cyrilzakka/clinical-trials huggingface dataset:
Comparison of Desensitizing Materials

To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.

Dentine hypersensitivity (DH) is a condition that occurs in non-pathological, non-defective teeth and is defined as "a short, sharp pain in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which cannot be attributed to any other dental defect or pathology". The incidence of DH ranges from 4% to 74% in several studies. Mandibular first molars, canines and premolars of both jaws are most commonly affected by DH.

The pathogenesis of DH is linked to exposure of dentinal tubules that can occur in the oral cavity due to dental erosion from acidogenic diets, aggressive tooth-brushing, injudicious use of whitening products, gingival recession, periodontal debridement or surgery. The most commonly reported initiating factor is cold drinks. Management usually involves methods that can achieve one or both of the following objectives; i) alteration of fluid flow in the dentinal tubules and ii) modification or blocking of the pulpal nerve response.

A broad range of products that achieve these objectives have been developed after rigorous trials and can be used in-office or at home depending on the severity of the condition. These products are commonly referred to as desensitizing agents. Grossman suggested that an ideal desensitizing agent should be non-irritating to the pulp, relatively painless on application, easy to apply, rapid in action, effective for long periods of time and should not stain the teeth.

The use of dentine desensitizers has become one of the most common methods in managing DH. The most commonly used desensitizers contain components such as fluoride, triclosan, benzalkonium chloride, ethylene diaminetetraacetic acid and glutaraldehyde. Fluoraphat Pro (Neumunster, Germany) and VivaSens® (Ivoclar Vivadent, Schaan, Liechtenstein, Switzerland) are two agents that have been tested for use as dentine desensitizers and are currently available for commercial use. In the present study, two such varnishes VivaSens (Ivoclar Vivadent, Schaan, Liechtenstein, and Switzerland) and Fluoraphat (Promedical Neumunster, Germany) have been used. The present study aims to establish which of the two desensitizing agents has better efficacy in reducing hypersensitivity in patients who have been previously diagnosed with DH.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged between 18 and 50 years
* Patient should have at least 2 teeth with dentinal hypersensitivity
* Sound tooth structure
* Willingness to participate in the study

Exclusion Criteria:

* Gingival recession
* Caries
* Non-carious lesions (attrition, abrasion, erosion, abfraction)
* Teeth restored with dental filling
* Fractured or cracked tooth
* Microleakage
Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan

It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular remodeling. The investigators believe that this study will help document the nature of beneficial changes that occur in patients with Pulmonary Arterial Hypertension (PAH) in response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular structure and function accompany clinical improvement.

Subjects will have Optical coherence tomography (OCT) and Intravascular Ultrasound (IVUS) imaging during the right heart catheterization that diagnoses them as having PAH. Subjects will start their bosentan and will be followed by monthly clinic visits for 4 months. At 4 months they will have repeat OCT and IVUS imaging.

Eligibility Criteria:
Inclusion Criteria:

1. WHO GROUP 1
2. AGE 18-75
3. Baseline 6-min walk distance (6MWD) between 200 and 450 m
4. Diagnosed with pulmonary artery hypertension during right heart catheterization (Mean Pulmonary Artery Pressure \> 25mmHg)

General Exclusion Criteria

1. Pregnant or nursing
2. Acute or chronic illness other than those associated with PAH (collagen vascular disease, human immunodeficiency virus, or anorexigen use)
3. Previously received any investigational medications, prostanoids, or phosphodiesterase inhibitors
4. eGFR \< 60
5. Angina
6. Syncope
7. Failing right ventricle
8. Hemoptysis
Translational-Omics in Aortic Stenosis (TOmAS) Biobank

The objective of the TOmAS Biobank is the conservation of biological material (plasma, saliva, and tissue explanted during surgery), genetic material (DNA, RNA, etc.), and clinical data ("material/data") collected from patients with cardiovascular diseases (CVD) as well as from control participants, in order to allow future studies evaluating novel proteomic, transcriptomic and epigenomic markers (as well as other emerging -omic technologies) for CVD (i.e. aortic stenosis, cardiomyopathy, myorcardial infarction, etc). The study of physiological and genetic factors will allow for the discovery of new genomic and other -omic (including proteomic, transcriptomic and epigenomic) biomarkers associated with CVD which will lead to an improved understanding of the underlying biology of CVD and may provide future insights into the prevention and treatment of this type of disease.

