Kornimate/medical-research-clean huggingface dataset:
spectral lighting and intestinal failure

Conditions: Intestinal Failure

Summary: the goal of this exploratory n-of-1-study is to compare markers of metabolism in infants with intestinal failure between two lighting environments. investigators are seeking to learn whether supplementing the lighting environment of infants with intestinal failure with blue and violet wavelengths of light will allow more efficient utilization of the nutrition provided to participants by influencing hormones involved in regulation of growth and development as compared to a conventional lighting environment. pre-clinical studies suggest that violet and blue wavelengths of light are involved in molecular pathways that help regulate metabolic activity.


Eligibility criteria:
inclusion criteria: * greater than or equal to 32 weeks post-menstrual age (pma) * diagnosis or anticipated diagnosis of intestinal failure by qualified provider * have an anticipated hospital stay of at least 5 weeks following initiation of study participation exclusion criteria: * infants with major congenital anomalies outside of the gastrointestinal tract * infants with aneuploidy (having an abnormal amount of chromosomes) * infants \<32 weeks post-menstrual age (pma) * infants who are anticipated to require a major surgery after enrollment other than anastomosis.
effective study of live attenuated varicella vaccine to treat severe resistant psoriasis

Conditions: Psoriasis

Summary: immunotherapy was reported in the treatment of psoriasis. treatment of resistant psoriasis may be difficult and cyclosporine can induce some remission. the investigators hypothesized that the combined use of live attenuated varicella vaccine as an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis can give positive responses.


Eligibility criteria:
inclusion criteria: * severe psoriasis: at least 30% of body involved) according to the rule of nine. * resistance to conventional therapy (puva, methotrexate, retinoids): (maximum pasi 50% improvement while on treatment for a duration not less than 6 months). * immunologically competent individuals with * seropositive for the varicella antibodies exclusion criteria: * any contraindication to live attenuated varicella vaccine * any contraindication to cyclosporine

Keywords: severe resistant
the incidence of extra-articular manifestations in participants with ankylosing spondylitis treated with golimumab (mk-8259-012)

Conditions: Ankylosing Spondylitis

Summary: the objective of this study is to determine the difference in the annual incidence rate of uveitis attacks in participants with ankylosing spondylitis (as) before start initial anti-tnf therapy and after treatment with golimumab (glm).

this is an open-label, history-controlled, multi-site study of glm in participants with as. for evaluation of the primary study outcome measure, participants will serve as their own control. the period before start of treatment with an anti-tumor necrosis factor (tnf) agent will serve as historical control for the incidence of extra-articular manifestations, with a review of the medical records done for the previous 1-year period. each participant will participate in the study for approximately 12 months from the time the participant signs the informed consent form through the final contact. after screening, two to four weeks before study start, each participant will be receiving study treatment for approximately 12 months, depending on the response to glm after 3 months. all participants will be followed for a minimum of 12 months, irrespective of the duration of glm treatment.

Eligibility criteria:
inclusion criteria: * may not have been treated with glm prior to study enrollment * must be able to provide retrospective data concerning extra-articular manifestations and episodes with a recall period of at least 12 months prior to anti-tnf use * must have definite as according to the modified new york criteria in the netherlands * must be candidate for treatment with anti-tnf agent according to the assessment of spondyloarthritis international society (asas) consensus * must be able to adhere to dose and visit schedules exclusion criteria: * any exclusion criteria stated in the summary of product characteristics for golimumab * use of any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening
an effectiveness, safety, and palatability study of pancrelipase microtablets in infants and toddlers with cystic fibrosis and fat malabsorption

