Kornimate/medical-research-clean huggingface dataset:
tracking early emergence of sound perception impairments in fxs with multimodal fnirs/eeg-preschool age

Conditions: Fragile X Syndrome

Summary: individuals with fragile x syndrome show differences in how they understand and learn language from infancy. they frequently have lifelong delays in speech and language as well. in addition, they experience other auditory symptoms, including being very sensitive to certain sounds as well as being more sensitive than others to loud sounds. the underlying brain activity for sound perception and speech learning in fragile x is not well understood, especially in the infant, toddler, and preschool years. this study uses behavioral assessment of speech and language abilities, neuroimaging, and hearing tests to understand how speech and hearing are different in children with fragile x syndrome.

fragile x syndrome (fxs) is the leading monogenic cause of intellectual disability and autism and is associated with extremely high risk for early delays in speech and language. while early childhood is essential for speech and language development, neural mechanisms for language impairments have been studied entirely in older children and adults with fxs. therefore, markers for speech and language impairments are unavailable in young children with fxs to predict severity, test potential mechanisms, and track response to intervention. the investigators have identified a hallmark brain-based phenotype of hyperresponsiveness to sounds in adolescents and adults with fxs. this fundamental alteration in cortical responses to sound could influence early language delays, but this phenotype has not been explored in infants or toddlers with fxs. specifically, in this study the investigators will use simultaneous eeg/fnirs during presentation of simple speech, stories, and nonspeech sounds to quantify and localize auditory hypersensitivity and neural differentiation in 30 preschoolers with fxs. the investigators will assess specificity through comparison with 30 typically developing controls and 30 mental-age matched children with a history of premature birth and language delays.

Eligibility criteria:
inclusion criteria: * diagnoses of fragile x syndrome, typical development, or history of premature birth * able to sit independently * english is spoken at home exclusion criteria: * for all participants: no seizures in the past 6 months * for typical development group and fragile x group: not born prior to 32 weeks gestation
breclim-2 - a rct investigating local treatment for breast cancer liver metastases

Conditions: Breast Cancer; Liver Metastases

Summary: breast cancer is the second most common cancer in sweden with an incidence of 8000 per year. the role of surgery for distant breast cancer metastasis beyond local lymph nodes remains controversial even though some reports suggest there might be a survival benefit from resection of oligometastases in the liver. the purpose of this multicentre randomized clinical trial is to evaluate local treatment for breast cancer liver metastases, compared to systemic oncological treatment only. the primary endpoint is time to death from any cause, which will be compared using cox proportional hazard regression. the secondary endpoints are three years survival, progression-free survival, median overall survival and quality of life. the aim is also to evaluate overall safety and predictive factors for survival during oncological and surgical treatment. the overall purpose is to ameliorate treatment for advanced breast cancer.


Eligibility criteria:
inclusion criteria: * signed informed consent * \>18 years old * ecog 0-1 * breast cancer history * breast cancer liver metastasis verified by biopsy * patient amendable for liver surgery and pre- and postoperative oncological treatment * 1-4 liver metastasis amendable to surgery with functional liver remnant volume \>30% * liver metastasis (and skeletal metastasis) stable or responding to preoperative oncological treatment exclusion criteria: * non-skeletal extrahepatic disease * non-resected primary tumour * pregnancy * progression of disease upon oncological treatment
a 5-year longitudinal observational study of patients with primary biliary cholangitis

Conditions: Biliary Cirrhosis, Primary

Summary: this is a 5-year, longitudinal, observational study of patients with pbc designed to specifically address important clinical questions that remain incompletely answered from registration trials. in addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.


Eligibility criteria:
inclusion criteria: * adult patients (age 18 or older) being treated or managed for pbc exclusion criteria: * inability to provide written informed consent * simultaneous enrollment in another prospective registry or clinical trial or study where pbc treatment outcomes are reported, except where approved or conducted as an adjunct project of target-pbc
evaluation of sarcopenia in elderly at the emergency department

Conditions: Sarcopenia

Summary: the goal of this observational study is to evaluate in elderly patients for the frequency of sarcopenia and its relationship with mortality in a university hospital. the main questions it aims to answer are; 1. what is the frequency of sarcopenia in elderly patients at emergency department? 2. is sarcopenia associated with mortality in an elderly patient admitted to the emergency department?


