Kornimate/medical-research-clean huggingface dataset:
perioperative multimodal general anesthesia focusing on specific cns targets in patients undergoing cardiac surgeries

Conditions: Postoperative Delirium; Hemodynamic Instability; Pain; Neurocognitive Dysfunction

Summary: in the pathfinder 2 trial, the study investigators will test the intraoperative eeg-guided multimodal general anesthesia (mmga) management strategy in combination with a postoperative protocolized analgesic approach to: 1. reduce the incidence of perioperative neurocognitive dysfunction in cardiac surgical patients 2. ensure hemodynamic stability and decrease use of vasopressors in the operating rooms 3. reduce pain and opioid consumption postoperatively

the investigators propose to randomize (1:1) 70 patients undergoing cardiac surgery to the perioperative eeg-guided mmga bundle (described in full below) or standard-of-care management based primarily on the use of sevoflurane for unconsciousness and intermittent doses of fentanyl and hydromorphone for antinociception. the team will test the intraoperative eeg-guided mmga management strategy in combination with a postoperative protocolized analgesic approach to reduce the postoperative increase of surgical and delirium markers, reduce intraoperative abnormalities in brain health monitoring, ensure hemodynamic stability and decreased use of vasopressors in the operating rooms and reduce pain and opioid consumption postoperatively. the team will also investigate whether eeg-guided mmga strategy reduces the incidence of perioperative neurocognitive dysfunction in cardiac surgical patients. this approach will further individualize care and minimize the use of intraoperative vasopressor-inotropic dose, dose of anesthetic medications, and postoperative opioids given to each patient potentially preventing hemodynamic complications and post-operative cognitive dysfunction after surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years * undergoing any of the following types of surgery with cardiopulmonary bypass limited to coronary artery bypass surgery (cabg), cabg+valve surgeries and isolated valve surgeries. exclusion criteria: * preoperative left ventricular ejection fraction (lvef) \<30% * emergent surgery * non-english speaking * cognitive impairment as defined by total moca score \< 10 * currently enrolled in another interventional study that could impact the primary outcome, as determined by the pi * significant visual impairment * chronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year) * hypersensitivity to any of the study medications * known history of alcohol (\> 2 drinks per day) or drug abuse active (in the past year) history of alcohol abuse (≥5 drinks/day for men or ≥4 drinks/day for women) as determined by reviewing medical record and history given by the patient * liver dysfunction (liver enzymes \> 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.
first-in-man safety and efficacy trial of a novel non-invasive bladder emptying device: the nibed study

Conditions: Urinary Retention

Summary: the non-invasive bladder emptying device (nibed) is a handheld medical device that is applied to the penis during urinating to aid bladder emptying in urinary retention patients with increased residual urine volume. this pilot study primarily seeks to determine the safety of the nibed. secondary objectives are to assess the efficacy of the nibed, which is defined as the ability of the medical device to aid or improve bladder emptying, i.e. leads to less residual urine compared to not using the nibed. during the intervention, the study participant will urinate with and without the nibed. safety variables such as penile pain, penile lesions and hematuria will be recorded. efficacy will be assessed by measuring voided volume, residual volume, voiding time and urine flow rate.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * age 18 years or older * sex: male * diagnosed with underactive bladder (uab) (confirmed with urodynamic testing) exclusion criteria: * acute urinary tract infection * patients on anti-coagulants (exception aspirin) * penile pain (nprs score \>2) * pain during voiding (nprs \>2) * penile lesions (nrs score \>2) * hematuria \>2+ * mechanical subvesical obstruction (confirmed by cystoscopy) (exception bpo) * transurethral resection of the prostate (turp) less than three months before visit 2 * penile abnormalities (buried penis, peyronie's disease, skin lesions) * asensitive bladder (no sensation of bladder fullness) * shy bladder * indwelling transurethral catheter * inability to understand and follow the study protocol * previous enrolment into the current study * enrolment of the investigator, his/her family members, employees and other dependent persons * participation in another interventional clinical trial within 3 months prior to visit 2 or planned participation during the trial * lacking capacity for consent

Keywords: medical device bladder emptying underactive bladder benign prostatic obstruction residual urine non-invasive
a study of mk0359 in patients with chronic asthma (0359-013)

Conditions: Asthma

Summary: a study to test the effect of mk0359 in lessening the symptoms of asthma as compared to placebo.


