Kornimate/medical-research-clean huggingface dataset:
utilizing the hitsystem for optimizing paediatric art retention and adherence in western nyanza province, kenya

Conditions: Pediatric HIV Infection

Summary: overall, there are an estimated 98,000 children living with hiv in kenya. children who are initiated on art in kenya and other low resource settings face several challenges with ongoing care due to current limitations of paediatric hiv treatment services. high quality paediatric hiv care requires routine monitoring of clinical and virologic status, support for art adherence, and patient outreach to optimize retention in care. the hiv infant tracking system (hitsystem) is a web-based, system-level intervention that has dramatically improved eid hiv-related outcomes in kenya, tanzania, and malawi. the objective of this study is to implement and evaluate the impact of hitsystem 3.0 on paediatric clinical outcomes, adherence, retention and viral suppression over 12 months among children in hiv care. outcome measurements will be evaluated separately in children aged ≤2 years and in those aged 3-16 years. primary outcomes 1. the proportion of hiv infected children in each arm who are retained in hiv care at 12 months. retention will be defined as regular engagement with hiv care, as measured by having attended the last three scheduled monthly appointments on time (see section 3.3 for further description). 2. the proportion of hiv infected children who are virally suppressed (vl \<50) at the end of the 12-month follow-up period. the proposed trial design is an unblinded crt with two arms: the hitsystem 3.0 intervention vs. standard of care (soc) as the control. the crt will be implemented in 20 health facilities (10 intervention and 10 control) in western nyanza province in kenya and will collect data from hiv-infected children aged ≤16 years. outcomes will focus on art retention, adherence and viral suppression. outcomes will be assessed among all hiv positive children aged ≤16 years attending the trial facilities for hiv care at the start of the trial, or who are diagnosed as hiv positive during the first 12 months of the trial. follow-up data will be collected on each child for 12 months. therefore, the total duration of the trial will be for 24 months. all hiv-positive children and their caregivers attending health facilities randomised to the intervention arm will be monitored by the hitsystem 3.0. the study will be conducted in western nyanza province, kenya, which comprises six counties.


Eligibility criteria:
inclusion criteria: health facilities must meet the following criteria to be eligible for the trial: 1. level 3-5 and located in the western nyanza province. 2. currently provide pmtct, eid and paediatric art programmes. 3. either government or private not-for-profit 4. agreement to participate, which will be granted by both kisumu county minister of health, as well as the facility director of medical operations (dmo). exclusion criteria: 1. facilities that are classified as level 1-2. 2. facilities that are participating in other research involving paediatric art programmes. 3. private commercial facilities
specific neurodynamic exercises on disability and neck pain in old women

Conditions: Neck Pain

Summary: this is a randomized, parallel, double-blind clinical trial. the main objective is to compare the efficacy of multimodal exercise with specific neurodynamic exercises and multimodal exercise with non-specific exercises in disability and neck pain in women older than 65 years. the intervention in both groups will be carried out for 4 weeks, with three weekly sessions. two evaluations will be carried out, a pre-intervention evaluation and a post-intervention evaluation. we will assess neck pain, disability, upper limb strength, cervical mobility, cervical pressure pain thresholds, kinesiophobia and catastrophism.


Eligibility criteria:
inclusion criteria: * women older than 65 years. * neck pain exclusion criteria: * tumors * pacemakers * fibrillations * cardiac pathology or uncontrolled hypertension * history of severe trauma/recent cervical surgery * uncontrolled systemic and inflammatory pathologies * congenital collagen compromise * presence of difficulties in performing the initial evaluation tests * language barriers * pending litigation or legal claim

Keywords: exercise neck pain neurodynamic elderly
efficacy and safety study of tjcs for treatment of moderate to severe dry eye syndromes

Conditions: Dry Eye Syndromes

Summary: the purpose of this clinical study is tjcs eye drops 0.05%(cyclosporine ophthalmic nano-emulsion) group and restasis eye drops 0.05%(cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in moderate to severe dry eye disease.


