Kornimate/medical-research-clean huggingface dataset:
reach for health study: obesity-related mechanisms and mortality in breast cancer survivors

Conditions: Breast Neoplasms

Summary: this objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. the reach for health study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. after completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. the intervention was powered on the main effects and the planned analyses are to compare: metformin to placebo and a separate comparison of lifestyle intervention to control. the interventions will last for 6 months. concentrations of circulating biomarkers will be assessed at baseline and 6 months.


Eligibility criteria:
inclusion criteria: * bmi at least 25.0 kg/m2 * diagnosed with stage i, ii, or iii breast cancer within past 5 years * treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation * not scheduled for or currently undergoing chemotherapy * accessible geographically and by telephone * able to communicate dietary and physical activity data via telephone * if taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period * post-menopausal at diagnosis exclusion criteria: * preliminary bloodwork outside of specified ranges * evidence of renal insufficiency, liver disease, or congestive heart failure * currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams) * recent initiation (\< 3 months ago) of thiazides or β-blockers * taking insulin or other antidiabetic drug * other primary or recurrent invasive cancer in past 10 years * unable to commit to study requirements

Keywords: obesity survival weight loss metformin biological markers
avad: asthma with small airways dysfunction

Conditions: ASTHMA

Summary: the aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction. the objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction.


Eligibility criteria:
general inclusion criteria: * man or woman * age ≥ 18 years * asthma * inform consent signed * affiliated to health insurance specific inclusion criteria : asthma with proximal airways obstruction group * maximal voluntary ventilation (mmv)\<80% * mmv / forced vital capacity (fvc)≤70% * carbon monoxide transfer coefficient (kco)\>80% specific inclusion criteria : asthma with small airways dysfunction group * maximal voluntary ventilation (mmv)≥80% * mmv / vital capacity(vc)\>70% * carbon monoxide transfer coefficient (kco)\>80% general exclusion criteria: * pregnant woman or breastfeeding * patient participating to other biomedical research * patient who have participated to other biomedical research within the past 3 months * patient refusing to sign the inform consent specific exclusion criteria : * patient who stopped smoking since less than 12 months * pathological state related to obstructive distal airway damage * broncho-pulmonary infectious disease within the past 4 weeks * solid tumor curated by chemotherapy or chest radiotherapy * chronic respiratory disease * asthma exacerbation within the past 3 months * oral or systemic corticotherapy within the past 3 months

Keywords: asthma phenotype small airway proximal dysfunction
post approval study to evaluate the trulign™ toric posterior chamber iol

Conditions: Cataract

Summary: to evaluate the incidence of iol vaulting (ie, position change) of the trulign™ toric iol following cataract surgery.

the objective of this post approval safety study is to evaluate the incidence of iol vaulting (ie, position change) of the trulign™ toric iol following cataract surgery at up to three years post implantation.

Eligibility criteria:
inclusion criteria: * subjects who are able and willing to comply with the follow-up schedule * subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction * subjects must require a lens power from 4 to 33 d * subjects must have a best corrected visual acuity (bcva) equal to or worse than 20/40, with or without a glare source exclusion criteria: * subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery * subjects with associated ocular conditions which could affect the stability of the iol * subjects with clinically significant irregular corneal astigmatism in the study eye
automated surveillance, alert, and rapid diagnosis of thrombotic microangiopathies: the asard-tma study

Conditions: Thrombotic Microangiopathies

Summary: recently a pilot study was conducted to evaluate the impact of an electronic alert (e-alert) triggered by the automated algorithm in the efficiency and rapidity in tma patients' identification in our university hospital a. gemelli over 12 months.the tma diagnostic algorithm has been implemented in the laboratory software of the hospital and applied whenever a patient in the emergency ward or any other department undergoes blood tests that include platelet count and lactate dehydrogenase. the basic profile in the emergency ward always has these two parameters. the algorithm automatically identifies patients with a predicted probability of tma \>90% (6); if this criterion is associated with a platelet count\<100 x 109/l, an automated warning to the hematologist on-call is issued with an sms, and the patient enters the tma diagnostic process defined in the diagnostic and treatment pathways (percorso diagnostico e terapeutico assistensiale, pdta). the on-duty hematologist urgently evaluates the patient for whom a warning has been issued, relating with the clinician(s) of the ward in which the patient is located. if the suspicion of tma is confirmed, the diagnostic procedures outlined in the pdta are performed, with the immediate execution of 2nd level tests. if the on-duty hematologist considers the diagnosis of ahus possible, they contact the on-call nephrologist directly for immediate diagnostic investigation and specific urgent therapeutic measures, as needed. the tma-expert hematologist and/or tma-expert nephrologist is notified as soon as possible by the on-duty hematologist of all cases, both highly suspected and uncertain, and follow up all patients to complete the diagnostic workup to confirm or rule out the diagnosis and implement the appropriate clinical measures. therefore, the treatment in smaller hospitals that do not have a 24-hour hematological guard service available and the same awareness for tma. the present study aims to validate these results by testing the system in a multicenter study involving centers with different availability of the hematologist and awareness for tma.


