cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Preheated and Repeated Preheated Versus Conventional Bulk Fill Resin Composite

A Randomized clinical trial to evaluate the clinical Performance of Posterior Restorations of Bulk Fill Resin Composite without Preheating Versus Repeated Preheating for One, Five and Ten times .The null hypothesis of this study is that there is no significant difference in clinical performance of the restoration during restoring posterior teeth when using bulk-fill without preheating and after repeated preheating for one , five and ten times in restoration of posterior teeth.

Dental resin composites are widely used for adhesive restorative procedures nowadays due to the significant improvement in their physical and mechanical properties. However, volumetric shrinkage is still an inherent drawback of the polymerization of the resin matrix .

Preheating improves adaptation, polymerization shrinkage and degree of conversion without affect mechanical properties of resin composite restorations.

In clinical situation, composite resin syringe is repeatedly used for restoration of several cavities and if preheating is applied, this syringe will undergo several heating cycles so repeated preheating effect on composite resin should be tested.

Follow up Period will be 1 year , Evaluation will be done at 3,6,9 and 12 months .

Eligibility Criteria:
Inclusion Criteria:

* a)Inclusion Criteria of participants

  1. Patient age between (18-60) years old.
  2. Patient is capable of informed consent. 3-Patients with a high level of oral hygiene.

     b)Inclusion Criteria of teeth:

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  1. vital teeth
  2. Carious molar teeth.

Exclusion Criteria:

* a)Exclusion criteria of participants

  1. Participants with general systematic illness.
  2. Experience with allergic reactions against any component of used materials.
  3. Concomitant participation in another research study.
  4. Patients receiving Orthodontic treatment.
  5. Pregnant or lactating females.
  6. patient with heavy Bruxism habits.

     b)Exclusion criteria of the teeth

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  1. The tooth to be filled is an abutment tooth for a removable prosthesis.
  2. The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile).
  3. Endodontically treated tooth.
  4. tooth with previous restoration
  5. Exposed tooth.
Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo

A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo.

Subjects must have been enrolled in a prior IDN-6556 study to be eligible.

A multi-center, post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo.

This phase 2 observational study will enroll subjects from Study IDN-6556-07 (Post Orthotropic Liver Transplantation - NCT02138253), IDN-6556-12 (NASH Fibrosis - NCT02686762), IDN-6556-14 (NASH Cirrhosis and Severe Portal Hypertension - NCT02960204) or IDN-6556-17 (Decompensated NASH Cirrhosis - NCT03205345) who have received at least one dose of emricasan or placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects previously treated with at least 1 dose of emricasan or placebo from clinical studies IDN-6556-07 (post orthotopic liver transplant due to HCV), IDN-6556-12 (NASH fibrosis), IDN-6556-14 (NASH cirrhosis), or IDN-6556-17 (NASH cirrhosis).
2. Subjects able to provide written informed consent and able to understand and willing to comply with the requirements of the study.

Exclusion Criteria:

1. Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply, in the investigator's judgement, with study procedures.
2. Treatment with an investigational drug following treatment with emricasan or placebo.
3. Previous transplant unless subject was enrolled from IDN-6556-07 (post orthotopic liver transplant due to HCV).
Oklahoma Study of Native American Pain Risk III: Stress and Resilience

The goal of this observational study is to learn about the relationship between environmental structural racism and discrimination and chronic pain risk in Native American adults. The main questions it aims to answer are:

1. How does environmental structural racism and discrimination affect chronic pain-promoting mechanisms in Native Americans?
2. What psychosocial factors buffer the negative effects of environmental structural racism and discrimination on chronic pain-promoting mechanisms?

Native Americans experience higher rates of chronic pain than the general U.S. population, and previous research has shown that pain-free Native Americans transition to chronic pain at almost three times the rate of non-Hispanic Whites. Yet, little is known about the mechanisms that contribute to this pain disparity.

