Kornimate/medical-research-clean huggingface dataset:
comparison in pulmonary compliance between curosurf and survanta in preterm infants with respiratory distress syndrome

Conditions: Respiratory Distress Syndrome

Summary: this is a null hypothesis study. the investigators hypothesize that there will be no difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute intervals after administration of either surfactant and there will be no differences in the number of doses needed between the two surfactants in premature infants admitted to our nicu.

premature newborn infants may have impaired lung function as a result of their prematurity. when this occurs, the newborns show poor oxygen and carbon dioxide exchange and difficulty in breathing. the reason for these symptoms is due in part to the lack of special chemicals in the lungs, called phospholipids or surfactant. the lack of these special chemicals causes the babies lung to be difficult to ventilate. treatment of this condition can require placing an artificial airway (endotracheal tube) into the babies windpipe (intubation) and use of a breathing machine (ventilator). in addition, physicians frequently give these special chemicals (phospholipid) through the childs airway. there are several different types of phospholipids available for this treatment in newborns but very limited amount of studies have been done to examine differences in the ability to ventilate between the various types of surfactant. the investigators propose to examine immediate changes in ability to ventilate (dynamic compliance) at specific time intervals after administration of either type of surfactant; curosurf or survanta.

Eligibility criteria:
inclusion criteria: * preterm infants between 28 and 31 6/7 weeks' gestational age * inborn to um nicu * \< 12 hours of age * respiratory distress syndrome * radiographic evidence * need for endotracheal intubation * oxygen requirement \> 30% fio2 * decision to give surfactant by the treatment team exclusion criteria: * major congenital anomaly * sepsis syndrome in extremis
modified bortezomib-based combination therapy for multiple myeloma

Conditions: Multiple Myeloma

Summary: to investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.

multiple myeloma (mm) is a common hematological malignancy in chinese elderly population. the application of novel drugs improved the clinical outcome and survival of mm patients,even though mm remains an incurable hematological malignancy. bortezomib is a typical one among these novel agents, its application resulted in great success, but its adverse events and high expense restricted its widely usage. investigators modified the dose and frequency of bortezomib administration in combination therapy: patients in the modified group received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide，while patients in the control group received similar combination therapy except with conventional bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11. the aim of this study is to investigate whether the modified bortezomib-based therapy may attain a similar efficacy as the conventional ones.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma based on standard diagnosis criteria: * plasmacytomas on tissue biopsy * bone marrow plasmacytosis * monoclonal immunoglobulin spike on serum electrophoresis * lytic bone lesions. * must have relapsed or relapsed/refractory disease * 18 years of age or older * all baseline studies must be performed within 21 days of enrollment. * ecog performance status of 0 to 2 exclusion criteria: * renal insufficiency (serum creatinine levels \> 2mg/dl) * concomitant therapy medications that include corticosteroids * peripheral neuropathy of grade 3 or greater or painful grade 2 * evidence of mucosal or internal bleeding and/or platelet refractory * anc \< 1000 cells/mm3 * hemoglobin \< 8.0 g/dl * ast (sgot and alt) \> 2 x uln * intolerance to bortezomib or cc-5013 in the past or significant allergy to either compound, boron or mannitol * known hypersensitivity to thalidomide or the development of erythema nodosum * active infection or serious co-morbid medical condition * pregnant or breast-feeding women * prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
the association of intestinal microbial metabolites and cardiac function in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: recently, more and more studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases.bile acids (bas), short chain fatty acids (scfa) and trimethylamine oxide (tmao), the main metabolites of intestinal flora, are the key mediators of the interaction between gut and host. we aim to explore the association of bas and scfa with cardiac function in patients with ami.

cardiovascular disease is the leading cause of death in china, and acute myocardial infarction (ami) is the main cause of death of cardiovascular disease. in recent years, clinical epidemiological studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases such as diabetes, hyperlipidemia, hypertension, atherosclerosis, coronary heart disease, heart failure and so on. bile acids (bas), short chain fatty acids (scfa) and trimethylamine oxide (tmao), the main metabolites of intestinal flora, are the key mediators of the interaction between gut and host. it is suggested that intestinal flora and its metabolites participate in the pathophysiological process of cardiovascular disease through inflammation, oxidative stress and programmed death, and have the potential to be intervention targets. basic and clinical studies have shown that tmao is associated with the onset and poor prognosis of ami by promoting the development of atherosclerosis and thrombosis, but there are few reports on the relationship between bas or scfa and ami. we aim to explore the association of bas and scfa with cardiac function in patients with ami.

