinum toxin a, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections. the concerned muscular groups are the sternocleidomastoid (scm), the trapezius muscle and the splenius capitis.


Eligibility criteria:
inclusion criteria: * patients from 18 to 75 years old; * malignant tumor of aerodigestive ways, in forgiveness; * treatment containing the external radiotherapy ended since \> 6 months * life expectancy \> 6 months; * patient complaining from cervical spasms with functional disability; * negative pregnancy test; * women under effective contraception; * patients benefiting from a national insurance scheme; * patient having given a written consent. exclusion criteria: * cervico-facial surgery with reconstruction by pedicled flap * implantable chamber with catheter in the internal jugular vein near the spasm; * muscular, neurological pathology or malformative pulling a disorder of perception of the pain, an amyotrophy, a muscular weakness affecting the cervical axis or the upper limbs; * disorder generalized by the muscular activity (ex myasthenia); * cervical osseous or muscular pathology pulling pains and disability before the beginning of the treatment (cervical degenerative osteoarthritis diagnosed to the cervical radiography, the slipped disc); * previous cervical injection of botulinum toxin ; * local infection at the level of one of the sites proposed for injection; * histories of epilepsy; * patients presenting a hypersensitivity to the botulinum neurotoxin a or in one of its excipients; * patients under anticoagulation therapy, under antibiotic treatment by aminoglycosides or amino 4 quinoline, under myorelaxant treatment or that must undergo an intervention with curarisation; * patients for whom a surgical operation is planned in the zone interested in the treatment * pregnant or breast-feeding women; * patients for whom questionnaires will not be assessable (handicaps of communication, patient not speaking french, etc.).
selva: a phase 3 study evaluating qtorin 3.9% rapamycin anhydrous gel in the treatment of microcystic lymphatic malformations

Conditions: Microcystic Lymphatic Malformation

Summary: selva: a multicenter, phase 3 baseline-controlled study evaluating the safety and efficacy of qtorin 3.9% rapamycin anhydrous gel in the treatment of microcystic lymphatic malformations the main purpose of this study is to assess the change in microcystic lymphatic malformations iga after 24 weeks of treatment with qtorin 3.9% rapamycin anhydrous gel in approximately 40 participants with microcystic lymphatic malformations. efficacy will be evaluated at 24 weeks and patients have the option of continuing on treatment for \>24 weeks.


Eligibility criteria:
key inclusion criteria: * participant must be at least 6 years of age at time of consent * participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation key exclusion criteria: * participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation * participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy * the participant's treatment area is mainly in any wet mucosa or within the orbital rim * participants who are pregnant or planning to become pregnant

Keywords: lymphangioma circumscriptum lymphatic malformation vascular malformation topical sirolimus rapamycin congenital malformation non-infective disorder of lymphatic vessels and lymph nodes
therapeutic effect of tacrolimus in combination with low dose corticosteroid in adult patient with minimal change nephritic syndrome

Conditions: Minimal Change Disease

Summary: the hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.

a pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (prograf cap®) in adult patient with minimal change nephritic syndrome.

Eligibility criteria:
inclusion criteria: * from 18yrs to 80 yrs , man and women * minimal change disease is diagnosed by kidney biopsy * on screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0 * on screening, the patient shows that the serum albumin is below 3.0g/dl * the patient sign on the concent form exclusion criteria: * the patient have experience to take tacrolimus or cyclosporin for 1 month * if it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day * steroid dependent or steroid resistant or frequent relapse case * uncontrolled hypertension * pregnancy or anticipate pregnancy with 6 month * hypersensitivity to tacrolimus or macrolide * acute hepatitis or the level of ast or alt is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dl

Keywords: minimal change disease tacrolimus corticosteroid
gitmo aml/mds-relapse registry study

