Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of intracellular tfv-dp and ftc-tp in hiv-infected adolescents

Conditions: Human Immunodeficiency Virus (HIV); Tuberculosis; Coinfection

Summary: tenofovir (tfv) disoproxil fumarate (tdf) plus emtricitabine (ftc) or lamivudine (3tc) is the preferred nucleoside backbone of first-line antiretroviral therapy (art) for adolescents in sub-saharan africa. in addition, tdf/ftc is recommended for preexposure prophylaxis (prep) for human immunodeficiency virus (hiv) infection in adolescents at substantial risk of acquisition of hiv infection, as well as for hepatitis b virus (hbv) treatment in those with hbv/hiv coinfection. the efficacy tdf and ftc are dependent on intracellular concentrations of the active phosphate anabolites, called tfv diphosphate (tfv-dp) and ftc triphosphate (ftc-tp). however, the intracellular pharmacokinetics of tfv-dp and ftc-tp to examine the adequacy of current dosages in african adolescents has not been previously studied. thus, examining the pharmacokinetics (pk) of these widely used antiretrovirals in african adolescents is important as art outcomes remain poor and the recommended dosages of these drugs for children and adolescent were extrapolated from drug approval clinical trials in adult in the united states and europe.

this study will evaluate the intracellular pk of tfv-dp and ftc-tp in ghanaian hiv-infected adolescents with and without tb coinfection. as the clinical effects of tdf and ftc are related to the intracellular concentrations of the phosphate anabolites, called tfv-dp and ftc-tp, there is a need to understand the cellular pharmacology of tdf interactions in african hiv-infected adolescents with and without tb, as the study team cannot extrapolate from us patients not on antituberculosis (anti-tb) drugs. this study will enroll hiv-infected adolescents aged 10 to 18 years old with and without tb coinfection who are already established on art. the study team hypothesize that younger age, adenosine triphosphate (atp)-binding cassette subfamily c (abcc) single nucleotide polymorphisms (snps) and anti-tb therapy may influence the intracellular tfv-dp and ftc-tp concentrations in adolescents.

Eligibility criteria:
inclusion criteria: * hiv-infected adolescents aged 10 to 19 years old who are stable on antiretroviral regimen containing tdf/ftc (300/200 mg daily) for at least 8 weeks. exclusion criteria: * unable to obtain informed signed consent from parent(s) or legal guardian. * pregnant or breast feeding. * require therapy for other opportunistic infections other than tuberculosis (tb).

Keywords: pharmacokinetic pharmacogenomic tenofovir diphosphate emtricitabine triphosphate adolescents
the brain activity changes in the development of chronic low back pain

Conditions: Chronic Pain; Low Back Pain

Summary: the purpose of this longitudinal exploratory prospective study is to investigate the brain changes in the development of chronic low back pain.

background and purpose: chronic low back pain (clbp) is an adverse symptom not only to individuals but also to society. it impacts negatively on multiple aspects, such as physical activities, functional ability, quality of life and psychological status. moreover, clbp causes economic burden to both individuals and society. however, not all low back pain progresses to chronic condition. cross-sectional studies have shown brain activated differently in people with clbp as compared with healthy ones during rest and movement. in addition, lower cortical excitability or stronger functional connections between medial prefrontal cortex and nucleus accumbens were observed in those becoming clbp according to previous longitudinal studies. also, image studies have shown a shift in brain regions from pain related areas to those that control emotion and memory. according to these results, the brain activity is related to the persistence of pain. however, how brain activity changes during the chronicity of low back pain is still not fully understood. therefore, the purpose of present study is to compare the brain changes in people with lbp with or without pain chronicity. methods: this is a longitudinal exploratory prospective study. demographic data will be collected at baseline. the outcomes will be measured at entry of the study and at 24 weeks post-pain. outcomes include pain intensity which is rated by numerical rating scale(nrs), and brain activities which is recorded by electroencephalography (eeg) during resting and movement conditions. statistical analysis: according to the nrs at 6 month post-pain, the participants whose nrs sore ≥ 2 will be grouped in the clbp group and those nrs ≤ 1 will be grouped in the recovered low back pain (rlbp) group. two-way anova with repeated-measures and tukey's post hoc test will be used to analyze the differences between time and between groups. the changes of pain intensity during movement will be used as confounder for the analysis. statistical significance is set at p\<0.05.