Eligibility criteria:
inclusion criteria: the patient, aged 18-85 years, had undergone coronary angiography and agreed to be enrolled and signed the informed consent. ami : according to st segment elevation myocardial infarction diagnostic criteria. uap: 1. typical chest pain symptoms; 2. negative in markers of myocardial injury; 3. the stenosis of main coronary artery or its main branches is more than 50% control: 1. atypical chest pain symptoms 2. negative in markers of myocardial injury; 3. the stenosis of main coronary artery and its main branches is less than 50% exclusion criteria: 1. acute infection or application of antibiotics in the past 3 months; 2. chronic heart failure; 3. history of inflammatory or absorptive bowel disease and bowel resection; 4. acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 5 times of normal value); 5. renal insufficiency (serum creatinine \> 220μml/l or creatinine clearance rate \< 30 ml/min); 6. malignant tumor; 7. autoimmune diseases; 8. uninformed patients

Keywords: bile acids short chain fatty acid cardiac function
comparison of short segment mono-axial and poly-axial pedicle screw fixation for thoracolumbar fractures

Conditions: Spine Fracture

Summary: comparison of short segment mono axial and poly axial pedicle screw fixation in thoracolumbar fractures regarding the best correction of the fracture and deformity and the maintenance of the correction.

* thoracolumbar spine trauma represents the most common area fractured in the spine in a large series of 3,142 patients with traumatic spinal fractures, wang et al., 2012, reported that 54.9% of the patients had fractures in the thoracolumbar spine. patients with complete neurological deficits generally have thoracic fractures, possibly due to a small canal diameter when compared to the cervical or lumbar spine although grouped together, tlst is comprised of injures to the more rigid thoracic spine (t1-t10), the flexible and transitional thoracolumbar junction (t11-l2), more susceptible to injuries, and the lumbar spine l3-5. early diagnosis and adequate management may improve patients' outcome and decrease its inherent disability.(1) * morphological classification of thoraco-lumbar fractures is based on the magerl classification modified by the aospine classification group. for this evaluation radiograms and ct scans with multiplanar reconstructions are essential. in some cases additional mr images might be necessary.(2) * the goal of fracture treatment is to obtain and maintain a stable reduction and early mobilization. a secondary aim is to restore sagittal alignment which has gained increasing emphasis in the last decade.(3) * posterior short segment fixation including the proximal and distal adjacent normal vertebrae is the most commonly performed surgery for the vast majority of thoracolumbar fractures, posterior pedicle screw fixation has been shown to be simple, familiar, efficient, reliable, and safe for the reduction and stabilization of most fractures and remains the most popular technique.(4) * the aim of our study is to compare between monoaxial short segment pedicle screw fixation and polyaxial short segment pedicle screw fixation

Eligibility criteria:
inclusion criteria: * thoracolumbar fractures d4 - l3. * neurologically free. * age of the patients to be from 20 to 60 years. * type a3 and a4 according to the ao classification. exclusion criteria: * pathological or osteoporotic fractures. * lumbar degenerative diseases. * multisegement spine fractures. * poly traumatized patients

Keywords: thoracolumbar fractures
the effect of proprioception of platelet rich plasma for patients with ankle sprain

