Kornimate/medical-research-clean huggingface dataset:
tear film stability of dailies® aquacomfort plus® contact lenses vs. myday® daily disposable contact lenses

Conditions: Refractive Error

Summary: the purpose of this study is to evaluate tear film stability of dailies® aquacomfort plus® (dacp) compared to myday® after 12 hours of lens wear.


Eligibility criteria:
inclusion criteria: * must sign an informed consent form; * adapted, current soft contact lens wearer; * required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (d)); * cylinder ≤ -1.00 d in both eyes at visit 1; * vision correctable to 0.1 logarithm of the minimum angle of resolution (logmar) or better in each eye at distance with pre-study lenses at visit 1; * willing to wear study lenses up to 12 hours and attend all study visits; * able to be successfully fitted with study lenses; * unstable tear film with a nik-but value below 13 seconds in either eye without lenses; * other protocol-defined inclusion criteria may apply. exclusion criteria: * any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; * use of artificial tears and rewetting drops during the study; * monocular (only 1 eye with functional vision) or fit with only 1 lens; * any abnormal ocular condition observed during visit 1; * history of herpetic keratitis, ocular surgery, or irregular cornea; * pregnant or lactating; * participation in any clinical study within 30 days of visit 1; * current myday® or dailies® aquacomfort plus® lens wearer; * other protocol-defined exclusion criteria may apply.

Keywords: dacp dailies® aquacomfort plus tear film stability nik-but
urinary symptoms after posterior tibial nerve stimulation

Conditions: Posterior Tibial Nerve Stmulation

Summary: overactive bladder (oab) is a common syndrome affecting 7 million people in france, very often of idiopathic origin. current therapeutic management of oab primarily involves hygiene and diet rules, patient education, behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation. however, the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness. in the event of persistent symptoms, the management of oab is essentially based on the prescription of an anticholinergic medication. the effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses. but the side effects of anticholinergics are known and some are very common (particularly dry mouth and constipation). the principle of the posterior tibial nerve stimulation (tns) by implanted (percutaneous) or adhesive (transcutaneous) electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder. posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session. tns is also possible transcutaneously (tens) with daily 20-minute stimulation of the ankle, in the form of a self-administered treatment at home, over a period of 3 months. this treatment modality seems equivalent to the percutaneous approach. given its numerous advantages, the use of tens is therefore expanding, and is currently recommended by many learned societies (sifud, afu). in this study, we wish to evaluate the tensi+ medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder.


Eligibility criteria:
inclusion criteria: * women over 18 * patients who have benefited from treatment with the tensi+ device in the context of overactive bladder * intervention between april 2023 and february 2024 * person having expressed his non-opposition exclusion criteria: * inability to understand the information given * person deprived of liberty * person under guardianship

Keywords: overactive bladder posterior tibial nerve stmulation
multidisciplinary approach to improve diabetic foot care: an investigation of clinical and economic outcomes.

Conditions: Multidisciplinary Approach; Clinical Pharmacists; Diabetic Foot Ulcer (DFU); Multidisciplinary Care Team; Diabetes; Economic Outcomes

Summary: the study intervention was applying multidisciplinary approach consisting of an endocrinologist, a diabetes specialized nurse, and a clinical pharmacist to assess and improve diabetic foot care using a systematic screening, patients' risk categorization, therapy optimization, and tailored education.

this is a single-blinded randomized controlled trial (rct) study involving diabetic patients with (t1dm) and (t2dm) attending endocrine/diabetes, as well as, diabetic foot specialized surgery clinics for routine follow-ups at jordan university hospital (juh) between 17 july 2022 and 30 dec 2022. the study evaluated the impacts of multidisciplinary approach in improving diabetic foot care. the clinical pharmacist role was to assess disease control, and to identify patients' therapeutic and educational needs through well-structured three months follow-up interviews with patients and/or their family members. moreover, the study investigated the impacts of multidisciplinary approach on health-related quality of life (qol) at baseline and at the end of the study. economic outcomes were also investigated relating to hospitalizations, length of stay, and cost of treatments. the control group received standard care by hospital staff.