Eligibility criteria:
inclusion criteria: * age≧ 20 y/o * this is the 1st episode of low back pain in the past year * pain in the region of the lower back (bound by the thoracolumbar junction superiorly, and by the gluteal fold inferiorly) * pain duration \< 12 weeks * average pain intensity in the past 7 days is ≧ 3/10 (numeric rating scale) * mini-mental state examination ≧ 24 exclusion criteria: * pain onset duration \< 7 days * history of chronic pain * pain area other than the specify area * any systematic disease, fracture or cancer * present any neurological sign related to pain * infection * received any brain or spine surgeries, hip arthroplasty or any other kind of surgeries in the past 3 months * diagnosed with any neurological or psychological disease

Keywords: pain chronicity low back pain electroencephalography brain activity
etanercept with tacrolimus for psoriasis

Conditions: Psoriasis

Summary: the study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (sq) weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg sq weekly plus placebo ointment twice daily.

the study is designed to evaluate the efficacy of etanercept 50 mg sq weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg sq weekly plus placebo ointment twice daily. subjects will be either beginning etanercept therapy or already using a stable dose of etanercept when they begin to apply tacrolimus to half of their body and placebo ointment to the other half. the study is double blinded. total duration of the study is 12 weeks.

Eligibility criteria:
inclusion criteria * adults 18 years or older with moderate to severe psoriasis, who are candidates for systemic or phototherapy, with a baseline score of 6 or higher on the target lesion score, and a baseline score of 3 or higher on the physician's global assessment, on each side of the body * patients who are already on a stable dose of etanercept for at least 2 months and have the above criteria * subjects must have target lesions on each side of the body that are at least 1.5 cm in diameter and roughly symmetrical in appearance and location exclusion criteria * inability to understand consent or comply with study requirements * pregnancy or unwillingness to use adequate birth control method * lactation * psoriasis plus ultraviolet a (puva) or systemic therapy within the past 4 weeks (other than a stable dose of enbrel for at least 2 months) * ultraviolet b (uvb) or topical therapy (other than over-the-counter moisturizers) within the past 2 weeks * active tuberculosis or other opportunistic infection * demyelinating disease * uncontrolled congestive heart failure * known allergy to or any contraindications to using topical tacrolimus or etanercept * lack of insurance coverage or inability/refusal to pay out of pocket for etanercept and standard of care laboratory tests and ppd/cxr

Keywords: psoriasis tacrolimus etanercept
antibiotic prophylaxis for elective cesarean section

Conditions: Infection of Cesarian Section Wound Following Delivery

Summary: a randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.

comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)

Eligibility criteria:
inclusion criteria: * patients undergoing elective cesarean section with gestational age 37 weeks or more exclusion criteria: 1. fever greater than 38°c or maternal sepsis. 2. cephalosporin allergy. 3. exposure to any antibiotic agent within 1week before delivery. 4. patents having premature rupture of membranes and acute chorioamnionitis. 5. patients with chronic diseases (diabetes mellitus, renal disease and cardiac disease). 3) morbid obesity (bmi\>30)

Keywords: elective cesarean section antibiotic prophylaxis timing of antibiotic prophylaxis post cesarean section infection
the comparative efficacy of peri-articular and intraarticular tranexamic acid in total knee arthroplasty

Conditions: Osteoarthritis,Knee

Summary: post-operative bleeding in total knee arthroplasty (tka) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. intravenous and topical tranexamic acid (txa) have been well established in reducing blood loss postoperatively. however, there are lack of data on peri-articular txa injection during tka. therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular txa injections, intraarticular txa injections and control group.

patients scheduled for unilateral primary tka; 108 patients were randomly assigned to receive peri-articular txa, intraarticular txa and control group. 36 patients received either: (i) 15 mg/kg peri-articular txa combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (ii) 2 g of intraarticular txa after complete capsular closure just before tourniquet deflation (group 2). (iii) don't receive any route of txa in control group (group 3). hemoglobin (hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. serum txa was recorded at 2 and 24 hours after operation. the reviewers were blinded to treatment group.

