Kornimate/medical-research-clean huggingface dataset:
a safety, tolerability, and pharmacokinetic trial with cvx-241 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to determine if cvx-241 (pf-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.

the study was prematurely discontinued on 14 september 2011 due to no significant pharmacological effects (safety/pd/efficacy) through 25 mg/kg cohort, the t1/2 based on vegf binding was shorter than expected and the current and/or higher doses were not considered feasible for further development. there were no safety concerns associated with the decision to terminate the program/study.

Eligibility criteria:
inclusion criteria: * confirmed solid tumors unresponsive to current therapy or for which there is no standard therapy. * stage 2 only: histologically or cytologically documented eoc or ppc with \< or equal to 3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen. * adequate coagulation, liver, and renal function. * candidate for dynamic contrast-enhanced magnetic resonance imaging \[dce-mri\] evaluation * eastern cooperative oncology group \[ecog\] performance status of 0 or 1 exclusion criteria: * history of clinically significant toxicity to vascular endothelial growth factor \[vegf\] inhibition. * evidence of bleeding problems. * uncontrolled hypertension. * patients with primary brain cancer and/or non-small cell lung cancer of squamous cell histology

Keywords: treatment non-randomized single group assignment safety study neoplasms carcinoma cancer malignancy
strategies to maximise patient comfort during eswl

Conditions: Nephrolithiasis

Summary: extracorporeal shockwave lithotripsy is an outpatient treatment for patients with intrarenal calculi. standard of care involves offering oral analgesia prior to commencing the treatment. most patients do not take the offered analgesia after the initial treatment. it has been suggested that distraction techniques may be equivalent to oral analgesia in improving tolerability of extracorporeal shockwave lithotripsy treatment. the use of distraction techniques also removes the potential side effects of mediation administration.

the investigators are aiming to assess if distraction techniques help improve patient comfort while undergoing extracorporeal shockwave lithotripsy treatment for renal calculi. improved tolerability of treatment would result in longer duration of time on the lithotripsy machine and may lead to better stone fragmentation. outcomes will be completion of treatment and scores on the short form mcgill pain questionnaire. patients will be randomised into three groups. the randomisation will not be blinded as this is not possible within the design of the study. the first group will be given stress balls to squeeze during treatment and will also receive standard care (the offer of oral analgesia). the second group will be given headphones to listen to music during treatment and will also receive standard care. the third group will receive standard care. prior to commencing extracorporeal shockwave lithotripsy, patients will be given the shortened health anxiety inventory score to complete. following lithotripsy treatment, patients will be given the short form mcgill pain questionnaire to complete. the initial pilot study will aim to recruit sixty patients and further recruitment will take place on the basis of the outcomes of the pilot study. inclusion criteria all patients over eighteen years old undergoing extracorporeal shockwave lithotripsy for the first time exclusion criteria patients not capable of giving informed consent patients in whom extracorporeal shockwave lithotripsy is contraindicated

Eligibility criteria:
inclusion criteria: * over 18 years old * first eswl treatment exclusion criteria: * patients not capable of giving informed consent * patients unsuitable for eswl
study to evaluate the use of direct oral anticoagulants in uk clinical practice for patients with a first stroke attributable to nonvalvular atrial fibrillation

Conditions: Atrial Fibrillation

Summary: national institute of health and care excellence (nice) guidance recommends anticoagulation for stroke prevention in high risk patients with nonvalvular atrial fibrillation (af). early evidence suggest that patients with atrial fibrillation (af) who do not receive anticoagulation are more likely to experience a stroke. however, the characteristics of patients experiencing a first af-related stroke in real-world settings, who have not been receiving anticoagulation, have not been well documented. it is unclear how the direct anti-fxa oral anticoagulants have been used within real world practice since the introduction of edoxaban in 2015.

this non-interventional study will focus specifically on the patient characteristics, management pathways, and patient reported experiences associated with real world use of three direct anti-fxa oral anticoagulants (doac) commonly used within united kingdom clinical practice; apixaban, rivaroxaban and edoxaban. the primary objective will describe the demographics, clinical characteristics and medical history of patients presenting with a first ischaemic stroke with af who have not received anticoagulation (for any reason) in the 12 months prior to stroke, by type of anticoagulant treatment subsequently prescribed for secondary prophylaxis of stroke. secondary objectives of the study will describe management pathways of patients initiated on doacs (apixaban, edoxaban or rivaroxaban) for secondary prophylaxis of stroke, including timing and reasons for any dose changes or treatment switches to alternative anticoagulants; describe hospital resource use and clinical assessments associated with doac treatment for secondary prophylaxis of stroke; describe real world patient-reported adherence to doacs for secondary prophylaxis of stroke; and describe patient experience and treatment satisfaction for patients receiving doac therapy for secondary prophylaxis of stroke.

