Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to antidepressant treatment

Conditions: Major Depressive Disorder

Summary: to evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with major depressive disorder (mdd)


Eligibility criteria:
inclusion criteria: * the patient is an outpatient consulting a psychiatrist. * the patient has a recurrent major depressive disorder diagnosed according to dsm-iv-tr™. the current major depressive episode (mde) should be confirmed using the mini international neuropsychiatric interview (mini). * the patient had at least one previous mde before the age of 60 years. * the patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressants treatments. * the patient, if a woman, must have had her last natural menstruation ≥24 months prior to the screening visit. * the patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential. exclusion criteria: * the patient has any current psychiatric disorder or axis i disorder (dsm-iv-tr™ criteria), established as the primary diagnosis, other than mdd. * the patient has a current axis ii (dsm-iv-tr™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder. * the patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current mde. * the patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (dsm-iv-tr™ criteria). * the patient, in the opinion of the investigator, or according to columbia suicide severity rating scale (c-ssrs), is at significant risk of suicide. * the patient has had neuroleptic malignant syndrome. * the patient has any relevant medical history or current presence of systemic disease. * the patient has a neurodegenerative disorder. * the patient has, at the screening visit an abnormal ecg that is, in the investigator's opinion, clinically significant. * the patient has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission for \>5 years prior to the first dose of imp. * the patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. other inclusion and exclusion criteria may apply.
intestinal microbiome dynamics in solid organ and stem cell transplant recipients

Conditions: Transplantation Infection; Kidney Transplant; Complications; Stem Cell Transplant Complications; Liver Transplant; Complications; Microbial Colonization

Summary: this is a pilot study designed to investigate the alterations in the gut microbiome that occur during the course of kidney transplantation, liver transplantation, allogeneic hematopoietic stem cells and mesenchymal stem cells transplantation in association with the clinical outcomes.

this is a pilot study designed to investigate the dynamic changes in the intestinal microbiome that occur during the course of kidney transplantation, liver transplantation, allogeneic hscs and mesenchymal stem cells transplantation. four patient cohorts will be followed. cohort a: patients receiving kidney transplantation. cohort b: patients receiving hematopoietic stem cells transplantation. cohort c: patients receiving mesenchymal stem cells transplantation. cohort d: patients receiving liver transplantation. included participants are defined as patients with at least three analyzable stool samples including a baseline sample before the transplantation.

Eligibility criteria:
inclusion criteria: * participants enrolled into kidney transplantation or hscs transplantation or mscs transplantation or liver transplantation programs with fecal samples collected over the course of their initial transplant hospitalization. * be willing and able to provide written informed consent for the study. exclusion criteria: * patients were excluded from the study if their first sample was not collected prior to the start of transplantation procedure. * samples were excluded from the analysis if they were not aliquoted and stored frozen within 24 hours of collection.

Keywords: microbiome gut microbiome stem cell transplantation kidney transplantation
a study of the effects of ketoconazole taken orally has on the pk profiles of a dose of gsk189075 in healthy volunteers

Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Summary: the purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single dose of gsk189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of gsk189075 in healthy volunteers. the study will see whether ketoconazole causes gsk189075 to stay in your bloodstream for a longer period of time. it will also examine whether gsk189075 causes any changes in the amount of glucose you have in your urine.


Eligibility criteria:
inclusion criteria: * are a healthy, non-smoking male or female. * are 18 to 55 years old, inclusive. * have a body weight of \> or equal to 110 pounds. * are a female who is unable to have any more children and have a negative pregnancy test. * are willing and able to provide written informed consent before the start of any study-related procedures. * are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions. exclusion criteria: * smoke or use any tobacco products. * have a known allergic reaction to ketoconazole or study drug. * have a history of regular alcohol consumption greater than 7 drinks per week for females or greater than 14 drinks per week for males. * have a positive drug or alcohol or smoking test at screening or check-in to the clinic. * have participated in another clinical trial within 30 days prior to screening in which you have received an investigational drug. * have donated a pint of blood within 56 days before the first dose of study drug. * have any known or suspected stomach condition (or stomach surgery within the 6 months prior to dosing). * have abnormal liver test results. * have a documented history or diagnosis of cirrhosis. * have positive results for hepatitis c or b, or hiv at screening. * have blood pressure outside of the normal range. * are a male subject who is unwilling to either abstain from sexual activity or unwilling to use birth control during the course of the study. * are using non-prescription drugs, vitamins, herbal or dietary supplements (including st john's wort) within 7 days before the first dose of study medication, * have any abnormality identified on the screening physical or laboratory examination that the study physician feels would make it inappropriate for you to participate in the study.