Eligibility criteria:
inclusion criteria: * aged above 18 years old. * diabatic patients with t1dm and t2dm attending endocrine/diabetic and/or diabetic foot specialized surgery clinics for routine follow-ups at jordan university hospital (juh). * diabetic patients with or without previous diabetic foot ulcers (dfus) and/or amputation. exclusion criteria: * patients who were attending the clinics at the time of recruitment with active diabetic foot lesions and/or ulcers. * patients who were taking corticosteroid medications. * patients who were admitted to the hospital (inpatient admissions). * pregnant women attending gestational dm clinics. * patients with cognitive impairments and/or incapable to provide consent.

Keywords: multidisciplinary approach clinical pharmacists jordan jordan university hospital diabetic foot ulcer (dfu) multidisciplinary team diabetes economic outcomes
blinatumomab in pediatric b-cell acute lymphoblastic leukemia (all) with minimal residual disease (mrd)

Conditions: Pediatric ALL, B Cell; Minimal Residual Disease

Summary: this is a single-arm, open-label, multi-center phase i study using blinatumomab for pediatric b-cell acute lymphoblastic leukemia patients with positive of minimal residual disease. 1 cycle of blinatumomab treatment followed by hematopoietic stem cell transplantation. blinatumomab has approved to treat adults and children with b-cell precursor all who are in remission but still have mrd. however, data on the effects and safety of blinatumomab in children with b-precursor all with mrd positive are insufficient.


Eligibility criteria:
inclusion criteria: * immunophenotypic evidence of cluster of differentiation 19 (cd19) positive b precursor all * age \<18 years at the time of informed consent/assent * b cell precursor all in first or later hematologic complete remission (cr) defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks * persistent or recurrent mrd ≥10\^-4 in an assay with a minimum sensitivity of 10\^-5 before hematopoietic stem cell transplantation * bone marrow function as defined below: absolute neutrophil count ≥1,000/μl, platelets ≥50,000/μl (transfusion permitted), hemoglobin level ≥9 g/dl (transfusion permitted) * renal and hepatic function as defined below: aspartate aminotransferase (ast), alanine aminotransferase (alt), and alkaline phosphatase (ap) \< 2 x upper limit of normal (uln), total bilirubin \<1.5 x uln, creatinine clearance ≥ 50 ml/min * negative hiv test, negative hepatitis b (hbsag) and hepatitis c virus (anti-hcv) test * negative pregnancy test in women of childbearing potential exclusion criteria: * presence of circulating blasts or current extramedullary involvement by all * history of relevant central nervous system (cns) pathology or current relevant cns pathology (e.g. seizure, epilepsy, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis) with the except of cns leukemia that is well controlled with intrathecal therapy * current infiltration of cerebrospinal fluid by all * history of or active relevant autoimmune disease * systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis) * radiotherapy within 4 weeks prior to study treatment * autologous hematopoietic stem cell transplantation (hsct) within six weeks prior to study treatment * therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment * treatment with any investigational product within 4 weeks prior to study treatment * known hypersensitivity to immunoglobulin or to any other component of the study drug formulation * active malignancy other than all with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix * active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
immediate effects of the hvla talocrural distraction technique in soccer players

Conditions: Ankle Injury; Plantar Pressure

Summary: this clinical trial aims to evaluate the effect of a high-speed, low-amplitude physiotherapy technique at the ankle level, when performed on amateur soccer players.

in this randomized, single-blind, cross-sectional and prospective clinical trial, the effect on ankle mobility and changes in plantar pressure centers obtained after performing a high-velocity, low-amplitude physiotherapy technique in amateur soccers will be assessed. two intervention groups are used; in one of them this treatment will be applied in a real way, and in the other one a simulation will be carried out.

Eligibility criteria:
inclusion criteria: * men over 18 years old * men that played or have played soccer as an amateur or professional on a regular basis * no previous musculoskeletal history that would contraindicate hlva techniques (recent fractures, osteosynthesis material placed in the joint, infections...) exclusion criteria: * subjects under 18 years old * subjects who have suffered musculoskeletal pathology in the lower limb that contraindicates manipulation or who have a medical diagnosis of chronic ankle instability * subjects who suffer neurological or cognitive alterations that prevent the understanding of questionnaires or physical tests; and those who have not signed the informed consent documents

Keywords: ankle manual therapy plantar pressure center mobility
16w interventional study on titration and dose/efficacy assessment of exelon in chinese alzheimer's disease patients