Conditions: Acute Myeloid Leukaemia; Myelodysplastic Syndrome

Summary: the proposal arises from the increasingly pressing need to have a program of therapy for the prevention of relapse after allogeneic transplantation in patients with acute myeloid leukemia or myelodysplasia, especially if they undergo transplantation with positive minimal residual disease. these therapeutic approaches include molecular target drugs (for example, flt-3 inhibitors when this gene lesion is present) or apoptosis inducers in combination with hypomethylating agents (for example, the combination of venetoclax and azacitidine or decitabine) or adoptive immunotherapy (for example, with infusion of donor lymphocytes). to date, most of these therapeutic approaches are used in the phase of hematological relapse of the disease; less often they are used in the phase of persistence of minimal residual disease at the molecular level or in the phase of loss of molecular chimerism on cd34+ cells, also due to the prescribing constraints of the competent authorities (aifa). it is believed that the collection of the italian experience can provide important information on the use of different therapeutic platforms, in different settings. this information could be the starting point for the design of prospective and multicenter studies to be proposed in the near future.


Eligibility criteria:
inclusion criteria: * all patients with aml and mds who underwent allo-sct from 2015 to 2021, who relapsed and received salvage therapy for the relapse. exclusion criteria: * patients with a diagnosis other than aml and mds transplanted in the same period.
the efficacy of the 7 days tailored therapy as the 1st eradication of h. pylori infection

Conditions: Helicobacter Infection

Summary: to compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on h. pylori culture and antimicrobial susceptibility testing.

as increasing antimicrobial resistance in korea, the effectiveness of empirical helicobacter pylori (h. pylori) therapies have been declined. recently, 10-day sequential therapy was not sufficient to overcome tough situation for h. pylori eradication. thus, in this study, the investigators evaluated the efficacy of h. pylori eradication between a 7 days tailored therapy (7 day ppi based triple therapy, bismuth quadruple therapy or moxifloxacin contained triple therapy) for h. pylori infection based on the results of antibiotics resistance by using h. pylori culture and minimal inhibitory concentration (mic) and the 10 day sequential therapy for the first eradication of h. pylori infection, and the investigators analyzed the prevalence of the antibiotic resistance in the tailored therapy group.

Eligibility criteria:
inclusion criteria: * the patients who proved h. pylori infection following three methods 1. positive rapid urease test (clotest) 2. histologic evidence of h. pylori by modified giemsa staining 3. positive urea breath test * male and female korean adult (aged ≥ 18 years) exclusion criteria: * patients who received eradication therapy for h. pylori infection, previously * h. pylori eradication failure because of poor compliance * the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (ppi) within 2 weeks * advanced gastric cancer or other malignancy * abnormal liver function or liver cirrhosis * abnormal renal function or chronic kidney disease * other severe concurrent diseases * previous allergic reactions to the study drugs * pregnant or lactating women

Keywords: helicobacter pylori tailored therapy eradication
a study for comparison of canagliflozin versus alternative antihyperglycemic treatments on risk of heart failure hospitalization and amputation for participants with type 2 diabetes mellitus and the subpopulation with established cardiovascular disease

Conditions: Diabetes Mellitus, Type 2; Cardiovascular Diseases

Summary: the primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. the date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-april-2013 to 15-may-2017 and outcome data for these participants will be analyzed and reported in this study.


Eligibility criteria:
inclusion criteria: * first exposure to the particular drug(s) in database (index date) * exposure start is between 1 april 2013 and 15 may 2017 * at least 365 days of continuous observation time prior to index * at least 1 condition occurrence of 'type ii diabetes' any time in the prior continuous observation time (which is at least 365 days long) before or on the index date (first exposure to the particular drug(s) in database) for cohort with 'established cardiovascular disease - at least 1 occurrence of 'conditions indicating established cardiovascular disease' on or any time in the prior continuous observation time (which is at least 365 days long) prior to the index date exclusion criteria: - participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study
evaluating the safety and efficacy of sb injection in patients with advanced or metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine efficacy of sb injection in colorectal cancer.

all eligible patients will receive sb injection therapy for 6 cycles (14\~21 days for each cycle). efficacy will be evaluated every 3 cycles.

