Kornimate/medical-research-clean huggingface dataset:
doxorubicin, paclitaxel, and carboplatin in treating patients with primary stage iii, stage iv, or recurrent endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining doxorubicin, paclitaxel, and carboplatin in treating patients who have primary stage iii, stage iv, or recurrent endometrial cancer.

objectives: * determine the response rate and duration of response in patients with primary stage iii or iv or recurrent endometrial cancer treated with sequential doxorubicin, paclitaxel, and carboplatin. outline: patients receive sequential chemotherapy comprised of doxorubicin iv once every 2 weeks for 3 courses, followed by paclitaxel iv over 1 hour once weekly for 9 courses, and then carboplatin iv once every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 18-46 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven primary stage iii or iv or recurrent endometrial cancer * bidimensionally measurable disease by x-ray, ct scan, mri scan, or physical exam * sole site may be within a previously irradiated area if documented disease progression since prior radiotherapy patient characteristics: age: * adult performance status: * karnofsky 70-100% life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count greater than 1,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin, sgot, and alkaline phosphatase no greater than 1.5 times normal renal: * creatinine no greater than 1.8 mg/dl cardiovascular: * left ventricular ejection fraction at least 50% other: * no active uncontrolled infection * no greater than grade ii neuropathy * no other active malignancy * not pregnant * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior doxorubicin * greater than 6 months since prior paclitaxel, carboplatin, or other platinum compounds endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy and recovered surgery: * not specified

Keywords: stage iii endometrial carcinoma stage iv endometrial carcinoma recurrent endometrial carcinoma
a safety and pharmakokinetic study of a4250 alone or in combination with a3384

Conditions: Orphan Cholestatic Liver Diseases; Primary Biliary Cirrhosis; Progressive Familial Intrahepatic Cholestasis; Alagille Syndrome

Summary: the primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of a4250 after single or multiple oral doses in healthy subjects. in addition, will evaluate a4250 in combination with cholestyramine.


Eligibility criteria:
inclusion criteria: 1. healthy males or non-pregnant, non-lactating healthy females 2. bmi of 18 to 32 kg/m2 or, if outside the range, considered not clinically significant by the investigator 3. willing and able to communicate and participate in the whole study 4. provided written informed consent 5. agreed to use an adequate method of contraception exclusion criteria: 1. had participated in a clinical research study within the previous 3 months 2. were study site employees, or immediate family members of a study site or sponsor employee 3. had previously been enrolled in this study 4. history of any drug or alcohol abuse in the past 2 years 5. regular alcohol consumption, in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine) 6. current smokers and those who had smoked within the last 12 months. a breath carbon monoxide (co) reading of greater than 10 ppm at screening 7. females of childbearing potential who were pregnant or lactating (female subjects must have had a negative urine pregnancy test at admission) 8. did not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening 9. clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator 10. positive drugs of abuse test result 11. positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results 12. history of cardiovascular, renal, hepatic, chronic respiratory or gi disease as judged by the investigator 13. serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients eg lactose or contraindications to cholestyramine/questran 14. presence or history of clinically significant allergy requiring treatment as per the judgement of the investigator hayfever was allowed unless it was active 15. donation or loss of greater than 400 ml of blood within the previous 3 months 16. were taking, or had taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol, hormone replacement therapy \[hrt\] and hormonal contraception) or herbal remedies in the 14 days before imp administration unless they were not considered to have interfered with the objectives of the study, as agreed by the pi and sponsor's medical monitor on a case by case basis 17. failed to satisfy the investigator of fitness to participate for any other reason
manual therapy on oral opening, swallow function and upper quarter mobility on head and neck cancer survivors

Conditions: Head and Neck Cancer; Trismus; Dysfunction

Summary: trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (hnc). it is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. in addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients. the goal of this clinical trial is to determinate the effectiveness and safety of manual therapy (mt) on oral opening, swallow function, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors. participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises and b) motor control exercises (usual care). the assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.

manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. measurements are done before starting, after the last intervention and 6 weeks after finishing the treatment.

