Kornimate/medical-research-clean huggingface dataset:
a study of atezolizumab in combination with nab-paclitaxel compared with placebo with nab-paclitaxel for participants with previously untreated metastatic triple-negative breast cancer (impassion130)

Conditions: Triple Negative Breast Cancer

Summary: this multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (mpdl3280a) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (tnbc) who have not received prior systemic therapy for metastatic breast cancer (mbc). the safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mbc and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.


Eligibility criteria:
inclusion criteria: * metastatic or locally advanced, histologically documented tnbc characterized by absence of human epidermal growth factor 2 (her2), estrogen receptor (er), and progesterone receptor (pr) expression * no prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic tnbc * eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control) * a representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting er, pr, and her2 negativity. participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with medical monitor * eastern cooperative oncology group performance status of 0 or 1 * measurable disease as defined by recist v1.1 * adequate hematologic and end-organ function exclusion criteria: * known central nervous system (cns) disease, except for treated asymptomatic cns metastases * leptomeningeal disease * pregnancy or lactation * history of autoimmune disease * prior allogeneic stem cell or solid organ transplantation * positive test for human immunodeficiency virus * active hepatitis b or hepatitis c * receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo
electromagnetic field versus diclofenac drugs on primary dysmenorrhea

Conditions: Electromagnetic Field; Dysmenorrhea

Summary: electromagnetic field versus diclofenac drugs on primary dysmenorrhea: arandomized controlled trial in the egyptian women

background: primary dysmenorrhea is one of the most common complaints of women and is also the most common gynecological problem worldwide. these cramps are recurrent and 90% adolescent girls and about 50% women suffer from it. purpose of the study: to determine which is more effective in alleviating primary dysmenorrhea; pulsed electromagnetic field or diclofenac drugs. methodology: the study was a randomized, double-blinded trial, fifty adult females participated in this study, were divided randomly into two groups equal in numbers: group (a) received pulsed electromagnetic field applied on pelvic region, 3 times per week for 3 months, 20 minutes per day and group (b) received diclofenac tablets, 50 mg only with onset of menstrual pain. all participants in both groups (a and b) were assessed pre- and post-treatment through measuring progesterone level in the blood, assessment of pain using visual analogue scale and physical as well as psychological symptoms by using menstrual symptom questionnaire.

Eligibility criteria:
inclusion criteria: -regular menstrual cycle 21-35 days lasting 3-7 days exclusion criteria: * irregulars or infrequent menstrual cycles, pacemaker, myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis

Keywords: dysmenorrhea pulsed electromagnetic field diclofenac
follow-up study for exubera

Conditions: Diabetes Mellitus

Summary: in studies of exubera in persons with diabetes, lung cancer occurred in a few more people who were taking exubera than in people who were taking other diabetes medicines. all subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. there is currently not enough information to determine if any of the observed lung cancer cases were related to exubera use, therefore, the study is being conducted to further investigate whether exubera use makes the appearance of lung cancer more likely.

both retrospective and prospective components all subjects who participated in one of the 17 included exubera clinical trials will be invited to participate in the current study.

Eligibility criteria:
inclusion criteria: * previously participated in an eligible exubera clinical trial * willing to provide study doctor with at least one alternate contact person exclusion criteria: * participated in an investigational study of an unapproved drug since completing the exubera trial * ever used an other (non-exubera) inhaled insulin

Keywords: observational study exubera
invent-vision study

Conditions: Otitis Media

Summary: the objective of the study is to evaluate the safety and efficacy of the acclarent tympanostomy tube delivery system (tds) for the placement of tympanostomy tube tt(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.


