Kornimate/medical-research-clean huggingface dataset:
study of bgb-a333 alone and in combination with tislelizumab in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: bgb-a333 is a humanized igg1-variant monoclonal antibody against programmed cell death 1-ligand 1 (pd-l1), the ligand of an immune check point- receptor, programmed cell death-1 (pd-1). bgb-a317 is a humanized, igg4-variant monoclonal antibody against pd-1. this study tested the safety and anti-tumor effect of bgb-a333 alone and in combination with bgb-a317 in participants with advanced solid tumors.


Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically confirmed advanced or metastatic disease (unresectable) that is resistant to standard therapy or for which treatment is not available, not tolerated or refused 2. has eastern cooperative oncology group (ecog) performance status ≤1 3. has adequate organ function key exclusion criteria: 1. active brain or leptomeningeal metastasis. 2. active autoimmune diseases or history of autoimmune diseases that may relapse. 3. with severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma) 4. concurrent participation in another therapeutic clinical trial. 5. received prior therapies targeting pd-1 or pd-l1. note: other protocol defined inclusion/exclusion criteria may apply.
wavefront analysis and contrast sensitivity after cataract surgery with akreos advanced optics intraocular lens implantation

Conditions: Lens Implantation, Intraocular

Summary: purpose: to determine whether implantation of an intraocular lens (iol) with a modified anterior and posterior aspherical surface (akreos ao, bausch \& lomb,inc) results in reduced ocular aberrations (spherical aberration) and in improved contrast sensitivity after cataract surgery. study hypothesis: the implantation of an intraocular lens (iol) with a modified anterior and posterior aspherical surface (akreos ao, bausch \& lomb,inc) results in reduced ocular aberrations (spherical aberration) and improved contrast sensitivity after cataract surgery. setting: department of ophthalmology, hospital das clínicas, university of são paulo, são paulo, brazil. overall study design: this will be an intraindividual randomized double-blinded prospective study. patients will be randomized to receive an aspheric iol akreos ao in one eye (25 eyes; bausch \& lomb, inc), and an spheric iol akreos fit (25 eyes; bausch \& lomb, inc.) in the fellow eye. ocular aberrations with a 5.0 mm and 6.0 mm pupil will be measured with a dynamic retinoscopy aberrometer after 1 and 3 months. uncorrected and best-corrected visual acuity, out-focus performance and contrast sensitivity under mesopic and photopic conditions will be also measured. all patients will be followed for 3 months.

patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0d (diopters) will be eligible for inclusion in the study. exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, iol tilt, iol decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up. patients will be examined before surgery and at 1, 7, 30, 90 days after surgery.

Eligibility criteria:
inclusion criteria: * patients with bilateral visually significant cataract with corneal astigmatism lower than 2.0d (diopters) exclusion criteria: * ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities * surgical complications * intraocular lens (iol) tilt, iol decentration greater than 0.4 mm (estimated by retroillumination) * incomplete follow-up.

Keywords: intra-ocular lenses comparative study ocular aberrations contrast sensitivity
ketamine for opioid use disorder

Conditions: Opioid Use Disorder

Summary: the goal of this clinical trial is to learn if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. the main questions it aims to answer are: * does ketamine reduce craving for opioids in patients with opioid use disorder? * does ketamine reduce symptoms of opioid withdrawal such as depression, pain, and poor sleep quality? * do patients who take ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the placebo? researchers will compare ketamine to an active placebo (a look-alike substance that contains a drug that does not do anything to help the condition it is supposed to treat but will mimic some of the side effects of ketamine) to see if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. participants will: * be given ketamine or a placebo 4 times over a period of 2 weeks * visit the clinic weekly and monthly for checkups and tests for 90 days post-intake


