cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Manual Toothbrushes in Removing Tooth Stains

Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.

The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form;
* Male and female subjects, aged 18-70, inclusive;
* Good general health and good oral health based on the opinion of the study investigator;
* Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
* A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
* Available for the duration of the study;
* Clinical evidence of a tendency to form extrinsic stains on anterior teeth.

Exclusion Criteria:

* Presence of orthodontic appliances/retainers involving scorable teeth;
* Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
* Tumor(s) of the soft or hard tissues of the oral cavity;
* Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
* Five or more carious lesions requiring immediate care;
* Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
* Concurrent participation in another clinical study;
* Self-reported pregnancy and/or lactating women;
* Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study;
* History of allergies to oral care/personal care consumer products or their ingredients;
* History of alcohol and/or drug abuse.
Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.


Eligibility Criteria:
Inclusion Criteria:

* Male subject ≥18 years of age on the day of signing the ICF.
* A confirmed clinical diagnosis of CF.
* Exocrine pancreatic insufficiency (documented in the subject's medical record).
* Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration

Exclusion Criteria:

* History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator.
* Unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 2 weeks prior to study drug administration.
* Need for supplemental oxygen during the day, and \>2 L/minute while sleeping.
* History of solid organ or hematopoietic cell transplantation.
* History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices).
* Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to study drug administration.
* Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3x the upper limit of normal, and/or total bilirubin ≥1.5x the upper limit of normal.
Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUT

In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.

This is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.

The primary goal is to evaluate the influence of vitamin D supplementation on the regulatory FoxP3+ T cells in the gastrointestinal mucosa under controlled conditions within 2 months.

The secondary study goals are to evaluate the effect of vitamin D supplementation on peripheral induced tregs and on other important immune cells in the tissue (NK, NKT cells and LPCD) and in the blood (NK, NKT cells, Th17, Th1, Th2 cells) within 2 months.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* non smoker
* BMI: 20-30 kg/m²
* Healthy

Exclusion Criteria:

* hypercalcemia \> 2,65 mmol/L
* pregnancy
* chronic diseases
Fluconazole Pharmacokinetics in Infants

The purpose of this study is to determine the pharmacokinetics of fluconazole in infants and evaluate the dose exposure relationship of current fluconazole dosing in infants who are receiving fluconazole for the prevention or treatment of systemic fungal infections.

Systemic fungal infections in neonates are associated with high morbidity and mortality. The increasing use of intravenous central catheters, parenteral nutrition, and antibiotics in neonatal intensive care units has contributed not only to improved survival but also to the increasing incidence of fungal sepsis particularly in preterm infants. Decreasing fungal colonization can decrease the risk of systemic fungal infection. Fluconazole is a potent antifungal agent in the triazole family. Fluconazole has been shown to reduce the risk of fungal colonization and systemic infection however we do not have sufficient pharmacokinetic information in neonates to support dosing guidelines. In this study, we will perform a population pharmacokinetic study in neonates receiving fluconazole as standard of care. Fluconazole levels will be measured using a liquid chromatography/tandem mass spectroscopy (LC/MS/MS) assay from very small quantities of blood appropriate for neonates. Pharmacokinetic data obtained in this study will support appropriate dosing of fluconazole in neonates and provide information regarding drug metabolism in neonates.

Eligibility Criteria:
Inclusion Criteria:

1. Infant born \>23 weeks gestational age with postnatal age \<120 days
2. Due to receive fluconazole therapy for clinical care
3. Permission from attending neonatologist
4. Informed consent of parent or legal guardian
Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2)

Stroke has an enormous impact on both individual and society. Novel treatments are required to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be neuroprotective and help restore functional outcome when compared to control. These outcomes are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very soon after the stroke occurs. The mechanisms of protection are unclear but may be due enhancing the body's ability to protect itself from further injury by favorably altering cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic conditioning (IC) is an intervention already applied during cardiac surgery to protect the heart from damage and it may be effective after an acute myocardial infarction. The investigators therefore plan to conduct a pilot randomised controlled trial assessing the feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC. Secondary outcomes include tolerability, safety and clinical efficacy. The results will inform the design of future trials of a potential intervention is that is pragmatic, non-invasive and simple to administer.


Eligibility Criteria:
Inclusion Criteria:

1. Suspected clinical stroke with 6 hours of onset of neurological symptoms;
2. Age \>18;
3. Written or witnessed oral consent, or relative/consultee advice.