Eligibility criteria:
inclusion criteria: * individuals with hnc * individuals over 18 years of age * individuals who have undergone oncological surgery of the head and neck and/or radiotherapy * having finished oncological medical treatment between 3 and 36 months before inclusion * having a medical diagnosis of trismus and/or tmd and/or cervical or shoulder dysfunction * spanish native speakers exclusion criteria: * sequelae of previous stroke * structural instability and/or osteoporosis of the cervical spine, spondylosis, cervical herniated discs * active osteoradionecrosis or open wounds (fistulas, soft tissue necrosis) in the anatomical treatment area * tracheostomized individuals * metastasis or active cancer * refuse to participate.
the effect of music on pain and women satisfaction during diagnostic outpatient hysteroscopy in postmenopausal women

Conditions: Hysteroscopy

Summary: the aim of this study is to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and satisfaction in postmenopausal women


Eligibility criteria:
inclusion criteria: * menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings) exclusion criteria: * patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding
preoperative vs. pathologic size in breast cancer: a prospective study

Conditions: Mastectomy; Breast Neoplasm Malignant Primary

Summary: breast cancer, the most prevalent malignancy among women globally, is increasing in incidence. while non-metastatic breast cancer requires surgery, determining the optimal extent of resection remains challenging. inadequate resection margins necessitate reoperation, leading to increased psychological stress, costs, and potentially compromised cosmetic outcomes and prognosis. accurate preoperative assessment of resection extent is crucial and involves various factors, including imaging studies, physical examinations, tumor molecular subtypes, and intraductal carcinoma components. this prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients.

breast cancer is the most prevalent malignancy among women globally, leading to surgical interventions for non-metastatic cases. while breast cancer generally has a favorable prognosis, achieving negative resection margins at initial surgery is crucial for optimal outcomes. the challenge associated with accurately predicting the extent of resection preoperatively, as failure to secure clear margins may necessitate further resection or total mastectomy, resulting in increased psychological stress, higher healthcare costs, compromised cosmetic results, and potential negative impacts on long-term prognosis and quality of life. many factors contribute to predicting the optimal resection extent, including imaging studies, physical examination findings, tumor molecular subtypes, presence and extent of intraductal carcinoma components, etc. despite the availability of these predictive factors, their integration and practical application in clinical decision-making remain challenging. this prospective observational study aims to address this gap by analyzing the interplay of these factors in real-world clinical settings, with the primary objective of deriving an integrated predictive model to guide surgeons in determining the optimal extent of resection preoperatively.

Eligibility criteria:
inclusion criteria: adult patients (≥ 19 years old) diagnosed with breast cancer (invasive and in situ). patients scheduled for surgical resection of the tumor availability of both preoperative tumor size assessments and pathologic measurements post-surgery exclusion criteria: patients with recurrent breast cancer inflammatory breast cancer patients who did not undergo surgery patients whose preoperative tumor size data is not available or deficient for analyzing

Keywords: breast cancer mastectomy ductal carcinoma in situ
caring light project for family caregivers

Conditions: Alzheimer Disease

Summary: caring light is designed to help caregivers of someone with alzheimer's disease and related dementia to cope with the difficulties related to caregiving, reduce stress, and improve quality of life.

the goals of this study are to evaluate materials related to dementia caregiving and how to cope with difficult situations faced by caregivers. based on this research, the investigators are developing the new caring light mobile app with a self-paced program to enhance the quality of life, a curriculum that incorporates relaxation techniques, and coping skills training.

Eligibility criteria:
inclusion criteria: * care for an individual with alzheimer's disease or other dementia. * own a smartphone or tablet and have internet access. * minimum age of 18 years old. * spend at least 8 hours/week caring for a person with dementia. exclusion criteria: * severe psychological or physical illness. * inability to read and follow english instructions. * high level of depressive symptoms. * unwillingness to participate in all aspects of the study.
northern colorado covid-19 biobank

Conditions: Covid19

Summary: the noco-cobio project is a biobanking effort to store and preserve saliva, nasopharyngeal, stool and blood specimens from sars-cov-2 pcr (polymerase chain reaction) positive individuals.

the investigators have created a biorepository of stool, saliva, nasopharyngeal swab specimens, peripheral blood mononuclear cells, serum, and plasma from sars-cov-2 infected individuals for research purposes. the multifaceted biorepository will be used to establish markers predicting various presentations of covid-19 (coronavirus disease 2019).