Eligibility criteria:
inclusion criteria: * you are between the ages of 18 and 45 * you have had a history for at least a year of copd symptoms * your current asthma treatment is limited to short-acting beta-agonists(such as albuterol) * you have a history of smoking one pack of cigarettes per day for 7 years * you will not be away from home for more than 5 days during the study exclusion criteria: * you are unwilling to limit your alcohol use to less than 5 drinks per week * you have been in a research study with an investigational drug or vaccine in the last 4 weeks * you have donated blood in the last 4 weeks * you have been hospitalized or had major surgery in the last 4 weeks * you have been treated in the emergency room within the last 4 weeks or hospitalized within the last 3 months for your asthma * you have a history of heart problems in the last 6 months * you have a history of stomach problems * you are unwilling to avoid grapefruit juice throughout the study
study to evaluate the safety and efficacy of cj-30060 in hypertensive patients with hyperlipidemia

Conditions: Hypertension With Hyperlipidemia

Summary: to evaluate the safety and efficacy of cj-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia


Eligibility criteria:
inclusion criteria: * aged between 19 and 74 years * patient with dyslipidemia and hypertension exclusion criteria: * at screening, sisbp ≥ 200 mmhg or sidbp ≥ 120mmhg or ldl-c \> 250mg/dl or tg ≥ 400mg/dl * at screening, sisbp difference is ≥ 20 mmhg or sidbp difference is ≥10 mmhg * secodary hypertension * type i or uncontrolled diabetes mellitus (hba1c ≥ 9 %)
safety of a topical antifungal treatment for tinea cruris, tinea pedis and tinea corporis

Conditions: Tinea Pedis; Tinea Cruris; Tinea Corporis

Summary: the purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with product 33525.


Eligibility criteria:
inclusion criteria: * evidence of tinea cruris, tinea pedis, or tinea corporis. additional criteria listed in protocol exclusion criteria: * pregnancy and allergies. additional criteria listed in protocol
adrcs in the treatment of hand dysfunction due to scleroderma

Conditions: Scleroderma, Diffuse

Summary: the primary objective of this study is to assess the safety and efficacy of the celution device in the processing of an autologous graft consisting of adipose derived regenerative cells (adrcs) in the treatment of hand dysfunction due to scleroderma.

the primary objective of this study is to assess the safety and efficacy of the celution device in the processing of an autologous graft consisting of adipose derived regenerative cells (adrcs) in the treatment of hand dysfunction due to scleroderma.

Eligibility criteria:
key inclusion criteria: * diffuse cutaneous scleroderma (duration \> 5 years) * cochin hand function scale ≥ 20 units * symptoms consistent with raynaud's phenomenon * ability to safely undergo liposuction key exclusion criteria: * active infection * contracture(s) of any finger * sympathectomy within 6 months of screening visit * rheumatoid arthritis

Keywords: hand dysfunction scleroderma scleroderma, diffuse
open-label extension study of upadacitinib in adult participants with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a study for adults (18-75 years) who have successfully completed treatment either with dupilumab or with upadacitinib in the study m16-046. at the end of m16-046, they have the option to receive upadacitinib with a duration of 52 weeks beyond the timeframe of study m16-046. there will be a 30 day follow-up visit after the treatment period is completed. main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study m16-046.


Eligibility criteria:
inclusion criteria: * participants should have successfully completed treatment in the m16-046 study, without meeting any permanent discontinuation criteria. * participant is judged to be in general good health (other than ad) as determined by the principal investigator and remains eligible as per the criteria for the study m16-046 to continue treatment in the long term extension study. exclusion criteria: * requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions. * female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Keywords: atopic dermatitis upadacitinib abt-494 rinvoq
postural control, ankle and trunk proprioception in type 2 diabetes

Conditions: Type2diabetes

Summary: the investigators aim to assess the postural control, ankle, and trunk proprioception, plantar sensation, and general cognitive status in patients with type 2 diabetes.

the investigators aim to assess the postural control on different floors with eyes open, eyes closed, and cognitive dual-task, ankle, and trunk proprioception, plantar sensation, and general cognitive status of patients diagnosed with type 2 diabetes between the ages of 18-65, and to compare them with healthy controls.

