Kornimate/medical-research-clean huggingface dataset:
a placebo-controlled trial of modafinil (provigil) added to clozapine in patients with schizophrenia

Conditions: Schizophrenia

Summary: this pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. modafinil will be initiated at 100 mg/d. after 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. dose escalation will be based upon persistence of sedation versus emergence of side effects.

this pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. modafinil will be initiated at 100 mg/d. after 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. dose escalation will be based upon persistence of sedation versus emergence of side effects. 1. evaluate tolerability and safety of modafinil compared to placebo using the saftee and vital signs. 2. evaluate the effect size of modafinil compared to placebo upon wakefulness and fatigue using the epworth sleepiness scale (ess) and the fatigue severity scale (fss). 3. evaluate the effect size of modafinil compared to placebo upon negative symptoms using the sans total score. 4. evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests. 5. evaluate the effect size of modafinil compared to placebo upon weight, bmi, waist/hip circumference and fasting glucose and lipids. 6. effect the variability of response in placebo and modafinil groups for each of the outcome measures.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, any subtype or schizoaffective disorder * ages 18-65 years * capable of providing informed consent, or capable of providing assent with a guardian who provides informed consent * stable dose of clozapine for at least 1 month * three months of stable psychotic symptoms exclusion criteria: * serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.) * current substance abuse * pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile. * unable to complete neuropsychological tests * history of serious blood dyscrasia requiring discontinuation of clozapine * serious suicidal or homicidal risk within the past six months * current treatment with a psychostimulant

Keywords: schizophrenia clozapine cognition metabolic syndrome negative symptoms wakefulness fatigue
effect of treatment of low anterior resection syndrome after rectal cancer surgery

Conditions: Low Anterior Resection Syndrome

Summary: a randomized controlled trial (rct) in patients who underwent sphincter preserving surgery due to rectal cancer. the study will analyze the effect of transanal irrigation (tai) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

a randomized controlled trial (rct) in patients who underwent sphincter preserving surgery due to rectal cancer. the study will analyze the effect of transanal irrigation (tai) and medication that can help control of the bowel movement in patients with low anterior resection syndrome. an interim analysis will be made after 40 included patients in the study.

Eligibility criteria:
inclusion criteria: * patients that have undergone surgery for rectal cancer (sphincter saving surgery, low anterior resection) * adult ≥ 18 years old * have scoring major lars (according to the low anterior resection syndrome score) exclusion criteria: * stoma * recurrent disease * another colorectal surgery * inflammatory bowel disease (ibd)
extension study to evaluate the long-term safety, tolerability, and maintenance of effect of biib074

Conditions: Neuropathic Pain From Lumbosacral Radiculopathy

Summary: the primary objective of the study is to evaluate the long-term safety and tolerability of biib074 in participants with neuropathic pain from lumbosacral radiculopathy (plsr). a secondary objective is to investigate the maintenance of effect during long-term treatment with biib074 in participants with neuropathic plsr. for all efficacy assessments, baseline will be prior to randomization into study 1014802-203. another secondary objective is to evaluate the impact of treatment with biib074 on quality of life (qol).

this study was previously posted by convergence pharmaceuticals, ltd., which has been acquired by biogen. this is an extension study to 1014802-203.

Eligibility criteria:
key inclusion criteria: * has completed study 1014802-203 for its complete duration. key exclusion criteria: * has met an exclusion criterion for the preceding double-blind phase 2b study (study 1014802-203). * had a protocol deviation regarding inclusion or exclusion criteria for the double-blind phase 2b study (study 1014802-203). * had a treatment-related ae or sae that would pose an increased risk for continued treatment with biib074, or discontinued study treatment in the double-blind phase 2b study (study 1014802-203) due to an ae or sae. * did not return for all study visits after discontinuing treatment in the double-blind phase of the phase 2b study. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: neuropathic pain from lumbosacral radiculopathy
safety, efficacy and acceptability of flavocoxid (limbrel)a pilot study

Conditions: Osteoarthritis

Summary: safety, efficacy and acceptability of flavocoxid

safety, efficacy and acceptability of flavocoxid (limbrel) compared with naproxen in subjects with osteoarthritis of the knee. a pilot study

Eligibility criteria:
inclusion criteria: oa of the knee,k-l grade 2-3 in general good health is currently taking an nsaid or cox-2 inhibitor - exclusion criteria: pregant or nursing women grade 1 or 4 oa any significant medical condition that in the opinion of the physician might put the subject at risk in this study any form of arthropathy other than oa any condition that might confound the evaluation of the pain, stiffness or function of the target joint intra-articular cotticosteroid inkection in the target joint within 3 month of the screening visit concomitant use of other anti-inflammatory or anti arthritic medication or products(including otc and herbal preparations) low dose aspirin for cardio-protection is allowed concomitant use of coumadin or other anticoagulant or anti-platelet medication concomitant use of gastro-protectiv medications including, but not limited to, h2 blockers and proton pump inhibitors, including otc and herbal products history of allergy to flavonoids -
the effect of yoga practice on chronic back pain

