Kornimate/medical-research-clean huggingface dataset:
role of supar in periodontitis and cvd

Conditions: Metabolic Disturbance; Periodontal Diseases

Summary: soluble urokinase-type plasminogen activator receptor (supar) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease (cvd). the investigators compared the impact of gingival health, periodontitis (cp), chd or of both diseases (cp+chd) on saliva and serum supar levels.

the aim of this study was to evaluate a possible association between both saliva and serum supar levels in patients with cp and with cvd and if the serum supar levels are mediated by serum crp.

Eligibility criteria:
inclusion criteria: * presence of at least 15 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
contrast sensitivity assessment in pediatric cataract surgery with iol implantation

Conditions: Contrast Sensitivity

Summary: the study evaluates contrast sensitivity in older children following surgery for lamellar and posterior subcapsular cataracts. often, pediatric surgeons tend to delay surgery in these children who present beyond the amblyogenic age group. these cataracts are often compatible with reasonable visual acuity and therefore some surgeons prefer to wait for surgery, whereas others tend to operate. the study evaluates improvement in contrast sensitivity at different spatial frequencies following cataract surgery for lamellar and posterior subcapsular cataracts in older children.

all patients undergoes temporal clear corneal incision, manual anterior continuous curvilinear capsulorhexis, bimanual irrigation/aspiration for lens removal and residual cortex, posterior capsule management based on the age of the patient either manual posterior capsulorhexis (pccc) upto 6 years or leaving intact posterior capsule and implantation of single-piece acrysof sn60wf (alcon laboratories, forth worth, texas) hydrophobic acrylic iol in-the-bag. postoperatively, all the patients are examined first for high contrast sensitivity and then for low contrast at 1 week, 1 and 3 months respectively. the results are analyzed for corrected distance visual acuity (cdva) which is recorded in logmar units at preoperative and 1 and 3 months postoperatively. monocular high-contrast snellen visual assessment for distance is done with the early treatment diabetic retinopathy study chart (vector vision acuity chart at 100% contrast) with corrected distance visual acuity cdva at 4 m under photopic condition. similarly at preoperative and 1 and 3 months postoperatively contrast sensitivity testing is also performed using the csv 1000e sine wave grating test face (vector vision, usa) with the patient seated at a distance of 2.5 m from the chart. the test is performed after the patient is adapted to the room luminance for 5 minutes. the non viewing eye was occluded for each measurement, and the best spectacle refractive correction is placed in front of the viewing eye. testing is being tested under two lighting conditions: photopic (85cd/m2) and mesopic (2.7cd/m2). the contrast sensitivity values are documented in log units. sensitivity levels at each frequency range from 0.7 to 2.08 (3 cpd), 0.91 to 2.29 (6 cpd), 0.61 to 1.99 (12 cpd), and 0.17 to 1.55 (18 cpd) log units. this testing is performed with the patient wearing their refractive correction in form of spectacles.

Eligibility criteria:
inclusion criteria: * children older than 4 years and lamellar and posterior subcapsular cataracts undergoing cataract surgery with iol implantation exclusion criteria: * eyes with traumatic or subluxated cataract,

Keywords: contrast sensitivity , pediatric cataract surgery,
treatment of the cholesterol defect in smith-lemli-opitz syndrome

Conditions: Smith-Lemli-Opitz Syndrome

Summary: the purpose of this study is to determine whether supplementation with an oil-based cholesterol suspension will correct the biochemical abnormalities in cholesterol and its precursors in individuals with the smith-lemli-opitz syndrome.

this study involves treating individuals with the smith-lemli-opitz syndrome, a rare inborn error of cholesterol metabolism, with supplemental cholesterol to determine it effects on biochemical sterol metabolites, growth, neuropsychological development, ophthalmologic and auditory function, erg (electroretinogram) parameters, and cns metabolites as determined by brain mrs-imaging. safety of the supplemental cholesterol suspension is monitored by tests of hematologic, renal, and liver function at periodic intervals. there is also a substudy that is investigating potential genotype-phenotype correlations, as well as another that studies biochemical parameters of light sensitivity in cultured skin fibroblasts from affected patients.