Eligibility criteria:
inclusion criteria: * adult patients with osteoarthritis in need of a tka exclusion criteria: * inflammatory arthritis * post-traumatic arthritis * a history of or current venous thromboembolic disease * any underlying disease of haemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel) * preoperative hemoglobin \<10 g/dl or a platelet count \< 140,000 /ul3 * allergy to txa

Keywords: tranexamic acid peri-articular injection intraarticular injection total knee arthroplasty blood loss
randomized, double-blind, placebo, controlled cross over design topical morphine for analgesia in pediatric procedures

Conditions: Pain

Summary: introduction: opioids, such as morphine, act at receptors in the central nervous system, but many studies have suggested direct action peripherally on opioid receptors in sensory neurons terminals, melanocytes, keratinocytes and fibroblasts. these receptors are stimulated when occurs inflammatory processes. hypothesis: treatment with topical morphine 0.1% applied 30 minutes before an invasive procedure, decreases pain in children. method: a randomised double-blind parallel study to evaluate the effect of topical application of a 0.1% morphine gel in patients undergo a procedure. 22 patients in each group will be included. randomly assigned to either the morphine gel or a placebo hydrogel, it will be applied 30 minutes before the procedure and the first day every 4 hours. general basic sedation and systemic analgesia will give for all the patients. efficacy of treatment will be measured with "face, legs, activity, cry, consolability scale" (flacc scale).

the use of an opioid such as morphine topical gel 30 minutes before a procedure would be effective in reducing pain in children. it has proven effective analgesic with minimal adverse effects, especially in children older than 6 months, and even its use is authorized in young children.

Eligibility criteria:
inclusion criteria: * hospitalized children aged 1 month to 10 years, who needs a medical procedure over previously injured skin, associated with moderate-severe pain. exclusion criteria: * refusal to participate

Keywords: pain management
the effect of mulligan mobilization technique on balance, pain and functionality in patients with chronic low back pain

Conditions: Chronic Low-back Pain; Lumbal Disc Herniation; Imbalance

Summary: this study was aimed to investigate the effectiveness of mulligan mobilization technique on balance, pain and functionality in patients with chronic low back pain and to compare it with exercise.37 patients aged between 18-65 who applied to fındıkzade medipol hospital were included in the study. the individuals participating in the study were divided into two groups, 18 control and 19 mulligan groups, according to the randomization table. the intervention was performed 3 times a week for 4 weeks. conventional physiotherapy and exercise program accompanied by a physiotherapist were applied to the control group, and conventional physiotherapy and mulligan mobilization technique were applied to the mulligan group. conventional physiotherapy methods included ultrasound (us), transcutaneous electrical nerve stimulation (tens), and hotpack. the patients were evaluated with tecnobody static balance device, algometer, electrogoniometer, visual analog scale, oswestry low back pain disability questionnaire before and after the treatment.


Eligibility criteria:
inclusion criteria: * experiencing non-specific chronic low back pain for more than 3 months * the diagnosis has been confirmed by the health board report * be over 18 years old * be younger than 65 years old * pain of at least 2 severity according to vas * voluntarily agree to participate in the study exclusion criteria: * previous lumbar trauma or operation * long-term use of corticosteroids * cancer * pregnancy * osteoporosis * systemic diseases * spinal deformities * lumbal stenosis * ankylozone spondylitis * spondylolisthesis * spinal deformities * lumbal stenosis

Keywords: balance chronic low back pain exercise lumbal disc herniation manual therapy mulligan mobilization
long term clinical and functional outcome in rotationplasty patients

Conditions: Disability Physical; Psychological Adaptation

Summary: rotationplasty is a very special surgical technique. in its most frequent variant it allows, in the bone sarcomas of the distal femur, to remove all the thigh tissues including the knee joint keeping intact the innervation of the leg and the foot that are transplanted proximally after a 180 ° rotation and joined to the proximal femoral stump. it is currently the first choice in children under the age of 6 with a bone sarcoma localized to the distal femur but also finds indication in all age groups in cases of extremely voluminous and extended to the entire thigh with the oncological need to remove in block femur, knee and all the muscular involved. the objective of the study is to obtain information about the clinical and functional status of the limb operated in long-term surviving patients. in particular in this study the problem of the possible degenerative pathology of the hip on the operated side will be addressed. moreover the psychic and psychological well-being of this population with particular reference to gender and motherhood will be tested.

30 long term survivors of rotationplasty patients at the ior will be welcomed by the research team. they will be introduced to the aims of the research and the methodology and timing of the assessment. the two-day agenda will be communicated to perform in a coordinated manner so that each patient performs all the exams: * x ray pelvis * physiatric, orthopedic and prosthetic examination * proprioceptive test with delos system * psychological questionnaires

Eligibility criteria:
inclusion criteria: - rotationplasty patients operated at ior exclusion criteria: - disagreement of patient to participate to the study (or of part of it)
aviation study: a safety, pharmacokinetics, pharmacodynamics and preliminary efficacy study of tern-201 in patients with non-cirrhotic non-alcoholic steatohepatitis

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (pk), pharmacodynamics (pd) of tern-201 in patients with non-cirrhotic nash.


