Kornimate/medical-research-clean huggingface dataset:
improved discrimination of central and obstructive apnoeas in infants

Conditions: Central And Obstructive Apnoeas In Infants

Summary: referral of infants to the respiratory sleep disorders breathing team with apnoeas \[pauses in their breathing\] and apparent life-threatening episodes are frequent. while the majority of such episodes do not have a significant underlying problem a potentially life threatening condition accounts for a significant proportion of cases. in order to fully assess an infant, a full-scale overnight polysomnography study would be required. unfortunately due to the complexity of such studies and because the equipment is generally fully booked for many weeks ahead it is extremely difficult to arrange timely assessment. hence, currently, we are largely reliant on simple screening with pulse oximetry (measuring oxygen levels in the blood with a simple probe). this is able to identify potentially significant problems, but it is does not help to determine whether this is because the baby simply stops breathing for a period due to disturbance of its control of breathing, or whether it is experiencing obstructive episodes, for which there are a number of causes. this new equipment to be assessed would potentially provide a simple, robust means of undertaking definitive studies simply and effectively on the medical wards with assessment of chest and abdominal wall movement being linked to pulse oximetry. this is likely to provide a substantial and significant improvement on our current practice. the benefits will be that, for those with no significant underlying problems, we will be able to provide much greater reassurance for the parents, which is clearly very valuable, while in those with a problem we will be able to distinguish those with central or obstructive apnoea with a degree of certainty that will greatly streamline further assessments and treatment.


Eligibility criteria:
inclusion criteria: •infants between 36 weeks post conception and one year old referred to the respiratory and sleep team for central or obstructive apnoea or apparent life threatening events. exclusion criteria: •chest wall deformity on injury that precludes the use of the volusense paediatric device.
functional outcomes of a criterion-based rehabilitation protocol for acl reconstruction in amateur athlete

Conditions: Knee Ligament Injury; Anterior Cruciate Ligament Injuries

Summary: although current rehabilitation protocols following anterior cruciate ligament reconstruction (aclr) are based on the graft remodeling process, there is uncertainty about its time schedule. moreover, there are individual differences in neuromotor learning and flexibility after aclr. this study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following aclr. although current rehabilitation protocols following anterior cruciate ligament reconstruction (aclr) are based on the graft remodeling process, there is uncertainty about its time schedule. moreover, there are individual differences in neuromotor learning and flexibility after aclr. this study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following aclr.


Eligibility criteria:
inclusion criteria: * amateur male athletes who underwent aclr surgery with an autologous hamstring (hs) graft. * ranging in age from 18 to 35 years. * underwent a pre-operative rehabilitation program with minimal knee effusion, full extension, good patellofemoral mobility * ability to actively control the quadriceps. exclusion criteria: * aclr with any graft other than a hamstring graft * acl revision surgery * associated medial or lateral ligamentous injuries * previous meniscectomy or meniscal repair * simultaneous meniscectomy or meniscus repair with the aclr * cartilage damage.
pcle for the diagnosis of cancer in unknown bile duct stricture

Conditions: Cholangiocarcinoma; Bile Duct Inflammation

Summary: this study will collect data from patients undergoing an ercp procedure with probe-based confocal laser endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate the diagnostic performance of pcle for the diagnosis of indeterminate biliary stricture when associated with other diagnostic information (standard ercp and tissue sampling).

this trial aims at evaluating the performance diagnosis of pcle for the detection of bile duct cancer, in patients with indeterminate biliary stricture when associated with other diagnostic information. the hypothesis is that ercp with cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ercp alone or ercp with tissue sampling, by improving the sensitivity of detection and by providing a real-time diagnosis. direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary duct lesions will be compared for the combination of ercp alone, endomicroscopy plus ercp imaging, and ercp plus endomicroscopy plus tissue sampling. these information will be reviewed retrospectively by a second physician. these presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). secondary objectives include collecting patient management recommendation. yet, effective management recommendation is left as the discretion of the physician.

