Kornimate/medical-research-clean huggingface dataset:
b/f/taf vs atripla double-blind switch study in hiv-1 infected adults

Conditions: HIV-1-infection

Summary: atripla (atp: ftc/tdf/efv) was the first single pill treatment for hiv and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with hiv. however, atp has not been recommended as a "preferred" treatment for hiv since 2015, due to there now being single pill treatments that work better. there are a lot of people who are still taking atp and it is working for them. however, it has the potential to cause serious side effects (chronic kidney disease and fractures and serious neurological effects). these side effects are caused by components in atp (namely the tdf and efv parts). also, the efavirenz (efv) component is not compatible for treatment of hepatitis c (hcv) - which is often also seen in people who have hiv. for these reasons, there is a need to find a better alternative treatment for these people currently being treated with atp.

b/f/taf (bictegravir/ftc/taf) is an investigational single pill drug treatment drug that contains neither tdf nor efv. this study is looking at whether changing people to this new drug treatment will continue to suppress their hiv and have fewer side effects.

Eligibility criteria:
inclusion criteria: 1. hiv-1 seropositive 2. age \> 21 years 3. receiving atp \> 2 years as their only art, with hiv-1 rna \< 50 copies/ml at screening and all hiv-1 rna tests \< 100 copies/ml in the past 18 months 4. no documented resistance mutations to the components of atp 5. any cd4 count, but no active aids-defining opportunistic infections or cancers 6. hbsag+ permitted if plasma hbv dna is unquantifiable and the patient does not have decompensated liver disease exclusion criteria: 1. pregnancy, breastfeeding or planned pregnancy in the next 2 years 2. documented resistance to the components of atp 3. active aids-defining opportunistic infection or cancer 4. cancer in past 3 years, except non melanoma skin cancer 5. active psychotic disease or active depression that may interfere with study participation according investigator discretion 6. any illness with a life expectancy less than 2 years 7. egfr \< 50 ml/min 8. urine protein/creatinine \> 40 mg/mmol 9. patients who the investigator feels are unlikely to commit to the study requirements for any reason 10. prescription drug therapy for osteoporosis (calcium and/or vitamin d is allowed)
cerebellar rtms in patients with multiple sclerosis

Conditions: Patients with Multiple Sclerosis

Summary: to determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis.

forty patients with multiple sclerosis suffering from ataxia less than five in edss score will be recruited from the outpatient clinic at faculty of physical therapy as well as kasr al-ainy multiple sclerosis unit (kamsu), cairo university. the study will be applied during the remission period. patients will be assessed by biodex balance system, berg balance scale, four square step test and nine-hole peg test to investigate coordination in both equilibrium and non-equilibrium. patient will be divided into two groups.the study group will be treated by high frequecy cerebellar repetitive transcranial magnetic stimulation besides a tailored physiotherapy program, while the control group will be treated by sham cerebellar repetitive transcranial magnetic stimulation with a tailored physiotherapy program as well. the treatment duration for each patient will take weeks.

Eligibility criteria:
inclusion criteria: * clinically definite ms (relapsing, remitting and secondary progressive) patients * patients who are medically stable and free from relapses three months before * ambulant patients without an assistive device and score less than 5 on the kurtzke expanded disability status scale (edss) * patients receiving their disease modifying drugs but no medication changing during the previous three months. * patients who had mri evidence of lesions in the cerebellum or in the cerebellar pedunculi. * right handed patients. * severity of ataxia range from 4 to 10 according to scale of assessment and rating ataxia (sara). * did not apply cerebellar transcranial magnetic stimulation before. exclusion criteria: * any other neurological deficits or orthopedics abnormalities. * ataxic manifestations for other cause rather than multiple sclerosis. * other neurological manifestations (e.g. spasticity, visual loss) * secondary musculoskeletal complication such as contractures or deformities. cardiovascular, pulmonary, hepatic, renal, hemopoietic and thyroid diseases. * pregnant women. * addicted individuals. * previous surgeries in the brain. * any magnetic or metallic devices implanted (like cochlear implants) . * psychotic deficits or history of epileptic seizures.

Keywords: patients with multiple sclerosis coordination transcranial magnetic stimulation
assessment of dot spectacles in chinese children

Conditions: Juvenile Myopia; Myopia

Summary: this is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial of 12-months duration to evaluate the continued safety and efficacy of diffusion optics technology (dot) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of juvenile myopia in children of chinese origin.