Conditions: Chronic Back Pain

Summary: chronic low back pain is notoriously difficult to treat and is a primary contributor to lost work days and excessive health expenditures, and whose treatment has, in part, contributed to the opioid crisis. surgery is only an option in a minority of these patients, usually confined to those with structural instability. yoga is an ancient modality whose benefits are currently being studied.

the purpose of this research study is to determine whether a 6 week standardized yoga practice is superior to usual conservative therapies in the treatment of chronic back pain at 6 months. there is enough data that the most recent acp guidelines have included yoga as a treatment for chronic back pain, but more data needs to be generated regarding the efficacy of this modality in treating the chronic back pain population.

Eligibility criteria:
inclusion criteria: * willingness to and ability to participate in study procedures * chronic back pain (pain above the gluteal cleft of at least 3 months duration) exclusion criteria: * indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis) * cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice
sleep disorder in inflammatory bowel disease and its association with disease activity

Conditions: Sleep Disorder; Inflammatory Bowel Diseases

Summary: recently, an association between active inflammatory bowel disease (ibd) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. this study aimed to investigate prevalence of poor sleep quality in ibd and association with disease activity by subjective and objective measures. prospective observational study is conducted with expected sample size of 100 patients. participants are classified into active and inactive disease status according to standard ibd severity assessment measures. demographic data, disease activity, quality of life, sleep questionnaire (validated psqi questionaire), and seven-day sleep data acquired from ambulatory wrist actigraphy were obtained. association between sleep quality and disease activity will be analyzed.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosed inflammatory bowel disease, followed up in siriraj hospital, mahidol university exclusion criteria: * unstable medical conditions * known psychiatric disease * patients who could not withhold sedative drugs * pregnant patients * obese patients with body mass index (bmi) ≥ 35 kg/m2 * refuse to sign a consent/ had cognitive impairment
factors associated to intensive care admission and mortality in patients with emphysematous pyelonephritis

Conditions: Emphysematous Pyelonephritis

Summary: emphysematous pyelonephritis is a lifethreatening necrotizing infection of the kidney characterized by accumulation of gas in the renal parenchyma and within the surrounding tissues. the aim of the study is to report the outcome of the management of this condition at the investigators institution and to determine the microbiological characteristics, antibiotic resistance patterns, and to analyze factors predicting mortality and intensive care unit admission.

the investigators are planning to perform a retrospective study analyzing cases of emphysematous pyelonephritis from a single tertiary care institution in the north of mexico in the period of 2011-2021. the diagnosis of emphysematous pyelonephritis is confirmed by computed tomography. demographic, clinical, biochemical, therapeutic management, and outcomes will be collected. variables will be analyzed to determine factors associated with admission to intensive care unit and mortality. urine cultures will be analyzed and drug resistance profile will be determined using microdilution plate. clinical and demographic characteristics will be analyzed using chi square test for categorical variables, and t-test for numerical variables. statistical significance is set at p\<0.05. statistical analysis will be performed with the spss software version 20.0.

Eligibility criteria:
inclusion criteria: * emphysematous pyelonephritis confirmed with computed tomography * systemic inflammatory response * urinary tract infection symptoms * complete medical records * both genders included * \>18 years old exclusion criteria: * other infectious causes * asymptomatic bacteriuria * incomplete medical records * endourologic procedure 3 months before recruitment

Keywords: emphysematous pyelonephritis intensive care unit mortality risk factors
microbial adhesion to metallic versus non metallic surfaces of bounded removable partial denture

Conditions: Polyetheretherketone

Summary: a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both peek versus cobalt chromium alloy denture base.

this study aimed to compare the adhesion of microorganisms to the non metallic denture base of peek and metallic denture base of cobalt chromium alloy in patients with class iii modification 1