Eligibility criteria:
inclusion criteria: * male or female \> 18 years of age * indicated for ercp for indeterminate bile duct stricture * referral patients with indeterminate biliary stricture coming in for first ercp procedure at referral institution or * patients who had previous non-diagnostic tissue sampling (brushing biopsies or eus-fna) taken during a previous ercp or eus-fna for an indeterminate biliary stricture * willing and able to comply with study procedures and provide written informed consent to participate in the study exclusion criteria: * subjects for whom ercp procedures are contraindicated * known allergy to fluorescein dye * patients suffering primary sclerosing cholangitis or chronic pancreatitis. * patients with post-transplant stricture * if female, pregnant based on a positive hcg serum or an in vitro diagnostic test result or breast-feeding
clopidogrel use and long-term safety after drug-eluting stents implantation

Conditions: Coronary Artery Disease

Summary: the purpose of zest-late (evaluation of the long-term safety after zotarolimus-eluting stent, sirolimus-eluting stent, or paclitaxel-eluting stent implantation for coronary lesions - late coronary arterial thrombotic events) trial is to assess the relationship between long-term clopidogrel use beyond 1 year and long-term rates of death or mi after des implantation and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

prospective, two arms, open-labeled, randomized multi-center trial of approximately 2,000 patients enrolled at 19 centers in korea. among all patients enrolled in the zest (comparison of the efficacy of zotarolimus-eluting stent versus sirolimus-eluting stent versus paclitaxel-eluting stent for coronary lesions) trial, event-free patients who survived the first 12 months without nonfatal mi or repeat revascularization will be randomized to discontinue clopidogrel therapy at 12 months after des implantation. all patients will be followed for another 12 months.

Eligibility criteria:
inclusion criteria: 1. among the participants in the zest trial, event-free patients who survived the first 12 months without nonfatal mi or repeat revascularization 2. the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: 1. contraindication to antiplatelet therapy 2. non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). 3. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 4. bleeding diathesis 5. recent stroke within 6-months 6. concurrent organ damage (creatinine level \> 2.0mg/dl or ast and alt \> 3 times upper normal reference values) 7. patients with left main stem stenosis (\>50% by visual estimate)

Keywords: stent antiplatelet therapy
silver diamine fluoride after minimal caries removal technique in asymptomatic young permanent teeth with deep caries

Conditions: Deep Caries

Summary: this study is comparing between the silver diamine fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex

the study will be carried on young permanent molars with open apices \& with deep caries. incomplete caries removal and application of indirect pulp capping materials where silver diamine fluoride (group i) will be compared with glass ionomer only (group ii). then final restoration with composite resin for both groups. children will be followed up for 9 months.

Eligibility criteria:
inclusion criteria: 1. patients free from any systematic diseases. 2. young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed. 3. absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility) 4. the absence of clinical symptoms of irreversible pulpitis. 5. absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption). 6. compliant patient/ parent. exclusion criteria: 1. teeth with previous restorative treatment. 2. unrestorable teeth. 3. uncooperative patients.
study of the effect of mometasone furoate/formoterol (mf/f), montelukast and beclomethasone dipropionate (bdp) on plasma cortisol levels of children 5-11 years old with persistent asthma (p05574)

Conditions: Asthma

Summary: the purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.


Eligibility criteria:
inclusion criteria: * diagnosis of persistent asthma of ≥6 months duration * body weight ≥18 kg * able to discontinue prescribed inhaled corticosteroid (ics) or ics combined with long-acting beta-agonist (laba) before starting study medication * use of a low or medium daily dose of ics (either alone or in combination with a laba) with no use of oral corticosteroids within 3 months prior to screening visit * stable asthma regimen (daily dose unchanged) for ≥2 weeks prior to screening visit * documented positive responsiveness to bronchodilators * ability to use a peak flow meter correctly and to perform spirometry and pef measurements * ability to use an inhaler correctly * consent/assent for the trial and for pharmacogenetic testing (note: if unwilling to consent/assent for pharmacogenetic testing, inclusion in the study is still allowed, but no pharmacogenetic samples will be obtained.) exclusion criteria: * use of a high dose of ics for ≥30 days within 6 months prior to screening visit * treatment in the emergency room (for a severe asthma exacerbation requiring systemic corticosteroid treatment) or hospitalization for management of airway obstruction within 3 months prior to screening visit * ever required ventilator support for respiratory failure secondary to asthma * upper or lower respiratory tract infection (viral or bacterial) within 2 weeks prior to screening visit * clinically significant abnormal vital sign * evidence of oropharyngeal candidiasis * history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder that may interfere with study participation. specific examples include but are not limited to insulin-dependent diabetes, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis * allergy to or intolerance of corticoids, beta-2 agonists, montelukast or any of the inactive ingredients in the medications used in this study * participation in this same study at another study site * previous randomization into this study * participation in another investigational study for the duration of this study * use of any investigational drug within one month prior to screening visit * previous participation in a study with mf/f or montelukast * direct association with or family member of one of the investigators or study staff * sibling of a participant in this study
efficacy of laser acupuncture on carpal tunnel syndrome following hand flexor tendon repair

