Kornimate/medical-research-clean huggingface dataset:
carvedilol pah a pilot study of efficacy and safety

Conditions: Pulmonary Hypertension; Cardiac MRI <40

Summary: estimate the effect of chronic beta-adrenergic receptor blockade with carvedilol on rv function in patients with pah. assess the safety and tolerability of chronic carvedilol therapy in patients with pah

this is a prospective, open label, uncontrolled, pilot study examining the safety and efficacy of beta-blocker therapy with carvedilol on rv function in stable pah patients with world health organization (who) functional class ii or iii symptoms and rv ejection fraction (ef) \< 40%. twenty-five evaluable patients will be enrolled at the university of minnesota. specific aims: 1.1 primary efficacy endpoint: adult males and females on a stable dose of an approved pah medication will undergo cardiac magnetic resonance imaging (mri), right heart catheterization (rhc), echocardiogram, 6-minute walk test (6-mwt), measurement of plasma nt-probnp and serum catecholamine, and quality of life assessment. patients will receive carvedilol (3.25 mg/kg bid escalating to 25 mg/kg bid over 3 months). testing is repeated at the end of the study (month 6). rvef measured by cardiac mri is the primary efficacy endpoint. we define a 5% increase in rvef as a meaningful change.

Eligibility criteria:
inclusion criteria: 1. subjects will be eligible to participate in the study if all of the following conditions exist: 2. age \> 18 years 3. who category 1 pulmonary arterial hypertension (dana point 2008) 4. who functional class ii-iii 5. rvef by cardiac mri \< 40% 6. mean pulmonary artery pressure \> 40 mm hg 7. stable on pah-specific therapy as defined by no change in pah-specific treatment and functional class in the past 3 months. patient can be on either mono or combination pah-specific therapy exclusion criteria: * 1. subjects will be excluded from participation in the study if any of the following conditions exist: 2. significant persistent bradycardia (resting heart rate \ 100 bpm) 5. use of anti-arrhythmic drugs 6. hypotension defined as systolic blood pressure \ 15 mm hg 11. asthma

Keywords: hypertension pah
development of a multidisciplinary network for clinical and laboratory research for sma

Conditions: Spinal Muscular Atrophy

Summary: the goal of this observational study is to to establish profiles of clinical progression in patients affected by the different types of sma (type i, ii and iii) treated with the currently approved drugs using a structured battery of clinical tests. another goal of the study is to assess the progression of the disease in patients identified through neonatal screening.

the collection of 2-year longitudinal clinical data will be conducted in newly treated patients at baseline, 6-, 12-, 14- and 22-months post-treatment. parameters will include motor function, fatigability, respiratory function, event-free survival and death, and swallowing and feeding modalities. it is anticipated that at least 30 new patients will be enrolled in the study. importantly, information will also be collected on patients who may decide to switch treatment during the duration of our study, trying to establish if the switch to a new drug (or as an add-on should patients take a new treatment after being treated with gene therapy) may be associated with changes in clinical phenotype. the aim is to apply a newly established clinical protocol that allows identifying minor signs of disease that are easily missed in the absence of an nbs-detected diagnosis. indeed, not all infants identified as sma-positive through the nbs are truly asymptomatic, as a proportion of them may appear paucisymptomatic and their minor signs could be possibly not detected in the absence of a positive screening test.

Eligibility criteria:
inclusion criteria: * all sma patients exclusion criteria: * inability to understand or to provide informed consent.

Keywords: spinal muscular atrophy
the use of intrathecal morphine in the management of acute pain following decompressive lumbar spinal surgery

Conditions: Acute Pain Following Decompressive Lumbar Spinal Surgery

Summary: the primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for degenerative lumbar spine disease. secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine. based on our literature review, we expect a significant improvement in pain scores and functional status and minimal side effects with the use of intrathecal morphine. with improved pain and function we would also expect shorter hospital stays in those patients receiving intrathecal morphine.

adult patients (\>18 yrs or older) undergoing instrumented fusion for degenerative lumbar spine disease will be recruited and randomized to receive one of two treatments. the first group will receive an injection of morphine (200mcg) into the intrathecal space at the time of the operation. the second group will receive a saline injection. the pharmacy will prepare the aforementioned injections and deliver them to the operating room to ensure all parties are blinded. both groups will then have a standardized analgesic regimen (including pca morphine and parenteral analgesics) available to them in the post-operative period. each group will be followed at regular intervals post-operatively. at each follow-up, visual analogue pain scores, side effects and narcotic use will be assessed. patients will also have a daily functional assessment which will dictate the time of discharge. hospital stay will be measured from time of admission to time where patient no longer requires acute hospital care based on the functional assessment.

