Kornimate/medical-research-clean huggingface dataset:
a study of abiraterone acetate plus prednisone with or without abemaciclib (ly2835219) in participants with prostate cancer

Conditions: Prostate Cancer

Summary: this study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. prednisolone may be used instead of prednisone per local regulation.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate. * metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by ct or magnetic resonance imaging (mri). * progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (adt)/post orchiectomy defined as one or more of the following: * psa progression * radiographic progression per response evaluation criteria in solid tumors (recist)1.1 for soft tissue and/or per prostate cancer working group 3 (pcwg3) for bone, with or without psa progression * have adequate organ function. * eastern cooperative oncology group (ecog) performance status (ps) 0-1. exclusion criteria: * prior therapy with cytochrome p450 (cyp)17 inhibitors. * prior treatment with abemaciclib or any cyclin-dependent kinase (cdk) 4 \& 6 inhibitors. * prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer \[mhspc\] are eligible). prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-t. participants who had prior radiation or surgery to all target lesions. * currently enrolled in a clinical study involving an investigational product. * gastrointestinal disorder affecting the absorption or ability to swallow large pills. * clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (child-pugh class b and c).

Keywords: metastatic castration resistant prostate cancer mcrpc
anti-psychotic medication (stable dose) weight loss study

Conditions: Obesity

Summary: this is a pilot study to determine the safety and efficacy of an investigational product (ihbg-10) on weight change and changes in body composition in subjects who have been taking a stable dose of certain anti-psychotic medications for longer than three months.

a total of 80 subjects will be enrolled in this study: 20 subjects will be randomized to receive placebo, and 60 will be randomized to receive the investigational product (20 who are on a stable dose of seroquel, 20 who are on a stable dose of risperdal, and 20 who are on a stable dose of zyprexa). the investigational product or placebo will be taken 15 minutes prior to the three main meals of the day. subjects will continue to take their prescribed anti-psychotic medications. participation in this study involves four study visits.

Eligibility criteria:
inclusion criteria: * men and women, age 18 and older * agree to keep diet, exercise and all current health habits stable during participation in the study * currently on a stable dose of risperdal (risperidone), seroquel (quetiapine) and/or zyprexa (olanzapine) for at least three months exclusion criteria: * current active acute psychotic episode * women who are pregnant, breastfeeding, or planning to become pregnant * prior bariatric surgery * use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month * obesity as a result of a clinically-diagnosed endocrine problem

Keywords: obesity weight loss weight management anti-psychotic medication zyprexa seroquel risperdal
cross-sectional study for identification and description of severe asthma patients

Conditions: Asthma

Summary: this will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. investigational product will not be administered. approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. the study will not include a run-in or follow-up period. this study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. this study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.


Eligibility criteria:
inclusion criteria: * at least 12 years of age at study visit. * participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the european respiratory society/ american thoracic society (ers/ats) guidelines for severe asthma: asthma which requires treatment with guideline suggested medications for global initiative for asthma (gina) steps 4-5 asthma for the previous year (i.e., at least 12 months). patients must be treated with high dose ics plus at least one of the following: laba, leukotriene modifier, theophylline, or continuous or near continuous systemic corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year). special circumstance: if patient is on a fixed dose combination medication, then the maximum recommended dose of the ics/laba combination per local label is acceptable. * able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. a parent or legal guardian must provide informed consent for participants less than 18 years of age at study visit (or less than minimum age to be considered an adult per local laws). exclusion criteria: participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to visit 1 (note: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)

Keywords: mepolizumab omalizumab sb-240563 severe asthma reslizumab
the role of anthropometric measurements and ultrasonograpic suprasternal adipose tissue thickness

Conditions: Intubation; Difficult or Failed; Obesity; Anesthesia

Summary: prediction of difficult preoperative intubation in obese patients and completion of preparations for difficult intubation both reduce the risk of repeated intubation and prevent complications. in this study, the investigators aimed to evaluate whether anthropometric measurements are superior in defining difficult preoperative airways.

