Kornimate/medical-research-clean huggingface dataset:
telehealth monitoring in inflammatory bowel disease: effects on medication compliance, self-efficacy, and quality of life

Conditions: Inflammatory Bowel Disease (IBD); Medication Compliance; Quality of Life; Telehealth Monitoring

Summary: this randomized controlled trial aims to evaluate the effect of nurse-led telehealth monitoring on medication adherence, self-efficacy, and quality of life in individuals with inflammatory bowel disease (ibd). the study will be conducted at the ibd outpatient clinic of istanbul university-cerrahpaşa, cerrahpaşa medical faculty. participants will be randomly assigned to either an intervention group receiving a 3-month structured telehealth program (including education, counseling, phone calls, and reminders) or a control group receiving only standard care and an educational booklet. outcomes will be assessed at baseline and after 12 weeks.

this randomized controlled trial aims to assess the impact of a nurse-led telehealth monitoring program on medication adherence, self-efficacy, and quality of life in patients with inflammatory bowel disease (ibd). the study will be conducted at the ibd outpatient clinic, istanbul university-cerrahpaşa, cerrahpaşa medical faculty hospital. participants will be randomly assigned to either an intervention or control group. the intervention group will receive a 12-week structured telehealth program including an educational booklet, video content, a zoom-based group session, biweekly phone calls, and reminder messages. the control group will receive only standard care and the educational booklet, with no additional intervention. assessments will be conducted at baseline (week 0) and at the end of the intervention (week 12) using validated tools: harvey-bradshaw index (hbi), simple clinical colitis activity index (sccai), medication adherence report scale (mars), medtake test, ibd self-efficacy scale, ibd quality of life questionnaire, and ibd distress scale. the effectiveness of the intervention will be determined by comparing pre- and post-intervention outcomes between the two groups.

Eligibility criteria:
inclusion criteria: * individuals aged 18 years or older * individuals aged 18 years or older * able to read and write in turkish * diagnosed with inflammatory bowel disease (ibd) for at least 6 months * in clinical remission (harvey-bradshaw index score \< 5 or simple clinical colitis activity index score \< 3) * able to use a smartphone * have access to an online messaging application (e.g., whatsapp) and a valid e-mail address * capable of downloading and using a mobile or computer-based video conferencing application (e.g., zoom) * willing to participate in the study voluntarily exclusion criteria: * diagnosed with any psychiatric or cognitive disorder * having any condition that impairs communication * pregnant women * patients receiving infusion-based treatment * having an advanced chronic disease

Keywords: inflammatory bowel disease medication compliance self-efficacy quality of life telehealth monitoring crohn&amp;#39;s disease ulcerative colitis
antigen rapid test screening to prevent sars-cov-2 transmission (covid-19) at mass gathering events.

Conditions: Covid19

Summary: to investigate the impact of rapid antigen testing for severe acute respiratory syndrome corona virus-2 (sars-cov-2), the investigators plan to conduct a large trial to assess the impact of using rapid tests to screen people before participating at a mass gathering event, i.e. a music concert. among participants who wish to attend and fulfill the inclusion criteria, half will be offered access to rapid testing and concert (provided the test is negative), and the other half will not. allocation will be by randomisation. a week after the concert both groups will be tested by means of a standard pcr-test.

