Kornimate/medical-research-clean huggingface dataset:
study to evaluate effect of sofosbuvir/velpatasvir/gs-9857 fixed-dose combination on the pharmacokinetics of a representative hormonal contraceptive medication, norgestimate/ethinyl estradiol

Conditions: HCV Infection

Summary: this study will evaluate the effect of sofosbuvir (sof)/velpatasvir (vel)/voxilaprevir (vox) fixed-dose combination (fdc) + voxilaprevir on the pharmacokinetics (pk) of a representative hormonal contraceptive medication, norgestimate/ethinyl estradiol (ortho tri-cyclen® lo (oc)) and will assess the effect of norgestimate/ethinyl estradiol on the pk of sof/vel/vox+vox.


Eligibility criteria:
inclusion criteria: * premenopausal female * must have a calculated body mass index (bmi) ≥ 19.0 and ≤ 30.0 kg/m\^2 at screening * must have a negative serum pregnancy test at screening and urine pregnancy test at day -1 * be willing and able to comply with all study requirements. exclusion criteria: * lactating female * have a history of any of the following: * significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity) * known hypersensitivity to the study drugs, the metabolites or formulation excipients * believed, by the study investigator, to be inappropriate for study participation for any reason
multi-year study of fluzone high-dose influenza vaccine compared with fluzone® vaccine in adults aged 65 years and older

Conditions: Influenza

Summary: the aim of this study is to determine the efficacy of fluzone high dose vaccine and that of fluzone® vaccine in the elderly. primary objective: to measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations. secondary objectives: * to compare the clinical efficacy of fluzone high dose vaccine with that of fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus. * to compare the clinical efficacy of fluzone high dose vaccine with that of fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.

the occurrence of influenza-like illness (ili) will be determined in elderly participants vaccinated with either fluzone high dose or fluzone® vaccine. the presence of influenza virus in the respiratory tract of vaccinated individuals with ili will be confirmed by two methods.

Eligibility criteria:
inclusion criteria : * aged ≥ 65 years on the day of vaccination * informed consent form signed and dated. * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria : * participation in another interventional clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure in the 4 weeks preceding the trial vaccination or planned participation in another clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure during each year of participation in the study trial. * vaccination against influenza in the 6 months preceding the trial vaccination. * systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to fluzone vaccine or to a vaccine containing any of the same substances. * personal history of guillain-barré syndrome. * dementia or any other cognitive condition at a stage that could interfere with following the trial procedures. * thrombocytopenia, bleeding disorder, or anticoagulation therapy contraindicating intramuscular (im) vaccination. * known or suspected human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c seropositivity. * alcohol abuse or drug addiction that could interfere with the subject's ability to comply with trial procedures. * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * bedridden subjects.

Keywords: influenza respiratory tract infections influenza-like illness elderly fluzone® efficacy
role of cbd in regulating meal time anxiety in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: no studies of cannabidiol (cbd) have focused on anorexia nervosa (an). dose, side effects, tolerability, acceptability of pure cbd in an must be established. the current study is an important first step in the investigation of cbd for an. cannabis products have been recently legalized in many states, and cbd in particular has been shown to reduce anxiety. therefore, cbd may represent a promising new treatment for an. the endocannabinoid system is involved in the regulation of functions relevant to eating disorders. furthermore, data suggest that eating disorders are associated with alterations of the endocannabinoid system. prior attempts to target the endocannabinoid system in an have focused on cb1 receptor agonists that can increase anxiety. moreover, cbd may be particularly beneficial in decreasing anxiety in an via its action at serotonin receptors. lastly, the impact of cbd on eating behavior and weight in an must be determined. the current study seeks to explore these hypotheses using the aims in the following section.


Eligibility criteria:
inclusion criteria: 1. must currently meet dsm-5 criteria for an-r and an spectrum disorders (i.e., atypical an) based on the structured clinical interview for the dsm-5 (scid-5-rv) 2. have a duration of illness ≥ 6 months 3. be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician exclusion criteria: 1. psychotic illness/other mental illness requiring inpatient hospitalization 2. current dependence on drugs or alcohol 3. physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight or liver disease which may affect pharmacokinetics of the study drug 4. use of other psychoactive medications 5. significant changes in medication in past month 6. expression of acute suicidality 7. previous hypersensitivity reaction to epidiolex or any of its constituents
genomic profiling of genetic and rare diseases

