Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of ziprasidone in children and adolescents with bipolar i disorder (manic or mixed)

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar i disorder (manic or mixed).


Eligibility criteria:
inclusion criteria: * dsm-iv criteria for bipolar i disorder (manic or mixed); age 10 - 17 years exclusion criteria: * imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for qt prolongation
(-)-epicatechin and pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary arterial hypertension (pah) is a progressive disease that results in severe activity limitation and death. there are few treatments for pah and the available medications are expensive, difficult to administer and have significant toxicities. (-)-epicatechin is a non-toxic compound that naturally occurs in foods such as tea, wine and chocolate. clinical intervention studies using dark chocolate in normal volunteers and subjects at risk for or with established cardiovascular disease have demonstrated improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, glucose tolerance and inflammatory markers. our study intends to examine the hemodynamics effects of purified (-)-epicatechin in subjects with pulmonary arterial hypertension. we hypothesize purified (-)-epicatechin will reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: * male or female age 18 or older * nyha class ii-!v * 6 minute walk distance \< 450 meters * outpatients with suspected who group i pah or and established diagnosis of who group i pah undergoing clinically indicated right heart catheterization * written informed consent obtained from subject and ability for subject to comply with the requirements of study exclusion criteria: * pregnancy * breast feeding * systolic blood pressure \ 160 * history of migraine headaches * allergy or intolerance to chocolate, tea or wine * subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason

Keywords: pah
corticospinal excitability and rehab in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: to determine differences in thigh muscle function in individuals with and without knee arthritis, and also determine the effectiveness of common physical therapy interventions on clinical and patient oriented outcomes.

the primary objective of the proposed research evaluates the concurrent changes in corticospinal excitability and central sensitization of pain pathways for their influence on quadriceps voluntary activation. a secondary objective is to establish the feasibility of an intervention study to determine if changes in the excitability of these supraspinal motor and sensory processes can be modified by physical therapy interventions targeting pain and muscle strengthening. we hypothesize that patients with knee osteoarthritis will show measurable deficits in quadriceps voluntary activation that can be explained by lower levels of corticospinal excitability and increased pain sensitization. a 1 week physical therapy intervention will improve voluntary activation and reduce pain with concurrent changes in underlying motor and sensory processes. we further hypothesize that part of this improvement will be attributed to positive treatment expectation.

Eligibility criteria:
inclusion criteria: * age 19-65 * grade i or ii knee osteoarthritis confirmed by radiographs or other imaging and at least one of the following: * age \> 50 years old * morning stiffness \< 30 minutes * crepitus * meet at least 3 of 6 diagnostic criteria for osteoarthritis: * age \> 50 years old * morning stiffness \< 30 minutes * crepitus * bony tenderness * bony enlargement * no palpable warmth exclusion criteria: * bmi \> 30 * history of traumatic spine or lower extremity injury within the last 6 months * previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity) * cardiac pacemaker * metal implants in head * current pregnancy * neurological disorders * history of seizures * unable to give consent or understand the procedures of this study

Keywords: knee osteoarthritis grade i and ii knee osteoarthritis arthritis
preterm lung patient registry

Conditions: Bronchopulmonary Disease

Summary: the goal of the preterm lung patient registry is to collect data on individuals with neonatal lung disease to better understand the illness and ultimately improve their care and survival. the patient registry was established in 2008 as a means to monitor important trends in the bpd population and to improve understanding, treatment, and survival.

the preterm lung patient registry is an observational study designed to identify epidemiologic and genetic factors associated with chronic lung disease in former preterm infants or those with lung disease in the neonatal period. the patient registry is used by both clinicians and researchers to better understand bpd and to improve care of individuals with bpd. it is used to assess phenotype and genotype information from former preterm infants with lung disease. data in the patient registry will be analyzed and an regular report of bpd health trends will be created. using this information, bpd clinicians can address quality improvement initiatives, and examine changing health care issues, including nutritional status, infection control, pulmonary treatment, metabolic and associated genetic variants. the patient registry will also play an important role in directing clinical care and in the design of clinical research studies. researchers use the registry to help in investigating various aspects of neonatal lung diseases like bpd, including medications, diagnostic procedures, and eligibility for clinical trials.