Eligibility criteria:
inclusion criteria: 1. above the age of 65 admitted to the emergency department 2. able to walk without support 3. no lower extremity fracture 4. no disease with neuromuscular involvement exclusion criteria: 1. in the presence of a cerebrovascular event 2. those in need of critical intervention when applying to the emergency department 3. unconscious patients
varenicline adjunctive treatment in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.

this is a double-blind, placebo controlled clinical trial in schizophrenia patients. outcome measures include biomarkers and clinical symptoms and functions, and smoking cessation. neurobiological and cognitive markers will be measured for short term (2 weeks) and longer-term (8 weeks). current schizophrenia treatments are mostly ineffective against primary negative symptoms and the cognitive and information processing deficits associated with the disorder. previous research has identified several neurophysiological deficits in schizophrenia that are enduring, frequently occurring before psychosis, and mark the disease liability. these schizophrenia endophenotypes provide important targets for novel treatment development as they represent the core deficits of the disorder. we hypothesize that sustained nicotinic and dopaminergic modulation by varenicline may ameliorate the core neurobiological deficits seen in schizophrenia patients, which would lead to subsequent clinical improvement. neurobiological and neurocognitive markers and clinical and functional measures will be obtained to determine 1) short-term effect of varenicline on biomarkers; and 2) longer-term improvement in clinical symptoms, smoking cessation, and functions; and how biomarker changes predict these improvements.

Eligibility criteria:
inclusion criteria: * age 18-60 * dsm-iv diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder * clinically stable with no change in antipsychotic medications and increase of daily dose for 4 weeks prior to enrollment * sufficient understanding of the study and risks (esc score 10 or above) exclusion criteria: * major medical illness history including, but not limited to, history of heart attack, stroke, tia (transient ischemic attack) * history of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration * dsm-iv diagnosis of substance dependence within 6 months except nicotine and marijuana * on nicotine replacement therapy (nicotine patch, gum, or nasal spray) * uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95) * ekg of second or third degree atrioventricular (av) block * renal insufficiency with estimated creatinine clearance \<40 ml/min * women who have positive urine pregnancy tests * women who are pregnant, plan to become pregnant, or in breastfeeding

Keywords: varenicline neurobiology clinical trial cognitive deficits schizophreniform disorder
covid-19: early detection of worsening by voice and respiratory pattern characteristics

Conditions: Sars-CoV-2 Infection; COVID-19

Summary: in some clinical forms of covid-19, an uncontrolled hyper-inflammatory reaction known as a "cytokine storm" appears abruptly, around day 7, and is associated with rapid respiratory deterioration, requiring hospitalization in an intensive care unit (icu). at present, although risk factors for this severe form have been described, there are no validated criteria for determining which individual patients will develop this aggravation. the study of respiratory sounds (amplitude, frequency, ...) has made it possible in other respiratory pathologies (e.g., chronic obstructive pulmonary disease) to predict exacerbations several days in advance. having a predictive respiratory pattern for worsening in covid-19 would make it possible to anticipate the need for intensive care hospital beds, by means of a tool easily available on a mobile phone.


Eligibility criteria:
inclusion criteria: * french speaking * affiliated to a social security system * owning a mobile phone capable of accessing the covoice application exclusion criteria: * incapable adults * people deprived of their liberty * people under administrative or judicial supervision * patients intubated or hospitalized in intensive care unit

Keywords: voice
quetiapine in patients with bipolar and alcohol abuse/dependence

Conditions: Bipolar Disorder; Alcohol Abuse/Dependence

Summary: the abuse of alcohol is especially common in people with bipolar disorder. however, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. the purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.