Conditions: Rare Diseases; Genetic Disease

Summary: in italy, over 2 million patients are affected by rare diseases (rd), which pose significant challenges due to their clinical diversity, long diagnostic processes (often 4-5 years), and high socio-healthcare costs. the italian healthcare system has recognized these challenges, leading to initiatives like a national rare diseases (rd) registry, a comprehensive list of rare diseases (rds) eligible for healthcare exemptions, and the establishment of a national committee for rare diseases. research on the genetic mechanisms of rare diseases (rds) is robust, particularly for innovative therapies, and ranks second to oncology. the policlinico universitario a. gemelli irccs foundation serves as a key reference institute for rare diseases (rd) in lazio, managing over 10,000 patients through accredited centers. a recent initiative aims to enhance the rare diseases network by integrating genomic knowledge with clinical practice. the project focuses on utilizing next generation sequencing (ngs) for early genetic diagnosis, promoting personalized medicine. given the challenges the national health service faces in resource allocation for rare diseases (rd) and the recent approval of a new outpatient healthcare tariff, this initiative is timely. the foundation seeks to replace targeted genetic tests with whole exome sequencing (wes), increasing the identification of molecular conditions and reducing diagnostic turnaround times.


Eligibility criteria:
inclusion criteria: * age 0-90 years * patients with suspected rare disease/genetic disease diagnosed based on the clinical criteria/instrumental examination performed by a reference physician experienced in the specific condition (e.g., phenotype attributable to a known genetic syndrome, known neuromuscular disease, known organ-specific disease such as hypertrophic/dilated cardiomyopathy) to undergo genetic analysis * patients with a phenotype suggestive of a rare disease/genetic disease not specifically linked to a known condition * patients with suspected rare disease/genetic disease, who have undergone quantitative genetic analyses (e.g., array-cgh) or qualitative analyses (e.g., ngs panel of known genes), which yielded negative results * patients who have already received a genetic etiological diagnosis and for whom the current project can address further questions such as the personalization of a prevention or therapy pathway. exclusion criteria: * individuals (patients, parents, and/or legal guardians) who refuse to participate in the project for any reason.
a study to compare the pharmacokinetics and safety/tolerability of br-ups (ulipristal acetate) 5 mg tablet with inisia (ulipristal acetate) 5 mg tablet

Conditions: Uterine Myoma

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety / tolerability of br-ups (ulipristal acetate) 5 mg tablet with inisia (ulipristal acetate) 5 mg tablet in healthy female volunteers

this is a randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of br-ups (ulipristal acetate) 5 mg tablet with inisia (ulipristal acetate) 5 mg tablet in healthy female volunteers

Eligibility criteria:
inclusion criteria: * a subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol. * a healthy female volunteers, aged 19-45 years * bmi 18 \~ 27(kg/m2) exclusion criteria: * history or presence of clinically significant medical or psychiatric condition or disease. * history of gastrointestinal disease and resection * history of clinically significant hypersensitivity to study drug, any other drug * a subject with clinically significant genital bleeding * participation in any other study within 3 months * positive results for urine β-hcg in screening or lactating women * a subject is using a method of hormone contraception and a progesterone intrauterine device
interferon gamma-1b in friedreich ataxia (frda)

Conditions: Friedreich Ataxia

Summary: friedreich ataxia (frda) is a progressive neurodegenerative disease of children and adults for which there is presently no therapy. recently, a study reported that interferon gamma (ifn-g) could raise frataxin protein levels in both cell lines derived from patients with friedreich ataxia and in a mouse model with friedreich ataxia. the present study will test whether ifn-g is safe, tolerated and potentially efficacious in a heterogeneous cohort of children with frda.

study objectives: primary: • to assess the effect of interferon gamma-1b (ifn-g) on increasing frataxin expression and protein in children with frda. secondary: * to assess the effect of ifn-g on neurological outcomes (fars, performance measures, and hearing) in subjects with frda. * to assess the effectiveness of ifn-g on quality of life in subjects with frda. * to assess the safety and tolerability of ifn-g at the currently approved dose in the frda population. study phases: screening - during screening, subjects will be assessed for inclusion and exclusion criteria. intervention - subjects will begin treatment at baseline visit and the dose of study medication will be increased to the maximum dose over four weeks. the subjects will be maintained at the maximum dose for 8 weeks. after 12 weeks, treatment will stop. study medication will be administered via subcutaneous injections three times per week for 12 weeks. follow-up - follow-up visits will occur at 7 and 28 days after the subject has completed the 12 weeks of active treatment.