Eligibility criteria:
inclusion criteria: - for all patients: * participants presenting to the study centre with a first ischaemic stroke which is, in the clinician's opinion, attributable to nonvalvular af * participants aged 18 years or over at time of first stroke for group 2 patients: \* participants initiated on apixaban, edoxaban or rivaroxaban after their first stroke exclusion criteria: * for all patients: * participants prescribed any anticoagulant for any purpose in the 12 months prior to stroke diagnosis * participants with haemorrhagic stroke * participants with diagnosis of transient ischemic attack * participants with severe cognitive or emotive deficit * participants whose medical records are not available for review * participant unwilling or unable to give written informed consent * for group 2 patients: * participant unwilling or unable to complete the patient-reported questionnaires

Keywords: atrial fibrillation direct oral anticoagulants edoxaban apixaban rivaroxaban
investigation of kinesiophobia and functional status of patients after mpfl reconstruction

Conditions: Medial Patellofemoral Dislocation; Kinesiophobia

Summary: our aim in this study is to examine the functional and clinical results of patients who have undergone mpfl reconstruction at least 2 years after the operation. the presence of kinesiophobia of the patients will be evaluated and its relationship with functional outcomes will be examined.


Eligibility criteria:
inclusion criteria: * undergone unilateral medial patellofemoral ligament (mpfl) reconstruction * at least 2 years after the operation exclusion criteria: * patellar instability * knee ligament injury * meniscus injury * knee osteoarthritis * ankle ligament injury * ankle osteoarthritis * any neurological disease
bayesian estimation of diagnostic performance for cardiovascular autonomic neuropathy

Conditions: Diagnostic Performance of Cardiovascular Autonomic Neuropathy

Summary: this study aimed to evaluate the reference values for the short-term heart rate variable (hrv), estimate the performance of cardiovascular autonomic neuropathy (can) diagnostic tests in the absence of a gold standard, and assess can prevalence in our cross-sectional dataset.

the can prevalence is rapidly growing in all populations worldwide. no document has been reported about normal reference values for can using this test in the chinese population. this study aimed to evaluate the reference values for the short-term hrv in a large cross-sectional dataset, and to estimate sensitivities and specificities of can diagnostic tests using the bayesian approach, in the absence of a gold standard in another independence dataset. finally, can prevalence was estimated in the investigators' cross-sectional dataset. firstly, the reference the values for the short-term hrv were calculated in the investigators' previous study (including 371 healthy subjects). this study dataset contained 88 subjects who completed both the short-term hrv test and ewing's test. simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the bayesian approach without a gold standard.

Eligibility criteria:
inclusion criteria: * survey participants with undiagnosed can, aged 30-80 years, were included in this study. exclusion criteria: * some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their ca function 11. briefly, the exclusion criteria were as follows: 1. history or findings of arrhythmia, and hyperthyroidism or hypothyroidism; 2. pregnancy or lactation; and/or 3. serious hepatic or renal dysfunctions.

Keywords: bayesian estimation short-term heart rate variability cardiovascular autonomic neuropathy diagnostic performance
tissue sample collection from patients with fanconi anemia

Conditions: Fanconi Anemia; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: collecting and storing samples of tumor tissue from patients with fanconi anemia to test in the laboratory may help the study of cancer in the future. purpose: this laboratory study is collecting and storing tumor tissue samples from patients with fanconi anemia.

objectives: * acquire rare solid tumor samples from patients with fanconi anemia in order to create a fanconi anemia cell repository at the oregon health and science university cancer institute. * study repository tissue using a variety of molecular methods, including gene microarrays. * develop cancer cell lines that are publicly available from tissue archived from patients with fanconi anemia. outline: tumor biopsies are collected from patients with fanconi anemia and archived for future molecular studies, cell line generation, and general usage by the research community at large. medical information about the patient's cancer is also archived. projected accrual: not specified.

