Kornimate/medical-research-clean huggingface dataset:
body water content in cyanotic congenital heart disease

Conditions: Heart Defects, Congenital

Summary: adults with cyanotic congenital heart disease have elevated levels of plasma proatrial natruretic peptide (proanp) which most likely results in chronic dehydration, leading to reduced oxygen transport to tissues and shortness of breath with activity. the purpose of this study is to characterize adults with cyanotic congenital heart defects with respect to their body composition (water and fat-free mass) and resting metabolic rates. the study consists of several measures of how much body water, fat and lean tissue a subject has, and measures the number of calories the subject's body uses at rest. adult subjects with cyanotic congenital heart disease will be recruited along with healthy noncyanotic control subjects matched for age, gender, and body weight.


Eligibility criteria:
inclusion criteria: * resting blood pressure below 140/90

Keywords: cyanotic congenital heart disease
a study to assess the interaction between asp1707 and itraconazole in healthy female subjects

Conditions: Pharmacokinetics; DDI (Drug-Drug Interaction); Healthy Subjects

Summary: the purpose of this study to explore the effect of multiple oral doses of itraconazole on the pharmacokinetics of a single oral dose of asp1707 in healthy female subjects. this study will also evaluate the safety and tolerability of a single oral dose of asp1707 alone and in combination with itraconazole.

subjects will be confined in the clinical unit for up to 15 days.

Eligibility criteria:
inclusion criteria: * female subject must be either of non child bearing potential, post-menopausal prior to screening, or documented surgically sterile. or, if of childbearing potential, must agree not to try to become pregnant during the study and for 28 days after the final study drug administration, must have a negative urine pregnancy test at day -1 and, if heterosexually active, agree to consistently use two forms of highly effective form of birth control starting at screening and throughout the study period and for 28 days after the final study drug administration. * female subject must not be breastfeeding at screening or during the study period, and for 28 days after the final study drug administration. * female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration. exclusion criteria: * female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening. * subject uses grapefruit (more than 3x 200 ml) or marmalade (more than three times) in the week prior to admission to the clinical unit until esv, as reported by the subject. * subject is a vulnerable subject (e.g., subject kept in detention).

Keywords: healthy subjects asp1707 itraconazole
mri before biopsy in diagnosing patients with prostate cancer

Conditions: Prostate Cancer

Summary: this pilot clinical trial studies how well magnetic resonance imaging (mri) before biopsy works in diagnosing patients with prostate cancer. mri is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. this diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. the lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.

primary objectives: i. identification of one of more lesions suspicious for prostate cancer using a novel mri protocol, not identified by transrectal ultrasound (trus) alone and to determine if the lesions identified by mri demonstrate clinically significant prostate cancer based on pathologic findings (ie. gleason \>= 7 or percentage of core involved with cancer \> 50%). secondary objectives: i. average time for mri scan per patient. ii. correlation of lesions on mri to radical prostatectomy specimens. iii. to determine whether mri 3 dimensional (3d) t2 half-fourier acquired single turbo spin-echo (haste) or sampling perfection with application optimized contrast using different flip angle evolutions (space) protocols provide improved rates of prostate cancer detection. iv. yield of additional clinically significant prostate cancer diagnoses based on mri targeted lesions on biopsy. v. rate of benign pathology identified by mri (i.e. false positives). vi. to compare costs associated with the use of mri over trus biopsy alone. outline: participants undergo pelvic mri. within 1-2 weeks, patients undergo scheduled prostate biopsy.

Eligibility criteria:
inclusion criteria: * abnormal prostate-specific antigen (psa) blood test * \> 2.5 ng/ml for men \< 50 years (yrs) of age * \> 3.5 ng/ml for men \< 60 yrs of age * \> 4.5 ng/ml for men \< 70 yrs of age * abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate) * scheduled for a trus biopsy based on clinical suspicion for prostate cancer exclusion criteria: * individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer * contraindications to trus/prostate biopsy (bx) * currently on blood thinning agents (plavix, coumadin etc.) or bleeding disorder * active urinary tract infection * acute painful perianal disorder (i.e. rectal abscess) * contraindications to mri * patients with ferromagnetic or otherwise non-mri compatible aneurysm clips * the presence of an implanted pacemaker or implanted defibrillator device * patients with contraindications for mri due to embedded foreign metallic objects: bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient * implanted medical device not described above that is not mri-compatible * known history of claustrophobia * individuals with a short life expectancy (\< 10 years)
liver and the spleen stifness in adult patients with gaucher's disease using ultrasound shear wave elastography

