cyrilzakka/clinical-trials huggingface dataset:
Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment

Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, phase 4.

About 10% of children may have behavioral problems during dental treatment, but the evidence for sedative protocols that benefit the care in pediatric dentistry are still weak. This randomized, masked, controlled, parallel design study aims to evaluate the efficacy, safety and cost-effectiveness of intranasal sedation with ketamine / midazolam in healthy children aged 2 to 6 years old. Children will be selected among those with dental decay that do not allow dental treatment to be performed, and need at least two restorations under local anesthesia and rubber dam isolation. It is estimated a preliminarily a sample of 84 children equally divided into three groups: A) Ketamine (4.0 mg / kg up to 100 mg) + midazolam (0.2 mg / kg, maximum 5 mg) intranasally; B) ketamine (4.0 mg / kg up to 100 mg) + midazolam (0.5 mg / kg, maximum 20 mg) orally; C) midazolam (1.0 mg / kg, maximum 20 mg) orally. The hypothesis is that ketamine / midazolam combination, administered intranasally, it constitutes an effective sedative regime, safe and cost-effective for use in pediatric dentistry in the public service. The primary endpoint is the behavior of the child. Secondary endpoints are: sedative administration acceptance, procedure memory and salivary cortisol levels within each intervention group. Additionally, we will evaluate: the occurrence of pain and associated changes in facial expressions with potentially painful stimuli in children sedated for dental care; caregivers and paediatric dentists' stress and perception about sedation; adverse events that occur during and after administration of sedatives; cost-effectiveness of the sedative protocols. The experimental design is planned to minimize systematic and random errors and to contribute to higher level of evidence in future systematic reviews. The outcomes of this study have potential impact on public and private health practice, and may support institutional guidelines dealing with this theme.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists I (healthy) or II (mild and controlled systemic disease such as persistent asthma)
* Small risk of airway obstruction (Mallampati less than 2 or tonsillar hypertrophy occupying less than 50% of the oropharynx)
* No medical history of neurological or cognitive changes
* Absence of facial deformities
* Term birth
* No use of drugs that may impair cognitive functions
* At least two teeth with cavities without pulp involvement, requiring dental restoration under local anesthesia and rubber dam

Exclusion Criteria:

* Positive or definitely positive behavior (Frankl et al, 1962) in a dental treatment session conducted by the research team
Registry of Use and Application of Sensor Augmented Pump (SAP) Therapy Under Daily Life Conditions

The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP) therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps and continuous glucose monitoring systems in Germany.

The purpose of this registry is to reflect the daily practice with Sensor Augmented Pump (SAP) therapy usage in Type 1 Diabetes Mellitus (DM) patients treated with Medtronic insulin pumps (Paradigm VEO®) and continuous glucose monitoring systems in Germany. In addition, the aim is of this registry is to support:

* obtain reimbursement for SAP therapy in Germany
* building a platform (advisory committee) for discussion of SAP data.
* looking for deficits with implementation of glucose sensor data in diabetes therapy management and development of "follow-up education" materials.

This is a national multi-center, post-market non-interventional prospective study with CE marked and commercially available devices and consumables.

The study will be conducted from March 2012 to April 2013 in Germany. The duration of individual patient participation is 3 to 6 months.

Health outcomes will be measured in approximately 75 patients between 6-65 years old diagnosed with Type 1 DM over a period of at least 3 months in approximately 15 centers. The patients are under treatment of Paradigm VEO® without any additional insulin injections and use continuous glucose monitoring, or patients that are not using continuous glucose monitoring, but that are willing to start with SAP. The enrolled subjects have a first visit inquiring the status data (including upload of device data in CareLink software, Hemoglobin A1c (HbA1c) value measurement) without any intervention. Thereafter, the SAP therapy is optimized based on individual continuous glucose monitoring (CGM) data during a second visit one month later and then a last visit like the first visit in which the status will be determined.

Parameters of glycemic control will be measured, such as the frequency of hypoglycemia (glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (Visit 1) and after the visit 2 when an adjustment of the therapy has been discussed with the patient based on the collected CGM results between the two first visits.

