Kornimate/medical-research-clean huggingface dataset:
long-term safety study of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women

Conditions: Heavy Menstrual Bleeding; Uterine Fibroids

Summary: this is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. this study is double-blinded in the first year and an open-label for the next three years.


Eligibility criteria:
inclusion criteria: * participant is a premenopausal female at the time of screening. * participant has a diagnosis of uterine fibroids documented by a pelvic ultrasound \[transabdominal ultrasound (tau) and transvaginal ultrasound (tvu)\]. * participant has heavy menstrual bleeding (hmb) associated with uterine fibroids as evidenced by menstrual blood loss (mbl) \> 80 ml during each of two screening menses as measured by the alkaline hematin method. * participant has negative urine and/or serum pregnancy test during washout (if applicable) and/or screening and just prior to first dose. * participant has an adequate endometrial biopsy performed during screening, the results of which show no clinical significant endometrial pathology. exclusion criteria: * participant has screening pelvic ultrasound or saline infusion sonohysterography (sis) results that show a clinically significant gynecological disorder. * participant has history of osteoporosis or other metabolic bone disease. * participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. * participant has a history of major depression or post-traumatic stress disorder (ptsd) episode within 2 years of screening, or a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). * participant is using any systemic corticosteroids for over 14 days within 3 months prior to screening or is likely to require treatment with systemic corticosteroids during the course of the study. over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.

Keywords: elagolix sodium heavy menstrual bleeding (hmb) heavy uterine bleeding leiomyomata menorrhagia elagolix + norethindrone acetate elagolix + e2/neta elagolix safety efficacy abt-620
a study comparing irinotecan and cisplatin (ip) with etoposide and cisplatin (ep) following ep/trt for ld-sclc

Conditions: Small-Cell-Lung Cancer

Summary: to evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.

the japan clinical oncology group (jcog) previously conducted a randomized phase iii trial comparing irinotecan and cisplatin (ip) with ep in patients with extensive-stage sclc. the response rate and overall median survival were significantly better for ip, i.e. 84.4% and 12.8 months with ip, versus 67.5% and 9.4 months with ep, respectively. the 2-year survival rates were 19.5% for ip and 5.2% for ep (7). these encouraging results prompted us to explore the use of ip in lsclc.

Eligibility criteria:
inclusion criteria: 1. cytologically, histologically proven small-cell lung cancer 2. limited disease 3. age 20-70 years old 4. performance status of 0-1 5. measurable disease 6. no prior treatment for small-cell lung cancer 7. no history of chemotherapy 8. adequate organ functions 9. written informed consent exclusion criteria: 1. pericardial effusion 2. active concomitant malignancy 3. pregnant or lactating women 4. interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.

Keywords: small-cell lung cancer limited-stage small-cell lung cancer combined modality therapy chemotherapy radiotherapy irinotecan cisplatin
kovanaze vs. articaine in achieving pulpal anesthesia of maxillary teeth - general

Conditions: Caries,Dental; Apical Periodontitis

Summary: the primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between kovanaze nasal mist and articaine needle anesthesia.

in june 2016, an intranasal delivery system of local anesthesia called kovanaze, gained fda approval. kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face. with the ability to avoid the traditional painful injection kovanaze offers promise in the field of maxillary anesthesia and this study intends to: 1. compare kovanaze to conventional needle anesthetic in adults 2. evaluate patient anxiety, tolerance and acceptability of kovanaze in patients undergoing dental procedures

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists class i or ii * preoperative heart rate of 55 to 100 beats per minute * maximum blood pressure reading of 166/100 mmhg * treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia * adults who require restorations in the maxillary teeth that would need local anesthesia exclusion criteria: * inadequately controlled thyroid disease * five or more nosebleeds in the past month * known allergy to any study drug or para-aminobenzoic acid * history of methemoglobinemia * taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol); * taking oxymetazoline-containing products (i.e., afrin) in the last 24 hours.