Eligibility criteria:
inclusion criteria: * former preterm infant

Keywords: premature birth neonatal respiratory distress chronic lung disease epidemiologicfactors genetic factors
efficacy and safety of antimicrobial stewardship intervention in hospitalized covid-19 patients (covasp)

Conditions: Covid19; COVID-19 Pneumonia; COVID-19 Lower Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome; SARS-CoV2 Infection; SARS-CoV-2 Acute Respiratory Disease

Summary: covid-19 is respiratory disease caused by the severe acute respiratory coronavirus 2 (sars-cov-2), a novel coronavirus which has spread rapidly across the world with over 149.9 million laboratory confirmed cases and over 3.1 million reported deaths since december 2019. approximately 4-8% of hospitalized patients with covid-19 have co-infection with bacterial pathogens however there is widespread and often broad-spectrum antibiotic use in these patients. this is a prospective, multi-center, non-inferiority pragmatic clinical trial of antimicrobial stewardship prospective audit and feedback versus no antimicrobial stewardship intervention on physicians attending to patients with proven sars-cov-2 infection confirmed by nucleic acid testing in the preceding 2 weeks of hospitalization for acute covid-19 pneumonia. prospective audit and feedback is the real time review of antibacterial prescriptions and immediate feedback to prescribers to optimize antimicrobial prescriptions. hospital beds will be stratified by covid unit and critical care unit beds, and will be computer randomized in a 1:1 fashion into 2 arms (antimicrobial stewardship intervention versus no antimicrobial stewardship intervention) prior to study commencement at the participating site. patients hospitalized to study-eligible beds will be followed for primary and secondary outcomes. the objective of this study is to determine the effect of an antimicrobial stewardship intervention (prospective audit and feedback) on clinical outcomes in patients hospitalized with acute covid-19.


Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of hospital admission. * confirmed sars-cov-2 infection by nucleic acid testing in the preceding 14 days of hospital admission. * admitted from the community (including continuing care facilities). * admitted to a hospital bed designated in the study. * spo2 ≤94% requiring supplemental oxygen or chest imaging findings compatible with covid-19 pneumonia. exclusion criteria: * the patient is enrolled in another clinical trial that involves antibacterial therapy. * the patient's goals of care is anticipated to be designated "total compassionate care" or palliative care within 48 hours of admission. * the patient's progression to death is anticipated to be imminent and inevitable within 48 hours of admission. * the patient was attended by any member of the research team within 30 days of enrollment. * the patient is transferred from another acute care center.

Keywords: antimicrobial stewardship antibiotic stewardship prospective audit and feedback quality improvement antibiotics
intraprostatic injection of tranexamic acid decrease blood loss during monopolar turp

Conditions: Benign Prostatic Hyperplasia; Transurethral Resection of the Prostate; Tranexamic Acid

Summary: this study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during transurethral resection of the prostate.

benign prostatic hyperplasia (bph) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy. the accurate cause is not well known; however, "reactivation" of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (bph). benign prostatic hyperplasia (bph) is a common condition that affects elderly men. recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms. transurethral resection of the prostate (turp) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (bph), recognized as the 'gold standard' of the surgical treatments of enlarged prostates. the most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (uti) (3.6%), bleeding requiring transfusions (2.9%), and transurethral resection syndrome (1.4%). as the prostate has a rich blood supply, bleeding is one of the most common complications of transurethral resection of the prostate.

Eligibility criteria:
inclusion criteria: * patient with an age between 50 and 85 years old * who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g. * undergoing transurethral resection of the prostate exclusion criteria: * patient refusal. * patients hypersensitive to tranexamic acid, or on antiplatelet and anticoagulant drugs. * patients with a history of thrombotic events, bleeding disorders, chronic kidney disease. * patients with abnormal liver function test. * patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a uti or who receiving 5α-reductase inhibitors.
clinical evaluation to assess the safety and efficacy of gentlemax pro plus

Conditions: Pseudofolliculitis Barbae; Unwanted Hair; Pigmented Lesions; Vascular Lesion; Onychomycosis; Wrinkle; Acne