Eligibility criteria:
inclusion criteria: * male or female, 18 to 75 years of age * overweight or obese with a body mass index (bmi) ≥ 25 kg/m2 * presumed nash based on clinical characteristics or prior liver biopsy * alt ≥ 43 iu/l for men and ≥ 28 iu/l for women * mri-ct1 value\> 800 ms * written informed consent exclusion criteria: * history or clinical evidence of chronic liver diseases other than nafld * history or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment * history of liver transplant, or current placement on a liver transplant list * weight loss of \> 5% total body weight within 3 months prior to screening note: other protocol-defined inclusion/exclusion criteria could apply.

Keywords: vascular adhesion protein-1(vap-1)/ semicarbazide-sensitive amine oxidase (ssao) nonalcoholic steatohepatitis (nash) nonalcoholic fatty liver disease (nafld)
value of screening mri brain in stage iv non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer Metastatic

Summary: patients with newly diagnosed stage iv non-oncogene addicted nsclc, who are fit for systemic treatment and don't have any symptoms of brain disease will undergo an mri of the brain to screen for brain disease.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iv metastatic nsclc, not amenable to curative treatment. * fit for systemic treatment (ps 0-2) according to standard of care. * no symptoms of brain disease disease assessed according to standard clinical care by the thoracic oncologist. exclusion criteria: * prior/concomitant therapy for stage iv disease. * oncogenic diver mutation (e.g. egfr, alk, ros1, ret, met, and braf) with approved targeted treatment. * contraindications for mri scan with contrast as per standard of care protocol of the institution.

Keywords: brain metastasis screening
infertility and pregnancy outcomes of fertility spared gynecological oncology patients

Conditions: Fertility Disorders; Gynecologic Cancer

Summary: fss which aims to preserve a woman's fertility while still effectively treating the cancer, has become an increasingly popular option for young women diagnosed with these types of cancers. it is important to assess how fss affects a woman's reproductive health, sexual function, psychological well-being, and overall quality of life. this research aims to provide valuable insights into the long-term effects of fss on a woman's life, and can help healthcare providers make informed decisions about the best treatment options for their patients.

this is a prospective cohort study that aims to evaluate the infertility and pregnancy outcomes, as well as the quality of life of women who underwent fertility-sparing surgery for gynecological malignancies. the study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods. participants recruited from a tertiary care hospital, and women diagnosed with gynecological malignancies (e.g. cervical, ovarian, endometrial cancer) who underwent fertility-sparing surgery between 2010 and 2022. women who have undergone total hysterectomy, bilateral salpingo-oophorectomy, or adjuvant oncological treatment were excluded from the study. participants were contacted by phone and asked to complete questionnaires to assess their quality of life using the whoqol-bref and fertiqol scales.

Eligibility criteria:
inclusion criteria: * diagnosis of gynecologic cancer, and being fertile in the meantime * applying directly to gynecologic oncology department * demand of preserving the fertility exclusion criteria: * having hysterectomy prior to the diagnosis * having bilateral ooferectomy prior to the diagnosis * being in menopause * not accepting to fill the survey * high stage disease which is not able to have fss

Keywords: fertility sparing gynecologic malignancy quality of life infertility
clinical and economic outcomes in laparoscopic sleeve gastrectomy versus roux-en-y gastric bypass surgery

Conditions: Morbid Obesity

Summary: study objectives: 1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery 2. support multi-disciplinary bariatric sites in germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

the objectives of this study are the following: to generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery; and to support multi-disciplinary bariatric sites in germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

Eligibility criteria:
inclusion criteria: * all patients aged from 18 to 65 years of age, inclusive * bmi \> 40 or bmi \> 35 with co-morbidities * eligible for weight-loss surgery * planned laparoscopic gastric sleeve resections or roux-en-y bypass surgery * insurance approval status: approved * written informed consent exclusion criteria: * bmi \> 55 * planned two-stage procedures * prior bariatric procedures (including gastric banding) * serious mental or physical co-morbidities at the discretion of the investigator * insurance approval status: rejected

Keywords: gastric sleeve gastric bypass roux en y morbid obesity laparoscopy