Conditions: Cystic Fibrosis; Steatorrhea

Summary: the purpose of this study is to evaluate the effectiveness and safety of pancrease mt (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers

the objective of this randomized, investigator-blinded, parallel group, multicenter, pilot study is to evaluate the preliminary safety, palatability and effectiveness of pancrelipase microtablets to improve fat absorption. the hypothesis is that pancrease mt will provide effective, safe and palatable pancreatic enzyme supplementation to be used for the treatment of fat malabsorption in a cohort of infants with cystic fibrosis-related pancreatic insufficiency. on day 1 of the study, parents will be instructed to administer 500 units lipase/kg/meal for a full five days. stool will be collected and analyzed during the last 72 hours of this baseline period. on day 6 of the study, subjects will be randomly assigned to one of four treatment groups. parents will be instructed to administer the appropriate dose for a full five days and stool will be collected and analyzed during the last 72 hours of this randomized treatment period. patients will receive pancrease mt 500 units lipase/kg/meal by mouth for a maximum of five doses per day for the first 120 hours. patients will receive pancrease mt 500, 1000, 1500 or 2000 units lipase/kg/meal by mouth, for a maximum of five meals per day for the next 120 hours.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis * excessive discharge of fat in feces * stable patient requiring pancreatic enzyme therapy exclusion criteria: * no stable antibiotic therapy for small bowel overgrowth * no hypersensitivity to pork products * no use of prokinetics eg, metoclopramide or cisapride within the last 30 days * no nasogastric feeding tube feeding * no use of steroids * no use of concomitant h2 blockers or proton pump inhibitors as concomitant therapy

Keywords: cystic fibrosis pancreatic insufficiency steatorrhea fat malabsorption pancrelipase
impact of total nephrectomy on patients with kidney stone

Conditions: Kidney; Urolithiasis; Nephrectomy; Treatment Outcome; Complications

Summary: the aim of this study is to investigate the outcomes of total nephrectomy on patients with kidney stone disease.

the aim of this study is to retrospectively investigate the effects of total nephrectomy on renal function, quality of life, early and late complications and development of the stone disease on the remnant unit on patients with kidney stone disease.

Eligibility criteria:
inclusion criteria: * total nephrectomy * kidney stone disease exclusion criteria: * \< 18 y.o. * cancer * kidney transplant * solitary kidney
bioequivalence study of ag2202

Conditions: Bioequivalence Study

Summary: the objective of this study is to evaluate the human bioequivalence of ag2202t and ag2202r.

to evaluate the bioequivalence of two formulations of ag2202t and ag2202r after a single oral dose administration in healthy korean subjects under fasting conditions.

Eligibility criteria:
inclusion criteria: * subjects aged 19 years or older at the time of screening * subjects with a bmi of 18.0-30.0 kg/m2 * subjects who do not have clinically significant congenital or chronic diseases and who do not have any pathological symptoms or findings as a result of general clinical examination * subjects who are deemed eligible based on the screening tests exclusion criteria: * subjects who have taken drugs that induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose or who have taken drugs that may interfere with the investigational product within 10 days prior to the first dose * subjects who have taken the investigational drug within 6 months prior to the first dose * subjects who donated whole blood within 8 weeks prior to the first dose, or donated blood components within 2 weeks, or received a blood transfusion within 4 weeks prior to the first dose
motivational interviewing to improve medication adherence among hispanic adults with depression

Conditions: Depression

Summary: this study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among hispanics.

depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. studies have shown that people of hispanic descent tend to underutilize mental health care services. additionally, hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. this may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. this study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in hispanics. participants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. all participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. participants will also receive an electronic medication container that will record how consistently medication is taken. participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. the group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. all participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at months 2 and 5.

Eligibility criteria:
inclusion criteria: * self-identifies as hispanic * dsm-iv diagnosis of any unipolar depressive disorder (i.e., mdd, dysthymia, or depressive disorder not otherwise specified) * currently taking antidepressant medication exclusion criteria: * clinically significant suicidal ideation * dsm-iv diagnosis of any substance-related disorder, bipolar disorder, or psychotic disorder/features within 12 months prior to study entry * unstable general medical condition

Keywords: dysthymia major depression hispanics latinos motivational interviewing adherence
synaptic density and progression of parkinson's disease.

Conditions: Parkinson Disease

Summary: aim: to assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with pd. design: we will include 30 pd patients and 20 healthy controls. all subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11c-ucb-j pet-ct and 18f-fe-pe2i pet-mr at baseline and after 2 years.


