Kornimate/medical-research-clean huggingface dataset:
simple once daily triple regimen including tenofovir, emtricitabine and efavirenz in hiv-1 infected patients (anrs 1207)

Conditions: HIV Infection

Summary: in the context of sub-saharian africa, this trial evaluate one of the most simple treatment available for hiv-1 infected patients. the combination proposed is a triple antiretroviral therapy with only one intake of 3 pills per day. this combination has already been studied in the north countries. here in senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.


Eligibility criteria:
inclusion criteria: * documented infection with hiv-1 (elisa- western blot) * outpatient of masculine or feminine gender * in female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device * no previous treatment with antiretroviral therapy * cdc group c (except tuberculosis if cd4 count is over 350 /ml), cdc group b with cd4+ count under 350/ml and cdc group a with cd4 count under 200/ml. * patient has provided informed written consent * patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator exclusion criteria: * deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible * patient participating in a different clinical study * presence of serious or developing pathology * severe liver failure (tp under 50% et bilirubinemia over 3 lsn) * thrombocytopenia with platelet level under 50 000 cells /ml * known severe renal pathology (creatinine clearance under 50 ml/min) * clinical or biological problem corresponding to indications of grade over or equal 3 of who classification * karnofsky under 70 percent * opportunistic infections * patients taking medications not recommended in the context of the protocol

Keywords: simplification regimen hiv infection once a day naive patients sub-saharian africa treatment naive
the effects and safety of low calcium dialysis on coronary artery calcification in maintenance hemodialysis patients

Conditions: Coronary Artery Calcification

Summary: this study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in maintenance hemodialysis (mhd) patients.

mhd patients recruited in this study were randomly divided into two groups: routine dialysis group (with dialysate calcium concentration 1.5mmol/l) and low calcium dialysis group (with dialysate calcium concentration 1.25mmol/l). all patients were dialyzed thrice weekly for 4 hours with a bicarbonate-based solution. they were followed up in every dialysis interview during the 1-year study, the occurrence of all adverse reactions associated with dialysis were recorded during the study. all patients received heart spiral ct examination before and at the end of the study. coronary artery calcification was assessed by a certain professional who was not affiliated to the dialysis center.

Eligibility criteria:
inclusion criteria: * maintenance hemodialysis (mhd) patients who dialyze thrice weekly in our hospital with serum ipth \<500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests. * patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function. * patients who signed informed consent documents at the time of enrollment in the study. exclusion criteria: * patients whose heart or lung function are poor, or with unstable hemodynamics. * patients who are diagnosed active pulmonary tuberculosis, aids, malignant tumour, or decompensated liver cirrhosis. * patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.

Keywords: maintenance hemodialysis patients coronary artery calcification low calcium dialysate effects safety
the prevalence and implications of obstructive sleep apnea in the population of a wound center

Conditions: Obstructive Sleep Apnea; Non-healing Wounds

Summary: this study is looking at the prevalence of sleep apnea in a wound center population. it uses both screening surveys and take home devices. some measures of wound healing ability are being looked at as well.

patients with chronic non-healing wounds often have major co-morbidities such as diabetes and cardiovascular diseases \[1\]. obstructive sleep apnea (osa) is present in up to 24% of middle-aged adults \[2\], and is far more prevalent in patients with existing cardiovascular disease \[3\]. patients with osa are at increased risk of developing diabetes l \[4\]. osa is an established cause of hypertension\[5\], and has an estimated prevalence of 40% in all patients with hypertension \[6-8\]. similarly a strong association exists between osa, coronary artery disease \[6, 7\] and stroke \[8\]. osa may be present in over 50% of patients with heart failure \[9\]. patients with chronic non-healing wounds stand to benefit from identification and treatment of severe co-morbidities such as osa. such identification and treatment of osa will impact the survival of these patients \[10, 11\], and may also contribute to improved morbidity via impacting wound healing. several unexplored links exist between osa and wound healing. osa is a disorder of intermittent hypoxia and is associated with increased oxidative stress \[12\]. humans with osa and animal models of intermittent hypoxia developed impaired vascular function and nitric oxide deficiency. patients with osa have impaired endothelial function even in the absence of clinically apparent cardiovascular disease \[13-15\]. increased sympathetic activity and episodic pressor response are well documented in osa. patients with osa have increased vascular tone and baseline vasoconstriction \[16\]. impaired vascular reactivity to hypoxia was also demonstrated in animal models exposed to 2 weeks of intermittent hypoxia\[17\]. therefore, in patients with chronic non-healing wounds, osa is likely to further complicate the healing process. osa as a disorder of oxidative stress and vascular impairment is most likely an important co-morbidity in patients with non-healing wounds. other potential mechanisms of interaction are the inflammatory response associated with osa

Eligibility criteria:
inclusion criteria: * osu wound clinic patient exclusion criteria: * unable to complete survey * under 18yrs old

Keywords: sleep apnea obstructive sleep apnea wound healing non-healing wounds
enablers and barriers to hydroxyurea use for sickle cell disease jamaica

Conditions: Sickle Cell Disease

Summary: sickle cell disease (scd) is associated with a lifetime of medical and socio-behavioural complications that require coordination of care from multidisciplinary teams. access to adequate care for scd is important as inadequate access can contribute to increased acute care utilization, disjointed care delivery, and earlier mortality for many scd patients. hydroxyurea (hu) is the first drug approved for the treatment of scd and improves many adverse outcomes of scd and yet its use remains sub-optimal. this mixed-methods study aims to identify the barriers and enablers that scd patients, caregivers of children (under age 18 years), and health care providers (including physicians, nurses and pharmacists) identify for health care access and hu utilization. the findings may guide development and implementation of strategies to improve access to scd healthcare and hu uptake which may result in significant benefits to patients, families and the healthcare system including possible reduction in healthcare utilization. participants will be recruited from the sickle cell unit, kingston and from all four jamaican regional health authorities. questionnaires and interview guides for provider and patient/caregiver assessments are adapted, with permission, from the sickle cell disease implementation consortium tools. the study will also examine data on hu usage from the national health fund of jamaica since its addition of scd to its list of chronic illnesses in 2015. all data collected will be de-identified and maintained in a secure database, with access limited to key personnel. there is minimal risk to participants. participants will be selected only because of the specific problem under investigation, and not because of easy availability, diminished autonomy, or social bias.


Eligibility criteria:
inclusion criteria: * scd patients (ages 18 and over) * adult caregivers of scd children/adolescents under 18 years * healthcare providers: physicians, nurses and pharmacists who treat and interact with sickle cell patients exclusion criteria: * scd patients below age 18 years * scd patients who are acutely ill

Keywords: hydroxyurea access to care jamaica
china registry of watchman

Conditions: Atrial Fibrillation; Left Atrial Appendage Closure

Summary: this registry is designed to observe the safety and effectiveness of watchman left atrial appendage closure technology in a chinese population.

in this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a watchman device based on real clinical practice will be enrolled. enrolled subjects will be followed up for 5 years.primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.

Eligibility criteria:
inclusion criteria: non-valvular atrial fibrillation patient with cha2ds2-vasc≥2, and with any one of the following items: 1. not suitable for long-term anti-coagulation therapy; 2. stroke or embolism events in spite of warfarin treatment with intended inr 3. has-bled≥3 exclusion criteria: patient with any one of the following items will be excluded from the study: 1. clinical exclusion criteria (any of the items) a congestive heart failure nyha iv, b atrial septum defect, asd surgery or closure c cardioversion or catheter ablation is planned within 30 days d with mechanic valve e left atrial appendage resection f heart transplantation g symptomatic jugular artery disease h previous stroke or tia within 30 days i long term warfarin therapy is needed or contraindicated to warfarin j contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine trials l pregnant women or plan to pregnant during the study period m estimated life \< 5 years 2 echocardiography exclusion criteria (any of the items) a lvef\ 32mm or \< 17mm f the depth of left atrial appendage is less than the width g prominent mitral stenosis (area \<1.5cm2) 3 subject is not able to or will not complete the follow ups as planned

Keywords: atrial fibrillation left atrial appendage closure watchman
safety and tolerability of a novel malathion formulation in infants and toddlers with head lice

Conditions: Lice Infestations

Summary: in a previous phase ii study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. based on the results of that study, this formulation is currently in a phase iii study for that population. the current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.