Keywords: cavities, crowns
wastewater surveillance to boost covid-19 vaccine uptake

Conditions: Vaccination; Wastewater Surveillance

Summary: the goal of the study is to determine the effect of a communications campaign sharing wastewater surveillance data to influence vaccine uptake in a metropolitan and non-metropolitan environment. the study will be conducted in onondaga and cayuga counties in new york state. individuals of all ages within the selected counties, located in metropolitan and non-metropolitan environments will receive the intervention. the evaluation study design is a comparison-control trial. the primary outcome measure is the proportion of vaccine-eligible individuals in the county that received the covid-19 vaccine stratified by type of vaccine dosage and age group. vaccination data will be aggregated to the county by the state department of health and shared with the research team. wastewater data will be pulled from the wastewater surveillance network. a difference in differences analysis will be used to estimate the effect of the intervention on both the outcomes between intervention and comparison groups following the intervention, while adjusting for potential confounding factors.


Eligibility criteria:
inclusion criteria: * none - county-level vaccine uptake - no direct interaction with people getting vaccines exclusion criteria: * none
resident-to-resident elder mistreatment intervention for dementia care in assisted living

Conditions: Assisted Living, Resident to Resident Elder Mistreatment

Summary: resident-to-resident elder mistreatment (r-rem) is a significant problem in long-term services and support settings (ltss), and likely to cause physical and or psychological distress. the proposed project tests an intervention developed for use by ltss staff. as such, it represents an important step in the process of developing approaches for ameliorating and preventing r-rem in assisted living residences which house residents with dementia and related behavioral disorders, and is thus likely to have significant public health impact.


Eligibility criteria:
inclusion criteria: * all long term residents residing at each facility at baseline, for those unable to consent, proxy consent will be sought exclusion criteria: * residents receiving hospice care, * facilities will have the option to exclude individuals for selected reasons, (e.g., severe psychosis)
a study of aleglitazar in combination with metformin in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin therapy

Conditions: Diabetes Mellitus Type 2

Summary: this multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin therapy. patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. the anticipated time on study treatment is 26 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * diagnosis of diabetes mellitus, type 2 * patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening * hba1c \>/=7% and \</=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit * fasting plasma glucose \</=240 mg/dl at pre-randomization visit * agreement to maintain diet and exercise habits during the study exclusion criteria: * patients with type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months * any previous treatment with thiazolidinedione or a dual ppar agonist * any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin) * any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening * symptomatic congestive heart failure classified as new york heart association class ii-iv at screening
intubation in morbidly obese: a comparison of airtraq and ilma

Conditions: Intubation; Difficult or Failed; Intubation Complication

Summary: bmı \> 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. divided into two groups airtraq and ilma. their effectiveness is evaluated.

80 patients, 18-65 years of aged asa i-iii, bmi\> 35 patients enrolled in this trial. divided into two groups ; airtraq and ilma . bmi\>35, upper airway tumour , respiratory infection less than ten days, excluded from this study. patients demographic and airway variables were recoded. patients were premedicated. after standard anesthesia induction, anesthesia was induced with propofol and fentanyl. rocuronium was used for neuromuscular blockade. the device insertion and intubation times, number of intubation attempts, mucosal damage, need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor complications were recorded.

Eligibility criteria:
inclusion criteria:18-65 years of age * asa i-iii * bmi\>35 exclusion criteria:bmi\<35 * patients have airway tumor * patients undergoing head and neck surgery * upper respiratory infection less than 10 days prior the surgery

Keywords: airtraq intubating laryngeal mask airway bmi>35
age and gender in tmj sounds

Conditions: Temporomandibular Disorders (TMD)

Summary: the temporomandibular joint (tmj) plays a crucial role in masticatory function, and its proper lubrication is essential for smooth, frictionless movement. disruptions to the lubricating system, often due to age-related changes or parafunctional activities such as teeth clenching or bruxism, can increase joint friction, leading to vibrations or intra-articular sounds. these sounds have become an essential diagnostic tool for assessing internal derangements of the tmj. while magnetic resonance imaging (mri) is considered the gold standard for diagnosing tmj disorders, its limitations in evaluating intra-articular structures have led to the development of alternative methods, such as joint vibration analysis (jva). this study explores the relationship between age, gender, and tmj vibration frequencies using jva in a cohort of 367 participants. we analyzed four key vibration parameters: range of motion (rom), total integral left (til), total integral right (tir), and frequency distributions in the \ 300 hz segments.