the world health organization (who) defines obesity, the incidence of which has increased significantly worldwide and is one of the important causes of difficult airway in terms of anesthesia, as obesity when the body mass index (bmi) is above 30. access to the upper airway is difficult in obese patients, in whom excessive adipose tissue accumulates in the breast, neck, chest, and abdomen. determining preoperative difficult intubation parameters in obese patients and entering the case preparation both reduce the risk of repeated intubation and prevent intraoperative and postoperative complications. however, there are still insufficient tests to predict difficult intubation. many studies have shown that multiple factors such as mallampati score, high body mass index (bmi), increased neck circumference, and the ratio of neck circumference to thyromental distance are predictors of difficult intubation in obese patients. the introduction of ultrasonography into daily use has led to the use of ultrasonographic parameters in predicting difficult intubation and laryngoscopy. in this study, the investigators aimed to evaluate whether ultrasonography is useful in defining difficult preoperative airways, in addition to anthropometric measurements.

Eligibility criteria:
inclusion criteria: * 18-60 years * asa 1-3 * bmi ≥30 kg/m2 * asa 1-3 * scheduled for elective abdominal surgery under general anesthesia exclusion criteria: * \ 60 years * asa\>3 * bmi\<30
effects of behavioral interventions on mechanisms of pain regulation and hedonic regulation

Conditions: Chronic, Non-neuropathic Back Pain

Summary: the overarching aim of this project is to conduct a randomized controlled study to determine whether mindfulness-oriented recovery enhancement (more) vs. a support group (sg) can improve pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back pain patients (cnbp) and thereby improve clinical pain, affect, and opioid use.


Eligibility criteria:
inclusion criteria: 1. age 21-60 years of age 2. english fluency 3. 20/20 vision with corrective lenses 4. current chronic, non-neuropathic back pain diagnosis determined by physician assessment 5. reporting pain ≥3 on 0-10 scale with opioid medication 6. current use of prescription opioids for ≥3 consecutive months 7. ability to understand study procedures and to comply with them for the entire length of the study exclusion criteria: 1. mindfulness experience (e.g., mbsr or shamatha/vipassana meditation) 2. psychosis 3. untreated, active suicidality in the past month 4. and severe non-opioid substance use disorder in the past year as assessed with the mini 5. clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain 6. pregnancy 7. inability or unwillingness of individual to give written informed consent 8. physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.
cannabis use on sedation for oral surgery procedures

Conditions: Cannabis Use

Summary: the use of cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. the purpose of this clinical trial is to clarify the influence of chronic cannabis use during office based general anesthesia for extraction of teeth. the procedures will be performed in the oral and maxillofacial surgery clinic at the college of dentistry.


Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * class i or ii according to the american society of anesthesiology (asa) * need for dental extractions * extraction procedures with similar level of complexity exclusion criteria: * surgical time lesser than 10 or greater than 30 minutes * asa status of iii or greater * bmi greater than 30 k/m2 * pregnancy * use of anti-depressants, sedatives, or other mood-altering medications * history of illicit substance abuse, alcoholism, or chronic opioid use
a trial of centanafadine efficacy and safety in adolescents with attention- deficit/hyperactivity disorder

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: this trial was conducted to evaluate the efficacy and safety of the centanafadine once daily (qd) extended release (xr) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (adhd).

the trial consisted of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day follow-up period.

