Kornimate/medical-research-clean huggingface dataset:
diaphragmatic breathing exercise improves non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes and hyperlipidemia in recent years. aerobic exercise indeed reduces adipose, hepatic insulin resistance and hepatic fat. however, diaphragmatic breathing improves cardiopulmonary function, the oxygen content of the body and therefore reduces inflammation of cells. the aim of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing exercises instead of aerobic exercise to reduce the fat in liver inflammation.

the non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes and hyperlipidemia in recent years. aerobic exercise indeed reduces adipose, hepatic insulin resistance and hepatic fat. however, diaphragmatic breathing improves cardiopulmonary function, the oxygen content of the body and therefore reduces inflammation of cells. the aim of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing exercises instead of aerobic exercise to reduce the fat in liver inflammation. the project intends to be accomplished within three years because of the ideal exercise leaves an uncertain question for curing non-alcoholic fatty liver disease. hence, with the literature and empirical data analysis to review and identify the strength of patients' motion and duration, carry out a pilot observational study by including 20 patients, then teach diaphragmatic breathing exercises in the first year of the project. observe the initial correlation measurement, the variables of the following one month and three months. for the second year, develop the training of diaphragmatic breathing process with assisting device (diaphragmatic breathing-facilitated exercise device). use diaphragmatic breathing exercise assisting device in a 12-week program of diaphragmatic breathing on randomized clinical trial, verifying the impact of this item interventions on patients' metabolism indicators in the final year.the project includes people who are over 20 years old without the non-alcoholic fatty liver disease. taking liver function, body mass index, the thickness of subcutaneous fat, heart rate variability, metabolism indicators are mainly study measured variables. regression analysis helps understand the correlation between breathing exercise and indicators related to the disease. with the intervention of diaphragmatic breathing assist device, the program extensions to the two-factor analysis of variance (two-way anova) as the results of verification. the study results can provide a reference for clinicians, thereby improving the prognosis of non-alcoholic fatty liver disease people.

Eligibility criteria:
inclusion criteria: * patients who are confirmed by echo without non-alcoholic fatty liver disease and over 20 year-old, and willing to learn the exercise. exclusion criteria: * patients who could drop out the trial if he or she doesn't want to continue the exercise.
glucocorticoids in patients with igg4-rd

Conditions: IgG4-related Disease

Summary: this is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with igg4-related disease. patients will be followed for three months to measure the primary outcome and secondary outcomes.


Eligibility criteria:
inclusion criteria: * males and females * age 18-70 years old with informed consent * patients with igg4-rd: 1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2. elevated serum igg4 (\>1.35 g/l) 3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and igg4+ plasma cells on immunohistology when performed); 4. exclusion of other diseases. exclusion criteria: * previously or currently received glucocorticoid and(or) immunomodulator * pregnancy or lactating * concurrent severe and/or uncontrolled and/or unstable diseases * patient with malignancy

Keywords: igg4-related disease igg4-rd
clinical trial study to evaluate the performance and safety of ainara®

Conditions: Vaginal Disease

Summary: this study evaluates treatment with the medical device ainara® compared to a ha-based gel (hyalogin) on the improvement of vaginal dryness

this is an open, comparative, multicenter study that evaluates the performance and safety of the medical device ainara®. in this study we use polycarbophilic vaginal moisturizing gel (ainara®) compared with a ha-based gel (hyalogin) for symptomatic treatment of vaginal dryness and we will monitor its impact on vaginal dryness symptoms evaluated by vaginal health index and vaginal analogue scale.

Eligibility criteria:
inclusion criteria: * non-pregnant and in menopausal transition period (late peri-menopause) women following the straw criteria and with a break in menstrual periods of at least 60 days, aged ≥ 45 to ≤ 55 years. * diagnosis of vaginal dryness by subjective dryness, any objective sign of vva, ph\>5 as reported in the agata study and vhi \< 15. * body mass index of ≥ 18.5 to ≤ 36 kg/m2. * females of child bearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study. * able to communicate adequately with the investigator and to comply with the requirements for the entire study. * capable of and freely willing to provide written informed consent prior to participating in the study. exclusion criteria: * women in post-menopausal (total cessation of menses for ≥ 1 year from the date of the screening visit). * malignancy (also leukemic infiltrates) within 5 years prior to day 0 (except for treated basal cell/squamous cell carcinoma of the skin). * genital bleeding. * estrogen vaginal treatment during the study period (permitted only if terminated at least 6 months before study). * systemic estrogen therapy (permitted only if terminated at least 6 months before study). * subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. * clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhoea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e. tuberculosis). * psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety). * known allergy to tested imds or its excipients. * drug or alcohol abuse within 12 months of day 0. * participation in an interventional clinical study or administration of any investigational agents in the previous 30 days. * presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
bcma car-t for dynamic high-risk multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a single-arm, open-label study to evaluate the efficacy and safety of bcma car-t in dynamic high-risk patients with multiple myeloma