Eligibility criteria:
inclusion criteria: * age of 18years or over * patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions * life expectancy \>/= 5 months * not available to any of resectable surgery or radiotherapy * patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by 1. absolute neutrophil count \>/= 1.0 x 10\^9/l, platelet count \>/= 75 x 10\^9/l 2. total bilirubin \< 2.0 mg/dl 3. aspartate aminotransferase and/or aspartate aminotransferase \< 5 x upper limit normal 4. creatinine \< 2 x upper limit normal * ecog status 0 to 2 * female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago * patients or their legal representatives who have signed the informed consent form. exclusion criteria: * have inflammatory bowel diseases * have severe diarrhea or ileus * previous total colectomy * have ileostomy * known brain or spinal cord metastases * patients who have received chemotherapy within the previous 4 weeks * patients who have received radiotherapy related tp colorectal cancer within 4weeks * patients who have participated in other clinical study within the previous 4weeks * pregnancy or lactation period * human immunodeficiency virus antibody (+) * have active infection or serious concomitant systemic disorder incompatible with the study * clinically hypertension or diabetes mellitus not well controlled with medication * clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction * presence or history of malignancy other than colorectal cancer within 5years * have severe neurologic or psychological disorder * patients who have history of allergy with this investigational drug(sb injection) * obvious cognitive or physical impairment that would prevent participation
personalised real-time interoperable sepsis monitoring (prism)

Conditions: Sepsis; Abdominal Sepsis; Infections; Clinical Deterioration; Hemodynamic Instability

Summary: the goal of this prospective observational study is to develop and utilize an artificial intelligence (ai) model for the prediction of postoperative sepsis in patients undergoing abdominal surgery. the main questions it aims to answer are: 1. can a remote ai-driven monitoring system accurately predict sepsis risk in postoperative patients? 2. how effectively can this system integrate and analyze multimodal data for early sepsis detection in the surgical ward? participants are equipped with non-invasive ppg-based wearable devices to continuously monitor vital signs and collect high-quality clinical data. this data, along with demographic and laboratory information from the electronic health record (ehr) of the hospital, are used for ai model development and validation.


Eligibility criteria:
inclusion criteria: * patients undergoing elective abdominal surgery. * postoperative admission to the surgical ward. * age 18 years or older, who are able and willing to participate and have given written consent. * on admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high. exclusion criteria: * \<18 years of age known allergy or contraindication to the monitoring devices. * pre-existing conditions that could interfere with the study (e.g., chronic sepsis, immunodeficiency disorders). * day case surgery. * pregnancy. * immediate transfer to icu postoperatively. * patient refusal or unable to give written consent.

Keywords: sepsis surgical ward artificial intelligence decision-support continuous monitoring wearable devices
pain perception with a comfort-ın jet injection and conventional dental injection

Conditions: Pain; Local Infiltration; Anesthesia; Fear; Anxiety; Needle Phobia

Summary: the investigators aimed to compare the effectiveness of the comfort-in system, which is a jet injection type, and infiltrative anesthesia with a traditional injector, and to measure the effect of children's anxiety on the severity of pain.

among the children between the ages of 4 and 10 who were admitted to clinic between 2018-2020, whose clinical and radiographic examinations were completed; patients with deciduous teeth that needed the same dental treatment (filling or amputation) with symmetrical local anesthesia application and positive (3) or definitely positive (4) according to the frankl behavior evaluation scale were included in the study. in study with a split-mouth design, infiltration anesthesia was applied with a conventional dental injector to one of the symmetrical teeth requiring the same treatment, while the comfort-in jet injection system was applied to the other by the same physician. patients were randomized into two grups according to the injection technique. group1: needle-free injection system(comofrt-in) 2:dental injection method. the pain intensity was assessed during anesthesia(pain 1), during treatment(pain 2), at the end of the treatment(pain 3) and on the postoperative 1st day (pain 4)by the specially 7 colors (white, yellow, green, blue, magenta, red, black) using the wong-baker facial expressions and pain grading scale.anxiety levels were recorded using the modified children's dental anxiety scale face version. the data were analyzed by ibm spss statistics 19, the significance level was taken as p \<0.05.the datas were analyzed with a three-way variance method in repeated.

