Kornimate/medical-research-clean huggingface dataset:
maintaining oral health with bio-products

Conditions: Dental Caries; Dental Erosion

Summary: this study will follow a randomised, double-blind, cross-over design. participants will use mouth rinses containing plant extracts and/or fluoride, as well as a mouth rinse containing only water (placebo). they will use oral appliances containing sterilized enamel and dentine slabs, which will be later collected for analyses. the cross-over design will allow participants to use all rinses, allowing for a comparison between the rinses within each individual.

this study will be made in three in situ parts. participants will wear an oral appliance containing sterilized enamel and dentine slabs. during this experimental phase, they will use the designated mouth rinse. after this period, the investigators will remove the enamel and dentine slabs, and will also collect salivary pellicle and any bacterial biofilm forming on the participant's teeth. participants will also donate saliva for proteomic analysis (protein profile) to verify if there are any differences in proteins in saliva to proteins in the pellicle. throughout the whole study, all participants will use standardized oral hygiene products. the experimental mouth rinses contain plant extracts that could interact with salivary proteins and influence the salivary pellicle and oral biofilm, thus bringing positive results against tooth (enamel and dentine) demineralisation.

Eligibility criteria:
inclusion criteria: * participants will be healthy young adults of both sexes, with normal salivary flow, with no cavitated caries lesions, no gingivitis or periodontal disease, no severe erosive tooth wear, and no other serious general or oral conditions. * participants will have signed an informed consent form. exclusion criteria: * presenting oral diseases or conditions, such as untreated cavitated caries lesions, gingivitis or periodontitis, severe erosive tooth wear, etc. * participants who are under orthodontic treatment (wearing braces), * contraindications to the mouth rinses under study, e.g. known hypersensitivity or allergy to the investigational product, * participants using drugs that cause hyposalivation, * women who are pregnant or breast feeding, * intention to become pregnant during the course of the study, * individuals suffering from clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.), * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * participation in another study with investigational drug within the 30 days preceding and during the present study, * enrolment of the investigator, his/her family members, employees and other dependent persons, * specific exclusions for the disease under study, * specific concomitant therapy washout requirements prior to and/or during study participation
evaluate azithromycin plus chloroquine and sulfadoxine plus pyrimethamine combinations for intermittent preventive treatment of falciparum malaria infection in pregnant women in africa

Conditions: Intermittent Preventive Treatment In Pregnancy (IPTp)

Summary: the primary objective is to establish superiority of azcq over sp in protective efficacy for iptp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

after interim analysis of efficacy data by an external data monitoring committee, this study was terminated. investigators were notified on 22 aug 2013. there were no safety concerns that led to this termination.

Eligibility criteria:
inclusion criteria: * pregnant women (all gravidae) with ≥14 and ≤26 weeks of gestational age (by ultrasound). * evidence of a personally signed and dated informed consent/assent document. assent will be obtained from subjects \<18 years of age. * subjects who are willing to and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * subjects who are available for follow up at delivery and on 28 days post delivery. exclusion criteria: * age \ 35 years old. * multiple gestations as per the ultrasound at screening. * clinical symptoms of malaria. * hemoglobin \< 8 g/dl (at enrollment). * any condition requiring hospitalization at enrollment. * history of convulsions, hypertension, diabetes or any other chronic illness that may adversely affect fetal growth and viability. * inability to tolerate oral treatment in tablet form. * known allergy to the study drugs (azithromycin, chloroquine, and sulfadoxine-pyrimethamine) or to any macrolides or sulphonamides. * requirement to use medication during the study that might interfere with the evaluation of the study drug eg, trimethoprim-sulfamethoxazole use in subjects positive for hiv infection. * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation. * evidence of current obstetric complications that may adversely impact the pregnancy and/or fetal outcomes, including presence of congenital anomalies, placenta previa or abruption. * known severe sickle cell (ss) disease or sickle hemoglobin c (sc) anemia. * known family history of prolonged qt syndrome, serious ventricular arrhythmia, or sudden cardiac death.