Eligibility criteria:
inclusion criteria: patients admitted to the emergency ward or inpatients of the involved hospitals with suspicion of tma: * based on the clinical evaluation of the care physicians * based on the alerts issued by the automated algorithm exclusion criteria: * patients with a predictive probability of tma \< 90% (6) according to the diagnostic algorithm
effects of dry needling using spinal and peripheral sites versus peripheral sites only

Conditions: Plantar Fasciitis; Achilles Tendinitis; Patellofemoral Pain Syndrome

Summary: the purpose of this study is to determine if dry needling both low back and extremity areas is more effective for reducing pain and improving strength, balance and functional performance among patients with chronic musculoskeletal conditions compared to dry needling of extremity areas only.

this study will determine if spinal and peripheral dry needling sites results in decreased pain, increased muscle strength, increased proprioception and increased functional performance among individuals with chronic musculoskeletal conditions of the lower extremities, such as plantar fasciitis, achilles tendinopathy, and patellofemoral pain syndrome. specific aims are to determine if individuals with chronic musculoskeletal conditions of the lower extremities receiving dry needling to both spinal and peripheral sites exhibit differences in pain, muscle strength, proprioception, and unilateral hop test scores compared to individuals with chronic musculoskeletal conditions of the lower extremities receiving dry needling to peripheral sites only.

Eligibility criteria:
inclusion criteria: * unilateral chronic lower extremity musculoskeletal condition * ability to perform a unilateral one-quarter squat on involved side without pain * asymptomatic during walking exclusion criteria: * history of systemic neurological or arthritic condition * history of bony or peripheral nerve trauma or surgery lower extremities * no contraindications to dry needling * not currently receiving treatment for the chronic lower extremity musculoskeletal condition

Keywords: orthopedics
effectiveness of arginin and potassium nitrate dentifrices in dentin hypersensitivity therapy

Conditions: Dentin Sensitivity

Summary: introduction: dentin hypersensitivity (dh) could be defined as a brief and sharp pain in response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to any dental condition or pathology. multiple therapies for the treatment of dh have been studied, including equivocal evidence about the efficacy of potassium nitrate salts and recent investigations a promising new 8% arginin dentifrice. aim: the aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm sodium monofluorophosphate (d1) and 5% potassium nitrate/2500ppm sodium fluoride (d2) dentifrices in the treatment of dentin hypersensitivity. methods: parallel-design, double-masked, randomized controlled clinical trial. fifty healthy volunteers aged 18 to 70 years who attend at the faculty of dentistry , university of chile, with dh and a visual analog scale (vas) score ≥4 at least in two anterior and/or premolar teeth, will be selected and randomized into two treatment groups: t1 (n=25): 8% arginine/1450 ppm sodium monofluorophosphate dentifrice (d1); and t2 (n=25): 5% potassium nitrate/2500 ppm sodium fluoride dentifrice (d2). environmental, dietary and oral hygiene habits will be recorded in a clinical chart, while o´leary plaque index and dentin hypersensitivity (dh) measurements will be clinically assessed, at baseline, 4 and 8 weeks. dh will be evaluated through the mean vas value in response to evaporative and thermal stimuli at baseline, 4 and 8 week follow-up. the data will be analysed through stata® v11 program.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years * dentin sensitivity in at least 2 teeth (incisors, cuspids and/or bicuspids) with a vas score ≥4 * good general health exclusion criteria: * defective or extensive restorations, deep dental caries, pulpitis, chipped teeth, * bridgework, dentures or crowned teeth that could interfere with the evaluation of hypersensitivity * pregnancy or lactation * ongoing treatment with anti-inflammatory or sedative drugs * systemic conditions that are etiologic or predisposing to dentine hypersensitivity, like chronic acid regurgitation * ongoing periodontal therapy or periodontal surgery in the preceding 3 months * allergic responses to the dentifrices * hypersensitivity treatment in the preceding 3 months