Exclusion Criteria:

1. Pre-morbid dependency mRS\>3;
2. Dementia;
3. Coma (GCS\< 8);
4. Malignancy or significant co-morbidity thought to limit life expectancy to \<6 months;
5. Blood sugar \< 3.5 mmol/L;
6. Taking part in another clinical trial of an investigational medicinal product (CTIMP);
7. Pregnancy.
Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program

Two-arm, parallel-group, non-crossover, single-center pilot randomized controlled trial, enrolling up to 180 participants to evaluate the effect of the Pivot smoking cessation program (intervention) compared to usual care (commercially available app smoking cessation program plus optional nicotine replacement therapy, control).

The present pilot randomized controlled trial compares user engagement and retention, change in attitudes towards quitting smoking, change in smoking behavior and participant feedback in adult smokers randomized either to the Pivot (intervention) or commercially available (control) smoking cessation programs.

We aim to assess participants' use of Pivot program and commercially available program. There will be a focus on assessing use and engagement, changes in attitudes towards quitting smoking and changes in smoking behavior over the course of the 2-year study, as well as participant feedback on the set-up, design, use experience, and impact of each program.

Eligibility Criteria:
Inclusion Criteria:

* 21+ years of age
* Current daily cigarette smokers (at least 5 cigarettes per day) for the past 12 months
* Plans to quit smoking in the next 30 days
* Resident of the United States
* Able to read and comprehend English
* Owns and uses a smart phone compatible with the study app (iPhone 5 and above with operating system (iOS) 12 and above, or, Android 7.0 and above with operating system Android 7.0 and above)
* Has daily internet access on smart phone
* Comfortable downloading and using smart phone apps
* Willing to sign the Informed Consent Form

Exclusion Criteria:

* Pregnancy (self-reported)
* Health contraindications to nicotine replacement therapy (NRT) use (irregular heartbeat, high blood pressure not controlled with medication, heart attack or stroke in last 2 months, pregnant or breast feeding, skin allergies to adhesive tape or serious skin problems, stomach ulcers, history of seizures)
* Using other smoking cessation support, including apps and/or actively taking medication to quit smoking
* Daily marijuana use
* Residence with another person who is a participant in this study
* Immediate family member is a participant in this study
* Failure to provide contact or collateral information, failure to verify email address, and/or failure to demonstrate videoconference capability
* Participation in a previous study sponsored by Carrot Inc.
Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

This study represents a phase I clinical trial that utilizes natural killer (NK) cell therapy for patients diagnosed with liver cancer, specifically those classified as Child-Pugh A and falling within the Barcelona Clinic Liver Cancer (BCLC) stages B or C. The expected results include determining the suitable treatment dosage, identifying any resulting side effects, and calculating the average duration of progression-free survival. The target group for the study consists of all individuals diagnosed with liver cancer. At the same time, the practical sample consists of those who received medical care for liver cancer at Cipto Mangunkusumo Hospital (RSCM) between May and December 2022. The chosen research sample comprises liver cancer patients who fulfill the predetermined participation criteria. The necessary sample size for discerning appropriate treatment dosages and the occurrence rate of potential side effects shall consist of 2-3 liver cancer patients who are administered autologous NK cells. The process for isolating these NK cells adheres to the guidelines established by Miltenyi Biotec.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-60 years old
* Patients with Hepatocellular Carcinoma (HCC) staged as BCLC B and C
* Karnofsky Performance Status (KPS) score ≥ 70
* Expected patient survival of more than three months
* The following parameters are within the normal range:

Platelet count ≥ 80,000/µL White blood cell count ≥ 3000/µL Neutrophil count ≥ 2000 Hemoglobin ≥ 9 mg/dL International Normalized Ratio (INR) 0.8-1.5 Adequate liver function (bilirubin \< 2, SGOT and SGPT \< 60 U/L) Adequate kidney function (serum creatinine \< 1.3, serum urea \< 10)

Exclusion Criteria:

* Refusing to participate in the study
* Afflicted by other malignancies, whether non-HCC liver or other malignancies
* Patients are affected by other conditions such as hypertension, severe coronary disease, myelosuppression, respiratory disorders, and acute or chronic infections
* Patients who have previously undergone transplantation and received other stem cell therapies
First Trimester Fetal Thymus Volume May Predict Preeclampsia

The exact etiology of preeclampsia remains unclear but is known to involve immunological factors. The thymus is one of the main organs involved in the development of the fetal immune system. The aim of this study was to explore the association between fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.