to investigate the impact of rapid sars-cov-2 antigen testing on the incidence of covid-19, the investigators plan to conduct a large trial to assess the impact of using rapid tests to screen people before participating a mass gathering event, i.e. a music concert. the hypothesis is that screening by means of rapid testing eliminates any increase in risk of covid-19 from attending a mass gathering event. the investigators will recruit individuals aged 18-45 years, who wish to attend a specific concert, have not received vaccination or had covid-19 in the past six months, and are not in any risk group for severe disease. at recruitment, all participants (both concert and no-concert groups) will sign a consent form where they commit to using a contact tracing app, and to allowing the research group to use their data in the norwegian emergency preparedness register (beredt c19). they will also consent to having a covid-19-test (pcr) conducted 6-8 days after the concert date. after placing their payment, they will be randomised to be given access to a music concert (concert group), or not (no-concert group). those who are randomised to the concert group will be tested for sars-cov-2 using a rapid antigen test, shortly before the concert. those who test positive will be excluded from attending the concert and will immediately be offered a pcr-test. all participants will be instructed to stay at home if they have symptoms of covid-19 or are in quarantine. participants who have symptoms or are quarantined at the time of the follow-up test will be offered a test through home visit by a mobile clinic. infection control measures will be applied to all concert participants in line with standards established by the sector, e.g. hand hygiene measures and a logistical system that seeks to minimise the risk of transmission during entry to the arena and exit after the concert

Eligibility criteria:
inclusion criteria: * aged 18-45 years * willingness to be randomised and to have a pcr-test taken a week after mass gathering event (both intervention and control groups) exclusion criteria: * vaccinated for covid-19 * having tested positive for sars-cov-2 the last 6 months * risk factors for severe covid-19

Keywords: covid-19 infection control rapid test
comparison of efficacy of less invasive surfactant treatment under nasal cpap and nasal ippv

Conditions: Respiratory Distress Syndrome

Summary: non invasive ventilation is important in the care of preterm infants with respiratory failure, and surfactant treatment can be use with non invasive ventilation. however, there is no consensus on the best non-invasive ventilation mode for surfactant treatment in preterm infants. objective: to compare the effectiveness of nasal intermittent positive pressure ventilation (nippv) versus nasal continuous positive airway pressure (cpap) in preterm infants ≤ 29 week gestational age.

this curlispap study was a multicenter, randomized controlled study at six level iii neonatal intensive care units (nicus) in turkey. the protocol was approved by the ethics committee of each participating centre and turkish ministry of health, turkish medicines and medical devices agency. non invasive ventilated preterm infants with respiratory distress syndrome and gestational age from 241/7 weeks to 296/7 weeks were enrolled within 6 h of birth. infants with major congenital malformations, need of mechanical ventiation, need of entubation in delivery room and lack of parental consent were excluded. enrolled infants will randomize into two study groups (nippv group and cpap group). the short binasal prongs will use as interface. for all the groups, if the fraction of inspired oxygen (fio2) requirement is persistently higher than 0.30 target spo2 90-94%. for all groups surfactant by "lisa" technique and with special catheter (lisacath, chiesi pharmaceutics) of surfactant (curosurf, chiesi pharmaceutics) 200 mg/kg. the primary end-point, need of mechanical ventilation within 72 hours following surfactant treatment, will compared between the groups. short and long-term neonatal outcomes will also evaluate.

Eligibility criteria:
inclusion criteria: * gestational age 24 -29 week * clinical and radiological diagnosis of rds * born in a hospital with a study center * spontaneous breathing * within the first 6 hours * non-invasive ventilation and fio2 requirement \>0.30 * parental concent exclusion criteria: * major congenital malformations * need of mechanical ventiation * need of entubation in delivery room * air weak syndrome * no parental concent

Keywords: ncpap nippv lisa
imatinib in dermatofibrosarcoma protuberans (dfsp)

Conditions: Dermatofibrosarcoma

Summary: the purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (dfsp).

this study is aimed to investigate the efficacy of imatinib (glivec) in the treatment of primary and locally relapsed dermatofibrosarcoma protuberans (dfsp). dfsp is a cutaneous neoplasm well known for its overexpression of the platelet-derived growth factor (pdgf). herein, imatinib provides a systemic treatment option that offers the possibility of a reduction of the wide surgical margins used today in surgery of primary dfsp, or even of a complete avoidance of surgical treatment in this disease. since imatinib exerts its function via interference with protein tyrosine kinase activities, it inhibits the platelet-derived growth factor receptor (pdgf-r) signaling cascade that plays a crucial role in the pathogenesis and tumor growth of dfsp. since imatinib has been shown to shrink metastatic lesions of dfsp, there is a strong rationale to expect that it also decreases cell proliferation and tumor growth in primary dfsp.

