Kornimate/medical-research-clean huggingface dataset:
deep brain stimulation for idiopathic craniofacial dystonia: gpi or stn

Conditions: Craniofacial Dystonia; Deep Brain Stimulation

Summary: meiges is a prospective, multicenter, randomized controlled clinical trial with the primary hypothesis that, stn-dbs is non-inferior to gpi-dbs for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia.

evaluating therapeutic effects of gpi-dbs vs. stn-dbs on patients with idiopathic craniofacial dystonia: clinical data of patients at different treatment time points will be collected, using different clinical assessments. the main purpose is to assess whether stn-dbs is non-inferior to gpi-dbs for motor symptoms improvements at 365 days postoperatively in patients with idiopathic craniofacial dystonia. primary endpoints: differences between the two groups in bfmdrs-m change scores in the stimulation state from before to 365 days (±14 days) after stn-dbs and gpi-dbs. secondary endpoints: differences between the two groups in bfmdrs-m change scores in the stimulation state from before to 90, 180 days (±14 days) after stn-dbs and gpi-dbs. differences between the two groups in bfmdrs-d, bdsi, jrs, mmse, moca, hrsd, hama, sf-36 and programming parameters change scores in the stimulation state from before to 365 days (±14 days) after stn-dbs and gpi-dbs.

Eligibility criteria:
inclusion criteria: 1. adult subject (male or female, 18-75 years); 2. diagnosed with idiopathic craniofacial dystonia for more than 1 year, including at least one of the eye and oromandibular region. cervical dystonia may be present; 3. treated with oral drugs or botulinum toxin injections, but with no satisfactory curative effect; 4. normal cognitive function with mmse score ≥ 24; 5. informed consent signed. exclusion criteria: 1. only cervical dystonia, or combined with dystonia in other parts of the body other than the cervical region; 2. diagnosed with other neuropsychiatric diseases(alzheimer's disease, amyotrophic lateral sclerosis, parkinson's disease, etc.); 3. history of brain surgery; 4. severe depression with hrsd score ≥ 35; 5. contraindications to neurosurgery(cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc); 6. contraindications to ct or mri scanning(claustrophobia, etc); 7. pregnant or breastfeeding female, or has positive pregnancy test prior to randomization; 8. contraindications to general anesthesia (severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.); 9. expected lifetime \< 12 months; 10. currently receiving an investigational drug or device; 11. other circumstances that the investigator considers unsuitable to participate in this study or that may pose a significant risk to the patient (inability to understand or comply with research procedures and follow-up, etc.).

Keywords: craniofacial dystonia deep brain stimulation globus pallidus internus subthalamic nucleus
vitamin d and hiv-cardiovascular disease in children and young adults

Conditions: Vitamin D Deficiency

Summary: the relationship of vitamin d levels in children and young adults to atherosclerosis.


Eligibility criteria:
inclusion criteria - documentation of hiv infection between ages of 8 and 25 * on stable art for at least 12 weeks for the hiv+ patients * cumulative duration of art for at least 48 weeks for hiv + patients * healthy child/young adult with age and race matched to hiv+ patient for the hiv- controls * absence of hiv based on medical and medication history exclusion criteria: * taking \> 800 iu of vitamin d per day * parathyroid or calcium disorders * acute illness and active inflammatory condition * chronic illnesses that include malignancy, diabetes, cad * pregnancy and lactation * creatinine clearance \<50 ml/min * hgb \< 9.0 g/dl * ast and alt \> 2.5 upper limits of normal

Keywords: vitamin d deficiency hiv+ children hiv+ young adults
an exploratory investigation of a b12 vitamin to increase energy and focus

Conditions: B12 Deficiency Vitamin; Energy Supply; Deficiency; Mood

Summary: this study aims to examine the effects of sourse's hype bites at being able to increase vitamin b12 levels to promote positive health outcomes. participants will consume hype bites daily. participants will also take surveys and blood samples to examine both the subjective experience of taking hype bites as well as changes in biomarkers across the trial.