Eligibility criteria:
inclusion criteria: * subjects with frda confirmed by genetic testing with 2 expanded guanine-adenine-adenine repeats * females who are not pregnant or breast feeding, and who do not intend to become pregnant. females of child-bearing potential must use a reliable method of contraception and must provide a negative urine pregnancy test at screening * stable doses of all medications, vitamins and supplements for 30 days prior to study entry and for the duration of the study * parent/guardian permission (informed consent) and child assent exclusion criteria: * any unstable illness that in the investigator's opinion precludes participation in this study * use of any investigational product within 30 days prior to enrollment * subjects with a history of substance abuse * presence of clinically significant cardiac disease * history of hypersensitivity to ifn-g or e. coli derived products * presence of severe renal disease or hepatic disease * clinically significant abnormal white blood cell count, hemoglobin or platelet count * any subject planning a scheduled surgical procedure during the study

Keywords: friedreich ataxia interferon gamma-1b frda
the association of gut microbes and their metabolites with post-stroke depression

Conditions: Acute Ischemic Stroke

Summary: in this study, the clinical data of patients with ais were collected, 16s rna was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma，to explore the influence of gut microbiota and its metabolites on stroke prognosis.

in recent years, more and more studies have been conducted on the gut-brain axis, and gut microbes can affect the brain by regulating immune responses, metabolites, and neurotransmitters. the composition of gut microbiota may affect stroke prognosis, including focal neurological deficits, cognitive impairment, anxiety and depression, and fatigue. in this study, 16s rna was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma. the clinical data of patients were collected, including age, gender, and medical history, nihss, mrs, mmse, patient health questionnaire-9（phq9）, social support rating scale（ssrs）, laboratory and radiology results. the neurological recovery of the patients was assessed after 3 and 6 months, and the presence or absence of post-stroke depression（psd） and post-stroke fatigue（psf） was assessed by the hamilton depression scale, the fatigue severity scale（fss） and the multidimensional fatigue scale（mfs）. to evaluate the relationship between gut microbiota and its metabolites and stroke prognosis.

Eligibility criteria:
inclusion criteria: 1. patients who suffered from acute ischemic stroke 2. within 7 days of the onset 3. signing the informed consent, willing and able to attend all study visits exclusion criteria: 1. severe aphasia，dysarthria, hearing loss，cognitive and consciousness impairment and unable to cooperate 2. previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics 3. gastrointestinal disease, and pregnant or lactating women 4. serious systemic diseases including malignant tumors 5. any antibiotics, probiotics or prebiotic treatment within 1 months

Keywords: gut flora acute ischemic stroke prognosis
pilot study 1: efficacy and safety of sublingual dexmedetomidine (bxcl501) for the treatment of agitation in the emergency department

Conditions: Agitation; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders; Bipolar Disorder

Summary: this is a single-arm pilot study to examine the impact of bxcl501 (sublingual film formulation of dexmedetomidine) administration on reducing the severity of undifferentiated acute agitation in patients presenting to the emergency department with underlying bipolar disorder or schizophrenia. this study is designed to evaluate bxcl501 for its fda-approved indication -- treatment of agitation associated with bipolar disorder or schizophrenia -- applied in the emergency department setting.

this pilot study will enroll 30 male and female adults with primary psychiatric complaint and a documented diagnosis of bipolar i disorder, bipolar ii disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder, presenting to the emergency department with clinical signs of acute agitation. eligible subjects will receive an initial dose of bxcl501 (180mcg) and a repeat dose (90mcg) 2 hours after the first bxcl501 dose in the event of persistent or recurrent agitation (up to two repeat doses) while under medical supervision in the emergency department. efficacy and safety assessments will be conducted periodically before and after dosing.

Eligibility criteria:
inclusion criteria: * english speaking adults age ≥18 years * patients with an established diagnosis of (1) bipolar i disorder, (2) bipolar ii disorder, (3) schizophrenia, (4) schizoaffective disorder, or (5) schizophreniform disorder * judged to be clinically agitated at the time of screening and baseline with a amss ≥2 * able to read, understand, and provide written informed consent * subject judged to be likely capable of self-administration of bxcl501 sublingually or buccally exclusion criteria: * likely to be discharged, admitted, or transferred from the ed within 6 hours after study medication administration * administration of benzodiazepines or antipsychotic drugs in the 2 hours before study treatment * treatment with alpha-1 noradrenergic antagonists * female patients who are pregnant or are breastfeeding * hypotension (systolic blood pressure \<100 mmhg or diastolic blood pressure \<60 mmhg) and/or bradycardia (heart rate \<55 beats per minute) at the time of screening or baseline evaluation * history of dysautonomia * patient with a known diagnosis of familial long qt syndrome, second degree or third degree atrioventricular block without pacemaker, or sick sinus syndrome * patients with serious or unstable medical illnesses determined by the study investigators or qualified designees * patients with history of allergic reactions to dexmedetomidine * patients previously enrolled and completed the current study * patients actively enrolled in other ed-based studies involving pharmacological or behavioral interventions
efficacy of corticoid infiltration in quadratus lumborum syndrome

