Kornimate/medical-research-clean huggingface dataset:
inspiratory muscle activation pattern analysis in assisting precision in inspiratory muscle training in patients with chronic respiratory disease

Conditions: Chronic Respiratory Disease; Inspiratory Muscle Training; Sternocleidomastoid Muscle; Surface Electromyography

Summary: background \& objective: inspiratory muscle training (imt) is known to improve strength and endurance of inspiratory muscles. however, clinical beneficial effects of imt for patients with chronic respiratory disease remain inconclusive. the purposes of the study are to investigate in patients with chronic respiratory disease: (year 1) main (diaphragm) and accessory inspiratory muscle (sternocleidomastoid muscle) activation pattern during various imt loading using group-based trajectory modeling (gbtm); and (year 2) effectiveness of individualized imt program (based on results of year 1) on clinical outcomes. methods: (year 1) patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study. patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. surface electromyography (emg) of diaphragm and sternocleidomastoid muscle will be used to use inspiratory muscle activation during various conditions. other outcomes include maximum inspiratory pressure, and functional exercise capacity will be measured. inspiratory muscle activation will be used for gbtm analysis. patient will then be trained with individualized imt program based on the gbtm analysis input form results of year 1.


Eligibility criteria:
inclusion criteria: * age \> 20 years old * has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks * can cooperate with the measurements of this study exclusion criteria: * any clinical diagnosis that will influence the measurement, including any history of * neuromyopathy * angina, acute myocardial infarction in the previous one month * pregnancy * participated in inspiratory muscle training program in the previous three months * any psychiatric or cognitive disorders, for example: mini-mental state examination (mmse) \< 24, that will disturb the communication and cooperation of the study
study evaluating neratinib (hki-272) in combination with vinorelbine in subjects with solid tumors and metastatic breast cancer

Conditions: Breast Cancer; Advanced Malignant Solid Tumors

Summary: the purpose of this study is to identify the highest tolerable dose of neratinib (hki-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors. the study will be conducted in two parts. in the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of hki-272 and vinorelbine in patients with advanced solid tumors. in the second part of the study, approximately 60 additional subjects with metastatic erbb-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of hki-272 in combination with vinorelbine. up to 20 additional subjects with erbb-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.


Eligibility criteria:
inclusion criteria: * confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which hki-272 plus vinorelbine is a reasonable treatment option (part 1 only) or confirmed pathologic diagnosis of erbb-2-positive breast cancer (current stage iv) in female subjects for which vinorelbine plus hki-272 is a reasonable treatment option (part 2 only). * at least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only). * at least 1 measurable lesion as defined by response evaluation criteria in solid tumors (recist). exclusion criteria: * more than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only). * prior treatment with vinorelbine for metastatic setting, or prior treatment with any erbb-2 targeted agents except trastuzumab (part 2 only). up to 20 subjects with erbb-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2. * prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).

Keywords: metastatic breast cancer hki-272 neratinib nerlynx pb-272
transcranial pulse stimulation on motor cortex

Conditions: Healthy Adults

Summary: transcranial pulse stimulation (tps) is a newly developed non-invasive brain stimulation (nibs) technique from austria \& germany with highly promising applicability in neuropsychiatric disorders. clinical trials have shown a beneficial effect of tps in patients with alzheimer\&#39;s disease and depression. however, the mechanism of action of tps treatment is unknown. there is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of tps. the primary motor cortex is a common target when investigating the neuromodulation effect of nibs techniques. here, a randomized, cross-over, single-blind, sham-controlled clinical trial is proposed to probe the effects of tps over the primary motor cortex on modulating motor response and motor behavior.


Eligibility criteria:
inclusion criteria: * age 18 to 65 * no physical, neurological or psychiatric disorder * right-handedness exclusion criteria: * background with neuroscience * tps and tms contraindications, including metal implants, pregnancy, coagulation disorders, thrombosis, brain tumor, cortisone therapy up to 6 weeks before first stimulation, pacemakers or cochlear implants.
awake prone positioning in moderate to severe covid-19

Conditions: COVID-19; SARS-CoV2 Infection; COVID-19 Acute Respiratory Distress Syndrome; Acute Hypoxemic Respiratory Failure; Respiratory Distress Syndrome, Adult

Summary: the purpose of this study is comparing vital signs between standard care and prone position groups. standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. for those randomized to prone position, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day.

this study is a pragmatic open label randomised controlled trial. after being informed about the study and potential risks, all patients having written informed consents will be randomised into two groups. standard care group will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. to reduce bias, the study team will make visits at a similar schedule to those to patients in the intervention group, however these visits will be confined to general advice and measurement of vital signs. patients will receive written advice more general in nature about covid-19 disease. for those randomized to prone position group, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day. the team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position. the exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers. compliance with the intervention will be evaluated by observation (manual and using in-room cameras) at fixed time intervals. in a subgroup of 100 patients accelerometer/gyrometer devices will be used to measure movement and position (this will be expanded to all patients if equipment is available). other outcome measures (spo2, heart rate etc) will be measured using standard monitoring equipment currently used at study sites, including wearable devices.