Eligibility criteria:
inclusion criteria: 1. age 18 to 65 years old 2. recent history (most recent 2 weeks prior to clinic intake) of routine use of illicit opioids, 5+ times/week 3. fulfillment of dsm-5/icd-10 criteria for moderate-to-severe opioid use disorder 4. acceptance into methadone treatment for opioid use disorder within the past 14 days at the time of screening. exclusion criteria: 1. routine use of prescribed medications for oud (5+ days/week) for longer than the 14 days leading up to clinic intake. source: self-report, h\&p 2. recent prescribed or illicit benzodiazepine, ketamine, or pcp use that exceeds 5+ days/week for the last 3 months. source: h\&p 3. pregnant and/or breastfeeding. source: uds, h\&p 4. stage 4 hypertension, defined by a systolic blood pressure (sbp) \> 180 mmhg or a diastolic blood pressure (dbp) \> 120 mmhg. source: h\&p 5. clinically significant abnormal findings for which study participation is deemed unsafe. source: h\&p 6. severe mental illness or psychiatric disorder for which study participation is deemed unsafe (except for depression, ptsd, and substance use disorder). source: h\&p 7. \*\*severe hepatic impairment (baseline alkaline phosphatase or aspartate aminotransferase \> 5 times the upper limit of normal. source: labs * note: due to time constraints in the study design, exclusion criterion #7 does not need to be met before the initial consent to participate. this criterion only needs to be established prior to the first esketamine/placebo session. this will allow us to enroll participants as soon as possible, giving more time and flexibility to complete the baseline/weekly assessments before the first esketamine/placebo session. individuals that are initially enrolled and subsequently do not qualify due to severe hepatic impairment will be considered screen failures and withdrawn from the protocol.

Keywords: opioid use disorder ketamine craving treatment adherence methadone
pharmacogenetics, therapeutic drug monitoring (tdm) and active pharmacovigilance as innovative tools aimed at the optimisation/ appropriateness of drug therapy

Conditions: Adverse Drug Reaction (ADR)

Summary: the primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, tdm (therapeutic drug monitoring) and medreview into the clinical practice in order to optimize the appropriateness of drugs prescription and to minimise the risk of adverse drug reactions (adrs) in adult cancer patients and in pediatric patients affected by chronic inflammatory diseases. this approach of active pharmacovigilance will also allow a better definition of the causality assessment of adrs through the direct implementation of data quality in the reporting forms. the study may therefore constitute an example of an approach for both the prevention of adrs and the optimization of drug use, and for the integration of pharmacogenetics, tdm, and the medreview data into the national pharmacovigilance reports for an improved and innovative evaluation of adverse events, aiming at the implementation of this approach in the regional context.

primary aim of the study: to implement the use of pharmacogenetics, tdm, and medreview at the regional level supporting their utility through an observational approach to assess the effects of these innovative methods, already active in irccs, for the optimization of appropriate drug use and minimization of adr risk in adult and pediatric oncology patients, as well as pediatric patients with chronic inflammatory diseases. specifically, the aim is to evaluate the incidence of adrs in patients treated based on pharmacogenetics, tdm, and medreview compared to historical cases treated according to the standard of care before the implementation of the proposed innovative methodologies. secondary aims of the study: 1. to evaluate the "causality assessment" between adr and drug based on the enhanced data quality deriving from the integration of pharmacogenetics, tdm and medreview into the pharmacovigilance report. 2. to propose the systematic integration of the results related to pharmacogenetics, tdm, and medreview within the existing fields of the current adr reporting form. this aims to develop a proposal for updating aifa procedures related to the inclusion of this type of evidence-based information in the national pharmacovigilance network (rnf), with a potential update of the reporting form.

Eligibility criteria:
inclusion criteria: patients who are candidates for therapy with: * abemaciclib, * palbociclib, * ribociclib, * letrozole, * tamoxifen, * olaparib, * niraparib, * rucaparib, * imatinib, * sunitinib, * sorafenib, * regorafenib, * lenvatinib, * irinotecan, * capecitabine, * 5-fluorouracil, * infliximab, * cyclophosphamide, * methotrexate, * adalimumab, * 6-mercaptopurine/azathioprine
pegfilgrastim in patients with alcoholic hepatitis

Conditions: Alcoholic Hepatitis

Summary: this is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and df≥32.

standard of care treatment will be with either prednisolone 40 mg/day for 28 days or pentoxifylline 400 mg tid for 28 days. the patient's physician will decide the standard of care treatment the patient will receive. patients will be randomized (1:1) to receive either no additional drug treatment (soc group) or to receive a pegfilgrastim (neulasta®, 6 mg) sq. patients will be seen in-person at screening, randomization (day 1), day 8, day 29, week 12, and week 24. safety examination and blood tests will be performed. in addition, biological specimens will be saved for research purposes at these time points. total duration of patient participation is 24 weeks.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of alcoholic hepatitis with maddrey's discriminant function score ≥32. age 18 years or older. exclusion criteria: * renal failure (creatinine \>2.0 mg/dl) * bilirubin \<5 mg/dl * uncontrolled recent upper gastrointestinal bleeding * known hiv infection * uncontrolled infection, or pregnant.