This study aims to better understand the role of environmental and society-wide stressors, like structural racism and discrimination, in contributing to this pain disparity. It is believed that these environmental and social stressors may contribute to chronic pain risk by increasing an individual's mental and physical stress levels. In turn, increased stress may alter how an individual responds to pain, both physically and emotionally, which may place them at greater risk for developing chronic pain in the future.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Native American/American Indian

Exclusion Criteria:

* \<18 years of age
* Self-reported history of cardiovascular, neuroendocrine, musculoskeletal, or neurological disorders
* Surrent chronic pain, defined as persistent, bothersome pain on more days than not for at least 3 months)
* Self-reported current substance dependence
* Sse of medication that could interfere with testing (e.g., recent use of analgesics, antidepressants, or anti-anxiety medications)
* Inability to speak English
* Current psychosis (assessed by Psychosis Screening Questionnaire)
* Serious cognitive impairment (assessed by \<20 score on the Montreal Cognitive Assessment \[MoCA\])
* Possible peripheral neuropathy (assessed by nerve conduction study)
Comparative Study of Two Multifocal Intraocular Lens With Different Add Power

This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction \[MR\]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18
* cataract patients with lens opacities classification higher than grade III
* patients who desire to be spectacle indepence for distance and near vision

Exclusion Criteria:

* previous ocular surgery or trauma
* presence of corneal opacities
* fundus abnormalities
* glaucoma
* uveitis
* amblyopia
* systemic disease
* posterior capsule rupture during cataract surgery
Study of Testosterone and rHGH in FSHD

The purpose of this study is to investigate the safety and tolerability of combination therapy with recombinant human growth hormone (rHGH) and testosterone in adult male patients with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.

This is a single-center, open-label study of daily human growth hormone (Genotropin®, 5.0 μg/kg via subcutaneous injection) and testosterone (testosterone enanthate, 140mg via intramuscular injection every two weeks) for 24 weeks in men with FSHD with a 12 week washout period. A total of 20 subjects will be enrolled at the University of Rochester Medical Center in Rochester, NY.

Eligibility Criteria:
Inclusion Criteria:

* A genetically confirmed diagnosis of FSHD (or clinical symptoms suggestive of FSHD with a first degree relative with genetically confirmed FSHD)
* Hematocrit of ≤ 50%
* Prostate-specific antigen ≤ 4.0 ng/ml (or ≤ 3.0 ng/ml if the participant has a first-degree relative with prostate cancer)
* Fasting blood glucose \<126 mg/dl
* Able to walk continuously for six minutes (cane, walker, orthoses allowed)
* Able to independently administer intramuscular and subcutaneous injections (or have a family member who is capable and willing to administer these injections)

Exclusion Criteria:

* Diabetes
* Obesity (BMI\>35 kg/m2)
* Cardiovascular disease (heart failure, coronary artery disease, uncontrolled hypertension, untreated hypercholesterolemia)
* Untreated thyroid disease
* Deep vein thrombosis
* Untreated severe sleep apnea
* Past pituitary disease
* Significant musculoskeletal injury and/or pain that affects walking
* A systolic blood pressure over 160 or a diastolic pressure over 100
* Plans to dramatically change exercise habits
* Liver disease
* Renal disease
* Cancer (other than basal cell skin cancer)
* Plans to conceive
* Heavy alcohol use (greater than 50g/day)
* Current testosterone or HGH use
* Current use of medications that interfere with the growth hormone or gonadal endocrine axis.
Patient Expectations After Implantable-cardioverter Defibrillator (ICD) Implantation

This study will be a qualitative survey to understand the expectations of defibrillator patients with regards to their device. It is unknown what ICD (implantable-cardioverter defibrillator) patients understand about their device and its purpose, thus we will be talking to them about their device. Also, we will be interested in studying their beliefs on how the ICD impacts their life expectancy and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* All patients are eligible for inclusion. We hope to acquire a wide range of ages but are not limited to a specific set.

