Kornimate/medical-research-clean huggingface dataset:
study of pah subjects with ltot use that have demonstrated improved exercise tolerance with the use of inhaled nitric

Conditions: Pulmonary Arterial Hypertension

Summary: study of pah subjects with ltot use that have demonstrated improved exercise tolerance with the use of inhaled nitric oxide

phase 3, multicenter, randomized, double-blind, placebo controlled withdrawal study of pulmonary arterial hypertension(pah) subjects with ltot use that have demonstrated improved exercise tolerance with the use of inhaled nitric oxide (ino)

Eligibility criteria:
inclusion criteria: 1. signed informed consent form prior to the initiation of any study mandated procedures or assessments 2. subjects must be enrolled in the pulse pah-004 clinical trial and must have been on ltot and on open-label treatment with ino 75 mcg/kg ibw/hr for at least 4 months 3. subjects must have achieved ≥ 30 meter improvement in 6mwd after 4, 8 or 12 months of open-label treatment with ino 75 mcg/kg ibw/hr as compared to either their pulse pah-004 week 2 end of run-in or end of study (eos)in pulse-pah-004. 4. subjects are willing and considered in the judgement of the investigator able to use the inopulse device continuously for up to 24 hours per day 5. female subjects of childbearing potential must have a negative pregnancy test (serum or urine) at randomization. all female subjects must use an effective method of birth control to avoid pregnancy. exclusion criteria: 1. subjects with episodes of worsening of pah in the last 30 days prior to pulse pah-007 baseline/randomization 2. subjects that experience pulmonary rebound in pulse-pah-004 3. change in dose or types of pah specific therapies in the last 30 days prior to baseline/randomization 4. subjects who require treatment with riociguat 5. subjects who early discontinued drug/device usage due to withdrawal of consent or an adverse event requiring termination from treatment in pulse pah-004 6. women who are pregnant 7. the concurrent use of the inopulse device with a continuous airway pressure (cpap), bilevel positive airway pressure (bipap, or any other positive pressure device.

Keywords: pah inhaled nitric oxide ino long term oxygen therapy oxygen therapy
to relieve pain and anxiety - an intervention study in ambulance services

Conditions: Acute Myocardial Infarction; Pain

Summary: this is an intervention study focusing on both medical and nursing questions. the study is a joint project between the ambulance services at four cities in west sweden and knowledge and research centre, prehospen at university of borås. the aim is to prove the importance of a caring relation between a patient and a caregiver in cases when a caregiver treats a patient with benzodiazepines (midazolam). the overall aim is to show that knowledge and skills in both caring science and medicine can be applied at the same time in order to relieve pain and anxiety in acute myocardial disease. the nursing intervention involves a professional development course for caregivers. the course is expected to deepen the caregivers' knowledge about the encounter with patients as well as cardiovascular treatment. following questions are formulated: a. what are the effects regarding relieving pain and anxiety in acute myocardial disease? b. what are the effects regarding circulatory influence? c. what are the effects regarding patients' experiences of the ambulance services? d. what are the effects regarding number of care days in relation to acute myocardial disease? e. what are the effects of patients' disease complications?


Eligibility criteria:
inclusion criteria: 1. patients in ambulance service with chest pain and suspicion about acute coronary syndrome. 2. at least 4 on a coloured analogue scale. exclusion criteria: 1. blood pressure less than 100 mmhg 2. children under 18 years 3. under the influence of alcohol 4. under the influence of drugs 5. treatment with benzodiazepines 6. disorientated 7. communication problems 8. trauma

Keywords: the focus is the pain reduce in the first 15 minutes for patients suffering an acute myocardial infarction, treated by caregivers in ambulance service.
supra-annular vs. annular valves for small annuli

Conditions: Aortic Valve Stenosis; Implantation, Heart Valve Prosthesis

Summary: open-label, prospective randomized comparison of supra-annular valves (medtronic evolut pro) vs. annular valves (edwards sapien ultra) for small annuli (≤23 mm)

patient prothesis mis-match (ppm) remains a clinical dilemma in transcatheter aortic valve replacement (tavr) and has been linked to higher rates of morbidity and mortality. supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. patients with small annuli are particularly vulnerable to ppm, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in ppm rates and outcomes when compared to annular valves.