Conditions: Alzheimer's Disease

Summary: to investigate the efficacy of exelon capsule at maximal tolerated dose in mild to moderate chinese ad patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration


Eligibility criteria:
key inclusion criteria: * have a diagnosis of dementia of the alzheimer's type according to the dsm-iv criteria and have a clinical diagnosis of probable ad according to nincds/adrda criteria * mmse score of ≥ 10 and ≤ 26 * the treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine a, or memantine at least 2 weeks * be in stable medical condition * have signed off informed consent form by patients or his/her legal guardian key exclusion criteria: * severe ad * patients with a history of cerebrovascular disease, active or uncontrolled epilepsy, active hypothyroidism, asthma, cns infection, other neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition * attending other clinical trials or taking other clinical trial drugs * a score of \> 4 on the modified hachinski ischemic scale (mhis); * patients who is using any achei or memantine

Keywords: alzheimer's disease ena713 chinese patients instinct
the effect of physiotherapy on dysfunctional breathing in children and adolescents with and without asthma

Conditions: Dysfunctional Breathing; Asthma in Children; Asthma

Summary: the purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma. children and adolescents with dysfunctional breathing, are invited to participate in the intervention study. participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. participants are followed a year after the intervention, to compare the development in asthma control ( if asthma) and quality of life.

the purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma. all children and adolescents aged 10-17 years, followed in our outpatient clinic with the diagnose of asthma are invited to fulfill the nijmegen questionnaire (nq) and the asthma control questionnaire (acq5) children and adolescents where asthma was investigated and ruled out are invited to fulfill the nq. data from the electronic patient journal are used as descriptives. participants with dysfunctional breathing (nq \>= 23) are invited to participate in the intervention study. participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. participants are followed a year after the intervention, to compare the development in asthma control measured by acq5 (if asthma) and quality of life measured by pedsql. the effect of physiotherapy is analyzed separately for participants with and without asthma. in addition, primary outcomes are analyzed in a regression model with asthma status, age and sex as explanatory variables.

Eligibility criteria:
inclusion criteria: asthma group: * asthma diagnosed by lung function tests and/or typical symptoms. * treatment with inhaled corticosteroids in minimum 3 months. * acq5 \>= 1.5. * nq \>= 23. nonasthma group * asthma denied after lung function tests ( exercise challenge or mannitol challenge) * nq \>= 23. exclusion criteria: * other significant cardiopulmonary or muscoluskeletal conditions. * complex functional conditions involving other organ systems. * patients who already had the physotherapeutical intervention before study start.

Keywords: dysfunctional breathing asthma in children asthma in adolescents physiotherapy
effects on in-game decision making processes

Conditions: Athletic Injuries

Summary: this study aims to investigate the effects of analytical thinking skills and reaction speed on performance in female football players.

this study aims to investigate the effects of analytical thinking skills and reaction speed on performance in female football players.

Eligibility criteria:
inclusion criteria: * accepting the voluntary basis * to be between the ages of 18-35 * to take part in professional football clubs * not having suffered any serious injury in the last 6 months * to be able to participate in the tampa kinesiophobia scale * to be able to actively participate in technology-based tests such as decision-making simulations and blazepod exclusion criteria: * not accepting the voluntary basis * individuals who have had a surgical procedure in the last six months * use of nsaids and similar disease modifying drugs in the last month (diaserein, glucosamine etc.)

Keywords: exercise
exploration of immune response to early pcv13 vaccination in conjunction with autologous transplant

Conditions: Multiple Myeloma

Summary: there is no study hypothesis. the purpose of this study is to see if the pneumococcal conjugate vaccine (pcv13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.

this is a pilot study to determine the safety of pcv13 administered to patients with myeloma before and at +7-10 days and +21-24 days after autologous hematopoietic stem cell transplant; and,to quantify the immune response induced by pcv13 vaccination in patients with myeloma when administered before and early after autologous psct.

