Kornimate/medical-research-clean huggingface dataset:
a study of two methods of determining when to begin or change anti-hiv treatment

Conditions: HIV Infections

Summary: primary: to compare the clinical efficacy of two decision making strategies for initiating or changing antiretroviral therapy: decision making based on current clinical practice alone (i.e., initiating or changing therapy based on cd4 count decline and/or clinical progression) versus decision making based on plasma hiv rna quantitation in addition to current clinical practice. secondary: to evaluate toxicity, biological markers, and patient management in the two arms. although changing therapies is a common strategy in the treatment of hiv disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. the technology of measuring hiv rna in plasma has been suggested as a tool for monitoring clinical drug efficacy. however, uncertainty remains about whether aggressive antiretroviral treatment to lower hiv rna and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring cd4 counts and hiv-related symptoms.

although changing therapies is a common strategy in the treatment of hiv disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. the technology of measuring hiv rna in plasma has been suggested as a tool for monitoring clinical drug efficacy. however, uncertainty remains about whether aggressive antiretroviral treatment to lower hiv rna and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring cd4 counts and hiv-related symptoms. patients are randomized to a decision making strategy for initiating or changing therapy based on current clinical practice alone vs. decision making based on plasma hiv rna quantitation in addition to current clinical practice in patients with \ 20 cells/mm3. the remaining patients in the ccp arm will have cd4 counts obtained according to their clinicians' current clinical practices. medications, clinical status, and changes in antiretroviral therapy will be recorded for all patients in the study. patients are stratified by cd4+ cell count (\<100 cells/mm3 \[200 patients\] vs. 100-300 cells/mm3 \[900 patients\]).

Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cd4 count \<= 300 cells/mm3. * no stage 2 or worse aids dementia complex. * life expectancy of at least 6 months. * reasonably good health. * age \>= 13yrs. * signed informed consent. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * disorders or conditions that may prevent adequate compliance with study requirements. patients with the following prior conditions are excluded: * stage 2 \>= aids dementia complex.

Keywords: acquired immunodeficiency syndrome aids-related complex antiviral agents decision making physician's practice patterns
treatment decision making between oncologists and women with newly diagnosed breast cancer and their healthy companions

Conditions: Breast Cancer

Summary: rationale: a study that looks at communication between patients and doctors may help oncologists improve patient satisfaction with their treatment plan. purpose: this phase i trial is studying treatment decision making between oncologists and women with newly diagnosed breast cancer and their healthy companions.

objectives: primary * to determine the association between women's and physicians' participatory communication behaviors (e.g., patients asking questions, physicians soliciting questions) on treatment decision-making process and health outcomes. secondary * to capture the language used in the treatment-decision interactions. * to assess the degree of variation in the language used among physicians and patients who are active participants and those who are less inclined to participate in the treatment decision-making interaction. outline: patients and their companions undergo consultation with the physician for treatment decision making. the treatment discussion is audio/videotaped for approximately 45 minutes. patients complete one short survey prior to physician consultation. after the treatment discussion, patients complete two short surveys, one immediately after the visit in the waiting room before leaving for the day, and the second one a week after the visit by a web-based survey or by mail. projected accrual: a total of 300 women with breast cancer and 600 companions of these women will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets one of the following criteria: * woman with newly diagnosed early-stage breast cancer * caregiver or companion willing to participate in study patient characteristics: * speaks native english or has learned to speak english fluently * patient's companion ≥ 18 years old (if applicable) * able to complete questionnaires without assistance * not pregnant prior concurrent therapy: * not specified

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer
stress management and resiliency training program for parkinson's disease

Conditions: Parkinson Disease

Summary: smart-pd is an 8-session program designed to decrease the physiological, emotional, cognitive and behavioral effects of stress in participants with parkinson's disease and their caregivers by teaching cognitive-behavioral techniques and relaxation skills to help participants learn to elicit the relaxation response, alter cognitive appraisals, improve healthy lifestyle behaviors and access social support. the smart program has been shown to be effective for reducing mental health symptoms such as depression and anxiety as well as physical symptoms such as pain and in promoting positive health behaviors.