Keywords: survival pegfilgrastim cirrhosis, alcoholic
orca study: osteoarthritis and risks associated with the consumption of nsaids

Conditions: Osteoarthritis

Summary: cross-sectional epidemiological study in patients with diagnosis of osteoarthritis (oa) in order to evaluate risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (nsaid).

objective: to evaluate the presence of risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (nsaid) in patients diagnosed with osteoarthritis (oa). materials and methods: a multicentric, cross-sectional epidemiological study, will be carried out in patients ≥ 38 years of age, with a previous diagnosis of primary or secondary oa, according to criteria of the american college of rheumatology (acr). the presence of at least one risk factor for the use / prescription of nsaids is the main variable. the secondary variables to be evaluated include: demographical characterization of the patients, current disease status (level of pain and functional limitation), treatment (s) used (related or not to oa) and events side effects associated with the treatment (s). the analysis will be carried out from two perspectives: a first descriptive approach and a second analytical approach.

Eligibility criteria:
inclusion criteria: * age ≥ 38 years * previous diagnosis of osteoartritis (primary or secondary) at least 30 days before or more, in at least one or more of the following locations: knee and / or hip and / or hand, according to criteria of the american college of rheumatology (acr) exclusion criteria: * refusal to participate in the study by the patient. * patients who, in the judgment of the investigator, do not understand or are not willing to adequately answer to the questions. * mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.
validation of a new shortness of breath with daily activities questionnaire in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate a new questionnaire to capture the patient experience of copd. the information collected will be used to validate the shortness of breath with daily activities questionnaire.

dyspnea, referred to by patients as "shortness of breath" or "breathlessness," is frequently associated with decreases in functional status, quality of life, and disabilities. currently available questionnaires do not specifically address the shortness of breath component of copd. the development of a patient reported outcome questionnaire that will specifically assess shortness of breath with daily activities (sobda) in patients with copd is needed.

Eligibility criteria:
inclusion criteria: * adults ≥ 40 years of age * established clinical history of copd by ats/ers definition * former or current smoker \> 10 pack years * evidence of dyspnea exclusion criteria: * has a respiratory disorder other than copd * cancer not in complete clinical remission * clinically significant cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine, or hematological abnormalities that are uncontrolled

Keywords: pulmonary disease, chronic obstructive dyspnea
rapidly absorbable versus non-absorbable sutures for mohs surgery repair on the face: a randomized controlled split-scar study

Conditions: Scars

Summary: this study aims to compare scar outcomes between rapidly absorbable and non-absorbable sutures (stitches) for the closure of wounds after skin cancer removal on the face.


Eligibility criteria:
inclusion criteria: * mohs surgical wound on the face * wound greater than or equal to 4 cm in length * subject is willing and capable of cooperating to the extent and degree required by the protocol and will be able to come for follow-up assessments * subject has read and signed subject information and informed consent form exclusion criteria: * surgical wound less than 4 cm in length * surgical site outside of face * subject to be be treated with radiation therapy after surgery * subject is not willing or able to attend for follow-up assessments

Keywords: scar outcome mohs surgery face
patient notifier feature for reduction of anxiety

Conditions: Tachycardia, Ventricular

Summary: this study is intended to look at the effect of the sjm vibrating patient notifier™ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety


Eligibility criteria:
inclusion criteria: * patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an sjm icd with the patient notifier™ feature; * patient is willing and able to independently comprehend and complete the study-related questionnaires; * patient has signed the study specific informed consent form. exclusion criteria: * have already had a patient notifier™ alert since implant; * had a prior device implant (pm or icd); * have not been discharged from the hospital since device implant; * have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records; * cannot commit to the follow-up schedule; * have a life expectancy of less than 1 year; * are on a waiting list for a heart transplant; * are less than 18 years old; * are pregnant;

Keywords: primary and secondary prevention for ventricular tachycardia
combination deplin® and antidepressant therapy for a major depressive episode (mde)- a retrospective analysis

Conditions: Major Depressive Disorder

Summary: this is a retrospective chart review study to determine if deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.


