cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.

This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.

This randomized, open-label, multicenter, 2 parallel-group study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with liraglutide. Subjects with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetics will be recruited into the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on their current regimen of metformin, TZD, SU, or any combination of these oral antidiabetic medications
* BMI \>/=20kg/m2 and \</=45 kg/m2
* Fasting C-peptide \>/=0.8 ng/mL (\>/=0.26 nmol/L)
* HbA1c between 7.0% and 10.0%, inclusive
* Female subjects of childbearing potential must be practicing adequate contraception.

Exclusion Criteria:

* History of cancer
* History of treated diabetic gastroparesis
* Current biliary disease or history of pancreatitis
* History of significant GI surgery
* Recent clinically significant cardiovascular and/or cerebrovascular disease
* Hypertension
* History of human immunodeficiency virus infection
* History of or current liver disease or acute symptomatic infection with hepatitis B or hepatitis C
* History of alcohol or substance abuse
* Female subject is pregnant, lactating, or \<6 weeks postpartum
* Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients, excipients of albiglutide, or Baker's yeast
* History of type 1 diabetes mellitus
* Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., liraglutide)
* Receipt of any investigational drug or liraglutide within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
* History or family history of thyroid disease
Kissing As a Protective Factor Against Acidic PH in Saliva

The pH of saliva can be acidic or alkaline; When it is acidic, the tooth enamel is demineralized, that is, weakened. Additionally, bacteria in the mouth can increase and cause infections such as cavities. This occurs when we consume sugary or fermented drinks, such as soda or beer.

The intention of the research team is to give some of these drinks to the study participants and verify the decrease in salivary pH. Next, a group of people will be asked to kiss their partner on the mouth, and then the pH will be measured again to see if it increases, that is, if it stops being acidic faster than in the group that did not kiss.

The aim is to demonstrate that kissing on the mouth between two people can protect teeth from cavities by rapidly increasing the pH of saliva after it has decreased to become acidic.

The goal of this intervention study will be to determine if oral kissing between two people can increase salivary pH more quickly after drinking artificial juices, soft drinks, or (non-alcoholic) beers. It will also be studied whether the pH restoration time is faster when only one person kisses one of the named drinks or when both people do it. The main questions that are intended to be answered are the following:

* Is the act of kissing on the mouth capable of increasing the pH of saliva more quickly than physiologically after consuming a sugary or fermented drink that has decreased it?
* Is the increase in salivary pH after an oral kiss more accelerated when only one person consumes sugary or fermented drinks than when both people do so? The investigators will measure the basal pH of all participants before providing them with one of the drinks (artificial fruit juice, soda, or non-alcoholic beer). The researchers will then give the drinks and measure the decrease in salivary pH in all groups. Control group participants will not kiss; They will only wait for the salivary pH to neutralize physiologically. The rest of the couples will be divided into two groups: the group in which only one person in the couple consumes the sugary or fermented drink, and the group in which both people in the couple do so.

Saliva pH measurements will be performed, after initiation and consumption of the drinks, every 5 minutes for up to 40 minutes. That is, until the restoration of salivary pH is ensured in all groups.

Participants:

* They will be between 18 and 30 years old to reduce the probability of consuming medications that alter salivary pH.
* They should not be taking medications that alter the pH of saliva.
* They must be in good health.
* They should not have abscesses in the oral cavity.
* They must have good oral health according to the loss proposed and the observed index.

Eligibility Criteria:
Inclusion Criteria:

* They must be in good health
* They must have good oral health according to the raised loss and observed index.
* They will be between 18 and 30 years old to reduce the probability of consuming medications that alter salivary pH.

Exclusion Criteria:

* Be taking medications that alter the pH of saliva.
* Have abscesses in the oral cavity
Validation of the Stayhealthy BC1 Body Comp Analyzer

The purpose of this study was to validate the Stayhealthy BC1 bioelectrical impedance analyzer to assess percent body fat in children and adults. The BC1 was compared to dual-energy x-ray absorptiometry assessment of body fat for adults and to hydrostatic weighing assessment of body fat for children. We hypothesized that the BC1 would provide similar measures of body fat between devices with acceptable limits of agreement.

The BC1 body composition analyzer is manufactured by Stayhealthy. It is a handheld, noninvasive bioelectrical impedance device. When held, the BC1 sends an electrical impulse through the body to determine body fat, muscle mass, and body hydration. Bio-impedance devices measure the change in electrical resistance in body tissues by using a detectable electrical signal that passes through the body. The method is based on the principle that lean body mass contains virtually all the water and conducting electrolytes in the body and provides a good electrical pathway. In contrast, fat or fat-containing tissues produce a poor electrical pathway. By inducing a low-energy, high -frequency signal, a measurement of the baseline resistance to flow of electrical current can be assessed. The resistance measurement relates directly to the volume of the conductor. Through repeated measurements and identifying other parameters (i.e. gender, weight, age and height) proprietary equations were developed that determine total body water, fat free body mass, and total body fat.