Eligibility criteria:
inclusion criteria: * scheduled to undergo tympanostomy tube insertion * at least 6 months old * behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement) * no history of sensitivity or reaction to anesthesia chosen for the procedure exclusion criteria: * pregnant or lactating females * significantly atrophic, bimeric, or completely atelectatic tympanic membrane * otitis externa * lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal * cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane * electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) * anatomy that precludes sufficient visualization of and access to the tympanic membrane * anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Keywords: tympanostomy tube placement iontophoresis
effects of vitamin d and calcium supplementation on health and well-being of vitamin d deficient uae citizens

Conditions: Vitamin D Deficiency

Summary: the trial plan to determine whether a daily capsule containing vitamin d(3) (2000 iu), calcium (600 mg), both, or a placebo for 6 months in uae citizens with evidence of vitamin d deficiency will lead to a clinical benefit. the proposed study will also determine the threshold of vitamin d and calcium intake or levels considered optimal for uae citizen's health

the proposed study is a two by two factorial, randomized controlled intervention trial. following informed written consent of eligible subject's blood and urine samples will be taken for measurements of vitamin d, markers of bone turnover and related biochemical variables. patients who have evidence of vitamin d deficiency will then be randomly assigned to receive daily vitamin d(3) (2000 iu), calcium (1000 mg), both, or a placebo for 6 months. all subjects will have a calcium and vitamin d rich food and other lifestyle modification advises during the study period. patients will otherwise be managed according to standard practice. clinical assessment that includes general and self-rated health, bone density, muscle strength, physical activity and dietary intakes will be performed at baseline, and repeated at 3, 6 and 12 months post-randomisation. information on other important variables likely to influence vitamin d status including age, reproductive \& menopausal history, smoking, medications, adiposity, exposure to sunlight, dietary intake including supplements, skin pigmentation, chronic illness and medications will be collected and adjusted for during the analysis

Eligibility criteria:
inclusion criteria: 1. biochemical evidence of vitamin d deficiency exclusion criteria: 1. renal disease or stones or hypercalcaemia, 2. use of calcium and/or vitamin d supplementation, bisphosphonates, steroid medications, hormones or diuretics.
enhanced stress resilience training for critical care nurses

Conditions: Job Stress; Burnout

Summary: job stress and burnout are significant problems affecting physical health, emotional well-being, job performance, and retention of nurses. enhanced stress resilience training (esrt) is a theory-driven, evidence-based intervention to increase stress resilience and decrease burnout among clinicians. this study is a randomized waitlist-controlled trial to examine the efficacy, feasibility, and long-term sustainability of the 5-week esrt intervention to improve psychosocial and occupational well-being of critical care nurses.

the critical care setting is a stressful work environment where nurses provide intensive care to patients with life-threatening conditions. regular job stress from the complex and fast-paced critical care work environment has been further intensified during the covid-19 pandemic, which resulted in unprecedented challenges to health systems and has affected psychosocial and occupational wellbeing of healthcare workers. high or chronic job stress that is not properly managed can lead to burnout, which is characterized by emotional exhaustion, depersonalization, and decreased personal accomplishment. burnout has negative impacts on physical and mental health (e.g., fatigue, anxiety, depression, sleep disorders), job performance or productivity (e.g., absenteeism, presenteeism), quality of care and patient care outcomes. burnout also negatively affects nurses' retention and job turnover. the global prevalence of burnout among nurses ranges from 0.1% to 47.8% (pooled prevalence 11.2%) and critical care nurses are reported to have the highest prevalence of burnout (14.4%) among all specialties. therefore, there is a substantial need to address burnout and promote occupational wellness of critical care nurses. enhanced stress resilience training (esrt) is a theory-driven, evidence-based intervention developed by ucsf associate professor of surgery, dr. carter lebares aimed at increasing stress resilience and decreasing burnout among clinicians. the purpose of this study is to examine the efficacy, feasibility, and long-term sustainability of the 5-week esrt intervention to improve psychosocial and occupational well-being among critical care nurses. the study will conduct a randomized waitlist-controlled trial among 100 ucsf critical care nurses.

Eligibility criteria:
inclusion criteria: * adult critical care nurses employed at ucsf health. exclusion criteria: * those who cannot commit to participation in all five esrt sessions * temporary travel nurses.