Eligibility criteria:
inclusion criteria: * be between the ages of 18-65 * volunteering to participate in researc * being diagnosed with type 2 diabetes according to the criteria of the american diabetes association (ada) exclusion criteria: * insufficient cognitive level * traumatic nerve injury * presence of congenital anomaly in the upper extremity * presence of systematic disease (eg: rheumatological) * having a problem involving the neurological system * surgery involving the upper extremity in the last 6 months

Keywords: type 2 diabetes postural control proprioception sensation cognition
the safety and efficacy of the 4 channel nmes on swallowing

Conditions: Dysphagia

Summary: this study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. the purpose of this study is to investigate the difference in 4ch nmes and 2ch nmes, and to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.

* design: prospective study * inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study * intervention: participants are divided into two group and applied electrical stimulation by a "synchronized electrical stimulation device(sesd)" in 4channel or 2channel neuromuscular electrical stimulation. * main outcome measures: videofluoroscopic parameters, eq-5d (euroqol-5d) questionnaire, ii. m. d anderson dysphagia inventory

Eligibility criteria:
inclusion criteria: * patient who do not belong to the criteria excluded for subjects aged 19 years or older * patient who is confirmed to be dysphagia by videofluoroscopy * patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury * those voluntarily agreeing to the clinical trial exclusion criteria: * patient who refuse inspection, do not agree * simple "commend obey", first step is impossible * when instructions can not be executed due to dementia, psychiatric disorders, etc. * dysphagia occurs due to respiratory failure, neck surgery, etc., * pregnant women and lactating women

Keywords: stroke cervical spinal cord injury
carpal tunnel syndrome and amyloidosis

Conditions: Amyloidosis; Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. the investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid.

carpal tunnel syndrome (cts) can be caused by the deposition and accumulation of misfolded proteins called amyloid and is often an early manifestation of systemic amyloidosis. patients with cardiac amyloidosis often have carpal tunnel syndrome that precedes cardiac manifestations by several years, and many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand. the investigators sought to identify the prevalence and type of amyloid deposits in patients undergoing carpal tunnel surgery and evaluate for cardiac involvement

Eligibility criteria:
inclusion criteria: * patients undergoing carpal tunnel syndrome surgery exclusion criteria: * none

Keywords: carpal tunnel syndrome amyloidosis
carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding

Conditions: Esophageal Varices

Summary: carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

a randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Eligibility criteria:
inclusion criteria: * • aged \>18 years * cirrhotic patients with arterial hypertension * endoscopic evidence of medium/large-sized esophageal varices exclusion criteria: * • history of variceal bleeding or previous primary prevention of varices. * portal vein thrombosis or previous porto-systemic shunts as tips. * patients on drugs affecting portal pressure (beta blockers, nitrates). * advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia. * patients with severe respiratory diseases (copd, bronchial asthma). * uncontrolled diabetes mellitus * renal impairment * hepatocellular carcinoma * allergy to carvedilol * pregnancy or lactation
study of alvimopan drug for treatment of constipation due to prescription pain medication

Conditions: Constipation; Bowel Dysfunction

Summary: a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. the study will require five visits over a five-week period.


Eligibility criteria:
inclusion criteria: * participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the screening visit. * participant is taking opioid therapy for persistent cancer pain. * participant meets the definition of opioid-induced bowel dysfunction as follows: since starting opioid therapy, the subject has had decreased bowel movement (bm) frequency and at least one of the following constipation symptoms \[sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)\]. * participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications. * participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits. exclusion criteria: * participant is pregnant or lactating, or planning to become pregnant. * participant is not ambulatory. * participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the screening visit. * participant is unable to eat, drink, take/hold down oral medications. * participant is taking opioids for the management of drug addiction. * participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the screening visit and throughout the entire study. * participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. this would include a subject who has reported no bowel movement for 7 consecutive days prior to the screening visit. * participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (gi) obstruction, or contribute to bowel dysfunction. * participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study. * participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study. * participant is human immunodeficiency virus (hiv)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis b), or has ever been infected with hepatitis c.