Eligibility criteria:
inclusion criteria: * probable or confirmed covid-19 infection according to who criteria * moderate or severe covid-19 respiratory infection according to vietnamese guidelines * requirement for supplemental oxygen therapy exclusion criteria: * invasive mechanical ventilation, or non-invasive ventilation (niv) with cpap or bipap or imminent need for these * contraindications to prone position (see appendix 5) * pregnancy * severe obesity (bmi \>35), * altered level of consciousness (gcs \<13) * attending doctor judged prone position to be unsuitable for the patient for any reason * patients in whom there is a decision that care will not be escalated * failure to have informed consent

Keywords: prone position severe covid-19 acute respiratory distress syndrome (ards) vietnam
serial screening and treatment of bacterial vaginosis trial

Conditions: Bacterial Vaginosis; Preterm Delivery

Summary: the purpose of this investigator-initiated randomized control trial is to determine if bacterial vaginosis infection increases the likelihood of preterm delivery in women with history of preterm delivery. subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control.

preterm delivery affects 10% of all pregnancies in the united states. this risk is further increased in pregnant women with a history of preterm delivery. there are multiple etiology contributing of preterm labor. of these, the presence of inflammation and infection have been a well-established cause. bacterial vaginosis (bv), a common vaginal infection in pregnancy, may often be asymptomatic. studies demonstrate a strong association between bv and preterm labor. therefore it is recommended that women at high risk for preterm delivery are treated for this infection irregardless of symptoms. in this study the investigators hypothesize that increased testing for bacterial vaginosis, with subsequent timely treatment, may decrease the risk of preterm delivery in patients who are at high risk. the investigators suspect that the increase in monitoring will help diagnose asymptomatic bacterial vaginosis infections allowing for prompt treatment and avoidance of preterm labor. subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control. no experimental drugs or devices will be used. * the intervention-arm will have a pelvic exam performed with vaginal swab collection at their initial obstetric visit. the women undergoing the intervention will then subsequently undergo additional vaginal swab collections in 2 week intervals starting at 16 weeks gestational age until 34 weeks gestational age. * the control arm will undergo the standard of care. there will be no placebo for the control group.

Eligibility criteria:
inclusion criteria: * female * age greater than or equal to 18 years old * pregnancy at less than 32 weeks gestational age at initial obstetric visit with loma linda maternal fetal medicine (mfm) clinic * history of at least one prior preterm delivery \>16 and \<37 weeks not due to iatrogenic indications, or short cervical length \<2.5cm * willing to receive prenatal standard of care and comply with treatment plan and other study procedures at loma linda exclusion criteria: * patients not deemed to be high risk for preterm delivery * patient with cervical dilation ≥1cm on initial exam or with protruding membranes * current pregnancy is multigestation * medical indications for iatrogenic preterm delivery during this pregnancy (e.g. preeclampsia with severe features) * desires termination during this pregnancy

Keywords: bacterial vaginosis vaginoses, bacterial
efficacy and safety of different doses of indacaterol

Conditions: Asthma

Summary: this study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of asthma, and: 1. receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening 2. prebronchodilator forced expiratory volume in 1 second (fev1) at screening ≥50 and ≤90% of predicted normal 3. an increase of ≥12% and ≥200 ml in fev1 over prebronchodilator value within 30 minutes after inhaling albuterol exclusion criteria: * smoking history \>10 pack-years * patients with a diagnosis of chronic obstructive pulmonary disease (copd) * patients with seasonal allergy whose asthma is likely to deteriorate during the study period * patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening * patients who have had an intubation for a severe asthma exacerbation * patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions * patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy other protocol-defined inclusion/exclusion criteria may apply

Keywords: indacaterol asthma salmeterol
effects of omega-3 fatty acids on muscle wasting

Conditions: Muscle Wasting

Summary: the risk of muscle wasting, and sarcopenia is high in the intensive care unit patients and associated with adverse clinical outcomes. the etiology of muscle wasting is multifactorial and medical nutrition therapy plays a key role in treatment and prevention. the purpose of this study is to evaluate the effect of omega-3 fatty acids in the treatment and/or prevention of muscle wasting in critically ill trauma patients.

low skeletal muscle mass and loss of lean tissue in critically illness have been associated with negative clinical outcomes. critically ill patients may lose about 25% of their skeletal muscle mass within 7 days of admission to the intensive care unit. besides increased protein catabolism, other factors inherent to the icu environment contribute to muscle loss, including patient immobility and interruptions in nutrient delivery. this combination of factors is especially debilitating in patients with preexisting low muscle stores due to sarcopenia, chronic illness, or malnutrition. although preservation of skeletal muscle mass is important for recovery in critically ill patients, the mechanism of muscle wasting is not unknown. muscle wasting is a multifactorial process and it may be the consequence of several events, including oxidative stress, inflammatory conditions and muscle remodeling. omega-3 fatty acids with their anti-inflammatory, antioxidant and anabolic effects can be a key factor for an effective treatment.