Eligibility criteria:
inclusion criteria: * histological diagnosis of primary or recurrent dermatofibrosarcoma protuberans * measurable tumor parameters (by magnetic resonance imaging \[mri\]) * patient \>/= 18 years of age * ecog performance status \< 3 * adequate organ function * patients must be able to swallow capsules * female patients of childbearing potential must have negative pregnancy test * written, voluntary, informed consent; must include investigational use of tumor tissue biopsies. exclusion criteria: * any evidence of distant metastases * patient has received any other investigational agents within 28 days of first day of study drug dosing * patient is \< 5 years free of another primary malignancy except basal cell skin cancer or cervical carcinoma in situ * grade iii/iv cardiac problems as defined by the new york heart association * severe and/or uncontrolled medical disease * known diagnosis of human immunodeficiency virus (hiv) infection

Keywords: dermatofibrosarcoma imatinib tyrosine kinase inhibitor
anticoagulation post laparoscopic splenectomy

Conditions: Portal Vein Thrombosis; Splenic Vein Thrombosis

Summary: splenic/portal vein thrombosis is an alarming complication of splenectomy. retrospective studies in the literature have shown the incidence of symptomatic splenic/portal vein thrombosis to be between 0.7% (rattner et al., 1993) to 8% (winslow et al., 2002). this is a single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy. all participants will receive one dose of pre-operative low molecular weight heparin (lovenox®) subcutaneously, 2 hours prior to surgery. participants will be randomized pre-operatively to treatment or control group however the treatment allocation will not be revealed until the surgery is complete. postoperatively, those assigned to the treatment group will receive 40 mg of lovenox® subcutaneously once a day for 21 days; those in the control group will not. patients with severe renal impairment will receive an adjusted dose of lovenox® (30 mg subcutaneous dose daily). all patients will have a baseline abdominal doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to monitor for the presence of portal vein and/or splenic vein thrombosis. they will also have their lipase and liver function tests checked to correlate with the imaging findings.


Eligibility criteria:
inclusion criteria: * scheduled to undergo laparoscopic splenectomy at the university of alberta or grey nun's community hospitals * capable of understanding the purpose and risks of the study and willing/able to sign a statement of informed consent * willing to undergo daily subcutaneous injections of lovenox® exclusion criteria: * pregnant or nursing * unable or unwilling to provide informed consent * bleeding diathesis or currently on anticoagulation therapy (i.e. coumadin, heparin, lmwh) * hemorrhagic cerebral vascular accident * severe uncontrolled hypertension * diabetic or hemorrhagic retinopathy * contradictions to anticoagulation (i.e. active gi bleed, gastric or duodenal ulcer, sustained platelet count \< 50 x103/ul, splenectomy due to trauma or history of heparin induced thrombocytopenia) * conversion to open splenectomy * allergy to lovenox®, heparin, or other low molecular weight heparins * bacterial endocarditis

Keywords: anticoagulation thrombosis portal vein thrombosis splenic vein thrombosis splenectomy randomized laparoscopic splenectomy lovenox
impact of helicobacter pylori infection on prolactin levels in reproductive-age women to determine whether h. pylori infection is associated with elevated prolactin levels and assess the clinical implications

Conditions: HELICOBACTER PYLORI INFECTIONS; Hyperprolactinaemia

Summary: the research is a cross-sectional observational study conducted at assiut university hospital. it will involve 75 women aged 18-45 with confirmed h. pylori infection. the study will measure serum prolactin levels and h. pylori infection status through stool antigen tests. the primary outcome is comparing prolactin levels between h. pylori-positive and negative women. secondary outcomes include analyzing correlations with clinical symptoms and demographic factors.