Eligibility criteria:
disease characteristics: * confirmed fanconi anemia * confirmed malignant solid tumor * biopsy of tumor tissue available patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: fanconi anemia unspecified adult solid tumor, protocol specific unspecified childhood solid tumor, protocol specific
advance care planning: communicating with outpatients for vital informed decision

Conditions: Advanced Care Planning; Shared Decision Making; Video Decision Aids; Communication Skills; Advance Directives; Natural Language Processing; Covid19

Summary: this pre-post, open-cohort design, pragmatic trial with 150 clinicians and will evaluate the effectiveness of the use of telehealth advanced care planning (acp) program by comparing acp documentation among 13,000 patients over 65

this study is investigating if the use of telehealth acp program will improve and sustain rates of acp from the time that the intervention is implemented compared to two time periods prior to the intervention. the comprehensive acp program combines two widely disseminated interventions to assess impact when used concurrently. * one is vitaltalk clinician communication skills training (www.vitaltalk.org) during which the primary care clinicians will practice acp with simulated patient actors under the guidance of a trained vitaltalk facilitator. * the second is the acp decisions video decision aids (www.acpdecisions.org) which are directed to patients and provide education about acp. this inclusive acp approach treats patients and clinicians as equal stakeholders providing both with the communication skills and tools needed to make decisions about covid-19 medical care before the toughest choices arise. * the training is four cumulative hours, most of which is spent in communication skills work, and the remainder learning how to introduce the videos into one's practice. no patients participate in the training. the ambulatory practices included in this intervention gain access to the acp decisions videos, which can be introduced to patients. videos may be seen in clinic or sent to patients' homes via an electronic or paper code. * we will recruit up to 30 clinicians from participating clinics who completed the intervention training and ask them to complete a qualitative interview to learn about their experience with the acp intervention.

Eligibility criteria:
inclusion criteria: * clinic eligibility: clinics affiliated with northwell health may be included in the study. * clinician, staff eligibility: any staff member identified by the site-pis are affiliated with northwell health. * patient eligibility: to be eligible for this study, individuals must be aged 65 or over, affiliated with the northwell health clinic. for each of the three periods of the study, those patients over the age of 65 who are engaged (e.g., seen in person, telehealth, etc.) with the clinic during that time period will be included in that time period exclusion criteria: * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners

Keywords: covid 19 advanced care planning shared decision making video decision aids communication skills serious illness decision making health care proxy advance directives natural language processing
do self-report and physician impressions of adherence to oral antipsychotic medication agree with objective data?

Conditions: Schizophrenia; Schizoaffective

Summary: the purpose of this study is to prospectively examine adherence to oral atypical antipsychotics in patients with schizophrenia. we are psrticularly interested in examining the level of agreement among self-report, physician impressions and objective measures of adherence. we believe that physicians, casemanagers, and clients significantly overestimate the level of adherence.

fifty schizophrenia patients will be recruited at the time of their clinic visit to tri-county mhmr services and the el paso community mhmr center. both physicians and patients will be asked to rate the patient's medication adherence on their index clinic visit. initial ratings will also occur at this visit. after filling their medication prescription, all subjects will be given electronic medication caps that record each time and date their medication container is opened. patients will then be followed in the community for the next 12 weeks to observe actual adherence to medication from the index visit to the next successive clinic visit. every two weeks pills will be counted and data will be retrieved from the electronic medication caps. during the first and last two weeks of study, blood will be sampled on two randomly selected occasions approximately 72 hours apart. self-report and physician assessment of adherence, symptom and attitudinal measures will be obtained a second time at the second clinic visit 12 weeks after the index visit.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * between the ages of 18-55 * no documented history of head injury, mental retardation or neurological disorder

Keywords: schizophrenia schizoaffective mems adherence to antipsychotic medication
how do super lean subjects keep resistant to body weight gain?

Conditions: Thinness; Health Behavior; Genetics

Summary: obesity is the 5th leading cause of global death, and is major risk factors for many chronic diseases, such as type 2 diabetes, cardiovascular diseases, hypertension and cancer. obesity is caused by an imbalance between energy intake and energy expenditure, and it is widely agreed to be a consequence of a gene by environment interaction. although on average obesity rates are increasing, the shape of the distribution of adiposity is changing: it is becoming more right skewed. this is because there is a population of very lean subjects that has remained almost unchanged by the epidemic. the investigators have called these very lean individuals that are resistant to the epidemic and sustain a bmi \< 18.5 kg/m2 'super lean' subjects. we have very little understanding of the lifestyles of these individuals and how they are able to maintain their super lean phenotype, and whether the basis of their leanness is primarily genetics.

in this study, the investigators will recruit a sample of 150 super lean healthy volunteers with a bmi \>15 and \< 18.5 kg/m2 aged 20-40 years, in parallel with an age matched group of 150 healthy subjects with a bmi ≥22 and \< 25 kg/m2 as the control group. the investigators will screen out any individuals with eating disorders. in both groups, the investigators will study their lifestyles in particular focusing on their physical activity patterns and their food intake choices (monitored via food intake diaries and supported by metabolomics analyses of their urine to detect biomarkers of different food groups). saliva samples will be collected for genotyping. the investigators will snp genotype the individuals for 30 known polymorphic loci previously linked to obesity to establish if they have a particular genetic profile linked to their lean phenotype.

