Kornimate/medical-research-clean huggingface dataset:
study to assess potential interactions between intravenous cocaine and oral lorcaserin

Conditions: Cocaine Abuse

Summary: the primary objective of this study is to determine if there are significant interactions between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine infusions by measuring adverse events (aes) and cardiovascular responses including heart rate (hr), blood pressure (bp), and electrocardiogram (ecg) (including qtc).


Eligibility criteria:
inclusion criteria: * be volunteers who are not seeking treatment for drug addiction. * be between 18 and 50 years-of-age. * meet diagnostic and statistical manual (dsm-iv) - text revision (tr) criteria for current cocaine abuse as assessed using the mini neuropsychiatric interview (version 6.0). * have a body mass index (bmi) within a range of 18.0 to 34.0 kg/m2 and a minimum weight of at least 50.0 kg at screening. * have experience using cocaine by the smoked or i.v. route at least 6 times in the past 12 months prior to clinic intake (day -3) and at least one use within the past 30 days. * provide a urine sample positive for cocaine at least once during screening (days -28 to -4). * be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures. * females must have a negative serum pregnancy test at screening and negative urine pregnancy test at intake prior to receiving the first dose of investigational drug. they must also be postmenopausal, have had a hysterectomy, been sterilized, have a partner with a vasectomy, or agree to use one of the following methods of birth control starting at least 14 days prior to clinic intake: 1. diaphragm and condom by partner 2. condom and spermicide by partner 3. intrauterine device and condom by partner 4. sponge and condom by partner 5. complete abstinence from sexual intercourse 6. oral contraceptives, depo-provera, norplant, patch, and intrauterine progesterone contraceptive * be able to comply with protocol requirements, rules and regulations of the study site and be likely to complete all the study treatments. exclusion criteria: * please contact site directly for more information
enhancing intergenerational health in nigeria: peripartum as critical life stage for cardiovascular health

Conditions: Hypertension in Pregnancy; Hypertension; Obesity and Overweight; Maternal Morbidity and Mortality; Maternal and Child Health Outcomes

Summary: the purpose of the enhance-cvh study is to promote intergenerational cardiovascular health (cvh) of women and children in abuja and the surrounding federal capital territory of nigeria. the study team plans to achieve this through an adaptation of an existing evidence based intervention - parents as teachers (pat) curriculum + healthy eating active living taught at home (health) - among pregnant women with obesity and their children in nigeria. the aim of the study is to evaluate the effectiveness and implementation of community health educator-led delivery of the pat+health intervention via home visits to answer the following main questions: * will the women participating in the intervention have a greater change in weight from baseline to 18-month follow up compared to the women who do not? * will the women and children in the intervention group display better cvh promoting lifestyle behaviors compared to those in the control group? participants in the study will complete baseline surveys and have clinical data, lab data, and body measurements captured. participants will also have these procedures repeated at birth and every 6 months up to 24 months post-delivery. once randomized to the intervention group, participants will complete 40 biweekly pat+health curriculum delivery sessions, each lasting approximately 60-90 minutes.


Eligibility criteria:
inclusion criteria: •≥18 years of age, * pregnant women under 14 weeks gestation, * singleton gestation, * body mass index \> 30 kg/m2 * willing to participate in enhance cvh for 2 years, * planning to receive prenatal care and deliver at either one of the participating primary healthcare, centers or university of abuja teaching hospital, and * able to give informed consent for study participation, understanding she and her child will both be involved. exclusion criteria: * current enrollment in a weight loss program, * inability to engage in a walking program, * active substance abuse * treatment with medications known to impact weight (e.g., corticosteroids, antipsychotics), * plan to relocate within the next 2 years, or * unwilling to provide informed consent.