Conditions: Low Back Pain

Summary: this study has the primary goal of evaluating the efficacy of corticoid infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration.

this study has the primary goal of evaluating triamcinolone's efficacy on the ultrasound- guided infiltration in the quadratus lumborum syndrome, aiming to determine if there are benefits with the use of corticosteroids and if they exist, if this improvement comes only from the systemic effects of corticosteroid administration. it is an interventional study, double-blinded and randomized, in a sample of patients followed in the chronic pain unit (hospital of braga, portugal), proposed for ultrasound infiltration of the quadratus lumborum muscle. the selection of the patients will take into account the inclusion and exclusion criteria, until reach the required sample size (66 patients). the confirmation of the inclusion criteria will be done by a physiatrist blind to randomization. different protocols will be randomly applied to patients after obtaining written informed consent. the techniques will be performed by two anesthetists. the data will be obtained through questionnaires filled out on the day of the technique and in the course of 1, 3 and 6 months in chronic pain consultation and by telephone call 72 hours after the procedure. it will be a psychologist, blind to randomization, to fill the questionnaires. patients will be also evaluated in consultation, at the same time, the course of 1, 3 and 6 months. after the data collection it will be performed a statistical analysis.

Eligibility criteria:
inclusion criteria: i) patients followed in the chronic pain unit proposed to have ultrasound- guided infiltration of the quadratus lumborum muscle. ii) written informed consent. iii) presence of 4 of the following clinical criteria evaluated by a physiatrist: * pain below the 12th rib and 5 cm lateral to the transverse process of l1 during palpation, with referred pain to the iliac crest; * pain on palpation of the trigger points in the quadratus lumborum muscle; * exacerbation of the pain with with postural changes when lying down, walking, sitting and/or squatting; * lumbar pain with muscle stretching; * painful palpation of trigger points at the level of l4 vertebral body, 1 to 2 cm above the iliac crest. exclusion criteria: * rheumatologic disease; * psychiatric disease; * neurological disease; * history of anticoagulation use; * pregnant patients; * uncontrolled diabetes mellitus; * patients on corticosteroid therapy; * allergy to the medication to be used; * anterior realization of ultrasound techniques for low back pain ; * anterior realization, of invasive techniques, less than 6 months, with administration of medication.

Keywords: quadratus lumborum syndrome; ultrasound- guided infiltration
effect of heredity and environment on asthma development and severity in puerto rican children

Conditions: Asthma; Hypersensitivity

Summary: asthma is a major public health problem among puerto ricans. little is known, however, about the effect of heredity and environment on the development and severity of asthma in this population. this study will examine the relationship between asthma and certain genetic and environmental factors in puerto rican children.

asthma is a chronic disease that causes constriction of the airways. people with asthma may experience wheezing, coughing, chest tightness, and trouble breathing. although asthma is a major public health problem among puerto ricans, little research has been done to determine the influence of heredity and environment on the disease in this population. to learn more about these relationships, this study will examine the effects of certain genes and allergens on the development and severity of asthma in puerto rican children. this observational study will recruit both children with asthma and children without asthma. participants will meet with study staff twice during the study. the first visit will take place at participants' homes. participants will complete questionnaires about demographics, respiratory and general health, and household characteristics. lung function testing, collection of blood samples, and collection of household dust samples will also take place at the home-based visit. the second visit will take place at the study site. at this visit, participants will undergo allergy tests on the skin and a methacholine challenge test to assess their airway responsiveness and asthma severity. the methacholine challenge test will involve inhaling mist through a mouthpiece and blowing forcefully into a special apparatus called a spirometer. parents will be asked to provide information about their children's exposure to pets in early life. each visit will last approximately 1.5 hours and will be scheduled close to the date on which a participant enters the study.

Eligibility criteria:
inclusion criteria: for participants with asthma: * diagnosis of asthma * history of wheezing within 12 months prior to study entry * has four grandparents that were born in puerto rico for participants without asthma: * no diagnosis of asthma * no history of wheezing within 12 months prior to study entry * has four grandparents that were born in puerto rico exclusion criteria: * significant pulmonary disease other than asthma * hospitalization in the neonatal intensive care unit and requiring ventilatory support * history of cigarette smoking for more than 5 pack-years (\[number of packs smoked per day\] x \[number of years of smoking\])

Keywords: puerto rican allergies