Kornimate/medical-research-clean huggingface dataset:
effect of cannabis on cigarette use behavior

Conditions: Cannabis Use; Tobacco Use; Cigarette Smoking

Summary: the purpose of this study is to determine the impact of tetrahydrocannabinol (thc) administration on motivational, subjective, and physiological effects of cigarettes. the study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. researchers will compare multiple doses of thc and a placebo in participants who smoke cigarettes and either smoke or vape thc in the laboratory.

a full-factorial laboratory study will be conducted to determine the impact of acute thc administration on the dose-related motivational, subjective, and physiological effects of combustible cigarettes. this study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of thc on combustible tobacco use. the study will use multiple active doses of thc and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard thc unit doses). participants will be randomized to either smoked or vaporized thc administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of thc and tobacco administration on study outcomes.

Eligibility criteria:
inclusion criteria: 1. healthy non-treatment seeking adults aged 21 or older 2. report daily use of combustible tobacco cigarettes 3. biological confirmation of cigarette use: have an expired carbon monoxide (co) level of more than 8 ppm and a positive urine cotinine test at screening 4. report current use of cannabis (at least 1 occasion per week) 5. have experience with the inhalation route of administration for cannabis 6. biological confirmation of cannabis use: have a positive urinary thc drug test at screening. 7. for women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study. exclusion criteria: 1. report current intention to reduce or quit cannabis or tobacco use within the next 30 days 2. meet diagnostic and statistical manual (dsm-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine 3. test positive for illicit drugs other than cannabis and tobacco 4. positive breath alcohol test at study admission 5. have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity 6. have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the columbia suicide severity rating scale (c-ssrs) 7. are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding 8. have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., prinzmetal's angina) 9. are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

Keywords: cannabis cigarette marijuana thc tobacco
observational study in participants with chronic lymphocytic leukemia (cll), multiple myeloma (mm) and non-hodgkin's lymphoma (nhl) in latin america

Conditions: Multiple Myeloma; Leukemia; Lymphoid; Lymphoma; Non-Hodgkin

Summary: the primary purpose of the study is to quantify participants' demographic parameters, country standard therapies, treatment patterns and outcomes among participants with chronic lymphocytic leukemia (cll), multiple myeloma (mm) and non-hodgkin's lymphoma (nhl) in oncology concentration hospitals in latin america.

this is a retrospective (take a look back at events that already have taken place), non-interventional, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adult participants with a diagnosis of cll, mm or nhl anytime since 01 january 2006. only data available from clinical practice will be collected. all eligible participants at participating centers will be included regardless of participant's demographics, prior or current treatments for disease, or clinical outcome. the period of observation will span from 01 january 2006 through present, but all eligible participants must be followed for a minimum of 1 year, unless the participant died within that first year. participant demographic parameters, standard therapies, treatment patterns and outcomes will be primarily quantified.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic lymphocytic leukemia (cll), multiple myeloma (mm), or non-hodgkin lymphoma (nhl) anytime since january 1, 2006 * at least one year of data following first observed diagnosis except in the case of the participant death within one year following first observed diagnosis * participant must sign a participation agreement/informed consent form (icf) exclusion criteria: - having one and only one consult in the center

Keywords: multiple myeloma chronic lymphocytic leukemia non-hodgkin lymphoma
a trial of mechanical axis with soft tissue release balancing vs functional alignment with bony release balancing in total knee replacement using stryker's mako robot

Conditions: Osteoarthritis

Summary: this study is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. all patients will be treated with the same knee system, implanted using mako robotic-arm assisted technology.