Conditions: Laser Acupuncture; Flexor Tendon Repair; Hand Surgery; Carpal Tunnel Syndrome (CTS)

Summary: the purpose of this study is to determine the efficacy of laser acupuncture in alleviating cts symptoms following flexor tendon repair in the hand.

this study holds significant importance for clinical practice, patient care, and research. * clinical practice: it provides a potential framework for physical therapists to design targeted and effective interventions for laser acupuncture on cts following flexor tendon repair in the hand. * patient care: improved rehabilitation outcomes can enhance patients' physical functionality, independence, and overall quality of life, addressing a critical gap in post-operative complications. * research advancement: by contributing to the limited body of literature on laser acupuncture in this context, the study can stimulate further research and innovation in carpal tunnel syndrome following hand flexor tendon repair.

Eligibility criteria:
inclusion criteria: * adults aged 20-40 years who have undergone flexor tendon repair surgery. * patients who have undergone primary or secondary repair of flexor tendons in the hand at zone 4 (zone of carpal tunnel as it often be complicated by postoperative adhesions due to close quarters and synovial sheath of the carpal tunnel) (fulchignoni c et al., 2020). * surgery occurred within a specific timeframe, often within 6-12 weeks prior to inclusion (peters se, jha b, ross m., 2021). * patient have clinical and electro diagnostic evidence of cts. * all patients enrolled to the study will have their informed consent. exclusion criteria: * pre-existing neurological disorders. * systemic illnesses affecting nerve function (e.g., diabetes). * contraindications to laser therapy. * pregnancy or breastfeeding. * active infections or open wounds in the hand or wrist. * previous history of carpal tunnel release surgery or received an injection of steroid for cts. * previous history of brachial plexus injury or median nerve injury. * other severe neurological or musculoskeletal conditions. * epilepsy or any psychological disorders. * cancer. * spots over the treated points. * pacemaker or implanted devices.
nir arthroscopic fluorescence angiography of menisci

Conditions: Meniscus Rupture

Summary: this trial is an explorative single center, single-arm study to assess whether vascularization of the meniscus can be visualized intraoperatively using arthroscopic near-infrared (nir) fluorescence using icg during standard of care meniscal repair treatment.

the meniscal healing process is based on two fundamental principles: a solid primary fixation, and a well-functioning biological process of cicatrization, where the presence of vascularization is thought to play a major role. intra-operative near infrared fluorescence angiography using indocyanine green (icg) is a widely used method for operative assessment of vascularization. fluorescence guided detection of the vascularity surrounding a meniscal tear could be of great value to predict meniscal healing after repair. this pilot study will explore the technical feasibility of intraoperative near-infrared fluorescence angiography of the meniscus in patients undergoing arthroscopic meniscal repair. technical challenges for nir fluorescence arthroscopy are the visibility of the vascular perfusion in microvessels in the dense meniscus, motion artifacts encountered with arthroscopy and wash in of icg using a fluid irrigation system. the included patients will be subdivided in four equal subgroups in order to evaluate alteration of nir fluorescence signal during arthroscopy in combination with a tourniquet and/or irrigation pump system.

