Kornimate/medical-research-clean huggingface dataset:
mucolytics in patients on invasive mechanical ventilation due to severe acute respiratory syndrome coronavirus 2

Conditions: Corona Virus Infection; Pneumonia, Ventilator-Associated

Summary: it is planned to include patients over 18 years of age of both sexes, admitted to the intensive care unit of clinical hospital centre split for respiratory insufficiency caused by severe acute respiratory syndrome coronavirus 2 in need of invasive mechanical ventilation. the patients will be divided into four groups. group 1 will receive n-acetylcysteine inhalation, group 2 will receive inhalation with a 5% sodium chloride solution, and group 3 will receive inhalation of 8.4% sodium bicarbonate, group 4 is a control group and will not routinely receive inhaled mucolytics preventively. all inhalations will be given twice a day 12 hours apart. the first inhalation will be included within 12 hours of the patient being enrolled in the intensive care unit. patients will be randomized according to the type of inhalation they will receive, randomization will be done by all researchers through the random.org website, and the inhalation will be given by a nurse according to the agreed protocol. research goals the aim of this study is to determine whether there is a difference in the frequency and duration of ventilator-associated pneumonia (vap) and whether there is a difference in the number of days spent on mechanical ventilation and in mortality in these four groups of patients. hypothesis coronavirus disease 2019 patients on invasive mechanical ventilation and preventive sodium bicarbonate inhalation will have a lower incidence of ventilator-associated pneumonia and fewer days spent on invasive mechanical ventilation than patients inhaled with n-acetylcysteine, 5% saline, or patients without preventive inhalation.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age with coronavirus pneumonia who need invasive mechanical ventilation. exclusion criteria: * patients with polytrauma, * pregnant women, * severe hemodynamic instability, * patients with pulmonary edema, * less than 3 days spent in the icu, * patients who have microbiologically proven bacterial infection on arrival.

Keywords: coronavirus disease 2019 pneumonia, ventilator-associated hypertonic saline bicarbonate n-acetylcysteine
study to evaluate the immunogenicity and safety of an investigational pandemic influenza vaccine in children

Conditions: Influenza

Summary: the objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of gsk biologicals' investigational vaccine gsk1562902a.

this protocol posting was modified according to the protocol amendment 2 (dated 16-june-2011). the impacted section is eligibility criteria.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parents/legally acceptable representatives (lars) can and will comply with the requirements of the protocol. * children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination. * written informed consent obtained from the parent(s)/lar(s) of the subject. * healthy children as established by medical history and clinical examination before entering the study. * parent/lar access to a consistent means of telephone contact, land line or mobile, but not a pay phone or other multiple-user device. * subjects who are likely to reside in the vicinity of the study centre for the duration of the study. in studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of any neurological disorders or seizures. * acute disease at the time of enrolment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests. * administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period. * any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study. * child in care. * previous vaccination at any time with an h5n1 vaccine. * medical history of physician-confirmed infection with a h5n1 virus.

Keywords: h5n1 influenza infection influenza vaccine gsk1562902a
the safety and effectiveness of bis-pom pmea in hiv-infected patients

Conditions: HIV Infections

Summary: to study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-hiv activity of bis-pom pmea ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to hiv-infected patients.

patients are randomized to receive bis-pom pmea at one of three fixed dose levels or placebo daily for 2 weeks. at each dose level, nine patients receive bis-pom pmea and three patients receive placebo.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry. patients must have: * hiv seropositivity. * cd4 count \>= 100 cells/mm3. * p24 antigen (immune-complex dissociated) \>= 50 pg/ml. * life expectancy of at least 6 months. prior medication: allowed: * prior prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * active, serious infection (other than hiv infection) requiring parenteral antibiotic therapy. * malignancy other than cutaneous kaposi's sarcoma. * clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. * gastrointestinal malabsorption syndrome. * inability to take oral medication. concurrent medication: excluded: * any parenteral antibiotic therapy. * diuretics. * amphotericin b. * didanosine (ddi). * fluconazole. * foscarnet. * ganciclovir. * interferon-alpha. * interferon-beta. * isoniazid. * aminoglycoside antibiotics. * ketoconazole (topical allowed). * itraconazole. * rifabutin. * rifampin. * stavudine (d4t). * zalcitabine (ddc). * zidovudine (azt). * lamivudine (3tc). * any investigational agents (except with sponsor approval). * systemic therapy for kaposi's sarcoma. patients with the following prior condition are excluded: history of lactose intolerance. prior medication: excluded within 2 weeks prior to study entry: * any parenteral antibiotic therapy. * diuretics. * amphotericin b. * didanosine (ddi). * fluconazole. * foscarnet. * ganciclovir. * interferon-alpha. * interferon-beta. * isoniazid. * aminoglycoside antibiotics. * ketoconazole (topical allowed). * itraconazole. * rifabutin. * rifampin. * stavudine (d4t). * zalcitabine (ddc). * zidovudine (azt). * lamivudine (3tc). * any investigational agents (except with sponsor approval). excluded within 4 weeks prior to study entry: systemic therapy for kaposi's sarcoma. active substance abuse (including alcohol) as determined by questionnaire or positive drug screen.