Inherited from parents, DNA is organized into genes and is unique to each individual. Genes contain the information that dictates how cells function and hence, can also influence the risk of developing diseases. Due to the uniqueness and variability between each individual, genes can confer different risks of developing diseases when comparing one person to another person (or a group of people). When a biological product can be measured to predict whether someone is at a higher risk for a certain disease, it is called a "biomarker". Biomarkers include, but are not limited to genetic material (such as DNA) and certain proteins found in the heart and the blood. By studying genes and proteins isolated from biological samples (blood, saliva and heart tissue), investigators of this Biobank hope to characterize known biomarkers, identify novel biomarkers and ultimately, improve the diagnosis and treatment of heart diseases.

The purpose of this research is to: (1) perform a genetic study of cardiovascular diseases, such as aortic valve diseases and (2) create a biobank (that will include blood samples, genetic material, and tissue explanted at surgery) to be used for analysis in the future.

Eligibility Criteria:
Inclusion Criteria:

* CVD diagnosis including, but not limited to: Aortic Stenosis, Coronary Heart Disease, Heart Failure, Atrial Fibrilation, Dilated Cardiomyopathy, Myocardial Infarction, and Spontaneous Coronary Artery Dissection.
* Undergoing cardiac surgery for non-aortic valve pathology

Exclusion Criteria:

* Individuals with Congenital heart disease will be excluded
Association Between Non-alcoholic Fatty Liver Disease (NAFLD) and Coronary Artery Calcification

Coronary artery disease are 8 times more prevalent in patients with NAFLD then the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial

Coronary artery disease are 8 times more prevalent in patients with NAFLD that the general population and are being considered the most common cause of death. Cardiac CT is a reliable non invasive method in demonstrating Coronary Plaques. However the association between coronary artery calcium score (CAC) and NAFLD remains controversial. AIM: the aim is to evaluate the association between CAC score ( CT) and NAFLD (CT). the working hypothesis is that Beside the traditional risk factors including age, diabetes, NAFLD is also associated with moderate to high risk of CAD.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo cardiac CT for patients with low to intermediate risk for CAD

Exclusion Criteria:

* Patients with PCI or CABG will be excluded
Corticosteroids for Acute Migraine in the Emergency Department

This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.


Eligibility Criteria:
Inclusion Criteria:

* Migraine without aura criteria (International Classification of Headache Disorders 3B )
* Headache rated as moderate or severe in intensity

Exclusion Criteria:

* Concern for secondary cause of headache
* Contra-indications to investigational medications
Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area

BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on physical activity in older adults.

METHODS: This was a randomized, parallel-group, prospective study. All participants received education program including home-based exercise. The IC group consisted of different modalities of exercise while the LEE group performed machine-based exercise. Body composition, muscle strength, and physical performance were measured at their baseline and 3 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. older than 50 years of age
2. high risk as defined from one of the following criteria

   * score\>=1 on one minute osteoporosis risk questionnaire
   * 10 year predicted fracture risk \>=20% for major osteoporosis fracture or \>=3% for hip fracture from FRAX
   * fall\>=2 times in pass 1 year
3. having a bone mineral density test within one year period
4. having the capability to understand the study and complete the study interventions
5. willing to participate for the intervention and study follow ups

Exclusion Criteria:

1. If patients were unable to meet at least the above inclusion criteria.
Lung Heart Rate Variability

The purpose of this study is to examine the effects of heart-rate variability biofeedback training on lung cancer patients receiving definitive radiation therapy. The target population consists of non-small cell lung cancer (NSCLC) patients receiving 6 weeks of radiation therapy. The study will utilize the Physiolab GP8 heart rate variability and respiration system to collect data as well as several survey instruments to analyze quality of life measures. The goal is to show the HRV training can improve certain QOL measures like anxiety and sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be older than 18 years of age
* Both women and men of all ethnic background are eligible to participate in the study.
* Must be diagnosed with non-small cell lung cancer and receiving 6 weeks of radiation therapy.
* Must be available and willing to participate in 4, approximately 1 hour HRV biofeedback treatment sessions.
* Signed informed consent

Exclusion Criteria:

* Participant is younger than 18 or older than 70
* Diagnosed with early stage NSCLC
* Patients who are pregnant
* Patients with cardiac arrhythmias
* Patients with Pacemakers
* Patients taking beta-blockers
* Patients with any major mental illness, cognitive impairment
* Incapable of giving informed consent
Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash.

Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic cholecystectomy
* 18 years old or over

Exclusion Criteria:

* Emergency surgery
* Under 18 year olds
The ACCESSIT Study

The study is designed to characterize and monitor the structure, degree of activation and function of the different respiratory muscles during mechanical ventilation after spine trauma and spinal cord injury.

In patients with spinal cord injury, separation from mechanical ventilation is an essential aspect of the prognosis. Denervation of specific muscles, as a consequence of the injury, can generate a dysfunction of the involved muscles and/or a disruption of their coordination during breathing. Respiratory muscle dysfunction is strongly associated with failure of weaning from mechanical ventilation. However, the pattern of activation and coordination of the different respiratory muscles, as well as their evolution over time, have been poorly investigated in spinal cord injury, particularly during the acute phase in intensive care unit.

Assessing the structure, activity, and function of the respiratory muscles at different time points after the injury would help to better understand the natural course of respiration in these patients and the possible therapeutic approaches. In fact, depending on the activation/deactivation and residual function of the respiratory muscles, there might be potential for recovery and training, with the possibility of improving patients' clinical outcomes.

In this preliminary physiological study, the investigators aim to assess the feasibility of monitoring non-invasively the respiratory muscles in mechanically ventilated adult patients with traumatic spine lesion, with and without spinal cord injury. The investigators also aim to assess, monitor, and compare over time the structure, degree of activation, function, and coordination of the different respiratory muscles.

Because the diagnosis of spinal cord injury is not always made immediately in spine trauma patients, and because other factors related to chest or abdominal trauma could interfere with the respiratory pattern, the plan is to study and follow patients with spinal cord injury, using patients with traumatic spine lesion without spinal cord injury as controls.

Eligibility Criteria:
Inclusion Criteria:

* Presence of traumatic spine lesion (with and without spinal cord injury)
* Requiring invasive mechanical ventilation, via oro-tracheal or tracheostomy tube,
* 16 years of age or older
* Patient or substitute decision maker able to provide consent

Exclusion Criteria:

* Expected withdrawal of treatments within 24 hours of screening
* Chronic respiratory failure already treated with mechanical ventilation before the injury
* Documented pre-existing neuromuscular diseases
Clobetasol Propionate Spray Versus Vehicle Spray for the Management of Moderate to Severe Plaque Psoriasis of the Scalp

The primary objective of this study is to evaluate the safety and efficacy of clobetasol propionate spray versus vehicle spray for the management of moderate to severe plaque psoriasis of the scalp.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosis of moderate to severe plaque psoriasis of the scalp

Exclusion Criteria:

* Subjects who need systemic treatment for their body psoriasis
* Subjects who have surface area involvement too large (\>20% Body Surface Area \[BSA\]) that would require more than 50 grams per week of study product
Telerehabilitation Program Bases Aerobic and Baduanjin Exercises in Post Stroke Elderly Patients

It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and will divided into two groups. The study group participants will involve in Telerehabilitation sessions will be based on low-impact rhythmic movements, guided by video with the Baduanjin exercise program ,the control group will receive the same aerobic exercises only

It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and will divided into two groups. The study group participants will involve in Telerehabilitation sessions will be based on low-impact rhythmic movements, guided by video, according to the protocol of (Schachter et al., 2003). The telerehabilitation program will be moderately intense aerobic exercise 3 times per week and will be included 3 parts: warm-up, central part, and cool-down. Each session : 30 min, 3 sessions/ week for 3 months.

