Kornimate/medical-research-clean huggingface dataset:
bioequivalence study comparing a new 80 mg atorvastatin tablet to a 80 mg atorvastatin commercial tablet

Conditions: Hypercholesterolemia

Summary: to determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (lipitor®).


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years. * body mass index (bmi) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening. * treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.

Keywords: bioqeuivalence, pharmacokinetics, atorvastatin
enhancing adherence by building online communities

Conditions: Type 2 Diabetes; Coronary Artery Disease; Obesity

Summary: the purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program.

stepping up to health with ecommunities is a study that takes what we already know about motivating sedentary, chronically ill people to walk, and begins to explore what it takes to keep people motivated to exercise over time: the ability to self-monitor behavior with accurate ecological momentary assessments. we have theorized that peer support, monitoring and competition are ways in which people can stay motivated to meet their walking goals; thus, we have built into this intervention online forums for participants to communicate with each other and garner support, as well as a pilot one-to-many competitive game based on the percent of an individual's goal met. our research question is whether online community participation can increase adherence to an internet-mediated walking program, which consists of an uploading pedometer, and going to a website to receive graphical and textual feedback as to whether participants are meeting gradually increasing walking goals. three hundred participants will spend four months in this randomized, controlled trial to compare the intervention alone to the intervention plus online community support.

Eligibility criteria:
inclusion criteria: * must have one or more of the following: coronary artery disease (cad); bmi 25 or higher; type 2 diabetes * must be sedentary, defined by less than 150 minutes of self-reported activity per week * must be 18 or older * must have access to a computer with an internet connection, a usb port, and windows 2000 (latest service pack), xp or vista * must be a regular email user (checking weekly) * must be able to communicate in english exclusion criteria: * pregnant * cannot walk a block (self-report) * not competent to sign consent * unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist) * type 1 diabetes

Keywords: heart weight overweight bmi diabetes type 2 diabetic walk walk* diab* obese exercise activity coronary pedometer
noninvasive intracranial pressure and hydrocephalus patients

Conditions: Hydrocephalus

Summary: using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (icp) based on patients who have had traumatic brain injuries. patients with hydrocephalus are typically treated with a shunt in order to reduce icp. at times the shunt can malfunction. we believe that our algorithm will help identify when a hydrocephalus patient's shunt has malfunctioned.

a malfunctioning ventriculoperitoneal (vp) shunt will typically cause a rise in intracranial pressure, which can be difficult to identify without costly imaging. novel, state-of-the art machine learning techniques can be leveraged to develop an algorithm that noninvasively estimates intracranial pressure. the resulting algorithm will accurately determine the presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.

Eligibility criteria:
inclusion criteria: 1. age: 31 days - 35 years 2. patients seen at children's hospital colorado neurosurgery clinic, emergency department or on an inpatient service 3. either hydrocephalus patients with a vp shunt in place (with or without suspicion of vp shunt malfunction), or patients with no known intracranial pathology. exclusion criteria: 1. pregnant patients 2. incarcerated patients 3. patients who object at any time to participating in the study.

Keywords: vp shunted normal intracranial pathology patients
evaluation of the beneficial effects of a nasal spray of resveratrol in children with seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: the aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.

the aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. the primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. the secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.

Eligibility criteria:
inclusion criteria: * children of both sexes, ranging in age from 4 to 17 years * history of seasonal allergic rhinitis, mild, moderate or severe, defined according to the aria guidelines in 2010, documented by recurrent episodes in the previous year and confirmed by a positive skin test results * written informed consent from at least one parent or a legal representative exclusion criteria: * lack of informed consent in writing by at least one parent or a legal representative * concomitant disorders, such as infection of the upper (sinusitis, etc..) or lower respiratory tract, nasal surgery in the last year, abnormalities of the respiratory tract, immune diseases * use of antihistamines, nasal or systemic corticosteroids, leukotriene modifiers, cromolyn sodium, in the last six weeks

Keywords: nasal obstruction sneezing itching rhinorrhea respiratory infections wheezing
a randomized control trial to assess early clinical and functional outcome of the rocc and lcs total knee implant designs

Conditions: Osteoarthritis

Summary: this is a prospective randomised control trial to compare the early clinical and functional outcome of the rocc and lcs total knee arthroplasty implant designs.

this study compares two similar designs of cementless rotating bearing total condylar knee replacements. the study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. the persons undertaking the assessments will be blinded to which implants the patients have.