Keywords: maternal hypertension maternal and infant cardiovascular health hybrid type 2 effectiveness-implementation obesity in pregnancy
smartphone application in reducing dental anxiety

Conditions: Dental Anxiety

Summary: evaluating the effectiveness of smartphone applications (tell-play-do) (tpd) in reduction of preoperative anxiety in children undergoing restorative treatment, as measured by heart rate and venham's picture test.

a total of at least 78 patients aged from 6-8 years will be included. all participants will be divided equally into two groups. study group tpd using smartphone application and control group (tell-show-do) (tsd) using traditional behavior management technique. dental anxiety using venham's picture test and heart rate using pulse oximeter will be assessed during dental treatment

Eligibility criteria:
inclusion criteria: * school-age children aged from 6-8 years. * presence of carious primary molars without pulpal involvement. * parents have the ability to write, read and willingness to participate in the study. * first dental visit to the clinic. * normal healthy children. exclusion criteria: * children with previous dental experience. * medically compromised children. * children with special needs (physical or mental).
anti-hypertensive effect of mycelia of antrodia cinnamomea

Conditions: Hypertension

Summary: this the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (gaba), adenosine and antrosterol-containing ac mycelia on blood pressure among people with mild hypertension. overall, ac mycelia consumption for 8 weeks could successfully reduce mean diastolic and systolic bp through the suppression of pra that is linked to downstream suppresion of angiotensin ii formation, which further decreases the sympathetic outflow that leads to hypertension. in addition to blood pressure lowering properties, ac mycelia also has beneficial effect in reducing oxidative stress, significantly. no adverse events were noted, suggesting that ac mycelia deserve its consideration as a candidate for safe alternative treatment to conventional anti-hypertensive medications.

this the first report undertaken to assess the effect of supplementation with oral gamma-aminobutyric acid (gaba), adenosine and antrosterol-containing ac mycelia on blood pressure among people with mild hypertension. forty-one subjects with systolic blood pressure (sbp) between 130 and 179 mm hg and/or diastolic blood pressure (dbp) between 85 and 109 mm hg were randomized to receive either ac mycelia or starch placebo for 8 weeks, and had follow-up observation for an additional 2 weeks. sbp in the subjects given gaba, adenosine and antrosterol-rich ac mycelia significantly decreased compared to those who received the placebo (p\<0.05). dbp also decreased after the intake of ac mycelia. compared to the placebo, ac mycelia significantly reduced plasma renin activity by a maximum of 25 % and 36 % on week 8. this suppression suggested that ac mycelia is a potent inhibitor of renin, and its bioavailability is sufficient to produce bp reduction after a short term of oral administration. neither adverse events nor abnormal laboratory findings were noted throughout the study period, suggesting that gaba, adenosine and antrosterol-rich ac mycelia significantly decreased borderline hypertension, which may support its consideration as a safe alternative treatment compared to conventional anti-hypertensive medications.

Eligibility criteria:
inclusion criteria: * eligible subjects were untreated hypertensive men or women aged between 20 and 80 years old with sbp between 130 and 179 mmhg and/or dbp between 85 and 109 mmhg as measured in a sitting position exclusion criteria: * subjects were excluded if they had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. they were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.

Keywords: antrodia cinnamomea mycelia blood pressure adenosine antrosterol clinical trial gamma-aminobutyric acid
multicenter, therapeutic use observational study to evaluate the effects of concurrent therapy of sarpogrelate

Conditions: Chronic Occlusive Arterial Disease

Summary: the study will evaluate the effect of anpl-one sr tablet on the improvement of symptoms in daily care environments using paq.

the purpose of this study is to evaluate the effect of anple-one sr tablet on the improvement of symptoms in daily care environments within the scope of 300 milligrams of anpl-one sr tablet (sarpogrelate hydrochloride agent) using paq.

Eligibility criteria:
inclusion criteria: 1. adults over 19 and under 80 years of age. 2. patients who first administered sarpogrelate hydrochloride drugs or less than 3 months to improve ischemic symptoms such as ulcers, pain, and coldness caused by chronic arterial obstruction (burger's disease, obstructive arteriosclerosis, diabetic peripheral angiopathy, etc.). 3. patient who voluntarily signed a written consent form approved by the clinical trial review committee or ethics committee and agreed to participate in the study by the patient or the subject's agent. exclusion criteria: 1. patient who is expected to have less than two years of life expectancy. 2. patient who have bleeding within a week of participation in the study 3. patient suffering from diseases that may increase bleeding during study participation (hemophilia, capillary placebo, digestive tube ulcer, urinary tract bleeding, hemoptysis, hyperself-bleeding, etc.). 4. a female patient who is likely to be pregnant or pregnant. 5. female patients who are lactating or are scheduled to be lactated at the time of participation in the study. 6. patients with severe renal disease and liver disease.
a study of apremilast in pediatric participants in children with mild to moderate plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.


Eligibility criteria:
inclusion criteria: * participants must have a weight of ≥ 20 kg. * participant must have an age and sex specific bmi value no lower in range than the fifth percentile on the growth chart for children and adolescents. * participant is able to swallow the study medication tablet. * diagnosis of chronic plaque psoriasis for at least 6 months prior to screening. * has mild to moderate plaque psoriasis at screening and study visit 1 as defined by: * psoriasis area severity index score 2-15, * body surface area 2-15%, and * static physician global assessment score of 2-3 (mild to moderate) * disease inadequately controlled by or inappropriate for topical therapy for psoriasis. exclusion criteria: * guttate, erythrodermic, or pustular psoriasis at screening and study day 1. * psoriasis flare or rebound within 4 weeks prior to screening. * active tuberculosis (tb) or a history of incompletely treated tb per local guidelines. * history of recurrent significant infections. * active infection or infection treated with antibiotic treatment within 14 days of study day 1. * any history of or active malignancy or myeloproliferative or lymphoproliferative disease. * current use of the following therapies that may have a possible effect on psoriasis: * conventional systemic therapy for psoriasis within 28 days prior to study day 1 (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters). * phototherapy treatment (ie, ultraviolet b \[uvb\], puva) within 28 days prior to study day 1. * biologic therapy: * etanercept (or biosimilar) treatment 28 days prior to study day 1 * adalimumab (or biosimilar) treatment 10 weeks prior to study day 1 * other tnf or il-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) within 12 weeks prior to study day 1 * anti-il-12 or anti-il-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to study day 1. * use of tanning booths or other ultraviolet light sources. * answer "yes" to any question on the columbia-suicide severity rating scale during screening or at study day 1. * female participant of childbearing potential with a positive pregnancy test assessed at screening and/or study day 1 by a serum and/or urine pregnancy test.

Keywords: apremilast otezla amg 407 cc-10004 pediatric plaque psoriasis
effect of isometric exercise on pain perception in rotator cuff related shoulder pain

Conditions: Rotator Cuff Tendinitis

Summary: the aim of this study is to compare the immediate effects of an acute bout of isometric exercise of the shoulder external rotator muscles above and below pain threshold on pain intensity, pain threshold, conditioned pain modulation and pain free force in external rotation. to evaluate the results of the exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and after and 45 minutes after each experimental condition.

the aim of this study is to compare the immediate effects of an acute bout of isometric exercise of the shoulder external rotator muscles above and below pain threshold on pain intensity, pain threshold, conditioned pain modulation and pain free force in external rotation. it will consist of a randomized three-treatment parallel-design study. the sample will consist of subjects with rotator cuff related shoulder pain (rcrsp). once the sample is selected, subjects will participate in three experimental sessions, which will occur in a randomized order: two exercise sessions (supra-threshold and infra-threshold isometric exercise) and one control session. in the first session, information regarding clinical and demographical aspects will be collected. a washout period of approximately 48 hours will separate each of the experimental sessions. to evaluate the results of the exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and 45 minutes after each experimental condition. pain intensity, pressure pain thresholds (ppt), conditioned pain modulation (cpm), maximal voluntary isometric contraction (mvic) and pain free isometric strength (pfis) will be measured.

Eligibility criteria:
inclusion criteria: * aged 18-80 years (likelihood of patients \> 80 having degenerative changes in the shoulder is increased) * pain localised to the proximal anterolateral shoulder region * positive for pain on at least one of the following three impingement tests: hawkins-kennedy, neer's, jobe's * positive for pain on resisted external rotation and/or abduction. exclusion criteria: * shoulder surgery within last 6 months * reasons to suspect systemic pathology including inflammatory disorders, cervical repeated movement testing affects shoulder pain and/or range of movement, passive external rotation deficit greater (less than 30º or a range of motion reduction of 50% or more as compared to the contralateral side), upper limb tension test a for cervical radiculopathy * atraumatic degenerative rotator cuff tear based on the cluster of clinical tests (painful arc, drop arm test, and marked weakness into er all three positive)

Keywords: isometric exercise rotator cuff pain threshold
study to compare axicabtagene ciloleucel with standard of care therapy as first-line treatment in participants with high-risk large b-cell lymphoma

Conditions: High-risk Large B-cell Lymphoma (LBCL)

Summary: the goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (soc) in first-line therapy in participants with high-risk large b-cell lymphoma.