Eligibility criteria:
inclusion criteria: age ≥18 years and ≤80 years, expected icu stay of seven days or longer written informed consent or requirements of local/national ethical committee exclusion criteria: pregnancy or breastfeeding neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, guillain-barre syndrome) current cancer or chemotherapy end-stage of renal failure or dialysis treatment or renal transplantation prior to icu admission burn injury history of transplantation pretibial edema uncontrolled hemorrhage uncontrolled hyperlipidemia acute pancreatitis acute thromboembolic diseases severe heart failure septic shock concurrent enrolment in a nutrition-related interventional study at the time of screening

Keywords: critical illness trauma fatty acids anthropometry nutrition disorders sarcopenia
atrial fibrillation recurrence after cryoballoon ablation

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the arctic front ablation system. for those with pulmonary vein reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac echo (ice) guidance. the achieve mapping catheter will be evaluated head-to-head with our current method of ice-guided recordings from a conventional mapping catheter with high output pulmonary venous pacing.


Eligibility criteria:
inclusion criteria: * patients undergoing re-do catheter ablation procedure after index procedure with cryoballoon ablation * at least 18 years old * able to read and understand informed consent exclusion criteria: * unable to give informed consent

Keywords: atrial fibrillation cryoballoon ablation
nt-probnp and troponin i in dengue children

Conditions: Dengue Shock Syndrome; Children, Only

Summary: to discribe concentration of nt-probnp and troponin i in dengue hemorrhagic shock children, in correlation between concentration of nt-probnp and troponin i with total fluid admission, respiratory support, using inotrope and vasopressor using.

treatment of children with dengue hemorrhagic shock syndrome (dss) is challenge, especially in cases with hypotensive shock, profound shock or whom do not have a response to initial crystalloid therapy. currently, treatment of dss remains almost supportive, with particular emphasis on careful fluid management. however, fluid overload is a common complication of this treatment, lead to many difficulties in management of severe dengue children, accompany with morbidity and mortality. diagnosis of fluid overload mostly based on clinical features and chest x-ray or ultrasound. until now, no biomarker are widely using for diagnosis of fluid overload in clinical. nt-probnp is secreted when stretching the wall of the cardiac muscle. this may a suitable biomarker to discover the fluid overload state in children with dss. troponin i is a biomarker of cardiac muscle damage.

Eligibility criteria:
inclusion criteria: * dengue shock children who admitted to icu exclusion criteria: * excluding the cases of children with cardiovascular disease, hyperthyroidism, taking drugs such as insulin, steroid, estrogen, growth hormone, thyroid hormone

Keywords: nt-probnp troponin i dengue children cardiac enzyme
a study to evaluate the effects of vildagliptin on the insulin response to glucose in subjects with pre-diabetes

Conditions: Pre-diabetes

Summary: this is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.


Eligibility criteria:
inclusion criteria: * bmi in the range 22-45 and with a stable weight for the last 6 months * blood glucose criteria must be met * written informed consent exclusion criteria: * pregnancy or lactation * previous diagnosis of type 2 diabetes or treatment with hypoglycemic agents * type 1 diabetes * evidence of cardiovascular complications as defined by the protocol * evidence of diabetic complications as defined by the protocol

Keywords: vildaglptin pre-diabetes
a pilot investigation detecting cryoablation scar by 3d late gadolinium enhancement

Conditions: Atrial Fibrillation; Cryoablation

Summary: this is a prospective trial investigating the effectiveness of a modified mri preparatory pulse sequence to improve pulmonary vein isolation visualization.


Eligibility criteria:
inclusion criteria: * men or non-pregnant women * a diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure * documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation. exclusion criteria: * contraindication to mri, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits * allergy to gadolinium-based contrast agent * previous atrial fibrillation ablation * renal dysfunction (estimated gfr \<60 ml/min/1.73m2) within 6 months * unwilling to provide informed consent for this protocol
pre-post study for supporting appropriate implementation of lung cancer screening

Conditions: Lung Neoplasms; Early Detection of Cancer; Decision Support Techniques; Primary Health Care

Summary: the primary objective of this study is to assess the effect of the decision aid on measures of decision-making such as knowledge, screening attitudes, decisional conflict, and screening intent.

using a single group, pre-post design, we aim to assess the effect of the decision aid on screening knowledge, screening attitudes, decisional conflict, and screening intent within 3 months of decision aid viewing.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to participate in this study: * age 55 - 80; * current smoker, or former smoker who has less than a 16-year quit history; * have at least a 30-pack year smoking history (average packs per day \* years smoking); and * patient of the internal medicine clinic at university of north carolina health care. exclusion criteria: all subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation: * ever diagnosed with lung cancer; * undergone chemotherapy or radiation therapy in the past 18 months prior to enrollment; * coughed up blood from lungs (also called hemoptysis) within the past year prior to enrollment; * experienced unexplained weight loss of 15-pounds or more during six months prior to enrollment; and * had a chest ct scan within the past 18 months prior to enrollment.