Eligibility criteria:
inclusion criteria: * patients are medically free exclusion criteria: * patients with badly broken abutments
remission factors in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: anorexia nervosa (an) is a complex and multifactorial psychiatric disease that affects mostly women and is characterized by a self-restriction of food intake leading to life-threatening consequences whose underlying mechanisms are largely unexplored. an encompasses a constellation of risk factors including genetic, biological, neuro-psychological and social factors. although an has a prevalence of only 1-3% in the general population, it has the highest mortality rate amongst any psychiatric disorder. recovery of normal feeding behaviour in patients often requires several months with a large between-patient variability and a high percentage of relapse, which can occur in 35 to 41% of the patients. there is a huge unmet need for optimal understanding of processes underlying relapse. reward processing abnormalities represents an important hypothesis underlying an development and perpetuation. we aim to investigate the mechanisms that contribute to the maintenance and chronicity of the disease after inpatient treatment with a longitudinal design across intensive standardized inpatient treatment. we will challenge our hypothesis through brain imaging, neuropsychological, metabolic and genetic approaches. one hundred twenty-five an female patients admitted for intensive inpatient treatment will be recruited and evaluated: at admission, after weight recovery and at 6 months after discharge with neurocognitive tests (including the delay discounting task), genetic/epigenetic examination, hormonal blood samples (at each visit and repeated sampling around a meal for a 10-patient subgroup) and brain imaging (including fmri during a delay discounting task for fifty patients). one hundred healthy controls will be also recruited and be subjected to the same study procedures.


Eligibility criteria:
inclusion criteria: * dms 5 criteria for anorexia nervosa * bmi \< 18.5 kg/m² * being able to consent * fluent in french * being affiliated to a social security scheme or being the beneficiary of such a scheme. * having signed the informed consent exclusion criteria: * deprived of liberty subject (judicial or administrative decision) * refusal to participate * presenting an unstabilized serious physical illness or psychiatric disorder compromising the follow up according investigator evaluation * contraindication for irmf * pregnant or breast-feeding women

Keywords: eating disorder anorexia nervosa delay discounting ghrelin genetic epigenetic
tramadol/acetaminophen(ultracet) as add-on therapy in the treatment of patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: tramadol 37.5 mg/apap 325 mg combination tablets (ultracet®) were effective and safe as addon therapy with cox-2 nsaid for treatment of osteoarthritis (5) and chronic low back pain (6).there is no clinical trial regarding tramadol usage in chronic inflammatory arthritis such as rheumatoid arthritis (ra) or ankylosing spondylitis. it would be important to do a pilot clinical trial on add-on effect of tramadol to nsaid in patients with as or ra.

ankylosing spondylitis (as) is a chronic inflammatory arthritis causing back pain, peripheral arthritis and enthesitis due to genetic background and autoimmunity. patients with ankylosing spondylitis usually suffered from chronic pain over spine and peripheral joints since their second or third decades. it may also cause severe social and psychological burden to patients and their family. exercise and non-steroid anti-inflammatory drugs (nsaid) are the standard first-line treatments for as（1）. only 50% of patients with as reach the asas response criteria（2） in clinical trials. patients with severe disease activity should be put on disease-modifying anti-rheumatic drugs (dmard), such as sulfasalazine（3） and anti-tnf biological agents. add-on of acetaminophen and low dose anti-depressant （4）can slightly improve the response rate. however, there is no data if tramadol or ultracet can benefit as.

Eligibility criteria:
inclusion criteria: 1. diagnosis of as, as defined by modified new york criteria for ankylosing spondylitis 2. active as, defined by bath ankylosing spondylitis disease activity index (basdai) \>3 cm at screening visit. 3. between 18 and 70 years of age. exclusion criteria: 1. change of dosage of disease modifying antirheumatic drugs (dmards) including glucocorticoid, hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. 2. change of dosage of biological agents within 4 weeks of baseline. 3. abnormality in chemistry profiles: serum creatinine 3.0 mg/dl; alanine aminotransferase (alt\[sgpt\]) 5 times the laboratory's upper limit of normal. 4. pregnant or breast-feeding women.
a trial to evaluate a device for the treatment of osa and snoring

Conditions: Obstructive Sleep Apnea; Snoring

Summary: to evaluate the safety and efficacy of the tongue advancement retainer device in treating subjects with obstructive sleep apnea (osa) and snoring.

the tongue advancement retainer device is a device that was developed to treat subjects with osa and snoring. the purpose of this study is to evaluate initial safety and effectiveness of this device in treating one or both conditions.

Eligibility criteria:
inclusion criteria: * • aged 18-65 * ahi greater than or equal to 10 but less than or equal to 60 (\<10 ahi \<60/hr) * complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth additionally subjects will in the screening phase must: * tolerate the device when being fitted * used the device for \>4 hours on at least two consecutive nights during the screening period. * be able to reliably demonstrate proper installation of the device after fitting. * be willing to trial the device for a 4 week period exclusion criteria: * • central sleep apnea events \>10% of the total events * evidence of cheyne stokes breathing * currently on treatment for osa or osa treatment discontinued less than 3 months prior. * currently on regular treatment with prescription hypnosedatives or prescription stimulants * very severe osa, defined as ahi\>60/hour and/or minimum oxygen saturation \<75% * need for immediate initiation of treatment as assessed by physician (e.g. excessive sleepiness posing driving risk) * previous surgery to treat osa (other than nasal surgery) * evidence of periodontal disease or tooth mobility * severe nasal obstruction or enlarged tonsils based on clinical assessment * unstable cardiovascular disease (untreated hypertension acceptable). * inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator * pregnant/breast feeding * any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.

