Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of paromomycin to treat visceral leishmaniasis

Conditions: Visceral Leishmaniasis

Summary: symptomatic visceral leishmaniasis(vl)is fatal; due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of vl. paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. this study will test the safety and efficacy of paromomycin in the treatment of patients with vl in india.


Eligibility criteria:
inclusion criteria: * age between 5-55 years (inclusive) of either gender. * newly diagnosed vl or vl treatment failure confirmed by spleen or bone marrow aspirate. * clinical signs and symptoms compatible with vl: fever of over two weeks duration and splenomegaly. * biochemical and haematological test values as follows: * haemoglobin \> 5.0g/100ml * white blood cell count \> 1 x109/l * platelet count \> 50 x 109/l * ast, alt and alkaline phosphatase \< 3 times upper normal limit * prothrombin time \< 5 seconds above control * serum creatinine levels within normal limits * serum potassium levels within normal limits * hiv negative exclusion criteria: * a history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study. * any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up. * an abnormal baseline audiogram (presentation with 75 db or higher at 8khz or below) and/or a history of significant vestibular or auditory dysfunction. * proteinuria (\> 2+). * a history of allergy or hypersensitivity to aminoglycosides. * a history of major surgery within the last two weeks. * pregnancy or lactation. \[note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.\] * previous treatment for vl within two weeks of enrolment into the study. * prior treatment failures with paromomycin or amphotericin b.
the effects of dry needling & kinesio tape on anterior knee pain

Conditions: Patellofemoral Pain Syndrome

Summary: patellofemoral pain syndrome(pfps) is one of the most common health-related complaints in today's societies. myofascial pain syndrome(mps) have been attributed as the main cause and primary source of musculoskeletal pain. trigger point of the vastus lateralis muscle may pull the patella superiorly and laterally, increasing compression of the patellofemoral joint during physical activities, result in pfps and anterior knee pain. the purpose of this study was to investigate the effects of dry needling \& kinesio tape on trigger point of vastus lateralis muscle in pfps subjects.

pain intensity, pain pressure threshold and disability of knee were collected at base line and at the end of treatment sessions.

Eligibility criteria:
inclusion criteria: 1. presence of a palpable taut band in muscle. 2. presence of a hypersensitive tender spot in the taut band. 3. reproduction of the typical referred pain pattern of the trigger point in response to compression. to detect active trigger point, trigger point pressure tolerance was assessed using a mechanical pressure algometer. the investigator applied continuous pressure with the algometer with an approximate pressure of 2.5 kg/cm2. 4. spontaneous presence of the typical referred pain pattern and/or patient recognition of the referred pain as familiar. 5- pain of at least 30 mm on a visual analogue scale (vas) from 0 mm (no pain) to 100 mm (worst imaginable pain). exclusion criteria: 1. had a history of fracture of knee joint, dislocation of patella 2. previous knee or ankle surgery 3. had a history of neurologic condition 4. having physical therapy within the past month before the study 5. pregnancy 6. taking anticoagulants (e.g. warfarin) 7. local infection

Keywords: knee pain,dry needling, kinesiotape,trigger point
trial assessing light intensity exercise on the health of older breast cancer survivors

Conditions: Inflammation; Cognitive Impairment; Anxiety; Alcohol Drinking

Summary: the trial assessing light-intensity exercise on the health of older breast cancer survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control condition.

the investigators will recruit 56 obese, older adult breast cancer survivors at least 1 year, and up to 10 years post-breast cancer treatment, and randomize them to either a 15 week light-intensity physical activity intervention, or usual care group. intervention: the participants will receive weekly support calls, and instructed to increase their light-intensity physical activity, to achieve at least 150 minutes per week. the frequency, intensity, time, and type of physical activity will be modified to maximize adherence and compliance. the support calls developed for this trial target older adults' capabilities, opportunities, and motivations for physical activity.

Eligibility criteria:
inclusion criteria: 1. female 2. age 65-84 years 3. 1-10 years post-breast cancer treatment 4. body mass index ≥30 5. ≥1 drink per week over the last month 6. ≥21 on the telephone interview for cognitive status 7. ≤7 on the alcohol use disorder identification test 8. fluent in written and spoken english 9. must be able to provide and understand informed consent 10. primary physician approval exclusion criteria: 1. body mass index \<30 2. \< 21 on the telephone interview for cognitive status 3. \>7 on the alcohol use disorder inventory test 4. other neurological or major psychiatric disorders 5. significant heart or lung disease 6. limited life expectancy 7. other factors that could potentially limit ability to participate fully in the intervention 8. self-reporting achieving over 150 minutes of moderate-to-vigorous physical activity per week.
sildenafil in covid-19

Conditions: Covid19; SARS-COV2 Infection

Summary: this randomised trial aims to assess the role of sildenafil in improving oxygenation amongst hospitalised patients with covid19.