this is an interventional study sponsored by the parkinson's foundation designed to measure the feasibility, acceptability, and initial impact of the smart-pd program on participants with a recent (less than five years) diagnosis of parkinson's disease and their caregivers. this program provides information and tools to help patients and their caregivers cope with the new pd diagnosis and manage the stress and negative mental health symptoms (such as anxiety and depression) associated with the diagnosis. smart-pd is a manualized 8-week intervention that teaches cognitive-behavioral techniques and relaxation skills to help participants learn to elicit the relaxation response, alter cognitive appraisals, improve healthy lifestyle behaviors (i.e., sleep, nutrition, physical activity) and access social support. participants will take baseline and follow-up questionnaires to ascertain the impact of the program on outcomes such as quality of life, emotional health, coping skills, and healthy lifestyle behaviors.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease within the past three years or caregiver of someone with a recent diagnosis of parkinson's disease * ability to participate in 8 weekly program sessions via microsoft teams or in-person (as available) * ability to provide informed consent exclusion criteria: * previous participation in the smart program
online mindfulness-based program for parents of children with autism

Conditions: Mindfulness; Psychophysiologic Reaction; Behavior, Health

Summary: the goal of the project is to investigate the effects of online 8-week mbsr intervention on diverse parents to support their children with asd. the investigators will conduct a randomized waitlist-controlled trial with a sample size 22 parents. this study utilizes psychological, behavioral and psychophysiological measures with parents of children with asd ages 6-12. the first aim is to determine if parents of children with autism from diverse populations are willing participate in and complete an online mbsr program and if online delivery is as effective as in-person program. the battery of parental-report psychological assessments to measure resilience, parental sleep and stress as well as children's behaviors will be administered before and after the treatment. the second aim is to investigate the effects of a virtual mbsr intervention on cardiovascular and sympathetic nervous activity measured by continuous eda and ekg. participants will participate in a validated laboratory stress protocol consisting of mental arithmetic and speech tasks before and after the mbsr intervention.

after the participants eligibility are confirmed, their signatures will be obtained on the consent form. three data collection phases are included in this protocol: baseline, post 3 months and post 6 months. all tests are identical in which phase. each test includes a survey packet and the lab experiment. the surveys packet includes: the connor-davidson resilience scale, mindfulness attention awareness scale, parenting stress index - 4th edition short form, pittsburgh sleep quality index, adult sensory processing scale, strength and difficulties questionnaire, and who quality of life-bref. for the lab experiment, ekg and eda data will be collected through lab protocol, which include a 5-min baseline recording followed by trier social stress test (speaking, math test) and then another 5-min rest period. after that, a pre-recorded 15-min mindfulness practice will be played for the participants to practice. after completing the baseline test, participants will be randomly grouped into the mbsr group or the waitlist controlled group. the online mbsr program is a 8-week group-based, intervention, which will be delivered by a umass trained mbsr instructor.

Eligibility criteria:
inclusion criteria: * have a child aged 6-12 years old that has been diagnosed by a psychiatrist or a psychologist with autism spectrum disorder * english speaking * parents do not receive any form of psychological or behavioral treatment at the time of referral * parents have never participated in a mbsr workshop prior to the enrollment * parents do not have previous meditation experience * parents do not have a severe mental illness (self-assessed), * parents agree to participate in the 8-week mbsr intervention exclusion criteria: * parents who currently receive psychotherapy or take medications for health issues
efficacy and safety of pl9643 ophthalmic solution in subjects with dry eye

Conditions: Dry Eye Disease

Summary: evaluation of safety and efficacy of pl9643 ophthalmic solution compared to placebo for the treatment of the signs and symptoms of dry eye.

the clinical trial is a phase 2, multi center, randomized, double masked and placebo controlled study. during a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive placebo ophthalmic solution (vehicle) bilaterally. during the screening period, exposure to the cae® will be conducted to ascertain eligibility to enter the study at visit 1 and visit 2. those who qualify at visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. the cae® exposure will occur at all visits.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age. * provided written informed consent. * have a reported history of dry eye * have a history of use or desire to use eye drops for dry eye symptoms * have corrected visual acuity greater than or equal to +0.7 in both eyes exclusion criteria: * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) * have any planned ocular and/or lid surgeries over the study period. * have an uncontrolled systemic disease. * be a woman who is pregnant, nursing or planning a pregnancy. * be a woman of childbearing potential who is not using an acceptable means of birth control * have a known allergy and/or sensitivity to the test article or its components. * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study * have used an investigational drug or device within 30 days of visit 1 * be unable or unwilling to follow instructions, including participation in all study assessments and visits
expand new drugs for tb [endtb]

Conditions: Tuberculosis, Multidrug-Resistant

Summary: this observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of mdr-tb. the information gathered in this study will inform doctors how best to use these tb drugs in the future.


