Kornimate/medical-research-clean huggingface dataset:
real-world treatment patterns and effectiveness of palbociclib and ai therapy

Conditions: Metastatic Breast Cancer

Summary: a retrospective observational analysis of de-identified flatiron health analytic database to describe patient characteristics, treatment patterns and effectiveness of palbociclib + ai as first-line therapy in hr+/her2- metastatic breast cancer (mbc) in the us clinical practices.

utilizing de-identified data derived from the flatiron health analytic database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of palbociclib + ai as first-line therapy in hr+/her2-mbc in the us real-world clinical practice setting. patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. descriptive and multivariate statistical analyses will be performed.

Eligibility criteria:
inclusion criteria: 1. female sex 2. at least 18 years old at mbc diagnosis 3. diagnosis of mbc at any point in patient history 1. icd-9 (174.x, 175.x) or icd-10 (c50.xx) diagnosis of bc 2. confirmation of metastatic disease 3. at least 2 document clinical visits 4. evidence of stage iv or recurrent mbc with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents 4. hr+/her2- 1. hr+: er+ or pr+ test before or up to 60 days after mbc diagnosis 2. her2-: any her2 negative test and the absence of a positive test (ihc positive 3+, fish positive/amplified, positive nos) before or up to 60 days after mbc diagnosis 5. palbociclib + ai or letrozole as first-line therapy for mbc during the period from february/2015 through august /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. ai was administered within (±) 28 days of palbociclib index date. exclusion criteria: 1. evidence of prior treatment with other cdk4/6i (ribociclib or abemaciclib), ai (letrozole, exemestane, and anastrazole), tamoxifen, raloxifene, toremifene, or fulvestrant for mbc 2. first structured activity greater than 90 days after mbc diagnostic date 3. treatment with a cdk4/6 inhibitor as part of a clinical trial

Keywords: breast cancer palbociclib real-world data retrospective study effectiveness
efficacy and safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

Summary: this study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.


Eligibility criteria:
inclusion criteria: * subject is a premenopausal female at the time of screening. * subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound). * subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \> 80 ml during each of two screening menses as measured by the alkaline hematin method. * subject has negative urine and/or serum pregnancy test in screening and just prior to first dose. * subject has an adequate endometrial biopsy performed during screening, the results of which show no clinically significant endometrial pathology. exclusion criteria: * subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder. * subject has history of osteoporosis or other metabolic bone disease. * subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. * subject has a history of major depression or post-traumatic stress disorder (ptsd) within 2 years of screening, or a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). * subject 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 injectable (for occasional use) corticosteroids are allowed.

Keywords: elagolix elagolix sodium heavy uterine bleeding heavy menstrual bleeding leiomyomata menorrhagia abt-620 elagolix + e2/neta elagolix + norethindrone acetate hmb
ketorolac as an adjuvant agent for postoperative pain control following arthroscopic acl surgery

Conditions: ACL Injury; Postoperative Pain

Summary: 1. the investigators aim to examine the use of iv and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following acl reconstruction surgery. 2. the investigators hypothesize that the use of iv and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following acl reconstruction surgery.


Eligibility criteria:
inclusion criteria: * patients between 18 and 89 years old * patients undergoing primary anterior cruciate ligament (acl) reconstruction surgery exclusion criteria: * patients below age 18 or above age 89 * illiterate or non-english speaking individuals * patients with contraindications to ketorolac * history of chronic alcohol or drug abuse * chronic use of psychotropic or analgesic drugs * known peptic ulcer disease or bleeding diasthesis * renal dysfunction (estimated glomerular filtration rate \< 50 ml/min/1.73m2) * breastfeeding women * pregnant women

Keywords: acl reconstruction ketorolac pain narcotic
histotripsy (histosonics®) for liver tumours

Conditions: Liver Tumour

Summary: histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. it works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. these bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. the technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. this study will enrol 20 patients with liver tumours (be it primary or secondary liver tumours), monitor their post-operative adverse events, and study the changes in tumour size and volume after treatment. histotripsy will be performed under general anaesthesia, with real-time monitoring by ultrasound, and deliver high-intensity ultrasound waves in single session or multiple sessions. similar to other minimal invasive treatments, patients will be admitted 1 day prior, then receive histotripsy on the next day and stay overnight for observation. patients will be discharged on the 3rd day if unremarkable. during the hospital stay, blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay.


