Kornimate/medical-research-clean huggingface dataset:
pet-mr-psa prostate cancer recidive study

Conditions: Prostate Cancer Recurrent

Summary: simultaneous pet/mri has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of mri with the high molecular sensitivity of pet in a single imaging session. the aim of this study is to evaluate the sensitivity and specificity of simultaneous 18f-fluciclovine pet/mri for detection of recurrent prostate cancer.

the patients follow standard treatment and follow-up after the pet/mri exam, which will be determined by the patient's treating urologist and/or oncologist. data from histopathology, clinical follow-up and follow-up imaging will be collected to establish a reference standard that defines the presence or absence of disease for each patient. the imaging findings will be compared with the reference standard to assess the sensitivity and specificity. the diagnostic accuracy of combined pet/mri and mri-only (the current clinical standard) will be compared.

Eligibility criteria:
inclusion criteria: * the criteria for biochemical relapse in accordance with the european association of urology (eau) guidelines on prostate cancer must be fulfilled (two consecutive measurements with psa \> 0.2 ng/ml following radical prostatectomy or psa \> 2.0 ng/ml above the nadir following definitive radiotherapy) * potential candidates for salvage treatment based on age and co-morbidity. exclusion criteria: * general contra-indications for a pet/mri exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia) * impaired renal function defined as estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2

Keywords: pet-mr recidive pet/mr imaging 18f-fluciclovine radical treatment recurrence
the efficacy of robot-enhanced therapy for children with autism spectrum disorders

Conditions: Autistic Disorders Spectrum

Summary: this trial will test the efficacy of robot-enhanced interventions for developing social skills in children with autism spectrum disorders (asd). the study will compare, in an equivalence design, an innovative intervention delivered by a semi-autonomous robotic agent with standard behavioral intervention. the target group is children between 3 and 6 years old which will be randomly allocated to one of the two treatments. each treatment will be delivered over 8 bi-weekly sessions of 45 minutes each.

autism spectrum disorders (asd) is characterized by a pattern of persistent deficits in communication and abnormal behaviors (i.e., repetitive and restrictive). previous research has shown promising results for the use of social robots to develop social skills in asd children. however, most of the research is based on case studies and single case experiments. rigorous clinical data comparing robot--enhanced therapy with standard therapy is needed to establish the efficacy of this innovative intervention. the present study is an equivalence randomised clinical trial which plans to include children with a diagnosis of asd between 3 to 6 years old. eligible children are randomly allocated in one of two groups: (1) standard therapy, derived from applied behavior analysis (aba) and (2) a robot--enhanced intervention in which the same treatment is delivered by a semi--autonomous robotic mediator agent (the robot acts as a mediator while the therapist is supervising the session). both interventions are delivered over 8 bi-weekly sessions of about 45 minutes each. the present study will provide some of the first rigorous data regarding the efficacy of robot--enhanced therapy delivered by an intelligent robotic agent which require less direct input from an operator to deliver the intervention, as compared to previous research. if the results demonstrate the equivalence of the two interventions, this could open the door for the dissemination of evidence--based interventions for asd children through the use of robotic agents.

Eligibility criteria:
inclusion criteria: * to be diagnosed using dsm-v criteria by a psychiatrist; * the diagnostic is confirmed by the autism diagnostic observation scale (ados; scores are in the clinical range).

Keywords: autism spectrum disorder robot-enhanced intervention imitation joint attention turn-taking
physical function in patients with chronic obstructive pulmonary disease

Conditions: COPD

Summary: the aims of the study are to examine the responsiveness of, and the correlation between field walk tests and physical performance test in patients with chronic obstructive pulmonary disease (copd) after participating in pulmonary rehabilitation.

patients with copd who are participating at pulmonary rehabilitation (pr) at haukeland university hospital will be asked and consecutive enrolled to the study. before and after pr the six-minute walk test, incremental- and endurance shuttle walk test, 30 sec sit-to-stand test and stair test will be used to evaluate change in physical capacity and -performance.