Keywords: ketoconazole, drug interaction, pharmacokinetics t2dm,
paleolithic diet in the treatment of glucose intolerance

Conditions: Hyperglycemia; Coronary Heart Disease

Summary: the purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance.

there is uncertainty about the optimal diet in the prevention and treatment of glucose intolerance and diabetes type 2, disorders which are very common in patients with coronary heart disease (chd). earlier studies have generally focused on intakes of fat, carbohydrate, fiber, fruit and vegetables. another approach compares foods that were available during human evolution with more recently introduced ones. twenty-nine chd patients with glucose intolerance or diabetes have been randomized to 1) a paleolithic ("old stone age") diet (n=14) based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts, or 2) a consensus (mediterranean-like) diet (n=15) based on whole grains, low-fat dairy products, vegetables, fruit, fish, and oils and margarines generally assumed to be healthy. primary outcome variables are changes during 12 weeks in weight, waist circumference, and area under the curve for glucose (auc glucose0-120) and insulin (auc insulin0-120) at the oral glucose tolerance test.

Eligibility criteria:
inclusion criteria: * hyperglycemia * coronary heart disease * increased waist circumference exclusion criteria: * body mass index \<20 kg/m2 * serum creatinine \>130 µmol/l * poor general condition * dementia * unwillingness/inability to prepare food at home (by study participant or partner) * participation in another medical trial * chronic inflammatory bowel disease * drug treatment with hypoglycemic agents * drug treatment with warfarin * drug treatment with oral steroid

Keywords: paleolithic diet mediterranean-style diet glucose tolerance diabetes type 2 weight loss waist
effectiveness of entresto (sacubitril/valsartan) in japanese patients with hypertension

Conditions: Essential Hypertension

Summary: this study is a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study will be used as secondary use of collected patient information in the database (japan medical data survey \[jamdas\]) owned by m3 inc. jamdas is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc.


Eligibility criteria:
inclusion criteria: 1. diagnosed with essential hypertension (international classification of diseases \[icd\]-10 code: i10) on the index date. 2. patients for whom data for the 6 months prior to the index date can be extracted as baseline data. 3. patients for whom blood pressure (bp) data can be extracted between weeks 8 and 12 after the index date. 4. patients whose bp data can be extracted on the index date. 5. patients whose bp value at baseline was 140/90 millimeters of mercury (mmhg) or higher. 6. patients with the prescription of 100 milligrams (mg) or 200 mg once daily as 100 mg or 200 mg tablets on the index date. exclusion criteria: 1. women with a record of pregnancy-related diagnoses, drugs, or medical procedures before or after the index date, or a record of delivery- or abortion-related diagnoses, drugs, or medical procedures after the index date. 2. prescription of concomitant angiotensin-converting enzyme inhibitor (acei); anatomical therapeutic chemical (atc) code: c09a on, after, or in the 2 days before the index date. 3. patients diagnosed with angioedema: icd-10: d84.1 under prescription of acei or angiotensin receptor blocker (arb); atc code: c09c. 4. patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date. 5. patients with severe impaired liver functions with child-pugh classification c.
comparison study of biofoam porous metal versus allograft to treat adult acquired flatfoot

Conditions: Adult Acquired Flatfoot

Summary: the purpose of this study is to compare the clinical and radiographic outcomes of a randomized, consecutive series of adult patients, with an acquired flatfoot, treated with a lateral column lengthening using an allograft bone wedge versus a titanium porous metal implant (biofoam, wright medical). null hypothesis: at six months postoperatively, there is no difference in the degree of correction as measured by the talonavicular coverage angle between patients randomized to allograft and biofoam. alternative hypothesis: at six months postoperatively, the degree of correction as measured by the talonavicular coverage angle will be less in patients randomized to allograft than the degree of correction in patients randomized to biofoam.