Exclusion Criteria:

* Non-English speakers will be excluded.
Sleep Quality in Patients With Advanced Cancer

The primary focus of this clinical study is the objective and subjective measurements of sleep quality in patients with advanced cancer using opioids. It also examines sleep disturbances and associations between sleep quality and symptoms in order to improve symptom management in patients with advanced cancer.

The overall aim of this study is to improve the clinical understanding of sleep quality in patients with advanced cancer using opioids and to improve the understanding of how sleep quality may best be measured in order to improve symptom management.


Eligibility Criteria:
Inclusion Criteria:

* A verified diagnosis of a malignant disease
* Presence of metastatic/disseminated disease
* Regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment corresponding to step III at the WHO pain ladder with a duration of treatment not less than 3 days
* Able to comply with all study procedures
* Signed informed consent according to ICH Good Clinical Practice and national/local regulations

Exclusion Criteria:

* Not consenting to participation
* Not mastering the language used at the study centre
* Severe cognitive impairment as judged by the principal investigator
* Any reason why, in the opinion of the investigator, the patient should not participate
* Impaired use of the dominant arm
* Local anatomical illness or abnormalities precluding the use of polysomnography (e.g. facial tumour)
* having received chemotherapy for more than 4 weeks, having received the previous dose less than 5 days ago and receiving the next dose within the study period.
Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

Septic shock is one of the causes of death in ICU and hospital. Refractory shock is the problem which healthcare providers should recognize though it is difficult to handle with. The corticosteroid called hydrocortisone is one of the treatment in refractory septic shock which requires vasopressor to maintain blood pressure. In recovery phase of septic shock and weaning off vasopressor, there is no definite way to taper off hydrocortisone.

According to secondary outcomes of several studies analyzed in systemic review was shown adverse events from corticosteroid uses including hyperglycemia, hypernatremia, muscle weakness, and superimposed infection. This trials will compare composite adverse events in early versus conventional cessation of hydrocortisone in septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Patient \>= 18 years old
* Diagnosis Septic shock from the definition of SEPSIS III criteria in intensive care unit or medicine ward or surgical ward at Siriraj hospital
* Received at least 1 catecholamines and hydrocortisone at least 200 mg/d
* Maintain mean arterial pressure \>= 65 mmHg even if titrate down catecholamines until low dose (\<=0.1 mcg/kg/min)

Exclusion Criteria:

* Patient sign Do not resuscitation and terminally ill
* Pregnancy
* Need long term steroid use due to other medical condition
Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use

Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring.

This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.

Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor.

After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use.

The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.

This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (Flotrac).
* Patients older than 18, for elective general surgery.

Exclusion Criteria:

- Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures
Sensitivity of Forced Oscillation Technique in Children With Asthma and Normal Spirometry

Exhibiting variable airway obstruction is a key factor in the diagnosis of asthma but too often it is undetected by spirometry.

Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in asthmatic children with normal spirometry pointing out its advantage in measuring AW obstruction in this population.

We will conduct a prospective observational study in 6-18 years old children with the diagnosis of asthma and a normal spirometry results.

Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO) to assess the sensitivity of FOT in diagnosing airway obstruction in this circumstances.

Background: Asthma diagnosis and control are based on history of recurrent typical symptoms and variable airflow obstruction by by measuring maximal expiratory flows with spirometry. However, in many children with asthma spirometry can be normal. The forced oscillation technique (FOT) is a simple, noninvasive technique performed during tidal breathing that is relatively easy to apply.

The objective of this study is to assess the sensitivity of FOT in children with asthma and normal spirometry.

Study design: this will be a prospective observational study. Population: 6-18 years old children visiting the pediatric pulmonary clinic at the investigators institution with the diagnosis of asthma and normal spirometry results (FEV1 \& FEV1/FVC \>80% and FEF25-75\>65%) either on treatment or before treatment.

Study protocol:

After obtaining written informed consent, participants will fill asthma control questionnaires. Family history and risk factors for asthma will be reviewed. Data on blood eosinophils and skin prick test for allergy will be collected from the medical files. Medication (controller and reliever) will be also documented.

FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances at the reported frequency), X5 (reactance at 5hz), AX5 (reactance area at 5hz), Fres (resonance frequency) will be reported.

Fractional exhaled nitric oxide (FeNO) will be measured using the single breath exhalation technique.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Must be able to perform spirometry and FOT tests
* Normal spirometry results (FEV1 \& FEV1/FVC \>80% and FEF25-75\>65%)

Exclusion Criteria:

* Chronic lung disease other than asthma
* Severe chronic medical condition such as heart failure, neuromuscular disease etc.
Observational Trial With Enbrel

The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo rapid change. Randomized controlled trials such as the TEMPO study have demonstrated the efficacy and safety of the combination of etanercept and methotrexate. Importantly, the TEMPO study showed that patients treated with etanercept and methotrexate could reach the newer therapeutic goals of low disease activity and remission, and that the physicians, patients, and payers are no longer prepared to accept the goal of "Reduction of symptoms". RCT are important and powerful tools in assessing efficacy and safety but have their limitations in terms of generalisability. In order to assess health economics, clinical effectiveness and safety of etanercept, they need to be measured by performing observational studies of unselected patients. This study aims to provide a holistic assessment of patients receiving etanercept in a real world setting. This will include centers that would not normally take part in RCT. The study will assess treatment with etanercept with descriptive statistics of the following parameters: Health economic, Safety, Effectiveness. In addition, there was a previous study of similar design, but of only 3 months duration (101354), which will allow comparison with historical data. Since previous study, there have been a number of significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once weekly), Definition of early RA has been modified to short disease duration (from 3 months to 1 year).

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis

Exclusion Criteria:

* Sepsis or risk for sepsis,
* Acute infection,
* Hypersensitivity against Etanercept
Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases.

To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception.

Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.


Eligibility Criteria:
Inclusion Criteria:

* Patient requiring a colorectal surgery with a terminal colostomy
* Elective or emergency surgery

Exclusion Criteria:

* Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
* Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
* Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs
* Is pregnant, or lactating.
* Allergic to any porcine or collagen products.
* survival \< 6 months
Seasonal Affective Depression (SAD) Study

A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder

A 7-Month Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300mg/day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase

Eligibility Criteria:
Inclusion Criteria:

* History of Major Depressive Disorder (MDD) with a seasonal pattern.

Exclusion Criteria:

* Current or past history of seizure disorder or brain injury.
* History or current diagnosis of anorexia nervosa or bulimia.
* Recurrent summer depression more frequently than winter depression.
* Primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Post-traumatic Stress Disorder(PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
* Initiated psychotherapy within the last 3 months.
Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled

We hypothesize that the use of MOBIDERM® after total knee prosthesis allows a greater and faster resorption of periarticular edema:

* improvement of knee flexion;
* faster functional gain;
* faster decrease in postoperative pain by decreasing tissue tension.


Eligibility Criteria:
Inclusion Criteria:

* Patient requiring a first total knee prosthesis (scheduled between Tuesday and Friday).
* Patient that has given his/her free and informed consent and signed the consent form.
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old (≥) and under 90 years old (\<).

Exclusion Criteria:

* The subject is in a period of exclusion determined by a previous study (therapeutic study)
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
* The patient is allergic to latex bandages.
* The subject has contralateral amputation, pressure ulcers, severe Obstructive Arteriopathy of Lower Limbs, lymphoedema or thromboembolic event of the lower limb (ipsilateral and / or contralateral / superficial or deep or detected by postoperative Doppler).
* The subject has chronic or active wounds or any cause that hinders normal rehabilitation or the application of a bandage.
* patient with a stroke / Disabling Neurological Pathology, Chronic Immunological Pathology / Systemic Disease.
* patient with Hepatic insufficiency.
* patient with Venous insufficiency (stages 3 and 4).
* The patient is on dialysis.
* The subject has cognitive or behavioral disorders (Parkinson's disease, cerebellar syndrome, opposition, agitation, dementia).
* The subject has a history of knee surgery.