Eligibility criteria:
inclusion criteria: * patients suitable for cementless knee replacement * patients skeletally mature and under 80 years of age at pre-operative clinic * patients presenting with osteoarthritis of the knee * patients must be ambulatory at time of pre-operative clinic * patients must be able to understand instructions and be will to return for follow-up exclusion criteria: * previous knee surgery (except arthroscopic/open menisectomy) * patients with inflammatory arthritis * patients with significant medical co-morbidity - asa iv * disorders causing abnormal gait or significant pain * patients unable to consent * severe visual impairment
clinical validation of the screening tool picterus jp using different smartphones

Conditions: Neonatal Jaundice

Summary: the overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of picterus jp on all smartphones.

the overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of picterus jp on all smartphones. picterus jp bilirubin estimates from a samsung s7 will be compared with three smartphones with different camera types and a tcb measurement the clinical outcomes will be compared to our camera validation systems. skin color measurements using a spectrophotometer will be used for technical optimization of the camera validation system

Eligibility criteria:
inclusion criteria: * infants born with gestational age \> 37 weeks. * birth weight ≥ 2500 grams * age 1 - 14 days exclusion criteria: * infants showing signs of inborn disease. * infants with skin rash or other skin disease that affects the skin where measurements are performed. * infants transferred to the pediatric ward for medical treatment. * infants that have received phototherapy in the last 24 hours
an observational study of avastin in participants with metastatic colorectal cancer (koralle)

Conditions: Colorectal Cancer

Summary: this observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (avastin). further, safety and efficacy in daily routine will be assessed.


Eligibility criteria:
inclusion criteria: * participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to summary of product characteristics (smpc) exclusion criteria: * contraindications for bevacizumab according to smpc
evaluation of cg-100 intraluminal bypass device

Conditions: Colorectal Cancer

Summary: evaluation of cg-100 intraluminal bypass device


Eligibility criteria:
inclusion criteria (pre-operative): 1. willing to comply with protocol-specified follow-up evaluations 2. 22-75 (inclusive) years of age at screening 3. diagnosed with colorectal cancer 4. has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
"eyemax insight" cholangioscopy for unexplained bile duct stenosis

Conditions: Bile Duct Stenosis

Summary: when clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. this study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ercp.

when clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. this study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ercp. the etiology of biliary strictures is complex, including not only malignant tumors , but also factors such as stones, inflammatory strictures, congenital variations and so on. currently, the main methods for diagnosing malignant biliary obstruction in clinical practice include clinical examinations, biochemical testing (such as serum ca19-9), imaging, and endoscopic retrograde cholangiopancreatography (ercp). however, these methods have limitations, such as the limited specificity and sensitivity of ca19-9 and the indirect imaging of ercp after contrast agent filling. therefore, these methods are relatively difficult to distinguish the benign and malignant nature of biliary lesions. this study intends to analyze the diagnostic value of the biliary endoscopy system for these unexplained bile duct stenosis.

Eligibility criteria:
inclusion criteria: unexplained bile duct strictures (cannot be clearly diagnosed by ct, mri or other imaging methods); exclusion criteria: * patients with cardiac dysfunction, acute pancreatitis, active viral hepatitis; * patients with mental illness; ③ previously underwent choledochoscopy examination; ④ malignant biliary obstruction;
post-operative pain control using direct continuous bupivacaine infusion after pelvic organ prolapse repair

Conditions: Post-Operative Pain; Pelvic Organ Prolapse

Summary: this prospective randomized controlled study will determine the efficacy of continuous local anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic organ prolapse procedures including posterior colporrhaphy and sacrospinous ligament fixation.

direct post-operative analgesia can be administered via a direct continuous analgesia pumps providing local anesthetic into a dissected area. to date, no studies have been conducted to evaluate pain control or infection with vaginal placement of catheters for pelvic organ prolapse surgery. to help pelvic surgeons assess the relative benefit of continuous local infusion of topical anesthetic following sacrospinous ligament fixation versus pca pump, we compared pain scores, narcotic, anti-pruritic and anti-emetic drug usage, and wound complications.