Conditions: Gaucher Disease; Liver Fibrosis; Spleen; Fibrosis

Summary: the investigated cohort will examine liver and spleen fibrosis in patients with gaucher disease(gd) by using shear wave elastography- swe to evaluation fibrosis of the tissue and to check the correlation of fibrosis with the biomarkers of disease severity.

to assess liver and spleen stiffness measurement using shear wave elastography-swe and evaluate liver and spleen fibrosis in patients with gaucher disease. to compare the elastography with the biomarkers that taken at the gd haematology clinic and to check the correlation with severity of liver and spleen fibrosis. swe is a safe with diagnostic accuracy regarding the liver (\& spleen) fibrosis. estimating spleen fibrosis is an innovative approach in liver disease and gaucher. the evaluation of fibrosis with this relatively new and safe method could avoid complications and invasive procedure in gd patients .

Eligibility criteria:
inclusion criteria: 1. patients with gaucher disease over the age of 18 years. 2. patients able to sign informed consent form. 3. women are not pregnant. 4. patients who read and understood the contents of the consent form and gave their written consent to participate in the study. exclusion criteria: 1. participants under the age of 18. 2. pregnant women. 3. participants are unable to sign an informed consent form. 4. participants with known liver disease not associated with gaucher disease such as liver cirrhosis, patients with hbv, hbc or liver cirrhosis.

Keywords: shear wave elastography
awareness of iron status evaluation in ugib

Conditions: Upper Gastrointestinal Bleeding

Summary: background: data on the awareness of the need to evaluate iron status and ida prevalence in acute ugib are limited. objectives: this study aimed to investigate the rate of evaluation of iron status and prevalence of iron deficiency anemia (ida) and the associated factors in patients with anemia hospitalized for acute upper gastrointestinal bleeding (ugib).


Eligibility criteria:
inclusion criteria: * patients \&gt; 18 years of age who were admitted because of acute ugib and were diagnosed with anemia from ugib during hospitalization. exclusion criteria: * patients who had previously undergone endoscopy at another institution before admission * patients who had a definite cause of ugib that was inconclusive * incomplete data for analysis.

Keywords: upper gastrointestinal bleeding anemia iron status iron deficiency
prospective two-year study to assess miconazole nitrate resistance in neonates and infants

Conditions: Diaper Rash

Summary: the purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.

the objective of this study is to investigate the potential for the development of resistance in candida spp. after repeated treatment courses of 0.25% miconazole nitrate ointment in neonates and infants up to one year of age.

Eligibility criteria:
inclusion criteria: * male or female neonate or infant up to 1 year of age with fitzpatrick skin type i-vi * clinical evidence of diaper dermatitis and a positive koh result for pseudohyphae and/or budding yeast at baseline visit * overall diaper dermatitis severity index score at baseline visit of 4-8 (must include an overall clinical grade of at least 2 for erythema) * wear commercially available diapers day and night for at least 7 days prior to enrollment and during the course of the 2 year study * caretaker must complete informed consent process exclusion criteria: * known sensitivity to any component of the formulation * no other skin conditions that may confound the evaluation of the drug efficacy or tolerability * known sensitivity to skin care toiletry products or diapers * history of hiv positive * chronic illnesses that require systemic medication that may confound the evaluation of study drug efficacy or tolerability (antibiotic therapy is not included) * treatment with a prescription product for diaper dermatitis or other skin condition 7 days prior to enrollment

Keywords: diaper dermatitis complicated by candidiasis
acetaminophen/codeine vs acetaminophen/ibuprofen for pain control and patient satisfaction after hand surgery

Conditions: Pain, Postoperative

Summary: the purpose of this research study is to find out if taking acetaminophen with ibuprofen (e.g. tylenol + advil), a non-opioid regimen, provides the same type of pain relief after hand surgery compared to acetaminophen and codeine (e.g. tylenol 3), an opioid regimen.

primary objective: to establish, through a randomized control trial, whether post-operative acetaminophen and ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to acetaminophen and codeine (opioid regimen). secondary objective: to establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction. sixty-three patients enrolled for each group (non-opioid and opioid). approximately 145 patients will be required to achieve complete data for 63 patients in each group (assuming 15% lost to follow-up \& failure to comply with study protocol).