Eligibility criteria:
inclusion criteria: * fit for general anaesthesia * liver tumour size \< 10cm * solitary or multifocal * primary liver tumour such as hepatocellular carcinoma or intrahepatic cholangiocarcinoma * secondary liver tumour such as liver metastasis * patients with operable or inoperable liver tumours * liver transplant candidates awaiting for liver graft exclusion criteria: * refusal to take part in clinical trial * child c liver cirrhosis * not fit for general anaesthesia

Keywords: liver tumour
elevated ffa and skeletal muscle lipid content

Conditions: Diabetes; Exercise Physiology

Summary: there is increasing evidence that skeletal muscle lipid content (intramyocellular lipid, imcl) markedly increases the risk of metabolic complications, including insulin resistance and cardiovascular events. the investigator hypothesizes that skeletal muscle is passively taking up ffas when the availability is high, thereby leading to an increased storage. to test this hypothesis, the investigator wants to manipulate ffa levels, by means of exercise, and monitor intramuscular lipid content. therefore the objective is to examine the effect of an exercise-induced elevation of ffa on skeletal muscle lipid content in healthy lean men. to this end, skeletal muscle lipid content will be investigated at baseline and after an exercise protocol and again after a four-hour recovery period from exercise, once in a condition with high ffa concentration, once with low ffa concentration. to achieve high- versus low ffa concentrations, an exercise protocol was chosen and participants had to perform this protocol once with a glucose supplementation and once without. skeletal muscle lipid content will be determined before, directly after exercise and 4 h post exercise (from muscle biopsies) with or without glucose supplementation.


Eligibility criteria:
inclusion criteria: * male sex * age 18-30 years * lean, bmi 18-25 kg/m2 * healthy * stable dietary habits * no medication use exclusion criteria: * female sex * engagement in programmed exercise \> 2 hours total per week * cardiac problems, such as angina pectoris, cardiac infarction and arrhythmias * first degree relatives with type 2 diabetes mellitus * any medical condition requiring treatment and/or medication use * unstable body weight (weight gain or loss \> 3 kg in the past three months) * participation in other biomedical study within 1 month prior to the screening visit * subjetcs, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed, cannot participate in the study

Keywords: exercise ectopic fat accumulation
perceived stress and anxiety levels of nurses

Conditions: Stress; Anxiety

Summary: this study was conducted to determine the effect of web-based progressive relaxation exercises applied to nurses working in a pandemic hospital on perceived stress and anxiety. in this randomized controlled clinical trial, nurses working in the pandemic hospital were randomly assigned to the control and intervention groups.

the coronavirus disease-2019 (covid-19) epidemic increases the stress and anxiety level of nurses due to many factors. this study was conducted to determine the effect of web-based progressive relaxation exercises applied to nurses working in a pandemic hospital on perceived stress and anxiety. in this randomized controlled clinical trial, nurses working in the pandemic hospital were randomly assigned to the control and intervention groups. the web-based relaxation exercises program was trained and implemented online for 4 weeks by a trainer for the intervention group.the perceived stress scale (pss) and the state-trait anxiety inventory (stai) were completed online by participants in both groups before and after the intervention

Eligibility criteria:
inclusion criteria: * those between the ages of 18-55 * nurses working in the pandemic hospital exclusion criteria: * nurses who did not agree to participate in the study * research termination criteria; * nurses who begin to receive support from a psychiatrist, * nurses who begin to use psychiatric medication, * nurses who are covid positive, * moreover, the study was terminated with the nurses who wanted to leave the study.