Keywords: acquired immunodeficiency syndrome aids-related complex antiviral agents adenine
longitudinal changes in characteristics of covid-19 survivors and their long-term follow-up study

Conditions: Prognosis; Sequelae

Summary: follow-up study of coronavirus disease 2019 (covid-19) survivors has rarely been reported. we aimed to investigate longitudinal changes in the characteristics of covid-19 survivors after discharge.

from december 2019, coronavirus disease 2019 (covid-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (sars-cov-2), has spread across the globe. numerous studies have been performed so far to investigate clinical characteristics, risk factors, potential treatment and pathogenesis of covid-19. however, little information is available on the long-term prognosis and possible sequelae of covid-19 survivors who have recovered and been discharged from hospital. hence, the investigators conducted a prospective study to investigate the long-time prognosis and the possible sequelae of covid-19 survivors. the investigators evaluated demographic and clinical characteristics, laboratory and radiological findings,pulmonary function tests, electrocardiogram, complications as well as treatment and symptoms and signs of covid-19 patients.

Eligibility criteria:
inclusion criteria: patients with confirmed covid-19 who have complete hospitalization data. exclusion criteria: suspected cases of covid-19.

Keywords: covid-19 follow-up consequences
effect of smoking cessation on tuberculosis treatment outcomes

Conditions: Tuberculosis, Pulmonary

Summary: this study was a randomized controlled trial conducted at ojha institute of chest diseases, dow university of health sciences, karachi, among pulmonary tuberculosis patients


Eligibility criteria:
inclusion criteria: * pulmonary tuberculosis patients of age 18 years or above * registered under directly observed treatment short course (dots) at ojha institute of chest diseases * reported to have smoked 100 plus cigarettes in past and currently smoking cigarettes exclusion criteria: * extra pulmonary tuberculosis * drug resistant tuberculosis * pregnancy * positive history of epilepsy

Keywords: smoking cessation
peri-articular tranexamic acid injection in total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: this study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.

intravenous tranexamic acid (iv txa) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (tka) but its safety regarding venous thromboembolic events (vtes) remains in question. the direct, local application of txa may reduce systemic toxicity whilst maintaining good or better bleeding control compared to iv txa. the topical application of txa via hemovac drains has been reported previously with good results. however, there are no data on peri-articular txa injections during tka.

Eligibility criteria:
inclusion criteria: * adult patients with osteoarthritis in need of a tka exclusion criteria: * inflammatory arthritis * post-traumatic arthritis * a history of or current venous thromboembolic disease * any underlying disease of haemostasis * cirrhosis * chronic renal failure * patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel) * know allergy to txa * defective color vision * preoperative hemoglobin \<10 g/dl * platelet count \< 140,000 /ul3

Keywords: tranexamic acid peri-articular injection total knee arthroplasty blood loss osteoarthritis, knee
assessing immunoresponse post eribulin: eribulin and immunogenicity in advanced breast cancer

Conditions: Breast Cancer Female; Neoplasm, Breast; Breast Cancer Metastatic

Summary: after progression of disease after one chemotherapy, metastatic breast cancer patients will be randomized 1:1 to one of the following treatment arms: arm a. eribulin arm b. paclitaxel blood draws for immune analysis will be performed before start of therapy, on day 1 of cycle 2 and on day 21 of cycle 4 (end of therapy) for the primary study aim. patients will be treated under study conditions for a maximum of 4 therapy cycles.

this is a prospective, randomized phase iv study. patients who progressed after one chemotherapy in the metastatic setting will be randomized 1:1 to one of the following treatment arms. arm a. eribulin 1.23 mg/m2 on days 1 and 8 q21d arm b. paclitaxel 80 mg/m2 on days 1, 8, and 15 q21d blood draws for immune analysis will be performed before start of therapy on day 1 of cycle 1, on day 1 of cycle 2 (pre dose each) and on day 21 of cycle 4 (end of therapy) and assessed for the primary study aim. patients will be treated under study conditions for a maximum of 4 therapy cycles.