experimental: after obtaining informed consent, 100 patients with bipolar i, or ii disorders and alcohol abuse/dependence confirmed by a structured clinical interview (scid) will be enrolled. from referral sources in the community we have developed over the past 3 years. a medical history and physical examination, including an eye exam with an ophthalmoscope, will also be performed at baseline to rule out serious medical illnesses and cataracts. baseline labs including a liver panel and cbc will be obtained. women of child-bearing potential will be given a urine pregnancy test. baseline measures of psychiatric symptoms will be assessed with the hrsd, ymrs, and barratt impulsiveness scale. alcohol cravings will be assessed with the obsessive compulsive drinking scale (ocds). alcohol use including number of drinks/2 weeks, days used in the past two weeks, and days of heavy use will be obtained as will a urine drug/alcohol screen. alcohol use and cravings will also be recorded throughout the study. side-effects will be assessed with a general side effects scale, the abnormal involuntary movement scale (aims), simpson-angus scale (sas), and barnes akathesia rating scale (bars). ggt levels will also be repeated at weeks 6 and 12. the subjects will be randomized and receive quetiapine or identical appearing placebo add-on therapy in a double-blind fashion for 12 weeks. subjects will return every two weeks for reevaluation with the above outcome measures and for upward titration of study drug. all subjects will be given the option of receiving open-label quetiapine for an additional 4 weeks (with continuing assessment of mood and alcohol use/cravings every 2 weeks) at the end of the study or discontinuing medication.

Eligibility criteria:
inclusion criteria: * bipolar i or ii * ages 18-70 exclusion criteria: * life threatening medical condition causing participation in the study hazardous * alcohol abuse within the past 2 weeks * history of cataracts or likely cataracts on baseline eye exam * history of hepatic cirrhosis or ast or alt more than three times normal limit * current active suicidal or homicidal ideation * history of allergic reaction, poor response or intolerable side effects to quetiapine * antipsychotic use within 7 days of beginning quetiapine therapy * mental retardation, dementia or other severe cognitive impairment
modulation of airway reactivity with chronic mechanical strain

Conditions: Asthma

Summary: the purpose of this study is to see if the use of a machine called cpap will help children with asthma breathe better. cpap is a machine that produces airflow to help people with breathing problems. to use it, you will wear a mask connected by a hose to the cpap machine. we believe that use of cpap may be a treatment for children with asthma.

during the previous funding period of this project, our laboratory demonstrated that chronic mechanical strain imposed on the airways in vivo using continuous positive airway pressure (cpap) results in a dramatic reduction in airway reactivity in vivo in mice, ferrets and rabbits1-3. lungs, airways and airway smooth muscle (asm) tissues isolated from cpap-treated animals studied in vitro exhibited lower responsiveness to bronchoconstrictors1-3. we also observed this suppression of airway responsiveness by chronic mechanical strain in a rabbit model of allergic asthma5. these animal studies led to a small clinical trial in which adults with asthma were treated with nocturnal cpap for 1 week. cpap caused a significant reduction in airway reactivity in these patients6. this novel approach for treating airway hyper-reactivity is currently being evaluated in a nih multi-center phase ii clinical trial of adults with mild to moderate asthma (u01 hl108730).

Eligibility criteria:
inclusion criteria: * children 8-17 yrs olds with severe asthma (n=120) will be recruited from the pediatric high risk asthma clinic and pulmonary clinics at riley hospital for children at indiana university health. * severe asthma will be defined by the need for medication therapies following steps 4-6 according to the national institutes of health's asthma care quick reference, september 2012 or high dose of inhaled corticosteroids * on a stable regimen of asthma medications for at least 8 weeks prior to enrollment without systemic corticosteroids for ≥ 4 weeks exclusion criteria: * obese (\>95% predicted bmi) * congenital heart disease or chronic lung disease * history of pneumothorax * inability to perform pulmonary function testing * oxygen saturation \<93% * forced expiratory volume at one second (fev1) \<70% predicted * provocative concentration causing a 20% drop in fev1 from baseline (pc20) ≥16 mg/ml of methacholine.
long-term safety study of canagliflozin (ta-7284) in combination with glp-1 analogue in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of canagliflozin (ta-7284) in combination with glp-1 analogue in patients with type 2 diabetes for 52 weeks.

this is an open-label study to evaluate the long-term safety and efficacy of canagliflozin (ta-7284) in japanese patients with type 2 diabetes mellitus, who are receiving treatment with glp-1 analogue on diet and exercise and have inadequate glycemic control. the patients will receive ta-7284 100mg orally for 52 weeks.