Eligibility criteria:
inclusion criteria: * age 18yrs or older * elective surgery for instrumented fusion of the lumbar spine for stenosis (\< 5 levels) * with back and/or leg pain * patients who meet asa class 1 or 2 exclusion criteria: * patients unable to speak english * known allergies to morphine or other opioids * spinal surgery other than lumbar spine surgery * history of severe respiratory illness including copd and asthma * history of obstructive sleep apnea * pregnancy * lumbar procedures performed in minimally invasive fashion * patients lacking mental capacity to use pca * patients on sustained release narcotics * patients undergoing revision of previous instrumented lumbar spine surgery * patients with psychiatric disorders.
sweat and gas sensor for healthy skin and atopic dermatitis

Conditions: Healthy Adults; Atopic Dermatitis; Wearables; Sweat Sensor; Gas Sensor

Summary: pilot study of a wearable gas and sweat skin sensor

the objective of this study is exploratory and deploys two wearable sweat and gas sensors which detect the composition of sweat proteins and volatile gases emitted from the skin in healthy subjects and patients with atopic dermatitis.

Eligibility criteria:
inclusion criteria: * age ≥18 years old * subjects willing and able to comply with requirements of the protocol * healthy adults or subjects with atopic dermatitis exclusion criteria: * age \<18 years old * subjects unwilling and able to comply with requirements of the protocol * history of skin allergy to medical adhesive tape * history of heat stroke, heat related or exercise related * non-english speaking subjects
is thymus size of infants who born to covid-19 positive mothers associated with neonatal morbidities?

Conditions: Covid19; Thymic Hypoplasia

Summary: covid-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal covid-19. therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal covid-19 and to demonstrate any possible association of this measurement with neonatal morbidities.

covid-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. fetus is known to be influenced by maternal systemic infections. thymus size of fetus and the neonate, is proven to be changed by primarily inflammatory/infectious diseases. investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal covid-19. therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal covid-19 and to demonstrate any possible association of this measurement with neonatal morbidities.

Eligibility criteria:
inclusion criteria: * infants born to covid-19 positive or negative mothers * accepted to participate with an informed consent * infants who required to get chest x-ray within the first 6 hours exclusion criteria: * infants whose mothers' have any kind of acute or chronic systemic disease or inflammation/infection * lack of an informed consent * infants who did not require to get chest x-ray within the first 6 hours
instrumental assessment of motor symptoms by means of wearable sensors in patients with parkinson's disease

Conditions: Parkinson Disease; Motor Disorders

Summary: the clinical management of parkinson's disease (pd) is frequently challenged by the occurrence of motor disorders and complications, such as freezing of gait, fluctuations and the on-off phenomenon, primarily manifesting at home. therapeutic decisions are usually based on periodic neurological examinations and patients' anamnestic experience collected in an outpatient setting, thus limited by several issues, including "recall bias" and subjective, semi-quantitative and operator-dependent evaluations in non-ecological settings. in the last two decades, new wearable technologies, consisting of "wireless" sensors (e.g., inertial, electromyography), have been widely applied to quantitatively assess movements in physiological and pathological conditions, even for prolonged periods in free-living settings (i.e., long-term monitoring). the aim of this study is to evaluate motor symptoms in patients with pd, such as bradykinesia, tremor, gait disturbances and balance disorders, objectively and quantitatively through the application of wearable sensors in intra- and extra hospital settings, also during common activities of daily living, in order to obtain ecological data possibly useful in the therapeutic management of the disease.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease according to current consensus criteria and confirmed by follow-up clinical evaluations; * ability to walk independently exclusion criteria: * dementia (mmse \< 24/30); * comorbidities affecting gait (e.g., rheumatological or orthopedic issues); * atypical parkinsonism.