Eligibility criteria:
inclusion criteria: * those who have had a positive sars-cov-2 pcr test exclusion criteria: * under 18 years of age * pregnant

Keywords: biobank biorepository sars-cov-2 infection covid-19 coronavirus
ventilatory weaning guided by a new index

Conditions: Respiration, Artificial

Summary: mechanical ventilation (mv) is an essential therapy for patients with acute respiratory failure. the ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. in this sense, indices that can predict successful weaning are of great value.

mechanical ventilation (mv) is an essential therapy for patients with acute respiratory failure. the ventilatory weaning process should be started when the precipitating causes of the use of the ventilatory prosthesis are resolved. inappropriately slow weaning exposes the patient to unnecessary discomfort, increases the risk of complications and increases the cost of hospital treatment. in this sense, indices that can predict successful weaning are of great value. our study aimed to evaluate the performance of a new ventilatory weaning index, the timed inspiratory effort index (tie index), as a weaning predictor in comparison with the traditionally used spontaneous breathing test (sbt). the study is a randomized controlled trial of a cohort of mechanically ventilated patients over 24 hours admitted to the icu of hospital e clínica são gonçalo (hcsg), located in the city of são gonçalo, state of rio de janeiro, brazil. the tie index is calculated as the ratio of the maximum inspiratory pressure developed in the last 30 seconds of a 60 second period of unidirectional airway occlusion by the time required to reach this value.

Eligibility criteria:
inclusion and exclusion criteria our study included patients over 18 years old, under mechanical ventilation, who remained for more than 24 hours of invasive ventilatory assistance and who were able to start the process of weaning. exclusion criteria comprised tracheostomy, chronic neurological disorders, low level of alertness, and chronic immune suppression states, including positive serology for hiv.

Keywords: mechanical ventilator ventilator weaning spontaneous breath test predictive index
improving aspirin use in diabetes: a cluster randomized trial

Conditions: Diabetes Mellitus

Summary: our aim is to determine if a patient-directed intervention is more effective than computerized clinician reminders alone for improving aspirin use in adults with diabetes.

many patients with diabetes do not use aspirin to prevent cardiovascular events. quality improvement initiatives involving both patients and physicians may be more effective than physician-directed approaches alone. in a large urban primary care internal medicine practice, this study seeks to test if a patient-directed intervention is more effective than computerized clinician reminders alone for improving the appropriate use of aspirin in adults with diabetes. the study design is a cluster-randomized trial by physician. the frequency of self-reported regular aspirin use will be compared between patients cared for by physicians in the computerized reminder alone group and the computerized reminder plus physician-supervised, nurse practitioner intervention group.

Eligibility criteria:
inclusion criteria: diabetes mellitus * age at least 40 years old * at least 2 clinic visits in the 18 months prior to the intervention exclusion criteria: * primary care physician declined enrollment

Keywords: diabetes mellitus cardiovascular diseases aspirin quality of healthcare
plasma rich in growth factors for treatment of medication related osteonecrosis of the jaw

Conditions: Osteonecrosis Due to Drugs, Jaw

Summary: medication related osteonecrosis of the jaw (mronj) consists of progressive destruction of bone in the maxillofacial area. it is an established complication which occurs in patients who take two main classes of antiresorptive drugs: bisphosphonates (bp) and denosumab. prgf is a autologous platelet-enriched plasma obtained from the patient's own blood. it contains proteins that can influence and promote cell recruitment and its beneficial effect could consist in improving bone and soft tissue healing. these benefits are likely to apply to mronj surgery, as it is suggested by small retrospective or prospective case series. this is a randomized, multi center study comparing the outcomes of surgery alone and prgf plus surgery in patients requiring surgical treatment for mronj. to assess the superiority of surgery plus prgf compared to surgery alone in patients treated for mronj. primary endpoint for this scope is a composite of clinical or radiological recurrence rate of disease during a 12 months post-operative period. secondary endpoints are: a) morbidity, defined as nerve injury, bleeding, vascular or wound complications. b) post- and peri-operative pain defined by the treated subjects according to a standardized vas score c) quality of life (qol) defined by a standardized scale.