Eligibility criteria:
inclusion criteria: * written informed consent prior to beginning of trial specific procedures * subject must be female and aged ≥ 18 years on day of signing informed consent * ecog 0-1 * histologically confirmed, her2 negative breast cancer determined by core biopsy of tumor lesion. human epidermal growth factor receptor 2 (her2) negativity is defined as either of the following by local laboratory assessment: in situ hybridization (ish) non-amplified (ratio ≤ 2.2), or ihc 0 or ihc 1+. * indication for chemotherapy * previous therapy with one chemotherapy line * target lesion (recist 1.1) * adequate organ function defined as: creatinine clearance \> 50 ml/min anc ≥ 1.5 x 10 3 /μl thrombocytes \> 100 x 10 3 /μl exclusion criteria: * her2 positive disease * indication for an anti-hormone treatment * active infection requiring systemic therapy. * active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs. * history of primary or acquired immunodeficiency (including allogenic organ transplant). * active or prior documented inflammatory bowel disease (e.g., crohn's disease, ulcerative colitis). * severely impaired liver function (child pugh c) * hypersensitivity to study medication or any of its components * neuropathy (pnp) \> grade 2 (ctcae 5.0) * congenital long qt syndrome * preexisting concomitant use of strong cyp3a4 and cyp2c8 inhibiting or inducing drugs * life expectancy of less than three months * pregnancy (contraception is required according tocontraceptive guidance) * lactation * known history of following infections: human immunodeficiency virus (hiv), history of acute or chronic hepatitis b or hepatitis c * has received a live-virus vaccination within 30 days of planned treatment start. seasonal flu vaccines that do not contain live virus are permitted. * does not agree to blood collection

Keywords: immunoresponse
imaging study of allocation of pacing targets in cardiac resynchronization therapy

Conditions: Systolic Heart Failure

Summary: magnetic resonance image guided delivery of left and right ventricular leads to optimal myocardial targets will result in improved clinical response to crt using left ventricular remodeling criteria.

cardiac dyssynchrony and scar are important variables for realization of clinical response to cardiac resynchronization therapy (crt). results from a previous study suggest that paced heart segment characteristics do predict this response and our ability to identify venous pathways to optimal segments is feasible using cardiac ct and mri. in an ongoing feasibility study we are using these capabilities to guide the delivery of crt lead systems to optimal myocardial targets. a computer software program has been developed that can create an interactive, 3d integrated cardiac model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony. although this feasibility study is ongoing, early results show this method of guiding the crt leads to optimal targets with these individualized models to be safe and effective. this trial will be a larger multi-centre randomized blinded trial to determine the therapeutic impact of mri guided left ventricular and right ventricular lead placement with respect to improving clinical response rates for crt.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. ejection fraction ≤ 35 %. 3. qrs duration ≥ 120 msec. 4. nyha class ii-iv. 5. on maximum tolerated heart failure medication therapy ≥ 6 weeks. 6. clinically accepted for crt device implantation. exclusion criteria: 1. failure to provide consent. 2. ccs class iii-iv angina. 3. recent q-wave myocardial infarction or revascularization procedure ( ≤ 3 months). 4. standard contra-indications to mri. 5. documented severe allergy to intravenous contrast dye ( iodinated ct contrast or gadolinium mri contrast). 6. estimated glomerular filtration rate (egfr) ≤ 45 ml/min/m2. 7. patient is pregnant.