Keywords: burnout job stress resilience nurse critical care
three-month chan-chung qigong improves physical function performance and quality of life

Conditions: Cognitive Dysfunction; Cognitive Aging; Grip; Exercise Training; Physical Endurance; Cognitive Decline

Summary: the purpose of this study aimed to evaluate the effect of the three-month chan-chung qigong program in improving physical functional performance and quality of life in patients with mild to moderate cognitive impairments.a quasi-experimental design was adopted. subjects were recruited from cognitive impairments outpatients these subjects,41were assigned to the control group and 41 to the experimental group in which chan-chuang qigong was administered.

this study randomized controlled trial with four repeated measurements was conducted between apply 2016 and october 2017. participants in the qigong group were given a structured program about chan-chung qigong for 3 months; those in the control group received usual care for cognitive impairment during the same study period. the intervention effects were measured by muscular strength, muscular endurance, and 6-min walk distance at baseline, month 1, month 2, and month 3. in addition, qol was measured at baseline and month 3.

Eligibility criteria:
inclusion criteria: * participants invited in this study were aged more than 60 years, diagnosed with the clinical dementia rating (cdr) ≦1, able to communicate, free to stand and walk, and willing to participate this study. exclusion criteria: * the exclusion criteria were as followings: use of hormone drugs, brain trauma, head surgery, vitamin b12 deficiency, decreased memory and judgment due to hypothyroidism or malnutrition with medical contraindications for exercise, and practicing qigong or exercise regularly.

Keywords: cognitive inpairment qigong / exercise muscle strength /endurance quality of life physical activity
lateral mini approach vs anterior approach for plating of proximal humerus fracture

Conditions: Closed Fracture Proximal Humerus, Neck

Summary: a prospective randomized clinical trial is proposed to compare the plate fixation of proximal humerus fractures using a minimally invasive lateral approach and the traditional anterior approach.forty five patients will be assigned to each approach (total of 90 patients) and will be assessed 7 times over a two-year period. the trial's primary objectives will be to demonstrate the efficacy of the plating technique in terms of speed of recuperation of function. the quick dash will be used for evaluation of function.the study will also examine secondary end-points of pain, range of motion, esthetic satisfaction and radiographic outcome, as assessed by the components of the constant score3,4, sf-12v2 questionnaire, and patient scare assessment scale questionnaire. furthermore, the assessment of safety will be based on the rates of all reported complications and adverse events at 2 years


Eligibility criteria:
inclusion criteria: 1. humeral surgical neck fracture, neer ii valgus-type neer iii 2. patient willing to participate in the study 3. patient available for follow-up through at least two years 4. patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk 5. patient fluent in french and/or english and able to understand his/her role in the study exclusion criteria: 1. inflammatory arthritis 2. prior shoulder pathology 3. active local or systemic infection 4. neurologic or musculoskeletal disease that may adversely affect mobility 5. participation in any other pharmaceutical, biologic or medical-device clinical investigation 6. severe documented psychiatric disease 7. severe ipsilateral elbow or wrist disease 8. fracture resistant to reduction attempts through the minimally invasive lateral approach

Keywords: humerus fracture
preoperative educational videos on maternal stress whose children received congenital heart disease surgery: during covid-19 panic

Conditions: COVID-19; Educational Videos; Maternal; Uncertainty; Anxiety; Depression; Congenital Heart Disease; Children

Summary: during covid-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more after education, and until the day of discharge. compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more on the discharge day if their child had surgical or post-surgical complications.

aims and objectives: during covid-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. background: mothers experience uncertainty, anxiety and depression if their children undergo conditions mentioned above. such stress would be more during covid-19 panic. design: a randomized control-group pretest-posttest design. the consort checklist is used. methods: during covid-19 panic, in a teaching hospital, 120 mothers whose children underwent first elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine education plus digital video disk before surgery; and group 2: 60 mothers receiving routine education. between groups, mothers' uncertainty, anxiety and depression levels were compared (1) before education, (2) after education (before surgery) and (3) on the discharge day. among mothers whose children had surgical or post-surgical complications, the effect of watching the digital video disk on uncertainty, anxiety and depression at discharge day was evaluated.