Eligibility criteria:
inclusion criteria: 1. children 6-13 years of age 2. ser error between -0.75d and -5.00d 3. willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear exclusion criteria: 1. prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-k) 2. astigmatism worse than -1.50 dc (by manifest refraction) in either eye 3. anisometropia (ser manifest refraction) greater than 1.00 d
spectacles lens in concussed kids

Conditions: Concussion, Mild; Convergence Insufficiency; Accommodation; Insufficiency

Summary: we will be looking at 3 treatment arms in the form of different type of glasses to see if one is superior to helping kids have sustained a concussion and are symptomatic.

recent studies have shown children who sustain a concussion are susceptible to having chronic symptoms (post-concussion syndrome). this chronicity can lead to delays in returning to learn and returning to play. blurry vision, double vision, eye strain and eye tracking problems are some of the reported chronic symptoms that can affect patients' daily activities. concussion awareness has increased recently and there is a surge of interest to better understand and treat the symptoms of post-concussion syndrome. currently, ocular treatment for patients are often empirically determined. common treatments are vision therapy and/or bifocal glasses. there has yet to be any standardization or prospective studies looking into treatment for these concussed patients with ocular symptoms and findings. the objective of this protocol is to compare three different types of glasses (typical prescription glasses for kids, typical glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare coating) as treatment options for participants who are still symptomatic four weeks out from their concussion. the main outcome is the effectiveness of these three different options in reducing patients' symptoms and improving the participants' visual findings.

Eligibility criteria:
inclusion criteria: * sustained a concussion \> 6 weeks \< 16 weeks from date of initial visit * criteria for concussion: formally diagnosed by physician * minimum best corrected visual acuity: 20/25 in right and left eyes at distance and 20/30 both eyes at near * minimum stereopsis: 500" global * ciss score \> 16 * refractive error at least + 0.50d sphere or cylinder * ability to clear \> 0.50 cycles per minute in monocular accommodative flipper of and binocular accommodative flipper of +/-1.50 exclusion criteria: * diplopia from nerve palsies * retinal pathology * previous treatment of any amount of bifocal lenses and base in prism since concussion. * vision therapy \> 6 weeks since concussion
botulinum toxin a injectable solution in the management of bruxism: a clinical trial study

Conditions: Nocturnal Bruxism

Summary: a clinical trial study to investigate the potential performance of btxa on masseter muscle on patient with nocturnal bruxism and to check the pain scale and share this clinical experience.

experimental group we will use btx-a administration group. all patients (male/female) with bruxism associated with chronic pain in masseter muscles bilaterally participated in this study. the patients age 18-60 years. according to the diagnostic grading system of bruxism all subjects will have an assessment including a bruxism questionnaire (i.e., oral history taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism signs and symptoms.

Eligibility criteria:
inclusion criteria: 1. moderate to severe pain in relation to the masseter muscles and tmj area related to bruxism during clinical examination. 2. aged 20-60 patients. 3. tooth-grinding sounds corroborated by family members or caregivers. 4. cases where bruxism resulted in occlusal surface attrition of posterior teeth exclusion criteria: 1. pain in the orofacial region, 2. insomnia, 3. known botulinum toxin allergy, 4. pregnancy, 5. neuromuscular disease, 6. bleeding disorders, 7. antibiotic therapy, 8. pulmonary disease that produced coughing during sleep, 9. infectious skin lesion at the site of the injection.

Keywords: bruxism
efficacy and impact on function of two different doses of nab-paclitaxel in elderly with advanced breast cancer

Conditions: Breast Cancer

Summary: this is a randomized study evaluating the efficacy and impact on function of two different doses of nab-paclitaxel in elderly patients with advanced breast cancer.

this open-label, randomized phase ii trial evaluates in parallel two doses of nab-paclitaxel (100 and 125mg/m2) given weekly for 3 weeks every 28 days, in elderly women aged 65 years or older, as first line treatment for advanced breast cancer (locally recurrent or metastatic). a short geriatric evaluation of co-morbidity and functional status will be performed before study entry. the functional status will be monitored at baseline and at every cycles during treatment.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; her2 receptor negative or her2 positive but with contraindication to anti-her2 therapy (e.g. known congestive cardiac failure). * measurable disease or non-measurable but evaluable disease according to recist 1.1 criteria * ecog performance status 0-2 * estimated life expectancy of ≥ 12 weeks * no known active/symptomatic cns metastases * no previous chemotherapy for breast cancer in the advanced setting * adequate organ function including ( hemoglobin ≥ 9g/dl; absolute neutrophil count ≥ 1.5 x 10\^9/l; platelets ≥ 100 x 10\^9/l; bilirubin ≤ 1.5 mg/dl; alt and ast ≤ 3 x uln (with or without known hepatic metastases); alp ≤ 2.5 x uln; serum creatinine ≤ 1.5 uln or calculated creatinine clearance (crcl) ≥ 50ml/min according to the cockcroft gault formula * written informed consent (according to ich/gcp and national/local regulations) exclusion criteria: * significant peripheral neuropathy (significant peripheral neuropathy is defined as ≥ grade 2 on ctcae v4.0 criteria) * clinically significant comorbidities including: uncontrolled cardiac arrhythmias (except rate-controlled atrial fibrillation), nyha class iii or iv cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity * other malignancy within the last 5 years, except for adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ * intake of any concomitant medications or therapies that may potentially interact with the trial agent. any prohibited medication must be discontinued at least 14 days prior to trial entry * presence of any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before trial registration