The repetition rate will determine the intensity of the exercises: 10, 15, 20, or 25 repetitions per minute. The exercise intensity of each telerehabilitation session will be individually adjusted by the participants' Modified Borg perceived exertion. With the Baduanjin exercise program is delivered individually, at each patient's home, through telerehabilitation, with direct remote supervision by a physiotherapist. Each session consists of a short preparatory phase (stretching exercises and abdominal breathing patterns) follows by a set of seven movements, adapts from the eight-section brocade Baduanjin exercise that originally comprises eight movements, repeated a certain number of times.The control group will receive the same aerobic exercises only

Eligibility Criteria:
Inclusion Criteria:

* • The subject selection will be according to the following criteria:

  * All Patients of this study will be diagnosed as stroke and the diagnosis will be confirmed by computed tomography or MRI (El-Tamawy et al., 2021).
  * Age of patients will be more than or equal 65years (males and females).
  * All patients will be hemodynamically stable.

Exclusion Criteria:

* • The potential participants will be excluded if they meet one of the following criteria:

  * Patients who cannot follow instructions as sensory aphasia, blindness, dementia, and deafness.
  * Patients with any orthopedic, neurological, or chest disorders that affect trunk muscles control or cause respiratory disorders as COPD.
  * Patients with psychiatric disorders.
  * Patients with unstable cardiovascular conditions.
  * uncontrolled hypertension, or other concomitant respiratory diseases
  * participate at any research or rehabilitation program during the period of this study
Donor Site Healing Response to Low Level Laser Therapy Following Skin Graft Surgery

PURPOSE:

The purpose of the study is to evaluate the effect of (LLLT) on donor site wound healing following skin graft surgery.

BACKGROUND:

The skin graft is a beneficial reconstructive technique for accelerating wound healing .Managing donor site after graft harvesting is very important, and often, patients have more discomfort at the donor site than the recipient burn site itself.Using techniques that accelerate wound healing may enhance patient satisfaction.

Low-level laser therapy (LLLT) has been used in several medical fields, including healing of diabetic, surgical, and pressure ulcers.

Accelerating the healing process and reducing pain during healing are beneficial for the following reasons: faster return to work, lower risk of wound infection, improved quality of life, and possibly reduced need for analgesia.

HYPOTHESES:

It is hypothesized that:

Low level laser therapy has a positive effect on donor site wound healing following skin graft surgery in burned patients.

RESEARCH QUESTION:

Is low level laser therapy has a positive effect on donor site healing following skin graft surgery in burned patients?


Eligibility Criteria:
Inclusion Criteria:

* Patients are both males and females.
* Their Age will be range between 20-40 years.
* All patients suffering from third degree burn with TBSA for burn will be ranged from 20% to 35%.
* All patients undergoing split thickness skin graft surgery.
* All patients will begin the treatment program from the 1st day post operative
* All patients enrolled to the study will have their informed consent.
* All patients have donor sites from the thigh.

Exclusion Criteria:

* • Patients with associated diseases (Diabetes mellitus, infectious diseases, autoimmune disease) that will interfere with the healing process.

  * Patients taking medication that alter the healing process (e.g., corticosteroids, chemotherapy or radiation.
  * Pregnancy or epilepsy.
  * Elderly patients.
  * Subjects who have photosensitive problems
  * History of trauma or accidental injuries.
  * Skin diseases.
  * History of surgery on particular donor site.
Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children

This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from at least one parent/ legal guardian to take part in the study.:
* Diagnosis of asthma
* pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
* Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total daily dose FP 200mcg or equivalent)

Exclusion Criteria:

* history of life-threatening asthma
* history of asthma exacerbation for asthma within 6 months prior to screening.
* Culture-documented or suspected bacterial or viral infection
* significant abnormality or medical condition
* Present use of any tobacco products
Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients

The aim of this study is to determine the Ceftolozane-Tazobactam Plasmatic Levels and and analyse the clinical impact that might have the dose regimens that have been used until now.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old.
* Hospitalised for a serious illness.
* Treated with Ceftolozane-Tazobactam
* Patients that signed the Informed Consent.

Exclusion Criteria:

* Allergic to any component of Ceftolozane-Tazobactam.
* Any surgical or medical evidence that according to the investigator could interfere with the pharmacodynamics of the medication: absorption, distribution, metabolism or excretion.
* Concomitant terminal illness.
* Unable to sign the Informed Consent.