Keywords: p. falciparum malaria iptp
assessment of the efficacy and safety of lixisenatide in patients with type 2 diabetes insufficiently controlled with basal insulin +/- metformin

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: - to assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of hba1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients. secondary objectives: * to assess the effects of lixisenatide over 24 weeks on : * percentage of patients reaching hba1c\<7% or ≤6.5%, * 2-hour postprandial plasma glucose (ppg) and plasma glucose (pg) excursions during standardized meal challenge test, * fasting plasma glucose (fpg), * change in 7-point self-monitored plasma glucose (smpg) profile), * body weight, * change in daily basal insulin dose. * to assess lixisenatide safety and tolerability. * to assess anti-lixisenatide antibody development.

maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Eligibility criteria:
inclusion criteria : - patients with type 2 diabetes mellitus (t2dm) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin. exclusion criteria: at screening: * age \< legal age of adulthood. * hba1c\ 10.5%. * basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 u/day for at least 2 months prior to screening visit. * if metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit. * history of hypoglycemia unawareness. * body mass index (bmi) ≤20 kg/m². * use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
medication adherence program

Conditions: Hypertension; Medication Adherence; Behavior and Behavior Mechanisms

Summary: randomized controlled trial testing the efficacy of the supporting tailored adaptive change and reinforcement for medication adherence program (star-map), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. participants (n=402) \>=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, blue cross blue shield of louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.


Eligibility criteria:
inclusion criteria: * fully insured by blue cross blue shield of louisiana (bcbsla) * continuously enrolled in bcbsla for one year * planning to remain a member of bcbsla for next year * english-speaking * telephone access * aged ≥40 years * diagnosis of essential hypertension (icd-10-cm code i10) * currently filling antihypertensive medication * low antihypertensive medication refill (proportion of days covered (pdc) \<0.8) * low self-report adherence (4-item krousel-wood medication adherence scale (k-wood-mas-4) score ≥1) * uncontrolled blood pressure (bp) (systolic bp ≥130 mm hg or diastolic bp ≥80 mm hg) * desire to improve bp exclusion criteria: * living in a household with someone already enrolled in the study * enrollment in another clinical trial for drug adherence or bp control * moderate to severe cognitive impairment
randomized study of pancrelipase with bicarbonate (pancrecarb) capsules in reducing steatorrhea in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: objectives: i. compare the efficacy of enteric coated pancrelipase with bicarbonate (pancrecarb) capsules versus the patient's usual enteric coated pancreatic enzyme without bicarbonate in decreasing fecal fat and nitrogen losses in patients with cystic fibrosis.

protocol outline: this is a randomized, multicenter study. in the first treatment period, patients are randomized to one of two treatment arms. arm i: patients receive enteric coated pancrelipase with bicarbonate (pancrecarb) capsules before meals and snacks for 7 consecutive days. arm ii: patients receive their usual enteric coated pancreatic enzyme without bicarbonate capsule before meals and snacks for 7 consecutive days. patients receive approximately 50% of their usual lipase dose during treatment. food intake is recorded on days 1-3, food intake is weighed and recorded on days 4-7, and stools are collected over 72 hours on days 5-7 to determine fecal fat and nitrogen excretion. anthropometric measurements including height, weight, and skinfolds are assessed. in the second treatment period, patients are switched to the alternate treatment arm after a 3 day washout period. patients receive the opposing treatment as per protocol.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * clinical diagnosis of cystic fibrosis duplicate sweat chloride measurements greater than 60 meq/l on samples collected after pilocarpine iontophoresis * patients with a history of malabsorption who consume at least 1,000 to 2,500 lipase units/kg/meal --prior/concurrent therapy-- * no concurrent oral antibiotics, antacids, h2 receptor antagonists, or any drugs known to interfere with digestion --patient characteristics-- * weight for height greater than the 5th percentile * no prior meconium ileus with intestinal resection * no known hypersensitivity to pancrelipase or pork protein

Keywords: cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease
monitoring of neoadjuvant therapy in locally-advanced breast cancer