Eligibility criteria:
inclusion criteria: * bmi \< 40 on a stable, consistent dietary regimen must be on a vegan or vegetarian diet may experience the feeling of being tired often/several times a week. may experience brain fog may experience negative mood states exclusion criteria: * females who are pregnant or breastfeeding currently take vitamin b12 during the past four weeks chronic conditions such has oncological of psychiatric disorders anyone with ibs or ibd anyone with a previous severe allergic reaction anyone unwilling to follow the study protocol

Keywords: vitamin deficiency energy mood-states focus
thyroid disease serum repository

Conditions: Thyroid Disease

Summary: thyroid disease is more common among females and is increasing in incidence. otolaryngology faculty members and residents will perform head and neck examinations as part of the subject's routine care. if the participant is noted to have thyroid disease, they will be asked if they would like to participate in the research portion by having approximately 10cc's of blood drawn. faculty and staff will complete a data collection sheet that will contain demographic and clinical data.


Eligibility criteria:
inclusion criteria: * participants with benign or malignant thyroid disease.
otx-14-001: a phase 2 study evaluating the safety and efficacy of otx-dp for the treatment of chronic allergic conjunctivitis

Conditions: Chronic Allergic Conjunctivitis

Summary: the objective of the study was to evaluate the efficacy and safety of otx-dp (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis


Eligibility criteria:
inclusion criteria: * has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen * has a positive bilateral cac reaction to a perennial allergen within minutes of instillation exclusion criteria: * history of ocular surgical intervention within the past 3 months * presence of an active ocular infection or positive history of an ocular herpetic infection at any visit * use any of the following disallowed medications during the period indicated
tissue distribution of f18-fdg labeled abmsct in patients with type2 diabetes mellitus

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: stem cells have promising potential in treating diabetes. however the therapeutic outcome in diabetic patients will profoundly depend on their delivery to pancreas. our objective is to label stem cells with pet tracer f18-fdg to carry out in vivo cell tracking. the labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. patients will be followed up for the next 6 months. glucagon stimulated c peptide will be measured at baseline and at 6 months and homa ir and homa beta will be calculated.

our objective is to label stem cells with pet tracer f18-fdg to carry out in vivo cell tracking. the labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. patients will be followed up for the next 6 months. glucagon stimulated c peptide will be measured at baseline and at 6 months and homa ir and homa beta will be calculated.

Eligibility criteria:
inclusion criteria: * • patients with type 2 diabetes mellitus between 30 and 65 years of age. * duration of diabetes ≥ 5 years. * failure to triple oha in optimal doses {glimepiride (4 gm), metformin(2-2.5 gm) and pioglitazone(15mg)}. * requiring insulin therapy for last six month * on stable doses of insulin (≥0.4 iu/kg/day, vildagliptin, metformin (2 gm), pioglitazone (15mg) for last three months. * gad antibody negative status. exclusion criteria: * patients with type 1 diabetes mellitus or secondary diabetes * patients with serum creatinine \> 1.5 mg/dl * abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory). * history of cholecystitis/ cholelithiasis/ cholecystectomy. * seropositivity for hiv, hbsag and hcv. * history of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months.
assessment of anti-aging efficacy of marine collagen peptides

Conditions: Skin Condition; Hair Fragility; Nails, Ingrown

Summary: to assess the anti-aging efficacy of marine collagen peptides on skin, hair and finger nails for human


Eligibility criteria:
inclusion criteria: * healthy adults aged above 18 years old exclusion criteria: * subjects who are not volunteers * subjects who have been diagnosed with dermatitis, cirrhosis, and chronic kidney failure * subjects who have known cosmetic, drug or food allergies. * patients are taking medicine for chronic diseases * subjects receiving treatments for scalp, hair transplant, and other scalp medical care in past 12 weeks. * subjects getting a manicure and perm in past 12 weeks. * female who is pregnant or nursing or planning to become pregnant during the course of the study. * subjects receiving facial laser therapy, chemical peeling or uv overexposure (\&gt; 3 hr/week) in the past 12 weeks. * students who are currently taking courses taught by the principal investigator of this trial. * subjects are not willing to reveal the results of pictures after taking the product * vegetarian.