Eligibility Criteria:
Inclusion Criteria:

* boys and girls 10-17 yrs and men and women 18-80 yrs

Exclusion Criteria:

* acute illness
* pregnancy
* pacemaker or defibrillator
Aripiprazole and Prolactin Study

Antipsychotic medicines are used routinely in people with severe mental illness or learning disability. Antipsychotics often induce hyperprolactinemia (high prolactin level) and in almost all women, and some men, this causes hypogonadism (impaired ovarian or testicular function)often with osteoporosis, partly explaining psychiatric patients' high fracture risk. Reducing prolactin by changing antipsychotic or adding a dopamine agonist often worsens psychosis. Adding aripiprazole to current antipsychotic normalizes prolactin in adult schizophrenic patients, without serious side effects. We thus plan a study of add-on aripiprazole in people with antipsychotic induced hyperprolactinemia.

Our main hypothesis is that aripiprazole will normalize or reduce prolactin sufficiently to restore normal ovarian and testicular function. Our secondary hypothesis is that restoration of normal ovarian and testicular function will improve bone mineral density in patients in whom this was reduced at the time of entry into the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants willing and able to give informed consent for participation in the study.
* Males or Females, aged 16-50 years (women), 16-60 (men).
* Diagnosed with antipsychotic induced hyperprolactinaemia of sufficient severity to induce secondary hypogonadism.
* Stable dose of current regular antipsychotic medication for at least three months prior to study entry.
* Female participants of child bearing potential willing to ensure that they or their partner use effective contraception during the study and for 1 month thereafter
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant to be notified of participation in the study.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Plans to donate blood during the study
* Participants who have participated in another research study involving an investigational product in the past 8 weeks
* Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Plans to donate blood during the study
* Participants who have participated in another research study involving an investigational product in the past 8 weeks
Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam

For decades, vitamin K antagonists are the main oral anticoagulants used for primary and secondary prevention of arterial and venous thromboembolic events. Both observational and randomized controlled trials have confirmed an outstanding outcome (the percentage of time in the therapeutic range-TTR, effectiveness and safety) in patients received anticoagulation management provided by pharmacists (AMPP) in comparing with usual physician care.

However, at present, pharmacist-managed anticoagulation services are still not popular in developing countries. In addition, there are few studies evaluating the patient outcomes with the AMPP model in Vietnam. Above all, it is important to explore whether AMPP is superior to other usual models in the improvement of effectiveness and safety.

The study is a randomized controlled trial. Patients who will use VKA are prospectively divided into routine group and pharmacist intervention group.

For the intervention group, patients receive an intensive medical education from pharmacists in anticoagulation management service. Pharmacists regularly provide telephone and outpatient follow-up. At the end of the 12-month follow-up, the percentage of TTR and major bleeding events will be evaluated in both groups.

Clinical data is designed to be collected from 800 patients, 400 patients in each group. Data will be analyzed by SPSS 20.0 software. P \< 0.05 is considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients received a discharge prescription with VKA therapy from November 2018
* Patients agree to participate in the study
* Age 18 and older
* Duration of VKA therapy ≥12 months

Exclusion Criteria:

* Patients with cognitive impairment as diagnosed by physician
* Geographical and financial conditions do not allow patients to guarantee follow-up examination on schedule
* Patient has less than 3 INR test results after the first day participating in the study
* Cannot contact patient by phone call or face-to-face communication after the first day participating in the study
The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee

The purpose of this study is to determine whether probiotics in addition to standard of care (SOC) can improve immunological markers following treatment for prosthetic joint infection (PJI). The study aims to determine whether probiotics in addition to SOC decrease immunological markers following treatment for PJI, improve medical and surgical complications and mortality in patients with PJI, and lead to improved gastrointestinal (GI)-specific patient reported outcomes measures (PROMs) in patients with PJI.


Eligibility Criteria:
Inclusion Criteria:

* Patients ages 18-90 years of age.
* Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria
* Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision total joint arthroplasty (TJA) for PJI with an anticipated plan for eventual discontinuation of oral/IV antibiotics.
* Patients with prior PJI in the same joint that has recurred.
* Patients who understand the benefits and risks associated with taking a probiotic and are willing and able to provide informed consent.

Exclusion Criteria:

* Fungal PJI.
* Inflammatory bowel disease, diverticulitis, history of intestinal surgery, or gastrointestinal issue where there is concern for gut integrity.
* Severe acute gastrointestinal diseases (active bowel leak, acute colitis, acute pancreatitis).
* Active endocarditis.
* History of pancreatitis
* History of intolerance to probiotics.
* Patients that are pregnant or lactating.
* Immunocompromised patients and patients with immunosuppressive conditions (uncontrolled HIV, chemotherapy for cancer treatment, stem cell transplantation, immunosuppressive medications for solid organ transplant, systematic corticosteroid use, immunosuppressive medications for autoimmune dysfunction, and neonates).
* Patients who are critically ill.
* Revision TJA for aseptic reasons.
RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE

This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of \[Isothiazolyl-3-14C\]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.