Eligibility criteria:
inclusion criteria: * control: bmi 20-25 kg/m2, healthy, age 20-40 years old superlean: bmi 15-18 kg/m2, healthy, with no eating disorders and diabetes, age 20-40 years old exclusion criteria: * pregnant women and women in lactation subjects are suffering from eating disorders or diabetes.
efficacy and safety of an innovative treatment of opiate use disorders

Conditions: Opioid-use Disorder; Opioid Dependence; Opioid Abuse

Summary: investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be healthier, more mature, and less traumatized. investigators will compare an active and a sham treatment given twice weekly for 4-weeks. investigators hope this will lead to a significant weapon in the battle against the opioid epidemic as well as lead to psychological and physiological insights into possible relations among trauma, cerebral laterality, and addiction.

this project is to demonstrate that a novel treatment for opiate addiction is safe and far superior to a sham comparison treatment. the treatment is hoped to significantly aid in the battle against the opioid epidemic that is ravaging much of the country and the world. the treatment consists of using a 4-minute application of transcranial photobiomodulation, near infra-red mode, through a supra-luminous led, to one side of the forehead over the brain hemisphere that we determine (through a proprietary test) to have a more positive emotional valence. based on preliminary data, we anticipate that the treatment will be very effective in reducing drug cravings, anxiety, and depression as well as in reducing relapses. aim i will offer twice-weekly treatments to two groups, active and sham, for 4-weeks and will look specifically for differences in opioid cravings, anxiety, depression, and opioid use. the investigators will evaluate participants weekly for safety and efficacy for 3-weeks post-treatment. in aim ii a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.

Eligibility criteria:
inclusion criteria: * all patients must between the ages of 18 and 70 * meet criterion for a history of opioid use disorder (oud) on a diagnostic interview. * have opioid cravings * enrollment will be made without regard to gender or ethnicity. * patients who are receiving treatment for oud or other psychiatric disorders, either psychological or pharmacological treatments, may continue their treatment during the time of the study but will be asked to try not to alter their treatment from the onset of the experiment until its conclusion. the statistical analysis will include covariates for doses of buprenorphine and methadone and use of non-prescribed opioids exclusion criteria: * past history of a psychotic disorder (including schizophrenia or schizoaffective disorder) * history of violent behavior * history of a past suicide gesture or attempt, a history of current suicidal ideation, \*history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), \*pregnancy * current acute or chronic medical condition requiring a medication that has psychological side-effects. * impaired decision-making capacity in the judgment of the investigators.
tele-spirometry in primary care - randomized clinical trial cluster: the effectiveness of telemedicine in asthma

Conditions: Asthma

Summary: the purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with asthma.

this study is a randomized clinical trial for patients with asthma from a primary care. the purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of asthma symptoms.

Eligibility criteria:
inclusion criteria: * individual with diagnosis asthma, asthma control test \<20, spirometry from telessauders-universidade federal do rio grande do sul (from randomization cluster) exclusion criteria: -low quality spirometries (inadequate)

Keywords: telemedicine asthma control test primary health care spirometry
recovery therapy trial

Conditions: Schizophrenia; Psychotic Disorders; Mood Disorders

Summary: this project will systematically apply a specialist version of cognitive behaviour therapy (cbt), known as recovery therapy, to a random sample of patients with psychotic disorders. previously, the therapy has been developed and efficacy established, but the extent of applicability to (unselected) mental health service patients is unknown. the main aim is to establish the extent to which this therapy is acceptable and effective for mental health service clients. a secondary aim is to develop guidelines for the conduct of such therapy in public mental health settings.


Eligibility criteria:
inclusion criteria: * acceptance by the participating community mental health services for case management * a preliminary dsm-iv diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychotic features, or delusional disorder * a recovery "need" in one of the areas addressed by the therapy exclusion criteria: * a preliminary dsm-iv diagnosis of brief psychotic disorder, drug-induced psychosis, mood disorder without hallucinations or delusions, or any other disorder (eg. personality disorder, ptsd) even where psychotic features are/have been present * non-english speaking * comorbid intellectual disability

Keywords: cognitive therapy psychotic disorders treatment outcome