Kornimate/medical-research-clean huggingface dataset:
oseltamivir pharmacokinetics in morbid obesity

Conditions: Morbid Obesity

Summary: this trial asks the question: do people of much greater than average body weight need more of a drug called oseltamivir than current recommendations suggest. oseltamivir is a drug given to people who have influenza, and currently is also being used to fight the new h1n1 influenza. some people of larger than average body weight require larger amounts of drugs to see the same effects as others of an average body weight. no studies have ever been conducted looking at the possibility of oseltamivir being one of those drugs. our study's hypothesis states that those of an above average body weight will have different amounts of drug in their blood than those of people of normal body weight if they are given the normal amount prescribed for influenza. our study will give oseltamivir to twenty people for 7 days. half of the people will be of normal body weight and the others will be of a much higher than normal body weight. using blood samples the investigators will determine if the amounts of oseltamivir are significantly lower in the blood of patients in the above normal body weight group.


Eligibility criteria:
inclusion criteria: * males and females aged 18 to 55 years * written informed consent * subjects without medical history, physical finding or laboratory finding, which, in the opinion of the investigator, could pose a safety concern or interfere with the protocol. exclusion criteria: * allergy to oseltamivir * blood donation within 3 months before oseltamivir administration * medications that may interfere with the disposition of oseltamivir (e.g. probenecid) * anemia * estimated creatinine clearance \< 60 ml/min (as calculated by the modified cockcroft gault equation below) creatinine clearance= (140-age) x 1.2 x adjusted body weight (x 0.85 if female) serum creatinine (umol/l) adjusted body weight = ideal body weight + \[0.4 (actual bodyweight-ideal body weight)\] * gastrectomy * enterectomy (or any other surgical procedure that would interfere with absorption) * clinically significant haematological (rbc count, wbc count, wbc differential count, platelets count and haemoglobin level) or biochemical (alt, ast, creatinine and urea) abnormalities as per the judgement of the investigator * clinically significant cardiac conduction abnormality noted on baseline electrocardiogram. * influenza like illness (fever and/or cough plus one of the following sore throat, fatigue, myalgia, headache) within 7 days of enrolment * pregnancy * inability to consume study meals provided due to special dietary requirements such as food allergies.

Keywords: oseltamivir pharmacokinetics obesity oseltamivir pharmacokinetics in obesity
bullying experiences among alexandria faculty of medicine students

Conditions: Bullying

Summary: a cross-sectional study was conducted at faculty of medicine, alexandria to study the prevalence, types and consequences of bullying among medical students. an online survey was distributed among medical students. the data collection continued for two academic years: 2021-2022 and 2022-2023.

a survey based study was implemented. questionnaire was used to collect sociodemographic data, exposure to different types if bullying, response and consequences of bullying

Eligibility criteria:
inclusion criteria: * medical students enrolled at undergraduate or graduate programs of faculty of medicine who were exposed to bullying exclusion criteria: * medical students who were not exposed to hullying

Keywords: bullying, medical students, learning environment
study to identify if ovr health's vr-kit is safe to use and helps to improve focus, attention and reduce worry & rumination.

Conditions: Anxiety; Depression, Anxiety

Summary: this is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the safety and efficacy of ovr health's vr experience to improve control over the focus of attention and reduce worry and rumination in individuals who have reported problems with these issues.


Eligibility criteria:
inclusion criteria: * male or female over 18 years old * must be in good general health * self-reported with the following symptoms (as assessed by questions and questionnaires in study material): * finding it hard to let go of difficult thoughts. * looking out for signs of a potential threat in their environment (or in their body) that unhelpfully maintains their problem. * engaging in repetitive, unhelpful patterns of negative thinking (worry \& rumination). • these may be due to a diagnosis of a mental health condition, but this is not required for entry into the study. * good understanding of written and spoken english * willing and able to give informed consent * willing and able to follow the study protocol * willing and able to use vr headset at home * wifi connection to connect vr headset at home * willing and able to return vr headset exclusion criteria: * current diagnosis of epilepsy, dementia, or another neurological disease that may prevent the use of vr hardware and software * individuals with suicidal or self-harm thoughts * significant visual, auditory, or balance impairment * insufficient comprehension of english * primary diagnosis of alcohol or substance abuse disorder, or personality disorder • significant learning disability * current active suicidal plans or self-harm (in which case participant will be referred to appropriate crisis service) * receiving current alternative psychotherapy treatment * unwilling to provide consent * unwilling to follow the study protocol

