cyrilzakka/clinical-trials huggingface dataset:
Naproxen on Tooth Sensitivity Caused by In-office Bleaching

This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old patients of both genders presenting good general/oral health;
* All maxillary anterior teeth presenting shade equal or darker than 2M2 at Vita bleachguide guide (Vita-Zahnfabrik, Germany);
* Signed the form accepting to participate of this study.

Exclusion Criteria:

* Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.
* Undergone tooth-whitening procedures;
* Pregnant/lactating;
* Presence of periodontal diseases;
* Presence of severe tooth discoloration by tetracycline stains or fluorosis;
* Any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure);
* Continuous use of drugs with anti-inflammatory actions;
* Presence of tooth hypersensitivity at baseline measurement;
* Any known adverse effects caused by Naproxen;
* Non-attendance to any session of evaluation or bleaching.
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers

The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.

While mammography is the most accepted breast cancer screening test, it is less sensitive in women with dense breast tissue, who have a four fold high risk for developing breast cancer. Thermalytix is a novel automated breast cancer screening solution that uses artificial intelligence (AI) over thermal images to detect and localise breast cancer lesions in women. In this study the performance of Thermalytix over mammography is evaluated in women with dense and non-dense breast tissue who presented for a health check-up at a hospital. All women underwent Thermalytix and mammography, and participants who were reported as positive on either test were recommended for further investigations. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated across age-groups, menopausal status, and breast densities against the current standard-of-care diagnostic modalities.

Eligibility Criteria:
Inclusion Criteria:

1. Female subjects equal to and above 18 years
2. Subjects who are willing to give written informed consent for study participation
3. Subjects who are ready to comply with the study related visits and procedures

Exclusion Criteria:

1. Subjects who are pregnant
2. Subjects who are lactating
3. Subjects who have undergone either lumpectomy or mastectomy
4. Subjects who have undergone chemotherapy in the last 2 weeks at the time of study enrollment
5. Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator
Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants

The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures

Vaccination is a leading public health intervention for reducing morbidity and mortality from influenza worldwide. Vaccine optimization is hampered by lack of understanding the natural history of infection and immunity, including the full complement of maternal immunity imparted to infants. This gap in understanding can be addressed only through a well-designed birth cohort study. Up to 1500 mother-infant pairs will be enrolled at or after week 34 in pregnancy over three flu seasons, up to four years of age depending on birth month, at two sites. Follow-up will occur from the third trimester until the child is three to four years of age, along with medical records review to ascertain outcomes not captured through weekly illness and respiratory surveillance, and medical record review up to 18 years of age. The primary aim is to rigorously document the natural history of infection and immune response to influenza in study infants for at least three entire flu seasons.

Eligibility Criteria:
Inclusion Criteria:

* Mother pregnant and ≥ 34 weeks gestation and ≥ 18 yrs. of age
* Plans to deliver at local hospital
* Lives within designated home zip codes:
* No plans to move outside study area within study timeframe
* Cell phone that can be used for text messaging
* Singleton live born infant, born ≥ 34 weeks gestational age (GA)

Exclusion Criteria:

* Fetal or infant death prior to maternal hospital discharge
* Mother known to be infected with HIV based on medical records
* Major congenital anomalies, prenatally diagnosed or other major disorder or anomaly as determined by the PI
* Reported use of heroin, cocaine or methamphetamines during pregnancy
* Adoptive infant
* Enrolled in any investigational vaccine trial or other interventional randomized, clinical trial involving the mother or infant that the PI's deem to be in conflict with study outcomes
DynaCT Imaging in EVAR: Comparing Clinical Benefit of DynaCT to Multidetector CT as the Current Gold Standard.

The aim of this study is to evaluate a new way to create CT-like images during intra-operative procedures. We want to prove that the quality and information received from DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm.

The study will compare images from the new modality (DynaCT) with the present modality (Multi detectorCT). We make three different set of images from each modality.

