cyrilzakka/clinical-trials huggingface dataset:
Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

Background: Dentine hypersensitivity is a common oral complaint from older adults. It induces pain, affects oral hygiene practice, limits food choices and negatively affects the quality of life. Silver diamine fluoride (SDF) is a desensitizing agent but well-designed clinical trials are lacking. The objective of this study is to evaluate the effectiveness of SDF in reducing dentine hypersensitivity in older Chinese adults.

Methods: This is a double-blinded randomised clinical trial recruiting 166 healthy older adults aged 65 or over after having written consent. A trained calibrated examiner will conduct clinical examination and assess dentine hypersensitive using a blast of compressed air delivered from 3-in-1 syringe. Older adults with a tooth with a self-perceived sensitivity score (SS) of 8 or above will be recruited. They will then be block randomised to receive either 38% SDF solution or 5% potassium nitrate every 4 weeks on the exposed root surface of the most hypersensitive tooth. The visible plaque index, bleeding on probing and probing depth (mm) will be recorded on the most hypersensitive tooth. The same examiner will perform clinical examination and assess the dentine hypersensitivity using the same tools and methods at 4-week and 8-week follow-ups. The examiner and older adults will be blinded to treatment allocation. The primary outcome is the percentage of change in SS before and after intervention at 8 weeks. The secondary outcome will be the percentage of change in VPI before and after intervention at 8 weeks.

Clinical significance: It will provide evidence to manage dentine hypersensitivity in older adults in clinical care.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy;
* no known or suspected allergy to the study ingredients or materials
* have all active dental diseases under control but reported hypersensitivity

Exclusion Criteria:

* using any desensitizing agent within one month
* have major systemic diseases such as cancer
* receive medications that may affect pain perception within one month
* have dentine hypersensitivity due to other dental conditions such as caries
* are not able to give written consent
Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls

This study examines a redesign of pediatric primary care overweight/obesity treatment, augmenting typical in-person visits with: (1) direct-to-patient video telehealth to tailor counseling advice to families, (2) that leverages certified health coaches as a part of the care team, and (3) creates skills building in real-time within the home environment.

Investigators will recruit children with an elevated body mass index (BMI) (85th to \<99th percentile) and a parent. Dyads will participate in a 24-week intervention with a total of 26 contact hours. Dyads will participate in weekly education sessions for the first 12 weeks and bi-weekly sessions for the remaining 12 weeks. Additionally, dyads will participate in weekly exercise sessions.

Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3-months and 6-months.

Eligibility Criteria:
Inclusion Criteria:

Children:

* Ages 9-13 years
* BMI 85th to \<99th percentile
* Must be a patient within Health System Pediatric Primary Care
* Must be English or Spanish speaking

Parent:

-Must be English or Spanish speaking

Exclusion Criteria:

Children:

* Cannot have an emotional, social, or physical disability that would prevent them from participating in the protocol
* Non-English or Non-Spanish speaking
* Cannot have a medical condition resulting in unintentional weight gain (i.e. Prader Willi)
* Females cannot be pregnant
* In addition, children will potentially be excluded from participation if they have a positive screen during an interview led pre-screening eating disorder questionnaire

Parent:

-Non-English or Non-Spanish speaking
Does Occlusive Hydrocolloid Silver-containing Wound Dressing After Sternotomy Reduce Surgical Side Infection After Cardiac Surgery?

Wound healing disorders are a major problem in cardiac surgery. They prolong the inpatient stay and are associated with a high health and, above all, psychological burden for patients. They also represent a major organizational, medical and financial challenge for the treatment team. There is therefore still a great need for effective prevention of wound healing disorders. It goes without saying that wound management plays a major role in the development of wound healing disorders. Nowadays, there are a large number of products from various manufacturers and studies for efficient wound healing disorder prophylaxis. One point of criticism is that most of the existing studies are financed by the manufacturer. Due to the otherwise broad range of applications for all wounds in various specialist areas, it remains to be clarified whether such products can achieve a reduction in the rate of wound healing disorders, especially in cardiac surgery. After extensive literature research, we are of the opinion that the Aquacel Surgical Ag dressing, a new silver-coated hydrocolloid dressing, can be offered to cardiac surgery patients at our clinic as an effective prophylaxis against wound healing disorders.The study is a randomized prospective clinical trial. It is being conducted at the Clinic for Cardiothoracic and Vascular Surgery and has already been approved by the Rhineland-Palatinate Ethics Committee. The study should include 440 heart patients and last for 12 months. It will compare the Aquacel Surgical Ag bandage against our conventional methods. This study is being conducted independently of the industry. We want to prove that an intelligent investment in the prophylaxis of wound healing disorders is worthwhile for both patients and the clinic. If the outcome of the study is positive, this dressing will be be used regularly in our cardiac surgery clinic.