Eligibility criteria:
inclusion criteria: * male or female, age 20 or over * patients with moderate to severe dry eye * screening both eyes, the corrected visual acuity is 0.2 or more exclusion criteria: * screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions. * screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease) * intraocular pressure(iop)\> 25 mmhg * patient using or to use punctual plug within 1 months. * patients with contact lens.
a study of ro4989991 in patients with allergic rhinitis

Conditions: Asthma

Summary: this multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the safety and tolerability of subcutaneous doses of ro4989991 in patients with allergic rhinitis who are otherwise healthy. the anticipated time on study treatment is 2 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age, inclusively * a history of allergic rhinitis diagnosed by a physician, but otherwise healthy * a positive skin prick test to at least one standardized allergen at screening * a body mass index (bmi) between 18 and 32 kg/m2, inclusively exclusion criteria: * history or presence of any respiratory disease or condition other than allergic rhinitis * use of prescription medication or herbal remedies within 14 days of dosing the study drug * use of over-the-counter (otc) medications within 7 days of dosing the study drug * acute infection (including viral infections) 6 weeks (8 weeks for respiratory infections) preceding dosing or any ongoing chronic infection * positive test for human immunodeficiency virus (hiv) or hepatitis b or c
rehabilitation for arm coordination and hand movement in systemic sclerosis

Conditions: Systemic Sclerosis; SSc

Summary: the purpose of this study is to test two rehabilitation programs to improve arm function for patients with scleroderma. this is a phase 2 randomized controlled trial in which participants will be assessed at baseline, 8 weeks, and 18 weeks. participants will be randomized into an intensive intervention (8 individual sessions of occupational therapy plus a home exercise app) versus a home app treatment alone. the results of this study will be used to design a large multi-site trial in which optimized rehabilitation strategies can be used to help patients improve their arm function.

the specific aims of this study are to: 1. determine the short and longer-term effects of an intensive (8-week in-person occupational therapy treatment with prescribed home exercises) on improving arm function versus home exercise alone. this study's hypothesis is that immediately following treatment at 8 weeks and at 18 weeks, participants randomized to the in-person occupational therapy will have significant improvements in the quickdash disability measure, promis physical function measure, and total active hand function compared to the home exercise alone. 2. determine how adherence to home exercise in both groups influences treatment effects. this study's hypothesis is that adherence will independently predict improvement in outcomes at 8 and 18 weeks regardless of treatment group assignment and that higher adherence to the home exercise program will result in greater and more long-lasting improvements.

Eligibility criteria:
inclusion criteria: * have a diagnosis of systemic sclerosis including: * diffuse cutaneous subset * disease duration \< 5 years from 1st non raynaud phenomenon sign or symptom * have a contracture of the hand and other joint in at least one arm, such as wrist, elbow, or shoulder, with the ability to demonstrate active range of motion in that arm * willing to travel to participate in therapy and outcome assessments. * have an android, iphone, ipad or computer tablet to load the home exercise app. * english speaking exclusion criteria: * issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to use home exercise app, etc.)
the effect of timing of removal of wound dressing on surgical site infection rate after cesarean delivery

Conditions: Surgical Site Infection

Summary: a randomized controlled trial measuring surgical site infection rate as a function of timing of wound dressing removal.

a randomized controlled trial with a sample size of 602 patients to study the effect of timing of wound dressing removal on the surgical site infection rate. 300 patients were randomized to a group that had the wound dressing removed between 12-30 hours postoperatively. 302 patients were randomized to a group that had the wound dressing removal between 30-48 hours postoperatively. statistical analyses were performed to determine if the timing of dressing removal had statistical significance on the surgical site infection rate, the primary outcome.

Eligibility criteria:
inclusion criteria: * patients ages 18-50 years; * medically competent (no proxies or prisoners); and * multifetal and singleton gestations from 23 0/7 weeks to 42 0/7 weeks gestational age. exclusion criteria: * inability to obtain informed consent; * fetal death; * immunocompromised patients; patients taking immuno-suppressants; history of documented surgical site infection; or patients requiring reoperation within the 6 week postoperative period for indications other than wound dehiscence/debridement/infection.
remote ischemic preconditioning for renal and cardiac protection in congestive heart failure (rich) trial

Conditions: Acute Kidney Injury; Heart Failure; Contrast Induced Nephropathy; Coronary Angiography; Percutaneous Coronary Intervention

Summary: this is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.

the rich trial is a prospective, multicenter, randomized clinical trial to determine the effect of remote ischemic preconditioning on contrast associated acute kidney injury, and to characterize the effect of remote ischemic preconditioning on brain natriuretic peptide, functional capacity at one month, and major adverse kidney events (persistent renal dysfunction, renal replacement therapy, and death) at three months in patients with congestive heart failure with reduced left ventricular ejection fraction undergoing coronary angiography and/or percutaneous coronary intervention.

Eligibility criteria:
inclusion criteria: * age 18 years * diagnosis of heart failure with reduced lvef \<50% * pre-procedure intravenous normal saline fluid restriction status * society for cardiovascular angiography and interventions (scai) aki risk score (\>1%) * referral for coronary angiogram and/or pci * suspected stable coronary artery disease or acute coronary syndrome exclusion criteria: * inability to give informed consent * unstable bp (sbp \> 200 or \<80 mmhg) at the time of enrolment * upper limb peripheral arterial disease * unavailability of at least one arm for ripc/sham-ripc application * kidney transplant * renal disease requiring dialysis * prior exposure to contrast media within 72hrs preceding coronary angiography * pregnancy * prisoner

Keywords: contrast-induced acute kidney injury congestive heart failure contrast induced nephropathy coronary angiography percutaneous coronary intervention coronary artery disease remote ischemic conditioning acute coronary syndrome acute kidney injury major adverse kidney events ischemic preconditioning
research on the safety and efficacy of intraoperative radiation therapy in malignant cerebral tumor

Conditions: Glioblastoma; Brain Tumor, Primary; Brain Tumor - Metastatic

Summary: according to the latest national cancer statistics released by the national cancer center in february 2022, intracranial tumors account for about 60%-70% of the more than 3.5 million cancer patients, and the morbidity and mortality remain high. intracranial malignant tumors have become a problem that needs to be solved urgently because of their early recurrence, rapid progression, and short survival, and intracranial malignant tumors include high-grade gliomas, metastases, lymphomas, etc. glioblastoma (gb) is the most common primary malignancy in the adult central nervous system, accounting for about 57% of all gliomas and 48% of all primary weighted nervous system malignancies. at present, the standard treatment for glioblastoma is mainly surgical treatment, supplemented by postoperative concurrent chemoradiotherapy and adjuvant chemotherapy, but the prognosis of patients is still poor, with a one-year survival rate of 40.6%, a five-year survival rate of only 5.6%, and an average survival time of 12-15 months. for patients diagnosed with intracranial malignancies (including high-grade glioma, metastases, lymphoma, etc.), multimodal image-guided microsurgery combined with postoperative chemoradiotherapy recommended by the guidelines, and intraoperative radiotherapy with tumor bed radiation therapy to achieve targeted and precise tumor treatment, thereby improving the prognosis of patients (including progression-free survival and median overall survival, etc.)


Eligibility criteria:
inclusion criteria: * 18-75 years old, non-pregnant or lactating women * kps ≥60 * mri and ct of the brain with contrast should be considered for diagnosis of high-grade glioma or other malignant brain tumors * no other underlying diseases that affect survival time, follow-up or quality of life, and no other serious organic lesions * not receive radiotherapy, chemotherapy and other treatment methods for intracranial lesions in the past; * tumor located supratentorium, and the position should ensure that the tumor resection volume is more than 90%; * the required dose of standard radiotherapy exceeds normal tissue tolerance * no related contraindications such as intraoperative radiotherapy and craniotomy. exclusion criteria: * refuse to undergo craniotomy or radiation therapy; * the postoperative paraffin pathological results were not high-grade gliomas or other cranial malignant tumors; * refuse to participate in the clinical trial after informed consent without the above exclusion criteria.

Keywords: brain tumor intraoperative radiation therapy
impact of music in the preoperative stress of children undergoing general surgery

Conditions: Stress, Physiological; Stress, Psychological

Summary: preoperative anxiety and stress are present in up to 60% of pediatric patients undergoing surgery, having a great physiological and emotional impact on children in both the short and long term. there are many reports on the use of music therapy in the perioperative period as a complementary technique in the preoperative stress and anxiety management. however, there are no assessments of the effect of this intervention on the physiological variables, such as salivary cortisol.

60 patients aged 5-7 years, asa (american society of anesthesiologists) status i-ii, scheduled for general surgery at the hospital of the catholic university and associate institutions, will be considered for inclusion. 30 will receive music as intervention and 30 will received usual treatment. salivary cortisol samples will be obtained preoperatively, in the surgical ward (or), and in the post-anesthesia care unit (pacu). secondary outcomes will be m-ypas (yale preoperative anxiety scale) for children, and stai (state-trait anxiety inventory) for parents scales.

Eligibility criteria:
inclusion criteria: * elective surgery * asa i-ii * parents' consent exclusion criteria: * history of endocrine diseases (hypothyroidism, treatment with growth hormone, severely obese) * taking glucocorticoid inhalers or oral corticosteroids * children with severe hearing problems * patients requiring emergency surgery * refusal to participate in the study

Keywords: perioperative period music
study to evaluate efficacy and safety of inclisiran in children with heterozygous familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia - Heterozygous

Summary: this is a pivotal phase iii study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (hefh) and elevated low density lipoprotein cholesterol (ldlc).

this is a two-part (1 year double-blind inclisiran versus placebo / 1 year open-label inclisiran) multicenter study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (hefh) and elevated low density lipoprotein cholesterol (ldl-c) on stable standard of care background lipid-lowering therapy.

Eligibility criteria:
inclusion criteria: * male or female participants, 6 to \<12 years of age at screening * hefh diagnosed either by genetic testing or on phenotypic criteria * fasting ldl-c \>130 mg/dl (3.4 mmol/l) at screening * for participants 8 to \<12 years, on an optimal dose of statin (investigator's discretion) unless statin intolerant, with or without other lipid-lowering therapy (e.g. ezetimibe). for participants \<8 years, the use of background lipid-lowering treatment is based on investigator's discretion. * participants on lipid-lowering therapies (such as statin and/or e.g. ezetimibe) must be on a stable dose for ≥30 days before screening with no planned medication or dose changes during study participation. exclusion criteria: * previous treatment (within 90 days of screening) with monoclonal antibodies directed towards pcsk9 * secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome * homozygous familial hypercholesterolemia (hofh) * body weight \<16 kg at the screening and/or randomization (day 1) visit * active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (alt), aspartate aminotransferase (ast) elevation \>3x uln, or total bilirubin elevation \>2x uln (except patients with gilbert's syndrome) * pregnant or nursing females * recent and/or planned use of other investigational medicinal products or devices

Keywords: heterozygous familial hypercholesterolemia (hefh), ldl-cholesterol (ldl-c), children, pediatric, small interfering ribonucleic acid (sirna), inclisiran, familial hypercholesterolemia, heterozygous fh, hypercholesterolemia, lipoprotein(a), hyperlipidemia, dyslipidemia, heart failure, cardiovascular diseases, cholesterol, aortic stenosis
urological physical therapy in htlv-1 with urinary symptoms

Conditions: Tropical Spastic Paraparesis; HTLV-1

Summary: urological physical therapy is described to improve urinary symptoms in patients with myelopathy or neurological dysfunction and to increase the quality of life. although it was never tested on htlv-1 associated overactive bladder syndrome, an disabling disease that is common seen in ham/tsp patients but can also appear as an isolated form. our hypothesis is that urological physical therapy can improve urinary symptoms like incontinence, urgency and nocturia in htlv-1 infected population with those complains.

the t-lymphotropic virus type 1 (htlv-1) is an human retrovirus that was proved to be the main agent of the acute t cell lymphoma/leukemia (atll) and a progressive neurological disease called htlv-1 associated myelopathy/ tropical spastic paraparesis (ham/tsp). the htlv-1 was first isolated in 1980 and it is endemic in japan, caribbean, africa and south america. it is estimated that about 20 million people is infected worldwide. in brazil it is present in all states with variable prevalences. the factors associated with htlv-1 transmission in brazil are related to the social and demographic condition, characterized by rural exodus and increase of urban population in the coast areas. several studies based in brazil reported that the epicenter of htlv-1 infection is on bahia, maranhão and pernambuco with the highest prevalence of 1,8% in salvador, bahia capital. the urinary incontinence is a bladder-sphincter disturbance often found in htlv-1 patients. in this infection the most common pathology finding is overactive bladder syndrome due detrusor overactivity and sphincter-detrusor dyssynergia and the symptoms are urgency, nocturia and incontinence. this disabling disease is associated with psychosocial issues like loss of self confidence, social isolation and reduced quality of life. the physical therapy treatment have the objective of promote social adequacy and reestablish the bladder function. it is based on resources like: bladder reeducation, biofeedback, kinesiotherapy of the pelvic wall, utilization of vaginal cones and electrostimulation. those can be associated or not with anticholinergic drugs and bladder catheterization. the need of urologic and gynecologic physical therapy follow up in patients with htlv-1 and neurogenic bladder is important to reduce disability, preserve pelvic muscles and renal function.

Eligibility criteria:
inclusion criteria: * patients with htlv-1 with more than 18 years and neurogenic bladder defined by urodynamic study. exclusion criteria: * diabetes mellitus, * stroke, * multiple sclerosis, * parkinson disease, * use of pacemaker, * urinary infection.

Keywords: htlv-1 neurogenic bladder physical therapy tropical spastic paraparesis