Keywords: obd (induced bowel dysfunction) cancer pain pain medication constipation bowel bowel dysfunction
mental health services for prisoners with smi

Conditions: Mental Disorder

Summary: interventions that address criminogenic risk factors, such as thinking for a change (t4c), are not used with prisoners with serious mental illness (smi) because of the neurocognitive and social impairments associated with smi. this study examines the effectiveness of t4c with a modified delivery system designed specifically to address the unique needs of persons with smi in prison, including improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes).

interventions are urgently needed to improve the delivery and impact of mental health services for persons with serious mental illnesses (smi) in prison. treatments addressing the symptoms of mental illness form a critical component of the continuum of services needed by prisoners with smi. however, a growing body of literature shows that mental health treatments need to be combined with treatments that directly address criminogenic risk factors (i.e., those factors most closely associated with criminal activities). despite promising evidence, interventions that address criminogenic risk factors, such as thinking for a change (t4c), are not used with prisoners with smi because of the neurocognitive and social impairments associated with smi. this study examines the effectiveness of t4c with a modified delivery system designed specifically to address the unique needs of persons with smi in prison. this small-scale randomized controlled trail (rct) explores the potential effectiveness of t4c-smi towards improving impulsivity, criminal attitudes, and interpersonal problem solving (treatment targets) and levels of aggression, and the amount of behavioral infractions and time spent in administrative segregation in prison (outcomes). the study will also examine whether the treatment targets for t4c-smi mediate the intervention's impact on outcomes. the long-term goal is to grow the evidence-base for interventions with the capacity to improve prison and community-reentry outcomes for persons with smi. this study will provide the data needed to implement a rigorous rct in a future study and supports nimh's mission to develop innovative interventions in mental health services.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * have a diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic features or major depressive disorder with psychotic features * have moderate to high risk levels of criminogenic risk factors as determined by the level of service and case management inventory (ls/cmi) * have at least one year or more remaining on their prison sentence at the time of the screening interview exclusion criteria: * has participated in t4c-smi within 6 months prior to study
treatment of peri-implant mucositis with standard of care and bioptron hyperlight therapy

Conditions: Mucositis Oral; Dental Implant Failed

Summary: objectives: the aim of this study was to evaluate in a cohort of patients with peri-implant mucositis: (a) the efficacy of professional mechanical debridement therapy assisted using bioptron hyperlight therapy on the reduction of periodontal indexes (b) the reduction of total oxidative salivary stress. material and methods forty subjects with a diagnosis of peri-implant mucositis were enrolled in this study and randomly assigned to the study group (mechanical debridement therapy assisted using bioptron hyperlight therapy) or control group (mechanical debridement therapy alone). the study duration was 6 months. data on plaque index (pi), bleeding on probing (bop), probing pocket depth (ppd) and pain relief on visual analogue scale (vas) were recorded at t0, t1 (14 days), t2 (1 month) and t3 (6 months). group differences were assessed using student's t-test and pearson's chi-squared test of homogeneity


Eligibility criteria:
inclusion criteria: * male or female, 30-60 years old. * with diagnosis of peri-implant mucositis. * plaque index (pi) ≥ 40%. * al least one implant site with ppd≥4 mm, bop+ and suppuration. * no uncontrolled diabetes, cardiovascular diseases, bone metabolism disorders, no autoimmune diseases (lichen planus, pemphigoid, pemphigus and systemic lupus erythematosus). * no pharmacological therapies, no chemo-radiotherapies. * no smoking (\>10 cigarettes/day), alcohol and/or drug consumption. * no pregnancy or breastfeeding. * no allergy. exclusion criteria: -

Keywords: peri-implant mucositis dental implants bioptron photobiomodulation