Eligibility criteria:
inclusion criteria: * ages 25-75 * unresponsive to conservative treatment * patient with acquired flatfoot deformity, who is a candidate for lateral column lengthening (stage iib) = (greater than \> 40% uncoverage of talar head by navicular on standing ap radiograph) exclusion criteria: * less than 25 years of age and greater than 75 years * pre-existing infection * peripheral neuropathy * charcot arthropathy * peripheral vascular disease * rhematoid arthritis (ra) or inflammatory arthropathy * metal allergy or sensitivity to metal

Keywords: adult acquired flatfoot biofoam porous metal implant allograft bone wedge
evaluation of the safety and performance of the harmoni® toric lens

Conditions: Aphakia; Corneal Astigmatism; Cataract

Summary: the purpose of this study was to evaluate the safety and effectiveness of the harmoni® modular intraocular lens system with a toric optic (hmtiol) in subjects with pre-existing corneal astigmatism in need of cataract surgery.

subjects with visually significant bilateral cataracts (cortical, nuclear, posterior subcapsular, or a combination) were implanted unilaterally (in one eye only) or bilaterally (in both eyes) with the hmtiol. a total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. the total duration of participation for each subject was up to 6 months, including the preoperative period (up to 3 months). alcon research, llc, acquired clarvista medical in 2017. this study was designed and conducted by clarvista medical, inc. the study results were collected, analyzed, and provided by clarvista medical, inc. to alcon research, llc.

Eligibility criteria:
key inclusion criteria: * planned removal of visually significant bilateral cataract by manual phacoemulsification cataract extraction * pre-existing corneal astigmatism in at least 1 eye of 0.75 to 2.50 diopter (d) * target dioptric lens power within the range of 16 - 26 d * willing to discontinue contact lens wear for the duration of the study * bcva projected to be ≤0.2 logarithm minimum angle of resolution (logmar) * stable cornea * dilated pupil size at least 7.0 millimeters (mm) * able to understand and provide informed consent. key exclusion criteria: * history of any intraocular or corneal surgery in study eye (including refractive) * pregnant or lactating * history of any clinically significant retinal pathology or ocular diagnosis in study eye that could alter or limit final postoperative visual prognosis * history of ocular conditions which could affect the stability of the iol in study eye * any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction in study eye * any visually significant intraocular media opacity other than cataract in study eye * uncontrolled glaucoma in study eye * uncontrolled systemic disease * severe dry eye that would impair the ability to obtain reliable study measurements * systemic medication that may confound the outcome or increase the intraoperative and postoperative risk to the subject.

Keywords: toric intraocular lens
study of taste deficits

Conditions: Taste Disorder; Healthy

Summary: this study will explore the genetics of taste and taste deficits. the sense of taste plays a crucial role in food choices, allowing people to identify beneficial foods (those with high caloric value, which are typically sweet) and foods likely to be toxic (usually bitter substances). the loss of sense of taste in older people plays a role in decreased appetite and poor nutrition. taste deficits may adversely affect people in ways that are not well understood. this study will examine why some people (about one-fourth of all people in the united states) cannot taste a substance called phenylthiocarbamide (ptc). the inability to taste ptc is due to inherited factors that are not yet clear. individuals age 18 and older who can taste ptc and individuals who cannot taste ptc may be eligible for this study. participants will taste a number of liquid solutions until they find one with a clear taste. then they will taste another group of solutions and decide which ones have that taste and which have no taste. finally, they will taste a third group of solutions until they find one with a different taste. about 2 tablespoons of blood will be drawn from participants for genetic tests related to the sense of taste.