Keywords: virtual reality
efficacy and safety of a dolutegravir-based regimen for the initial management of hiv infected adults in resource-limited settings

Conditions: HIV-1 Infection

Summary: several reports indicate that treatment failure due to hiv resistance or to adverse event-related discontinuation could compromise the effectiveness of scaling-up antiretroviral treatment (art), especially when lack of access to viral load is a concern. combined with other nucleoside reverse transcriptase inhibitor, dolutegravir (dtg) is a very promising alternative to the current first-line non nucleoside reverse transcriptase inhibitor-based regimens. initial evaluations of dtg conducted in high income countries showed excellent efficacy and safety and indicated high genetic barrier thus preserving second line treatment. as a consequence, dtg-based regimens have been recently included in the first-line options in the national guidelines for art of several high-income countries. however, the clinical trials evaluating dtg-based regimens have been conducted in highly controlled conditions, including baseline resistance testing and regular viral load monitoring. moreover, these trials included a high proportion of men with rare co-morbidities. there is need to evaluate how a dtg-based regimen will perform in real-world conditions within resources-constrained settings, where viral load monitoring is limited, and where the majority of hiv patients are women with important family planning consideration and namsal trial is a randomized clinical trial which aims to evaluate efficacy and safety over 48, 96 and 192 weeks of dtg + tenofovir disoproxil fumarate/lamivudine versus efavirenz (efv) + tenofovir disoproxil fumarate/lamivudine in 606 art-naïve hiv-1-infected adults in cameroon. a set of efficacy and safety endpoints will be compared over 48, 96 and 192 weeks between the two arms including the proportion of patients with viral load \<50 copies/ml and incidence of severe adverse events.


Eligibility criteria:
inclusion criteria: * hiv-1 infected * age ≥ 18 years * abtiretroviral-naïve, including above 7 days of cumulative prior antiretroviral therapy at any time prior to study entry. * for women of childbearing potential: acceptance to use effective contraceptive methods * provision of written informed consent exclusion criteria: * infection with hiv-1 group o, n, p * infection or co-infection with hiv-2 * absolute neutrophil count (anc) \< 500 cells/mm3 * hemoglobin \< 7.0 g/dl * platelet count \< 50,000 cells/mm3 * ast and/or alt \> 5 x upper limit of normal (uln) * calculated creatinine clearance \< 50 ml/min * active opportunistic or severe disease not under adequate control * for women of childbearing age : pregnancy/breastfeeding * history or presence of allergy and/or contraindications to the trial drugs or their components * severe psychiatric illness * severe hepatic failure patients co-infected with tuberculosis (tb), receiving a tb treatment and with stable clinical condition will not be excluded.

Keywords: dolutegravir efavirenz-low-dose
enhancing fitness with preoperative exercise in colorectal cancer surgery

Conditions: Colorectal Cancer

Summary: this study examines whether a home-based telephone-guided preoperative exercise programme is feasible and effective in improving cardiorespiratory fitness in patients with colorectal cancer who are high risk due to their existing co-morbidity.

preoperative exercise, also know as prehabilitation, has been shown to improve physical fitness and potentially reduce postoperative complications in patients undergoing surgery. patients are often labelled high risk for surgery due to their existing ill-health e.g. heart and lung disease. high risk patients comprise approximately 12% of all elective cancer cases, but account for 80% of all post-operative mortality. complications significantly affect the quality of life of each crc patient, both in the short and long-term, and can also impact on survival. it is critical that patients who are deemed at high risk of complications are optimised in the preoperative period. exercise in the period before surgery is therefore one potential method of improving high risk patients' physical fitness levels while potentially reducing their risk of postoperative complications and subsequent mortality.

Eligibility criteria:
inclusion criteria: * primary operable colorectal cancer; * awaiting surgery with curative intent; * deemed high risk by the responsible clinical team; * ability to mobilise independently exclusion criteria: * patients with primary or recurrent inoperable colorectal cancer. * patients undergoing preoperative chemo- and/or radiotherapy. * patients who decline or are deemed unfit for operative management. * patients who lack capacity to consent.