Keywords: breast cancer elderly patients
navigate kidney: a multi-level intervention to reduce kidney health disparities

Conditions: Kidney Diseases; Chronic Kidney Diseases

Summary: the overarching goal of this project is to refine and adapt previous work on the navigate-kidney project for latinx with ckd. the investigators hypothesize that the multilevel navigate-kidney program intervention will reduce the rate of central venous catheter use at krt start (primary outcome), increase the rate of optimal krt starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for latinx with advanced ckd. the project will have four (4) aims.

the overarching goal of this project is to eliminate structural racism and reduce kidney health disparities faced by latinx (gender-inclusive term; includes hispanics, latino/a/x) individuals. the team developed navigate-kidney, a community health worker (chw) intervention to improve clinical and person-centered outcomes for latinx with kidney failure receiving maintenance hemodialysis. the investigators now aim to test navigate-kidney among individuals with advanced ckd stage 4/5. the investigators hypothesize that compared to standard care, the multilevel navigate-kidney intervention will reduce the composite endpoint, defined as (1) time to transition to krt and central venous catheter use or (2) death (primary outcome), increase the rate of optimal krt starts and optimal krt process measures (secondary clinical outcomes), increase patient activation, reduce social challenges, and reduce decisional conflict (patient-centered outcomes) for latinx with advanced ckd stage 4/5 (egfr 15-29 ml/min/1.73m2). the investigators will also evaluate navigate-kidney implementation outcomes using the prism (practical robust implementation and sustainable model) science framework and conduct an economic evaluation to inform policy change.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age, * adults who self-identify as latino/e/a/x and/or hispanic, * adults who are not pregnant, * adults who are not incarcerated, * adults who have advanced kidney disease with an egfr of 15-29 ml/min/1.73m2). no other measures are used to identify eligible patients. exclusion criteria: * anyone who does not meet the criteria outlined above.

Keywords: kidney chronic dialysis transplant
the efficacy of topical formulation containing ciplukan (physalis angulata linn.) on psoriasis vulgaris lesions

Conditions: Psoriasis Vulgaris; Inflammation

Summary: psoriasis vulgaris is a chronic inflammatory skin disease mediated by the immune system, with a complex pathogenesis that requires long-term therapy. various inflammatory mediators that activate and are produced from the nf-κb signaling pathway play a role in the pathogenesis of psoriasis vulgaris. topical corticosteroids are the first-line therapy for all severity levels of psoriasis vulgaris, possessing immunosuppressive, anti-inflammatory, and antimitotic effects. however, long-term use can lead to side effects such as atrophy, striae, telangiectasia, hypopigmentation, acneiform eruptions, perioral dermatitis, and hypertrichosis.

ciplukan (physalis angulata linn.) contains seco-steroids and flavonoids, which exhibit anti-inflammatory, antiproliferative, and immunosuppressive effects. these effects suggest that ciplukan (physalis angulata linn.) could serve as an adjuvant topical therapy for psoriasis vulgaris. however, studies on the effectiveness of ciplukan (physalis angulata linn.) extract in topical formulations for patients with psoriasis vulgaris have not yet been conducted. therefore, a study is needed to assess psoriasis vulgaris lesions both subjectively using the modified pasi score and objectively using high-frequency ultrasonography and spectral doppler ultrasonography. this would evaluate the effectiveness of ciplukan (physalis angulata linn.) cream as an adjuvant topical therapy for psoriasis vulgaris in reducing inflammation and accelerating clinical improvement of skin lesions in patients with psoriasis vulgaris.

Eligibility criteria:
inclusion criteria: * age 18 - 60 years * diagnosed with psoriasis vulgaris based on medical history, physical examination, and severity assessment using the pasi score exclusion criteria: * pregnant or breastfeeding women. * patients currently undergoing systemic therapy for psoriasis vulgaris. * patients who have not discontinued systemic therapy/phototherapy for psoriasis vulgaris ≤ 30 days. * patients with psoriasis vulgaris who have not discontinued topical therapy (other than moisturizers) ≤ 14 days. * psoriasis vulgaris lesions located in trauma-prone areas, palms, soles, face, and skin folds.