Keywords: fish collagen
amantadine as adjunctive therapy to antipsychotics in schizophrenia

Conditions: Schizophrenia

Summary: amantadine as add-on therapy to antipsychotics may improve schizophrenia positive, negative and cognitive symptoms.


Eligibility criteria:
inclusion criteria: * under antipsychotics with residual symptoms exclusion criteria: * pregnancy * lactation

Keywords: schizophrenia amantadine residual symptoms
therapeutic hypercapnia after aneurysmal subarachnoid hemorrhage - optimum duration of hypercapnia

Conditions: Vasospasm Intracranial

Summary: temporary hypercapnia leads to a reproducible increase of cerebral blood flow (cbf) and brain tissue oxygenation (stio2) as shown in a previous study (trial-identification: nct01799525). the aim of this study now was to measure the course of carbon dioxide partial pressure (pco2) reactivity after prolonged hypercapnia, and to evaluate the therapeutic effect of graded hypercapnia.

cerebral vasospasm still is the leading cause of delayed cerebral ischemia (dci) and secondary ischemic deficits after aneurysmal subarachnoid hemorrhage (sah). hypercapnia leads to a reproducible increase of cerebral blood flow (cbf) and brain tissue oxygenation (stio2) as shown in a previous study (trial-identification: nct01799525). furthermore, the increase of cbf and stio2 sustained after normalization of ventilation and no rebound effect was found. so, a possible optimization of the hypercapnic period may lead to prolonged effects of increased cbf and stio2. aim of this stuy is to find the ideal duration of hypercapnia and to evaluate the therapeutic effect of graded hypercapnia. for this, intubated and mechanically ventilated patients with an aneurysmal sah hunt/hess 3-5, fisher grade 2-4 on the initial ct scan and supplied with an external ventricular drainage will be included within the first 96 hours after ictus. between day 4 and 14 they undergo a trial intervention in which the respiratory minute volume will be reduced in order to maintain a target paco2 of 50 - 55 mmhg for 2 hours. arterial blood gas analysis (abg) and transcranial doppler sonography (tcd) is performed in 15-minute intervals. intracranial pressure (icp), cerebral perfusion pressure (cpp), and cardiovascular parameters are monitored continuously, serial measurement of cbf and stio2 under continous hypercapnia is performed. primary endpoint of this trial is change of cbf under hypercapnia, secondary endpoints are stio2, measures non-invasively with near-infrared spectroscopy, mean flow velocity of intracranial vessels in tcd, delayed cerebral infarction in cranial ct and glasgow outcome score (gos) after 6 months.

Eligibility criteria:
inclusion criteria: * aneurysmal sah * aneurysm occluded by clipping/coiling within 96 hours * hunt/hess 3-5 * fisher 2-4 on initial ct scan * intubated, sedated and mechanically ventilated patient * continous drainage of cerebrospinal fluid (csf) exclusion criteria: * age under 18 years * pregnancy * common obstructive lung disease (cold) * potential of hydrogen (ph) in abg \< 7,25 * icp \> 20 mmhg

Keywords: sah hypercapnia dci
infection in digeorge following chd surgery

Conditions: DiGeorge Syndrome; Congenital Heart Defects

Summary: we propose a retrospective review of patients with digeorge syndrome having undergone cardiac surgery to evaluate the incidence of blood stream and/or surgical site infection. the hypothesis is that we will find an increased number of infections for this sub-group. we will compare the incidence of infection to children of similar age and diagnosis to evaluate for variances in the incidence of infection.

