Kornimate/medical-research-clean huggingface dataset:
a long-term study to evaluate the safety of asoprisnil in the treatment of women with endometriosis from study m01-398

Conditions: Endometriosis

Summary: the objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study m01-398.

endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. the major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. the objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study m01-398. the safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Eligibility criteria:
inclusion criteria: * completed 3 months of dosing and month 3 procedures in study m01-398 * otherwise in good health * month 3 (m01-398) ultrasound reveals no significant gynecologic disorder exclusion criteria: * any abnormal lab or procedure result the study-doctor considers important * anticipated need for excluded hormonal therapy or unapproved narcotics

Keywords: pelvic pain dysmenorrhea dyspareunia infertility asoprisnil
a pharmacokinetic drug-drug interaction (ddi) study between sitaxsentan and sildenafil, and between sitaxsentan and tadalafil after multiple doses

Conditions: Pulmonary Arterial Hypertension

Summary: sitaxsentan has a low drug-drug interaction potential and it did not have a clinically relevant effect on pharmacokinetics of sildenafil (a cyp3a sensitive substrate and pde5 inhibitor). tadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and ambrisentan. based on overall clinical drug-drug interaction profiles, and in vitro cyp enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan and tadalafil is not expected. sildenafil is not expected to affect sitaxsentan pharmacokinetics (pk), as sitaxsentan is a substrate of cyp3a4 and cyp2c9, where sildenafil did not show clinically relevant effect on pk of substrates of cyp3a4 and cyp2c9.


Eligibility criteria:
inclusion criteria: * healthy male subjects and women of non-child bearing potential between the ages of 21 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs). * an informed consent document signed and dated by the subject or a legally acceptable representative. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at screening. * a positive urine drug screen. * subjects with hepatic dysfunction, defined as aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \>1.5 times the upper limit of the normal range at screening. a retest may be done if ast and/or alt within 1.5- to 2- times the upper limit of the normal range at screening, and the average of the first and repeated test values should be used to decide the eligibility.

Keywords: a pharmacokinetic drug-drug interaction study between sitaxsentan and tadalafil and between sitaxsentan and sildenafil at the steady-state
efficacy of pregabalin in subjects with post-stroke central neuropathic pain

Conditions: Central Neuropathic Pain

Summary: efficacy and safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (cpsp)


Eligibility criteria:
inclusion criteria: * positive history of clinical stroke at least 4 months prior to randomization cpsp--3 months prior to screening exclusion criteria: * history of dementia or any other severe cognitive impairment * diabetic peripheral neuropathy (dpn)

Keywords: post-stroke pain, pregabalin
long-term beneficial metabolic effects of adrenalectomy in subclinical cushing's syndrome of adrenal incidentaloma

Conditions: Cushing Syndrome

Summary: objective: to determine the metabolic effects of the adrenalectomy in subclinical cushing's syndrome of adrenal incidentaloma. methods: 234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group).


Eligibility criteria:
inclusion criteria: * patients with both unilateral adrenal incidentaloma and hypercortisolism * definition of hypercortisolism * overnight dexamethasone suppression test, serum cortisol\>1.8ug/dl * 24hr urine cortisol \> upper reference limit exclusion criteria: * patients who took medication influencing cortisol secretion * patients with definite clinical feature of cushing syndrome * moon face * abdominal striae * skin or proximal muscle atrophy * metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure, rheumatic disease, hematologic disease * patients who took following medication * insulin * oral hypoglycemic agent * thyroid hormone * anti-hyperlipidemic drug * sex hormone * patients who taking steroid hormone or who took steroid hormone more than 2 weeks within 1 year * psychiatric disease

Keywords: subclinical cushing syndrome hypercortisolism adrenal incidentaloma adrenalectomy
effect of kinesiotape on postural control in non-operated anterior cruciate ligament subjects

Conditions: Knee Injuries; Cruciate Ligament Rupture; Anterior Cruciate Ligament Injuries; Motor Control; Balance

Summary: anterior cruciate ligament (acl) injuries are the most common traumatic knee ligament injuries. this lesion has a devastating influence on patients' activity levels and quality of life. acl injuries are most frequent between the ages of 15 and 45 years. individuals who choose conservative treatment must undergo physical therapy to strengthen muscles around the knee, notably the quadriceps femoris and hamstring muscles. it had been described that in absence of surgical treatment, the knee remains unstable and vulnerable to injury having a much poorer prognosis. this study aims to analyze the effectiveness of neuromuscular taping (kinesiotape) compared to placebo in patients with non-operated anterior cruciate ligament rupture.


Eligibility criteria:
inclusion criteria: * patients of both sexes, diagnosed with acl rupture (clinical and imaging) between 18 and 60 years old and not yet operated. * rupture isolated or combined with meniscopathy including bucket-handle. * partial or complete acl rupture. exclusion criteria: * cognitive impairment that prevents understanding of simple commands. * unhealed wounds in the knee complex. * severe skin diseases and alterations. * previous history of allergy to any type of bandage. * neurological disease with impaired balance. * manifest deformity of the musculoskeletal system
study to investigate the efficacy and pharmacokinetic profile of k-877-er compared to k-877-ir

Conditions: Dyslipidemia

Summary: a study to evaluate the efficacy of k-877 extended release (er) once daily (qd) compared to k-877 immediate release (ir) twice daily (bid).


Eligibility criteria:
inclusion criteria: * able to provide written informed consent before any study-specific evaluation is performed * at screening, have a mean fasting tg level of ≥180 mg/dl and \<550 mg/dl; at subsequent qualification period visits confirm fasting tg level of ≥200 mg/dl and \<500 mg/dl * able to meet all inclusion criteria outlined in clinical study protocol exclusion criteria: * require lipid-altering treatments other than study drugs, statins, ezetimibe, or pcsk9 inhibitors during the study * known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists * meet any other exclusion criteria outlined in clinical study protocol
interaction of mtnr1b genotype and type of breakfast (protein-enriched v carbohydrate-rich) on postprandial glucose response.

Conditions: Glucose Metabolism Disorders

Summary: the risk version of the mtnr1b gene (which codes for a melatonin receptor) has been associated with type ii diabetes (t2d) and associated physiological markers. people with the risk version of the gene have reduced secretion of insulin when melatonin levels are high (between evening and morning) and impaired glucose tolerance when they eat late. previous research suggests eating a protein enriched breakfast can improve glucose response. therefore, the present study will investigate if the version of the mtnr1b gene that people have is associated with their glucose response after breakfast. also, whether a protein enriched breakfast improves glucose response in participants with the risk version of the gene. measures of glucose response collected over the two-week duration of the study will be compared between groups with the different versions of the gene. these findings can be used to provide personalised nutrition advice which may reduce the risk of t2d.


Eligibility criteria:
inclusion criteria: * aged 18-48 years\*, not diabetic, not sleep disorder, not relevant medication (weight loss, sleeping, melatonin), not restricted diet, not allergic to oats, milk, wheat, barley or soya, not implanted medical device, such as pacemakers. exclusion criteria: * aged \ 48 years, diabetic, sleep disorder, eating disorder, taking relevant medication (weight loss, sleeping, melatonin), following a restricted diet, implanted medical device, such as pacemakers.
incidence of emergence delirium in the pacu

Conditions: Emergence Delirium

Summary: emergence delirium (ed) is serious complication in the postoperative period in paediatric anaesthesia, reported incidence is 20-60%. it is characterized by psychomotor and perception disorder with excitation of paediatric patients. emergence delirium has impact on morbidity and even on mortality of paediatric patients in the postoperative period. the potential risk factors for ed development include sevoflurane, which is the dominant anaesthetic agent used in the paediatric patients, and which is actually the only inhalation agent used for inhalation anaesthesia induction. the incidence of ed is higher in postoperative period, for example in the post-anaesthesia care unit - pacu. patients with ed are at higher risk of psychomotor anxiety, agitation, unintentional extraction of intravenous cannula, and nausea and vomiting. for the therapy of ed propofol, midazolam and eventually ketamine in a reduced dosage are used.

after the approval of the study by the ethics committee of the university hospital brno and registration of the protocol at clinicaltrials.gov, the incidence of emergence delirium (ed) using paed, watcha and richmond agitation and sedation scale (rass) score in patients hospitalized in the post-anaesthesia care unit (pacu) after general anaesthesia, in the departement of paediatric anaesthesia and intensive care unit, university hospital brno in the term from 1.9.2020 until 30.6.2021 will be measured. paediatric emergence delirium (paed) score, watcha score and richmond agitation and sedation scale (rass) will be measured in 0., 5., 10., 15., and 20. minute after pacu admission and after obtaining rass ≥ - 2 . emergence delirium is defined as paed score above 10 points. in the case of ed development, the duration of ed will be measured as well as the number of therapeutic interventions and the cumulative dose of administered sedatives. the average paed, watcha, rass scale will be reported, the incidence of postoperative nausea and vomiting (ponv) and the cumulative dose of administered antiemetics, the type of anaesthesia induction (inhalation vs. intravenous), type of anaesthesia (tiva, combined, inhalational), length of the surgery, type of the surgery will be reported.

Eligibility criteria:
inclusion criteria: * patients after general anaesthesia hospitalized in the pacu in the term rom 1.9.2020 until 30.6.2021. exclusion criteria: * patients in the age from 0 to 1 month.

Keywords: emergence delirium anaesthesia paediatric patient
a prospective trial of bipap administration vs. non-positive pressure therapy for pediatric status asthmaticus

Conditions: Status Asthmaticus

Summary: though bipap is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for bipap in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. in this study, which is among the first randomized studies of bipap use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.


Eligibility criteria:
inclusion criteria: * primary diagnosis of asthma exacerbation * admitted to cohen children's medical center (ccmc) picu * ccmc respiratory severity score of 6 or higher at the time of enrollment * prior history of asthma or reactive airway disease exclusion criteria: * no prior history of asthma or reactive airway disease * facial or airway anomalies precluding bipap mask use * tracheostomy * lack of airway protective reflexes * neurologic or musculoskeletal abnormalities affecting respiration * underlying cardiovascular problems that may be negatively affected by positive pressure ventilation * intracranial problems (such as in the setting of head injury) that may be negatively affected by positive pressure ventilation * respiratory compromise for which emergent endotracheal intubation or non-invasive positive pressure ventilation is warranted as determined by the on-service attending physician
early lung cancer detection in patients with sputum cytology and autofluorescence bronchoscopy in people at high risk of lung cancer

Conditions: Lung Neoplasms

Summary: lung cancer is the commonest malignant disease with a 5-year survival of 14%. in hong kong, it accounts for about 30% of all cancer death. the poor prognosis of lung cancer is due largely to the late clinical presentation of the disease. in order to improve the prognosis of lung cancer, an obvious approach is to develop sensitive methods for detecting lung cancer at much earlier stages when treatment is more likely to be curative. however, the best way for identifying early lung cancer is still need to be determined. we hypothesis that by examining specimens that contain shed bronchial epithelial cells i.e. sputum, lung cancer can be sampled in its earliest possible phase. and by using autofluorescence bronchoscopy, a system specifically designed to detect early lung cancer/pre-invasive lesions, to identify the source of abnormal cells, we may able to detect eraly lung cancer and followed by curative treatment to improve the prognosis of this disease.


Eligibility criteria:
inclusion criteria: * current or ex-smokers who have smoked at least 20-pack-years (e.g. 1 pack per day for 20 years or more) * informed consent exclusion criteria: * known malignant disease * unstable major medical disease * bleeding disorder * unwilling to have a bronchoscopy * women currently pregnant or nursing * known reaction to xylocaine, a local anaesthesia agent used for bronchoscopy

Keywords: lung cancer
mechanical modalities vs. standard care for edema and pain management after drf fixation

Conditions: Distal Radius Fractures

Summary: this single-blinded, randomized controlled trial (rct) will evaluate the added benefit of mechanical modalities (continuous passive motion (cpm) and intermittent pneumatic compression (ipc)) when integrated into standard therapy for managing postoperative edema and pain in patients undergoing distal radius fracture (drf) fixation. the primary outcomes are edema volume (measured via volumeter) and pain intensity (numeric pain rating scale, nprs) at 6 weeks post-operation. secondary outcomes include wrist/forearm range of motion (rom), grip strength, patient-rated wrist evaluation (prwe), and adverse events.


Eligibility criteria:
inclusion criteria: adults aged 18 years or older. undergoing surgical treatment for distal radius fracture with stable internal fixation. able to initiate formal rehabilitation approximately 2 weeks postoperatively. willing and able to attend in-clinic therapy sessions at the outpatient hand therapy center. exclusion criteria: unstable fixation or need for further surgical intervention. pre-existing conditions that would significantly affect upper limb function (e.g., severe arthritis, neurological disorders). history of skin conditions or allergies that contraindicate the use of mechanical devices. any contraindication to mechanical modalities (for example, severe peripheral vascular disease). inability to comply with study procedures or follow-up visits. pregnant or breastfeeding individuals.
open label extension of prior terms study to treat relapsing forms of multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting; Clinically Isolated Syndrome

Summary: the purpose of this study is to further evaluate the safety and efficacy of tovaxin in the treatment of relapsing forms of multiple sclerosis.

the subjects with positive myelin-reactive t cells (mrtc) in their blood during the previous terms study will immediately be eligible for tovaxin production and treatment in this open label extension study. the mrtc negative subjects will be monitored quarterly for safety, mrtc reactivity, paraclinical and clinical effect. subjects who become mrtc positive during the monitoring phase will then be eligible for tovaxin production and treatment in this study.