Keywords: dentin sensitivity arginin potassium nitrate dentifrice rct
durable effect of pcsk9 antibody compared with placebo study

Conditions: Hypercholesterolemia

Summary: to evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (sc) evolocumab (amg 145) compared with placebo when added to assigned background lipid-lowering therapy.

eligible participants with screening central laboratory low-density lipoprotein cholesterol (ldl-c) values ≥ 75 mg/dl (1.9 mmol/l) were instructed to follow national cholesterol education program (ncep) adult treatment panel iii (atp) therapeutic lifestyle changes (tlc) diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a 4-week stabilization period based upon their screening ldl-c and its distance from the individual's required goal as stipulated by their ncep atp iii risk category: 1. no drug therapy required - diet alone 2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (po) once daily (qd) 3. high dose drug therapy required - diet plus atorvastatin 80 mg po qd 4. maximal drug therapy required - diet plus atorvastatin 80 mg po qd plus ezetimibe 10 mg po qd. if the participant met entry criteria at the end of the lipid stabilization period they were randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52 weeks in addition to their background therapy.

Eligibility criteria:
inclusion criteria: * subject has provided informed consent. * fasting ldl-c ≥ 75 mg/dl and meeting the following ldl-c values on background lipid-lowering therapy: * \< 100 mg/dl for subjects with diagnosed coronary heart disease (chd) or chd risk equivalent * \< 130 mg/dl for subjects without diagnosed chd or chd risk equivalent * or on maximal background lipid-lowering therapy defined as atorvastatin 80 mg po qd and ezetimibe 10 mg po qd * fasting triglycerides ≤ 400 mg/dl exclusion criteria: * new york heart association (nyha) ii-iv heart failure, or last known left ventricular ejection fraction \< 30% * uncontrolled cardiac arrhythmia * myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke within 3 months prior to randomization, type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes * uncontrolled hypertension

Keywords: cholesterol high cholesterol elevated cholesterol raised cholesterol
efficacy and safety of ivabradine in severe congestive heart failure

Conditions: Heart Failure, Congestive

Summary: to evaluate the effects on heart function of ivabradine administered to patients with severe chronic heart failure


Eligibility criteria:
inclusion criteria: * systolic congestive heart failure * sinus rhythm, hr \>= 80bpm exclusion criteria: * unstable cardiovascular condition
knowledge translation intervention for acl injury prevention program in youth soccer

Conditions: Anterior Cruciate Ligament Injuries; Lower Extremity Problem

Summary: anterior cruciate ligament (acl) injuries of the knee are common in youth soccer players, and show an even higher prevalence in female soccer players. clinical practice guidelines recommend acl injury prevention programs (acl-ipp) to reduce injury risk, yet implementation in amateur youth soccer is low, reducing actual real-world effectiveness. this trial is a pragmatic effectiveness trial for acl injury prevention for amateur youth soccer players, using a knowledge translation intervention with the knowledge-to-action framework.

acl injury prevention programs (acl-ipp) are exercise programs recommended by clinical practice guidelines that have been shown to reduce the risk of an acl injury. however, implementation of these programs is low, which reduces the real-world effectiveness of these programs. this project will assess a knowledge translation intervention with youth soccer programs for implementation of acl-ipps utilizing the knowledge-to-action framework. the main educational intervention will be a knowledge translation (kt) intervention between the researchers, and coaches/players of youth soccer programs within the state of michigan. specifics of the knowledge translation intervention will or may include focus groups, surveys, in-person training, video handouts, and paper handouts. this will be compared to coaches/teams that are offered a handout that describes an evidence-based acl-ipp.

Eligibility criteria:
inclusion criteria: * amateur youth soccer organizations within southern michigan. exclusion criteria: * players above the age of 19 or below the age of 14 * teams that have dedicated medical staffing
adolescent idiopathic scoliosis and proprioceptive defect

Conditions: Adolescent Idiopathic Scoliosis; Idiopathic Scoliosis; Scoliosis

Summary: this is the first clinical study to examine the spinal and peripheral proprioceptive deficits in longitudinal terms among subjects with adolescent idiopathic scoliosis.