digeorge syndrome is a common genetic disorder that frequently results in congenital heart defects such as truncus arteriousus, coarctation of the aorta, interrupted aortic arch, tetralogy of fallot, pulmonary atresia with vsd, and several others. the defect is usually due to a deletion in the long arm of chromosome 22. approximately 25% of patients with digeorge have a congenital heart defect. these patients also have varying degrees of thymic hypoplasia with associated t cell dysfunction. they are at increased risk of infections and can be at risk for opportunistic infections when the degree of t cell dysfunction is severe. children undergoing cardiac surgery are at risk for infections in the post-operative period, prolonging hospital stay and increasing morbidity and mortality. the patient with digeorge syndrome may have higher rates of infection due to associated immune system dysfunction, however, this has not been previously reported from a large group of digeorge syndrome patients. children's healthcare of atlanta follows over 200 patients with digeorge syndrome, with the majority having previously undergone cardiac surgery. this group of patients may benefit from more extensive antibiotic prophylaxis following surgery if they indeed have significantly higher rates of infection, but the true incidence needs to be determined.

Eligibility criteria:
inclusion criteria: * children's healthcare of atlanta patients, egleston digeorge syndrome cardiac surgery 200 medical charts between jan 1, 1998 and april 31, 2005 with cardiac surgery and digeorge syndrome 200 medical charts between jan 1, 1998 and april 31,2005 with cardiac surgery and no digeorge syndrome exclusion criteria: * those who do not meet inclusion criteria

Keywords: pediatric digeorge syndrome congenital heart defects infections cardiac surgery
collaborating to implement cross-system interventions in child welfare and substance use

Conditions: Substance Use; Implementation; Child Maltreatment; System Fragmentation

Summary: as a result of the opiate crisis, child welfare agencies have experienced an increase in the number of children in foster care as parental substance use puts children at greater risk of maltreatment. to facilitate implementation of the sobriety treatment and recovery team (start) model, this study (1) identifies collaborative strategies associated with effective implementation and service outcomes given system and organizational context, (2) uses this evidence to specify strategies and develop a decision support guide to help agency leaders select collaborative strategies, and (3) assesses the feasibility, acceptability, and appropriateness of the decision support guide.

this is a multi-staged, mixed methods study that leverages a naturally occurring policy experiment in southern ohio. in aim 1, we will examine the collaborative strategies associated with implementation and service outcomes, given the context with 17 counties engaged in the ohio start pilot project. we will use a convergent mixed methods design, and integrate our qualitative and quantitative data using qualitative comparative analysis. for aim 2, we will specify the collaborative strategies and develop a decision support guide using the va's model of implementation strategy development (diagnose barriers, and convene an expert panel to design strategies). for aim 3, we assess the feasibility, acceptability, and appropriateness of the decision support guide using a sequential mixed methods design. in the first quantitative phase, we will conduct a randomized vignette experiment with agency directors in the 71 ohio counties that are not involved in the ohio start pilot project to compare the decision support guide with general implementation support. our second qualitative phase (which is dominant), will examine feasibility more in-depth by piloting the guide and conducting descriptive case studies with up to three new counties.

Eligibility criteria:
inclusion criteria: * our participants included implementation support professionals who provide training and technical assistance to child welfare agencies in ohio that are implementing ohio start. all individuals will be adults and recruited based on their employment/position. exclusion criteria: * individuals who do not provide implementation support.
post-marketing surveillance of linaclotide tablet in patients with irritable bowel syndrome with constipation or chronic constipation (excluding constipation due to organic diseases)

Conditions: Chronic Constipation (CC) (Excluding Constipation Due to Organic Diseases); Irritable Bowel Syndrome With Constipation (IBS-C)

Summary: the objective of this study is to evaluate the long-term safety and efficacy of linaclotide in post-marketing use.

this is a post-marketing long-term specified drug use-result survey study required for products in japan. the investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). for each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.