Eligibility criteria:
inclusion criteria: * symptomatic subjects with severe native aortic valve stenosis * aortic valve annulus mean diameter ≤23 mm * patient meet commercial indication for transcatheter aortic valve replacement (tavr) * institutional heart team determines that tavr is appropriate * patient's anatomy is appropriate for either medtronic evolute or edwards sapien 3 ultra exclusion criteria: * subject unable or unwilling to provide informed consent * intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure) * renal function precluding the administration of iodinated contrast (egfr \< 30ml/min/1.73m2). an exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media * pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures * patients at high risk for coronary obstruction * patients with low-flow low gradient aortic valve stenosis * patients at high risk for annular rupture with implantation of a balloon expandable valve

Keywords: implantation, heart valve prosthesis aortic valve stenosis transcatheter aortic valve replacement
fully covered self-expandable metal stents (fcms) in benign biliary strictures

Conditions: Biliary Stricture

Summary: endoscopic treatment of benign biliary strictures can be challenging. balloon dilation and/or plastic stent placement are currently the most popular techniques. partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. a novel fully covered metallic stent has recently been developed. the aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (fcsems) in this setting.

after inclusion, an endoscopic procedure (ercp) was performed in all patients in order to place a fcms across the benign biliary stricture. the fcms was left in place for 6 months and then extracted during a second ercp procedure. an opacification was performed to assess the efficacy of stenting. patients were followed up during one year after fcms extraction.

Eligibility criteria:
inclusion criteria: * a history of liver transplantation, chronic pancreatitis or biliary surgery * impairment of liver function tests such as elevated liver enzymes and/or cholestasis * a biliary stricture associated with ductal dilation detected by us, ct or mri, with a minimum distance of 2cm between the upper stricture's edge and the lower limit of the main biliary confluence or liver hilum . exclusion criteria: * an uncertainty about the benign nature of the stricture * an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum

Keywords: benign biliary stricture anastomotic biliary stricture after liver transplantation chronic pancreatitis biliary surgical procedure fully covered metal stent
microparticle generation after laparoscopic surgical treatment for endometrioma.

Conditions: Microparticle; Endometriosis; Laparoscopy

Summary: study objective: to evaluate serial generation of microparticles (mps) after laparoscopic stripping or co2 laser vaporization in surgical treatment of patients with ovarian endometrioma (oe). design: a prospective, randomized, blinded, pilot study, including 33 patients. setting: tertiary university hospital from april 2015 to june 2017. patients: 33 women with unilateral oe undergoing laparoscopic surgery. intervention: patients were randomly selected to undergo either co2 laser vaporization (l group) or laparoscopic stripping (s group) of oe. measurements and main results: blood samples were collected before surgery, and at 2 hours, 24 hours, 1 month, and 3 months after surgery. mps generation curve after ovarian endometrioma surgery was performed.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 years and unilateral symptomatic oes ≥3 cm. exclusion criteria: * previous pelvic surgery, history of cancer, suspected malignancy, presurgical suspicion or evidence of deep endometriosis, presurgical suspicion or evidence of premature ovarian failure, and the use of estrogen suppressive drugs, including oral contraceptives, gnrh-agonists, progestins, or danazol in the preceding 3 months. we excluded patients with suspicion of deep endometriosis according to an extensive preoperative work-up (including magnetic resonance imaging when necessary) routinely performed in such patients.
efficacy and safety of kd025 in subjects with cgvhd after at least 2 prior lines of systemic therapy

Conditions: Chronic Graft-versus-host-disease

Summary: this is a phase 2, randomized, multicenter study to evaluate the efficacy and safety of kd025 in subjects with chronic graft versus host disease (cgvhd) after at least 2 prior lines of systemic therapy

phase 2, open label, randomized, multicenter study in subjects with cgvhd who have previously been treated with at least 2 prior lines of systemic therapy. approximately 166 subjects with active cgvhd will be randomized (1:1) to receive treatment with one of two belumosudil (formerly known as kd025) regimens: * arm a: belumosudil 200 mg qd * arm b: belumosudil 200 mg bid with amendment 2, the sample size was increased from approximately 126 subjects, with additional subjects to be enrolled as follows: * 20 adolescents * 20 adults into a site-specific companion study to collect biospecimens these additional subjects will also be randomized (1:1) to arm a or arm b. any adolescent taking a proton pump inhibitor (ppi) or a strong cyp3a4 inducer will begin cycle 1 day 1 at the escalated dose of belumosudil 200 mg bid. randomization will be stratified according to prior cgvhd treatment with ibrutinib (yes / no) and severe cgvhd at baseline (yes / no). subjects may receive treatment in 28-day treatment cycles until clinically significant progression of cgvhd. subjects who have not achieved a response after 12 cycles of belumosudil should be withdrawn if in the investigator's judgment there is no evidence of clinical benefit. subjects will undergo evaluations as outlined in the study assessments table (appendix a). the primary endpoint is the overall response rate (orr) with responses as defined by the 2014 national institute of health (nih) consensus development project on clinical trials in cgvhd.