Eligibility Criteria:
Inclusion Criteria:

1. Coronary artery bypass surgery
2. Elective and primary surgery (no reoperations)
3. Complete median sternotomy
4. Age under 90 years
5. Weight in the range of 50-140kg
6. No known allergy to silver or other wound dressings
7. No immunosuppressive therapy or hormonal substitution therapy, except for thyroid hormone
8. Capacity to consent

Exclusion Criteria:

1. Failure of medical personnel to adhere to study protocol, e.g., not applying the right wound dressing according to study protocol
2. Patients own decision
3. Lack of harvesting of at least one internal thoracic artery
4. Peri- and post-operative ventilation for \>48h
5. Re-thoracotomy for reasons other than SSI, e.g., bleeding
6. Mortality within the first 30 days
Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.


Eligibility Criteria:
Criteria:

* Healthy male and female subjects aged 18 to 50 years.
* Women of nonchildbearing potential (WONCBP)
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers

The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of entacapone under fed conditions in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 55 years of age included, and in good health
* At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least five (5) minutes, and again when required after three (3) minutes in the standing position. Vital signs should be within the normal ranges
* Body mass index (BMI) within the range of 18 to 27 and weigh at least 50 kg
* Female subjects must have undergone hysterectomy, or must be postmenopausal.

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
* Receiving monoamine oxidase (MAO) inhibitors within 28 days prior to the first dose
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
* Significant illness within two weeks prior to dosing
* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
* Women of child bearing potential ( WOCBP)
* History or presence of glaucoma or any suspicious undiagnosed skin lesions

Other protocol-defined inclusion/exclusion criteria may apply
Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Atherosclerosis in Obese, Type II Diabetic Patients

To assess the impact of weight loss due to bariatric surgery, as compared to the effect of optimal medical therapy alone on endothelial function, subclinical atherosclerosis, cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study consists in a 2-arm randomized trial, in which patients will be randomly assigned to bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0) and 12 months thereafter (T1).


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes: the American Diabetes Association (ADA) recommends the following criteria for diagnosis of diabetes: HbA1c ≥6.5% OR fasting plasma glucose‡ ≥126 mg/dL (7.0 mmol/L) OR 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; 75-g glucose load should be used OR random plasma glucose concentration ≥200 mg/dL (11.1 mmol/L) in persons with symptoms of hyperglycemia or hyperglycemic crisis;
* indication to bariatric surgery: BMI ≥35 kg/m2 and one or more obesity related co-morbidities, including Type 2 Diabetes Mellitus.

Exclusion Criteria:

* overt cardiovascular disease (as assessed by clinical evaluation, physical examination, 12-lead ECG, 2D-echocardiogram);
* smoking habit;
* associated medical conditions, as chronic kidney disease (defined as creatinine clearance \<60 mL/min/L.73m2), liver cirrhosis, malignancies, chronic congestive heart failure, acute or chronic inflammatory disease;
* specific contraindication to bariatric surgery;
* pregnancy;
* medical conditions requiring acute hospitalization;
* psychological conditions which may hamper patient's cooperation;
* geographic inaccessibility.
Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test

The diagnosis of Growth Hormone deficiency in childhood requires the performance of an artificial pharmacological stimulation tests. There are number of substances that increase the secretion of growth hormone, among them Clonidine and Arginine. One of the possible side effects of both Clonidine and Arginine is a reduction in the blood pressure due to a decreased heart output and declined contraction of peripheral blood vessels. In cases where values of blood pressure at the end of the test are not recovered after two sessions of 15 minutes of physical activity, the patient is treated with I. V of 9%NORMAL SALINE (0. 20cc /Kg) administrated over 30-60 minutes.

The aim of the proposed study is to test whether administration of fluids during the combined Growth Hormone stimulation test Clonidine-Arginine will help in the recovery process from the test (blood pressure \> 90/50 mmHg after performing physical activity defined as 15-minutes hike in two consecutive sessions). The study design will be randomized, controlled, 2 arms study.