Eligibility criteria:
inclusion criteria: * aged between 4-10 years * having no developmental or systemic disorder or no history of allergy * having "positive" or "definitely positive" cooperation level according to the frankl behavior scale * having sufficient mouth opening * operation only on primary teeth * having decayed teeth that require anesthesia exclusion criteria: * patients younger than four years, older than 10 years, * patients with systemic or developmental disorders * children with an allergy history * 'negative' or 'definitly negative' behavior rating according to the frankl scale * patients whose mouth opening is not sufficient for dental treatment * operating only on permanent teeth * teeth that are beyond the treatment stage * when pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.

Keywords: comfort-in jet injection system needle-free injection dental pain dental anxiety and fear color of pain
effects of perioperative pregabalin for post-craniotomy pain

Conditions: Chronic Postoperative Pain; Headache

Summary: objective: to compare the incidence of chronic pain at 3 months among adults undergoing craniotomy between those received two different doses of pregabalin and those receiving placebo.

hypothesis: perioperative pregabalin will reduce the incidence of chronic post-operative pain, and will reduce the opioid consumption, opioid-related side effects, and hospital length of stay compared with placebo in patients undergoing elective craniotomy. methods: 316 adults (18-65y), asa i-iii, undergoing elective craniotomy will be randomized to receive: 100mg or 150mg pregabalin or placebo once pre-operatively and 50mg or 75mg or placebo twice daily for 14 post-operative days. nrs pain scores, opioid consumption and side effects will be assessed up to 48h, and long-term pain at days 7, 14, 30, and 90. the primary analysis will involve the comparison between the 2 treatment groups together vs. placebo. a stepwise method will be used to evaluate the pairwise comparisons. outcomes: the primary outcome will be the incidence of chronic post-craniotomy pain at 3 mos. important secondary outcomes are: neuropathic component of pain at 3 mos., total opioid consumption in the first 24h, and incidence and severity of opioid-related side effects at days 1, 2 and 7.

Eligibility criteria:
inclusion criteria: * adults, 18 to 65 years (limited to 65 years to lower the risk of over-sedation for elderly patients) * undergoing elective craniotomy (supratentorial or infratentorial) under general anaesthesia for: biopsy or resection of a tumour, clipping of an unruptured aneurysm, or excision of an arteriovenous malformation * asa physical status i-iii exclusion criteria: * predicted need for prolonged post-operative ventilation (\> 12 hours) * chronic pain secondary to previous craniotomy * known adverse reaction to drugs used (gabapentin, pregabalin, hydromorphone, and/or acetaminophen) * prior use of pregabalin or gabapentin (within 2 weeks before surgery) * current history of moderate to severe headaches (nrs ≥ 4) related to intracranial pathology (tumour pain) since it may be difficult to discriminate between ongoing tumour pain and surgery-related post-operative pain * current history of migraines * pre-existing chronic pain requiring chronic opioid use (30mg morphine equivalent within 4 weeks of surgery) * currently taking any drug that could interact with pregabalin * current history of alcohol or recreational drug abuse * known or suspected addiction to narcotic substances or chronic narcotic use in the last 2 weeks * history of malignant hyperthermia (contraindicates the anaesthesia protocol of this study) * history of angioedema * body mass index ≤ 18.4 or ≥ 35 * history of untreated obstructive sleep apnea * any condition that would contraindicate the use of patient-controlled analgesia (pca) * lacks fluency in english * pre-existing renal impairment (for pregabalin elimination) * pregnancy

Keywords: post-craniotomy pain pregabalin chronic post-craniotomy headache craniotomy