Eligibility criteria:
inclusion criteria: * the patient is a male or non-pregnant female between the ages of 40-80 years. * the patient requires a primary total knee replacement and is indicated for robotic-assisted surgery. * patient is deemed appropriate for a cruciate retaining knee replacement. * the patient has a primary diagnosis of osteoarthritis (oa). * the patient has intact collateral ligaments. * the patient is able to undergo ct scanning of the affected limb. * the patient has signed the study specific, ethics-approved, informed consent document. * the patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations. exclusion criteria: * the patient has a history of total, unicompartmental reconstruction or fusion of the affected joint. * patient has had a previous osteotomy around the knee. * the patient is morbidly obese (bmi ≥ 40). * the patient has a deformity which will require the use of stems, wedges or augments in conjunction with the triathlon total knee system. * the patient has a varus/valgus deformity ≥ 15°. * the patient has a fixed flexion deformity ≥ 15°. * the patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * the patient has a systemic or metabolic disorder leading to progressive bone deterioration. * the patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements. * patient has a cognitive impairment, an intellectual disability or a mental illness. * the patient is pregnant. * the patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).

Keywords: knee arthroplasty
imaging inflammation in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study is being done to learn about inflammation and amyloid in alzheimer's disease. a type of brain scan called a pet scan is used measure 1) inflammation and 2) abnormal accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in the brain. these are thought to be involved in alzheimer's disease. the investigators will also perform brain mri and do tests to measure the participants' memory and thinking.

this study is being done to determine the relationship between inflammation, cognitive impairment, and amyloid burden in elderly subjects with different clinical and biomarker profiles of alzheimer's disease (ad). participants will undergo amyloid pet imaging with 18f-florbetaben with target number of completers being 15 amyloid-positive elders with impairment, 15 amyloid-positive elders with normal cognition, 15 amyloid-negative elders with impairment, and 15 amyloid-negative elders with normal cognition. subjects will undergo screen that includes neuropsychological testing, brain mri, and pet imaging with 18f-florbetaben to define the above 4 groups. subjects will have 11c-pbr28 pet imaging to measure the 18 kda translocator protein (a marker of inflammation). subjects will have the option to have lumbar puncture performed to measure csf concentrations of amyloid,tau, phospho-tau, and inflammatory markers.

Eligibility criteria:
inclusion criteria: 1. age 60 and older. 2. meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild alzheimer's disease, or b) have no cognitive impairment based on history, exam, neuropsychological testing, and consensus diagnosis. mci and mild ad patients must have clinical dementia rating scale score of 0.5 or 1. unimpaired subjects must have clinical dementia rating scale score of 0. 3. subjects unable to provide informed consent must have a surrogate decision maker 4. written and oral fluency in english or spanish. 5. able to participate in all scheduled evaluations and to complete all required tests and procedures. 6. in the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study. exclusion criteria: 1. past or present history of certain brain disorders other than mci or ad. 2. certain significant medical conditions, which make study procedures of the current study unsafe. 3. contraindication to mri scanning. 4. conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.). 5. exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits. 6. low affinity binding on tspo genetic screen. 7. participation in the last year in a clinical trial for a disease modifying drug for ad. 8. inability to have a catheter in subject's vein for the injection of radioligand. 9. inability to have blood drawn from subject's veins.

Keywords: inflammation aging mild cognitive impairment
a study to evaluate the safety and effectiveness of alks 2680 in subjects with narcolepsy type 2

Conditions: Narcolepsy Type 2

Summary: the purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (nt2) when taking alks 2680 tablets compared to placebo tablets.


Eligibility criteria:
inclusion criteria: * 18-70 years of age * has a bmi ≥18 and ≤40 kg/m2 * meets the diagnostic criteria of narcolepsy type 2 according to icsd-3-tr guidelines. additionally, meets the following criteria: * has residual excessive daytime sleepiness * is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study * is willing to adhere to additional protocol requirements exclusion criteria: * significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator * is currently pregnant, breastfeeding, or planning to become pregnant during the study * is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to screening

Keywords: narcolepsy narcolepsy type 2 nt2 orexin-2 receptor agonist sleep sleep disorder excessive daytime sleepiness
pmcf-study using novosyn® quick suture material in ophthalmic surgery

Conditions: Dacryocystorhinostomy; Ectropion; Entropion; Ptosis; Eyelid Tumor Resection; Blepharoplasty