Eligibility criteria:
inclusion criteria: * males or females age 18-70 * the active arm (arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a cgi-s of ≥4 who began deplin and ssri or snri therapy at the same time beginning in january 2007 to the present; and, control group (arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began ssri or snri therapy matched in severity (cgi-s of ≥4) exclusion criteria: * folic acid \>400 mcg taken at any time during the study * psychotic features in the current episode or a history of psychotic features * any bipolar disorder (current or past) or any psychotic disorder (current or past) * current or past treatment with vagus nerve stimulation, ect, or transcranial magnetic stimulation * antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks

Keywords: depression combination therapy antidepressant deplin folate methylfolate
comparison study between protopic (tacrolimus ointment) and elidel (pimecrolimus cream) in treating pediatric patients with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: comparison of protopic ointment to elidel cream to assess the safety and efficacy in pediatric patients with atopic dermatitis

this is a two arm, randomized, investigator blinded study to compare protopic ointment to elidel cream in treating pediatric patients with moderate to severe atopic dermatitis

Eligibility criteria:
inclusion criteria: * diagnosis of atopic dermatitis which is rated moderate, severe or very severe using the investigator's global atopic dermatitis assessment involving a minimum of 5% of the body's surface area * if female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study exclusion criteria: * patient has a skin disorder other than atopic dermatitis in the areas to be treated * patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters * patient has clinically infected atopic dermatitis at baseline * patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug * patient has a known hypersensitivity to macrolides or any excipient of either study medication * patient has a chronic condition which is either not stable or not well controlled * patient is pregnant or breast feeding an infant

Keywords: atopic dermatitis protopic pediatric
using mobile phones to improve adherence to inhaled steroids

Conditions: Asthma

Summary: this study has two main goals. the first goal is to test whether a mobile phone intervention can increase adherence to daily inhaled steroid medications in african american adolescents prescribed this type of medication by his/her asthma doctor. the second goal is to use a mobile phone intervention to better understand real life patterns of use of quick-relief (beta2-adrenergic agonist) asthma medication in this population.


Eligibility criteria:
inclusion criteria: * 11-16 years of age * self-identify as african american * have persistent asthma * be on a prescription daily inhaled corticosteroid medication for asthma * be on a prescription inhaled beta2-adrenergic agonist medication for asthma exclusion criteria: * candidate refusal * the presence of other co-morbidities that could interfere wtih study participation * \> 60% adherence to inhaled corticosteroid medication, measured by the electronic dose counter, during the run-in period

Keywords: health status disparities minority health pediatrics behavioral intervention cellular phone peer group
the effect of knee flexion angle for graft fixation during single-bundle anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: the purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (kfa) during anterior cruciate ligament reconstruction (aclr) graft fixation has an effect on postoperative outcomes. the specific research questions are: what is the effect of the kfa on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (ap) knee stability; 4) rate of re-operation.


Eligibility criteria:
inclusion criteria: * male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and mri * no pre-existing arthritis as defined by the kellgren-lawrence radiographic rating system * patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion * surgical management with a transtibial or anteromedial portal single-bundle aclr with bone patella tendon bone (bptb) autograft by a fellowship-trained sports medicine surgeon. exclusion criteria: * acute acl injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters * associated grade iii injury to the mcl (medial opening \>10mm at 30 degrees of knee flexion or any medial opening in extension) * presence of a pcl or posterolateral corner injury * lack of informed consent.
frequency of sars covid-19 infection among malignant patients at south egypt cancer institute

Conditions: COVID-19

Summary: assessment the frequency of sars cov-2 infection among malignant patients at south egypt cancer institute

coronavirus disease (covid-19) is an infectious disease caused by the sars-cov-2 virus most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. however, some will become seriously ill and require medical attention. older people and those with underlying medical conditions like cardiovascular disease, diabetes, chronic respiratory disease, or cancer are more likely to develop serious illness. anyone can get sick with covid-19 and become seriously ill or die at any age cancer is one of the most common examples of immunocompromised states

Eligibility criteria:
inclusion criteria: * malignant patients. * pcr positive for covid-19 exclusion criteria: * pcr negative for covid-19