Eligibility criteria:
inclusion criteria: * confirmed active head lice infestation * parent or guardian must be able to apply treatment exclusion criteria: * allergy to pediculicides or hair care products * scalp conditions other than head lice * previous head lice treatment within the past 4 weeks * current antibiotic treatment

Keywords: pediculosis head lice
asymmetric primary closure and additional skin excision technique.

Conditions: Pilonidal Sinus; Pilonidal Disease of Natal Cleft; Surgical Technique

Summary: the aim of this study was to reduce the residual dead-space volume with a modification following the standard karydakis procedure.

all patients were operated in the jack-knife position under spinal anesthesia (sa). the gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. methylen blue was administered from the sinus openings in the gluteal region. then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia. in patients operated with standard karydakis procedure, a flap (karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. the prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl. in patients who were operated with the asymmetric primary closure with skin excision technique, after the karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally. in both groups, subcutaneous tissue was approximated with 2/0 vicryl. the skin was sutured with mattress technique using 2/0 prolene. no drains were used in patients from either group. patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.

Eligibility criteria:
inclusion criteria: * all patients between age of 18-65 who had chronic pilonidal disease exclusion criteria: * patients who did not accept the procedure * patients had undergone previous pilonidal sinus surgery * patientshad active infection * patients who were not minimum of 18 years of age

Keywords: karydakis modification pilonidal sinus seroma
effects of different exercise training modalities in alpha-1 antitrypsin deficiency patients

Conditions: Chronic Obstructive Pulmonary Disease; Alpha 1-Antitrypsin Deficiency

Summary: pulmonary rehabilitation (pr) including exercise training is highly effective by improving health-related quality of life, exercise capacity and symptoms in patients with chronic obstructive pulmonary disease (copd). therefore, pr is a main component in the management of copd. in a former study patients with alpha-1 antitrypsin deficiency (a1atd)-related copd (genotype pizz) have been found to show smaller improvements in exercise capacity after a 3-week inpatient pr program compared to copd patients without a1atd (genotype pimm)\[1\]. these between-group differences were mirrored by missing adaptations of the fatigue-resistant skeletal muscle fibre type i in a1atd patients. this was in contrast to copd patients without a1atd who increased the proportion of this fibre type after pr. myofibre type i is crucial because it enables patients for physical endurance activities (walking, cycling etc.) during their daily life. the aim of this study is to compare the effects of an exercise training program with high vs. moderate training intensity in order to find a training modality which improves training effects in a1atd patients.


Eligibility criteria:
inclusion criteria: * copd patients with a1atd (genotype pizz) * copd patients without a1atd (genotype pimm) * global initiative for chronic obstructive lung disease (gold) stage iii-iv * medical treatment according to recent a1atd guidelines exclusion criteria: * general exclusion criteria for physical training such as acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, acute heart failure, orthopedic comorbidities which prevent patients from participating in exercise training program. * no written informed consent * non-compliance

Keywords: pulmonary rehabilitation exercise training alpha-1 antitrypsin deficiency
feasibility of a yoga program for veterans with ptsd

Conditions: Stress Disorders, Post-Traumatic

Summary: this study is designed to examine the feasibility of a 12-week yoga program on physiological and psychological health and its neurobiological mechanisms in n=15 veterans with posttraumatic stress disorder (ptsd). the investigators will be examining specific parameters of health and mechanisms before and after the yoga program.


Eligibility criteria:
inclusion criteria: * u.s. military veteran * 18 years of age or older * diagnosis of ptsd as assessed by a score of \>30 on the ptsd-checklist version 5 (pcl-5) * willing and able to attend testing and yoga sessions at the athletic and human research performance center (ahprc) on the campus of marquette university * clear to participate in physical activity based on the physical activity readiness questionnaire (parq+) exclusion criteria: * currently pregnant or trying to become pregnant * positive score to one or more items on the par-q+ without physician approval * already established regular use of yoga (i.e., more than one day per week)
metabolic and functional impact of various breakfast models

Conditions: Metabolism and Nutrition Disorder

Summary: in the present study the investigators compared the hormonal and metabolic effects of three meal loads very popular among italian eating habits, both in the resting- and exercising state. given the lack of time is considered a common barrier to exercise adherence, we wanted to identify a low dose of exercise capable to produce health benefits in the post-absorptive status elicited by three commonly consumed meal-models in mediterranean countries. to this end, healthy young volunteers firstly underwent an oral glucose tolerance test (ogtt) and three meal tolerance tests. secondly, in an extra set of experiments, subjects cycled at low intensity for the last 20 minutes of the same glucose/meal tolerance test. glycemia, insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout ogtt and each test-meal load.