Eligibility criteria:
inclusion criteria: * biochemical confirmation of sterol defect associated with smith-lemli-opitz syndrome exclusion criteria: * inability to tolerate crystalline cholesterol * inability to travel to boston 3-4 times/year based on age

Keywords: cholesterol smith-lemli-opitz syndrome mental retardation sterols congenital anomalies
a phase i clinical study of sss59 monotherapy in patients with advanced malignant tumors

Conditions: Malignant Tumors

Summary: this study was an open-label phase i study to evaluate the safety, pharmacokinetics, and antitumor activity of sss59 as a single agent in patients with advanced malignancies.

this study includes 4 parts: part a1 (dose escalation and dose extension for qw administration), part a2 (dose escalation and dose extension for q2w administration), part a3 (dose extension for q3w administration), and part b (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with muc17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).

Eligibility criteria:
inclusion criteria: * histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies. * eastern cooperative oncology group (ecog) performance status of 0-1. * expected survival \>3 months. * signed informed consent form. * must have adequate organ function. exclusion criteria: * any remaining aes \> grade 1 from prior anti-tumor treatment as per ctcae v5. 0, with exception of hair loss and fatigue. * pregnant or nursing women or women/men who are ready to give birth. * symptomatic central nervous system metastasis. * allergy to other antibody drugs or any excipients in the study drugs. * underwent major surgery within 4 weeks prior to first dosing. * the patient is participating in another clinical study, unless it is an observational (non-intervention) clinical study or a follow-up period of an intervention study. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
assessment of efficacy and safety of therapy with covid-19 convalescent plasma in subjects with severe covid-19 (ipco)

Conditions: Severe COVID-19

Summary: this phase 2b clinical study will enroll adult subjects of both sexes with ards due to covid-19 necessitating invasive mechanical ventilation.

the primary objective of the study is the assessment of impact of immune therapy with covid-19 convalescent plasma on severity of covid-19. the secondary objectives is the impact of immune therapy with covid-19 convalescent plasma on markers for ards due to severe covid-19 infection; short-term all-cause mortality; time course of ards due to severe covid-19 and assessment of safety and tolerability of immune therapy with covid-19 convalescent plasma. as a primary endpoint/variable we will assess change in sofa score from baseline visit to day 8. the study design will be prospective, open-label, randomized, controlled and parallel-grouped.

Eligibility criteria:
inclusion criteria: 1. male or female subject aged ≥18 years. 2. estimated bmi ≥19kg/m² to ≤40kg/m². 3. florid1 sars-cov-2 infection confirmed by rt-pcr in tracheo-bronchial secretion sample or pharyngeal swab sample. 4. ards with horovitz index \<300mmhg. 5. necessity of invasive mechanical ventilation. 6. written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in germany ( 7. subject's assent if obtainable exclusion criteria: 1. previous exposure to covid-19 convalescent plasma. 2. adverse reaction to plasma proteins in medical history. 3. interval \>72h since endotracheal intubation. 4. current or imminent necessity of ecmo treatment. 5. pre-existing copd gold stage 4. 6. chronic congestive heart failure nyha ≥3. 7. pre-existing left ventricular ejection fraction \<30%.
effect of zoledronic acid in primary knee osteoarthritis

Conditions: Primary Osteoarthritis

Summary: we try to find out the effect of zoledronic acid over pain of primary knee osteoarthritis and also functional status in a period of 6 months.

this will be a double blind placebo controlled randomized clinical trial at department of rheumatology, bangabandhu seikh mujib medical university (bsmmu) from january 2023 to december 2023. total 92 primary knee oa patients will be enrolled by following the inclusion criteria of ages 50 years and above with primary knee oa informed written consent. then randomization will be done into group a and group b following a randomization table, each consist of 46 patients. consecutive sampling technique will be followed. primary knee oa will be diagnosed on the basis of acr clinical and radiological criteria. relevant laboratory investigations will be done. baseline pain status will be measured by bangla version of western ontario and mcmaster universities osteoarthritis index (womac), visual analog scale (vas) and numerical rating scale (nrs) and quality of life will be measure by european quality of life scale (eq-5d-5l). then one group will receive single infusion of 5mg zoledronic acid and another group will receive the placebo. each patient will be allowed take nsaids on requirement basis with documentation and follow non pharmacological treatment of oa. at the end of 6 months, again pain and functional status will be measured by womac scale

Eligibility criteria:
inclusion criteria: 1. \>= 50 years 2. knee oa by acr criteria 3. patient who will be willing to participate in the study exclusion criteria: * 1. known inflammatory arthritis 2. bmi \>= 40 kg/m2 3. prior diagnosis of cancer 4. prior use of bisphosphonates 5. use of intra articular corticosteroid or hyaluronic acid preparations within 3months 6. metabolic causes of oa (crystal associated arthritis, acromegaly, wilson's disease, haemachromatosis, hyperparathyroidism, dm) 7. mechanical causes of oa (epiphyseal dysplasia, congenital dislocations, limb-length inequality, hypermobility syndromes, avascular necrosis)
the effect of a musical intervention on stress response to venepuncture

Conditions: Pain; Stress, Physiological

Summary: randomised crossover trial in preterm infants less than 32 weeks to assess music therapy and sucrose versus sucrose on stress

the purpose of this study is to assess whether the use of music therapy as a non-pharmacological intervention around the time of venepuncture significantly decreases the stress response of a stable preterm neonate, as measured by salivary cortisol levels . the secondary aim of this study is to analyse the effect of music therapy on the eeg, and vital signs of the stable preterm neonate.