Summary: demonstrate the safety and efficacy of the gentlemax pro plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (pfb), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. evaluate gentlemax pro plus™ laser system for the clearance of acne.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age or older 2. willingness to provide signed, informed consent to participate in the study 3. presence of unwanted hair, moderate or greater benign pigmented lesions, active acne, vascular lesions, nails affected with onychomycosis, and/or wrinkles assessed as fitzpatrick wrinkle and elastosis score (fws) \>/= 1 4. willingness to adhere to study treatment and follow-up schedule 5. willingness to adhere to post-treatment care instructions 6. willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes 7. willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study exclusion criteria: 1. pregnant, planning pregnancy during the study, or breast feeding 2. blonde, grey, or white hair in subjects seeking hair removal 3. tattooed skin in the intended treatment area 4. active sun tan in the intended treatment area 5. history of active herpes virus simplex (hsv) or similar condition in the intended treatment area unless treated with prophylactic medication 6. history of melanoma 7. history of vitiligo in the intended treatment area 8. history of keloid or hypertrophic scar formation 9. history of melasma in the intended treatment area or per investigator's discretion 10. severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment 11. open wound or infection in the intended treatment area 12. history of light induced seizure disorders 13. the subject is not suitable, in the opinion of the investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety 14. dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study
study of yoga as a therapy for cystic fibrosis (cf) patients

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a lung disease that affects 30,000 children and adults in the us. incorporation of regular exercise into the lives of patients with cf is of interest because it may improve lung function and quality of life. yoga is an activity that may benefit patients with cf in many ways including strengthening muscles of breathing, improving lung function, and reducing stress which could improve quality of life and adherence to therapies. yoga has been shown to be beneficial in patients with other lung diseases such as asthma, but has not yet been studied in cf. the investigators hypothesize that yoga will be an activity that is safe and tolerable for cf patients 12 to 25 years of age. the primary aim is to investigate the safety and tolerability of an 8 week yoga program for patients with cf. the secondary aim is to determine the effect of yoga on many aspects of cf disease including respiratory symptoms, adherence to regular cf therapies, quality of life, lung function, exercise tolerance, and nutritional status. the long-term goal is to use the data obtained in this study to design a future study of the efficacy of yoga in a larger population of cf patients at multiple cf centers. this research has the potential to influence the prevention and treatment of cf by providing data which could be used to help understand the most appropriate and beneficial type of physical activity for cf patients.


Eligibility criteria:
inclusion criteria: o diagnosis of cf by: sweat chloride ≥60meq/l on two occasions or cftr genotype with two cf disease-causing mutations and one or more phenotypic features of cf * age ≥12 and ≤25 years * fev1 ≥40 % predicted at screening visit * informed consent and assent exclusion criteria: * wheezing on auscultation of the chest at the enrollment visit * oxygen saturation \< 90 % at the enrollment visit * initiation of treatment with oral, inhaled or intravenous antibiotics for an acute respiratory infection in the 2 weeks preceding the enrollment visit * pregnancy * history of lung transplant * practiced yoga regularly (≥1 time per week) in the month prior to enrollment * current enrollment in a therapeutic clinical trial * condition or situation which, in the opinion of the investigator, would affect the ability of the patient or family to complete study procedures

Keywords: cystic fibrosis yoga
symptom prevalence and severity in lumbar spine surgery with and without dura rupture

Conditions: Dural Tear; Bedrest; Lumbar Spine Surgery

Summary: the primary purpose of this study is to assess whether lumbar spine surgery patients with dura rupture differ in symptom prevalence and severity from other lumbar spine surgery patients in the early postoperative phase. this is in order to develop a symptom-specific mobilization algorithm (duramob) that can be used to assess whether patients with dura rupture safe can be mobilized earlier after lumbar back surgery to prevent bed rest complications

accidental dura rupture is a complication of lumbar spine surgery, with an incidence of 2-18% which can cause cerebrospinal fluid leakage leading to symptoms such as postural headache, photosensitivity, tinnitus, infection, and pseudomeningocele. traditionally, the condition is treated with postoperatively flat bed rest ranging from 0-72 hours, entailing an increased risk of complications due to bed rest. there is inconsistency in the length of prescribed flat bed rest for these patients, and no consensus exists nationally or internationally. the prescription of flat bed rest is generally made by the surgeons based on their clinical experience. this quality development project in the clinimetric field aims to develop an assessment tool (duramob) of perioperative symptoms prevalence and severity in lumbar spine surgery patients with and without dura rupture in the early postoperative phase. data is based on clinical auditing comprising a consecutive samples of patients in collaboration with " center for rheumatology and spine diseases", rigshospitalet-glostrup, denmark. the duramob instrument will be developed as an evidence-based algorithm for assessing the potential need for postoperatively restrictive bedrest after dura rupture, - and subsequently to be implemented in clinical perioperative practice. further scientific testing will following be carried out in a feasibility study and / or as a randomized controlled trial. this initial study will generate observational evidence investigating the first steps towards establishing a safe mobilisation regime for patients with surgical dura rupture. ultimately, we seek to avoid unnecessary bedrest and complications derived from perioperative immobilization. data will be protected in a local clinical database redcap hosted by the capital region data management system and follows gdpr regulations. the department leadership approved the project and the local ethical committee' waived the need for approval.

