Kornimate/medical-research-clean huggingface dataset:
short-term effects of deep breathing and progressive muscle relaxation exercises on musculoskeletal pain and well-being in high school students

Conditions: Deep Breathing Maneuver; PROGRESSIVE MUSCLE RELAXATION EXERCISES

Summary: exam stress in high school students, long hours of studying in the static posture, and lack of physical activity habits can cause physical and psychological discomfort in them. this discomfort can be physically seen as musculoskeletal pain, while as psychologically it can be observed as a decrease in well-being. this situation can cause the acute onset of musculoskeletal pain in students to become chronic with a decrease in well-being. on the contrary, we can observe an increase in musculoskeletal pain due to stress that may occur due to a decrease in well-being. musculoskeletal pain is a condition that is not fatal but severely impairs health and well-being (1). according to the biopsychosocial model, pain occurs in a complex interaction between biological, psychological and social factors (2). therefore, pain is both a subjective experience and a physical sensation with large individual differences (3). relaxation is now a non-pharmacological intervention that has been increasingly accepted in recent years to reduce and cope with pain (4). a person who is relaxed usually has a physical and psychological well-being and feelings of calmness (5). with relaxation exercises, the person starts to reduce anxiety level by coping with stress (6). in addition to relaxation techniques, deep breathing exercise, also known as diaphragmatic breathing, is a technique based on the idea that mind and body integration provides relaxation (7). breathing exercises are easy to learn and practice and benefit can be obtained from deep breathing exercises performed in a short time (5 minutes of practice may be sufficient) (8). in studies in which both techniques were used separately, it was reported to provide physical and psychological relaxation. the unique aspect of this study is the investigation of the effects of both techniques on pain and well-being in high school students using both techniques simultaneously. for this purpose, we planned to investigate the short-term effects of deep breathing and progressive muscle relaxation exercises on musculoskeletal pain and well-being in high school students.


Eligibility criteria:
inclusion criteria: * the inclusion criteria were voluntary acceptance to participate in the exercise program with parental consent, the absence of an orthopedic, neurological or psychiatric disorder that would affect participation in exercises, and full participation in exercise sessions. exclusion criteria: * those who did not meet the inclusion criteria and did not voluntarily agree to participate in the study

Keywords: deep breathing exercises progressive muscle relaxation exercises high school students musculoskeletal pain well-being
assessment of ovarian reserve after laparoscopic cystectomy versus aspiration/electrocoagulation in the treatment of ovarian endometrioma

Conditions: Ovarian Endometrioma; Ovarian Reserve

Summary: this is a prospective, multicentric (three centers: 1: shanghai first maternity and infant hospital, shanghai, china; 2: international peace maternity and child health hospital, shanghai, china, 3: shanghai tongji hospital, tongji university school of medicine, shanghai ,china), randomized clinical trial that includes patients undergoing laparoscopic surgery for primary unilateral ovarian endometriomas. eligible patients will be subjected to transvaginal ultrasound before surgery to perform cyst classification (central type, marginal type and outcrop type). patients are divided to two group: laparoscopic cystectomy group versus laparoscopic aspiration/electrocoagulation group. biopsy samples in aspiration/electrocoagulation group and excision samples in cystectomy group are all subjected to histopathological examination. follicular stimulating hormone (fsh), anti mullerian hormone (amh) and antral follicular count (afc) will be measured pre-operative and post-operative. the aim of the study is to determine whether and to what extent the two surgical procedures for ovarian endometrioma, cystectomy and aspiration/electrocoagulation, affect ovarian reserve. the investigators intend to confirm the clinical utility of ultrasonic classification of ovarian endometrioma, fsh, amh and afc in the assessment of ovarian reserve, and to promote their use in predicting decreased ovarian reserve. the surgical excision of cystic wall, cystic fluid and peritoneal fluid will be subjected to transmission electron microscope, high resolution mass spectrometry and single-cell rna sequencing to investigate their cellular and molecular features.


