cyrilzakka/clinical-trials huggingface dataset:
36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite

Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design.

The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the split mouth design. Thirty-five adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 70 Class I restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient much sign a consent form before participating in the current study. The study was conducted from October 2017 to June 2020 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% retention rate at 3 years) of posterior class I restorations restored with nanofilled composite observed in a previous study.28 According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 30 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 35 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary caries involving occlusal surface only with ICDAS 2 and 3
* Patients with cavities no more than one-third of the intercuspal distance
* Patients must have a good oral hygiene;
* Patients with tooth gives positive response to testing with an electric pulp tester
* Patients with normal and full occlusion,
* Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

* High caries risk patients with extremely poor oral hygiene,
* Patients involved in orthodontic treatment or periodontal surgery,
* Patients with periodontally involved teeth (chronic periodontitis)
* Patients with abutments should be excluded.
* Patients with heavy bruxism habits and clenching
Microcautery for the Treatment of Spider Leg Veins

To Evaluate the role of micro-cauterization use in the treatment and disappearance of spider leg veins.

Spider veins on the lower limbs are very common and have been reported to be presented in 41% of women over 50 years old. Sclerotherapy as a traditional treatment for spider veins has a low cost, though it may have adverse sequelae. Lasers have shown fewer but still substantial complications as well.1 Spider veins are small superficial veins that widen and become visible, often on the legs and most cutaneous spider veins are abnormalities of the horizontal vascular skin plexus or capillary loops.2 Spider leg veins are composed of a feeder vessel and ectatic venous sprouts in the reticular dermis. Their depth is between 180 µm and 1 mm in the skin.3 Spider veins may have a diameter that reaches several millimetres and can be blue, purple or red and may appear in the form of thin lines, webs or branches.4 There is a scarce available data from literature about the role of micro-cauterization in the treatment of spider veins. The micro-cauterization is an alternative in management of spider veins that delivered via Mole Freckle Pen German Technology.4 Cautery is a safe and effective tool for the treatment of superficial and small skin lesions. It is simple, cheap, and requires minimal training and the results are usually satisfactory Technology Specifications with insulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5 The current study aims to evaluate the role for micro-cauterization in the treatment and disappearance of spider leg veins.

Eligibility Criteria:
Inclusion Criteria:

* were patients with spider veins of less than 2.0 mm in diameter.

Exclusion Criteria:

* were patients with diabetes, anticoagulation therapy and/or patients with a known history of keloids
Role of Preoperative Carbohydrates Drinks, Dichloroacetate and Exercise on Postoperative Muscle Insulin Resistance

The aim of the study is to investigate whether preoperative interventions such as carbohydrate drinks, Dichloroacetate and exercise would inhibit or reverse the changes in molecular mechanisms regulating muscle carbohydrate oxidation and postoperative muscle insulin resistance in patients undergoing major abdominal surgery.

Forty patients undergoing open elective gastrointestinal surgery, will be randomized to four groups of 10 each. The patients will be randomised to receive either preoperative (1) oral carbohydrate drinks (CHO) or (2) infusion of Dichloroacetate with oral carbohydrate drinks (3) exercise or (4) standard care.

Since the interventions are qualitatively different and only the physiological mechanisms are being studied rather than the clinical outcomes, the study is not blinded and no placebo is used.

Analysis for cytokines, insulin, glucagon levels will be performed at screening, during surgery and on the 2nd postoperative day. Muscle biopsies will be taken at the beginning and end of surgery, from rectus abdominus and vastus lateralis muscles for analysis of mRNA (IL-6, TNF-α, Akt1, IRS-1, FOXO1, MAFbx, MURF1 and PDK4) and protein (MafBx, FOXO1, PDK4) expression and muscle metabolites (glycogen, lactate, triglycerides and FFA). Oral Glucose Tolerance Test (GTT) to be performed at the screening visit and on the 2nd postoperative day using a standard protocol. The techniques to be employed to study the above will include RT-PCR, radioimmunoassay, spectophotometry, bioluminometry, Western blotting and ELISA.