Eligibility criteria:
inclusion criteria: * patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation. exclusion criteria: * asa\> 3; * coagulopathy; * renal disease, * liver disease, * history of recent gastro-intestinal bleeding * pregnancy. * diagnosis of chronic pain currently taking opioid pain medication or with a history of drug abuse. * patients with a self-described allergy to asa, acetaminophen, nsaids and codeine. * all patients receiving a brachial plexus block for anesthesia and/or analgesia

Keywords: pain, postoperative
needle stick injuries in emergency medical service practice

Conditions: Cardiac Arrest; Needle Stick; Injuries; Glowe

Summary: during the pandemic era, medical personnel should wear full protective suits. however, they limit the performance of medical procedures. one of the main questions is whether to use double gloves. the study was based on dying gloves used during resuscitation. the gloves were secured with disposable hermetically sealed pouches and described by one of the ems team members - each time after resuscitation was completed.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * medical profession (paramedics, nurses, physicians) working in emergency medical service exclusion criteria: * not meet the above criteria * wrist or low back diseases

Keywords: needle stick injuries sars-cov-2 covid-19 personal protective equipment paramedic emergency medical service
effects of transcutaneous electrical nerve stimulation (tens) following hysterectomy

Conditions: Pain, Acute

Summary: the purpose of this study is to evaluate the effect of transcutaneous electrical nerve stimulation (tens) in patients after abdominal hysterectomy surgery.

the aim of this study is to evaluate the efficacy of the transcutaneous electrical nerve stimulation (tens) on postoperative pain and quality of recovery in patients following abdominal hysterectomy surgery under general anesthesia.

Eligibility criteria:
inclusion criteria: * patients aged between18-65 undergoing elective abdominal hysterectomy * asa (american society of anesthesiologist) i,ii physical status exclusion criteria: * not agreement with the study,dermatological lesion affecting the electrode place, * chronic or preprocedural use of opioids, steroids or psychoactive drugs, * allergy to drugs used during trials, * previous experience in tens, * kidney, liver, neurological or cardiovascular system disease * body mass index\>40

Keywords: acute pain transcutaneous electric nerve stimulation anesthesia recovery period
screening for convergence insufficiency in school-age children

Conditions: Convergence Insufficiency

Summary: the purpose of this study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting.

the purpose of the screening for convergence insufficiency in school-age children study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting (where it may not be feasible to do more than one test).

Eligibility criteria:
inclusion criteria: * age 9 to 17 years * enrolled in participating school * parental permission, assent * ability to complete testing exclusion criteria: referral on vision screening for reduced distance visual acuity or significant uncorrected refractive error

Keywords: normal
effect of lactoferrin supplementation on urinary tract infections in infants.

Conditions: Urinary Tract Infections in Children

Summary: the aim of the study was to evaluate the efficacy of orally administered bovine lactoferrin (blf) on urinary tract infections in neonates and infants. fifty-five patients with urinary tract infection were randomized to receive either blf (n = 27) or an identical placebo (n = 28) for 4 weeks. the patients were assessed clinically and laboratory.

this study was a prospective randomized controlled trial at a single university medical center. participants were neonates or infants with urinary tract infection (uti) admitted to the neonatal and infant pathology department of children's university hospital in the period from july 2015 to december 2017. the intervention was bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks compared with placebo in a control group. during hospital treatment, laboratory tests were performed to evaluate the activity of inflammatory markers (c-reactive protein, procalcitonin, interleukin-6 and interleukin-8 levels and white blood cell count). fifty-five patients heve been included in the study.

Eligibility criteria:
inclusion criteria: * neonates and infants with symptoms of urinary tract infection. * active infection at enrollment, confirmed and documented in medical record. * children with urinary tract infection treated according to current recommendations. exclusion criteria: * unconfirmed urinary tract infection. * critical illness and/or hemodynamic instability. * allergy or sensitivity to lactoferrin or bovine derived proteins or bovine milk. * children whose parents/guardians decline to participate.

Keywords: urinary tract infections infants lactoferrin
a genetic linkage study of schizophrenia