Eligibility criteria:
inclusion criteria: * 18 years or older; * patients with on mri confirmed zone 1 meniscal tear * patients with a clinical indication for arthroscopic meniscal repair * before patient registration, written consent must be given according to ich/gcp, national and local regulations. exclusion criteria: * prior operative treatment of the ruptured meniscus * any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient. in specific, these conditions concern smoking, diabetes and being overweight. * pregnancy * allergy to iodine, shellfish or icg; * psychological, familial sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
masked-uncontrolled hypertension management based on office bp or on out-of-office (ambulatory) bp measurement

Conditions: Masked Hypertension

Summary: master study is a 4-year prospective, randomized, open-label, blinded-endpoint study (probe) comparing 2 management strategies 1) office bp as a guide to treatment, or 2) 24-hour abp as a guide to treatment. study objectives are to investigate whether a management strategy based on out-of-office bp (ambulatory bp monitoring) versus a management strategy based on office bp measurements is associated with differences in outcome, including cardiovascular and renal intermediate end points at one year; cardiovascular events at 4 years and changes in a number of blood pressure-related variables throughout the study. patients will be followed-up during the first year focusing on changes in left ventricular mass index (lvmi, co-primary endpoint) and urinary albumin excretion (uae, albumin/creatinine ratio, co-primary end-point), and during the whole 48 month period for both changes in lvmi and uae and events including all-cause mortality, cv morbidity and mortality, cerebral morbidity and mortality.a total of 1240 subjects will be recruited by 30 centers, taking into account a dropout rate of 15% (620 subjects per randomization arm).


Eligibility criteria:
inclusion criteria: * male and female subjects * age 35-80 years * masked uncontrolled (in treatment) hypertension: office bp \<140/90 mmhg, and one or more of the following situations: * ambulatory daytime bp \>135/85 mmhg * ambulatory night-time abp \> 120/70 mmhg * ambulatory 24h abp \>130/80 mmhg * egfr ≥45 ml/min/1.73 m2 (ckd-epi creatinine equation 2009) exclusion criteria: * egfr \ 250 umol/l; * patients in unstable clinical conditions; * known secondary hypertension; * orthostatic hypotension (sbp fall \> 20 mmhg on standing); * dementia (clinical diagnosis); * hepatic disease as determined by either ast or alt values \> 2 times the upper limit of normal * history of gastrointestinal surgery or disorders which could interfere with drug absorption * known allergy or contraindications to one of the drugs to be administered in the study * history of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years * history of clinically significant autoimmune disorders such as systemic lupus erythematosus. * history of drug or alcohol abuse within the last 5 years * history of non-compliance to medical regimens and/or patients who are considered potentially unreliable * inability or unwillingness to give free informed consent * pregnancy or planned pregnancy during study period.
effects of atomoxetine on brain activation during attention & reading tasks in participants with adhd & comorbid dyslexia

Conditions: Attention Deficit Hyperactivity Disorder; Dyslexia

Summary: this study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional magnetic resonance imaging (fmri) in participants ages 10 to 16 years old with adhd and comorbid dyslexia

this is a randomized, placebo-controlled, double-blind, single site study that uses an fmri measurement to assess brain activation during attention and reading tasks and the effects of atomoxetine in reducing symptoms of adhd in participants with adhd and comorbid dyslexia. similar assessments are performed in two additional groups of participants with adhd only and dyslexia only to determine to what extent symptomatic change in the comorbid adhd \& dyslexia is achieved independently by atomoxetine effects on either condition. a healthy control group of non-adhd, non-dyslexia subjects (20) will be included to monitor practice effects \& effects of treatment that may be interpreted as normal maturation. the healthy control group will not be treated with any study medications.

Eligibility criteria:
inclusion criteria: * participants in the adhd-only or adhd+dyslexia groups must meet dsm-iv-tr criteria for adhd * participants in the dyslexia-alone group or adhd+dyslexia groups must meet criteria for dyslexia * participants must achieve a score of 80 or more on the full scale intelligence quotient * child or adolescent participants must be 10 to 16 years old * must be able to communicate in english * must be able to swallow capsules * be reliable to keep appointments for clinic visits \& all related tests * participants for healthy control group do not meet dsm-iv-tr criteria for adhd and/or dyslexia * participants for healthy control group must achieve a score of at least 80 but not \>120 on the full scale intelligence quotient exclusion criteria: * participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg. * participants with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions * participants with prior diagnosis of bipolar i or bipolar ii disorder or psychosis * participants with documented history of autism, asperger's syndrome, or pervasive developmental disorder * females who are pregnant or breastfeeding * participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks