Kornimate/medical-research-clean huggingface dataset:
the effect of malaria on disease progression of hiv/aids

Conditions: HIV Infections; Malaria

Summary: the purpose of this study is to find out whether malaria affects how hiv/aids disease progresses in an infected patient, and to determine the effect of reducing malaria infection on hiv disease progression in kumasi

malaria and hiv are among the most prevalent infectious diseases in sub-saharan africa and are major causes of morbidity and mortality in the sub region. because of the wide-spread geographical overlap in hiv and malaria, the probability for co-infections and the potential for interactions between the two diseases are high. even modest interactions may have substantial impact in populations. it is now clear that there are interactions between the two infections. hiv associated immunosuppression erodes the malaria acquired immunity of the hiv patients. the risk of parasitaemia, high parasite density and malarial fever increases with decreasing cd4 t cell counts and increasing viral load of hiv patients. plasmodium falciparum has been shown to stimulate hiv replication through the production of cytokines (including interleukin 6 and tumor necrosing factor α (tnf-α)) by activated lymphocytes. malaria treatment in hiv patients with malaria resulted in significant reduction of the median hiv viral load concentration. although it is now clear that malaria causes transient rises in hiv-1 viral loads, could repeated episodes of malaria in areas of intense transmission lead to a cumulative effect on viral load and accelerate decline in cd4 counts thereby accelerating hiv disease progression? if so, could the decline in cd4 count in individuals who have not yet started on anti-retroviral drugs be slowed down by intermittent malaria treatment? a controlled interventional study with mefloquine as malaria prophylaxis for 6 months will be used in hiv/aids patients who are not already on arts in kath, and malaria parasitaemia and density, hiv viral load and cd4 cell count will be monitored in both arms. comparison: malaria parasitaemia and density, hiv viral loads and cd4 cell counts will be compared between the intervention group and the control groups to determine the effect o malaria and malaria prophylaxis on hiv disease progression

Eligibility criteria:
inclusion criteria: * adult hiv patients attending the komfo anokye teaching hospital (kath) hiv clinic who do not yet fulfil the criteria for arts. this includes a cd 4 cell count of ≥ 300x106/l and world health organisation hiv stage i-iii exclusion criteria: * all children with hiv infection attending the hiv clinic at kath * adult hiv patients on arts attending the hiv clinic at kath * adult hiv patients with who stage iv and v aids

Keywords: human immune deficiency virus acquired immune deficiency syndrome malaria mefloquine prophylaxis hiv/aids treatment naive
clinical, morphological and functional aspects in myocarditis.

Conditions: Myocarditis

Summary: cardiac magnetic resonance (cmr) is accurate to identify acute myocardial damage (edema, hyperemia, and/or fibrosis) due to acute myocarditis (am). recently, two-dimensional strain echocardiography was also validated in order to provide important information on myocardial dysfunction in patients with am, even if no wall motion abnormalities are detected. no data are available about incidence of longitudinal myocardial dysfunction and its prognostic role in am.

in this study, the investigators will analyze the effect of acute myocarditis-induced damage on lv myocardial deformation and remodeling both in the acute myocarditis phase and follow-up period (about 2 years later). the investigators will use a combined approach including strain echocardiography to asses left ventricular myocardial deformation and late gadolinium enhancement (lge)cardiac magnetic resonance for the assessment of left ventricular damage.

Eligibility criteria:
inclusion criteria: * diagnosis of clinical suspected acute myocarditis (am) * diagnosis of am with cardiac magnetic resonance (cmr) according to lake louise criteria (myocardial edema, hyperemia, and lge). * absence of coronary artery diseases confirmed by coronary angiography or computed tomography in all patients with the exception of those younger than 30 years with a low risk of coronary artery disease. exclusion criteria: * previous heart diseases

Keywords: echocardiography cardiac magnetic resonance myocarditis
individual differences in diabetes risk: role of sleep disturbances

Conditions: Sleep; Diabetes

Summary: the hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (swa).


Eligibility criteria:
inclusion criteria: * healthy men and women with low slow wave sleep activity (swa) or high swa with the gender distribution in each group matching the gender distribution of active duty army personnel (85% men; 15% women) based on the following inclusion criteria: * age 18 to 29 years, * normal weight or modestly overweight (bmi ≤ 27 kg/m2 for women, bmi ≤ 28 kg/m2 for men), * normal findings on clinical examination, normal routine laboratory tests results, normal ekg, no history of psychiatric, endocrine, cardiac or sleep disorders. * only subjects who have regular life styles (no shift work, no travel across time zone during the past 4 weeks), habitual bedtimes between 7.0-8.5 hours, and do not take medications will be recruited. * an overnight polysomnography will be performed to rule out sleep-disordered breathing (apnea-hypopnea index \> 5/hour) and periodic limb movement disorder (plm arousal index \>1/hour). * women taking hormonal contraceptive therapy and pregnant women will be excluded. in women, all studies will be initiated in the early follicular phase. exclusion criteria: * tobacco use. * habitual alcohol use of more than 2 1 drink per day. * excessive caffeine intake of more than 300 mg per day and individuals with a metal implant or another metal object in their body. we estimate that we will need to recruit at least 60-70 individuals to obtain two gender-matched groups of 16 individuals with either low or high swa.

Keywords: sleep diabetes risk
does acupuncture activate endogenous pain inhibition in chronic whiplash?

Conditions: Whiplash

Summary: this physiological study examines whether acupuncture exerts short-term effects of analgesic mechanisms in patients with chronic whiplash pain. more specifically, it is examined whether acupuncture activates brain-orchestrated pain inhibitory action.

many patients with chronic pain, including those with chronic whiplash-associated disorders (wad), show features of central sensitization (cs), a process characterized by generalized hypersensitivity of the somatosensory system. it would be worthwhile identifying treatments able of activating the dysfunctional endogenous pain inhibition in patients with cs and chronic wad. acupuncture is a treatment method widely used for patients with chronic pain, including those with chronic wad. the effectiveness of acupuncture for the treatment of chronic (neck) pain is supported by several randomized controlled clinical trials, systematic reviews including meta-analyses. however, the effect-sizes are rather small and only short-term effects have been shown consistently. a randomized cross-over trial comparing acupuncture with relaxation is conducted in order to examine whether acupuncture vs. relaxation for patients with chronic wad results in: 1. immediate activation of endogenous pain inhibition (i.e. conditioned pain modulation); 2. concomitant pain relief; 3. and reduced disability level. further it is examined whether acupuncture vs. relaxation results in different autonomic nervous system responses.

Eligibility criteria:
inclusion criteria: * a diagnosis of chronic wad grade 1 to 3 according to the criteria as defined by the quebec task force classification * chronic neck pain and wad persisting for at least 3 months * age between 18 and 65 years exclusion criteria: * classified as wad grade 4 (neck complaints including fracture or dislocation, or injury to the spinal cord) * pregnant * initiated a new conventional therapy during the study period * taking analgesic drugs 48 hours before testing and/or nicotine, alcohol and caffeine 24 hours before testing

Keywords: whiplash chronic pain sensitization treatment acupuncture relaxation
treatment of tension-type headache with articulatory and suboccipital soft tissue therapy

Conditions: Tension-type Headache

Summary: background. headache is one of the most common causes of consultation in primary health care and neurology in europe. cervical muscle tension can maintain a restriction of joint motion at the suboccipital level, facilitating the referred head pain. objective. to evaluate the effectiveness of two manual therapy treatments for tension-type headache. methods. a randomized double-blind clinical trial was conducted, for a period of 4 weeks and a follow-up at one month post-treatment. eighty-four patients with tension-type headache were assigned to 4 groups (3 treatment groups and 1 control group). treatments included manual therapy of suboccipital soft tissue inhibition, occiput-atlas-axis global manipulation, and a combination of both techniques. outcome measures were: impact of headache, disability caused by headache, ranges of motion of the craniocervical junction, frequency and intensity of headache, and associated headache symptoms. results. after 8 weeks, there were significant improvements in impact of headache (p=0.01), disability (p=0.001), and craniocervical flexion (p=0.03) for the suboccipital soft tissue inhibition group; in headache impact and disability (p=0.000), pain intensity (p=0.02) and craniocervical flexion (p=0.004) and extension (p=0.04) for the occiput-atlas-axis group; and in impact (p=0.002), functional disability (p=0.000), headache frequency (p=0.002) and intensity (p=0.001), craniocervical flexion (p=0.008) and extension (p=0.003) and associated headache symptoms (p=0.01) for the combined therapy group, with effect sizes from medium to large. conclusions. occiput-atlas-axis and combined therapy group treatments are more effective than suboccipital soft tissue inhibition for tension-type headache. the treatment with suboccipital soft tissue inhibition, despite producing less significant results, also has positive effects on different aspects of headache.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years, episodes of headaches lasting from 30 minutes to 7 days, headache having at least two of the following characteristics: \*bilateral location * pressing non-pulsating quality * mild or moderate intensity * not aggravated by routine physical activity. * participants may present photophobia or phonophobia, nausea or vomiting, pericranial tenderness, with evolution of more than three months, and they must be under pharmacological control. exclusion criteria: * patients with other types of headache * headache that is aggravated by head movements * metabolic disorders or musculoskeletal complaints previous neck trauma * vertigo * dizziness * arterial hypertension * advanced degenerative osteoarthritis * neck joint stiffness * signs of malignancy * pregnancy * patients with cardiac devices * patients in process of pharmacological adaptation, and excessive emotional tension

Keywords: effectiveness tension-type headache manual therapy
pharmacokinetics of entospletinib in adults with normal and impaired liver function

Conditions: Oncology

Summary: the primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ento) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.


Eligibility criteria:
key inclusion criteria: * calculated body mass index from 18 to 40 kg/m\^2 * not pregnant * normal electrocardiogram * participants with impaired liver function must be sufficiently healthy based upon medical history and physical examination, vital signs, and screening laboratory evaluations. key exclusion criteria: * participation in another clinical study (current or within last 30 days) * hiv, hepatitis b virus, or active hepatitis c virus infection note: other protocol defined inclusion/exclusion criteria may apply.
physiological signals, activity and posture for surface mounted insertable cardiac monitor in heart failure study

Conditions: Heart Failure, Systolic; Heart Failure, Diastolic

Summary: to characterize the physiological signals collected from a wearable cardiac monitor (wcm) prototype device in subjects with heart failure and preserved ejection fraction (hfpef) and compare against signals from subjects with heart failure and reduced ejection fraction (hfref). to evaluate the relationship of physiological signals measured from a wearable cardiac monitor (wcm) prototype device with echo measures of systolic and diastolic function

this is a non-randomized, feasibility study that will enroll up to 100 participants clinically diagnosed with hfpef or hfref. approximately 70% of participants will have hfpef and 30% will have hfref. there will be one study visit per participant. the study visit includes device placement and data collection during postural changes. echocardiograms will also be collected throughout the study and at least 30% of participants will undergo a submaximal exercise test. the device will then be removed.

Eligibility criteria:
inclusion criteria: * patients with nyha class ii or iii heart failure defined by symptoms and signs of heart failure * documented episode of decompensated heart failure in the past 3 years, which either: a) resulted in a hospital admission (primary diagnosis) or b) was treated in out-patient clinic * hfref defined by documented evidence of ef ≤ 40% or * hfpef defined by documented evidence of: * ef ≥ 50% and no prior record of ef \< 40% * evidence of relevant structural heart disease or diastolic dysfunction on echocardiographic as defined in the 2016 esc guidelines * able to understand and willing to provide written informed consent to participate in the trial * age 21 years old or greater * willing and able to participate in the required testing exclusion criteria: * prior hospitalization, cv event or surgery within 6 weeks * subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system or include the usage of investigational drugs. * patients with active implantable medical devices * known allergy to materials used in the study (adhesive tape, titanium, ecg electrodes) * have a prosthetic cardiac valve, previously underwent cardiac valve surgery or have hemodynamically unstable (as judged by local investigator) valvular disease * subject is pregnant as indicated by patient record * patients with rash or open wound on torso locations where investigational devices will be placed * patient deemed as clinically unstable or unsuitable to perform prescribed testing as judged by the local investigator

Keywords: echocardiogram
impact of health literacy and other factors on glaucoma patient adherence in south india

Conditions: Patient Noncompliance; Health Literacy; Glaucoma

Summary: the purpose of this study is to determine how health literacy impacts glaucoma patient adherence (as measured by following up with the doctor) in tamil nadu, india. we hypothesize that individuals with better health literacy will have higher rates of follow-up with their ophthalmologist.

many studies have shown the importance of health literacy on patient adherence in the united states (juzych, m, et al., 2008; muir, kw, et al., 2006). low adherence in glaucoma patients leads to increased intraocular pressure, optic nerve damage, and blindness. to date, no research has been done with health literacy and patient adherence in the developing world. we will use tofhla and realm to assess the health literacy of glaucoma patients in tamil nadu, india. we will also survey other demographic information and patient knowledge of glaucoma. this information will be compared with follow-up rates to identify barriers to patient adherence.