Eligibility criteria:
inclusion criteria: * patients with confirmed multiple myeloma * eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant exclusion criteria: * pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine * hiv infection confirmed by nucleic acid testing (nat), as evaluated during pre transplant testing * common variable immunodeficiency or other inherited systemic immunodeficiency syndrome * active central nervous system (cns) malignancy * prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy. * history of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 (pcv7), pcv13, or any diphtheria-toxoid containing vaccine. * inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation * patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician * active or uncontrolled infection * diffusing lung capacity oxygenation (dlco) \<50 % * left ventricular ejection fraction (lvef) \<40% * bilirubin \>2

Keywords: autologous transplant multiple myeloma
gestational diabetes mother-infant cohort

Conditions: Gestational Diabetes Mellitus in Pregnancy; Cognitive Impairment; Cohort Study

Summary: the bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. the study investigated the results of blood glucose screening during pregnancy for the children's mothers, and followed up on the blood glucose management effectiveness of pregnant women with abnormal blood glucose levels before delivery. participants will be also surveyed the "s-s method for language development assessment, "gsell scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate the language development and family nurturing environment.

glucose management during pregnancy and the postnatal nurturing environment are keys to early detection and early intervention of language delay, which is important to reduce abnormal language development in children. in this study, mothers diagnosed with gestational diabetes mellitus in the department of hospital and offspring were used as participants. the investigators take a follow-up visit to participants' offspring using the s-s method of language development assessment, gsell infant and toddler development scale, and 0-6 years old family parenting environment evaluation scale. the bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.

Eligibility criteria:
inclusion criteria: * children 1.5-2.5 years old with no serious underlying diseases and no hearing impairment. exclusion criteria: * diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy; * neurological and hereditary metabolic diseases; (iv) deaf father/mother.

Keywords: child cognitive impairment intrauterine high-glucose environment acquired nurture environment
mri in diagnosing prostate cancer

Conditions: Prostate Cancer

Summary: rationale: diagnostic procedures, such as magnetic resonance imaging (mri), may help find prostate cancer and learn the extent of disease. purpose: this clinical trial is studying the safety of mri and to see how well it works in diagnosing prostate cancer.

objectives: * to determine the ability of multiparametric magnetic resonance imaging (mp-mri) to identify men who can safely avoid unnecessary biopsy. * to assess the ability of the mp-mri-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (trus) biopsy. * to estimate the cost-effectiveness of an mp-mri based diagnostic pathway. outline: this is a multicenter study. patients undergo multiparametric magnetic resonance imaging (mri) (t2-weighted imaging, diffusion-weighted mri, and dynamic contrast-enhanced mri) followed by template prostate mapping and transrectal ultrasound biopsy. some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. samples are banked for future research analysis. patients complete a quality-of-life questionnaire (eq-5d) at baseline, during, and after completion of study. an economic analysis will be performed for cost-effectiveness. after completion of study intervention, patients are followed up periodically.

Eligibility criteria:
disease characteristics: * men at risk of prostate cancer who have been advised to have a prostate biopsy * suspected stage ≤ t2 on rectal examination (organ confined) * serum psa ≤ 15 ng/ml within the past 3 months patient characteristics: * fit for general/spinal anesthesia * fit to undergo all protocol procedures including a transrectal ultrasound * no evidence of a urinary tract infection or history of acute prostatitis within the past 3 months * no contraindication to mri (e.g., claustrophobia, pacemaker, or estimated gfr ≤ 50) * no other medical condition precluding procedures described in the protocol prior concurrent therapy: * no prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable) * no prior hip replacement surgery

Keywords: stage i prostate cancer stage iia prostate cancer stage iib prostate cancer
utility and validity of a high-intensity, intermittent exercise protocol

Conditions: Fatigue

Summary: the purpose of this study is to identify an exercise-induced fatigue protocol to mimic central and peripheral acute fatigue effects associated with participation in vigorous dynamic sports activities and to understand the expected central (cardiovascular) and peripheral (muscular) impact of this protocol.

fatigue-related parameters (borg, heart rate, blood lactate level, concentric/eccentric force of the quadriceps muscle) will be measured before and after different short-term high-intensity, intermittent exercise protocols.

Eligibility criteria:
inclusion criteria: * men * ≥ 18 years * volley- and basketball, non-elite * ≥ 3 times per week sports participation * no acute or overuse low back/lower extremity injuries in the past 6 months exclusion criteria: * women * \<18 years * \>45 years * other sports than volley- and basketball * elite players * \<3 times per week sports participation * acute or overuse low back/lower extremity injuries in the past 6 months