Keywords: anxiety pandemics nurse stress
cervical manipulation (oaa technique) in exophories

Conditions: Exophoria

Summary: objetive: to assess the efficacy of the occipito-atlas-axis cervical manipulation technique to correct ocular divergence in subjects with exophoria. design: quantitative, experimental, longitudinal and prospective study. subjects: subjects over 18 years of age, with exophorias, without heterotropies and who do not present a contraindication to cervical manipulation. methods:subjects with this ocular mobility dysfunction are going to be evaluated objectively with the alternate cover test. the ocular deviation will be measured at 40 cm and at 4 meters. the individuals who were part of the experimental group underwent the oaa manipulation technique, and to those who were part of the control group a placebo maneuver. two measurements were taken from this moment, one immediately after the execution of the technique and another one week later.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of exophoria * being 18 years old. exclusion criteria: * having heterotropia or have been treated for it. * present contraindication to manipulation (recent fractures, sprains, or dislocations, local tumor, rheumatic polyarthritis, down syndrome, vertebrobasilar insufficiency, basilar impression, refusal to be manipulated). * having cervical manipulation before two weeks.

Keywords: cervical manipulation disorder ocular motility musculoeskeletal strabismus
interventions to prevent falls. precaisal study

Conditions: Accidental Falls; Old Age; Debility; Activity, Motor

Summary: this study aims to guide older people living in the community on appropriate strategies within a fall prevention program. this program is aimed at training in physical exercises carried out through group workshops or at preventing risk situations at home.

two-arm, non-blind, non-inferiority experimental design. multicenter, randomized trial. the study tries to assess whether a group intervention following the principles of the life program is no less effective than individual intervention in reducing the incidence of falls.

Eligibility criteria:
inclusion criteria: * older than 70 years * live at your address * are at risk of falls * timed up and go test time timed ≥ 12 seconds * able to walk 200 meters without personal assistance * speak and read in spanish exclusion criteria: * perform moderate to vigorous physical activity\> 150 min / week in the last 3 months * present any of the following medical conditions: * heart failure (new york heart association class iii and iv) * recent stroke (\<6 months) * parkinson's disease * in active cancer treatment (last 6 months) * class iii and iv chronic obstructive pulmonary disease * unstable fracture of the lower limb * lower limb amputated * treatment for less than 6 months of depression * uncontrolled resting blood pressure of a systolic pressure\> 160 or a diastolic pressure\> 100 or more * not being available for home visits within 11 weeks of the initial assessment: having planned trips or transfers of more than 2 months within the first 6 months of the study * moderate to severe cognitive impairment (mini mental cognitive assessment \<23) * current participation in another scientific intervention trial.
evaluation of dupilumab's effects on airway inflammation in patients with asthma

Conditions: Asthma

Summary: primary objective: to evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. secondary objective: to assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

the total study duration for each participant was between approximately 29 and maximum of 30 weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a treatment period of 12 weeks, and a post-treatment period of 12 weeks. participants who completed the treatment period could be eligible to participate in an open-label extension study.

Eligibility criteria:
inclusion criteria: * male and female adults with a physician diagnosis of persistent asthma for ≥12 months. * existing treatment with medium to high dose inhaled corticosteroids in combination with a long-acting beta agonist for at least 3 months with a stable dose ≥1 month prior to visit 1 (screening visit). * treatment with a third asthma controller for at least 3 months with a stable dose \>=1 month prior to visit 1 was allowed. * pre-bronchodilator forced expiratory volume (fev1) 55 to 85% of predicted normal. exclusion criteria: * participants \ 65 years. * fractional exhaled nitric oxide (feno) \<26 parts per billion (ppb) at visit 1 (screening visit). * chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, eosinophilic granulomatosis with polyangiitis \[churg-strauss syndrome\]) which could impair lung function. * a participant who experienced an asthma exacerbation that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to visit 1. * a participant who had experienced an upper or lower respiratory tract infection within the 4 weeks prior to visit 1. * evidence of lung disease(s) other than asthma. * previous smoker (smoking history \>10 pack-years) or current smoker (within 6 months prior to visit 1). * comorbid disease that might interfere with the evaluation of investigational medicinal product or conduct of study procedures (e.g., bronchoscopy). * anti-immunoglobulin e (ige) therapy (omalizumab) or any other biologic therapy within 6 months of visit 1. * exposure to another investigative study medication within a time period prior to visit 1 that is less than 5 half-lives of the study medication. * treatment with systemic (oral or injectable) corticosteroids within 28 days of visit 1. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
high flow nasal cannula weaning in acute bronchiolitis