Eligibility criteria:
inclusion criteria: * infants born at less than 32 weeks gestational age (from 23+0 weeks' up to and including 31+6 weeks' gestational age) * infants must now be \>32 weeks corrected gestational age * infants who are medically stable and due to have routine venepuncture as part of their management plan exclusion criteria: * inability to obtain informed consent from parent * infants with known hearing impairment * infants receiving sedative medications * any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis * infants with congenital abnormalities * infants with known eeg abnormalities

Keywords: neonate preterm pain music eeg venepuncture
egb 761 in the syndrome of mci with concomitant cvd

Conditions: Mild Cognitive Impairment; Cerebrovascular Disease

Summary: egb 761 has been demonstrated to be useful in improving cognitive and global clinical outcomes in patients with cognitive impairment or dementia, when administered at a daily dosage of 240mg in randomised controlled trials through several neuroprotective mechanisms of action. the study aims to determine the efficacy and safety profile of egb 761 as a prescribed clinical drug for patients with mci + cvd.

egb 761 has been demonstrated to be useful in improving cognitive and global clinical outcomes in patients with cognitive impairment or dementia, when administered at a daily dosage of 240 mg in randomised controlled trials through several neuroprotective mechanisms of action. the study aims to determine the efficacy and safety profile of egb 761 as a prescribed clinical drug for patients with mci + cvd. this study is an open label 52-weeks study in subjects who have both mci (based on the petersen criteria and albert ms criteria) and cvd. eligibility for enrolment will be assessed initially at a screening visit, which is to occur within 42 days of baseline. 134 male and female subjects will participate and 67 of the 134 will receive the drug. subjects will be randomized to the egb 761 arm and control arm in a 1:1 ratio using a block randomization method in groups of 4 subjects using an automated randomization software. the study will allow generating data in an asian and multi-racial population and allows physicians to offer clinically efficacious and alternative treatment for patients with mci + cvd.

Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with mci based on the petersen criteria and albert ms criteria * patients who have a global clinical dementia rating score of 0.5 * patients aged 45 to 85 years at study entry * patients who are literate and able to complete the cognitive evaluations in the opinion of the investigators * patients with the presence of cvd, defined as the presence of white matter hyperintensities (wmh) of fazekas grade 2 or 3 on mri brain imaging (done up to 12 months prior to recruitment) or ct scans for patients contraindicated from mri scans * patients who provide written informed consent to participate in the study exclusion criteria: * participants should not be receiving antidepressants, antipsychotics, benzodiazepines, acetylcholinesterase inhibitors or nmda antagonists during the study. additionally, contraindications for egb 761 as given in the local prescribing information/summary of product characteristics (smpc) should be observed.
prevention of scoliosis in patients with duchenne muscular dystrophy using portable seat device

Conditions: Scoliosis Neuromuscular; Duchenne Muscular Dystrophy; Lordosis Lumbar

Summary: this study will be conducted without blind method. the portable seat device devised to maintain lumbar lordosis will be made within 1 year after the loss of ambulation in the participants with duchenne muscular dystrophy with prospective design. in the control group, the presence of scoliosis will be calculated 5 years after the loss of ambulation in participants with duchenne muscular dystrophy through analysis of retrospective medical records who had not been applied the portable seat device.

in the retrospective data of seoul national university children's hospital, the incidence of 5-year scoliosis in the control group in the past using steroids alone was 70% in patients with confirmed duchenne muscular dystrophy. when applying the portable seat device (experimental group), the incidence of scoliosis is expected to decrease to 50% (ie, 35% because of 50% of 70%) compared with using steroid alone. in this study, investigators will enroll 70 control subjects who did not use the portable seat device through retrospective data. the number of subjects required to show the difference between the significance level of 5% and the power of 80% was 19, and 28 participants with dmd are required considering 30% dropout rate.