Eligibility criteria:
inclusion criteria: * pd diagnosis based on mds clinical diagnostic criteria for parkinson's disease * less than 5 years disease duration since motor symptom onset according to the patient * hoehn-yahr stage 1 or 2 in medication on state * capacity to understand the informed consent form exclusion criteria: * neuropsychiatric diseases other than pd * major internal medical diseases * relevant abnormalities on mr brain * history of alcohol or drug abuse * contraindications for mr * pregnancy * previous participation in other research studies involving ionizing radiation with \> 1 msv over past 12 months.

Keywords: parkinson disease pet ucb-j pe2i
a study evaluating the safety, efficacy, and pharmacodynamic effects of abt-981 in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Medial Compartment Knee Osteoarthritis

Summary: a phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of abt-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.


Eligibility criteria:
inclusion criteria: 1. radiographic knee osteoarthritis with kellgren-lawrence grade 2 or 3 2. body mass index (bmi) 18-34 kg/m2 3. one or more clinical signs and symptoms of active inflammation in the index knee exclusion criteria: 1. history of allergic reaction to any constituents of the study drug, or to any immunoglobulin g (igg)-containing product 2. history of anaphylactic reaction to any agent 3. significant trauma or surgery to the index knee 4. severe knee malalignment 5. any uncontrolled medical illness or an unstable treatment or therapy

Keywords: osteoarthritis synovitis knee pain
the brain ketone body challenge imaging study

Conditions: Alzheimer Disease

Summary: the brain ketone body challenge imaging study will measure how the brain uses different fuels. to do this, radioactive compounds will be used during positron emission tomography (pet) imaging. these compounds, called \[11c\]acetoacetate (acac) and \[18f\] fludeoxyglucose (fdg), are similar to the sugars and fats the brain already uses for fuel. these compounds safely allow researchers to see how the brain uses sugars and fats during pet scans.

after consuming a chilled 4 ounce shake which contains various dietary fats, cognitive testing and dual-tracer positron emission tomography scan will be completed. at visit 1, each participant will be randomized to challenge a (low calorie ensure®) or challenge b (ensure® plus ketone esters). at visit 2, each participant will undergo the remaining challenge (a or b) prior to the second imaging session. each visit is designed to be identical to the other and only vary the dose of ketone esters. randomization to either challenge at visit 1 will ensure that test/re-test learning effects are equally distributed between the challenge groups. this study consists of two visits that will take place over a two week period.

Eligibility criteria:
inclusion criteria: * diagnosis of mild cognitive impairment (mci) * stable medical condition * stable on medications for past 4 weeks * women must be post-menopausal exclusion criteria: * diagnosis of neurodegenerative illness (except for mci) * history of a clinically significant stroke * current evidence or history in past year of focal brain lesion, head injury with loss of consciousness or meeting any diagnostic and statistical manual 4 (dsm-iv) criteria for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse * diabetes that requires current use of diabetes medications * current use of cholesterol/lipid lowering medications * history of epilepsy or seizure within past year * contraindications for imaging (e.g. claustrophobia or high prior radiation exposure)

Keywords: memory dietary treatment
cerebral and cognitive markers of treatment resistance in obsessive compulsive disorder

Conditions: OCD

Summary: this study aims to define individual profiles of treatment resistants in order to find indicators and predictors of the therapeutic response.


Eligibility criteria:
inclusion criteria: * obsessive compulsive disorder diagnosed according to diagnostic and statistical manual 5 criteria (patients will be included regardless of the severity and resistance of their pathology and their levels of executive functions) * understand and accept the constraints of the study * be a beneficiary or affiliated to a health insurance scheme exclusion criteria: * present one of the diagnoses according to the criteria of the dsm 5: schizophrenic disorders, substance abuse or dependence to a substance according to the criteria of the m.i.n.i. version 5.0 (sheehan et al., 1998) * generalized anxiety disorder, social anxiety, nicotine dependence and history of a major depressive episode are not exclusion criteria according to the m.i.n.i. version 5.0 (sheehan et al., 1998) * have a serious intercurrent pathology * being a pregnant woman * being a woman of childbearing age without effective contraception. * being hospitalized under duress or on an outpatient basis in a care program * being under judicial protection (reinforced curatorship, guardianship)

Keywords: functional mri
evaluation of the sensory attributes of olopatadine 0.6% and azelastine 137mcg nasal sprays in patients w/allergic rhinitis

Conditions: Allergic Rhinitis

Summary: to compare patient perceptions of the sensory attributes, including taste and aftertaste, of olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.