Keywords: cardiomyopathy cardiac resynchronization therapy
external validation of simplified 4c mortality score by deleting crp

Conditions: COVID-19 Pandemic

Summary: the (coronavirus clinical characterisation consortoum) 4c mortality score is an accessible risk stratification score developed by the international severe acute respiratory and emerging infections consortium (isaric) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (glasgow coma scale), urea or blood urea nitrogen (bun) level, and c reactive protein (crp). it was derived and internally validated on a large, diverse cohort within the united kingdom but requires external validity to confirm its generalizability. a recent validation study demonstrated that the score could be simplified by deleting crp item which is favorable to its widespread use. we aim to validate a modified 4c score.

the clinical presentation and progression of covid-19 in patients is highly variable, which makes it difficult for clinicians to triage patients and determine their prognostic risk. the (coronavirus clinical characterisation consortoum) 4c mortality score is an accessible risk stratification score developed by the international severe acute respiratory and emerging infections consortium (isaric) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (glasgow coma scale), urea or blood urea nitrogen (bun) level, and c reactive protein (crp). it was derived and internally validated on a large, diverse cohort within the united kingdom but requires external validity to confirm its generalizability. a recent validation study demonstrated that the score could be simplified by deleting crp item which is favorable to its widespread use. the study aim to validate a modified 4c score. methods this is a multicenter retrospective observational, cohort study of patients admitted to five tunisian university hospitals (fattouma bourguiba hospital monastir, sahloul hospital sousse, farhat hached hospital sousse, taher sfar hospital mahdia, habib bourguiba hospital sfax, traumatology and burns center tunis), the study included medical records of all adult patients with confirmed covid-19 infection who were hospitalized from january 2020 and november 2022. a confirmed case of covid-19 was defined by a positive reverse transcriptase-pcr (rt-pcr) assay of a nasopharyngeal swab associated with compatible clinical manifestations. incomplete electronic record were excluded from the analysis. anamnesis, clinical, paraclinical, radiological, and outcome data were collected using a validated electronic case report form (ecrf). the primary outcomes measure was in-hospital death from any cause.

Eligibility criteria:
inclusion criteria: - admitted to one of the participating hospitals with a confirmed case of covid-19 defined by a positive reverse transcriptase-pcr (rt-pcr) assay of a nasopharyngeal swab associated with compatible clinical manifestations exclusion criteria: * incomplete electronic records were excluded from the analysis.

Keywords: score 4c sars-cov2 validation deleting crp
efficacy and safety of pactimibe in patients with atherosclerosis

Conditions: Atherosclerosis

Summary: the effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound


Eligibility criteria:
inclusion criteria: * increased cardiovascular risk (i.e. history of myocardial infarction, stroke, diabetes mellitus, left ventricular hypertrophy) * intima-media thickness greater than or equal to 0.8 mm as measured by ultrasonography * negative pregnancy test for females exclusion criteria: * whole blood donation (greater than or equal to 450 ml) during the last three months before study start * unstable angina, congestive heart failure or uncontrolled hypertension * renal disease including nephrectomy and/or renal transplant * hepatic disease or abnormal liver function parameters * drug abuse or alcohol addiction
post mastectomy hypofractionated radiotherapy in high risk breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to compare the efficacy and toxicities of hypofractionated radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients treated with mastectomy. it's hypothesized that the efficacy and toxicities are similar between the two groups.

eligible breast cancer patients with mastectomy and axillary dissection are divided into two groups: conventional fractionated (cf) radiotherapy of 50 gray (gy) in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region, and hypofractionated (hf) radiotherapy of 43.5 gray (gy) in 15 fractions within 3 weeks to the same region. during and after radiotherapy , the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Eligibility criteria:
inclusion criteria: * ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer * undergone total mastectomy and axillary dissection t 3-4 and/or 4 or more positive axillary lymph nodes. * fit for chemotherapy ( if indicated) , endocrine therapy (if indicated), and postoperative irradiation. * written informed concent. * c t3-4 , or c n2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy. * no supraclavicular or internal mammary nodes metastases. * no distant metastases .enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who did't receive neoadjuvant therapy. * enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and did't need adjuvant chemotherapy. exclusion criteria: * patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region * previous or concurrent malignant other than non melanomatous skin cancer * bilateral breast cancer. * immediate or delayed ipsilateral breast cancer reconstruction.
robot assisted supraomohyoid neck dissection via retroauricular approach

Conditions: Head and Neck Neoplasms

Summary: in this study we introduce and evaluate the feasibility of our surgical technique to hide the external scar of neck dissection using the robotic system via a modified facelift or retroauricular approach.


Eligibility criteria:
inclusion criteria: * diagnosed as squamous cell carcinoma of the oral cavity * no clinically identified cervical lymph node metastasis * surgery as initial treatment exclusion criteria: * suspicious neck metastasis * radiation or chemotherapy before the surgery * past history of neck surgery

Keywords: head and neck neoplasms neck dissection robotics