Primary outcome: The changes in indices of muscle insulin resistance and muscle protein breakdown at the beginning and at the end of surgery, in response to surgical stress.

Secondary outcomes: (a) The expression of muscle metabolites, reflecting muscle protein turnover (b) Clinical Outcomes: Length of stay and incidence of postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years of age, who are undergoing major elective open abdominal surgery will be included in the study. Patients should be able to provide a written informed consent to participate in the study.

Exclusion Criteria:

* Patients who are

  1. Undergoing emergency surgery
  2. Suffering from chronic illness, (e.g. diabetes) or other debilitating diseases
  3. On long term anti-inflammatory drugs, (e.g. NSAIDS, Steroids, immunosuppressant)
  4. On long term antibiotics
  5. On Statins
  6. On full therapeutic dose of anticoagulants, or aspirin \>325 mg/day, Clopidrogel \>75mg/day
  7. Suffering from bleeding diathesis
  8. Unable to give consent
  9. Pregnant or breastfeeding.
A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth

A study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.

Duration of the study for each subject, not including screening, will be 3 days including follow-up.

Eligibility Criteria:
Inclusion Criteria:

Body weight between 50.0 and 100.0 kg, inclusive, for males, and between 40.0 and 90.0 kg, inclusive, for females, body mass index between 18.0 and 30.0 kg/m2, inclusive.

Having given written informed consent prior to undertaking any study-related procedure.

Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, and ecg).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.

Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Trusted Messengers: Intervention to Promote COVID-19 Vaccination

The study aims to assess the impact of a multicomponent intervention to support Primary Care Provider (PCP) outreach to promote COVID-19 vaccination among vulnerable patients in and near Worcester, MA via a pragmatic, cluster randomized trial.

The goal of this study is to increase uptake of the COVID-19 vaccine among vulnerable populations through systematic primary care (PCP or clinic) text message outreach to unvaccinated patients, information provision via a study website, and resources to support PCPs.

The clinical trial will randomize 14 primary care clinics from three health systems in the Worcester, Massachusetts area to intervention or control. Eligible patients seen at a study clinic randomized to the intervention will receive a series of text messages from their PCP or primary care clinic recommending a study website as a trusted source of information about the COVID-19 vaccines and information on how and where to schedule a vaccination.

Providers at a study clinic randomized to the intervention will be provided resources to support their conversations with unvaccinated patients during the intervention. Resources will include access to the study website, factsheets to share with vaccine hesitant patients, prescription pads to be used to "prescribe' the website, and an electronic "smartphrase" that can automatically add information about the study website and how to schedule a COVID-19 vaccination to patients' After Visit Summary and/or clinic note.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen by a PCP at a participating clinic site within 3-years prior to study start
* Age \> / = 18 years

Exclusion Criteria:

* Patients who have received at least one dose of a COVID-19 vaccine series prior to the start of the intervention
* Non-Massachusetts residents
Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population

Severe traumatic brain injury (TCI), defined by an initial GCS of ≤ 8 and/or admitted to a neurosurgical intensive care unit, are responsible for diffuse brain lesions that can lead to multiple deficits, including impairment of sphincter functions: bladder, rectal and sexual.

Bladder-sphincter disorders are very common after a TBI. Urinary incontinence predominates, with a prevalence varying from 50 to 100% in the acute period following a TBI.

The variability of the clinical data is explained by the heterogeneity of the populations studied (severity of TBI, duration of coma, time to care) and the tools used to objectify sphincter disorders. The interest of this study is to make an evaluation and a prospective follow-up of sphincter disorders in this population during one year.

A first visit, planned as part of the care, within 3 months of TBI with a clinical examination and 8 to 11 questionnaires, depending on your sex and your transit, to assess cognitive functions, the sphincter sphere, the autonomy and mood achieved as part of your usual care. These questionnaires will be taken with the doctor during consultation, As part of the research, patient will be asked to additionally answer the sexuality questionnaire consisting of 23 questions.

