Kornimate/medical-research-clean huggingface dataset:
raltegravir + lopinavir/ritonavir or emtricitabine/tenofovir for hiv treatment naive subjects

Conditions: HIV Infections

Summary: a prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir (lpv/r) and a three drug regimen with raltegravir and two nrtis (emtricitabine/tenofovir) in hiv-1 infected treatment-naïve subjects. immunology substudy added to determine the kinetics of recovery of cd4 t cells and subpopulations (regulatory t cell \[t regs\], th-17 and th1) after treatment initiation with raltegravir based regimens and their relationship with functional cd8 t cells and if raltegravir containing therapies leads to decreases in markers of gut microbial translocation and of cellular and soluble markers of immune activation.

a009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with raltegravir and two nrtis (emtricitabine/tenofovir) in treatment-naïve subjects. hiv-1-infected subjects who are antiretroviral drug-naïve and have plasma hiv-1 rna levels ≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to raltegravir 400 mg bid + lpv 400 mg/rtv 100 mg bid (arm a) or raltegravir 400 mg bid + ftc 200 mg/tdf 300 mg qd (arm b). subjects will have measurements of hiv-1 rna and cd4+ and cd8+ t-cell counts at pre-entry and entry. the average of these measurements will be used to establish their baseline values. following entry, subjects will have plasma hiv-1 rna samples drawn at days 2, 4, 8 and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. cd38 expression on cd4+/cd8+ cells and cd38/hla-dr activation antigen on cd4+ and cd8+ cells and subsets t-cell percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by advanced flow cytometry.

Eligibility criteria:
inclusion criteria: * documented hiv infection * genotypic resistance without major resistance mutations within 30 days * antiretroviral drug-naïve * screening hiv-1 rna ≥5000 * women of reproductive potential * negative pregnancy test within 48 hours exclusion criteria: * acute or recent hiv-1 infection * currently breast feeding * use of immunomodulators * evidence of major resistance mutations * hbsag positive * acute hepatitis of any etiology or clinically significant liver disease * current imprisonment or involuntary incarceration

Keywords: hiv antiretroviral therapy naive integrase inhibitor hiv/aids treatment naïve
impact of lung recruitment maneuvers on driving pressure in cardiac surgery

Conditions: Respiration, Artificial; Lung Diseases; Atelectasis; Cardiac Surgical Procedures; Anesthesia, General

Summary: in anesthesia the incidence of postoperative pulmonary complications is frequent, especially in cardiac surgery where the incidence can reach 10%. respiratory morbidity in cardiac surgery is favored by multiple factors and is higher compared to anesthesia in "general" surgery. the prevention of these complications is a major challenge in the management of patients. influence of driving pressure level on respiratory morbidity was first demonstrated in management of acute respiratory distress syndrome (ards) in resuscitation. more recently, this notion has been introduced in anesthesia, with a correlation between increase driving pressure level and increase of post-operative respiratory complications. a method should reduce these levels of driving pressure: performing lung recruitment maneuvers. this technique has been successfully tested in abdominal surgery in particular in a study published by futier et al.. they systematized and standardized lung recruitment maneuvers and showed a decrease of postoperative pulmonary complications in abdominal surgery. thus, the realization of lung recruitment maneuvers, already used at the discretion of the practitioner, is now recommended by several teams of experts. the investigators propose in this "before-after" trial to evaluate variation in driving pressure due to systematic use of lung recruitment maneuvers, observed in patients operated in elective or urgent surgery. the secondary objective is to evaluate their impact on postoperative pulmonary complications.

this is a retrospective, before / after, monocentric trial.

Eligibility criteria:
inclusion criteria: * patients receiving elective or urgent cardiac surgery with cardiopulmonary bypass exclusion criteria: * emergency or salvage surgery * patient under guardianship * pregnancy

Keywords: driving pressure postoperative pulmonary complications
low birth weight follow-up

Conditions: Non Specific Effects of Vaccine; Bacillus-Calmette-Guerin; Low Birth Weight; Maternal Immunisation

Summary: the randomized control trail included 4,172 low-birth weight children between february 2008 and september 2013 in bissau. the children who were included in the rct and who are living in the bandim health project study area will be visited. the study assistants will ask about the health of the child and of both parents. furthermore, bacille calmette-guerin (bcg) scar status of both child and parents will be checked.