Conditions: Schizophrenia Sib-Pairs

Summary: we propose to study 900 sib-pairs with the disorder. our specific aims are: 1) to clinical assess a pedigree sample having adequate power to detect genes for schizophrenia. 2) to conduct a genome scan to find such loci. 3) to transmit all data to the nimh designated cell repository and data management centers. we will attain these goals by achieving the following: 1) from taiwan and china, we will collect 900 han chinese sib-pairs having dsm-iv schizophrenia. 2) we will examine all family members using the diagnostic interview for genetic study and the family interviews for genetic study. the pi participated in the development and field testing of these interviews and has an already established training program for their use. they have been translated into mandarin by the taiwanese investigators, who have used them in prior studies. 3) blood samples will be sent to the nimh designated cell repository for creation of lymphoblastoid cell lines. 4) clinical data will be entered using the database software created for the nimh human genetics initiative. data will be vetted and sent to the nimh designated data management center. 5) we will complete a genome scan using 450 markers spaced at an average of 10 cm intervals using markers that have been optimized for use in the han chinese population. the scan will be completed with no cost to the nimh through an agreement with millennim pharmaceuticals, a biotechnogy company in the the boston area that the pi has worked with on a prior genetic linkage study of schizophrenia. all genetic analyses will be approved by our consultant, eric lander, phd. 6) all clinical data will be made available to the scientific community by the end of the funding period. all genotypes wil be available one year after they are created but no later than a year after the funding period. this project as feasible because 1) the pi has already coordinated one multi-site genetic linkage study of schizophrenia and has participated in a second. 2) we have a long-standing relationship with our taiwanese collaborators and an effective, albeit, more recent working relationship with our chinese collaborators. 3) we have conservatively estimated that each site has access to more than enough available families having two schizophrenic siblings. 4) the pi's harvard team has had prior experience collaborating on genotyping and linkage analysis projects with millennium pharmaceuticals. this, and millennium's prior genotyping experience shows that the genotyping phase of the work is feasible.


Eligibility criteria:
inclusion criteria: * schizophrenia * han chinese population * two schizophrenia siblings, one normal parent and one normal sibling

Keywords: schizophrenia linkage taiwan han chinese population
acupuncture for relieving chronic pelvic pain

Conditions: Pelvic Pain

Summary: individuals with chronic pelvic pain will be identified, consented and enrolled in this study in which acupuncture will be offered in addition to current standards of care. the primary outcome will assess if there is a reduction of pain intensity from the baseline to 6 months as a result of treatment.

chronic pelvic pain as defined by the american college of obstetricians and gynecologists is "noncyclic pain of 6 or more months duration that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back or the buttocks and is of sufficient severity to cause functional disability or lead to medical care". this has devastating consequences both monetarily as well as emotionally and can lead to opioid addiction, depression and even suicide. acupuncture has been used to treat pain in china for millenniums and was one of the more effective ways to treat pain before morphine was discovered. acupuncture is feasible, economic and a safe way to treat chronic pain. patients with chronic pelvic pain will be identified and offered participation in the study. after the consent process is completed, patients will undergo a brief physical exam to rule out acute symptoms. the patient will be asked to complete a baseline pain inventory and genitourinary pain index survey before proceeding with acupuncture treatment. qualified patients will be requested to accept acupuncture treatments twice weekly for 12 consecutive weeks. each week the patient will be asked to report their current medications and changes in the dosage as well as their narcotic (opioid) doses and any changes in the dosages. patients will be followed up monthly for up to 3 months after treatment completion by phone to record their pain inventory as well as their genitourinary pain index survey.

Eligibility criteria:
inclusion criteria: * chronic pelvic pain persisting for at least 6 months * english speaking * able to provide informed consent exclusion criteria: * unable to provide informed consent * pregnant * prisoners * morbid obesity (bmi \>40, or \> 36 associated with hypertension and diabetes) * severe cardiac disease * active chemotherapy or radiation therapy * skin infections or lesions * severe copd * neuropathy * previous stroke * paralysis * needle phobia

Keywords: acupuncture
the safety integration stakeholders (saints) program to integrate worker and patient safety in oregon rural hospitals

Conditions: Accidental Falls; Injuries

Summary: the safety integration stakeholders (saints) program to integrate worker and patient safety in oregon rural hospitals. the rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act).

saints program will follow a semi-structured, block randomized control design along with a multi-method process evaluation to identify the extent to which the program was delivered as planned and if it led to the adoption of preventative measures. rct measures will consist of pre/post survey data (at 6 months, 12 months and 24 months) hosted through redcap and available via link. additional secondary, de-identified data in aggregate (e.g. # of patient falls, # of worker compensation claims) will supplement survey data. process evaluation will consist of implementation logs and interviews with key players (safety and quality officers, front-line peer leaders). the semi-structured design allows for customization among different rural healthcare sites that will have unique resources and needs, therefore requiring unique, tailored solutions. the combination of qualitative and quantitative. the saints program will be implemented in four stages. 1) involvement of patient and worker safety stakeholders (e.g., employee health and safety officer, quality director, unit medical directors), 2) use of social network analysis (sna) to identify peer-recognized safety leaders; 3) training modules to stakeholders on safety leadership, and 4)in implementation of qi cycles to address barriers to safe patient handling and mobility (sphm).

Eligibility criteria:
inclusion criteria: * employed at participating sites (critical-access hospitals in rural oregon) * patient-care workers (e.g. rns, cnas) exclusion criteria: * non-clinical staff (e.g. clerical, janitorial) * non-unit staff (e.g. physical therapy)

Keywords: patient falls patient-assist injuries safety climate