Keywords: cancer colorectal exercise physical fitness
early versus late lactoferrin in prevention of neonatal sepsis

Conditions: Neonatal Sepsis

Summary: the present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) lactoferrin administration, secondary aim was to study effect of lactoferrin administration on serum ferritin and follow up long term outcome (bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.

this study was carried out on 180 preterm neonates(\< 37 weeks of gestation counting from the first day of the last menstrual period and confirmed by ballard score) admitted to the neonatal intensive care units of ain shams university hospitals in the period from august 2014 to december 2015. enrolled subjects were further randomly subdivided into three groups according to the dose regimen of lactoferrin supplementation. * group a: (60 preterm neonates) who received oral lactoferrin supplementation in a dose of 100 mg/day starting on day 1 and continue for 4-6 weeks. * group b: (60 preterm neonates) who received oral lactoferrin supplementation in a dose of 100 mg/day starting on day 3 (48hrs-72hrs) of life and continue for 4-6 weeks. * group c: (60 preterm neonates) who match the subjected neonates, received placebo in form of distilled water.

Eligibility criteria:
inclusion criteria: 1. neonates with a \< 37 weeks of gestation counting from the first day of the last menstrual period. 2. preterm neonates are breast fed, artificially fed or on total parenteral nutrition. 3. preterm neonates born in, or referred to our neonatal intensive care unit in the first day of life free from infection and not fed. exclusion criteria: 1. neonates with underlying gastrointestinal problems that prevent oral intake. 2. neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities). 3. neonates with a family background of cow milk allergy. 4. neonates who will not have the chance to complete the study time (who will be referred to another hospitals). 5. neonates with early onset sepsis. 6. neonates whose parents decline to participate.

Keywords: late onset sepsis bovine lactoferrin
improving outcomes in vascular disease- aortic dissection

Conditions: Type B Aortic Dissection

Summary: the goal of this clinical trial is to determine whether an upfront invasive strategy of tevar plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type b aortic dissection.

the study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type b aortic dissection (utbad). patients with utbad and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. aortic interventions will allowable only as per protocol.

Eligibility criteria:
inclusion criteria: 1. age \> 21 years 2. stanford type b aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity) 3. acuity: within 48 hours - 6 weeks of index admission 4. ability to provide written informed consent and comply with the protocol 5. investigator believes anatomy is suitable for tevar exclusion criteria: 1. ongoing systemic infection 2. pregnant or planning to become pregnant in the next 3 months 3. life expectancy related to non-aortic conditions \< 2 years 4. unwilling or unable to comply with all study procedures including serial imaging follow-up 5. known patient history of genetic aortopathy 6. penetrating aortic ulcer and intramural hematoma 7. iatrogenic (traumatic) aortic dissection 8. prior surgery for aortic dissection

Keywords: tevar
ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee oa (osteoarthritis) who underwent unilateral total knee replacement

Conditions: Knee Osteoarthritis

Summary: post-operative pain following total knee replacement can be disabling and sometimes lead to the need for prolonged hospital stay. therefore development of improved post-operative modalities for total knee replacement surgery pain control is important. high-resolution ultrasound (us) allows accurate visualization of nerves and surrounding structures and can lead to higher success rates of nerve block. the investigators aim at comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia for patients with knee oa who underwent unilateral total knee replacement.


Eligibility criteria:
inclusion criteria: * male / female, bilateral or unilateral knee oa (osteoarthritis), and asa (american society of anesthesiologist classification) 1 and 2. exclusion criteria: * bilateral total knee replacement, revision total knee replacement, previous knee surgery, rheumatoid arthritis, avascular necrosis (avn) knee, post traumatic or post infectious oa, asa3 and 4.

Keywords: comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia
a study to evaluate the long-term efficacy and safety of karxt + karx-ec for agitation in alzheimer's disease (adagio-3)

Conditions: Alzheimer Disease; Agitation

Summary: the purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (ir) capsule (karxt) and xanomeline enteric capsules (karx-ec) in participants with agitation associated with alzheimer's disease who completed the parent studies cn012-0023 or cn012-0024.