Conditions: Ankle Sprain 2Nd Degree; Ankle Sprain 3Rd Degree

Summary: ankle sprain is a fairly common sports medicine clinic. in taiwan at least 150,000 to 200,000 people will suffer from ankle sprains every years. clinicians have been looking for ways to shorten treatment time and reduce discomfort. platelet rich plasma(prp) is an endogenous therapeutic technology that involved in regenerative medicine due to its potential to stimulate and accelerate tissue healing. prp can release lots of growth factors like platelet-derived growth factor (pdgf),transforming growth factor beta(tgf-β), vascular endothelial growth factor(vegf),epidermal growth factor(egf) and insulin-like growth factor (igf). its use had been based on the theory that increased autologous platelets, that then yield high concentrations of growth factors and other proteins, will lead to increased healing of tendon and soft tissue on a cellular level. in addition, there is no objective evaluation after treatment, so that patients can not provide effective and accurate quantitative feedback. in this study, the investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous prp injection therapy, autologous prp injection combined with general rehabilitation therapy.

the investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous prp injection therapy, autologous prp injection combined with general rehabilitation therapy randomly. the investigators also use the new ankle proprioception evaluation system and evaluation of clinical function after treatment. it is expected to establish another feasible and rapid treatment method for ankle sprain. combined with high accuracy ankle body defect evaluation method, it is helpful to design proper treatment and rehabilitation strategy in the future so as to improve the rehabilitation of limbs coordination and control capabilities.

Eligibility criteria:
inclusion criteria: * ankle sprain within one months * gr ii or gr iii ankle sprain (anterior talus fibular ligament)by sonogram proved * mmse≥23 * could cooperate the examination of the test exclusion criteria: * hemianopsia or hemineglect any brain lesion such as cerebrum of cerebellum involved movement * cancer victim * pregnant if needed prp treatment * liver cirrhosis * platelet \< 150000/ul * sepsis, leukemia * use anti-coagulation agents * under hemodialysis

Keywords: platelet rich plasma, proprioception, ankle sprain
clinical progression and costs in benign prostatic hyperplasia patients treated with early versus delayed combination therapy

Conditions: Benign Prostatic Hyperplasia

Summary: in patients with benign prostatic hyperplasia (bph), combination therapy with an alpha-blocker (ab) and a 5 alpha-reductase inhibitor (5ari) has been shown to reduce the progression of acute urinary retention (aur) and the incidence of prostate surgery, and also provides symptom relief. the objective of this study is to compare the likelihood of clinical progression (defined as aur and/or prostate-related surgery) and costs in bph patients who were treated with delayed combination therapy to bph patients who were treated with early combination therapy using data from a united states (us) healthcare claims database. the hypothesis of this study is that patients who are prescribed combination therapy early in their bph treatment will experience better clinical outcomes and lower healthcare costs compared with patients treated with delayed combination therapy. the null hypothesis is that no difference will be observed in outcomes or direct medical costs for patients treated with early combination therapy and patients treated with delayed combination therapy. the us healthcare claims database includes data from patients with medicare advantage as well as private health plan coverage including the impact health plan. about 14 million people were covered by this set of health plans in 2007 and were geographically diverse across the us. data from 2000 through 2009 were utilized. the study is a retrospective cohort analysis.


Eligibility criteria:
inclusion criteria: * male * age 50 or older at the index date (the date of the first filled prescription for an ab or 5ari during the enrollment period) * at least one claim with an icd-9 diagnosis code for bph (222.2 or 600.xx) in any position and at least one pharmacy claim for an ab (alfuzosin, doxazosin, tamsulosin, or terazosin) or at least one fill for a 5ari (dutasteride or finasteride) (with or without a diagnosis for bph) * continuous enrollment with medical and pharmacy benefits for 6 months prior to the index date (i.e., baseline period) and 12 months after the index date (follow-up period) exclusion criteria: * at least one pharmacy claim for an ab (alfuzosin, doxazosin, tamsulosin, or terazosin) any time during the pre-index period prior to the index date * at least one fill for a 5ari (dutasteride or finasteride) any time during the pre-index period prior to the index date * a diagnosis code for prostate cancer (icd-9 = 185, 198.82, 233.4, 236.5, 239.5, v10.46) or bladder cancer (icd-9 =188, 198.1, 223.3, 233.7, 239.4, v10.51) in any position during the pre-index or follow-up period * a pharmacy claim for finasteride 1 mg tablets (i.e., treatment of male-pattern baldness) during the pre-index or follow-up period * prostate surgery anytime during the pre-index period or 5 months after the index date