Eligibility criteria:
inclusion criteria: 1. must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment 2. 18 yrs of age or older 3. read and sign informed consent 4. females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control. exclusion criteria: 1. history of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride. 2. any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection. 3. impairment of sense of tast or smell (self reported) 4. asthma, except for mild, intermittent asthma (nat'l asthma guidelines) 5. congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption 6. patients w/a severe impairment of nasal breathing 7. anatomic abnormalities of as identified by nasal examination 8. history of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study. 9. history of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.

Keywords: rhinitis
acromio-clavicular dislocation type iii - conservative treatment versus surgical hook plate treatment

Conditions: Acromio-clavicular Joint Dislocation (Type III)

Summary: acromio-clavicular (ac) joint dislocation corresponds to 8.6% of all joint dislocations and represents a major injury to the shoulder girdle. the nature of the treatment is decided according to the severity of the lesion. the purpose of this study is to determine whether the surgical treatment is required or not for type iii ac joint dislocations.


Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years-old; * ac joint dislocation type iii with zanca x-ray view demonstrating cc distance of 200%; * trauma-surgery delay of less than 14 days; * consent form signed. exclusion criteria: * ac joint dislocation type i, ii, iv, v or vi; * associated neuro-vascular damage; * men or women \> 60 years-old; * open dislocation; * local skin damage; * dislocation in a polytrauma patient; * floating shoulder; * fracture of the ipsilateral or controlateral arm or shoulder girdle; * fracture of the coracoid process of the scapula; * history of previous surgery to the shoulder; * medical condition preventing surgery; * men or women unfit to consent; * any other condition that make the examinator thinks that the follow up would be problematic.

Keywords: acromio-clavicular joint dislocation type iii acromio-clavicular joint dislocation joint dislocation clavicle hook plate
clinical study 3mespe crowns

Conditions: Dental Caries

Summary: this clinical study seeks to address four independent questions that are all part of the delivery of care associated with the provision of a single item of treatment; an indirect restoration (known as a 'crown') to restore and cover a damaged tooth. the provision of a crown requires a series of sequential clinical and laboratory stages stages: 1. stage 1 - preliminary impression. taking a pre-operative impression of the tooth to be crowned. this will be used to enable the fabrication of the temporary crown after the tooth has been prepared. this is standard care and follows established clinical protocols. 2. stage 2 - preparation of the tooth. this involves cutting the tooth back to make space for the crown that will be fabricated to replace the missing structure. 3. stage 3 - taking an impression of the prepared tooth. from this a duplicate model will be made to fabricate the crown. to take the impression, the dentist will need to gently push the gums away from the tooth by fractions of a millimeter so that the margins of the preparation are clearly discernible. 4. stage 4 - provision of a temporary restoration that will provide satisfactory function for a limited period of time, until the definitive crown can be fitted. this temporary crown is designed to have a finite short-term durability and have an ease of manufacture and subsequent removal; hence the use of a specific cement that will enable this. 5. stage 5 - fitting of the definitive restoration. this is designed to be a durable restoration, with a mean life expectancy measured in years, but which is ultimately determined by a number of clinical, biological and patient specific parameters. definitive restorations are fitted with cement designed to retain the crown in permanent manner.


Eligibility criteria:
inclusion criteria: * patients in need of at least one full-coverage posterior restoration (crown) in a permanent premolar or molar. * if two teeth in opposing arches are in need of a full-coverage posterior restoration (crown) only the tooth or teeth in one arch will be included in the study. exclusion criteria: * patients who are unable to give informed consent or vulnerable population as defined in iso 14155 will not be enrolled. * patients with contraindications as described in the 'instructions for use' of the study materials