Eligibility criteria:
inclusion criteria: * patients who has been receiving a stable dose and regimen of glp-1 analogue over 12 weeks before administration of investigational dug * patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * patients with hba1c of ≥7.0% and \<10.5% * patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug exclusion criteria: * patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (cushing's syndrome, acromegaly, etc.) * patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy) * patients with hereditary glucose-galactose malabsorption or primary renal glucosuria * patients with systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg * patients with serious renal or hepatic disease * patients with egfr of \<45 ml/min/1.73 m2 * patients who are the excessive alcohol addicts * patients requiring insulin therapy * patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception

Keywords: insulin resistance
vasopressin and methylprednisolone for in-hospital cardiac arrest

Conditions: Heart Arrest

Summary: this is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. there will be ten enrolling sites in denmark. 492 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. the primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.


Eligibility criteria:
inclusion criteria: 1. in-hospital cardiac arrest 2. age ≥ 18 years 3. received at least one dose of adrenaline during cardiopulmonary resuscitation exclusion criteria: 1. clearly documented "do-not-resuscitate" order prior to the cardiac arrest 2. prior enrollment in the trial 3. invasive mechanical circulatory support at the time of the cardiac arrest 4. known or suspected pregnancy at the time of the cardiac arrest
avaulta versus anterior repair

Conditions: Vaginal Prolapse

Summary: summary: vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. however, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure. due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. the latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse. although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. others have observed shrinkage of the vaginal mucosa. however, in these studies large prolene mesh have been used. in contrast the recurrence rate is lowered up to 25%. the above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. we therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. the present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure. the present study includes only two more visits at the outpatient clinic after the surgical procedure. furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits. any participation in the study is totally voluntary and the patient may at any time withdraw herself. in any case the patient will receive our standard treatment. the study is performed in all the scandinavian countries.


Eligibility criteria:
inclusion criteria: * women aged \> 55 yr * women with anterior vaginal wall prolapse stage \>2 according to pop-q classification * good understanding the language in word and writing exclusion criteria: * a history of previous major pelvic surgery with the exception of a hysterectomy for reasons other than genital prolapse * patients with previous vaginal surgery because of defects in the anterior of posterior compartments * previous hysterectomy because of vaginal prolapse * patients with prolapse of uterus or an enterocele \> stage 2 * patients with previous tvt performed through the obturator membrane * history of genital or abdominal cancer * patients treated with corticosteroids * not able to understand the study protocol (language problems, cognitive dysfunction etc.)

Keywords: cystocele, anterior repair, mesh
the invigorate trial: a clinical trial to assess the efficacy and safety of subjects with seasonal allergic conjunctivitis.

Conditions: Allergic Conjunctivitis

Summary: the invigorate trial: a randomized, double-masked, crossover design, phase 3 clinical trial to assess the efficacy and safety of subjects with seasonal allergic conjunctivitis.

the invigorate trial: a randomized, double-masked, crossover design, vehicle-controlled phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (eec).

Eligibility criteria:
inclusion criteria: * be at least 18 years of age of either gender and any race * have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement * have a positive skin prick test to ragweed pollen within the past year of screening exclusion criteria: * known contraindication or hypersensitivities to any components of the investigational product medication or components * history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis; * presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening * presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial; * diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), stevens-johnson syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, cryopyrin associated periodic syndrome (caps), or keratoconus * woman of childbearing potential who is pregnant or nursing

Keywords: reproxalap invigorate adx-102