Eligibility criteria:
inclusion criteria: * diagnosis of adolescent idiopathic scoliosis * did not receive or failed conservative treatment exclusion criteria: * spinal injury, fracture, or spinal tumour * neurological deficit * brain or spinal cord abnormality * developmental delay * psychological disorder
pulmonary tele-rehabilitation program : feasibility and safety study

Conditions: Chronic Pulmonary Disease

Summary: chronic pulmonary disease like interstitial lung disease (ild) and chronic obstructive lung disease (copd) are a significant health problem in canada and around the world. in addition to the respiratory impairment resulting to a progressive dyspnea, these diseases are also characterized by a decrease in exercise tolerance and muscle dysfunction which affect the patient's quality of life. respiratory rehabilitation is the cornerstone of the management of chronic disease and it includes a set of personalized care mainly delivered in person by a transdisciplinary team and with the objectives of reducing the symptoms felt by the participants and improving their physical and psychosocial condition. the current containment due to the covid-19 pandemic increase the sedentary behavior of patients and prevents the holding of any respiratory rehabilitation activity. in this context, tele-rehabilitation appears to be a particularly well-suited solution because it would make it possible to offer a respiratory rehabilitation in a safe and effective manner while minimizing contact with the participants. although some studies support the feasibility of this intervention, more data is needed to validate its routine clinical application. the main objective of this study is to verify the safety and the feasibility of delivering pulmonary rehabilitation treatments entirely at home via a telerehabilitation patform developed at the institut universitraire de cardiologie et de pneumologie de québec (iucpq), and document its effectiveness in people with chronic respiratory disease. the secondary objectives will be: 1) to explore the effects of a telerehabilitation programm on exercise tolerance, muscle function, functional capacity and quality of life, and 2) to assess the satisfaction of participants and health care providers with telerehabilitation.


Eligibility criteria:
inclusion criteria: * the patient already participate to the telerehabilitation program in the ppmc at iucpq

Keywords: pulmonary telerehabilitation safety feasibility interstitial lung disease chronic obstructive lung disease
premixed bioceramic putty as an apical plug in immature anterior permanent teeth

Conditions: Periapical Periodontitis

Summary: following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): group i will be treated with mta as apical plug while group ii will be treated with premixed bioceramic putty as apical plug. after working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in mta group, mta will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with gic, composite. in the premixed bioceramic putty group, well-root™ pt will be placed into the apical 4 mm of the canals. after 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. the coronal restoration will be completed with gic, composite. children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment.


Eligibility criteria:
inclusion criteria: * nonvital immature permanent teeth as a consequence of trauma or dental caries * nonvital permanent teeth with radiographic evidence of immature root end development * clinically restorable teeth exclusion criteria: * immature nonvital permanent teeth presenting with signs/symptoms of internal/external resorption, moderate to severe mobility, periodontal bone loss * immature nonvital permanent teeth associated with developmental abnormalities. * patients with a history of systemically debilitating diseases * unrestorable remaining crown structure

Keywords: immature teeth apexification apical plug
physiotherapy and deontology in the temporomandibular joint dysfunction in patients with fibromyalgia syndrome.

Conditions: Temporomandibular Joint Dysfunction Syndrome

Summary: the purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.

design: randomized clinical trial. objective: to compare the therapeutic effects of physiotherapy and deontology protocol to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and diagnostic criteria for research temporomandibular joint dysfunction in patients with fibromyalgia syndrome (fms). background: the results on physiotherapy benefits for temporomandibular joint dysfunction in patients with fms are controversial. descriptive data and intervention studies are still scarce. methods and measures: sixty patients will be randomly assigned to experimental or control group. the experimental group will receive 24 sessions (twice a week) of kinesitherapy and myofascial release protocol, whereas the control group will undergo to deontology therapy (porting a deprogramming occlusal splint every night, an average of 8 hours per day, for 12 weeks of the treatment). pain levels, impact of fms symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction will be collected in both groups at baseline and 12 weeks after 48-hr the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. baseline demographic and clinical variables will be examined between both groups independent student t-test for continuous data and χ2 tests of independence for categorical data. separate 2x2 mixed model ancovas with time (pre-post) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment on pain, function, quality of sleep,depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction as the dependent variables.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia syndrome. * agreement to attend evening therapy sessions. * a chief complaint of acute pain (duration \<6 months) in the temporomandibular joint on at least one side. * the presence of joint clicking during jaw opening that was eliminated on protrusive opening. exclusion criteria: * history of recent trauma. * therapeutic co-interventions during treatment. * indication for surgical treatment of temporomandibular joint. * edentulism. * physical or mental illness that precludes attendance at therapy sessions.

Keywords: fibromyalgia syndrome, temporomandibular joint, pain.