the investigators evaluated postprandial responses (glucose, insulin, ghrelin, free fatty acids (ffa)) elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise were investigated. all subjects underwent a 50-g ogtt (a) and 3 test-meal loads: milk and cereals (b1); milk, apple and chocolate cream-filled sponge cake (b2); milk, bread, apple and hazelnut chocolate cream (b3). in the exercise trial, participants cycled for 20 minutes at 40% vo2max, 100 minutes after load ingestion.

Eligibility criteria:
inclusion criteria: * age between 18 and 40 years * normal body weight (bmi =18.5 - 24.9 according to nhlbi) * stable diet exclusion criteria: * diabetes, tipe 1 and 2 (ada criteria) * glucose intolerance (ada criteria) * dyslipidemia (atp iii according to ncep) * metabolic syndrome

Keywords: meal absorption exercise energy balance lipolysis
randomized clinical trial comparing coronary bypass grafting with or without cardiopulmonary bypass

Conditions: Ischemic Heart Disease

Summary: coronary artery bypass grafting (cabg) is a well established treatment modality for patients with coronary artery disease. for 30 years now cabg operations have been performed with the help of the heart lung machine (cardiopulmonary bypass). however, the heart lung machine is believed to be responsible for many of the side effects and complications seen in patients following cabg surgery. the organs most commonly affected are the brain, blood constituents, lungs and kidneys. in the last few years, stabilising devices have been developed that allow cabg operations to be performed safely without the use of the heart lung machine. our hypothesis was that cabg done without the heart lung machine may be better tolerated by patients resulting in lower morbidity, increased functional outcome and shorter hospital length of stay. enrolment into the trial was from 1998 to 2003 and included 300 patients. the last patient was enrolled in june of 2003. the initial results from the study suggest that excellent results can be obtained with both techniques and contrary to others no advantages could be demonstrated in in-hospital outcomes of patients performed without cardiopulmonary bypass (legare et al. circulation 2005).

we are now in follow-up to evaluate the medium term and long term outcomes of all 300 patients originally enrolled in above mentioned randomized clinical trial. the follow-up of patients is approved by the capital health research ethics board (cdha-rs/2004-295).

Eligibility criteria:
inclusion criteria: * any patient suitable for cabg surgery exclusion criteria: * emergency, concomitant procedure, low ejection fraction (\<20%)
bipolar maintenance study of lurasidone adjunctive to lithium or divalproex

Conditions: Bipolar I Disorder

Summary: this is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar i disorder in subjects with or without rapid cycling and /or psychotic features.

this study is to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar i disorder in subjects with or without rapid cycling and/or psychotic features.

Eligibility criteria:
inclusion criteria: open-label phase * 18 years of age or older * diagnostic and statistical manual of mental disorders, 4th ed., text revision (dsm-iv-tr) diagnosis of bipolar i disorder •≥ 1 manic, mixed manic, or depressed episode in past 2 years * ymrs or madrs total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or divalproex double-blind phase inclusion criteria: * subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on the ymrs and madrs over at least 12 weeks, with the allowance of two excursions (ymrs and/or madrs total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization exclusion criteria: open label phase * diagnosis of an axis i or axis ii disorder, other than bipolar i disorder, that is the primary focus of treatment within 3 months of screening * subjects for whom diagnostic agreement between the investigator and united biosource corporation (boston) (ubc) cannot be reached * ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month period) * subjects who test positive for drugs of abuse at screening. in the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the investigator will evaluate the subject's ability to abstain from cannabis during the study * unstable/inadequately treated medical illness * the subjects answers "yes" to "suicidal ideation" items 4 or 5 on the c-ssrs (at time of evaluation) double blind phase * subjects who in the investigator's judgment have not been compliant with study medication during the stabilization phase * subjects who have not stabilized during the open-label phase (within 20 weeks) * subjects who test positive for drugs of abuse at double-blind phase baseline. in the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the investigator will evaluate the subject's ability to abstain from cannabis during the study

Keywords: lurasidone latuda bipolar i