Conditions: Acute Bronchiolitis

Summary: the goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. this study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. the aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.

acute bronchiolitis is the most common cause of hospitalization among infants in finland, with its primary etiology being the rs- virus. acute bronchiolitis is defined in finland as an infant's first respiratory distress before the age of 1. there is no effective pharmacological treatment for acute bronchiolitis. high-flow nasal cannula therapy has been shown in large randomized trials to reduce the risk of intensive care unit admission for children. high-flow nasal cannulas are typically used at a flow rate of 2 liters per kilogram per minute. despite widespread use, there is insufficient evidence to determine whether high-flow therapy should be discontinued abruptly or gradually tapered. observational studies indicate that the majority of units opt for abrupt discontinuation. common criteria for discontinuation include weaning off supplemental oxygen and maintaining normal oxygenation on room air for 4-6 hours. gradual weaning has been shown in observational studies to prolong hospitalization compared to immediate cessation of therapy. in a randomized controlled trial conducted in a pediatric intensive care unit, direct discontinuation shortened the duration of treatment by up to two days. however, there have been no previous randomized trials conducted on bronchiolitis patients.

Eligibility criteria:
inclusion criteria: * clinically diagnosed acute bronchiolitis * high flow nasal cannula treatment has lasted for at least 12 hours * measured saturation 95 or more with room air * high flow rate is maximum 2l/kg/min * the treating doctors considers the infant suitable to be without high flow exclusion criteria: * major congenital anomaly of lungs, hearts or diaphragm * bacterial pneumonia * parents do not give consent

Keywords: acute bronchiolitis
a study to assess wound healing efficacies of different adhesive bandages

Conditions: Wound Healing

Summary: the purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.


Eligibility criteria:
inclusion criteria: * fitzpatrick skin type ii or iii * uniform skin color on both volar forearms * generally in good health based on medical history reported by the participant * -individual has signed the photographic release and informed consent documents along with (hipaa) disclosure * willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms exclusion criteria: * has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the investigational products (ips)/auxiliary/ancillary products * has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, or renal disease * presents with a skin condition that would, in the opinion of the pi or study physician, confound study results, increase risk to participant, or interfere with study evaluations * has excessive hair or tattoos on either volar forearm * has a known history of severe systemic immune system disorders * has self-reported type 1 or type 2 diabetes * has self-reported uncontrolled chronic diseases * is taking medication that would mask an adverse event, confound study results or alter/compromise the bleeding/healing process * is self-reported to be pregnant or planning to become pregnant * has a body mass index (bmi) above 35 * is self-reported to be an alcohol or drug abuser * has participated in another clinical trial within 10 days * either is or lives with someone who is a current employee of any company that makes/markets adhesive bandages or first-aid products
effectiveness of medical management of fibrous dysplasia of bone.

Conditions: Fibrous Dysplasia of Bone; McCune Albright Syndrome

Summary: the objective of our study was to assess the effectiveness of our reference center since its constitution. in a retrospective cohort study, we compared the activity of our center, including the time elapsed between diagnosis and access to the center and the diagnostic delay of patients with fibrous dysplasia between two periods, 1996-2006 (before certification of our center) and 2007-2019 (after certification of our center).


Eligibility criteria:
inclusion criteria: we have included children and adults with fd/mas who visited at least once in our center (outpatient and hospitalized patients). the diagnosis was established by an expert of the center, based on clinical, biological, imaging and/or histological arguments exclusion criteria: the absence of detectable bone lesion

Keywords: fibrous dysplasia of bone mccune albright syndrome rare bone disease healthcare organization