the study is a prospective, single-arm, single-centre, phase ii study designed to evaluate the efficacy and safety of bcma car-t in dynamic high-risk patients with multiple myeloma. patients received bcma car-t cells infusion after standard fc lymphoma deletion therapy.

Eligibility criteria:
inclusion criteria: 1. be informed and voluntarily sign the informed consent form (icf). 2. age between 18 and 75 years (inclusive). 3. have measurable disease meeting at least one of the following criteria: serum m-protein ≥1 g/dl (\>10 g/l) as detected by serum protein electrophoresis (spep), or quantifiable iga or igd levels for iga or igd-type myeloma; urine m-protein ≥200 mg/24 hours; in cases where serum and urine m-protein do not meet the above thresholds, an abnormal free light chain (flc) ratio (normal range: 0.26 to 1.65) and involved serum flc ≥100 mg/l. 4. have received only one line of standard anti-myeloma therapy, including: induction therapy with at least one proteasome inhibitor, one immunomodulatory agent, and corticosteroids; sequential autologous hematopoietic stem cell transplantation or consolidation therapy; maintenance therapy based on either a proteasome inhibitor or an immunomodulatory agent. 5. meet at least one of the following dynamic high-risk criteria: early relapse: disease progression or relapse within 18 months of starting first-line therapy, including progression or relapse within 12 months post-autologous hematopoietic stem cell transplantation; primary refractory disease: failure to achieve at least minimal response (mr) after four cycles of induction therapy; relapse with new genetic abnormalities: gain(1q), del(17p), or tp53 mutation. 6. confirmed expression of the bcma target antigen on mm cells by flow cytometry or bone marrow immunohistochemistry. exclusion criteria: 1. primary plasma cell leukemia. 2. concurrent amyloidosis. 3. involvement of the central nervous system (cns). 4. previous treatment with bcma-targeted therapy or car-t cell therapy. 5. disease progression or relapse within 3 months of autologous hematopoietic stem cell transplantation.
cervical i/f cage for anterior cervical fusion

Conditions: Cervical Intervertebral Disc Degeneration

Summary: the purpose of this study is to determine the clinical success of the cervical i/f cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate

this is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device, cervical i/f cage for fusion in one or two adjacent levels of the cervical spine. patients will be randomly assigned in a ration of 1:1 between the investigational and control groups. comparison: the device will be compared to a control group consisting of the 3 accepted standard of care treatments (autograft, autograft with an anterior plate, or allograft with an anterior plate). for two level fusions, the control group will be limited to autograft with a plate or allograft with a plate. based on the current literature, it is believed that there is no difference between the three treatments in terms of clinical success, fusion success, or safety issues. however, amongst the investigators there are preferred treatments. each investigator will choose one or more of the control treatments at study initiation. patients will then be randomized in a 1:1 cage:control randomization schema. approximately 240 subjects will be enrolled at 20 sites. eligible patients will have symptomatic degeneration of one or two adjacent cervical discs, have failed six weeks of non-surgical treatment, have sufficiently severe enough symptoms to warrant surgery, and have had no prior fusion surgery on the cervical spine.

Eligibility criteria:
inclusion criteria: * persistent recurrent neck and/or shoulder and arm pain refractory to 6 weeks of non-surgical therapy. * radiographic evidence of significant disc degeneration at one or two adjacent cervical levels (c4-7) exclusion criteria: * significant degeneration at more than two cervical levels, * prior surgical treatment of the cervical spine; laminotomy or foraminotomy allowed, * gross instability due to trauma, * disability in the lumbar spine, * infection in the disc or spine, past or present, * any active infection at time of surgery, * tumor in the spine, * significant osteoporosis or metabolic bone disease, * pregnant, lactating or wishes to become pregnant within duration of the study, * refusal to accept the use of autograft tissue.