Eligibility criteria:
inclusion criteria: * female with age between 18-40 years. * regular menstrual cycles * female diagnosed by ultrasound with unilateral ovarian endometrioma ≥4cm and ≤6cm. exclusion criteria: * hormone, gonadotropin-releasing hormone analogues or contraceptive therapy within 6 months before the current surgery and 6 months after surgery. * suspected or proven ovarian malignancy. * previous ovarian surgery. * evidence of polycystic ovary syndrome. * evidence of premature ovarian failure or premature menopause. * endocrinological diseases affecting ovarian reserve e.g. diabetes mellitus, hypothyroidism. * pregnancy test is positive. * lactation. * unable or unwilling to give written consent.
bilateral bispectral index, asymmetries and post-operative delirium

Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction

Summary: the primary objective of the study is to describe the value of interhemispheric asymmetry (asym), during the different intra- and peri-operative phases, in those patients who develop or do not develop post-operative delirium (pod) during the first 30 post-operative days and postoperative cognitive disfunction (pocd) in the first 90 post-operative days, in a population undergoing head\&neck and plastic surgery with a priori increased probability of pod.

values of the study variables will be extract in these specific moments (considering a delay of thirty seconds between the in vivo phenomenon and the instrument): (t1) bis probe application (t2) 60" before ga administration (t3) 60" after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation. daily follow-up for the first five post-operative days is performed in order to verify the onset of pod and a telephone follow-up at thirty and ninety post-operative days in order to verify the onset of pod / pocd. cam scale will be used for the diagnosis of pod; while for the diagnosis of pocd, 6-cit test will be used, the eq50 test in the case of tracheostomized patients.

Eligibility criteria:
inclusion criteria: -patients, undergoing head\&neck surgery, who have at least 3 of the following criteria (to establish "a priori" increased risk of pod): * age\> 70; * male sex; or asa iii; * smoker; * high blood pressure; exclusion criteria: * asa iv, v or asa ie, iie, iiie (patients with anesthetic risk asa\>iii and those undergoing urgent-emergency surgery will be excluded from the study); * past positive medical history for: * stroke; * dementia; * cerebral aneurysm; * intracranial mass; * head trauma; * epilepsy; * diabetes mellitus; * previous neurosurgical intervention; * psychiatric illnesses requiring chronic treatment; * patients undergoing surgery in the previous two weeks; * patients whose hospitalization duration is estimated to be less than five days; * lack of understanding of the italian language or english; * age \<18 years.

Keywords: bilateral bispectral index head&neck surgery plastic surgery postoperative delirium postoperative cognitive dysfunction interhemispheric asymmetries
development of a novel anti-caries chewing gum

Conditions: Dental Plaque; Dental Caries; Periodontal Disease

Summary: this research study is designed to evaluate the chewing gum's ability to modulate the oral microbiome in human participants, in addition to its safety.

the goal of this project is to develop a pre-biotic chewing gum that is designed to promote a healthy oral microbiome. the gum will contain compounds that will: a) be unable to be converted to acids; b) target the cariogenic s. mutans population; c) promote the stability of a healthy environment by modulating plaque ph via base-generating compounds; d) promote tooth remineralization by increasing saliva flow and by addition of calcium phosphate.

Eligibility criteria:
inclusion criteria: * in good general health, no relevant medical history * no dental treatment in the previous 3 months * willing to participate and give written informed consent exclusion criteria: * patients undergoing fixed or removable orthodontic treatment * patients using removable prosthesis * history of head and neck radiation therapy * history of adverse reaction or allergies to xylitol or other additives * antibiotics use in the last four weeks * patients with any systemic diseases * xerostomia (also medication-induced) * smokers * currently using any mouth rinse * pregnant or breastfeeding women
effect of bms-986165 on the pharmacokinetics of rosuvastatin

Conditions: Autoimmune Diseases; Inflammatory Diseases

Summary: the study is to assess the effect of coadministration of multiple doses of bms-986165 on the systemic exposure of rosuvastatin in healthy participants.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. healthy male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical exam, ecgs, and clinical laboratory determinations 3. subjects with body mass index of 18 to 32 kg/m2, inclusive. 4. women participants must have documented proof that they are not of childbearing potential. 5. men who are sexually active with wocbp must agree to follow instructions for method(s) of highly effective contraception for the duration of study treatment(s) plus 5 half-lives of bms-986165 (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days of post bms-986165 treatment. in addition, male participants must be willing to refrain from sperm donation during this time. exclusion criteria: 1. history of allergy to bms-986165, rosuvastatin, or related compounds, of myalgia or rhabdomyolysis while taking rosuvastatin or related compounds or any other drug allergy 2. any significant acute or chronic medical illness, active tb requiring treatment or documented latent tb within the previous 3 years, current or recent gastrointestinal disease, current or recent history of nausea, vomiting, constipation or irregular bowel movement 3. history of chronic headaches, syncope, orthostatic instability, or recurrent dizziness, biliary disorders, drug-induced acne or rash, fibromyalgia, neutropenia or thrombocytopenia 4. smokers who currently smoke, recent drug or alcohol abuse, blood transfusion within 4 weeks of study treatment administration, current skin findings that could interfere with the interpretation of study other protocol defined inclusion/exclusion criteria could apply
the effect of coltect (selenium, curcumin and green tea) on irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) causes many symptoms, including abdominal pain, irregular bowel movements and bloating. it may be caused by loe degree inflammation of the intestine. the ingredients of coltect which contains green tea, selenium, and curcumin have been proven very safe and have anti inflammatory and anti oxidant activity. the aim of the study is to see whether the use of coltect can improve symptoms in ibs patients.