Eligibility criteria:
inclusion criteria: * participants capable of achieving an inter-incisal opening of 30 to 50 mm without restrictions. * free from symptoms indicative of temporomandibular disorder (tmd). * possessing fully and/or prosthetically restored dentition. * demonstrating adequate mouth opening to facilitate the rotation of the condylar process. exclusion criteria: * individuals using psychotropic or narcotic medications, regardless of medical oversight. * regular consumption of painkillers or anti-inflammatory agents. * long-term treatment with cortisone or its derivatives. individuals who have sustained traumatic injuries to the maxillofacial region. * participants who have suffered the loss of organs and/or tissue in the maxillofacial area due to medical or traumatic causes.

Keywords: age gender temporomandibular disorders vibration frequencies
the effect of tocilizumab on procalcitonin and other biochemical and clinical markers in the setting of covid-19 pneumonia

Conditions: COVID-19 Pneumonia; ARDS

Summary: this study aims to establish whether tocilizumab has any significant effect on procalcitonin levels on patients diagnosed with covid-19 pneumonia requiring intensive care admission. the effects on other biochemical and clinical markers are also considered.

a retrospective study, involving the first fifty patients treated with tocilizumab for acute deterioration in covid-19 pneumonia in the intensive care unit (icu) at mater dei hospital in malta. the following parameters will be collected from medical records: * procalcitonin levels, daily for twenty days or until discharge or death. * namely white cell count (wcc), neutrophils, lymphocytes, * c-reactive protein (crp) * pao2/fio2 ratio (p/f ratio). this group will be compared to a control group was chosen from patients admitted to the icu who were not eligible for tocilizumab treatment, matched to the study group for age, gender, mode of ventilation required and length of stay in icu.

Eligibility criteria:
inclusion criteria: * confirmed covid-19 diagnosis * admitted to itu * tocilizumab treatment exclusion criteria: * none

Keywords: covid-19 pneumonia tocilizumab procalcitonin c-reactive protein
statin therapy to limit cognitive dysfunction after cardiac surgery

Conditions: Neurocognitive Dysfunction

Summary: the primary aim of our prospective, randomized, double-blind interventional clinical trial is to determine the effectiveness of high dose atorvastatin therapy to reduce post operative cognitive dysfunction (pocd) in patients undergoing cardiac valve surgery. we hypothesize that therapy with high dose atorvastatin will significantly reduce the incidence and/or severity of pocd.


Eligibility criteria:
inclusion criteria: * fifty informed and consenting patients for cardiac valve surgery with cpb , greater than 50 years of age and under the care of one or more of the investigators or consultants will be prospectively enrolled over a one-year period (plus one-year for follow-up). exclusion criteria: * patients with a history of the following disease entities will be excluded: * symptomatic cerebrovascular disease with substantial residual deficit, alcohol abuse, psychiatric illness, renal failure (creatinine\>2.0), * hepatic dysfunction (alt or ast \> 1.5 x uln), history of allergy or myopathy with statin therapy, pregnant or breastfeeding women or other comorbidities that in the opinion of the investigator could limit patient participation. exclusion criteria are designed to limit confounding and enhance differentiation of deficits related to surgery and or treatment. * patients who are unable to read and thus unable to complete the neurocognitive testing will also be excluded. * patients having concomitant carotid endarterectomy or other vascular surgery will also be excluded to provide a more homogeneous sample for comparison.

Keywords: neurocognitive dysfunction
cardiac autonomic function for risk stratification in the emergency room

Conditions: Autonomic Nervous System Activity

Summary: the aim of the study is to test the hypothesis that impaired cardiac autonomic function predicts adverse outcome in unselected patients presenting in the emergency ward.


Eligibility criteria:
inclusion criteria: - presenting at the emergency department of the university hospital of tübingen

Keywords: emergency care cardiac autonomic function deceleration capacity
electrical muscle stimulation in the development of acquired weakness in patients with severe sepsis and septic shock

Conditions: Polyneuropathies; Septic Shock; Muscle Weakness

Summary: the aim of this study is to compare the effect of ems and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

septic patients are at high risk of developing intensive care unit acquired weakness (icuaw). electrical muscle stimulation (ems) has become an alternative exercise for critical and non-cooperative patients.

Eligibility criteria:
inclusion criteria: * subjects admitted to the icu of the hcuch in the period between november 2016 to august 2017 and january to june 2018 * diagnosis of severe sepsis or septic shock * more than 48 hours in vmi * with sedation and / or neuromuscular blockade * autovalent prior to admission to the icu exclusion criteria: * subjects from other hospitals / clinics or units of the hospital * multiple trauma * previous neuromuscular pathology * pacemaker users * pregnant women * bmi\> 35 * epilepsy * those who have refused to sign informed consent

Keywords: polyneuropathies muscle weakness sepsis septic shock electrical stimulation intensive care unit
fluid resuscitation in septic shock patients with bmi elevation

Conditions: Sepsis; Septic Shock; Obesity

Summary: to explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.

early, goal-directed therapy with timely achievement of hemodynamic stability has been shown to clearly improve outcomes in patients with septic shock. although surviving sepsis campaign guidelines recommend a weight-based approach to initial fluid resuscitation (i.e. 30ml/kg),1 at present, there are no robust data to support whether dosing based on actual body weight or an alternative correction formula (ideal body weight, adjusted body weight) is superior. frissbe is a prospective, randomized, three-arm parallel-group pilot trial of alternative resuscitation strategies for obese patients with septic shock, looking at feasibility and safety of different weight-based approaches. subject treatment assignment will not be blinded. data will be collected and analyzed on an intent-to-treat basis. the study will enroll 60 subjects, with 20 subjects per treatment arm. subjects will be randomized to receive one of three weight-based initial fluid resuscitation strategies - 30cc/kg ideal body weight (ibw), 30cc/kg adjusted body weight (adjbw), or 30cc/kg actual body weight (abw).

Eligibility criteria:
inclusion criteria: * 18 years of age or older * bmi \> 30 * suspected infection, and either: * hypotension (a systolic blood pressure \< 90mmhg) or * blood lactate concentration \> 4mmol/l exclusion criteria: * pregnant * primary diagnosis of acute cerebral vascular event * acute coronary syndrome * acute pulmonary edema * status asthmaticus * major cardiac arrhythmia * active gastrointestinal hemorrhage * seizures * drug overdose * burns or trauma * requirement for immediate surgery * cd4\<50/mm3 * do-not-resuscitate order status * transferred from another hospital
deep vein lesion optimisation (develop) trial

Conditions: Venous Leg Ulcer

Summary: this is a prospective, single centre, randomised controlled, feasibility study recruiting patients with lower limb venous ulceration and great saphenous incompetence. patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (\>50%) iliac vein lesions plus compression therapy. the primary endpoints will be ulcer healing and procedural safety. secondary endpoints include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. follow up will be over a five-year period. this feasibility study is designed to include 60 patients. should it be practicable a total of 594 patients would be required to adequately power the study to definitively address ulcer-healing rates.

the single main research question for this trial is as follows: in adult patients with venous ulceration and great saphenous vein incompetence; does iliac vein assessment with ivus and stenting of significant occlusive disease in addition to superficial great saphenous venous ablation and compression compared to superficial venous ablation and compression alone offer improved ulcer healing rates at three months following treatment? primary objective to determine whether superficial venous ablation plus early iliac vein interrogation plus endovascular stenting in the presence of significant occlusive disease results in improved venous ulcer healing compared to superficial venous ablation plus compression therapy alone. secondary objectives 1. to determine the relative performance of duplex ultrasound compared to ivus for the prediction of nivls 3. to determine the rate of primary or recurrent ulceration up to five years following intervention 4. to assess patient quality of life in the short and medium term following each mode of intervention

Eligibility criteria:
inclusion criteria: * consenting patients * aged 18 and over * ultrasound detected great saphenous venous incompetence * an associated primary or recurrent lower limb venous ulcer(s) exclusion criteria: * ankle-brachial pressure index \<0.8 * previous inability to tolerate lower limb compression bandaging * inability to provide informed consent * previous lower limb arterial revascularisation procedure * contrast allergy * previous history of pelvic malignancy or pelvic radiotherapy * pregnancy * previous iliac vein intervention * previous superficial vein intervention * infection in previous 30 days * estimated glomerular filtration rate (egfr) \< 60 mls/kg/min * isolated short saphenous or perforator vein reflux only * leg ulcer of non-venous aetiology (as assessed by clinician) * unfit for endovascular intervention based on history and examination * any compression therapy within six-months * evidence of deep venous incompetence/thrombosis

Keywords: venous ulcer great saphenous incompetence iliac vein endovenous therapy