Eligibility Criteria:
Inclusion Criteria:

* Age over 65,
* Satisfactory renal function
Implementation of Evidence-based Breathing Retraining for Patients with Asthma in Region Zealand

This study aims to implement the evidence-based intervention breathing retraining into clinical care of patients with symptomatic asthma irrespective of asthma severity or comorbidities, and in a diverse multicentre setting to evaluate implementation outcomes. This will meet patients' needs and improve health and life situation in patients with uncontrolled asthma. Further, the study will evaluate implementation outcomes.

This study is a hybrid-designed prospective multicenter implementation evaluation study, in which the investigators secondarily will maintain measuring effectiveness of breathing retraining in a real-world setting including primary and secondary health care and add cross-sectorial co-operation. Thus, investigators include more primary outcomes.

The study is part of Exercise First-project, a collaboration of The National Health Service, Region Zealand and the research unit PROgrez, Department of Physiotherapy and Occupational Therapy at Næstved, Slagelse, Ringsted hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Doctor diagnosed asthma;
* Incompletely controlled asthma or worse: Asthma Control Questionnaire (ACQ5) score ≥0.8;
* Residence (or asthma treatment program) in Region Zealand, Denmark;
* Able to read and understand Danish or available assistance to help understand information material, intervention content and respond to questionnaires.

Exclusion Criteria:

* Unwilling to participate;
* Unable to participate in the intervention due to physical or mental condition.
Resting Metabolic Rate in Chronic Bed-Ridden Patients

Research objective: to measure resting metabolic rate (REE) in long term, bed ridden, chronically ill patients and to compare their measured energy needs to standard REE equations

Are standard REE equations suitable for estimating resting metabolic rate in long term, bed ridden, chronically ill patients?

Research objective: to measure resting metabolic rate (REE) in long term, bed ridden, chronically ill patients and to compare their measured energy needs to standard REE equations

Eligibility Criteria:
Inclusion Criteria:

* Age (years): 18-30, 31-60, 61-74, 75-100
* Confinement to bed at least for a year

Exclusion Criteria:

* Mechanical ventilation
* Tracheostomy
QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)

This national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with Pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older.
* Patient suffering from mild to moderate active proctitis or distal proctosigmoiditis (MAYO score ≥ 3 and ≤ 10) at inclusion based on clinical and endoscopic findings within 6 months before study inclusion.
* Patient with evidence of endoscopic active proctitis or distal proctosigmoiditis (Montreal classification E1 or E2 defined by an involvement not exceeding 25 cm from the anal margin) within 6 months before study inclusion.
* Treatment of the current flare with Pentasa® to induce a remission initiated by the patient, the general practitioner or the gastroenterologist, during the inclusion visit or during the week before the inclusion visit.
* Patient having received oral and written information on the study, without any objections for the use of his/her personal data, and having signed a written Informed Consent Form.

Exclusion Criteria:

* Patient included in an interventional study assessing treatment for active proctitis or distal proctosigmoiditis.
* Patient with left sided, colitis or pancolitis.
* Patient with severe proctitis (MAYO score ≥ 11 at inclusion).
* Patient previously treated with biologics.
* Patient treated with immunosuppressive within 1 month before study inclusion.
* Patient treated with corticosteroids within 2 weeks before study inclusion.
Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes

Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not related to obesity; however, sleep-disordered breathing in these patients was described in few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1 diabetes and even less their influence on the glycemic control.

This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization. The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15) who underwent polysomnography and continuous glucose monitoring of blood glucose


Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years
* with type 1 mellitus diabetes

Exclusion Criteria:

* Type-free diabetes (type 1 slow),
* Age \<18 years
* A poor compliance with the follow-up (meetings unfulfilled without justification).
* All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).
Mindfulness Training for First Responders

The present study evaluates the efficacy of Mindfulness-Based Attention Training on measures targeting cognitive abilities and emotional well-being in first responders.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are between 18 and 75 years of age
2. Individuals who are fluent English speakers
3. Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection
4. Individuals who are willing and able to consent to participate in the study
5. Participants in all phases of the study must be individuals who are affiliated with the Los Angeles County Fire Department