Eligibility criteria:
inclusion criteria: * participation during the low birth weight bcg trial between 2008 and 2013. exclusion criteria: * not living in the bandim health project's study area.
strategic use of big data in spine surgery - testing digital prediction of outcome in clinical praxis

Conditions: Constriction, Pathologic; Spine Degeneration; Surgery; Radiculopathy

Summary: the goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the dialogue support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice. the main questions it aims to answer are: * does its use alter patient-reported outcome measured by general assessment regarding leg pain and satisfaction in lumbar spinal stenosis? * does its use alter patient-reported outcome as measured by general assessment regarding arm pain and satisfaction in cervical rhizopathy? * how does the quality of life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery? eligible participants will be presented with their predicted postoperative outcome generated by the dialogue support tool, as an adjunct to the ordinary assessment by a spine surgeon. researchers will compare participants with a matched control group from the swedish spine register ("swespine") to see if the dialogue support tool can alter postoperative patient-reported outcome and satisfaction.


Eligibility criteria:
inclusion criteria: * refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy * 18 years of age or older * magnetic resonance imaging (mrt) examination within the last 12 months confirming the diagnosis, concurrent with symptoms described by the referring physician * giving informed consent exclusion criteria: * another condition found to be the reason for the symptoms. * not giving informed consent * need for further investigation that prevents inclusion within one month of the doctor visit.

Keywords: spine cervical radiculopathy lumbar spinal stenosis surgery neck prognostic model external validation
impact of different palatal contour designs on patients' satisfaction and oral health related quality of life

Conditions: Edentulous Jaw

Summary: the palatal rugae, refer to asymmetrical and irregular elevations of the mucosa located in the anterior third of the palate, on each side of the median palatal raphe and behind the incisive papilla. the lack of the rugae area on the polished areas of the dentures has been suggested to impact phonetics in denture patients due to lack of tactile feedback. therefore, the aim of this randomized crossover clinical trial was to compare patients' reported satisfaction with their complete dentures and oral health related quality of life, when provided with a denture with a rough palatal surface in the rugae area compared with a polished palatal surface or an open palatal surface.

the use of dentures could impact the patients' phonetics which could impact their speech. phonetics could be affected by multiple factors such as having a proper occlusal vertical dimension, proper occlusal plane, correctly positioned anterior and posterior teeth, and adequate contouring of the palatal surface. the lack of the rugae area on the polished areas of the dentures has been also suggested to impact phonetics in denture patients. the palatal rugae, refer to asymmetrical and irregular elevations of the mucosa located in the anterior third of the palate, on each side of the median palatal raphe and behind the incisive papilla. in addition to enhancing phonetics, the precise reproduction of the rugae in the complete dentures has been suggested to enhance mastication, deglutition and better taste perception. however, these suggestions were based on empirical evidence. many studies have described methods for replicating the patients rague on complete dentures or modifying the palatal area, however there are no clinical study to ascertain or negate the impact of this procedure. therefore, the aim of this randomized crossover clinical trial was to compare patients' reported satisfaction with their complete dentures and oral health related quality of life, when provided with a denture with a rough surface in their rugae on the anterior palatal area as opposed to a polished palatal surface or an open palatal surface. the null hypothesis was that there would be no difference in patients' reported satisfaction rate using visual analogue scale (vas) and oral health impact profile for edentulous patients (ohip-edent) questionnaire response between the three types of palatal contours after using each type for two month post-delivery.

Eligibility criteria:
inclusion criteria: 1. patients seeking a set of conventional maxillary and mandibular complete dentures at the university of jordan hospital, for the first time or as a replacement of their previous dentures. 2. patients aged between 45 and 80 years old. 3. patients had been completely edentulous for at least 3 months 4. patients without severe underlying medical conditions, neuromascular dysfunction, auditory problems, mental conditions, oral pathology, xerostomia, or tied tongue condition. 5. patients who approved and consented to participation.
cognitive behavioral therapy for adolescents with bulimia nervosa and higher weight (online treatment study)

Conditions: Bulimia Nervosa; Overweight or Obesity

Summary: this study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa (binge eating and purging, or going to extremes to lose weight).

this study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa. bulimia nervosa is when individuals binge eat (overeat while feeling like they lost control) and purge (do something extreme or unhealthy to lose weight or prevent weight gain). bulimia nervosa happens across different ages and body sizes. this study is focusing on adolescents who have a larger body size. adolescents will receive treatment that is 4 months of 45-minute sessions, weekly. treatment will occur over telehealth (e.g., zoom), and the whole study is online.