Conditions: Locally Advanced Breast Cancer

Summary: the purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. these methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. an important part of the study is to examine the same person with all methods in order to directly compare results. the four methods are: mri elasticity imaging (abbreviated mre), electrical impedance spectroscopy (abbreviated eis), microwave imaging and spectroscopy (abbreviated mis), near infrared spectroscopy (abbreviated nir). in addition to the experimental imaging methods, patients may also undergo a contrast-enhanced mri, and/or additional mammography, which will help researchers compare the experimental methods. these additional examinations are accepted diagnostic procedures; they are not experimental. some participants will have one or both of these additional examinations if clinically indicated.


Eligibility criteria:
inclusion criteria: 1. locally advanced breast cancer, with or without metastatic disease 2. patient to receive systemic therapy 3. breast size and epithelial integrity adequate to allow alternate imaging exams. 4. patient able to provide written informed consent. 5. no serious associated psychiatric illness 6. age ≥ 18 years old exclusion criteria: 1. cardiac pacemaker 2. any implanted electronic device 3. severe claustrophobia 4. allergy to the mri contrast agent gadolinium
modulation of remifentanil-induced postinfusion hyperalgesia

Conditions: Hyperalgesia, Secondary

Summary: in addition to alleviate pain there is growing evidence that µ-opioids enhance pain. this problem is known as opioid induced hyperalgesia(oih).the nmda receptor is involved in opioid induced hyperalgesia it may be possible to block oih by cyclooxygenase inhibitors. this has been demonstrated with parecoxib, a cox-ii inhibitor, in a experimental pain model.both cox-1 and cox-2 are expressed in the spinal cord. it would be of interest to investigate whether a cox-1 preferring inhibitor like ketorolac also can reduce opioid induced hyperalgesic in this experimental pain model.

remifentanil is an fast acting opioid which has become very popular to use during surgery. there are studies, both experimental 1-3 and clinical 4;5, which indicate that remifentanil after end of infusion trigger enhanced pain experience and enhanced opioid consumption postoperatively. therefore it is important to look at possibilities to block this enhanced pain experience (opioid induced hyperalgesia - oih). ketamin has demonstrated to block this effect 5;6 through the nmda receptor. unfortunately ketamin has some seriously side-effects like hallucinations, and is therefore not suitable in ordenary clinical use. recently, it has been demonstrated that parecoxib (a cox-2 inhibitor) can prevent remifentanil-induced postinfusion hyperalgesia in a study on healthy volunteers.7 cox-2 inhibitors have some disadvantages because of the longterm adverse effects like cardiac arrest. therefore it would be of interest to look at a cox-1 preferring nsaid, like ketorolac, to see if also non-selective nsaids can partly block remifentanil-induced postinfusion hyperalgesia. to investigate this and to provoke pain and secondary hyperalgesia we use an intradermal electrical pain model which is well established.1;7-9 detailed description of this model look at reference 7. h0 : parecoxib prevents remifentanil postinfusion secondary hyperalgesi. ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi ha : parecoxib and ketorolac prevent remifentanil postinfusion secondary hyperalgesi.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * allergy to the drugs used in the study

Keywords: hyperalgesia remifentanil ketorolac parecoxib cox-1 inhibitor cox-2 inhibitor
behavioral and electrophysiological effects of ketamine in treatment-resistant depression

Conditions: Major Depressive Disorder

Summary: the overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning.

major depressive disorder (mdd) participants with treatment-resistant depression (trd) will be recruited from mclean's ketamine clinic. suitability for ketamine treatment will be determined as typically done by the service - through evaluation by the clinicians on the staff of the ketamine service who perform psychiatric consultations and assessments for ketamine suitability. potential subjects will be informed about the study only after they have received a positive consultation at the clinic and have already agreed to receive the treatment. this study consists of a set of questionnaires, urine drug screen, and electroencephalogram (eeg) recordings.