Exclusion Criteria:

1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month
Comparison of Low Fat and Low Carbohydrate Diets With Respect to Weight Loss and Metabolic Effects

The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the investigators will measure cardiovascular and metabolic variables and will take blood samples in order to determine whether certain metabolites may predict the diet success.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \> 27 kg/m2
* No chronic medication (except oral contraceptives and L-Thyroxine) or possibility to stop medication for study duration
* Able to give written informed consent

Exclusion Criteria:

* Pregnancy and nursing
* Severe cardiovascular, liver, kidney, hepatic or orthopedic disease that need treatment
* Metabolic or endocrine disease that need treatment
* Hypertension blood pressure \> 160/95 mmHg or need of \> 2 drugs
* Previous stroke or cerebral ischemia
* Significant neurologic or psychiatric disease
* Any kind of eating disorder
* Bariatric surgery in the past
* Drug or alcohol abuse
* Any cancer in the past
* Acute and chronic infections
* Metallic implants (e.g. pace makers) or conditions that do not allow MRI scans
* Body weight \> 130 kg
Evaluation of an Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting

This was a study of a genotyping tool that reported on how subjects responded to medications and could be used in a community psychiatry practice to improve medication choice for depression. After the DNA test, an interpretive report was provided to the subjects' physicians. The hypothesis of this pilot study was that it was feasible to use this pharmacogenomic algorithm in a new setting to treat depressed subjects..

Antidepressant medications are among the most widely prescribed medications. However, only 35% to 45% of depressed patients have a complete remission of their illness when initially treated with these medications. Consequently, the Mayo Clinic psychiatric pharmacogenomic team developed a pharmacogenomic algorithm designed to improve the effectiveness and safety of antidepressant medications by providing guidance in medication selection and appropriate dosing. This algorithm has been incorporated into a new genotyping interpretative report. The pharmacogenomic algorithm is based on genotyping both copies of four informative genes. These four genes are: 1) the Cytochrome (P450 2D6) gene; 2) the Cytochrome (P450 2C19) gene; 3) the Serotonin Transporter gene (SLC6A4); and 4) the Serotonin 2A receptor gene (5HTR2A). The trial took place at the Franciscan Skemp Healthcare System in La Crosse, Wisconsin over the course of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is between the ages of 18 and 80.
2. Major depressive disorder or depressive disorder not otherwise specified as ascertained by a physician or mental health professional licensed to diagnose.
3. Patient is an outpatient and not in imminent need of inpatient hospitalization, or a discharging inpatient with scheduled follow-up with a Behavioral Health psychiatrist.
4. Patient has been referred to see a psychiatrist for optimum medication management.
5. Patient's Hamilton Depression Rating score is \>14
6. Ability to read, understand and sign an informed consent document

Exclusion Criteria:

1. Serious medical illness (as ascertained via the initial triage screening process)
2. Patients with a diagnosis of Bipolar I disorder
3. Patients with a diagnosis of Schizophrenia or Schizoaffective disorder
4. Patients who are legally unable to consent to enrollment in the study (i.e. patients with legal guardians)
The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women

A descriptive analysis involving 300 healthy pregnant women to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range.

A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.

Eligibility Criteria:
Inclusion Criteria:

1. The people who lived in the city more than five years, aged between 19 and 45, or the single pregnancy women who registered or checked in Peking University international hospital would be enrolled.
2. The pregnancy confirmed by the ultrasound or blood HCG test.
3. In order to build a pregnancy reference range of normal pregnant women who must meet the NACB standard.