study design and setting cross-sectional observational study conducted at assiut university hospital sample size: 75 women participants inclusion criteria: women aged 18-45, confirmed h. pylori infection, reproductive age exclusion criteria: recent antibiotic or ppi use, endocrine disorders, chronic illnesses affecting prolactin data collection participant recruitment from outpatient clinics laboratory assessments: stool antigen test for h. pylori using elisa method serum prolactin measurement via chemiluminescent immunoassay questionnaire for demographic information and medical history outcome measures primary: serum prolactin levels in h. pylori-positive vs. negative women secondary: correlation with clinical symptoms and demographic factors analysis the study will compare prolactin levels between h. pylori-positive and negative groups, analyze correlations with symptoms, and assess the influence of demographic factors on prolactin levels and h. pylori prevalence.

Eligibility criteria:
inclusion criteria: - 1. age range: women aged 18 to 45 years. 2. diagnosis of h. pylori infection: participants must have a confirmed diagnosis of h. pylori infection through non-invasive methods such as stool antigen tests or breath tests and igm serum. 3. reproductive age: women must be within reproductive age and not currently pregnant or breastfeeding exclusion criteria: * 1. recent antibiotic use: individuals who have taken antibiotics within the last month will be excluded to avoid interference with h. pylori detection. 2. use of proton pump inhibitors (ppis): patients using ppis or other medications that affect gastric acid secretion within the last month will be excluded. 3. endocrine disorders: women with known endocrine disorders such as hyperprolactinemia from other causes will be excluded. 4. chronic illnesses: individuals with chronic illnesses that could affect prolactin levels (e.g., renal failure, liver disease) will also be excluded.

Keywords: h.pylori prolactin level hyperprolactinemia
initiation of allopurinol at first medical contact for acute attacks of gout

Conditions: Gout; Gout Acute

Summary: medical teaching suggests allopurinol should not be initiated in the setting of an acute attack of gout, as rapid lowering of serum urate may exacerbate the attack. this study tests the hypothesis that there is no difference in patient reported daily pain or flair occurrences with early versus delayed institution of allopurinol during an acute gout attack.

design: randomized, placebo-controlled, double-blind trial. setting: outpatient clinics, white river junction veterans affairs medical center. patients: 57 men with crystal proven acute gout attack, at first medical contact, and within 7 days onset. intervention: subjects were randomized to receive allopurinol 300mg daily or matching placebo for 10 days. all patients received indomethacin 50mg tid for 10 days, prophylactic dose colchicine 0.6mg bid for 90 days, and open-label allopurinol starting at day 11. measurements: primary outcomes were patient reported pain on visual analogue scale (vas) for the primary joint, and self reported flares in any joint days 1-30. secondary endpoints included urate, sedimentation rates, c-reactive protein levels.

Eligibility criteria:
inclusion criteria: * first medical contact for acute attack of gout. * acr criteria for acute attack of gout * crystal proven by arthrocentesis on day of enrollment * primary gout exclusion criteria: * secondary gout * tophaceous gout * prior steroid, colchicine, or uric acid lowering therapy in the past 6 months. * uncontrolled chf * unstable angina * renal insufficiency (entry creat \> 1.3) * anticoagulant therapy * immunosuppressive therapy or chemotherapy in the past 6 months * pregnancy; or * known allergy to nsaid, colchicine, or allopurinol

Keywords: gout allopurinol acute gout
post-marketing surveillance study: 12 to 24 weeks study on the treatment emergent adverse events in patients with type 2 diabetes taking exenatide in korea

Conditions: Diabetes Mellitus Type 2

Summary: the objective of this regulatory post-marketing surveillance in korea is to reconfirm the clinical usefulness of exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about exenatide in general practice.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * male or female at least 18 years of age * patients who are to initiate exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice * patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information exclusion criteria: * are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug * are pregnant or have intentions of becoming pregnant within the duration of the study * contraindications
audiovisual aid pilot study