Eligibility Criteria:
Inclusion Criteria:

* patients with signed informed consent
* Type 1 DM and has been on insulin pump therapy for at least 3 months prior to signature of the informed consent
* patients use CGM component as part as part of the continuous subcutaneous insulin infusion (CSII) therapy for a minimum of 1 month

Exclusion Criteria:

* participation in any other trial
* any disease or drug treatment that can interfere with the outcome of sensor usage
* using CGM in CSII \< 3 days/week
* patients not willing to sign informed consent
* abuse of alcohol or drugs (exception of nicotine consumption)
* eating disorder, anorexia, bulimia or other mental disorders
Gulf Acute Heart Failure Registry

The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up.

Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region.

The Gulf Heart Association (GHA) initiated Gulf acute heart failure registry (Gulf CARE)is designed to assess epidemiology, clinical data, management and outcomes of AHF in six Gulf countries and whether published, professional guidelines on the diagnosis and treatment of heart failure are being applied appropriately in patients with heart failure. The registry will also provide a quantitative estimate as well as qualitative description of the hospital disease activity related to heart failure. The information gathered will identify management gaps in diagnosis and care of AHF patients that may be addressed by more effective implementation of current guidelines or development of AHF guidelines which may be appropriate to this region. Findings from this registry may help in knowing the current status of heart transplantation in the Middle-East countries as well as identify issues in establishing future heart transplant programme including selection of appropriate candidates and donors, requirements for pre- and post-transplant support.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute heart failure
* Admitted to the participating hospitals

Exclusion Criteria:

* Patients with acute heart failure who are discharged from the emergency room without admission.
* Patients transferred from non-registry hospital
* Failure to obtain informed consent
Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water

The primary objective of this study is to obtain the TPTD, GEDV and EVLW measurements from existing indwelling femoral arterial Volume View™ catheter and central venous catheters.

Transpulmonary thermodilution has been proposed to measure transpulmonary thermodilution cardiac output (TPTD), preload (GEDV, global end diastolic volume) and to quantify pulmonary edema (EVLW, extravascular lung water). The method currently available on the market is based on the estimation of time characteristics of the curve (mean transit time and down slope time).

The purpose of this study is to evaluate a new transpulmonary thermodilution method to assess the TPTD, EVLW and GEDV in patients requiring cardiac preload and lung water assessment. Up to one hundred (100) patients will be enrolled at four (4) study sites, (up to 25 subjects at each site). Hôpitaux Universitaires de Genève, Universität Bonn, Stadtspital Triemli Zürich, and Universitätsklinikum Aachen will participate in the study.

This is a prospective, observational data collection study.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must have clinical need for an indwelling femoral arterial catheter and central venous catheter.
2. Patient, or legal guardian, must sign consent to be in the study prior to data capture.
3. Patient must be at least 18 years old.
4. Patient height and weight are available prior to study.

Exclusion Criteria:

1. Patients with significant aortic valve regurgitation.
2. Patients being treated with an intra-aortic balloon pump.
3. Patients less than 40 kg in weight.
4. Female patients with a known pregnancy or planned pregnancy.
5. Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints.
6. Patients with peripheral vascular disease.
7. Patients with aortic aneurysm.
Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy Adults

To assess the safety and tolerability of ascending single oral doses of SAM-315, an investigational drug, in healthy adult subjects. To obtain a preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-315, an investigation drug, administered to healthy adult subjects.


Eligibility Criteria:
Inclusion criteria:

* Men and women of nonchildbearing potential aged 18 to 45 years
* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels must be within the upper limit of normal for eligibility.

Exclusion criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
* Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours and, grapefruit, grapefruit-containing products is prohibited 72 hours before study day 1.
Stay on Track: A Study of Exercise Effects During Radiation

The purpose of this study is to examine the impact of a lifestyle intervention. The study will examine the Stay on Track program, dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy.