Eligibility criteria:
inclusion criteria: * mothers, whose children underwent first elective cardiac surgery for congenital heart disease * mothers should have been the primary caregivers * mothers able to communicate effectively, either orally or in writing exclusion criteria: * mothers of children with genetic disorders * mothers of children with non-cardiac congenital anomalies * mothers of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and \* \* mothers of children with chronic lung diseases
waitlist-control trial of smartphone cbt for obsessive-compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: the investigators are testing the efficacy of smartphone-delivered cognitive behavioral therapy (cbt) treatment for obsessive compulsive disorder (ocd). the investigators hypothesize that participants receiving app-cbt will have greater improvement in y-bocs scores than those in the waitlist condition at treatment endpoint (week 12).

the primary aims of this study are to test the efficacy of a smartphone-based cbt treatment for adults with ocd recruited nationally. eligible subjects (n=58) will be randomly assigned to 12 weeks of smartphone-delivered cbt for ocd either immediately, or after a 12-week long waiting period (50-50 chance). the investigators hypothesize that smartphone-delivered cbt for ocd will be feasible and acceptable to individuals with ocd, and that it will lead to greater reductions in ocd symptom severity compared to the passage of time (waitlist control).

Eligibility criteria:
inclusion criteria: * at least 18 years of age * current diagnosis of primary dsm-5 ocd, based on mini * currently living in the united states exclusion criteria: * psychotropic medication changes within 2 months prior to enrollment (participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period) * past participation in ≥ 4 sessions of cbt for ocd * current severe substance use disorder * lifetime bipolar disorder or psychosis * acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the c-ssrs * current severe comorbid major depression, as indicated by clinical judgment and/or a qids-sr total score ≥ 21 * concurrent psychological treatment * does not own a supported mobile smartphone with a data plan * lack of technology literacy that would interfere with ability to engage with smartphone treatment
mutation of the btk gene and genotype-phenotype correlation of chinese patients with x-linked agammaglobulinemia

Conditions: Agammaglobulinemia, BTK

Summary: x-linked agammaglobulinemia (xla) is a humoral primary immunodeficiency in which affected patients have very low levels of peripheral b cells and a profound deficiency of all immunoglobulin isotypes. mutations in the gene encoding for bruton's tyrosine kinase (btk) are responsible for most of the gammaglobulinemia. we tend to investigate the gene mutation and clinical features of chinese x-linked agammaglobulinemia (xla) patients, and also examined the relationship between specific btk gene mutations and severity of clinical presentation.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of xla a.male patients with less than 2% cd19-positive b cells; b.recurrent bacterial infection; c.decreased or absent immunoglobulins in serum exclusion criteria for all groups: * presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for xla
assessment of multifocal continuous theta burst transcranial magnetic stimulation (ctbs) effects in generalized epilepsy patients.

Conditions: Generalized Epilepsy

Summary: the goal of this clinical study is to assess the efficacy of multifocal theta burst transcranial magnetic stimulation in the prevention of epileptic seizures in adult patients with generalized epilepsy. the main questions it aims to answer are: * how does multifocal continuous theta burst stimulation (ctbs) impact the frequency and severity of epileptic seizures? * does ctbs influence the quality of life in patients with generalized epilepsy? * what is the safety and tolerability profile of the experimental multifocal ctbs protocol?


Eligibility criteria:
inclusion criteria: - adult patients with generalized epilepsy (according to ilae 2017 classification of epilepsy). exclusion criteria: * refusal to sign the informed consent; * focal, combined or unknown epilepsy (according to ilae criteria); * drug-resistant form of epilepsy (according to ilae definition); * history or symptoms of renal or hepatic failure; * history of oncological disorder; * uncontrolled high blood pressure; * cognitive impairment; * psychiatric disorders; * signs of structural brain injury or focal neurological symptoms; * use of opioids or muscle relaxants; * history of substance abuse; * ferromagnetic implants in head and neck regions; * cardiac pacemakers; * pregnancy or lactation.

Keywords: tbs ctbs ige generalized epilepsy theta burst transcranial magnetic stimulation continuous
safety and efficacy of sparc1203 in allergic rhinitis

Conditions: Allergic Rhinitis

Summary: this study will assess safety and efficacy of sparc1203 delivered via nasal spray in patients with allergic rhinitis


Eligibility criteria:
inclusion criteria: * male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test exclusion criteria: * history or presence of perennial allergic rhinitis * upper or lower respiratory tract infection 2 weeks before visit 2 * significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone * immunizations or vaccinations within 4 weeks prior to visit 1