Eligibility criteria:
inclusion criteria: * patients with the diagnosis of duchenne muscular dystrophy diagnosed by genetic study were included. 1. within 1 year after loss of ambulation (vignos scale 7 points or more) 2. condition without scoliosis 3. conditions that do not have physical (eg, cerebral palsy) and mental (eg, moderate or higher intellectual disability) comorbid conditions that will affect the use of postural seat device. exclusion criteria: 1. patients who do not agree to participate in this study 2. patients not taking steroids 3. patient with scoliosis
a study to evaluate the effects and safety of treatment, treatment withdrawal, followed by re-treatment with cp-690,550 in subjects with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: the primary objectives of the study are to 1) compare the efficacy responses of cp 690,550 (5 mg bid and 10 mg bid) versus placebo following 24 weeks of cp 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of cp 690,550 (5 mg bid and 10 mg bid) following 4 -16 weeks of cp 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of cp 690,550 (5 mg bid and 10 mg bid) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.


Eligibility criteria:
inclusion criteria: * 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug; * psoriasis area and severity index (pasi) score of 12 or greater, and physician's global assessment (pga) score of 3 (moderate) or 4 (severe); psoriasis covering at least 10% of body surface area; * no evidence of active or latent or inadequately treated infection with tuberculosis or other serious infections. exclusion criteria: * non-plaque or drug induced forms of psoriasis; * cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (psoralen ultraviolet a; ultraviolet b). * any uncontrolled significant medical condition.

Keywords: opt retreatment opt chronic moderate severe treatment safety treatment withdrawal retreatment retreatment withdrawal cp-690,550 psoriasis vulgaris plaque psoriasis tofacitinib xeljanz nail psoriasis jak-inhibitor oral treatment pruritus itch dlqi rebound intermittent retreat
preference tiotropium respimat study in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: in copd the patient's ability to use inhalers correctly and their preference for the inhaler are both important factors in selecting an appropriate treatment for copd. this is a cross-sectional study where satisfaction, preference and handling of two different devices such as respimat and breezhaler will be evaluated by using the validated pasapq in copd patients

purpose: study design:

Eligibility criteria:
inclusion criteria: 1. all patients must sign an informed consent consistent with international conference on harmonization - good clinical practice (ich-gcp) guidelines prior to participation in the study and conducting any study procedures. 2. adult male or female patients with chronic obstructive pulmonary disease (copd) for less than a year who follow usual clinical practice of the participant sites and who are on treatment with spiriva® respimat®, hirobriz® breezhaler® / onbrez® breezhaler® / oslif® breezhaler® for at least of 3 months but not more than maximum of 6 months before the informed consent date. exclusion criteria: 1. previously included in this study or currently participating in another interventional study. 2. visual, cognitive, or motor impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaire. 3. patients who are treated simultaneously with both respiratory medications (spiriva® respimat® and hirobriz® breezhaler® / onbrez® breezhaler® / oslif® breezhaler®).
quality of life of children/adolescents in palliative care settings

Conditions: Palliative Care

Summary: investigators will propose to each family monitored by the teams to participate in the study (children between 1 and 18 years old, families understanding and speaking a minimum of french). semi-directed interviews are organized with children/adolescents and their parents who have agreed to participate in the study. the interviews are conducted by the care teams themselves. socio-demographic data are collected.

an information letter will be distributed to the children and parents and their non opposition to their participation will be sought (or assent for the child via a written document adapted to the age) will be systematically requested. several instruments will be used by the members of the paediatric teams during their routine home or hospital visits to children and their families: the cpos (downing 2018), the kindl (generic questionnaire on quality of life validated for healthy children, erhart et al. 2009), the qollti-f v.2 (questionnaire on quality of life for parents, cohen 2007, 2015). the interviews will therefore be semi-directed interviews with children/adolescents and their parents who have agreed to participate in the study. the interviews will be conducted by the care teams themselves. in addition to the cpos, kindl and qoolti-f, socio-demographic data are collected.

Eligibility criteria:
inclusion criteria: * children/adolescents aged 1 to 18 years with a serious illness and requiring follow-up by a regional pediatric palliative care resource team and/or temporarily hospitalized. * having given his non-opposition to his participation. * a minor of whom at least one of the two holders of parental authority has given his or her consent to the participation of their child. * child of whom one of the two holders of parental authority has himself agreed to participate in the study. exclusion criteria: * children/adolescents at the end of life (imminent death foreseeable). * children/adolescents and their parents who do not understand french. * child or parent under legal protection (guardianship, curatorship).

Keywords: child parents quality of life