Research Design. The investigators will be conducting an randomized trial in 60 women undergoing radiation treatment for breast cancer to examine the feasibility of a 12-week lifestyle intervention that addresses diet and physical activity and to explore the impact on behavioral, biological and psychosocial outcomes.

Procedure Summary. Patients who are eligible are consented by the research coordinator, after which a baseline assessment will be scheduled. The baseline assessment requires 60 minutes and includes questionnaires, height/weight, dual energy x-ray absorptiometry (DEXA), and phlebotomy. Participants will also wear the Fitbit for one week to establish baseline activity level. After the baseline assessment, women are then randomly assigned to: the 12-week "Stay on Track" lifestyle intervention or the 12-week self-guided control. Both groups complete a post-intervention and a 3-month follow-up visit identical to their baseline assessment. Self-guided controls can utilize their Fitbit and will receive informative binders 24 weeks' post-intervention.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age;
2. confirmed primary non-metastatic breast adenocarcinoma;
3. planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;
4. planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;
5. Have a Karnovsky Performance Score of 70 or above (see Appendix)
6. Patient's Body Mass Index (BMI) is greater than determine by the treating physician, not currently meeting physical activity guidelines: moderate physical activity for at least 30 minutes at least five days a week AND 2 weekly sessions of resistance exercise;
7. have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges);
8. understand and speak English;
9. physically able to engage in the intervention;
10. accepting of randomization (Note that anti-estrogen therapy is allowed.)

Exclusion Criteria:

1. Patients who have metastatic disease;
2. Patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer.
3. Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems.
4. Patients who have received chemotherapy for their breast cancer.
5. Patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
Sleep, Pain and Quality of Life in Chronic Pain Patients

The interventional study will have two main aims. First, to compare two interventions aiming to improve sleep in chronic pain patients. And secondly, to study the associations of sleep, mood, chronic pain and quality of life. Half of participants will go through iCBT intervention for insomnia and the other half will receive sleep hygiene education. Additionally, the study will gather information which patients will benefit/will not benefit the tertiary pain clinic treatment when the outcome variable is the Health-related Quality of Life (HrQoL).

Sleep disturbances associates closely with chronic pain. It now seems that sleep problems usually precede and maintain persistent pain. Anxiety and worry frequently precede and associate with disturbed sleep and chronic pain. Depression is usually a consequence of chronic pain. Pain and depression disturb sleep further. These elements form a vicious circle where poor sleep is a critical driver.

Previous studies have shown that sleep disturbances are a major contributor to the poor health-related quality of life (HRQoL) of patients with chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* fluency in Finnish

Exclusion Criteria:

* severe psychiatric conditions (e.g. scizopherenia)
18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment

18F-sodium fluoride (18F-NaF) was already investigated numerous times in the last 40 years as a PET alternative to standard 99m-technetium-derived bone scintigraphy. However, lack of universal tracer availability and higher costs contributed to the failure of 18F-NaF to systematically supplant bone scintigraphy as a standard of care.

Recently, an isotope shortage crisis occurred and evidenced the need to have non-reactor-derived alternatives for many nuclear medicine procedures, including bone scintigraphy. Since 18F-NaF is cyclotron-produced, it could become a necessary alternative to bone scintigraphy in case of another worldwide isotope shortage.

The study aims to evaluate the safety profile of 18F-NaF injection. Moreover, a patient registry will be compiled in order to perform sub-studies on 18F-NaF diagnostic performance on diverse bone and articular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated;
* Pediatric patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated for oncologic or infectious reasons
* Able to tolerate supine position
* Written consent

Exclusion Criteria:

* Healthy subjects
* Pregnancy
* Unable of maintaining supine position for more than 15 minutes
* Refusal to sign the consent form
* Known allergy or hypersensitivity to 18F-NaF or any of its constituants.
Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Pregabalin will decrease the total amount of opioid required in patients undergoing total abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related side effects in patients undergoing total abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status 1-2
* Age 18-64
* BMI 18-35
* Scheduled for elective total abdominal hysterectomy (with or without bilateral salpingo-oophorectomy)
* Gender: Female
* Consent: Obtained