Keywords: fusion cervical spine
understanding the effect of metformin on corus cad (or asges)

Conditions: Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Diseases; Coronary Heart Disease; CAD; CVD; CHD

Summary: the study goal was to understand the effect of metformin on age/sex/gene expression score (asges) or corus cad (henceforth "corus") in pre-diabetic patients who are medication naive. this study provided data to determine if the corus cad (asges) signature was different in pre-diabetic patients when metformin was newly prescribed and taken.

the study goal was to understand the effect of metformin on age/sex/gene expression score (asges) or corus cad in pre-diabetic patients who are medication naive. this study provided data to determine if the corus cad (asges) signature was different in pre-diabetic patients when metformin was newly prescribed and taken. the primary aim of this study was to evaluate whether metformin used in pre-diabetic patients to prevent progression to type ii diabetes had a significant effect on the gene expression levels measured in corus. this was a prospective study. subjects were enrolled from participating sites as applicable inclusion/exclusion criteria were met. the study aimed to enroll approximately fifty (50) patients.

Eligibility criteria:
inclusion criteria: at least 21 years of age any of the following: * chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia * low-risk unstable angina, or * asymptomatic individuals with a high probability of cad clinician diagnosis of pre-diabetes, per ada guidelines, such that metformin therapy is prescribed: * hga1c: \>5.7% - \<6.4%, * bmi\> 35 kg/m2 * age\< 60 yrs * prior gestational diabetes mellitus * fpg: \>100mg/dl - \<126mg/dl * ogtt: \>140mg/dl - \<200mg/dl willingness to comply with metformin therapy, for at least seven (7) days (p.o., per physician's dosage discretion) willingness to maintain a drug diary for duration of study, for full follow-up period (7 + 7 days) willingness and ability to provide two (2) samples for corus (baseline, 7 (+ 7) days post- medication start) provide written informed consent exclusion criteria: * history of or current level of hba1c \>6.5 * history of or current prescription of metformin or any other diabetic medication * history of myocardial infarction (mi) or prior revascularization * current mi or acute coronary syndrome (acs) * current new york heart association (nyha) class iii or iv congestive heart failure symptoms * current systemic infectious or systemic inflammatory conditions * subjects currently taking steroids, immunosuppressive agents or chemotherapeutic agents

Keywords: corus cad asges age/sex/gene expression score gene expression ges cad cvd chd precision medicine coronary artery disease angina pectoris chest pain cardiovascular disease coronary heart disease metformin
feasibility of a 8-week telerehabilitation program for patients with thoracic neoplasia receiving chemotherapy

Conditions: Lung Cancer

Summary: exercise-based rehabilitation improves physical function, fatigue and quality of life in patients with thoracic neoplasia. consequently, the need for rehabilitation across the continuum of care in oncology is growing rapidly. however, the implementation of this type of intervention is limited because of many barriers such as patients' symptoms and poor accessibility to programs. in this context, healthcare systems should develop and implement new approaches to dispense these services. consequently, telerehabilitation is a promising strategy to improve access and adherence to rehabilitation. objectives to investigate the feasibility, adherence and satisfaction of a home-based telerehabilitation program (telerp) with real-time physiological parameters acquisition in patients with unresectable thoracic neoplasia receiving chemotherapy and to explore its effects on patients' functional capacity. methods five patients receiving chemotherapy followed an 8-week telerp using real-time monitoring combined with interactive exercises. the telerp included supervised (15) and unsupervised (9) strengthening and cardiovascular exercise sessions at a rate of 3 sessions/week. the feasibility of the telerp, adverse outcomes, technical issues, program adherence and satisfaction were analysed. prior to and after the program, a six-minute walking test (6mwt), a timed up and go (tug) and a timed stair test (tst) were done to assess functional capacity


Eligibility criteria:
inclusion criteria: * patients had to have an ecog functional status of 0 (asymptomatic) or 1 (symptomatic but completely ambulatory); * have a sufficient understanding of verbal and written french instructions * live in a geographic region served by a high speed internet connection. exclusion criteria: * oxygen pulsed saturation (spo2) \<80% during the cardiopulmonary exercise test * contraindications to exercise testing according to the american thoracic society and american college of chest physicians exercise testing guidelines * cerebral or bone metastasis * a history of significant cardiovascular disease, hypertension, diabetes or musculoskeletal concerns that might limit their ability to perform active exercises * severe psychiatric illness compromising adherence to the rehabilitation training routine.