Exclusion Criteria:

1. The history of thyroid disorders.
2. Goiter.
3. Oral contraceptives or any drugs affected the function of thyroid.
4. With other chronic autoimmune disease, malignant tumor, blood disease, etc
5. Twin pregnancies and multiple pregnancies
A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects

This is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of GS-6615 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2
* Female subjects must be of non-childbearing potential as defined per the protocol
* Male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
* Willing and able to comply with the requirements of the protocol and directions
* Willing to avoid consumption of grapefruit, grapefruit juice and Seville oranges
* Willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages

Exclusion Criteria:

* Ongoing or history of any medical or surgical condition that, in the judgment of the Investigator, might jeopardize the subject's safety or interfere with the study objectives
* History of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
* Any abnormal ECG findings, abnormal laboratory value, or physical examination findings at Screening judged to be clinically significant
* Any abnormal neurological examination findings at Screening that is judged as clinically significant
* Hemoglobin \< 12 g/dL
* Serology test positive for HIV, or hepatitis B or C
* Positive urine drug test (including cotinine or ethanol)
* Use of systemic prescription medications or over the counter (OTC) medication, including multivitamins, and dietary and herbal supplement
* Use of any experimental or investigational drug or device within 30 days
* Female subjects who are of childbearing potential, pregnant or lactating
* Donation or loss of blood within 8 weeks and/or donation of plasma within 7 days
* History of drug or alcohol abuse
* Psychosocial or addictive disorders
Prenatal Iron and Malaria Study

The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.

As per recommendations by the World Health Organization (WHO), iron supplementation in children should be restricted in malaria-endemic areas because of concerns that it can lead to an increased burden of malaria. Universal iron supplementation continues to be recommended, however, for women during pregnancy and 3 months postpartum. Observational studies have shown that iron deficiency in parturient women is associated with a marked reduction in the prevalence and density of malarial parasites in the placenta. Plasmodium infections in pregnant women have devastating effects on the foetus and neonate, causing low birth weight, intrauterine growth retardation, preterm delivery, spontaneous abortion, stillbirth and neonatal mortality. Based on our previous work, the Kenyan government is currently drafting legislation for mandatory iron fortification of industrially milled flour. Implementation of the new fortification policy means that pregnant women will receive iron through a combination of fortified foods and supplementation. The investigators are concerned about the safety of the high iron intake resulting from such a policy.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 15-45 years resident in the predefined study area
* Pregnant, with gestational age \<23 weeks

Exclusion Criteria:

* Failure to provide a blood sample
* Initial haemoglobin concentration \<90 g/L
* Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes
* Obstetric history suggestive of eclampsia or pre-eclampsia
* Obvious mental retardation or metabolic disorder;
* No written consent
* Carrying multiples
* Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter
* Woman planning to deliver outside the research clinic.
Ketamine Versus Low Dose Thiopental for Induction of Anesthesia in Septic Shock

The aim of this work is to compare two protocols (ketamine-fentanyl-midazolam versus thiopental-fentanyl-midazolam) for induction of anesthesia in patients with septic shock aiming to find the most safe protocol with regards to hemodynamic status of patients.

Induction of anesthesia in hemodynamically compromised patients is a challenge for every anesthetist. Most of the intravenous induction agents have a negative effect on arterial blood pressure and cardiac output. Theoretically, the "ideal" emergency induction intravenous anesthetic should achieve rapid hypnosis and maintain the hemodynamic stability Ketamine has been reported as an induction anesthetic with a sympathomimetic activity. In patients with intact autonomic nervous system ketamine increases heart rate, cardiac output, and arterial blood pressure (ABP). Despite its sympathomimetic activity in hemodynamically stable patients, the hemodynamic response to ketamine in unstable cardiovascular conditions is not clear No studies to the best of our knowledge compared Ketamine and low dose thiopental in rapid sequence induction of anesthesia in hemodynamically unstable patients.

In this study, patients with severe sepsis or septic shock scheduled for surgery will be assigned to receive either ketamine or thiopental for induction of anesthesia. After induction of anesthesia, endotracheal tube will be inserted aided by succinyl choline. Invasive blood pressure will be monitored through a transducer connected to arterial catheter. Electrical velocimetry (cardiometry) device will be used for non-invasive monitoring of cardiac output and stroke volume.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis patients with shock index (heart rate divided by systolic blood pressure) \>0.7. or Sepsis patients with norepinephrine infusion.

Exclusion Criteria:

* Traumatic brain injury
* Cerebrovascular disorders