Investigators performed a prospective clinical study in 100 pregnant women in their first trimester of pregnancy who attended the Fetal Medicine Unit of the Medicine Faculty of Karadeniz Technical University during the study period. Maternal age, gravida, para, BMI, blood pressure, gestational age, CRL and fetal timus volume measured with VOCAL programme are recorded. For all patients routine clinical and ultrasound examinations were performed during pregnancy. Gestational age at birth, way of birth and newborn birthweight were recorded. The results were statistically compared in the SPSS 13.0 program. Student-t test and chi-square test were used for statistical analysis. ROC curve analysis was used for limit values. The data of patients with preeclampsia and without preeclampsia were compared. The ability of the thymus volume to predict the preeclampsia was tested using binary logistic regression analysis. P value \<0.05 was considered statistically significant.

The exact etiology of preeclampsia remains unclear but is known to involve immunological factors. The thymus is one of the main organs involved in the development of the fetal immune system. The aim of this study was to explore the association between fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.

Eligibility Criteria:
Inclusion Criteria:

* 11-14 weeks pregnancy with no abnormal ultrasonography evidence.

Exclusion Criteria:

Any history of obstetric complications Chronic hypertension Diabetes mellitus Infectious or autoimmune disease.
CanMove: A Physical Activity Program for Children With Cancer

This study will evaluate a physical activity intervention for children during acute cancer treatment. The intervention aims to encourage children to participate in increased levels of physical activity and reduce the amount of time they spend engaged in sedentary activities. This study also aims to evaluate different ways of assessing physical function in order to determine the best outcome measure to use for children during acute cancer treatment.

All participants will receive the intervention which involves weekly sessions with a physiotherapist and the provision of an activity tracker. The sessions will aim to help motivate participants to be more physically active and identify barriers to physical activity in their environment. The activity tracker will be used to set a steps per day goal for the participant to achieve.

The intervention will be assessed for feasibility using aspects of the Bowen Framework. Under this framework the intervention will be evaluated according to different domains:

* Acceptability: To what extent is a new idea, program, process or measure judged as suitable or satisfying
* Demand: To what extent is a new idea, program, process, or measure likely to be used
* Implementation: To what extent can a new program is successfully delivered to intended participants
* Practicality: To what extent can the program can be carried out with intended participants using existing means, resources, and circumstances
* Limited efficiency: Does the a new program show promise of being successful with the intended population

In order to find out the best way to assess physical function, participants will complete 5 different assessments. The results from these assessments will help to determine the best measure to use in this population.

Eligibility Criteria:
Inclusion Criteria:

* Is between the ages of 5-17 years at the time of consent
* Diagnosed (or relapsed) with cancer \>4 weeks and \<6 months at time of consent
* Currently receiving cancer treatment at the Royal Children's Hospital
* Has been an in-patient for \>7 consecutive days at the time of consent
* Provide a signed and dated informed consent form and/or has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf

Exclusion Criteria:

* Deemed by the treating medical team as unsafe to participate
* Child/adolescent unable to mobilise independent of clinical staff assistance, as classified by the research team at the time of consent (use of a gait aid or assistance from a primary carer/support person is accepted). For example, if a child/adolescent requires assistance from nursing staff or physiotherapist in order to walk, they will be excluded.
* Child/adolescent unable to follow simple instructions
* Suitable support person (18 years and over) not available to participate in continuous monitoring of daily steps in tandem with the child/adolescent
* No suitable access to a device to sync with a Fitbit
* Inability or unwillingness of participant or legally acceptable representative to give written informed consent.
Chronic Sleep Restriction and Driving

Young subjects and patients with nocturnal respiratory disorders are frequently involved in sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or snorers on simulated driving, objective and subjective sleepiness and objective and subjective cognitive performances. The effects of recovery night on these parameters are also assessed.

Principal objective :

To determine whether chronic sleep restriction affects more snorers driving performances than healthy subjects' driving performances.

To determine whether chronic sleep restriction affects more young people driving performances than mature subjects' driving performances.

Secondary objective :

To determine whether chronic sleep restriction affects more snorers reaction time performance and sleepiness than non snorers subjects'.

To determine whether chronic sleep restriction affects more young people reaction time performance and sleepiness than mature subjects'.

To determine how age and snoring intensity affects the degradation of performance over the 5 days of sleep deprivation.

To determine age-related changes in the time course of sleepiness during 5 days of chronic sleep restriction.