The same visit will be carried out at 6 months and at 1 year, also planned as part of the usual care.

If beyond 6 months vesico-sphincter complaints persist, a urodynamic examination will be realised in order to compare subjective complaints with a urodynamic examination (flowmeter, cystomanometry with +/- pressure / flow rate curve, sphincterometry).

This is a single-center research. The patients will be included in the neurosurgical intensive care unit of the Pitié Salpêtrière hospital and will be followed in the Physical Medicine and Rehabilitation unit of the same hospital.

Eligibility Criteria:
Inclusion Criteria:

* Have been the victim of a serious head trauma (initial glasgow ≤ 8 and / or admitted to neurosurgical resuscitation for less than 3 months
* Admitted to Neurosurgical Resuscitation at Pitié-Salpêtrière
* Aged 18 to 70
* Good written and oral comprehension of the French language
* Glasgow score = 15 at the time of inclusion and able to say no to opposition
* Patient information and not opposition

Exclusion Criteria:

* Severe comprehension disorders
* History of vesico-sphincteric disorders before TC
* Neurological and psychiatric history
* Patient not affiliated to a social security scheme or entitled
* Patient under guardianship / curators
Clinical Evaluation of the OtoSight

The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Children (17 years old or younger) scheduled for tympanostomy tube placement

Exclusion Criteria:

* Otoscopy contra-indicated or not possible per attending physician's decision
Assessment of Right Ventricular Volume in Tetralogy of Fallott (TOF) Patients

Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with Tetralogy of Fallot following repair; a comparison study to cMRI.

The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System to calculate right ventricular volumes in patients with Tetralogy of Fallot following surgical repair.

Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical sites.

The analyses will be the same for EDV and ESV. For either right ventricular volume, the primary effectiveness measure is the % difference between VMS and cMRI results, i.e. (VMS-cMRI)\*100%/average of VMS and cMRI results. There will be two null hypotheses for the primary analysis:

H0+: true mean % difference \> 10% and H0-: true mean % difference \< -10%

The observed mean % difference will be presented with 95% confidence intervals. The VMS right ventricular volume estimates will be regarded as equivalent to cMRI estimates if both H0+ and H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV. Since H0+ and H0- cannot both be true, the total type I error rate for each measure is 0.025 and the overall type I error rate for both EDV and ESV is 0.05.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Tetralogy of Fallot following surgical repair
* Patients who can be expected to lie motionless during imaging

Exclusion Criteria:

* Lack of informed consent
* Surgical repair for Tetralogy of Fallot with RV-PA conduit
* Known arrhythmia that interferes with image acquisition.
* Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials
* Pregnant woman
* Contraindications for MRI
Clinical Outcome Modelling of Rapid Dynamics in Acute Stroke

Stroke - still the second commonest cause of death and principal cause of adult neurological disability in the Western World - is characterised by rapid changes over time and marked variability in outcomes. A patient may improve or deteriorate over minutes, and the resultant disability may range from an obvious complete paralysis to subtle, task dependent incoordination of a single limb.

Unlike many other neurological disorders, stroke can be exquisitely sensitive to prompt and intelligently tailored treatment, rewarding innovation in the delivery of care with real-world, tangible impact on patient outcomes. Optimal treatment therefore requires both detailed characterisation of the patient's clinical picture and its pattern of change over time.

Arguably the most important aspect of the patient's clinical picture -- body movement -- remains remarkably poorly documented: quantified only subjectively and at infrequent intervals in the patient's clinical evolution. The combination of artificial intelligence with high-performance computing now enables automatic extraction of a patient's skeletal frame resolved down to major joints, like that of a stick-man, to be delivered simply, safely, and inexpensively, without the use of cumbersome body worn markers. Central to this technology is patient privacy, with the skeletal frame extracted in real time, ensuring no video data, from which patients can be identified, to be stored or transmitted by the device.

Our motion categorisation system -- MoCat -- will be used to study the rapid dynamics of acute stroke, seamlessly embedded in the clinical stream. By quantifying the change in motor deficit over time we shall examine the relationship between these trajectories with clinical outcomes and develop predictive models that can support clinical management and optimise service delivery.