Eligibility criteria:
inclusion criteria: * better than 20/100 corrected vision in better eye * must live within 50 miles of aravind eye hospital * clinical diagnosis of primary glaucoma * paying patient

Keywords: health literacy patient nonadherence patient noncompliance follow up india glaucoma
phase i trial of periocular topotecan in retinoblastoma

Conditions: Retinoblastoma

Summary: this is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.

patients with bilateral retinoblastoma who have relapsed after attempts of conservative therapy with standard regimens such as carboplatin, etoposide, vincristine and external beam radiotherapy who face immediate enucleation of their single remaining eye are eligible for this protocol. starting dose of topotecan will be 0.5 mg and dose escalation will be done by the accelerated titration method. any grade 3 ocular toxicity or grade 4 non ocular toxicity will be designed as the dose limiting toxicity. grade 2 scleral toxicity will be considered for dlt. in case of grade 2 ocular toxicity or grade 3 systemic toxicity, the escalation dose will be 0.25 mg. maximal dose will be 2 mg.

Eligibility criteria:
inclusion criteria: * group vb (reese ellsworth) * relapsed or progressed after carboplatin-based regimens and external beam radiotherapy * enucleation of the contralateral eye * normal renal and liver function exclusion criteria: * presence of glaucoma, rubeosis iridis, anterior chamber extension * extraocular disease * adequate follow up impossible for social reasons

Keywords: topotecan periocular chemotherapy
universal preventive resilience intervention to improve and promote mental health for teenagers

Conditions: Anxiety Symptoms; Depressive Symptoms; Behavioral Problem of Child; Mental Disorder in Adolescence; School Absenteeism; Bullying of Child; Cyberbullying; Violence in Adolescence

Summary: adolescence is a period of many physical, mental, emotional, and social changes. it is also associated with risk behaviour conducts. nonetheless, not all youths under disadvantage, adversity, or exposure to risk factors experience negative mental health outcomes. the concept of resilience provides one possible explanation for the ability of some individuals to maintain positive mental health. resilience is thus the ability of an individual or community to adapt to life challenges or adversities while maintaining mental health and well-being. the increasing prevalence of mental disorders amongst children (around 10-20% of young people) makes positive mental health promotion in schools necessary through intervention programmes. upright (universal preventive resilience intervention globally implemented in schools to improve and promote mental health for teenagers) is a research and innovation project funded by the european union´s horizon 2020 programme (no. 754919). upright general aim is to promote mental well-being and prevent mental disorders in youth by enhancing resilience capacities. it has been designed as a whole school approach addressing early adolescents, their families and the school community to finally create a real mental well-being culture at schools.

the operational objectives of upright are: * to co-create (involving adolescents, families, school staff, clinicians, policy makers) an innovative resilience holistic program in schools for the promotion of mental health in youth between 12 and 14 years; * to deploy an intervention in five different pan-european regions; * to better understand the natural history of mental disorders according to the resilience level and provide evidence of specific resilience factors promoting positive mental well-being longitudinally; * to demonstrate the effectiveness and predict future impact of an intervention in terms of improvement of quality of life, mental well-being, and academic performance, and a reduction of absenteeism and bullying cases; * to transfer the programme to europe and beyond by disseminating the results and enabling innovative action plans for mental well-being in the youth. the upright programme´s conceptual framework is structured in four different domains including skills for coping, efficacy, social and emotional learning and mindfulness practice. the intervention was developed by an innovative co-creation process (co-design, co-production and co-customization) participating five european regions representative of the cultural and socioeconomic variability (lower silesian in poland, basque country in spain, trento in italy, denmark and reykjavik capitol area in iceland).

Eligibility criteria:
inclusion criteria: * adolescents from 1st grade (12-14 years of age) studying in the participating schools, their families and teachers of these adolescents. exclusion criteria: * none
study of the impact of a social robot on unwanted loneliness in elderly people living in nursing homes

Conditions: Elderly People; Nursing Home Residents; Loneliness; Quality of Life; Wellbeing; Social Interaction

Summary: the goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. the main questions it aims to answer are: * can social robots reduce unwanted loneliness? * can social robots improve quality of live and well-being? the selected centers are organized in several classes of living units. living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). living units of the same class gather persons with similar characteristics. to compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group. the persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities. the intervention will last 8 weeks. to assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention.


Eligibility criteria:
inclusion criteria: * to be 65 years old or older. * to live indefinitely for more than 6 months in the participating nursing home (to avoid the effect of the adaptation period). * provide the informed consent. exclusion criteria: * impossibility to understand and/or answer the loneliness questionnaire for themselves. * to have physical, cognitive or other conditions preventing the use of the robot platform.

Keywords: social robots loneliness nursing homes quality of life wellbeing