Summary: the aim of this study is to show that the performance of novosyn® quick suture material is comparable with standard suture material used in ophthalmic surgery. in order to show that, various safety and efficacy parameters have been selected. the outcome regarding these parameters will be compared in 2 treatment groups. active control group will receive vicryl® rapide and the treatment group novosyn® quick for ophthalmic surgery. it was decided to design this study as a randomized trial, because limited clinical evidence is available in the literature for the active control group (vicryl® rapide) which can be used for comparison. eye operation will be randomly allocated on the left and right side (1:1) to both treatment groups. patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, blepharoplasty)


Eligibility criteria:
inclusion criteria: * patients undergoing an elective, primary ophthalmic surgery for dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, and blepharoplasty. * age ≥18 years * written informed consent exclusion criteria: * emergency surgery * previous ophthalmic surgery on the same eye * known allergy or inflammation reaction to suture material similar to vicryl® rapide or novosyn® quíck in previous surgery. * cicatrisation base alterations * concomitant medication, that might affect wound healing (e.g. immunosuppression therapy, anti-diabetic drugs, etc.)

Keywords: eye surgery suture material novosyn quick vicryl rapid
technology driven enhancement to engage & connect

Conditions: Depression

Summary: this study will investigate whether an intervention that includes remotely delivered therapy sessions and a digital mental health app, compared to only remotely delivered therapy reduces late-life depression

depression in mid- and late-life is characterized with reduced functions of the reward system. the investigators designed a psychotherapy that aims to improve reward functions through engagement in pleasurable activities and in turn reduce depression. prior work has shown that this therapy is acceptable and reduces depression. this study examines whether a hybrid intervention that combines clinician remotely-delivered psychotherapy, and a novel app named tree-connect, reduces late life depression. this tree-connect app uses a machine learning algorithm to promote adherence to therapy (completion of therapeutic homework) in late-life depression and increase cost-effectiveness and reach of treatment to older adults. this randomized controlled trials will test whether the hybrid intervention (clinician-delivered psychotherapy + app), compared to a condition that includes solely clinician-delivered therapy is acceptable and reduces late-life depression.

Eligibility criteria:
inclusion criteria: * adults aged 50-80 * capacity to provide consent for research assessment and treatment. * significant depression, i.e., phq-9 ≥10 (moderate severity of symptoms) * mini mental status exam (mmse) equal or greater than a score of 23. * off antidepressants or on stable dose for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period. exclusion criteria: * intent or plan to commit suicide in the near future. * inability to communicate in english. * history or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, specific phobia, or antisocial or borderline personality disorder. * neurological disorders (dementias, amnestic and multidomain mild cognitive impairment, parkinson's disease, epilepsy, etc.). * acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study. * for mri only: contraindications to mri scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to mri, and claustrophobia.
quickvue influenza a+b clinical field trial

Conditions: Influenza

Summary: a comparative study of different swab types used for collection of specimens for rapid inluenza testing


Eligibility criteria:
inclusion criteria: subjects must have: * fever (\>38°c) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms: * chills/sweats * cough * dyspnea (labored, difficult breathing) * fatigue * headache * myalgia (deep muscle aches) * nasal congestion * runny nose * sore throat exclusion criteria: * patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.
comparison of nn1250 with insulin glargine plus insulin aspart with/without metformin and with/without pioglitazone in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia, europe, and the united states of america (usa). the aim of this clinical trial is to compare nn1250 (insulin degludec (ideg)) with insulin glargine (iglar) plus insulin aspart (iasp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing nn1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. all oral anti-diabetic drug (oad) treatment will be discontinued, if applicable, when trial participant enters the trial (nn1250-3582) with the exception of metformin and pioglitazone. subjects who consent to participate in the extension trial (nn1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial nn1250-3582. the main period is registered internally at novo nordisk as nn1250-3582 while the extension period is registered as nn1250-3667.