Eligibility criteria:
inclusion criteria (mdd subjects): * all genders, races, and ethnic origins, aged between 18 and 70; * dsm-5 diagnostic criteria for mdd (diagnosed with the use of the structured clinical interview for dsm-5 (scid-5)); * a score of ≥32 on the inventory of depressive symptomatology-clinician rated (ids-c30). * capable of providing written informed consent, and fluent in english; * right-handed; * treatment resistant (as assessed using the mgh antidepressant response questionnaire) * have already decided to receive ketamine treatment as part of their standard clinical care inclusion criteria (control subjects): * all genders, races, and ethnic origins, aged between 18 and 70; * absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (scid-i/np); * a baseline quick inventory of depressive symptomatology (qids) score ≤ 5; * a baseline hamilton depression rating scale (hdrs) score ≤ 7; * capable of providing written informed consent, and fluent in english; * right-handed; * no first-degree relative with mood or psychotic disorder. exclusion criteria (all subjects): * serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; * history of seizure disorder; * history or current diagnosis of any of the following dsm-5 psychiatric illnesses: schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, substance abuse disorder; * clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication; * substance use assessed by physician as dangerous for ketamine treatment; * untreated glaucoma; * complex post-traumatic stress disorder (ptsd) with dissociation; * patients with a lifetime history of electroconvulsive therapy (ect). * participants with a lifetime history of ketamine use.
biofilm formation and antibiotic sensitivity patterns

Conditions: Orthopedic Surgery

Summary: detection of bacteria that form biofilm and its sensitivity to antibiotics in patients with surgical site infection after orthopedic surgery.

the available number of patients presenting in outpatient clinic or at operating theatre with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,...) will be subjected to full history and examined by physician. swabs from site of infection will be taken and subjected to the following steps to identify the causative bacteria: * culturing on blood agar, chocolate agar, macconkey agar and mannitol salt agar , gram staining and biochemical tests. * enzyme-linked immunosorbent assay (elisa) to detect biofilm formation. * antimicrobial susceptibility testing using the kirby-bauer disk diffusion method.

Eligibility criteria:
inclusion criteria: * patients with surgical site infection after orthopedic surgery that include insertion of implant (e.g plates , screws ,wires ,...) exclusion criteria: * if patient has no orthopedic surgery

Keywords: biofilm antibiotics
cardiac function and morphology evaluated by magnetic resonance imaging in growth hormone deficiency and acromegaly

Conditions: Growth Hormone Deficiency; Cardiac Function

Summary: to test the hypothesis that both lack and excess of growth hormone (gh) is associated with cardiac abnormalities. cardiac function and morphology will be evaluated by mri before and after treatment.

it is an open prospective noninterventional clinical study. treatment and follow-up will be according to usual guidelines, and will be unaffected by inclusion in the study. ghd patients will be treated with daily subcutaneous gh injections. patients with acromegaly will be treated with either transsphenoidal surgery or by medical treatment with long acting somatostatin analogues, dopamine agonist, gh antagonist or combinations of these treatment modalities. patients will be examined by cardiac mri before treatment and after one year of treatment.

Eligibility criteria:
inclusion criteria: * peak gh below 6.0 ng/ml during pyridostigmine-ghrh test. * nadir gh above 0.4 ng/ml and elevated levels of igf-i during oral glucose tolerance test exclusion criteria: * contraindications for magnetic resonance scan

Keywords: the gh-system and cardiac function
safety study of quickclot for bleeding control after adenotonsillectomy

Conditions: Sleep Apnea, Obstructive

Summary: hemostasis will be achieved during pediatric tonsillectomy/adenoidectomy with the use of quickclot.

the quickclot dressing contains kaolin, a natural mineral that promotes the body's clotting process. this dressing will be applied for one minute to the area where the tonsils/adenoids were. the investigators are hoping to develop a standard of practice where quickclot is a key addition for tonsillectomy surgery.

Eligibility criteria:
inclusion criteria: * diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders exclusion criteria: * patients with signs or symptoms of obstructed breathing * recurrent pharyngitis * history of bleeding disorder * history of prior adenotonsillectomy

Keywords: tonsillectomy adenoidectomy obstructive sleep apnea