Eligibility criteria:
inclusion criteria: * males and females aged 13 to 17 years (inclusive) at the time of informed consent/assent. * a primary diagnosis of adhd based on diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) diagnosis criteria as confirmed with the mini international neuropsychiatric interview for children and adolescents (mini-kid). * a minimum symptoms total raw score of ≥ 28 on the attention-deficit/hyperactivity disorder rating scale version 5 (adhd-rs-5) at baseline for all participants. * a score of 4 or higher on the clinical global impression - severity - attention deficit/hyperactivity disorder (cgi-s-adhd) at baseline. exclusion criteria: * a comorbid diagnosis of: tourette's disorder, generalized anxiety disorder severe enough to interfere with trial procedures, panic disorder, conduct disorder, psychosis, post-traumatic stress disorder, bipolar disorder, autism spectrum disorder, binge eating disorder, anorexia, bulimia, oppositional defiant disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), obsessive-compulsive disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or major depressive disorder (mdd) with current major depressive episode. * participants who are breast-feeding and/or have a positive pregnancy test result prior to receiving investigational medicinal product (imp). * a significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, current suicidal behavior, imminent risk of injury to self, active suicidal ideation. history of suicidal behavior (over the last 6 months). * body mass index (bmi) ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on united states (us) centers for disease control and prevention (cdc) criteria. * has initiated, changed, or discontinued receiving psychological interventions for adhd within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.

Keywords: centanafadine adhd
" role of diffusion weighted image in the diagnosis and follow up of breast cancer"

Conditions: Breast Cancer

Summary: breast mri has become an important tool for breast cancer detection and characterization.contrast enhanced mri(ce-mri) is currently the most sensitive detection technique for diagnosis of breast cancer.

most of the lesions that occur in the breast are benign lesions. it is important to recognize benign lesions and distinguish them from breast cancer. nowadays sonomammography still represents the primary imaging modality utilized for breast cancer screening and diagnosis. breast mri has become an important tool for breast cancer detection and characterization.contrast enhanced mri(ce-mri) is currently the most sensitive detection technique for diagnosis of breast cancer.diffusion weighted imaging provides micro-structural informations regadrding the diffusion of the water molecules in the tissue cellularity and tissue structure by using the quantitive analysis with the apparent diffusion coefficient (adc) values. using diffusion weighted imaging (dwi) combined to mri is helpful to distinguish malignant versus benign breast lesions and it also may reduce the number of unnecessarily breast biopsies.

Eligibility criteria:
inclusion criteria: * \* female gender * age more than 18 years * patients presented with breast lump * patients with recurrent breast cancer following chemotherapy or radiotherapy sessions. exclusion criteria: * male gender * age younger than 18 years * patients with recent breast trauma in the same diseased breast within the last 6 months * lactating female presented with acute symptoms as trauma or breast abscess * contraindication to perform mri examination .these include : cardiac pacemaker -metallic aneurysm clips
effectiveness of nefopam for thermoregulation during surgery

Conditions: Hypothermia

Summary: nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia

hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory defenses including vasoconstriction and shivering. nefopam, a non-opioid, nonsteroidal centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without sedation, making it an ideal candidate to counteract thermoregulatory shivering. since complete compartmental pharmacokinetics (pk) are lacking this prospective, randomized, double-blind study in 8 volunteers was set to investigate the pk of arterial nefopam samples with non-linear mixed effect modelling. a two compartment mammillary model independent of covariates was found to describe the data best and could be implemented to drive automated pumps, achieving and maintaining a desired plasma concentration.

Eligibility criteria:
inclusion criteria: * normal healthy volunteers ages 18-40 exclusion criteria: * history of alcohol or drug abuse

Keywords: nefopam pharmacokinetics shivering, thermoregulation anesthesia
high dose vs. standard influenza vaccine in adult sot

Conditions: Influenza; Immunosuppression

Summary: the study will test whether a high dose influenza vaccination results in improved immunogenicity in adult sot recipients as compared to standard vaccine. this will be a single center prospective observer-blind randomized controlled trial conducted at the toronto general hospital multi-organ transplant unit, university health network, toronto, ontario, canada.

influenza virus is an important cause of morbidity and mortality in the transplant population and can lead to viral and bacterial pneumonia. although the annual influenza vaccine is recommended for transplant patients, studies have shown that standard vaccine has poor immunogenicity. currently, there are no studies that define the effect of high-dose vaccine in adult transplant recipients even though this population could potentially benefit from it. the study will compare the immunogenicity of two different types of the influenza vaccine in 240 solid organ transplant patients during the 2016-2017 season. patients will be randomized to receive either high-dose or standard dose influenza vaccine. antibody titers will be evaluated by a standard hemagglutination inhibition assay. the hypothesis is that the patients who receive the high-dose influenza vaccine will reach a significantly greater response to the vaccine. this study advances research on the prevention of serious viral infections in transplant recipients. results from this study have the potential to directly improve patient care. if the use of the high-dose influenza vaccine is successful, this strategy may lead to significant reduction in burden of disease, hospitalization, and long-term morbidity.