Eligibility criteria:
inclusion criteria: * female patients greater than 18 years of age * undergoing posterior colporrhaphy at saint lukes hospital, kansas city, mo. exclusion criteria: * patients with chronic pain conditions requiring daily narcotics were excluded

Keywords: continuous bupivacaine infusion analgesia
short-term evaluation of motor and sensory function in post-covid-19 patients

Conditions: Motor Neuropathy; Sensory Neuropathy

Summary: sars-cov-2 infection reframed medical knowledge in many aspects, yet there is still a lot to be discovered. our aim is to evaluate neurological impact of covid-19; if there is any.

coronavirus disease 19 (covid-19) can cause neuropsychiatric, psychological and psychosocial impairments. literature regarding the sensory and motor affection of covid-19 is still limited. public health emergencies as covid-19 are likely to cause adverse neuropsychiatric impacts. cognitive impairments after sars-cov-2 infection were noticed, covid-19 patients complain of poor concentration, declined memory, and insomnia, as well as anxiety and depression symptoms. in a study; neurological manifestations described in 36.4% of 214 patients with confirmed covid-19. however, the symptoms described \[dizziness (not further defined), headache, and impaired consciousness\] are commonplace in many severe infections and represent disturbances in neurological function rather than a neurological disease per se. anosmia and ageusia have received much attention, but are ubiquitous in other common upper respiratory tract infections. while a reported increased risk of cerebrovascular disease.

Eligibility criteria:
inclusion criteria: * patients with confirmed rt-pcr covid-19 infection with mild to moderate severity based on the egyptian ministry of health (moh) protocol (version 1.4, november 2020) with neurological symptoms suggestive of peripheral neuropathy exclusion criteria: * patients presenting with neurological manifestations other than peripheral neuropathy, such as stroke, cerebral hemorrhage, encephalitis, or meningitis. * patients with any medical condition or comorbidities that may affect the result of the study as diabetes, arthritis, and carpel tunnel syndrome. * severe covid-19 patients with a critical condition that needs hospitalization and ventilatory support were also excluded from the study.

Keywords: covid-19 nerve conduction studies neuropathy complication
registry for participants with short bowel syndrome

Conditions: Short Bowel Syndrome

Summary: this is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (sbs) who are treated with teduglutide in a routine clinical setting. the registry will also evaluate the long-term clinical outcomes in participants with sbs. sbs participants treated and not treated with teduglutide will be enrolled.


Eligibility criteria:
inclusion criteria: 1. male and female participants, of any age, with a diagnosis of short bowel syndrome (sbs). 2. signed informed consent and medical records release by the participant or a legally acceptable representative 3. participants who have never received teduglutide treatment must be on parenteral nutrition (pn)/intravenous (iv) fluids support for at least 6 months at the time of enrollment. exclusion criteria: 1. participants currently participating in a blinded clinical trial or their extension studies. 2. participants who have never been on pn/iv support. 3. participants who are currently or previously exposed to any glucagon-like peptide 2 (glp-2) analogs other than teduglutide.

Keywords: short bowel syndrome sbs teduglutide gattex
safety and efficacy study of botulinum toxin type a for the treatment of neurogenic overactive bladder

Conditions: Overactive Bladder

Summary: this study will assess the safety and efficacy of botulinum toxin type a for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

botulinum toxin type a 300u has been discontinued from the study after regulatory approval of botulinum toxin type a 200u. patients remaining in the study who were allocated to receive botulinum toxin type a 300u at treatment 2 (and had not yet received it) will receive botulinum toxin type a 200u instead.