Eligibility criteria:
inclusion criteria: * any patient who receives a treatment regimen containing bedaquiline or delamanid at an endtb site will be invited to participate in this observational study, regardless of age or gender. * any patient who signs the study informed consent form will be included in the study. exclusion criteria: * refusal to participate in the study.
a single dose study of the safety, pharmacokinetics and pharmacodynamics of cdx-0159 in patients with cold contact urticaria, symptomatic dermographism, or cholinergic urticaria

Conditions: Cold Urticaria; Cold Contact Urticaria; Symptomatic Dermographism; Symptomatic Dermatographism; Cholinergic Urticaria

Summary: this is a study to determine the safety of cdx-0159 in patients with cold contact urticaria, symptomatic dermographism, or cholinergic urticaria.

this study is an open label phase 1 study evaluating the safety, pharmacokinetics, and pharmacodynamics of a single dose of cdx-0159 in patients with cold contact urticaria, symptomatic dermographism, or cholinergic urticaria who remain symptomatic despite treatment with antihistamines. twenty patients with cold contact urticaria, ten patients with symptomatic dermographism, and ten patients with cholinergic urticaria will be enrolled in four separate cohorts for a total of 40 patients. prospective patients will be screened with tests in clinic as well as daily at home diaries for 2 weeks prior to enrollment. cdx-0159 will be administered intravenously on day 1. post-treatment, patients will be followed for 12 weeks with an optional longer term follow up period.

Eligibility criteria:
key inclusion criteria: 1. diagnosis of cold contact urticaria, symptomatic dermographism, or cholinergic urticaria which does not respond to antihistamines * diagnosis for ≥ 3 months; symptoms of both hive (wheal) and itch/burning/painful sensation despite concurrent use of anti-histamines * during screening, in clinic, for cold contact urticaria, patients must have a positive cold stimulation test, for symptomatic dermographism, patients must have a positive frictest®, and for cholinergic urticaria, patients must have a positive pulse-controlled ergometry (pce) provocation test * on stable dose of antihistamines 2. other than a diagnosis of cold contact urticaria, symptomatic dermographism, or cholinergic urticaria, no other conditions which would introduce additional risk factors or would interfere with the study procedures, as determined by the investigator, based on a medical evaluation 3. female and male patients must use highly effective contraception from the time of the screening visit and for at least 150 days after receipt of study treatment 4. willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires key exclusion criteria: 1. a clearly defined diagnosis of hives or angioedema other than chronic urticaria. 2. receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months 3. treatment with immunosuppressives (e.g. systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine or others) within 4 weeks or 5 half lives 4. active covid-19 infection 5. hiv, hepatitis b or hepatitis c infection there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
myocardial infarction as the first manifestation of coronary heart disease: rates of heralded and unheralded myocardial infarction

Conditions: Myocardial Infarction

Summary: some myocardial infarctions (mi) occur as the first manifestation of coronary artery disease. these are termed 'unheralded' events as they have not been preceded by other forms of coronary artery disease. unheralded mis are important because of the high likelihood of missed opportunities for prevention. the proportion of mis that are 'unheralded' is unknown. this study aims to quantify the proportion of mis that occur 'unheralded' and also give an estimate of the incidence of 'unheralded' mi in the uk, compared to 'heralded' mi and those with angina of recent onset (mis with premonitory symptoms).

this study is part of the caliber (cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the nihr and wellcome trust. the central theme of the caliber research is linkage of the myocardial ischaemia national audit project (minap) with primary care (gprd) and other resources. the overarching aim of caliber is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. caliber has received both ethics approval (ref 09/h0810/16) and ecc approval (ref ecc 2-06(b)/2009 caliber dataset). using data from minap and gprd, patients experiencing their first myocardial infarction (mi) will be separated into three categories: * 'heralded mi': patients who have been diagnosed or treated for cardiovascular disease for more than 90 days before mi. * 'mi with premonitory symptoms': patients who have been diagnosed or treated for cardiovascular disease within the 90 days prior to mi. * 'unheralded mi': patients without a cardiovascular disease diagnosis or treatment at any time before mi. patients with mi will be identified in the linked gprd-minap record. using gprd population denominators, this study will establish the absolute incidence rates of first 'unheralded' mi by calendar year, age, sex, season, mi subtype (st-elevation mi and non st-elevation mi) and region and compare these to the rates of first 'heralded' mis and first 'mi with premonitory symptoms'.

Eligibility criteria:
inclusion criteria: * patients in gprd practices which are deemed "up to standard" by gprd criteria will be included if their practice agreed to be linked to the minap dataset. * age over 18. exclusion criteria: * patients will be excluded after experiencing their first mi. * patients will be excluded if they do not fulfil one of the inclusion criteria.