Eligibility Criteria:
Inclusion Criteria:

* Putative diagnosis of an acute stroke
* Admission on the stroke unit

Exclusion Criteria:

* Under 18 years of age
A Randomized Clinical Trial for Women With Vulvodynia

This study will evaluate the relative effectiveness of cognitive-behavioral therapy and supportive psychotherapy for the treatment of women with vulvodynia.

Many treatments used for women with vulvodynia are based solely upon expert opinion. This randomized trial aimed to test the relative efficacy of cognitive-behavioral therapy (CBT) and supportive psychotherapy (SPT) in women with vulvodynia. Of the 50 participants, 42 (84%) completed 10-week treatments and 47 (94%) completed one-year follow-up. Mixed effects modeling was used to make use of all available data. Participants had statistically significant decreases in pain severity (p's\<.001) with 42% of the overall sample achieving clinical improvement. CBT, relative to SPT, resulted in significantly greater improvement in pain severity during physician examination (p=.014), and greater improvement in sexual function (p=.034), from pre- to post-treatment. Treatment effects were well maintained at one-year follow-up in both groups. Participants in the CBT condition reported significantly greater treatment improvement, satisfaction and credibility than participants in the SPT condition (p's\<.05). Findings from the present study suggest that psychosocial treatments for vulvodynia are effective. CBT, a directed treatment approach that involves learning and practice of specific pain-relevant coping and self-management skills, yielded better outcomes and greater patient satisfaction than a less directive approach.

Eligibility Criteria:
Inclusion Criteria:

* Independently diagnosed with vulvodynia by two study physicians

Exclusion Criteria:

* Any conditions known to better account for the vulvar pain
* Psychotic illness
* Actively suicidal
* Substance dependent
* Life-threatening illness
* Initiated psychotherapy, psychopharmacologic treatment or pain medication within one month prior to beginning the assessment phase of the study.
A Human Mass Balance Study to Determine the Total Recovery of Radioactivity in Urine and Faeces Following a Single Oral Dose of 14C Radiolabelled ONO-4053

This is a single dose mass balance study in healthy adult male volunteers to investigate the metabolism and excretion of \[14C\]-ONO-4053.

This is a single centre, open-label, non-randomised study in healthy adult male subjects. Six subjects will receive a single dose of 14C ONO-4053 administered orally as a suspension. Safety measurements (ECG, vital signs, biochemistry and haematology) and adverse events will be monitored throughout the study. After administration of 14C ONO-4053 subjects will remain in the clinical facility for collection of blood, urine and faecessamples. Samples will be analysed for recovery of radioactivity and characterisation of metabolites of ONO-4053.

Eligibility Criteria:
Inclusion Criteria:

1. The subject has provided written informed consent
2. Healthy male subjects aged 35 to 65 years inclusive
3. Subject is not trying to father a child and is willing to use one of the contraception methods listed in the protocol 4 The subject has a body mass index of 19.0 to 30.0 kg/m2 inclusive. 5 The subject is healthy as determined by the Investigator 6 Regular daily bowel movements

Exclusion Criteria:

1. The Investigator deems the subject unsuitable for the study
2. The subject has, or has a history of, any significant disease or disorder (including any clinically significant laboratory findings) that would increase the risk for the subject if they were enrolled in the study
3. The subject has a history of acute gastrointestinal illness
4. The subject has used prescription medicine, non-prescription medicine, vitamins, herbal treatments or dietary supplements within 14 days of dosing.
5. Current smokers and those who have smoked within the last 12 months
6. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,

The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant


Eligibility Criteria:
Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
* Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following:.

  i) Autologous stem cell transplant (ASCT) ineligible patients.

ii) Patients after failure of ASCT.

- Must have at least one lesion that is \> 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan.

Exclusion Criteria

* Known central nervous system lymphoma.
* Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL).
* Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML).
* Other protocol-defined Inclusion/Exclusion criteria apply.