Eligibility criteria:
inclusion criteria: * patients with irritable bowel syndrome with constipation (ibs-c) or chronic constipation (cc) (excluding constipation due to organic diseases) who have used linaclotide for the first time

Keywords: linaclotide linzess irritable bowel syndrome chronic constipation
oral alkali production and caries prevention in children (cross-sectional component)

Conditions: Dental Caries

Summary: the fact that dental caries remains a major public health problem mandates that oral-health researchers explore new strategies for assessment of caries risk, as well as for caries prevention and management. dental caries occurs when acids produced by bacterial glycolysis of dietary carbohydrates causes demineralization of the tooth enamel. a major focus of caries research has been on identifying and characterizing acid-generating bacteria and the mechanisms of acid resistance. the purpose of this study is to investigate the type of bacteria that grows in the mouth and on teeth.

this study will require only one visit. the study visit will last about one hour. at the study visit, parent-administered questionnaires will be used to collect information on the following: (a) the participant's demographic background (age, gender, and race), (b) socio-economic status (parents' income and housing condition), (c) participant's oral health practice (feeding histories, diet habits, oral hygiene measures, and dental attendance), and (d) systemic diseases. during the study visit, the participant's complete medical and dental history will be obtained and reviewed, and a dental exam will be performed in order to determine participants' caries status, and intraoral pictures may be taken of participants' teeth. participants will not be allowed to brush or clean teeth using any type of oral hygiene procedures for 8 hours prior to sample collection. saliva and plaque (the solf white-yellowish material on the tooth surface) will be collected. the investigator will use a small probe to measure the ph of the dental plaque that builds up on the teeth. the participant will be asked to dip one finger into a glass containing a buffer solution and the probe will be placed on the teeth from which plaque will be taken. dental plaque will be collected from the participants between the ages of 2 and 5 with at least two teeth and who allow the dental examination and the sample collection procedures to be done safely. plaque samples will be collected by gently scrapping the tooth using a sterile instrument. if the participant does not have enough plaque samples, they will be asked to return on the following day. saliva will be collected by using cotton swabs or by asking the participant to spit into a sterile plastic container.

Eligibility criteria:
inclusion criteria: * age 2 to 5 years exclusion criteria: * treated with antibiotics within the past 3 months * taking any medication at the time of the study * uses orthodontic appliance, and * has performed oral hygiene procedures in the past 8 hour prior to the collection appointment.

Keywords: plaque saliva dental caries
empiric antibiotic therapy for ventilator-acquired pneumonia with gram-negative bacilli in intensive care

Conditions: Ventilator-associated Pneumonia

Summary: this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (vap) in the intensive care unit (icu) with the pharmacodynamic efficacy criteria considered relevant literature. the impact of these pharmacodynamic parameters on the clinical and microbiological vap will be evaluated.


Eligibility criteria:
inclusion criteria: 1. use of mechanical ventilation for more than 48 hours 2. clinical suspicion of ventilation-acquired pneumonia (vap) defined by new radiological persisting infiltrate (or ards) and one of the following features: purulent tracheal aspirates or temperature ≥ 38.3°c or leukocytosis\> 10 giga/l 3. high risk of multidrug-resistant bacteria, defined as either at least 6 days of mechanical ventilation or antibiotic treatment in the previous 15 days 4. implementation of a prior distal respiratory sample for microbiological diagnosis by bronchoalveolar lavage (bal) or distal sampling by protected catheter (pdp) 5. age ≥ 18 years 6. implementing a medical examination 7. obtain the written consent of the patient, one of its relatives or trusted person previously designated or emergency clause. exclusion criteria: 1. pregnant woman 2. expected death within 72 hours of diagnosis of vap patient 3. dialysis 4. no affiliation to a social security scheme (beneficiary or legal) 5. contraindication to one of classes of molecules used antibiotics (β-lactam / fluoroquinolones / aminoglycosides), contained in the summary of product characteristics for authorization on the market.