the etiology of irritable bowel syndrome is unknown but some evidence suggests it may be caused by a certain degree of inflammation, another theory is that intestinal flora has an influence on ibs. coltect combines 3 ingredients: green tea, selenium and curcumin, all of which have been shown to have anti inflammatory and anti oxidant activity. the aim of the study is to investigate if use of coltect can improve symptoms in ibs patients

Eligibility criteria:
inclusion criteria: * ibs as defined by the rome iii criteria * for those above age 40 a colonoscopy within the last 5 years * no new treatment in the last 2 weeks * not receiving any antibiotics in the last 2 weeks exclusion criteria: * any large abdominal operation (such as colectomy) in the past * a known disease of the gastrointestinal tract * any significant debilitating disease such as sever heart failure, un controlled diabetes,

Keywords: irritable bowel syndrome selenium curcumin green tea
depuy synthes lower extremity shaft nail registry

Conditions: Femoral Fractures; Tibial Fractures

Summary: the purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two depuy synthes lower extremity shaft nails: rfn-advanced retrograde femoral nailing system (rfna) and tn-advanced tibial nailing system (tna) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.


Eligibility criteria:
inclusion criteria: * skeletally mature adults age greater than or equal to (\>=) 22 years (retrograde femoral nail advanced \[rfna\], tibial nail advanced \[tna\]) and adolescents 12-21 years of age in which the growth plates have fused (tna only) * participant receives an rfna and/or tna based on a diagnosis of open or closed, unilateral or bilateral femoral shaft or distal femur fracture (rfna); unilateral or bilateral tibial fracture (tna); revision of malunion or nonunion of previous fracture, or impending pathologic fracture (rfna only) that will be treated operatively as part of standard of care. in addition, the following will be included: a) rfna only: femoral shaft or distal femur fracture can be periprosthetic (ppfx) fracture after total or unicondylar knee arthroplasty, or total or hemi hip arthroplasty requiring nail osteosynthesis * participant (legally authorized representative if participant is a minor) voluntarily signs the institutional review board (irb)/ ethics committee (ec) approved consent form * participant must be able to read and understand questions and responses in an available translated language for patient reported outcomes (pros) exclusion criteria: * participation in any other medical device or medicinal product study within the previous month. participation in observational studies is allowed * in the opinion of the principal investigator, participant is unable to comply with the requirements of the registry * participant has known allergies to implant components
transversus abdominis muscle release versus mesh only repair in the treatment of complex ventral wall hernia

Conditions: Hernia, Ventral; Hernia Incisional; Hernia, Abdominal

Summary: this trial was designed as a prospective randomized, controlled, intervention, with two parallel groups, and a primary endpoint of recurrence during 12 months' follow-up after initial treatment, with the randomization, was performed by an online software a 1:1 allocation.

eligibility criteria * both sexes * aged between 18 and 65 years old * presented complex ventral wall hernia or incisional hernia exclusion * pregnant * patients on steroid therapy * underwent their hernia repair on an emergency basis interventions * eligible patients were randomized in equal proportions between "mesh only repair" and "posterior component separation with transversus abdominis muscle release"

Eligibility criteria:
inclusion criteria: * patients with complex ventral-wall and incisional hernia exclusion criteria: * pregnant female * steroid therapy * emergency basis
pulsed rf neuromodulation and leukocyte-rich prp for refractory low back pain

Conditions: Multi-Organ Disorder

Summary: this clinical trial aims to check the safety and efficacy profile of pulsed radiofrequency (rf) neuromodulation combined with leukocyte-rich platelet-rich plasma (prp) injections for the treatment of refractory low back pain due to multifidus dysfunction. the trial will compare two groups: one receiving standard physical therapy and the other receiving pulsed rf neuromodulation and physiotherapy.

low back pain is a common condition, often associated with multifidus muscle dysfunction, which can result from aging, obesity, or limited movement. this dysfunction is characterized by fatty infiltration and loss of muscle function. surgical procedures involving posterior or transpedicular screw insertion can exacerbate this issue by damaging the multifidus muscle, leading to persistent pain. this study will investigate the effects of pulsed rf neuromodulation on the l2 and l3 segments bilaterally, with each side receiving treatment for 6 minutes. in addition, leukocyte-rich prp will be injected into the multifidus muscle, and patients will undergo a physiotherapy regimen. the primary outcomes will be compared with those of a control group receiving only physical therapy.