perfusion anomalies, namely hypoperfusion of healthy lung and vasoplegia with hyperperfusion of diseased lung areas, have been recently described amongst patients with covid19. in this triple-blind pilot randomised trial, adult patients with high clinical suspicion of sars-cov2 infection and perfusion defects in a substraction computed tomography angiography will be randomised in a 1:1 ratio to receive sildenafil or placebo. informed consent will be obtained from every included participant. patients requiring mechanical ventilation at baseline will be excluded, as will those who present a contraindication to sildenafil, previous users of sildenafil, those requiring therapy with nitrates, patients in which an order to limit therapeutic efforts has been issued, pregnant or breastfeeding women and those who decline to participate in this study. the primary outcome for this trial wil be oxygenation changes in blood gas analyses. secondary outcomes will include clinical deterioration requiring admission to an intensive care unit, requirement of high-flow nasal cannula or invasive mechanical ventilation and overall survival. patients will be followed-up until hospital discharge or up to fifteen days after randomisation. statistical analyses will be undertaken by a statistician unaware of treatment allocation under the intention-to-treat principle.

Eligibility criteria:
inclusion criteria: * adult participant with high clinical suspicion of a sars-cov2 infection. * hypoperfusion of healthy lung areas in a substraction computed tomography angiography within 24 hours of admission to the hospital. exclusion criteria: * requirement of therapy with nitrates of nitrites * arterial hypotension at presentation * recent diagnosis of coronary artery disease (\<6 months) * acute heart failure at presentation * recent stroke (\< 6 months) * chronic respiratory failure with co2 retention * known hypersensitivity to sildenafil * advanced liver disease (child-pugh class b or higher) * users of cytochrome p450 3a4 inhibitors (erythromycin, ketoconazole, itraconazole, saquinavir) * pulmonary hypertension * chronic users of phosphodiesterase 5 inhibitors * requirement of invasive mechanical ventilation at baseline * decision to limit therapeutic efforts at baseline * pregnancy or lactation * history of retinitis pigmentosa * known obstruction to left-ventricular outflow tract * unwillingness to participate in the trial

Keywords: covid19 sars-cov2 infection sildenafil phosphodiesterase 5 inhibitors
caries arresting in primary molar teeth using sdf vs art

Conditions: Dental Caries

Summary: this study aimed to evaluate the oral health related quality of life ( ohrqol), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using sdf alone or sdf in combination with art, using early childhood oral health impact scale (ecohis).

early childhood caries (ecc) is a type of dental caries in the teeth of infants and children that is represented as one of the most prevalent dental problems in this period, which can lead to pain, infection, interference with eating. according to the ada, (ecc) is described as "the presence of one or more decayed ( cavitated or non cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth" in children. overall, 50% of children have one or more decayed primary teeth by the end of toddler age, but the importance of these teeth should not be neglected, because, healthy teeth in childhood have an important role in the eruption of healthy permanent teeth, healthy nutrition, and aesthetic appearance. conventional treatment methods (drill and fill) involve the use of rotary burs under local anesthesia which develops pain and needs cooperative child and highly trained dental health personnel and consider an invasive technique, on the other hand (art) is an approach to increase accessibility to restorative treatment, inexpensive and can be employed in regions without electricity and running water. in addition, art is a minimally invasive treatment that requires no rotary instruments or local anesthesia to remove decayed tissue before sealing the cavity with high viscosity glass ionomer cement (gic). (sdf), a low-cost cariostatic agent and a noninvasive method for caries management, treatment with sdf are easy, effective, and well accepted, it is also an alternative to traditional restorative treatment and may influence the reduction of untreated carious lesions in childhood

Eligibility criteria:
inclusion criteria: • age: 4-6 years old age. * both genders. * decayed vital primary molars (asymptomatic teeth with active single-surface lesions, vital pulp no signs of irreversible pulpitis) . exclusion criteria: * history of systemic conditions. * allergy to silver. * oral ulceration. * teeth with proximal or multi-surfaces caries, pulp pathology.
sirt or tace plus lenvatinib and pd-(l)1 inhibitor in high burden hcc

Conditions: Hepatocellular Carcinoma Non-resectable

Summary: this multicenter retrospective study evaluated the efficacy and safety of selective internal radiation therapy (sirt) combined with lenvatinib and pd-(l)1 inhibitors (sirt-l-p) versus transarterial chemoembolization (tace) combined with lenvatinib and pd-(l)1 inhibitors (tace-l-p) in patients with hcc beyond up-to-seven criteria or with portal vein tumor thrombus (pvtt). tumor response, progression-free survival (pfs), overall survival (os), and adverse events (aes) were compared between the two groups.

consecutive patients with hcc beyond up-to-seven criteria or with pvtt treated with sirt-l-p or tace-l-p from june 2022 to october 2024 were screened. tumor response was evaluated according to modified response evaluation criteria in solid tumors (mrecist) and response evaluation criteria in solid tumors version 1.1 (recist 1.1). clinical outcomes, including tumor response, pfs, os, and aes were compared between the two groups.