Eligibility criteria:
inclusion criteria: * urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis * inadequate response to anticholinergic medication used to treat overactive bladder. * neurological respiratory impairment and abnormal pulmonary function test results exclusion criteria: * history or evidence of pelvic or urologic abnormality * previous or current diagnosis of bladder or prostate cancer * symptomatic or untreated urinary tract infection at time of enrollment
penile fracture: a comparison of erectile function after immediate repair versus delayed repair

Conditions: Erectile Dysfunction

Summary: to prospectively compare erectile function at 12 months, utilizing the abbreviated international index of erectile function-5 (iief-5) score, for men treated with an immediate repair versus a delayed repair.

this was a prospective randomized study conducted at 2 tertiary level institutions in jamaica, the university hospital of the west indies (uhwi) and the kingston public hospital (kph). all cases of penile fracture were recruited from the emergency room (er) of both hospitals between the period january 2015 to january 2017 and all patients were over 18 years of age. information on demographics, length of time since the injury, mechanism of injury and risk factors for erectile dysfunction (diabetes mellitus, hypertension, dyslipidemia, smoking) was collected. erectile function was objectively assessed utilizing the abbreviated international index for erectile function-5 (iief-5), and scores at initial presentation were taken to represent the premorbid erectile function. a block randomization sequence was created and cases were allocated 1:1 to either immediate repair (group 1) or delayed repair (group 2). allocation sequence numbers were kept concealed in sequentially numbered folders and access was only granted to the principal investigator. for group 1 (immediate repair) patients were admitted to hospital and underwent emergency repair via a subcoronal circumferential degloving approach. for group 2 (delayed repair) patients were not admitted. instead, they were discharged from hospital and given an elective surgery date 7 - 10 days after the injury. oral diclofenac sodium 50mg was prescribed to be taken as needed and instructions to abstain from any sexual activity. all patients were then re-examined at 6 weeks for quality assurance. they were then instructed that resumption of sexual activity would be safe. routine clinic visits were scheduled at 3 months, 6 months, and 12 months. iief-5 scores were obtained from all patients at 12months.

Eligibility criteria:
inclusion criteria: * men with penile fracture presenting to the emergency room exclusion criteria: * suspicion of concomitant urethral injury (blood at the meatus, gross/microscopic haematuria, urinary retention)

Keywords: penile fracture delayed localized repair
leveraging social media to identify and connect teens with eating disorders to a mobile guided self-help mobile intervention

Conditions: Eating Disorders

Summary: clinical or subclinical eating disorders (eds) impact 10% of individuals in their lifetime and are marked by significant functional impairment, early mortality, chronicity, and emotional distress. ed symptoms often emerge in adolescence, with peak onset age in the teenage years. early recognition and treatment of these devastating illnesses are needed to prevent long-term consequences and a chronic course. most (80%) individuals with eds, including teens with eds (tweds), do not receive treatment. due to major barriers to access and to the delivery of treatment for tweds, there is a need for a new model of service delivery that can identify and help tweds. we demonstrated our ability to harness social media to identify and efficiently recruit large numbers of tweds. our team has successfully developed a guided self-help cognitive behavioral therapy (cbt)-based mobile app for previous studies and have adapted this app to address the specific needs of tweds. in proposed study, we will test this updated mhealth intervention, which includes simplified language and tailored content relevant to adolescent issues and a social networking feature designed to facilitate group exchanges. this mhealth intervention will be investigated among 161 tweds recruited from instagram/facebook to test preliminary efficacy and feasibility of this mhealth intervention to improved eating disorder symptoms among tweds not currently engaged in treatment. we will also garnering feedback via a mixed methods approach on the efficiency, technical effectiveness, and satisfaction with mhealth intervention content and features. participants will be randomized to one of 3 study arms, including a control group (self-help version of the app), a group with access to the coached mobile app only, and a group with access to the coached mobile app plus social networking feature. we hypothesized that those with access to the coached mobile app intervention will have improved ed outcomes in comparison to the control group, and that those with access to the additional social networking feature will have the most improvement in ed symptoms out of all three groups.


Eligibility criteria:
inclusion criteria: * us resident * owns or has daily access to an ios or android smartphone * english-speaking * screen positive for a dsm-5 subclinical/clinical eating disorder other than anorexia nervosa (an) or at high risk for an eating disorder exclusion criteria: * currently engaged in eating disorder treatment * screen positive for anorexia nervosa * wards of the state or foster children

Keywords: mhealth eating disorders bulimia nervosa binge eating disorder teens adolescents social media