Eligibility criteria:
inclusion criteria: * participants must have completed study cn012-0023 or cn012-0024 per protocol. * participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more). exclusion criteria: * participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gi, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: agitation alzheimer disease karxt karx-ec
effects of diaphragm muscle therapy on pain and shoulder movement in subjects with rotator cuff injuries

Conditions: Rotator Cuff Injury; Diaphragm; Relaxation

Summary: a randomised and controlled trial to people diagnosed with rotator cuff injuries who are divided into 3 groups of treatment: shoulder myofascial trigger points release, manual diaphragm release and diaphragm mobilization through hipopressive gymnastic exercise. the pain and range of shoulder movement are assessed before and after the treatment in all the participants. hypothesis of the clinical study: the treatment of diaphragm muscle, via manual release or active mobilization, has impact on rotator cuff injury symptoms comparing with a standard treatment of shoulder myofascial trigger points release. discussion: the relation between shoulder and diaphragm muscle, through innervation (phrenic nerve and brachial plexus), embryology and myofascial connections, could lead to include in clinical practice the examination and treatment of other structures besides shoulder girdle such as diaphragmatic region in rotator cuff injuries.

this study is a randomised controlled trial evaluating clinical effects of a diaphragm treatment, via manual release or active mobilization, comparing with a standard treatment of shoulder myofascial trigger points release. a description of the 3 groups of treatment: 1. - experimental group 1: 3 diaphragm stretching techniques according to chaitow, ward and ricard, performed by a physical therapist are employed in this experimental group during 10 minutes. the participants are situated in a seated, supine and side bending position. 2. - experimental group 2: diaphragm mobilization through active hipopressive gymnastic exercise according to caufriez in two different postures. 3. - active comparator group: a ischemic compression technique in most painful myofascial trigger points in the infraespinatus and supraespinatus muscle during one minute each one. the shoulder flexion, abduction and external rotation range of motion will be assessed pre and postinterventions, as well as the pressure pain threshold with an algometer and the pain experienced by the individual in shoulder mobility with a numerical rating scale.

Eligibility criteria:
inclusion criteria: * participants of both genders aged between 18 and 65 years old * ultrasound and/or magnetic resonance imaging diagnosis of rotator cuff injury * pain or range of movement restriction in active shoulder flexion and/or abduction exclusion criteria: * use of analgesic or anti-inflammatory drugs 72 hours prior to the study * individuals with glenohumeral instability due to shoulder luxation or subluxation or bankart labrum injury * individuals who have received physical therapy treatment in last week * individuals who underwent thoracic or shoulder surgery or people suffering from rheumatisms * diabetic patients * people with a diagnosed neurological pathology * individuals with a diagnosed mental health problem * not being able to understand and sign the informed consent and information sheet

Keywords: rotator cuff injury diaphragm physical therapy manual therapy
evaluating antibiotic stewardship assisted by computer in the university hospital of nancy (macabao)

Conditions: Antibiotic; Healthcare Associated Infection

Summary: antibiotic resistance is one of the most pressing health threats that mankind faces now and in the coming decades. antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality. in order to tackle antibiotic resistance, a computerized-decision support system (cdss) facilitating antibiotic stewardship and an electronic surveillance software (ess) facilitating infection prevention and control activities will implement in our tertiary care university hospital. the investigators conduct a pragmatic, prospective, single-centre, before-after uncontrolled study with an interrupted time-series analysis 12 months before and 12 months after the introduction of the cdss for antibiotic stewardship (apss) and ess for infection surveillance (zinc). apss and zinc will assist respectively the antibiotic stewardship and the infection prevention and control teams of nancy university hospital (france). the investigators will evaluate the impact of the cdss/ess on the antibiotic use in adult (≥ 18 years) inpatients (hospitalised ≥ 48h). the primary outcome is the prescription rate by all healthcare professionals from the hospital of all systemic antibiotics expressed in defined daily doses/1 000 patients/month. concurrently, the investigators will assess the safety of the intervention, its impact on the appropriateness of antibiotic prescriptions and on additional precautions (isolation precautions) as recommended in guidelines, and on bacterial epidemiology (multidrug-resistant bacteria and clostridioides difficile infections) in the hospital. finally, the investigators will evaluate the users' satisfaction and the cost of this intervention from the hospital perspective.


Eligibility criteria:
inclusion criteria: * all inpatients ≥ 18 years and hospitalised ≥ 48h in nancy university hospital exclusion criteria: * the paediatric and gynaeco-obstetric departments

Keywords: antibiotic stewardship healthcare associated infection clinical decision support interrupted time series infection prevention and control antibiotic resistance