Eligibility criteria:
inclusion criteria: * have higher weight (\>85th bmi percentile or \>85th percentile in past year) * 2 binge/purge episodes per month for the prior 3 months * be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions); * read, comprehend, and write english at a sufficient level to complete study-related materials; * provide an approval form from a healthcare provider; * provide a signed and dated written assent (or consent for youth age 18 or 19) prior to study participation; * provide a signed and dated written consent from one parent prior to study participation; * be available for participation in the study for 4 months. exclusion criteria: * medical or psychiatric conditions requiring hospitalization or intensive care * anorexia nervosa * developmental or cognitive disorders that would interfere with therapy * pregnancy or breastfeeding * concurrent treatments (medication or psychological) influencing appetite or weight * began hormone therapy in prior 3 months
ulnar nerve echographic observation (ulnecho)

Conditions: Ulnar Neuropathies

Summary: there is currently no consensus on the normal ultrasound surface of the ulnar nerve at the elbow. the goal of this study is to study the ulnar nerve surface at the elbow in a population of asymptomatic subjects

100 elbows from 50 patients will be included, from a population of asymptomatic subjects, in order to measure the frequency of ulnar nerve which surface is \>8,3 mm². the measures will be realized centered on the epicondyle : 2 cm higher, and 2 cm lower with 2 echographs (esaote) and 2 observers. an inter and intra observer study will also be realized to determine the reproducibility and reliability of the measurements.

Eligibility criteria:
inclusion criteria: * patient aged 18 -to 80 years or older * patient without any current or previous pathology on the ulnar nerve * patients would be able to consent exclusion criteria: * patient under administrative supervision or legal guardianship

Keywords: ulnar neuropathies ultrasound
continence after vaginal prolapse surgery

Conditions: Pelvic Organ Prolapse; Urinary Incontinence

Summary: urinary incontinence after surgical correction of pelvic organ prolapse (pop) could occur. this is a condition that decreases both patients' satisfaction and quality of life. reports on the prevalence of urinary incontinence after pop surgery are controversial. concomitant surgery for incontinence could reduce this prevalence, whereas it increases treatment costs and the likelihood of surgical complications. therefore, it is of paramount importance to know the exact prevalence of urinary incontinence after pop surgery in our population and the potential risk factors associated with this condition.


Eligibility criteria:
inclusion criteria: * women who will undergo vaginal surgery for pelvic organ prolapse. exclusion criteria: * inability to give consent to the study.

Keywords: pelvic organ prolapse surgery urinary incontinence stress urinary incontinence urge-urinary incontinence
vascular function, insulin sensitivity, and vitamin d

Conditions: Insulin Sensitivity; Flow-mediated Dilation; Arterial Stiffness

Summary: the overall objectives of this study are to examine the relationships between circulating vitamin d, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin d deficiency in african americans (aa) and white hispanics (wh) is responsible for ethnic differences in insulin sensitivity and hypertension in aa, wh and european americans (ea), as well as mechanisms underlying the association between insulin resistance and blood pressure. we hypothesize that 1) serum 25(oh)d is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in aa and wh relative to ea is due to lower circulating 25(oh)d in aa, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(oh)d. acronyms: african american (aa), european american (ea), white hispanics (wh), serum 25-hydroxy vitamin d (25()h)d, body mass index (bmi), alabama (al).


Eligibility criteria:
inclusion criteria: * african american (aa), white hispanic (wh), and european american (ea) race * ages 19-60 years * negative urine pregnancy test * no evidence of diabetes * not on medications that can affect vascular functioning or insulin sensitivity exclusion criteria: * bmi \> 32 kg/m2 * diabetes or any chronic diseases * use of medication(s) known to influence body composition, vascular function, or glucose metabolism * regular smoking * regular use of illegal drugs and pregnancy

Keywords: insulin sensitivity vascular function flow-mediated dilation arterial stiffness glucose tolerance hypertension
prospective clinical study of preoperative and postoperative unilateral mild cataract patients

Conditions: Cataract Senile

Summary: this is to compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（iol） in one eye and mild cataract in the fellow eye.

the subjects are the patients who underwent monocular iol implantation before and present mild cataract in the fellow eye.compare preoperative and postoperative the binocular functional vision and the satisfaction of patients when the patients ask for the surgery (phacoemulsification and iols implantation)on the fellow eye. the type of iols maybe according to the patients preference and the eyes condition.the subjects will be divided into three groups according to the type of the iols，including monofocal group,bifocal group,and trifocal group.