Eligibility criteria:
inclusion criteria: * organ transplant recipient on at least one immunosuppressive * age \>=18 * outpatient status * greater than 3 months post transplant exclusion criteria: * has already received influenza vaccination for 2016-2017 season * egg allergy or allergy to previous influenza vaccine * febrile illness in the past one week * active cytomegalovirus viremia * use of rituximab in the past 6 months * ongoing or recent (in past 30 days) therapy for acute rejection * chronic kidney insufficiency (creatinine clearance ≤30ml/min or dialysis-dependent * previous life-threatening reaction to influenza vaccine (i.e. guillain barre syndrome) * receipt of intravenous immunoglobulin (ivig) in the past 30 days or planning to receive ivig in the next 4 weeks

Keywords: influenza solid organ transplant infection vaccine immunogenicity
to evaluate the performance of two monthly replacement silicone hydrogel contact lenses after 1-month of wear

Conditions: Myopia

Summary: to evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual frp cl wearers when worn for 1-month.

this study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement cl types. each lens will be worn bilaterally for approximately one month.

Eligibility criteria:
inclusion criteria: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. self-reports having had a full eye examination within the previous 2 years; 3. has read and signed an information consent letter; 4. is willing and able to follow instructions and maintain the appointment schedule; 5. is a habitual wearer of frequent replacement contact lenses; 6. anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study; 7. has refractive astigmatism no higher than -0.75dc in each eye; 8. can be successfully fit with both study lens types; 9. achieves at least 0.4 logmar va monocularly and at least 0.2 logmar va binocularly with each study lens type. exclusion criteria: 1. is participating in any concurrent clinical research study; 2. has any known active ocular disease and/or infection; 3. has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration; 4. is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration; 5. has known sensitivity to the diagnostic sodium fluorescein to be used in the study; 6. is an employee of the centre for ocular research \& education.
agmt austrian cll (chronic lymphocytic leukemia) registry

Conditions: Chronic Lymphocytic Leukemia

Summary: for until very recently cll has been considered an uncurable disease, with the only few exceptions of a part of patients capable of undergoing and successfully standing allogeneic stem cell transplant. however, the introduction of chemoimmunotherapy in particular the fcr (fludarabine, cyclophosphamide, rituximab) regimen has established a relevant population of igvh mutated patients, who remain relapse-free for up to 10 years with a clear plateau at this level. however, for the largest proportion of all cll patients the disease is still associated with a reduction in life expectancy as compared to a matched population. the field has made further substantial progress by the introduction of btk inhibitors and bcl2 inhibitors, novel antibodies as well as by the understanding of the role of minimal residual disease (mrd), mutations and their clonal evolution over time as risk factors and factors governing the kind and duration of therapy. due to the limited follow up of frontline therapy trials using novel drugs, it is not yet clear, what the long-term results with many of the new drugs will be. particularly, long-term pfs, the potential for cure and the long-term safety issues remain relevant parameters requiring examination, as are infections, interactions with other drugs or quality of life issues. cll has not been systematically assessed in austria to date. this medical registry of the agmt is thus the first austrian-wide standardized documentation of this disease.

this registry is designed as multicenter observational cohort of patients with cll. patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. this patient follow-up data will be obtained until patient death or loss to follow-up. for documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. participation in the registry must not interfere with treatment routines. only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic case report forms. to maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry. a written consent must be obtained prior to the input of data. no informed consent is required from deceased patients.

Eligibility criteria:
inclusion criteria: * the registry will include patients ≥ 18 years with cll. exclusion criteria: * there are no specific exclusion criteria.