Eligibility criteria:
inclusion criteria: * histologically or clinically confirmed diagnosis of hcc at bclc stage b or c (extrahepatic metastases were allowed) * eastern cooperative oncology group (ecog) performance status score 0 or 1 * child-pugh class a or b7 * unresectable hcc with intrahepatic tumor beyond up-to-seven criteria and/or with pvtt. exclusion criteria: * receipt of other loco-regional therapies, including hepatic arterial infusion chemotherapy, external radiation therapy, or radioactive seed implantation * prior systemic therapy * history of other malignancies * incomplete medical records

Keywords: hepatocellular carcinoma selective internal radiation therapy transarterial chemoembolization lenvatinib pd-(l)1 inhibitor
unrelated umbilical cord blood following hla-haploidentical hematopoietic stem cell transplantation in patients with β-thalassemia major

Conditions: Thalassemia Major

Summary: allo-hematopoietic stem cell transplantation(hsct) is the only way to cure β-thalassemia major at present. to expand donor pool，we developed a haplo-identical hsct (hi-hsct) platform. but in prior hi-hsct using high dose post-transplant cyclophosphamide in patients with leukemia, cytopenia post-transplant often developed, which was considered as a symptom of gvhd. therefore, the investigators add unrelated umbilical cord blood (ucb) to the hi-hsct. it has reported that, as third-party cells, ucb will reduce gvhd.the purpose of this study is to determine whether unrelated ucb following hi-hsct can improve outcomes of hi-hsct in patients with β-thalassemia major.


Eligibility criteria:
inclusion criteria: * β-thalassemia major * \< 18 year old * unrelated umbilical cord blood following haplo-identical hsct exclusion criteria: * ≥ 18 year old * hla- matched related donors * unrelated donor transplants * unrelated umbilical cord blood transplants * severe iron overload in heart by t2\*

Keywords: cord blood transplant haploidentical hsct thalassemia major
vitamin d status in inflammatory bowel disease

Conditions: Vitamin D Deficiency; Inflammatory Bowel Diseases

Summary: inflammatory bowel disease (ibd), comprising crohn's disease (cd) and ulcerative colitis (uc), is a a chronic, relapsing-remitting systemic disease. vitamin d is a secosteroid hormone that possesses immunomodulatory properties and has been demonstrated to potentially influence inflammatory bowel disease (ibd) pathogenesis and activity.

inflammatory bowel disease (ibd), comprising crohn's disease (cd) and ulcerative colitis (uc), is a a chronic, relapsing-remitting systemic disease and it is increasing sharply with rapidly increasing proportion in developing countries., and the common medications are not effective for most patients.the key underlying pathogenic mechanisms for both diseases is a dysregulated host immune response to commensal intestinal flora in genetically susceptible individuals.vitamin d is a fat-soluble vitamin, a secosteroid hormone whose active form, calcitriol or 1,25-dihydroxyvitamind3 (1,25(oh)2d3) plays important roles in immune regulation, particularly involving the innate immune system, cell differentiation and intercellular adhesion, promotes the production of anti-microbial peptides, including β-defensins and cathelicidins, the shift towards th2 immune responses, and regulates autophagy and epithelial barrier integrity.the relationship between vitamin d deficiency and ibd is bidirectional that vit d with its immunomodulatory effects influence ibd pathogenesis and activity and ibd itself can lead to vitamin d deficiency.vitamin d deficiency has associated with increased ibd activity scores, lower quality-of-life, an increased risk of ibd-related surgery and increased hospitalizations.\[4\]. vitamin d downregulate powerful proinflammatory cytokines, such as tnf, which enhance the durability of anti-tnf therapy in ibd and its deficency has been found to be associated with earlier cessation of anti-tnfα therapy( loss of response to biologic therapy.