Eligibility criteria:
inclusion criteria: * patients who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye * regular corneal topography and corneal astigmatism ≤ 0.75 diopter exclusion criteria: * pregnant or nursing women * in the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, marfan syndrome, etc.) * in the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logmar after surgery (amblyopia, strabismus, keratoconus, etc.) * pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.) * patients using systemic or ocular medication that affect visual acuity. * patients with history of ocular trauma or prior ocular surgery including refractive procedures * patients participating in other clinical trials during the study.

Keywords: unilateral cataract binocular functional vision multifocal intraocular lenses
the effect of case management in complex cancer pathways

Conditions: Colonic Neoplasms; Rectal Neoplasms

Summary: introduction: case management (cm) has been proposed as a method for optimizing the course of treatment for complicated cancer patients. however evidence of the effect of cm is limited and methodologically rigorous research is needed. aim: to analyze effects of nurse cm in complicated cancer care. methods: the study is designed as a two-arm randomized controlled trial (rct) including approximately 280 colorectal cancer patients. intervention group patients will be offered usual medical treatment plus supportive intervention from a case manager. control group patients will receive usual medical and supportive treatment. the intervention: case managers are registered nurses and possess thorough knowledge of cancer treatment and pathways. core intervention elements: planned and ad hoc personal and telephone contacts, surveillance of care pathways, coordination and dissemination of care plan (including transfer of patient-specific information to other departments and general practice). primary outcomes: patient evaluations of care pathways and "quality of life" (questionnaires). secondary outcomes: use of health care services and care process measures (the national health insurance service registry and the national patient registry; and gps' evaluations of continuity of care (questionnaire). schedule: * "case management used to optimize cancer care pathways: a systematic review" has been published in bmc health services research. * the cm manual has been written. questionnaires are under development and pilot testing. * two case managers have been appointed 1. january 2009. * after training and pilot testing of the intervention the rct will begin in march 2009. inclusion period is 12 months.


Eligibility criteria:
inclusion criteria: * colon or rectal cancer are highly suspected and a course of treatment at department p, aarhus university hospital is expected to follow. exclusion criteria: * do not speak and understand danish sufficiently to fill out questionnaires (due to dementia, some foreigners etc.)

Keywords: case management
effect of daily use proton pump inhibitors for one month on kidney function

Conditions: Proton Pump Inhibitor Allergy

Summary: the aim of this study to: evaluate the association between prolonged use of ppi and adverse renal outcomes on patients with normal renal function and others with abnormal renal function

proton pump inhibitors (ppis) are one of the most widely used classes of drugs and are prescribed primarily for gastric acid-related diseases, eradication of helicobacter pylori, and prevention of nonsteroidal anti-inflammatory drug (nsaid)-induced gastropathy,and gastroesophagial reflux diseases . although ppis have an excellent overall safety profile, some severe adverse effects, which include bone fracture, dementia, myocardial infarction, infections, micronutrient deficiencies, and kidney diseases,ppis may trigger acute interstitial nephritis,a potentially sever adverse event commonly associated with acute kidney injury the increase in prescription and inadequate use of this class of medication calls for studies on the effects of prolonged ppi therapy on renal function.

Eligibility criteria:
inclusion criteria: * patients with peptic ulcer disease or gastroesophagial reflux with normal l renal function * patients with peptic ulcer disease or gastroeosophagial reflux with abnormal renal function exclusion criteria: * 1- cigarette smoker: cigarette smoking status was defined categorically as current,former, or never smoker at baseline. 2-biabetic patients: diabetes mellitus is defined by a fasting blood glucose concentration \>_ 126 mg/dl ,random glucose level of \>200 mg/dl. 3-patients take corticosteroid 4-patients with hypersensitivity to these drugs