To compare the impact of total sleep or chronic sleep restriction on driving performances according to the age and snoring intensity.

To determine recovery facilities to chronic sleep restriction according to the age and snoring intensity.

Study plan :

G2: Group of subjects:

* patients
* controls

B1: Baseline normal night:

One night of normal sleep

A2: Acute sleep deprivation:

Night 1: night of total sleep deprivation Night 2: night of sleep recovery

C6: Chronic sleep deprivation:

Night 1 to 5: nights of sleep restriction Night 6: night of sleep recovery

Experimental plan : S20 \<G2\> \*B1 \* A2 \*C6

Eligibility Criteria:
Inclusion Criteria:

Healthy subjects inclusion criteria :

* Healthy males without snoring nor subjective daytime sleepiness (Epworth \<9)
* Intermediate chronotype
* Hypopnea/apnea index \<5
* Periodic movement index \<5
* Sleep efficiency \> 85 %
* Not taking medication modifying alertness
* Mean driving distance per year 15000 km
* Regular sleep-wake schedule.

Snorers inclusion criteria :

* Snoring males without subjective daytime sleepiness (Epworth \<9)
* Intermediate chronotype
* Hypopnea/apnea index \<5
* Periodic movement index \< 5
* Sleep efficiency \> 85 %
* Not taking medication modifying alertness
* Mean driving distance per year 15000 km
* Regular sleep-wake schedule

Exclusion Criteria:

Healthy subjects exclusion criteria :

* Short or long sleeper
* Shift- or night-worker
* Sleep, mood, neurological, cardiovascular, pulmonary, endocrinological,... disorders
* Alcohol
* Consumption of illicit drugs.

Snorers exclusion criteria :

* Short or long sleeper
* Shift- or night-worker
* Mood, neurological, cardiovascular, pulmonary, endocrinological,... disorders,
* Sleep disorder except snoring
* Alcohol
* Consumption of illicit drugs.
2024 NewAnescat Register

20 years ago, for the first time in Spain, a record was made of all the activity carried out by a medical speciality, called ANESCAT 2003. After 20 years, the increase in healthcare activity has exceeded the expectations and predictions that were made at the time. Therefore, it is necessary to make a new assessment of the work situation in which our speciality finds itself in order to be able to evaluate whether the increase in resources allocated has been proportional and therefore to be able to have objective data with a view to making new demands and planning future needs.


Eligibility Criteria:
The activity of all the areas in which the anaesthesiologist has some kind of work involvement over 24 hours during 14 days in a year is included through several questionnaires with different formats. Therefore all patients will be included without restriction criteria.
Bisphenol A and Muscle Insulin Sensitivity

This study examine oral bisphenol A consumption on muscle insulin sensitivity and hepatic glucose suppression. Half of the participants will receive a diet plus BPA and the other half will receive a diet plus no bisphenol A.

Evidence linking bisphenol A exposure with diabetes risk remains mainly associative in nature, and mechanism linking bisphenol A to type 2 diabetes remains unclear. The investigator's preliminary data suggests that in young adults, single oral BPA consumption significantly decreased glucose, insulin, and C-Peptide responses to an oral glucose tolerance test, suggesting that immediate consumption of bisphenol A has an effect on muscle insulin sensitivity, hepatic glucose suppression and/or digestion and absorption to lower blood glucose, insulin, and C-Peptide concentrations. The present experimental study evaluating the effects of bisphenol A over several days on the pathogenesis of type 2 diabetes will directly assess each of these potential mechanisms using gold standard measures (euglycemic hyperinsulinemic clamp technique and hepatic glucose suppression with glucose stable isotope infusion, and fecal microbiota).

Eligibility Criteria:
Inclusion Criteria:

* non-dieting
* sedentary (≤3 hour/week of aerobic exercise)
* normal-weight (BMI = 18.5 to 24.9 kg/m2)
* weight-stable for the previous 6 months
* free of any metabolic or chronic disease
* non-smoking, and sedentary

Exclusion Criteria:

* Hemoglobin A1C based on the American Diabetes Association guidelines of 5.7 to 6.4% (Prediabetes) or \>6.4% (Diabetes)
* impaired glucose tolerance
* type 1 diabetes
* type 2 diabetes
* colitis or any inflammatory bowel condition
* neurologic or psychiatric conditions
* smoking
* special diets (e.g. vegetarian, low-carbohydrate, Paleolithic, etc.)
* pregnant women or women trying to become pregnant