Eligibility criteria:
inclusion criteria: * diagnosed with copd, forced expiratory volume in 1 sec (fev1)/forced vital capacity (fvc) \<0.7 and fev1\<80% of predicted value. * able to walk corridor and stairs * norwegian speaking exclusion criteria: * copd exacerbations requiring medical treatment last 4 weeks prior to inclusion led to deferment of inclusion * not safe to exercise (e.g unstable angina) * mental illness and drug abuse that makes group treatment not suitable

Keywords: pulmonary rehabilitation exercise field walk test physical performance test
the effect of a blue light filtering iol

Conditions: to Compare the Effect of Two Types of IOLs; on the Incidence of Cystoid Macular Edema; After Cataract Surgery

Summary: to compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering iol) or an ultraviolet light filtering intraocular lens(uv-filtering iol).

the following parameters were measured for evaluation of blood retinal barrier disruption. * the incidence of macular leakage by fluorescence angiography (fa) * the mean fluorescein concentration in the vitreous by fluorophotometry (vfp) * the thickness of the macula by optical coherence tomography (oct) results * the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering iol group (p\<0.05), and was significantly lower compared with the uv-filtering iol group at 12 months. * the vfp significantly decreased in both group from 3 to 12 months. * the oct decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering iol group.

Eligibility criteria:
inclusion criteria: * cataract patients * all eligible for intraocular lens implantation exclusion criteria: * patients had undergone an intraocular operation * patients had hypertensive retinopathy * patients had diabetic retinopathy * patients had ange-related macular degeneration * no observable fundus * the cataract operation was more than 30 minutes in duration

Keywords: macula edema intraocular lens prospective randomized parallel clinical design
analysing the french covid-19 epidemic using a national sars-cov-2 rt-pcr database

Conditions: Covid-19; SARS-CoV Infection

Summary: analysing ths spread of covid-19 epidemics in a timely manner is key to implementing public health control strategies. the investigators propose to analyse a large set of laboratory sars-cov-2 rt-pcr data to explore potential links between ct values and epidemic parameters.


Eligibility criteria:
inclusion criteria: - a sars-cov2 rt-pcr result with a known sampling date exclusion criteria: - patient refusing to participate in research

Keywords: sars-cov2 infection tested for sars-cov2 infection with rt-pcr test ct epidemiology reproduction number
progression free survival (pfs) using erlotinib for non-small-cell lung cancer (nsclc) in chinese population

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this trial is an extension to ensure, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (nsclc) with mutations in the tyrosine kinase domain of egfr. this study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in nsclc patients from the ensure trial (nct01342965). patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. patients previously treated with erlotinib will be given cisplatin on day 1 and gemcitabine on days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).


Eligibility criteria:
inclusion criteria: * participant in ensure trial * disease progression during first-line treatment exclusion criteria: * n/a

Keywords: non-small-cell lung cancer (nsclc)
identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood

Conditions: Obesity

Summary: the investigators will compare 16srdna profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.

experimental evidence suggests that bacterial translocation from gut to tissue could be an initial step leading to diabetes. to test this hypothesis, a bacterial component that is highly conserved between different species of bacteria, the 16s rdna gene will be analysed both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and control.

Eligibility criteria:
inclusion criteria: * between 35 and 75 years old * colonoscopy and biopsies required diabetes population: * type 2 diabetes obese population: * android obesity exclusion criteria: * inflammatory bowel disease * colonic cancer * bariatric surgery * previous administration of antibiotic (within 15 days) * pregnancy

Keywords: bacterial gut type 2 diabetes. 16s rdna gene intestinal crypt
a study to assess efficacy and safety of rt001 in subjects with infantile neuroaxonal dystrophy

Conditions: Infantile Neuroaxonal Dystrophy

Summary: the purpose of this study is to evaluate the efficacy and safety of rt001 in patients with infantile neuroaxonal dystrophy (inad).

this is a single arm open-label study with a structured observation of inad patients treated with rt001. enrolled subjects will undergo observation and testing to determine the effect of rt001 treatment. fifteen to twenty eligible subjects will be treated with rt001 for long-term evaluation of efficacy, safety, tolerability, and pharmacokinetics.