Eligibility criteria:
inclusion criteria: * any patient with inflammatory bowel disease (either ulcerative colitis or crohns disease ) patients diagnosed through clinical evaluation ,laboratory ,colonoscopic and histopathological studies. exclusion criteria: * patients known to have malignancy, or metabolic disease associated with vitamin d and calcium abnormalities e.g. hyperparathyroidism and history of vitamin d supplementations. * patients with known biliary disease, chronic liver and kidney diseases. * patients with a mal-absorption syndrome other than ibd. * pregnant or lactating patients.
comparative assessment of compumedics somfit sleep monitoring device

Conditions: Sleep-Disordered Breathing

Summary: to study whether somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing

sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. however, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (psg) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. this "gold standard" technology is expensive and therefore does not allow to meet public health demand for diagnosis of sleep disorders, especially obstructive sleep apnea (osa) and also can be uncomfortable for the patients and distort their natural sleep architecture. to solve this problem, compumedics has recently developed a miniaturized, portable, automated and affordable sleep monitoring system with code name of "somfit" which is attached to patients' forehead and can be used in the comfort of patients' home. while somfit has already gained tga approval, the aim of this study is to compare somfit with the "gold standard" psg and another approved portable sleep testing device, itamar watchpat one, in terms of accuracy of characterising sleep neurological architecture and diagnosing osa, with the objective of applying for the international regulatory approvals.

Eligibility criteria:
inclusion criteria: * individuals aged 18 years or over * be able to give informed consent * referral for a diagnostic sleep study with indication of suspected sleep disordered breathing or history of diagnosed sleep disordered breathing exclusion criteria: * less than 18 years of age * unable or not willing to provide informed consent * need for nursing attendance during the time between 9 pm and 9 am * use of any osa treatments during any part of the psg study * previous reaction to skin preparation, tapes and electrode gels used at psg
spring - assess the clinical care pathway of population with t2d and ckd in four european countries using real-world data

Conditions: Type 2 Diabetes Mellitus (T2D) and Chronic Kidney Disease (CKD)

Summary: this study is being carried out in 4 countries (france, italy, spain and the uk) to understand the clinical care pathway of population living with type 2 diabetes who also have evidence of chronic kidney disease. the primary objective is to describe the population with t2d and ckd in terms of demography, clinical characteristics and medication use by ckd stage.


Eligibility criteria:
inclusion criteria: 1. adults (18 years old or older) diagnosed with t2d and treated with an antidiabetic medication before or at index date, set up on 1 january 2021 2. with evidence of kidney damage before or at index date: 1. diagnosed with ckd 2. or with a record of egfr below 60 ml/min/1.73 m\^2 3. or with a record of uacr above 30 mg/g 3. consulting a gp (all countries) or an endocrinologist (france, spain, italy) or a nephrologist (spain) of the thin® network. exclusion criteria: 1. aged less than 18 years old at index date 2. less than 360 days prior index date 3. less than 360 days after index date
atrial fibrillation screening in nursing homes

Conditions: Atrial Fibrillation

Summary: this study was designed to screen high risk patients in nursing homes for atrial fibrillation with intermittent electrocardiogram (ecg) recordings using a portable, smartphone-based, mobile ecg recording device (kardia mobile, alivecor, inc.). the investigators hypothesized that screening patients with 2 or more risk factors for atrial fibrillation would yield a higher incidence of atrial fibrillation compared to prior studies.

this is a prospective study that enrolled 245 residents from 15 participating nursing homes with ≥2 risk factors for atrial fibrillation. all residents gave informed consent or had a legally appointed representative who could consent on their behalf. exclusion criteria included residents with a prior diagnosis of atrial fibrillation, continuous rhythm monitoring over the past year, and pacemaker or implantable cardioverter defibrillator in situ. screening was performed using the smartphone-based, mobile ecg recording device. thirty second rhythm recordings were obtained on each resident on four different occasions within a month. all tracings were reviewed by a cardiologist and, in the case of any uncertainty, the diagnosis of atrial fibrillation was confirmed by an electrophysiologist. when atrial fibrillation was detected in a resident (primary endpoint), no further rhythm recordings were performed and the resident's nursing facility was then notified of the diagnosis. further evaluation and treatment were directed by the resident's primary care physician. all data were stored on a secure encrypted server with password protection. the investigators used chi-square and t-test analyses to determine if there were significant differences in demographic variables or risk factors for atrial fibrillation between residents with and without atrial fibrillation. logistic regression analysis determined if any combination of risk factors was predictive of a positive atrial fibrillation screen.

Eligibility criteria:
inclusion criteria: nursing home residents with ≥2 of the following risk factors for atrial fibrillation: * age ≥75 years * female sex * obstructive sleep apnea * peripheral vascular disease * diabetes mellitus * obesity (body mass index \[bmi\] \>30 kg/m2) * hypertension * congestive heart failure exclusion criteria: * prior diagnosis of af * continuous rhythm monitoring over the past year * pacemaker or implantable cardioverter defibrillator in situ
pk and safety study of vaginal rings containing dapivirine and levonorgestrel

Conditions: HIV Prevention

Summary: pk and safety study of vaginal ring containing dapivirine and levonorgestrel

a phase 1, randomized, double-blind pharmacokinetic and safety study of dapivirine/levonorgestrel

Eligibility criteria:
inclusion criteria: * healthy women exclusion criteria: * hiv infected women