Eligibility criteria:
inclusion criteria: 1. male and female subjects at least 12 years of age who have had allogenic hematopoietic cell transplant (hct). 2. previously received at least 2 and not more than 5 lines of systemic therapy for cgvhd 3. receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening 4. have persistent cgvhd manifestations and systemic therapy is indicated 5. karnofsky performance score of ≥ 60 (if aged 16 years or older); lansky performance score of ≥ 60 (if aged \< 16 years) 6. weight ≥ 40kg exclusion criteria: 1. subjects has not been on a stable dose / regimen of systemic cgvhd treatments for at least 2 weeks prior to screening. (note: concomitant corticosteroids, calcineurin inhibitors, sirolimus, mmf, methotrexate, rituximab, and extracorporeal photophoresis (ecp) are acceptable. systemic investigational gvhd treatments are not permitted). 2. histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening. 3. current treatment with ibrutinib. prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization.
efficacy and safety of oncoxin in patients with breast fibrocystic disease

Conditions: Breast Fibrocystic Disease

Summary: the purpose of the study is to evaluate whether oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: * patients with clinical and ultrasonographic confirmation of breast fibrocystic disease. * patients older than 20 years. * female patients. * informed consent. exclusion criteria: * presents of another disease not well controlled. * pregnant women or lactating. * patient which are receiving another products from other investigations trials.
a prospective randomized study comparing different dilation durations for endoscopic papillary balloon dilatation

Conditions: Choledocholithiasis

Summary: endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct stone. however, a need to switch to sphincterotomy is noted in about 20% of cases receiving dilation for lithotripsy. it is hypothesized that a longer dilation duration (5 min. vs. 1 min.) can decrease the need of switching to sphincterotomy.

endoscopic papillary balloon dilatation (epbd) has been proposed as an alternative to endoscopic sphincterotomy (est) for endoscopic treatment of common bile duct (cbd) stones. epbd is as effective as est in stone clearance with a lower risk of hemorrhage, and may preserve the function of sphincter of oddi. however, it has been reported that about 20% of patients undergoing epbd need est as a rescue procedure for lithotripsy. a longer dilation duraton of 5 mintues as opposed to 1 minute has been proposed to decrease oozing after dilation and facilitate lithotripsy, and it is hypothesized that it will reduce the need of switching to est.

Eligibility criteria:
inclusion criteria: * patients undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis exclusion criteria: * consent not obtained. * no apparent stone. * intradiverticular papilla. * prior est. * bile duct stricture. * pancreatic or biliary malignant disorders. * intrahepatic stones. * active acute pancreatitis. * sphincter of oddi dysfunction. * pregnancy. * primary sclerosing cholangitis or choledochocyst. * previous biliary surgery other than cholecystectomy. * stone impaction at ampulla. * precut for cannulation.

Keywords: endoscopic papillary balloon dilatation endoscopic sphincterotomy choledocholithiasis efficacy complication
effect of standardization of urine collection using peezy device as compared to clean peezy for dab

Conditions: Asymptomatic Bacteriuria; Urinary Tract Infections

Summary: this study aims specifically to compare the rates of contaminants between standard clean-catch urine collection and urine collected using the peezy device. in particular, this study will compare the rates of contamination as stratified by bmi status (i.e., bmi \< 30 and bmi ≥30). based on previous studies through luhs and the wolfe lab, we anticipate a reduction in contamination from sample collected using the peezy device, particularly among those pregnant women with bmi ≥30. to investigate this hypothesis we have designed a prospective unblinded randomized controlled trial comparing voided urine specimens obtained for asymptomatic bacteriuria in pregnant women presenting for obstetric care with use of standard clean-catch (cc) sampling method versus specimen obtained using peezy collection device.

recruitment procedures 1. all patients scheduled for "nob" (new obstetrics) appointments at loc will be screened for eligibility by residents and fellows 2. residents and fellows will recruit participants at loc and obtain informed consent. 3. there will not be any advertising for this study and no recruitment materials will be given to eligible participants. study procedures 4. residents and fellows will use a redcaps database to assign randomization, generate de-identified study labels, and provide study participants with assigned urine collection device as well as instructions on use. 5. participants will use a private bathroom to void and collect their urine specimen using either the peezy device or standard clean catch method as assigned. 6. urine specimens will be handed to loc nursing staff who will separate into 3 aliquots - 1 for clinical lab and 2 for wolfe lab. 7. wolfe lab aliquots will be labeled with the subject's study id and placed at 4°c for \<4 hours before transport to dr. wolfe's laboratory for inventory, storage and analysis 8. clinical lab specimen will be labeled with patient label and transported to clinical lab for standard urine culture per routine obstetric care.