Conditions: Stress, Psychological

Summary: little is known about perioperative stress responses and possible anxiety mitigating factors like audiovisual aids or iv sedation. most studies use surrogate markers and retrospective questionnaires, and are not based on real-time gathered data. skin conductance measurements allow the sympathetic discharge to be evaluated down to fractions of a second and enable us to continuously monitor stress responses as skin conductance responses/per second during the perioperative management. in our study, the investigators propose to examine the effect of personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia. patients will be randomly assigned to either receive traditional sedation or light sedation in addition to audiovisual equipment. the investigators hope to determine outcome estimates of the use of this equipment on stress levels using skin conductance measurements, request for further sedation, postoperative pain levels and analgesic consumption, time to discharge readiness, and overall patient satisfaction, and collect thus far unavailable data on the stress response to perioperative stresses (such as iv insertion and spinal placement) in order to allow for power analyses for future studies.

please note: after conducting the interim analysis and plotting the skin conductance data, we have determined that the graphs are not consistent enough to draw any conclusions. given the technical difficulties we have encountered with the med-storm stress detector, as well as the labor intensity associated with it, we have decided that we will no longer use it from patient 14 on. we will not mark the time points and hand movements described in the protocol, as this data was used to understand the skin conductance data. we will continue to enroll patients to complete this pilot/exploratory study, as the other secondary outcomes--in particular, the surveys--could provide valuable information.

Eligibility criteria:
inclusion criteria: * patients scheduled for primary, ambulatory, arthroscopic meniscectomy under spinal anesthesia exclusion criteria: * patients with psychiatric disease and those on antidepressants * contraindications to spinal anesthesia or allergy to study medication * age \< 18 years * patients with audiovisual impairments * patients with inability to communicate in english or understand the study requirements * chronic pain patients +/- opioid use * patients with (neuro)dermatoses encompassing the hand * patients with pacemakers * patients with diabetes or known neuropathic disease * patients with a history of epilepsy or seizure disorder * patients with a history of claustrophobia * patients with a history of epilepsy * patients with prior history of epilepsy or seizure disorder * patients undergoing a revision or open procedure

Keywords: audiovisual aids perioperative period anxiety
epoetin alfa (hemax®) phase iv study in chemotherapy induced anemia

Conditions: Antineoplastic Chemotherapy Induced Anemia

Summary: the purpose of this study is to assess safety and efficacy of weekly epoetin alfa (hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin \< 10g/dl) undergoing palliative care chemotherapy.

patients with non curable solid tumors or lymphoma with anemia (hemoglobin \< 10g/dl) undergoing palliative care chemotherapy will enter this 12 week single arm open label study. epoetin alfa 40.000-60.000 iu/week will be administered subcutaneously and controlled every 2 weeks. up or down titration will be performed according to the currently approved prescription guidance for a total of 12 weeks of treatment. study end points will be assessed every 4 weeks until final 12 week visit.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of non curable cancer or lymphoma * receiving a palliative chemotherapy regimen * hemoglobin \< 10.0 g/dl * performance ≤ 3 of eastern cooperative oncology group (ecog) performance status * life expectancy of ≥ 3 months * postmenopausal o premenopausal women receiving effective contraceptive method exclusion criteria: * active bleeding that may have caused anemia in the prior 30 days. * uncontrolled hypertension * anemia for another cause other than cancer or chemotherapy * untreated iron or folic acid deficiency * transfusion in the last 30 days prior to baseline visit * treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit * increased risk of thromboembolic disease * radiotherapy in pelvis or spine in the last 60 days * myelodysplasic syndrome * history of congestive heart failure * pregnant or lactating * patient with known allergy to human albumin or related products

Keywords: chemotherapy anemia epoetin alfa erythropoiesis stimulating agent (esa)