Eligibility criteria:
inclusion criteria: * for main period (nn1250-3582): * type 2 diabetes mellitus for at least 6 months * ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (oad) prior to trial start * hba1c 7.0-10.0 % (both inclusive) * body mass index (bmi) below or equal to 40.0 kg/m\^2 * for extension period (nn1250-3667): * completion of the 52 week treatment period in nn1250-3582 exclusion criteria: * for main period (nn1250-3582): * treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months * cardiovascular disease within the last 6 months * uncontrolled treated/untreated severe hypertension * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures * cancer and medical history of cancer
side effect prevention training (sept) for nocebo effects in breast cancer patients

Conditions: Female Breast Cancer

Summary: the purpose of this study is to evaluate a side effect prevention training (sept) that optimizes patients' response expectations before the start of adjuvant endocrine treatment (aet) to prevent nocebo side effects and enhance quality of life during longer term drug intake.

the majority of breast cancer patients discontinue today's standard adjuvant treatment (endocrine therapy) due to side effects and reduced quality of life. thereby, most side effects are unspecific, thus, not related to the specific pharmacological action of the drug, but to the individual treatment context and patients´ expectations (nocebo effects). the aim of this study is to evaluate a side effect prevention training (sept) that optimizes patients' response expectations before the start of pharmacotherapy to prevent nocebo side effects during longer term drug intake. using a randomized trial, we will study the time course of response expectations and side effects in breast cancer patients receiving either sept, standard medical care or an attention-control intervention ("supportive therapy") before the start of adjuvant endocrine therapy. we will analyze the effects of changing pre-treatment expectations on cancer-treatment related side effects, quality of life and adherence 3 and 6 months after the start of endocrine therapy. moderator analyses will be used to determine predictors of non-specific medication side effects and patients that are at high risk of experiencing them. furthermore, we will explore the mediating influence of coping behaviours, thereby providing insights into pathways of clinical nocebo effects. the study findings promise significant advances in the clinical application of nocebo research with strong implications for clinical and research practice.

Eligibility criteria:
inclusion criteria: * women with estrogen receptor positive breast cancer scheduled to start first-line adjuvant endocrine therapy with tamoxifen (+/- gnrh) or a third generation aromatase inhibitor at the breast cancer centre * sufficient knowledge of german language and ability to give informed consent * age of 18 and more exclusion criteria: * presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety) * presence of a life threatening comorbid medical condition

Keywords: randomized controlled trial patients´ expectations breast cancer adjuvant endocrine treatment nocebo
study on the clinical efficacy of teclistamab

Conditions: Multiple Myeloma; Hematologic Diseases

Summary: the aim of this study is to assess the clinical efficacy and safety of the anti-bcma/cd3 bispecific antibody teclistamab (tecvayli®) in a prospective, real-life setting in belgium.

to assess the clinical efficacy and safety of teclistamab (tecvayli®) in relapsed/refractory multiple myeloma patients who have received at least 3 prior lines of treatment and who will receive teclistamab (tecvayli®) as the next treatment. patients will be followed up prospectively until the end of study (24 months/2 years), or until disease progression, withdrawal of consent death or loss to follow-up, whichever occurs first. each patient will have a monthly follow-up from baseline until 6 months of treatment with teclistamab. then, data will be collected every 3 months until the end of study.

Eligibility criteria:
inclusion criteria: * age 18 years or older * written informed consent * has a diagnosis of relapsed and refractory multiple myeloma * has already received at least three previous treatments * is refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-cd38 monoclonal antibody * evidence of disease progression on the last line of therapy, based on determination of response by the imwg response criteria * anticipated to start treatment with teclistamab per routine clinical care or has started with teclistamab treatment ≤14 days before intended screening visit exclusion criteria: * has participated in a teclistamab trial (teclistamab or control arm) or teclistamab single patient request (spr) program * has started teclistamab treatment \>14 days before intended screening visit.

Keywords: teclistamab tecvayli hematology efficacy safety