Keywords: benign prostatic hyperplasia surgery 5-alpha-reductase inhibitor enlarged prostate acute urinary retention
effects of different physiotherapy programs on functional constipation

Conditions: Functional Constipation

Summary: this study compares the effectiveness of a more comprehensive behavioral treatment, physical activity and exercise program, as well as ctm and if current stimulation approaches at different frequencies on functional constipation symptoms and quality of life, compared to their counterparts in the literature.

functional constipation (fc), which is characterized by conditions such as excessive straining and difficulty in defecation, infrequent bowel movements, and incomplete defecation, is a common bowel disease that causes activity limitation and decrease in quality of life in children and adults, regardless of an organic etiology. in the literature, there are studies showing the effectiveness of different physiotherapy approaches such as behavioral therapy, exercise, neuromodulation applications, kinesiotape, abdominal massage in fc, and investigate and compare the effectiveness of connective tissue manipulation (ctm) and interferential (if) current stimulation applied in addition to behavioral therapy and exercise program. but there was any study which compare the effectiveness of these physiotherapy methods with each other and if current stimulation at different frequencies (100 hz and 0-100 hz). in addition, there are no randomized controlled studies comparing the current effects of if applied at 100 hz and 0-100 hz in individuals with fc. the treatment methods to be applied in this study are behavioral therapy, physical activity and exercise program, ctm and if current stimulation applied at a frequency of 100 hz and 0-100 hz. the diagnostic method to be used is based on the rome iv fc criteria and the bristol stool form scale.

Eligibility criteria:
inclusion criteria: * being able to read and write in turkish, * being between 18 and 65 years of age * having a diagnosis of functional constipation according to rome iv criteria * having body mass index \<35 kg/m2 exclusion criteria: * being pregnant * having comorbidities (chronic pelvic pain, neurological (parkinson's, multiple sclerosis, spinal cord lesion, etc.), metabolic / endocrine (diabetes mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases * health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.) * malignancy, acute inflammation, intestinal tumor * history of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy * contraindications to interferential current (thrombosis, pacemaker, metal implant etc.) * visual, auditory or cognitive problems which may prevent participation to the study * tumor, presence of skin problems in the application area * presence of laxative use for functional constipation in the last four weeks * alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer)

Keywords: functional constipation connective tissue manipulation interferential current stimulation exercise behavioural therapy conservative treatment
study of rsd1235 to evaluate safety in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is designed to determine the safety of rsd1235 in patients with atrial fibrillation.


Eligibility criteria:
inclusion criteria: * subject must have symptomatic af * subject must have adequate anticoagulant therapy exclusion criteria: * subject may not have class iv congestive heart failure. * subject may not have uncorrected electrolyte imbalance.

Keywords: investigational therapies atrial fibrillation treatment efficacy treatment effectiveness safety rsd1235
long-term extension study to assess safety and tolerability of oral ubrogepant tablets for the acute treatment of migraine in pediatric participants (ages 6-17)

Conditions: Migraine

Summary: migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. migraine is extremely common and disabling in children. the purpose of this study is to evaluate long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants. ubrogepant is a drug approved for the acute treatment of migraine in adults. pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. participants who completed the lead-in study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. around 1200 participants will be enrolled in the study at approximately 120 sites in the united states. participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. there will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. the study duration will be up to 54 weeks. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.


Eligibility criteria:
inclusion criteria: * completers of the lead-in study 3110-305-002 (in the main study or pk cohort) or those who screen failed due to being placebo responders. * demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an ae that may indicate an unacceptable safety risk for this study. exclusion criteria: * requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at visit 1. * an ecg with clinically significant abnormalities at visit 1 as determined by the investigator. * clinically significant abnormalities in physical examination at visit 1, as determined by the investigator. * significant risk of self-harm, based on clinical interview and responses on the c-ssrs, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, type 4 or 5 on the c-ssrs), or report suicidal behavior at visit 1 * any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.

Keywords: migraine ubrogepant ubrelvy