Eligibility criteria:
inclusion criteria: * pregnant \< 20 weeks gestational age * age \> 18 years old * english speaking exclusion criteria: * history of recurrent utis * need for ongoing antibiotics * urinary tract anomalies
evaluation of maintaining visual performance in participants who engage in electronic visual tasking while using restasis®

Conditions: Dry Eye Syndromes

Summary: this study will evaluate the efficacy of restasis® in participants with dry eye disease who engage in electronic visual tasking.


Eligibility criteria:
inclusion: * has eye symptoms when using video display terminals * has a reported history of dry eye in both eyes. exclusion: * diagnosed with eye infection or active inflammation. * has worn contact lenses within the past 7 days or anticipated use during the study. * has used any eye drops within 2 hours. * has had laser-assisted in situ keratomileusis (lasik) within 12 months. * has used restasis® within 90 days. * has had any eye and or/lid surgeries within 6 months. * has had cataract surgery in either eye. * has current punctal occlusion or anticipate a change in punctal occlusion status at any point during the study. * is currently taking any topical ophthalmic prescriptions or over-the-counter solutions, artificial tears, gels or lid scrubs that cannot be discontinued for the trial duration. * use of medication known to cause ocular drying that is not on a stable dose for at least 30 days.
dutasteride followed by ultrasound-guided biopsy in finding prostate cancer

Conditions: Prostate Cancer

Summary: rationale: diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. it is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer. purpose: this randomized phase iii trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.

objectives: * determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer. * determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride. * determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer. * determine the reduction in post-biopsy bleeding after dutasteride in these patients. * determine the cost effectiveness of this regimen in these patients. outline: this is a prospective, double-blind, placebo-controlled, randomized study. patients are randomized to 1 of 2 arms. * arm i: patients receive oral dutasteride once daily on days 1-14. * arm ii: patients receive oral placebo once daily on days 1-14. on day 14, patients in both arms undergo blood collection and contrast-enhanced (perflutren protein-type a microspheres) transrectal ultrasound. conventional gray-scale imaging, color doppler imaging, and power doppler imaging are performed. biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies. after completion of study procedures, patients are followed at 1 day. projected accrual: a total of 450 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * suspected prostate cancer due to 1 of the following criteria: * prior abnormal digital rectal exam * elevated prostate-specific antigen (psa) ≥ 2.6 ng/ml within the past 90 days * psa velocity \> 0.75 ng/ml/year * must be planning to undergo a transrectal ultrasound with biopsy patient characteristics: * must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy * must not be clinically unstable, severely ill, or moribund prior concurrent therapy: * more than 30 days since prior biopsy of the prostate * more than 1 week since prior acetylsalicylic acid or blood thinner * more than 30 days since prior participation in a clinical trial involving an investigational drug * no prior therapy for prostate cancer * no other concurrent 5-alpha reductase inhibitor

Keywords: prostate cancer
extension of aoc 1001-cs1 (marina) study in adult myotonic dystrophy type 1 (dm1) patients

Conditions: DM1; Muscular Dystrophies; Myotonic Dystrophy; Myotonic Dystrophy 1; Myotonic Disorders; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases

Summary: aoc 1001-cs2 (marina-ole) is a phase 2 extension of the aoc 1001-cs1 (marina) study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple-doses of aoc 1001 administered intravenously to adult myotonic dystrophy type 1 (dm1) patients

this study will continue to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of aoc 1001 in participants that enrolled in the randomized, placebo-controlled, first-in-human phase 1/2 aoc 1001-cs1 (marina) clinical study. participants from aoc 1001-cs1 are eligible to enroll in aoc 1001-cs2 if they have satisfactorily completed aoc 1001-cs1. the total duration of active treatment in aoc 1001-cs2 is up to 58 months. once participants have completed active treatment, they will be followed through an 8-week safety follow-up period. the sponsor may extend active treatment beyond 58 months at a future timepoint. as of september 2024, the dosing regimen was updated to every 8 weeks.

Eligibility criteria:
key inclusion criteria: * completion of aoc 1001-cs1 (marina) study with satisfactory compliance and no significant tolerability issues key exclusion criteria: * pregnancy, intent to become pregnant, or active breastfeeding * unwilling or unable to continue to comply with contraceptive requirements * any new conditions or worsening of existing conditions that in the opinion of the investigator or sponsor would make the participant unsuitable for the study or could interfere with participation or completion of the study

Keywords: dm1 myotonic dystrophy 1 myotonic dystrophy type 1 (dm1) myotonic dystrophy dm dystrophy myotonic myotonic disorders steinert disease marina-ole marina avidity biosciences avidity aoc 1001 myotonic muscular dystrophy