Exclusion Criteria:

* Patient refusal
* Allergy to study medication(s)
* Preoperative use of gabapentinoids
* Preoperative use of anticonvulsants
* Daily use of analgesics
* Hepatic disease
* Renal insufficiency (Cr \>2.0)
* Alcohol or drug abuse
* Pregnancy
* Language: Non-English speaking
* Patient expected to remain intubated after procedure

Dropout:

* Patient request
* Surgeon request
* Allergic reaction to pregabalin
* Surgical procedure significantly altered from scheduled procedure
A Study to Assess the Ingestion of Dentifrice by Children

The objective of this study was to examine the amount of dentifrice ingested and used by various age groups of children.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 2 and 12, inclusive
* Be healthy, with no illness that, in the judgment of the investigator or examining dentist, would interfere with the conduct of the test
* Be currently, and have been for at least three months immediately prior to the start of the study, brushing (or being brushed by care giver) their teeth on a daily basis
* Have parent/guardian complete and return the consent form

Exclusion Criteria:

* Have diabetes
* Be on dialysis
* Have an oral health condition that, in judgment of investigator or study medical personnel, could interfere with the conduct of the study.
* Wear metal braces
* Have an incomplete or missing consent form
Rate RESPONSIVe Pacing in Patients With Permanent AF Underwent AV Node ABLation and bivEntricular Pacing (RESPONSIBLE)

The purpose of this study is to evaluate the effect on distance covered in a 6 minute walking test of Rate Responsive pacing in patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing.

Patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing will be enrolled. Two 6' walking test (6WT), one during VVI 70/min biventricular pacing (RR off) and the other during VVIR 70-120/min biventricular pacing (RR on), will be performed one week apart; patients will be randomly and blindly assigned with a 1:1 ratio to group A (first 6WT RR off) or B (first 6WT RR on). The difference between the two tests will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Permanent, refractory atrial fibrillation treated with atrio-ventricular node ablation and biventricular pacing
* Left ventricular systolic dysfunction
* Ability to perform a 6-minute walking test
* Completion of the 18th year of age

Exclusion Criteria:

* Contraindications to 6 minute walking test
* IV NYHA Class
Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment with the LynxPatch Device

In this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the LynxPatch.

The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The study population includes 1100 patients that scheduled for an echocardiographic assessment or for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent, i.e., the subject must be able to understand and sign the Patient Information and Consent Form.
* Group 1: Patients that have an indication for an echocardiographic assessment.
* Group 2: Patients that are scheduled for a non-cardiac surgery

Exclusion Criteria:

* Subjects has implanted cardioverter defibrillator
* Subject is pregnant
* Subject is breastfeeding
* Subject has compromised skin in the location where the LynxPatch is intended to be positioned
In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency

The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.

This will be a prospective, open-label, crossover study in up to 12 stable subjects with chronic respiratory insufficiency who require LTOT. Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Subjects will participate in the study for up to 9 home visits, with Visits 1 and 2 each lasting for approximately 4 hours, and Visits 3-9 lasting approximately 1-2 hours each. Subjects may discontinue study participation at any time.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects, 21-80 years of age
* Diagnosis of chronic respiratory insufficiency including COPD and interstitial lung disease
* Requires use of continuous nasal oxygen of at least 2 lpm
* Reports limitation of activity due to fatigue or breathlessness
* Fluent in written and spoken English language
* Ability to be properly fitted with the Breathe nasal mask
* Ability to tolerate and be appropriately titrated on the Breathe ventilator
* Ability to communicate self-assessment of dyspnea, comfort, and fatigue
* Ability and willingness to participate in the study including walking and other activities of daily living
* Ability to provide written informed consent

Exclusion Criteria:

* Recent history of frequent or severe epistaxis
* Symptoms of acute respiratory exacerbation within 48 hours of Study Day 1
* Discharge from the hospital within 30 days of study enrollment
* Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment or who are unlikely to be able to comply with trial requirements
* Subjects with conditions that, in the Investigator's opinion, contraindicates study participation