Keywords: physalis angulata linn. mpasi ultrasonography
pocus: hemostatic potential and joint health in patients with severe hemophilia a on novel replacement therapies

Conditions: Hemophilia A; Factor VIII

Summary: this is a prospective, randomized control trial in which each patient will be randomly assigned to receive either extended half-life factor viii based replacement therapy or non-fviii based replacement therapy, which are both standard of care treatment for persons with hemophilia a.

this is a research study to find out if there is a difference in the way children with hemophilia a form a clot and also evaluate if they develop tiny bleeds within the joint and subsequently early joint changes when receiving extended half-life factor viii based replacement therapy vs non-fviii based replacement as part of their hemophilia treatment to prevent spontaneous joint bleeds. both therapies are standard of care therapies for patients with hemophilia a. the only experimental/research procedures as part of this study include the thrombin generation assay and ultrasound. all other procedures are standard of care.

Eligibility criteria:
inclusion criteria: * subjects with moderate hemophilia a (baseline factor viii activity 1-5%) or severe hemophilia a (baseline factor viii activity \<1%) on prophylactic standard half-life fviii infusions or subjects with moderate or severe hemophilia a who have not started prophylactic treatment * less than 18 years of age exclusion criteria: * subjects with documented fviii inhibitor * subjects with a history of ≥ 2 target joints * subjects with a history of synovectomy * currently using medications known to impact bone and mineral metabolism (e.g., bisphosphonates, corticosteroids, estrogen, testosterone, calcitonin, thyroid hormone therapy); * disease states known to affect bone integrity (e.g., primary hyperparathyroidism, paget's disease, clinically significant liver disease)
anxiety control by erythrina mulungu

Conditions: Dental Anxiety; Impacted Third Molar Tooth

Summary: this study evaluated the effectiveness of the erythrina mulungu in controlling anxiety in patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.

: in this research, characterized as a randomized, double-blind, crossover study, 30 healthy volunteered patients (05 men and 25 women) aged 18 or older who received a capsule of 500mg of mulungu matusa ® or placebo, orally, one hour before the procedure were selected. the level of anxiety was assessed through questionnaires and physical parameters, such as blood pressure, heart rate and oxygen concentration. data were collected, tabulated and analyzed by the following statistical tests: chi-square, t-test, anova and tukey test, friedman, fisher's exact test with significance level of 5%.

Eligibility criteria:
inclusion criteria: * indication of bilateral extraction of asymptomatic, impacted mandibular third molars exclusion criteria: * patients under the age of 18 * any general health problem based on the medical history and physical examination * history of use of any medication within 15 days before the beginning of the research * history of hypersensitivity to drugs, substances or materials used in this experiment * pregnancy or lactation * history of pericoronitis

Keywords: anxiety third molar surgery blood pressure heart rate oxygen saturation
out-of-hospital intubation with metal single use laryngoscope blades

Conditions: Cardiac Arrest; Coma; Major Trauma; Respiratory Distress; Shock

Summary: new single use laryngoscope metal blades are available for intubation. this type of blade is safer than the reusable ones concerning the interhuman cross infection risk. no clinical studies have compared the two types of blades in the emergency context. the primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.

all adult patients requiring tracheal intubation in the pre hospital emergency context will be included. all intubation will be performed by an emergency physician or a nurse specialized in anesthesia. for patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation. comparisons studied will be : intubation success rate at the first laryngoscopy, glottis exposure assessed by cormack and lehane classification, difficult intubation rate assessed by the intubation difficult score (ids), the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

Eligibility criteria:
inclusion criteria: * all adult patients requiring out-of-hospital intubation exclusion criteria: * patient under 18 years old * patients with criteria predictive of impossible intubation under direct laryngoscopy

Keywords: intubation out-of-hospital laryngoscope blades emergency
dual transversus abdominis plane block in pediatric renal transplant: effect on pain control

Conditions: Renal Failure

Summary: alleviating pain in children undergoing renal transplant is extremely challenging. large incisions as those of renal transplant (gibson's incision) require special techniques of pain control that don't affect hemodynamics or renal function. since the transplant incision doesn't cross midline; a dual-tap block is thought to be effective in providing pain control in such procedure as it will anesthetize the dermatomes t6-t12, the muscles of the anterior abdominal wall together with the underlying parietal peritoneum.


Eligibility criteria:
inclusion criteria: * 3-16 years * end stage renal disease * no known allergy to bupivacaine * both sexes exclusion criteria: * known allergy to bupivacaine

Keywords: pediatric renal transplant pain dual tab