Keywords: obstructive sleep apnea osa snoring tongue advancement retainer device
influence of freeo2 on percentage of time within oxygen saturation target using noninvasive ventilation (niv) and continuous positive airway pressure (cpap) for patients admitted for aecopd or bariatric surgery

Conditions: COPD Exacerbation; Oxygen Toxicity; Abdominal Obesity; Surgery

Summary: the main objective is to evaluate the freeo2 device combined with noninvasive respiratory support technique for copd patients and postoperative bariatric surgery patients. the main hypothesis is that freeo2 device for oxygen therapy associated with niv or nasal high flow oxygen therapy (nhfot) allows to reach better oxygenation and avoid hypoxemia and hyperoxia.

bariatric surgery patients: the main objective of this study is to evaluate the time spent in the spo2 target (+/- 2% spo2 target) and partial pressure of carbon dioxide (pco2) values on patients with morbid obesity after bariatric surgery. copd patients: the main objective of this study is to evaluate the time spent in the spo2 target (+/- 2% spo2 target) and pco2 values on patients with exacerbation of copd (hypercapnic patients) with different ventilatory supports (niv and nhfot) associated with freeo2.

Eligibility criteria:
inclusion criteria (aecopd): * respiratory acidosis (ph \ 45 mmhg), with or without niv (last blood gas available during hospitalization) * oxygen therapy and/or spo2 \<90% room air (fio2 \<= 50% or nasal cannula \<= 7 l/min to maintain spo2 90%) * high flow nasal cannula with flow \<= 30 l/min inclusion criteria (bariatric surgery post-op): * patients using cpap before the surgery (obstructive sleep apnea documented). * patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included. exclusion criteria: * age \< 18 * pregnancy * respiratory distress or other clinical situation requiring continuous niv or cpap * glasgow \< 12 or agitation/delirium/dementia (limiting niv) * any contraindication to niv (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery) * hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes) * refusal to consent to the study 5 patient with aecopd and 5 patient with bariatric surgery will be included.
bis monitoring effect on delirium occurrence and nursing quality improvement recovering from general anesthesia

Conditions: Delirium, Postoperative

Summary: ①effects of bis index (bis) monitoring on delirium incidence in post-anesthesia care unit (pacu) in patients undergoing general anesthesia ②effects of bis bis index (bis) monitoring on the quality of nursing care in the post-anesthesia care unit (pacu)

the effect of intraoperative anesthesia depth monitoring on delirium occurrence and improvement of nursing quality in the post-anesthesia care unit (pacu) remains unclear. we aimed to explore the effect of intraoperative anesthesia bispectral index (bis) monitoring on delirium occurrence and improvement of nursing quality in the pacu for patients recovering from general anesthesia. this randomized controlled trial included 120 patients, aged 20-80 years and classified as grades i-iii according to the american society of anesthesiologists. the bis-guided group (group b) underwent intraoperative monitoring of bis anesthesia depth (maintained within the anesthetic range \[40-60\]). the depth of anesthesia was not monitored in the non-bis-guided group (group c). the patients' vital signs were recorded at the beginning of the operation (t0), upon entering the pacu (t1), 15 min after extubation (t2), and after leaving the pacu (t3). delirium score, emergence period (extubation and pacu observation times), and adverse events in the pacu were monitored. the nursing activity score (nas) was used to evaluate the quality of care.

Eligibility criteria:
inclusion criteria: 1. age ranging from 20 to 80 years 2. estimated operation time of 2 to 3 h 3. body mass index ≤30 kg/m2 4. normal preoperative heart, liver, lung, and renal function. exclusion criteria: 1. past cognitive impairment (dementia, cognitive impairment, mental illness or mental disorder) 2. complex injuries: multiple fractures, chest and abdomen, pelvic and sacral trauma, head trauma, etc 3. contraindications to intraspinal puncture (coagulation dysfunction, thrombocytopenia, intraspinal space occupation, puncture site infection, etc.) 4. have a history of acute myocardial infarction or stroke within 3 months 5. patients with severe liver dysfunction (child-pugh c) or renal failure 6. contraindications to ketamine, such as malignant hypertension

Keywords: bispectral index; postoperative delirium