five years after randomization, participants who have received axicabtagene ciloleucel will transition to a separate long-term follow-up study (study kt-us-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility criteria:
key inclusion criteria: * histologically confirmed large b cell lymphoma (lbcl) based on 2016 world health organization (who) classification by local pathology lab assessment, including of the following: * diffuse large b-cell lymphoma (dlbcl), not otherwise specified (nos) * high-grade b-cell lymphoma (hgbl) * note: transformed dlbcl from follicular lymphoma or from marginal zone lymphoma is eligible if no prior treatment with anthracycline-containing regimen. * high-risk disease defined as an international prognostic index (ipi) score of 4 or 5 at initial diagnosis. * have received only 1 cycle of rituximab plus chemotherapy (r-chemotherapy). * adequate bone marrow, renal, hepatic, pulmonary, and cardiac function. * females of childbearing potential must have a negative serum or urine pregnancy test. key exclusion criteria: * the following who 2016 subcategories by local assessment: * t-cell/histiocyte-rich lbcl * primary dlbcl of the central nervous system (cns) * primary mediastinal (thymic) lbcl * b-cell lymphoma, unclassifiable, with features intermediate between dlbcl and classical hodgkin lymphoma * burkitt lymphoma * history of richter's transformation of chronic lymphocytic leukemia * presence of detectable cerebrospinal fluid (csf)-malignant cells, brain metastases, or a history of cns involvement of lymphoma. * presence of cardiac lymphoma involvement. * any prior treatment for lbcl other than the 1 cycle of r-chemotherapy. * history of severe immediate hypersensitivity reaction to any of the agents used in this study. * presence of cns disorder. history of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (pres) within 12 months prior to enrollment. * history of acute or chronic active hepatitis b or c infection. * positive for human immunodeficiency virus (hiv) unless taking appropriate anti-hiv medications, with an undetectable viral load by pcr and with a cluster of differentiation 4 (cd4) count \> 200 cells/ul. * medical conditions or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy of study treatment. please refer to protocol for further details. * history of clinically significant cardiac disease within 12 months before enrollment. * history of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years. note: other protocol defined inclusion/exclusion criteria may apply.
virtual reality software for patients with stroke

Conditions: Stroke

Summary: the goal os this clinical trial is to develop and validate a gamified, fully immersive, and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke. the main questions it aims to answer are: * to assess the effects of a gamified, fully immersive and stroke-specific virtual reality 10-week intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available vr system, on disability in patients with stroke. * to assess the effects of a gamified, fully immersive and stroke-specific virtual reality intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available virtual reality system, on quality of life, upper-body motor function, gross manual dexterity, handgrip strength, static and dynamic balance, and cognitive function in patients with stroke

stroke is the leading cause of long-term disability and ranks as the second most prevalent cause of mortality worldwide. according to data from the world health organization, since 2005, the global probability of a person experiencing a stroke has increased by 50 percent. it is expected that 1 in 4 individuals will face the risk of having a stroke in their lifetime. a stroke can result in significant loss of motor functions, communications abilities, weakness, or hemiparesis, leading to a diminished quality of life. therefore, improving the rehabilitation process is evidently of paramount significance. virtual reality has emerged as a novel strategy to improve neurological diseases; however, there is an absence of an immersive software designed specifically for stroke patients within a gamified environment. therefore, the aim of reset randomized controlled trial is to evaluate the effect of a gamified, fully immersive, and stroke-specific virtual reality software on disability in stroke patients.

Eligibility criteria:
inclusion criteria: * women and men with either an ischemic or hemorrhagic stroke * stroke between the last 7 to 14 days * functional independence before stroke (modified rankin scale \<3) * paresis of the lower extremity, upper extremity, or both, with a score ≤3 on the "motor arm" item of the national institutes of health stroke scale (nihss) scale * trunk control in seated and standing position * ability to understand basic instructions and to decide whether to sign informed consent exclusion criteria: * moderate-severe aphasia that precludes understanding the required tasks * cognitive impairment that precludes cooperation with tasks * serious behavioral problems or mental disorders * lower extremity deep vein thrombosis, quadriplegia, neurodegenerative diseases, lower limb fractures, or recent myocardial infarction * vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, or other unstable condition * a history of cerebrovascular disease (if not fully resolved) * photosensitive epilepsy

Keywords: stroke