Keywords: manifestation coronary heart disease myocardial infarction angina pectoris unheralded general practice research database myocardial ischaemia national audit project caliber
tai chi and hip school for patients with hip-oa.

Conditions: Osteoarthritis

Summary: a randomized, controlled study was conducted in southern sweden with two intervention programs for individuals with x-ray-verified hip osteoarthritis (oa). the patients were randomized to 1 of 3 groups; namely hip school, tai chi for arthritis (tca), or a group receiving no intervention. the results showed significant improvement in physical function and self-efficacy within the interventions groups tai chi and hip school. the tai chi group showed improvement in body awareness and quality of movements, and in self-efficacy between baseline and 6- month follow-up. the hip school group showed significant improvement in body awareness and quality of movements between baseline and 6-month follow-up.

a randomized, controlled study was conducted in southern sweden with two intervention programs for individuals with x-ray-verified hip oa. the patients were randomized to 1 of 3 groups; namely hip school, tca, or a group receiving no intervention. a total of 89 subjects attended the baseline appointment and were randomized to one of the three groups. physical function was assessed using, the hip osteoarthritis outcomes score (hoos, swedish version l.k 1.1), an observational assessment of movements the body awareness scale movement quality (bas mq) and the six minute walk test (6mwt). for assessment of hrql the medical outcomes study 36-item short form health survey (sf-36) was used. the arthritis self-efficacy scale (ases) records the patient's self-reported judgment of what he/she can do regardless of the degree of functional limitations or skill. six months after the final intervention all subjects were examined and assessed following the same procedure as at baseline. the 12 months follow-up contained the three questionnaires, hoos, ases and sf- 36 were sent out by mail. the results showed significant improvement in physical function and self-efficacy within the interventions groups tai chi and hip school. the tai chi showed improvement in bas mq, focusing on body awareness and quality of movements, and in self-efficacy between baseline and 6- month follow-up. the hip school group showed significant improvement in bas mq between baseline and 6-month follow-up.

Eligibility criteria:
inclusion criteria: * x-ray-verified hip oa, no walking aid and no joint replacements in the hips or knees. exclusion criteria: * no oa, joint replacement

Keywords: osteoarthritis patient education tai chi physical function
effect of pregabalin in patients with radiotherapy-related neuropathic pain

Conditions: Neuropathic Pain

Summary: rationale: pregabalin is effective on radiotherapy-related neuropathic pain. purpose: this randomized, double-blind, placebo-controlled trial aims to investigate the effect and safety of pregabalin in treating radiotherapy-related neuropathic pain.

radiotherapy for cancer is associated with peripheral neuropathies, especially with brachial plexus neuropathy and trigeminal neuralgia, which included painful sensation that are described as burning, aching, spasm, or tingling. though there is some recommendation about neuropathic pain, there is no definite drug which is recommended for radiotherapy-related neuropathic pain. pregabalin, a central nervous system(cns)-active compound, is an analog of the neurotransmitter gamma-aminobutyric acid. it has been proved an effective treatment for diabetic peripheral neuropathy and postherpetic neuralgia in previous clinical trials. this study plans to evaluate the efficacy of pregabalin versus placebo for relieving radiotherapy-related peripheral neuropathic pain, and assessed its safety.

Eligibility criteria:
inclusion criteria: 1. patients must have received radiation therapy for histologically confirmed head and neck cancer. 2. clinical evidence support the diagnosis of radiation-related neuropathic pain (confirmed by the michigan neuropathy screening instrument) and had a daily pain score of 4 or higher based on a numerical rating scale (0-10 points). 3. neuropathic pain defined according to clinical history, symptoms, physical signs, and a score\>= 12 in chinese version of leeds assessment of neuropathic symptoms and signs questionnaire by two neurology specialists. 4. the mean duration of pain is more than 4 weeks. 5. fertile women who are willing to take contraception during the trial. 6. routine laboratory studies with bilirubin \ /= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; hb \>/=9.0. 7. ability to understand and willingness to sign a written informed consent document. exclusion criteria: 1. current diagnosis of tumor recurrence or metastasis and evidence of tumor associated pain. 2. evidence of secondary neuropathic pain other than radiation. 3. treatment with carbamazepine, gabapentin or pregabalin within 30 days before study enrollment. 4. ongoing treatment for neuropathic pain. 5. history of anaphylactic response to pregabalin. 6. evidence of sever systematic diseases.

Keywords: radiation neuropathic pain pregabalin