Eligibility Criteria:
Inclusion Criteria:

* Children referred to combined Arginine- Conidine Growth Hormone stimulation test
* Girls: 7-14 years old and Boys: 7-16 years old
* Weight\>20 kg
* Normal thyroid function

Exclusion Criteria:

* BMI over percentile 85
* Genetic syndromes or chromosomal disorders
* Steroid treatment
* Renal failure
* Heart failure
Study of COVID-19 Prognostic Factors in Hospitalized Patients

Severe COVID-19 prognostic factors have been studied worldwide throughout the pandemic, but there is considerable variability. Therefore, the investigators will summarize the identified prognostic factors in the international literature and will conduct a retrospective cohort study to identify the prognostic factors of severe COVID-19 in hospitalized patients of the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain) between March 2020 and February 2021, compare them with those mentioned in the international literature and establish those most adequate to our population.

Background: Spain is one of the European countries most affected by the SARS-CoV-2 pandemic, with a fatality rate of 2.2%. Faced with the significant number of patients requiring intensive care, the number of beds increased considerably in the span of 11 months to respond to the situation. There is still no drug treatment or specific prognostic factors for COVID-19 that allow its proper management.

Objective: To study the prognostic factors of severity due to COVID-19 in hospitalized patients at Hospital de la Santa Creu i Sant Pau, and their comparison with the prognostic factors identified in the literature review.

Methods: In a first phase, the published studies will be reviewed to identify the existing prognostic factors through various platforms (MEDLINE, EMBASE, Cochrane). A retrospective cohort study will subsequently be carried out to determine the patients' characteristics and to identify the prognostic factors of severity. Patients over 18 years of age, diagnosed with COVID-19 and hospitalized between March 01, 2020 and February 28, 2021 will be included. A descriptive analysis of the cohort will firstly be performed, followed by an analysis of the possible prognostic factors through bivariate tests and multivariate analyzes. The occurrence of admission to intensive care, mortality, and hospital stay \> 30 days will be calculated with logistic regression (p \<0.05, a = 0.05, 95% confidence interval). Finally, the prognostic factors identified in the literature review will be compared with those determined in the cohort.

Eligibility Criteria:
Inclusion Criteria:

* Equal or older than 18 years old
* Hospitalized between March 1st, 2020, and February 28th, 2021.
* Be diagnosed with COVID-19 disease

Exclusion Criteria:

* Underaged patients
* \> 16h stay in the Emergency Unit
The Effect of Cold Spray Applied Before Local Anaesthesia

Coronary angiography is a reliable and valid method used in the diagnosis of Coronary Artery Disease (CAD). Coronary angiography is defined as the process of obtaining cineangiographic images by administering radio-opaque material to the coronary vessels via arterial route. Coronary angiography is frequently performed from brachial, radial and femoral arteries. The aim of coronary angiography is to determine the presence, localisation and extent of cardiovascular lesions.

Invasive interventions cause anxiety and pain in the patient, increase the level of anxiety and cause a number of negative effects such as increased use of sedative drugs, development of post-procedure complications, prolongation of the recovery process and hospitalisation time. It is stated that there is a positive relationship between reducing the anxiety of the patients and meeting the needs of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and above.
* Not having used any anesthetic substance before the procedure.
* Not having undergone angiography before.
* Having no communication problems.

Exclusion Criteria:

* Having previously undergone angiography.
* Having taken analgesics before angiography.
Nasogastric Tube Securement Comparison Study

This study evaluates the use of tape to secure nasogastric tubes compared to securement with a nasal bridle device.

Patients who need to have a tube placed through their nose and into their stomach for medical treatments will sometimes have it accidentally removed. A nasal bridle is a device where a magnetic is used to attach a small piece of cloth tape that loops around the nasal septum bone and secures to the nasal gastric tube to prevent it from being pulled out accidentally.

Eligibility Criteria:
Inclusion Criteria:

1. Admitted to Children's Hospital Colorado to:

   * 6th floor surgical inpatient unit, or
   * 8th floor medical inpatient unit, or
   * Heart Institute (Cardiac Intensive Care Unit or Cardiac Progressive Care Unit), or
   * Interventional Radiology.
2. Require a nasogastric or transpyloric tube (Corpak tube or clear feeding tube) for feeding or bowel cleanout.
3. Predicted length of use is at least 48 hours.
4. Newborn up to 21 years of age
5. Have a completed consent for enrollment into the study.