Eligibility criteria:
inclusion criteria: * refractory low back pain due to multifidus dysfunction. * pain persisting for more than 6 months despite conventional treatments. * ability to provide informed consent. exclusion criteria: * previous spinal surgery within the last year. * current use of systemic steroids or immunosuppressive medications. * known bleeding disorders or anticoagulant therapy. * pregnancy or lactation. * severe psychiatric or cognitive disorders. * any congenital or non-congenital disorders
study ffr116365, an open-label study of gw685698x in paediatric subjects with perennial allergic rhinitis

Conditions: Rhinitis

Summary: safety of gw685698x (55 µg/day, q.d.) nasal spray over a period of 12 weeks in japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will be evaluated. and secondarily, efficacy and systemic exposure of gw685698x (55 µg/day, q.d.) nasal spray over a period of 12 weeks in japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will also be evaluated.


Eligibility criteria:
inclusion criteria: * informed consent * 2 to \<15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient * diagnosis of perennial allergic rhinitis: a positive test response to house dust and/or dust mites on serum antigen-specific ige antibody test at visit 1. six months or more clinical history of perennial allergic rhinitis. a positive test result on nasal eosinophil count at visit 1/1a. * either subject's parent/guardian who signed icf or subject is able to complete assessments on the patient diary through the study. * alt \< 2xuln; alkaline phosphatase and bilirubin \<= 1.5xuln * average of 3tnss is \>= 3.0 in the last consecutive 4 days prior to visit 2. * completion of the patient diary on \>= 3 days of the last consecutive 4 days prior to visit 2 exclusion criteria: * has a seasonal pollen as an allergen * a nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to visit 1) * bacterial or viral infection of upper respiratory tract or eye * concurrent disease/abnormalities: clinically significant uncontrolled disease * known hypersensitivity to corticosteroids or any excipients in the investigational product * has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to visit 1 * use of the following medication and/or its combination drug within the specified time: anti-ige (within 6 months prior to visit 1), immunosuppressive medications or systemic corticosteroids (within 8 weeks prior to visit 1), topical corticosteroids (within 4 weeks prior to visit 1), immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to visit 1 * affiliation with investigator's site: relative or employee * history of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study. * bacterial or viral infection of upper respiratory tract or eye during the screening period.
inca: intracranial aneurysm treatment with nexsys

Conditions: Intracranial Aneurysm

Summary: prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion

prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion. target aneurysms are small unruptured aneurysms in the anterior and posterior circulation.

Eligibility criteria:
inclusion criteria: * age 18-80 years at screening * unruptured saccular ia in the anterior or posterior circulation with dimensions consistent with table 2 * ia appears suitable for nexsys device * patient willing to comply with study requirements * patient able to understand and sign a study-specific informed consent form exclusion criteria: * ruptured ia * any other ia that requires treatment in the next year * ia width \>10 mm * ia neck \>9 mm * ia has important flow from its base such that occluding the ia would cause stroke * target ia contains any device (e.g., coils) * inability to access the target ia with microcatheter * any congenital or iatrogenic coagulopathy * platelet count \<50,000/microliter * known allergy to platinum, nickel or titanium * known allergy to contrast agents * stenosis of the target ia's parent vessel \>50% * taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) * taking any anticoagulants (e.g., warfarin) * pregnant or planning pregnancy in the next 2 years * other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.) * participating in another study with investigational devices or drugs
multiple dose study to evaluate the safety of multiple doses of denosumab 120 mg in adults with severe chronic kidney disease (ckd) and ckd on dialysis

Conditions: Renal Impairment

Summary: the primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (ckd) and ckd on dialysis


Eligibility criteria:
inclusion criteria: * subjects at least 18 years old with severe ckd (defined as creatinine clearance \< 30 ml/min at both screening assessments) and ckd requiring hemodialysis * additional inclusion criteria apply exclusion criteria: * subjects must have calcium, phosphate, and magnesium levels appropriate for their condition and must not have other uncontrolled co-morbidities. * additional exclusion criteria apply