Eligibility Criteria:
Inclusion Criteria:

1. within a BMI range of 18.0 to 28.0 kg/m2 inclusive;
2. males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception
3. able to comprehend and willing to sign an Informed Consent Form (ICF);
4. able to void urine on a daily basis and 1 to 2 bowel movements per day.
5. able to swallow 60 mL of dosing suspension.

Exclusion Criteria:

1. history or presence of an abnormal ECG
2. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in.
3. exposure to significant radiation within 12 months prior to Check-in;
4. participation in any other investigational study drug trial
5. use of any prescription medications/products within 14 days prior to Check-in
6. use of any inhibitors or inducers of CYP3A4 taken within 30 days prior to Check-in, including but not limited to drugs listed in Appendix E;
7. receipt of blood products within 2 months prior to Check-in;
Metabolomics-based Sleepiness Markers

Estimating that people sleep on average up to two hours less over the last decades, sleepiness and fatigue need to be considered as significant societal problems of the modern world. Jurisdiction is precise on how to deal with overtired offenders since they were not allowed to use machines or vehicles in the first place, similar to drunk individuals or consumers of illicit drugs. In contrast to alcohol or illicit drug use, however, there are no quick roadside or workplace tests as objective (analytical) biomarkers for sleepiness.

Investigators hypothesize that increasing sleep drive or impaired wakefulness can be assessed by qualitative or quantitative fluctuations of certain metabolites in biological specimens, e.g., accumulation or decrease of endogenous substances related to sleep debt. Thus, this sleep study provides the necessary biological samples of either sleep-deprived, sleep-restricted, or control subjects, which are then analysed for appropriate metabolite biomarkers utilizing an untargeted metabolomics approach. In addition to established impairment tests, a state of the art driving simulator will be employed to objectively measure driving performance under all study conditions. Participants will also rate their subjective sleepiness using validated questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* understanding and spoken command of German language
* good health condition
* Body Mass Index between 18.5-24.9 kg/m2
* habitual average sleep duration between 7-9 hours / night
* habitual consumption of 3 or fewer caffeinated beverages / day
* habitual consumption of 5 or fewer alcoholic beverages / week
* good sleep quality: Pittsburgh Sleep Quality Index score ≤ 5
* reasonable oral hygiene (≥1 tooth brushing / day)
* normal or corrected-to-normal vision
* car driving license holder since at least 2 years (obtained in a country with right hand traffic) and regular driver (≥ 1 per week)

Exclusion Criteria:

* two or more time zone crossings in the last 3 months
* habitual napper
* history or presence of neurological disorder, psychiatric disorder, cardiovascular disorder, dental disorder or any disorder that could pose a risk in participating or that could possibly influence study measurements
* history or presence of a sleep disorder (screening night)
* use of illicit drugs (urinary drug screening)
* use of current medication (urinary drug screening) known to influence study measurements
* extreme chronotype (reduced Morningness-Eveningness-Questionnaire score ≤7 or ≥22)
* current smoker
* habitual use of energy drinks (\>1 / week)
* severe skin allergies or hypersensitivities
* food allergies
* hospital stay in past 6 months
* shift worker, night worker
* recent past (last 3 months) or present Covid-19 infection
* fainting at the sight of blood or needles
* participation in a clinical study less than 30 days ago or is currently participating in other clinical studies
* simulator sickness syndrome
* refusal to sign informed consent
Evaluation of the Ambu® AuraGain in Ambulatory Surgery

The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Ambu® AuraGain in patients undergoing ambulatory surgery by one anesthetist

Supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery. The Ambu® AuraGainTM (Ambu A/S, Ballerup, Denmark) is a new single-use, anatomically curved supraglottic airway with an integrated gastric access port designed to provide functional separation of the respiratory and digestive tracts allowing the exit of gastric contents and the passage of a gastric tube to manage gastric contents.

Its characteristics in the design, composition by a smooth and atraumatic material, the presence of the gastric drainage access, with potential improved patient safety and its characteristic of being disposable, suggests a significant expansion of its use in the coming years.

The series in the literature reporting performance or safety of use of the Ambu® AuraGainTM come from studies on selected cases and in certain surgical procedures. However, there are limited studies that have evaluated the efficacy of the device in routine clinical practice in patients intervened in ambulatory surgery and performed by a single investigator.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery procedures in ambulatory surgery usually performed with supraglottic devices.
* ASA physical status I-III patients
* Age 18-no limit

Exclusion Criteria:

* Patients with known difficult airway
* Patients with increased risk of aspiration
* Patient refusal to participate in the study
Treatment of Overweight and Obese Children -Using the "Holbaek-Method" in a Municipality Based Treatment Program.

In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life and concentration of fasting blood lipids and glucose during one year of treatment.

In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek and the care providers in each of the eight municipalities included are thought thoroughly to use this method.

The treatment effect is evaluated after one year, and the effect is assessed by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life (PedsQL), body composition and concentration of fasting blood lipids and glucose.

Eligibility Criteria:
Inclusion Criteria:

- Body mass index above 90-percentile for age and gender

Exclusion Criteria:

* None