Eligibility criteria:
inclusion criteria: * subjects who completed the terms study and received at least 1 study treatment injection * signed and dated statement of informed consent exclusion criteria: * pregnancy or breastfeeding * experienced a serious adverse drug reaction with confirmatory relationship to tovaxin in the terms study. * withdrew from terms study and did not continue participating in the remaining 52-week core terms study assessments. * non-compliant with terms study. * diagnosis of progressive-relapsing, secondary progressive or primary progressive multiple sclerosis (ms) while enrolled in the terms study. * medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study. * any significant change in the subject's medical condition after enrollment in the terms study which would have lead to his/her exclusion from participation in that study.

Keywords: tovaxin autologous t-cell vaccine (tcv)
retrospective analysis of a population of patients with with severe traumatic head injury and woken early

Conditions: Traumatic Head Injury

Summary: observational retrospective study that included all patients meeting the inclusion criteria from 1st january 2014 to 31st december 2015. the objective of the study is to describe and compare two populations of patients with severe traumatic head injury arriving under sedation in the department in whom the sedation was not continued.


Eligibility criteria:
inclusion criteria: - patients with traumatic head injuring arriving in the neurosurgery and traumatologic intensive care unit under sedation exclusion criteria: * brain death within the 48h following admission, * stroke leading to the traumatic head injury, * death within the 24h following admission, * patients not under sedation on admission to the unit, * non-sedated patients transferred directly to the operating theatre * traumatic brain injury in patients presenting chronic sub-dural haematoma, * continued sedation (\> 15h) in the icu.
effect of bariatric surgery versus optimal medical therapy on cardiovascular health and atherosclerosis in obese, type ii diabetic patients

Conditions: Obesity; Diabetes Mellitus, Type 2; Atherosclerosis

Summary: to assess the impact of weight loss due to bariatric surgery, as compared to the effect of optimal medical therapy alone on endothelial function, subclinical atherosclerosis, cardiovascular autonomic function in obese patient affected by type 2 diabetes.the study consists in a 2-arm randomized trial, in which patients will be randomly assigned to bariatric surgery or optimal medical therapy. each patient will be studied at baseline (t0) and 12 months thereafter (t1).


Eligibility criteria:
inclusion criteria: * type 2 diabetes: the american diabetes association (ada) recommends the following criteria for diagnosis of diabetes: hba1c ≥6.5% or fasting plasma glucose‡ ≥126 mg/dl (7.0 mmol/l) or 2-hour plasma glucose ≥200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test; 75-g glucose load should be used or random plasma glucose concentration ≥200 mg/dl (11.1 mmol/l) in persons with symptoms of hyperglycemia or hyperglycemic crisis; * indication to bariatric surgery: bmi ≥35 kg/m2 and one or more obesity related co-morbidities, including type 2 diabetes mellitus. exclusion criteria: * overt cardiovascular disease (as assessed by clinical evaluation, physical examination, 12-lead ecg, 2d-echocardiogram); * smoking habit; * associated medical conditions, as chronic kidney disease (defined as creatinine clearance \<60 ml/min/l.73m2), liver cirrhosis, malignancies, chronic congestive heart failure, acute or chronic inflammatory disease; * specific contraindication to bariatric surgery; * pregnancy; * medical conditions requiring acute hospitalization; * psychological conditions which may hamper patient's cooperation; * geographic inaccessibility.
efficacy and safety of shr-2010 injection in the treatment of primary iga nephropathy

Conditions: Primary IgA Nephropathy

Summary: the study is being conducted to evaluate the efficacy, and safety of shr - 2010 injection in patients with primary iga nephropathy.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. renal biopsy confirmed primary iga nephropathy 3. 24 hours urinary protein quantity ≥1g, or upcr≥0.8 g/g 4. egfr≥30 ml/min/ 1.73m2 5. 40kg≤ weight ≤100kg 6. has been treated with optimized supportive treatment. (acei or arb to maximum recommended dose or maximum tolerated dose). exclusion criteria: 1. systemic disease which may cause secondary iga deposition in the mesangial region 2. specific type of iga nephropathy 3. history of severe opportunistic infection 4. a history of chronic or recurrent infection within 1 year prior to screening 5. history of active digestive system within one year 6. have a malignant tumor or a history of malignant tumor 7. subjects who have received organ transplants 8. associated with other serious or poorly controlled systemic diseases 9. hepatitis, syphilis, human immunodeficiency virus (hiv) infection 10. received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period. 11. received any systemic glucocorticoid 8 weeks before screening or during run-in period