Keywords: telerehabilitation
identification of c7; evaluations of 2 sonographic methods using a transverse and a sagittal scan.

Conditions: Breastcancer

Summary: to determine the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify c7 spinous process compare to the fluoroscope (standard technique)

to identify the accurate level of upper thoracic spine is essential maneuver during breast surgery and axillary node dissection. palpation c7 spinous process is most common technique using to identify the level. however, the accuracy was lower than 50%. ultrasonography has been investigated to identify the cervical nerve roots by differentiating the transvers process of c6 and c7. however, there was no study on the accuracy of using ultrasound to identify cervical spine level before.

Eligibility criteria:
inclusion criteria: * healthy volunteer, age \>/= 18 exclusion criteria: * previous cervical spine surgery, cervical spine deformity, pregnancy

Keywords: ultrasonography to identify c7 spinous process
a feasibility study of the snuby®, a skin-to-skin garment, in the preterm infant

Conditions: Premature Birth; Breast Feeding

Summary: skin-to-skin care (placing the nappy-clad baby on the mother's bare chest and draping both in a blanket) is known to benefit both baby and mother. benefits to the baby include warmth, reduced crying, and stabilisation of heart rate, breathing and blood sugar, and promotion of breastfeeding while simultaneously reduces mother's anxiety, improves bonding, and increases breastmilk production. although these benefits are even more pronounced for preterm, studies show most preterm babies do not receive adequate skin-to-skin care due to fears such as dislodging intravenous lines, ventilation tubes, monitor wires and concerns about safety and privacy. measures are therefore required to increase maternal confidence and awareness and facilitate skin-to-skin care for preterm infants. snuby® (snuggle baby) is a purpose-built garment for facilitation of skin-to-skin care in preterm infants. it is made of comfortable, breathable bamboo fabric with an attractive appearance such that it can be worn as a normal garment. in addition, it has distinctive features that allow the baby to be placed in a specially designed pouch, in direct contact with the mother's skin, with supports for lines and tubes that may be attached to the baby. although many garments are commercially available for mothers to carry babies, no such specially designed garment has ever been tested scientifically and none are specifically designed for preterm babies. in this observational study, the investigators will initially test the feasibility of using the snuby® in preterm infants by inviting five mothers-preterm infant pairs, with mother's written informed consent, to use the garment under direct supervision. following this, the investigators will analyse the safety and acceptability of using it on a larger scale to facilitate skin-to-skin care in preterm babies. the investigators will gather information on the staff and mothers' knowledge of skin-to-skin care and their experience of using snuby®.

skin-to-skin contact is used as part of a package of kangaroo mother care across the world. this has been demonstrated to reduce neonatal morbidity, mortality, and inpatient stays for low birth weight and preterm infants (charpak and ruiz 2016). this study examines the effect a facilitating garment, the snuby® has on neonatal health outcomes associated with skin-to-skin contact, such as neonatal thermoregulation, breastfeeding status, and self-reported mother-infant bonding. it uses a mixed methods approach to address quantitative and qualitative outcomes including participant's perspectives, and measurable health markers.

Eligibility criteria:
inclusion criteria: * preterm (born at \< 37 weeks gestation) infants * admitted to the neonatal intensive care unit * well enough to receive skin-to-skin care * mothers who agree to participate and mothers of eligible preterm infants exclusion criteria: \*any infant or mother considered unsuitable for skin-to-skin care for medical reasons (as decided by the attending consultant neonatologist).
evaluation of an interactive mental wellness (i-am-well) program on final year nursing students

Conditions: Resilience; Practice Readiness; Depression; Anxiety; Stress; Physical Activity; Eating Behavior

Summary: this study aims to address the following research questions: evaluate the effectiveness of an interactive mental wellness (i-am-well) program on final year nursing students' anxiety, depression, stress, resilience, practice readiness, physical activity and eating behaviours. explore final year nursing students' experiences and perception of the i-am-well program. participants will be invited to participate in an asynchronous online i-am-well program


Eligibility criteria:
inclusion criteria: * final year nursing students enrolled in the undergraduate nursing program * above the ages of 18 years * able to comprehend the english language * have a device that can connect to the internet exclusion criteria: * students who refused to participate in the study