Eligibility criteria:
inclusion criteria: 1. male or female 18 months to 10 years of age 2. medical history consistent with the symptoms of classic inad (onset of symptoms between the ages of 6 months and 3 years) 3. homozygous for pla2g6 deficiency (variant alleles may be mixed heterozygotes) 4. must have impairment in at least 2 of the assessed categories at baseline 5. signed informed consent form (icf) prior to entry into the study 6. able to provide the necessary blood samples exclusion criteria: 1. received treatment with other experimental therapies within the last 30 days prior to the first dose 2. requiring mechanical ventilation, other than positive air pressure support primarily for mitigation of sleep apnea. 3. have a life expectancy of less than one year 4. diagnosis of atypical nad (anad) 5. unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to return for visits as scheduled

Keywords: inad infantile neuroaxonal dystrophy
psychological preparation prior to bariatric surgery

Conditions: Obesity; Psychological Disorders

Summary: is it feasible to perform a randomized controlled trial to assess whether or not psychological preparation seminars prior to bariatric (weight loss) surgery are beneficial to the investigators patients?

this is a feasibility study, assessing how possible it would be to perform a randomized controlled trial to see if preoperative psychological or mental health problems impacts on length of stay, short and long term health outcomes, weight loss, and if preoperative counseling has any effect.

Eligibility criteria:
inclusion criteria: * new referrals to the sheffield teaching hospital bariatric service exclusion criteria: * non-english speakers * patients that are not fit for bariatric surgery * patients that have already seen the bariatric psychologist
a study of teduglutide (revestive®) in children, teenagers and adults with short bowel disease

Conditions: Short Bowel Syndrome

Summary: the main aims of the study are to assess the safety profile of teduglutide (revestive®) in people with short bowel disease as well as how well people respond to the treatment with teduglutide (revestive®). this study is about collecting data only; participants receive teduglutide (revestive®) by their doctors according to the clinical practice but not as part of this study. only standard care information available in the participant's medical records will be reviewed and collected for this study. participants do not need to visit their doctor in addition to their normal visits.


Eligibility criteria:
inclusion criteria: * adult participants (greater than or equal to \[\>=\] 18 years) or pediatric (\>= 1 year and less than \[\<\] 18) with a diagnosis of sbs who are dependent on parenteral support. * have received at least one dose of teduglutide according to approved indications. * signed the mandatory consent that has been agreed with national regulatory authorities (anmat) as applicable. exclusion criteria: - not applicable.
mapracorat ophthalmic formulation in subjects with allergic conjunctivitis

Conditions: Conjunctivitis, Allergic

Summary: the objective of this study is to evaluate the dose response, and efficacy of mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (cac) model.


Eligibility criteria:
inclusion criteria: * positive history of ocular allergies and a positive skin test reaction * positive bilateral cac reaction exclusion criteria: * have known contraindications or sensitivities to the use of any of the study medications(s) or their components. * have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters. * had ocular surgical intervention within three (3) months prior to visit 1 or during the study and/or a history of refractive surgery within the past 3 months; * a known history of retinal detachment, diabetic retinopathy, or active retinal disease; * the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit. * use of any disallowed medications during the period indicated prior to visit 1 and during the study. * have planned surgery during the trial period or within 30 days after. * have an intraocular pressure that is less than 5 mmhg or greater than 22 mmhg or any type of glaucoma at visit 1
myofascial release and mobilization with impulse technique torsion in low back pain

Conditions: Low Back Pain; Chronic Disease

Summary: the purpose of the current randomized clinical trial was to compare the effectiveness of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability, and kinesiophobia in individuals with chronic non-specific low back pain.

design: randomized clinical trial. objective: to determine the effects of myofascial soft tissue release versus mobilization with impulse technique torsion (anterior) on pain, disability and kinesiophobia in individuals with chronic non-specific low back pain. methods and measures: sixty-four individuals will be randomly assigned to one of two groups. intervention: for 12-week, the group 1 will undergo treatment comprising a myofascial soft tissue release protocol (1/week) and the group 2 will receive a mobilization with impulse technique torsion (anterior) (1/week). main outcome measures: intensity of pain, disability, fear of movement, isometric endurance of trunk flexor muscles and lumbar mobility in flexion data will be collected at baseline, and 24hr after the last manual therapy application. mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Eligibility criteria:
inclusion criteria: * score ≥4 on the roland morris disability questionnaire * inability to achieve lumbar muscle flexion-relaxation in trunk flexion * low back pain for ≥3 months * not undergoing another physical therapy treatment exclusion criteria: * disease of the central or peripheral nervous system * having previously undergone spinal manipulative therapy * contraindication to low back thrust manipulation * a history of spinal surgery * treatment with corticosteroid in the past two weeks * clinical signs of radiculopathy * presence of lumbar stenosis * diagnosis of spondylolisthesis

Keywords: low back pain chronic pain manipulation manual therapy randomized controlled trial
heartprep: a virtually-delivered psychosocial intervention for mothers expecting a baby with congenital heart disease

Conditions: Congenital Heart Disease

Summary: congenital heart disease (chd) is the most common birth defect and is increasingly diagnosed prenatally. mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of chd. maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. in partnership with diverse parent and clinician stakeholders, our team designed heartprep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with chd. this project will pilot heartprep with mothers expecting a baby with chd to obtain preliminary data for a larger future trial. this intervention has the potential to improve emotional wellbeing in mothers expecting a baby with chd, thereby altering developmental trajectories for this large population of children.

congenital heart disease (chd) is the most common birth defect and is increasingly diagnosed prenatally. mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of chd. maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. targeted efforts to mitigate impacts of maternal stress for this highly vulnerable population are lacking. in partnership with diverse parent and clinician stakeholders, the investigators designed heartprep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with chd. heartprep will be delivered through the nemours app, an accessible tool for telehealth and patient education. the investigators aim to determine whether heartprep modules produce clinically significant improvements on outcomes in mothers expecting a baby with chd (proof-of-concept). this program of research has the potential to improve emotional wellbeing in mothers expecting a baby with chd, thereby altering developmental trajectories for this large population of children.

Eligibility criteria:
inclusion criteria: * expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life * partners of participating expectant mothers can also participate together with the mother * receiving fetal cardiac care at nemours children's health * speaks english or spanish fluently * age 18 or older * access to a computer, tablet or mobile device with internet access exclusion criteria: -fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year
the changes within the cells of the drainage system of the eye in patients with glaucoma

Conditions: Glaucoma

Summary: the purpose of this study is to try to identify the cause of damage to the drainage system of the eye (the trabecular meshwork). damage to this system may cause elevation in the pressure within the eye and thereby damage to the optic nerve and the vision.

during a routine trabeculectomy surgery, a corneo-scleral block that includes tm tissue will be collected at the operating room. this tissue is routinely removed during every trabeculectomy surgery. the tissue will be stored immediately in normal saline at 4 degrees celsius, and walked directly to the jefferson center for translational medicine at thomas jefferson university by the wills eye glaucoma research fellow. tm tissue will be identified using light microscope base on tm cell pigmentation. the ocular tissue will be fixed and placed in pre-cooled fixative on ice for 1 hour. the lengths of mitochondrial cross sections at the longest extent will be measured under electron microscopy (em) in order to identify the mitochondrial dynamics. quantitative polymerase chain reaction (qpcr) will be done to identify proteins responsible for mitochondrial fusion.

Eligibility criteria:
inclusion criteria: * minimum 2-year diagnosis of poag * moderate to advanced stage of the disease * ddls stages 5 through 10 with visual field loss * age between 21 and 80 years * planned trabeculectomy with or without concomitant cataract surgery exclusion criteria: * age ≤ 20 years old * any other type of glaucoma other than poag * patients who had undergone selective laser trabeculoplasty (slt) or argon laser trabeculoplasty (alt) * patients with history of ocular trauma * patients with previous eye surgery will be excluded both from the study and the control groups

Keywords: mitochondria trabeculectomy trabecular meshwork glaucoma surgery
study of lornoxicam or ketorolac or placebo for post-operative pain after bunionectomy

Conditions: Bunionectomy; Orthopedic Surgery

Summary: to determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. one-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.


Eligibility criteria:
inclusion criteria: * subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic. * subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications. * subjects are in generally good health with no uncontrolled chronic illnesses or diseases. exclusion criteria: * subjects who are pregnant. * subjects who have significant obesity. * subjects with medically significant heart, liver, kidney, lung or endocrine disease. * subjects with active viral disease, i.e. hepatitis, hiv.