Eligibility criteria:
inclusion criteria: * subjects must be candidates for surgical treatment for mronj at stage 2 or 3. * subjects must be \>18 and \<80 years of age * subjects must sign a informed consent prior to randomization and must agree to return to scheduled follow-up visits exclusion criteria: * subject has inability to understand and cooperate with the study procedures or provide informed consent * subject has bleeding diathesis or coaugolapthy, or will refuse autologous blood sampling * subject had a cardiovascular event in the past 30 days * subject has any condition that limits their anticipated survival to less than 3 months
penicillin allergy risk-stratification and delabeling of low-risk patients

Conditions: Antibiotic Allergy

Summary: children are often reported to have antibiotics allergies, with approximately 10% of the us population labeled as allergic to an antibiotic, however, recent studies have demonstrated that the majority of symptoms reported as an allergy by parents are often non-ige-mediated adverse reactions or symptoms of a viral illness (e.g. rash, vomiting, diarrhea). additionally, over 90% of patients with reported penicillin allergy have negative skin testing results. several studies in children have found that an allergy questionnaire can accurately identify those who are at low risk for severe antibiotic allergy and the allergy label can be safely removed. appropriately delabeling antibiotic allergies has been shown to improve patient care through changing prescribing behavior and lowering health care costs. in this study, the investigators will perform a randomized trial comparing a provider-targeted clinical decision support tool to a pharmacist-led approach. the physician-targeted cds tool will inform providers of their patient's allergy risk stratification result, protocol, electronic health record order and documentation support. the pharmacist-led approach consists of electronic health record dashboard that includes identical information to the provider arm. the primary outcome will be the frequency of penicillin allergy encounters with an allergy label removed at the time of discharge. secondary outcomes will include the percentage of encounter with a penicillin allergy label in the electronic medical record 3 months after discharge, hospital length of stay and antibiotic utilization.


Eligibility criteria:
inclusion criteria: pediatric hospital medicine service existing penicillin allergy label in the ehr screened as low-risk for true pcn allergy (based on usual-care nursing intake questions at time of admission) exclusion criteria: none, provider may opt out of cds tool at any time
the hospice advanced dementia symptom management and quality of life trial (has-qol)

Conditions: Dementia

Summary: the aliviado dementia care program (formerly known as the dementia symptom management at home program, or dsm-h) was developed to implement dementia friendly care for persons with dementia and their caregivers living in the community. aliviado dementia care-hospice edition is a systems level quality assurance performance improvement program that includes interdisciplinary team training, validated assessment instruments, patient-centered care plans, treatment algorithms for behavioral and psychological symptoms of dementia and terminal delirium, and caregiver education pamphlets. utilizing the r61/r33 mechanism, the aliviado dementia care-hospice edition was successfully implemented in 2 sequential pilot trials in the hospice setting in 2019 (r61 phase). following the successful pilot trials and the attainment of the r61 milestones, the investigators now seek to test the effectiveness of aliviado dementia care-hospice edition in a pragmatic rct in 25 hospice agencies across the nation (r33 phase) on its ability to reduce antipsychotic use (primary outcome) and effect quality (secondary and exploratory outcomes).

as the population ages, the incidence rate of alzheimer's disease and related disorders (dementia) is expected to triple. the national alzheimer's plan recognizes that while the number of persons with dementia (pwd) is increasing substantially, the healthcare and long term care systems are unprepared to provide high quality, effective and efficient care to the pwd and their caregivers. pwd often have many behavioral and psychological symptoms of dementia (bpsd) including agitation, depression and sleep disturbances that affect both the quality of life (qol) of the pwd and the caregiver. unfortunately, due to a lack of programs to insert evidence-based care into the community, and hospice system specifically, pwd receive inappropriate and even harmful care. the investigators have developed the aliviado dementia care program (formerly known as the dementia symptom management at home program, or dsm-h) to implement dementia friendly care for pwd and their caregivers in the community. initially developed for use in home healthcare (hhc), the investigators have modified the program for use in hospice. the aliviado dementia care-hospice edition is a systems level quality assurance performance improvement (qapi) program that includes workforce training, and agency level workflow changes.

Eligibility criteria:
inclusion criteria: interdisciplinary team (idt) members: * all english speaking idt members * employed or contracted by the participating agency who are receiving aliviado dementia care-hospice edition online or champion training * all pwd (persons with dementia) who are newly admitted to a participating hospice during the timeframe following implementation of the intervention who are over the age of 50 and have an icd-10 code corresponding to a dementia diagnosis in their chart will be eligible. * greater than 18 years of age exclusion criteria: idt members: • idt members who are per diem