Exclusion Criteria:

1. Burn patients because standard for placement is the nasal bridle;
2. Patients with contraindications for bridle placement , such as

   * mechanical obstruction of the nasal airway
   * facial or nasal fractures
   * fracture of the anterior part of the cranium, or basilar skull fractures
3. Any tubes placed for decompression (i.e. Salem Sump tubes)
4. Nasally intubated, or
5. With CPAP/BiPAP.
Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU

Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will be selected from microbiology laboratory data. Patient demographics and clinical data will be collected from the medical record. Microbiological results will be collected from the laboratory data.

INCLUSION CRITERIA - Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.

PRIMARY ENDPOINT

- The primary endpoint is 30-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.

Exclusion Criteria:

* Patient who is a minor, protected adult, or who refuses to participate.
The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

The purpose of this study is to determine if transcranially administered bright light has acute effect on anxiety symptoms.

Subjects (n=30) with anxiety symptoms will be recruited into the study. To be included into the study, subjects have to get at least seven points in BAI(Becks Anxiety Inventory). At the beginning of the study subject will be randomly assigned to 12 minutes of acute transcranial bright light or placebo exposure group. Anxiety symptoms will be measured using Spielberger State-Trait Anxiety Inventory (STAI, form Y1)self-rating questionnaire just before and 10 and 110 minutes after the experiment.

Eligibility Criteria:
Inclusion Criteria:

* Subject can read and understand the study protocol
* The written informed consent is obtained from subject
* Subject's BAI total score \>= 7

Exclusion Criteria:

* Subject has a lifetime psychotic disorder
* Subject abuses substance or has a dependence
* Subject has had suicidal idealization during the past month
* Subject use psychotropic medications
* Subject has unstable somatic disease
* Subject has used bright-light therapy for the current episode
* Subject is pregnant
* Subject is a relative of a member of research team
* Subject has used transcranial light treatment
Botulinum Toxin Injection for Treatment of Vaginismus

According to high rate of vaginismus (about 10 percent) which leads to unconsummated marriage (about 1 percent) and low efficacy for conventional treatments such as biofeedback therapy, analgesic drugs and pain killers and surgical treatment, there's necessity to find more effective method.

In our previous study, injecting botulinum toxin in 23 patients cured 75% of them.Now we are to make comparison between different doses of toxin injection and record the patient sexual satisfaction.

Vaginismus is the recurrent or persistent involuntary contraction of the perineal muscles surrounding the outer third of the vagina when penile, finger, tampon, or speculum penetration is attempted . Vaginismus can be primary, in which the women has never been able to have intercourse, or secondary, which is often due to acquired dyspareunia. It is relatively rare, affecting about 1% of women . Treatment of vaginismus is directed toward extinguishing the conditioned involuntary vaginal spasm. This can be accomplished by teaching Kegel exercises to acquaint the patient with voluntary control of her levator muscles. Medications such as lubricants, anesthetic creams, propranolol, or alprazolam to reduce anxiety have been used effectively, but approximately 10% of patients do not respond. Botulinum toxin type A has been successfully used to treat a wide range of muscular disorders such as strabismus, blepharospasm, and cervical dystonia. It is also been used to reduce facial lines and wrinkles.The extent of paralysis depends on the amount of toxin to which there is exposure relative to muscle bulk.In our previous study, one week after injecting botulinum toxin in 23 patients (95.8%) had a vaginal exam, which showed no or little resistance; 18 (75%) achieved satisfactory intercourse after the first injection. Now we are to make comparison between different doses of toxin injection and record the patient sexual satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Unconsummated marriage
* Difficult mating
* No response to biofeedback

Exclusion Criteria:

* Patient unlikely to have toxin injection
* Not having mutual life with partner
* Non treated pelvic and vaginal infection
Hepatic Small Vessel Neoplasm

Small-vessel hepatic tumor is a new tumor entity of vascular origin, described in 2016 by Gill et al, in a series of 17 patients. This rare lesion is difficult to diagnose on imaging because it shares a common radiological semiology with several other differential diagnoses ranging from benign hepatic angioma to more aggressive lesions such as angiosarcoma.

The aim of our study is to enable the imaging diagnosis of a new entity: small vessel hepatic tumor in order to improve diagnostic management.

Eligibility Criteria:
Inclusion Criteria:

* Histological evidence of a small vessel hepatic tumor either on biopsy or surgical specimen
* Cross-sectional imaging before the biopsy or pre-operatively (CT, MRI)

Exclusion Criteria:

* Patient under guardianship or curators