Eligibility criteria:
inclusion criteria: lumbar surgery patients age \>18 years - exclusion criteria: trauma surgery cancer surgery lumbar fusion surgery
impact of adnexal involvement of the severity and prognosis of chronic graft-versus-host disease

Conditions: Graft vs Host Disease; Chronic Graft vs Host Disease; cGVHD

Summary: this research study will help us learn more about how chronic graft-versus-host disease affects the skin, hair and nails. we are interested in knowing if hair and nail problems predict worse disease. this information may help us treat patients like you in the future.

* at the initial visit, participants will have a complete examination of their skin, hair and nails. we will also test muscle strength and movement by moving the participant's arms, legs and neck. photographs will be taken of the skin, hair and nails of they are abnormal. blood tests will be done to check the liver and blood cell count. the participant and their legal guardian will answer questions about how the participant feels and about their health. * participants will then be scheduled for follow up visits at 3 months, 6 months, and 12 months. at each subsequent visit the following will be done: a complete examination of the skin, hair and nails; a test of muscle strength; photographs will be repeated; blood tests to check liver and blood cell counts; and questions about how the participant feels and about their health.

Eligibility criteria:
inclusion criteria: * received hematopoietic stem cell transplant * meet the diagnostic criteria for cutaneous cgvhd exclusion criteria: * previous hsct (other then the current hsct)

Keywords: adnexal hair and nail chronic graft vs host disease children
impact of c3f8 or sf6 use and length of face-down positioning (7 vs 14 days respectively) in macular hole surgery

Conditions: Macular Holes; Visual Acuity Gain; Cataract; Complications

Summary: the primary purpose of the study was to compare the macular hole closure and visual acuity gain following vitrectomy using sf6 gas tamponade with 7 days of face-down positioning versus c3f8 gas tamponade with 14 days of face-down positioning. the secondary purpose was to report, in each group, the cumulative incidence of cataract development 1 year following macular hole surgery and the proportion of complications (\*). ((\*) hypertony, hypotony, retinal tear, retinal detachment and endophthalmitis) this prospective randomized study examined a 3 year period. the first patient was included in january 2010 and the last in november 2011. the 12-month follow-up spread out from march 2011 to december 2012. the first group included 31 patients who had undergone macular hole surgery using sf6 gas and who were advised to stay in face-down position for 7 days postoperatively (sf6 group). these patients were compared to 28 patients who had undergone macular hole surgery with c3f8 gas and who were advised to maintain a face-down position for 14 days. patients in both groups underwent vitrectomy, internal limiting membrane peeling, and fluid-gas exchange using either sf6 or c3f8. preoperative data included the characterization of the hole with optical coherence tomography (oct), the best correct visual acuity (va) recorded in number of letters using the early treatment diabetic retinopathy study (etdrs) chart, classification of the cataract according to the locs iii and the intraocular pressure iop. postoperative data included oct confirmation of the closure at 6 weeks and 1 year, 1 year's best corrected va recorded in number of letters (edtrs chart) and determination of cataract development and extraction as needed.


Eligibility criteria:
inclusion criteria: * idiopathic mh of stage 2-4 according to gass classification (confirmed by fundoscopic examination and oct) was included. exclusion criteria: * exclusion criteria includes: patients with a chronic macular hole (symptoms more than 12 months duration), base diameter of the hole larger than 0.5 disc area diameter, medias opacities that prevent fundus visualisation until the second branches of central retinal artery, age-related macular degeneration armd, diabetic retinopathy, past history of retinal detachment or vitrectomy and corneal pathology disrupting vision.
noninvasive diagnostic techniques in determination of site of lesion of auditory neuropathy spectrum disorder

Conditions: Auditory Neuropathy

Summary: cross-sectional study of population who have ansd

cross-sectional nonivasive study including study and control group aiming to determine site of lesion of auditory neuropathy spectrum disorder either presynaptic or postsynaptic by using electrophysiological measures

Eligibility criteria:
inclusion criteria: * age between 12 and 50 years oae and cm could be present disproportionate srs to pta level exclusion criteria: proportionate abr to pta level proportionate srs to pta level * presnce ol lesions in ct or mri

Keywords: auditory neuropathy