Keywords: parkinson's disease wearable sensors
to assess the effect of renal impairment on the blood levels of daclatasvir (dcv), asunaprevir (asv) and bms-791325 after multiple doses of a fixed dose combination tablet

Conditions: Hepatitis C

Summary: assess the effect of renal function on the blood levels of dcv, asv, bms-791325.

ind number: 79,599/101,943 primary purpose: other - phase 1 clinical pharmacology study to determine the effect of renal impairment on the exposure of dcv, asv, bms-791325 (fixed dosed combination) and bms-791325 given in multiple doses fixed dose combination (fdc) fixed dose combination of daclatasvir, asunaprevir and bms-791325 (dcv 3daa fdc)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects in group a must be in good health and have normal renal function * subjects in groups b-e may have clinical, electrocardiogram (ecg) and laboratory findings consistent with their degree of renal dysfunction * women of childbearing potential (wocbp) and male participants must agree to follow the required contraceptive methods exclusion criteria: * subjects in group a must not have any significant acute or chronic illnesses * subjects in groups b-e must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening * subjects in groups b-e may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (clcr) which has decreased from a previous clcr by 50% within the last 3 months * prior exposure to dcv, asv or bms-791325 within 3 months prior to study drug administration
the value of 68ga-grazytracer pet in monitoring responses to immunotherapy of advanced hepatobiliary malignancy

Conditions: Hepatobiliary Malignancy

Summary: this study aims to investigate the value of 68ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.

the investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. all participants will undergo a 68ga-grazytracer pet/ct after 3 cycles of immunotherapy to evaluate response. the imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Eligibility criteria:
inclusion criteria: 1. pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines 2. signed and dated informed consent form 3. commitment to comply with research procedures and co-operation in the implementation of the full research process 4. aged 18-75 years old 5. the patient is in good general condition with an expected survival of \&gt; 6 months exclusion criteria: 1. patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc. 2. intestinal perforation, complete intestinal obstruction 3. uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/l on the day of the trial 4. pregnant women and women who may be pregnant, women who are breastfeeding. 5. non-compliant person

Keywords: 68ga-grazytracer pet/ct immunotherapy advanced hepatobiliary malignancy
mexidol® sequential therapy of patients with primary open-angle glaucoma (poag)

Conditions: Primary Open-Angle Glaucoma (POAG)

Summary: hypothesis: the use of neurocytoprotectors helps restore the functional activity of mitochondria, improve the nervous activity of the retina and optic nerve, and stabilize the glaucomatous process.

hypothesis: mexidol® allows to optimize poag therapy by reducing mitochondrial dysfunction and stabilizing glaucomatous optic neuropathy by improving the functional activity of mitochondria and its energy-producing function

Eligibility criteria:
inclusion criteria: * an advanced stage of poag in one or two eyes * hypotonic-compensated intraocular pressure (iop) exclusion criteria: * degenerative diseases of the central nervous system, diabetes mellitus * primary mitochondrial dysfunction * a history of surgical interventions and damage to the organ of vision * acute or chronic inflammatory or hereditary degenerative eye diseases (anterior and posterior sections) * decompensation of concomitant somatic diseases * taking antioxidants/nootropic drugs 6 months before inclusion in the study * hypersensitivity to ethylmethylhydroxypyridine succinate or to any of the excipients

Keywords: glaucoma primary open-angle glaucoma (poag) glaucomatous optic neuropathy (gon) mitochondrial dysfunction neuroprotection mexidol ethylmethylhydroxypyridine succinate
impact of ostom-i alert sensor on quality of life in patients with ileostomy

Conditions: Ostomy

Summary: the purpose of this study is to evaluate patient satisfaction and quality of life in patients with ileostomy managed with or without the novel ostom-i alert device.

patients with ileostomy have impaired quality of life related to their ileostomy (person et al. dcr. 2012; 55: 783 - 787; scarpa et al. colorectal dis. 2010; 12: 914 - 920). although patients with ileostomy have better overall quality of life compared with colostomy patients (silva et al. worl j surg. 2003; 27: 421-424), the liquid nature of the ileostomy effluent predisposes these patients to bag overfilling and dehydration more so than colostomy patients (paquette et al. dcr 2013; 56: 974-979). this may be specifically important in populations with long term or permanent ileostomy. overfilling and breakage/leakage of the ileostomy bag can also affect patient's ability to function in social environments, go out in public, have intimate relationships with significant others, and interfere with sleep patterns (due to high output and nighttime overfilling of the ileostomy bag). the ostom-i alert is a novel device developed by a patient with ileostomy and now fda approved in the united states. the device is a sensor that clips onto any ostomy bag and sends a bluetooth signal to a mobile device app. an alarm lets the patient know before the stoma bag is at risk for overfilling and leaking. the potential advantage is that the device can prevent unexpected bag overfilling, breakage, and nighttime accidents. this may therefore lead to improved quality of life. the volume and output recordings can also be stored and emailed to the patient's health care providers, with potential to reduce ostomy related dehydration through more accurate volume recording and sharing. while the device has many applications, the purpose of this research study is to specifically evaluate patient quality of life after application of the ostom-i alert compared with standard ostomy care.