the primary goal of this study is to identify the underlying cause of deficits in the ability to taste different commonly consumed substances, including the bitter compound phenylthiocarbamide (ptc) as a model. individuals will be tested to identify those who can and cannot taste ptc, as well as for their ability to taste a variety of sweet, sour, salty, and savory substances. individuals will have 20 cc of blood drawn to obtain dna. these dna samples will then be analyzed for variation in genes whose products are known to be involved in taste perception pathways. information about individuals dna sequence variation will then be correlated with their taste phenotype to identify the specific genetic variation that causes phenotypic variation, providing molecular structure-function information in taste sensory pathways.

Eligibility criteria:
* inclusion criteria: * individuals age 18 years and older. * subjects must be medically healthy, with no cognitive impairment or physical swallowing inability or impairment * must be able to provide informed consent * must be able to read and understand english. * nih employees or staff may participate in this study if they meet the eligibility criteria. exclusion criteria: * cannot be younger than 18 years of age * subjects with suspected or known cognitive impairment or physical swallowing inability or impairment * subjects who are unable to provide informed consent * subjects who are taking any pyschoactive medications or medications that affect their nervous system, such as antidepressants or anti-psychotics. * subjects who have known problems with these sense of taste * subjects who are currently using tobacco

Keywords: phenylthiocarbamide phlebotomy chemoreceptors population associations non-tasters taste healthy volunteer hv normal control
prospective study of the feedback from an adherence monitor on asthma control

Conditions: Asthma

Summary: inhaled medications are the mainstay of the therapeutic management of respiratory disorders. considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. however, there is no tool that can detect and record errors in either the timing or the method dose administration the investigators designed a device that makes an acoustic record each time an inhaler is used. opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. when the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. together this means that errors in inhaler technique and timing of use can be quantified. in this study the investigators attached the device to a discus dry powder inhaler. in order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in hospital and already prescribed a discus inhaler. the investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.


Eligibility criteria:
inclusion criteria: * patients prescribed therapy equivalent to step 3 or higher on the asthma management guidelines for at least 3 months * at least one exacerbation in the previous year with systemic glucocorticoids * uncontrolled/partially controlled asthma by gina guidelines exclusion criteria: * allergy to salmeterol/fluticasone * patients controlled by gina guidelines

Keywords: asthma inhaler use
feasibility of aerodigestive stimulation therapy trial

Conditions: Feeding Disorder Neonatal

Summary: the goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. the main aims are: * to provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding. * to examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding. participants will have weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry (hrim) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 ml of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.

stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. during the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 ml of their prescribed feed. feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. the study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. a feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.

Eligibility criteria:
inclusion criteria: * nicu infant ≥37 weeks postmenstrual age not taking full oral feeds * consult to neonatal \& infant feeding disorder program for oral feeding difficulty with diagnostic manometry ordered * presence of peristaltic and sphincteric reflexes at initial manometry exclusion criteria: * potentially lethal chromosomal anomalies * craniofacial malformations * foregut malformations

Keywords: chronic tube feeding gastrostomy deglutition esophageal manometry
value of pet/ct imaging in the diagnosis of permanent central venous catheters infection

Conditions: Infection

Summary: the study hypothesis is that f-18-fdg pet/ct and microcalorimetry might have a diagnostic value in the detection of permanent central venous catheters (pcvc) infection when conventional means of pcvc infection detection are non-conclusive.

permanent central venous catheters are frequently infected and therefore need surgical removal. when a clear diagnostic for infection cannot be defined, catheter removal might be at risk for the patient, for the therapeutic follow-up and in terms of costs. pet/ct and microcalorimetry might help giving conclusive diagnostic of catheter infection.

Eligibility criteria:
inclusion criteria: * patients with confirmed catheter infection requiring surgical removal * patients with probable catheter infection requiring surgical removal * patients with planned removal of uninfected catheter * ≥18years old exclusion criteria: * extreme claustrophobia * pregnancy and breastfeeding * severe septicemia

Keywords: infection permanent central venous catheter device related