Eligibility criteria:
inclusion criteria: 1. patients with ileostomies in place without a plan for ileostomy take down in the next 4 months. 2. able to freely give written informed consent to participate in the study and have signed the informed consent form; 3. males or females, age 18 and older at the time of study screening; 4. patients with loop or end ileostomy at least 1 month since ileostomy creation 5. no plan for stoma reversal for the next 4 months to allow adequate time for study inclusion 6. patients who own an iphone, ipod touch, or android device exclusion criteria: 1. mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures; 2. children \<18 3. pregnant patients 4. patients with planned ileostomy closure in the next 4 months 5. patients with colostomy, more than one ostomy, or urostomy 6. patients unable or unwilling to come in for in person ostomi-i alert teaching and screening visits 7. patients without an iphone, ipod touch, or android device
collection of blood specimens from patients in al-3789 studies for elevated intraocular pressure (iop)

Conditions: Open-Angle Glaucoma

Summary: the objective of this study is to obtain blood samples from patients who are or were participants in any alcon al-3789 clinical trial. association will be conducted to search for genetic markers in patients with glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * patient must be currently or previously enrolled in alcon clinical study and received al-3789 exclusion criteria: * age related

Keywords: open-angle glaucoma iop
micrornas in patients with neurofibromatosis type 1

Conditions: Glioma; Neurofibromatosis Type 1

Summary: micrornas are small molecules which have recently been discovered in cells. they are known to be responsible for the normal development of cells and when they are disrupted can contribute to the development of cancer. many previous studies have been done evaluating the expression of micrornas in normal tissues as well as in a wide variety of cancers. recently, micrornas from tumor cells have been detected circulating in the blood of patients with cancer. this presents a novel opportunity to assess the utility of micrornas in the blood as an early predictor of cancer as well as a marker of response to therapy. no previous studies have been performed evaluating micrornas in archived tumor tissue and blood of patients with neurofibromatosis type 1 (nf-1). the investigators propose a feasibility study to evaluate the presence of micrornas in archived tumor tissue and the blood of patients with nf-1. if the investigators are able to identify circulating micrornas in this population of pediatric patients, they will build upon this data in proposing a future study.


Eligibility criteria:
inclusion criteria: * patients ages 2 years to 21 years. * patients with nf-1 being followed in the neurofibromatosis clinic. * patients have had mri imaging in the 24 months prior to enrollment on the study. * patients may have known concurrent malignancies such as plexiform neurofibroma. * patients and/or parents/legal guardians must have signed an informed consent and assent when applicable. exclusion criteria: * patients who have had prior tumor-directed therapy (including chemotherapy and/or radiation) * patients with a prior or current diagnosis of a malignant peripheral nerve sheath tumor. * patients who are considered too ill to participate as determined by their treating physician * patients who are pregnant or lactating
morphological characteristics of inferior pole patellar fractures and a finite element analysis combined with a retrospective clinical study of anchor suture and titanium cable cerclage treatment

Conditions: Inferior Patellar Fracture; Fracture Maps; Finite Element Analysis

Summary: the goal of this study is to compare the biomechanical stability and clinical outcomes of two treatment methods for inferior pole patellar fractures (ippf): anchor suture with patellar cerclage and kirschner-wire tension band combined with patellar cerclage. the study involves patients with ippf, focusing on fracture patterns and treatment outcomes. 1. undergo retrospective analysis of fracture patterns using fracture mapping. 2. participate in biomechanical analysis via finite element modeling of both treatment methods. 3. be part of a clinical comparison between two surgical treatments based on operative time, postoperative complications, and functional outcomes.


Eligibility criteria:
inclusion criteria: (1) diagnosis of ippf confirmed by x-ray or ct, and (2) patients aged between 18 and 70 years. exclusion criteria: (1) concomitant fractures of other parts of the knee, (2) open fractures, and (3) pathological fractures.

Keywords: inferior patellar fracture fracture maps finite element analysis retrospective study