cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months.

Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria.

In this study, Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or Giomer based injectable resin composite. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept. Their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received.The first group (A) (Intervention): Giomer based injectable resin composite (Beautifil Flow plus X F03, SHOFU, USA): The material will be applied according to manufacturer instructions. The second group (B) (comparator): Resin modified glass ionomer (Fuji II LC, GC): The material will be applied according to manufacturer instructions.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria (USPHS) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . The restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable, and Charlie represents a clinically unacceptable situation.

Eligibility Criteria:
Participant Inclusion Criteria

* Age 18-60 years.
* Co-operative patients approving to participate in the study.
* Male or female patients.
* Patients with good general health
* Moderate or high caries risk patient

Teeth Inclusion Criteria

* Cervical Class V carious lesions.
* Pulp asymptomatic vital carious teeth.

Participant Exclusion Criteria

* Systemic disease or severe medical complications.
* Participants with a history of allergy to any component of restorations will be used in the study.
* Lack of compliance
* Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits

Teeth Exclusion Criteria

* Presence of apical or periapical pathosis.
* tooth mobility
* Non-vital teeth.
* Teeth with advanced periodontal diseases.
* Teeth which need indirect restoration.
Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy

The main objective of the trial is to explore the efficacy and safety of combining short-term androgen deprivation therapy (ADT) over 6 months to focal ultrahypofractionated salvage radiotherapy (SRT) delivered in 5 fractions to the site of local recurrence within the prostate bed after radical prostatectomy where multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen (PSMA) PET/CT are used to precisely identify the local recurrence and compare it to previously published literature.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent according to ICH/GCP (International Council for Harmonisation/Good Clinical Practice) regulations before registration and prior to any trial specific procedures
2. Age ≥ 18 years at time of registration
3. WHO performance status 0-1
4. Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy (RP) at least 6 months before trial.Tumor stage pT2a-3b, R0-1, pN0 or cN0. according to the Union for International Cancer Control (UICC) TNM 2009.
5. Evidence of measurable local recurrence at the prostate bed detected by PSMA PET/CT and mpMRI within the last 3 months. In case of unclear local recurrence, a biopsy confirmation is recommended.
6. Patient must have non-metastatic (N0, M0) disease, as defined by a lack of nodal or distant metastases seen on PSMA PET/CT scan
7. Patients must have non-castrate levels of serum testosterone (≥50 ng/dL).
8. Patients must not have previously received hormonal therapy (LHRH agonists, antiandrogen, or both, or bilateral orchiectomy).
9. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Exclusion Criteria:

1. Persistent PSA (\> 0.4 ng/mL) 4 to 20 weeks after RP
2. Previous hematologic or primary solid malignancy within 3 years prior registration with the exception of curatively treated localized non-melanoma skin cancer
3. Usage of products known to affect PSA levels within 4 weeks prior to start of trial treatment phase including any form of androgen suppression agents and androgen deprivation therapy
4. Bilateral hip prosthesis
5. Severe or active co-morbidity likely to impact on the advisability of SRT
6. Treatment with any experimental drug or participation within a clinical trial within 30 days prior to registration (exception: concurrent participation in the biobank studies is allowed)
Acupuncture in Neonatal Abstinence Syndrome (NAS) Babies

This pilot study is intended to assess feasibility of auricular acupuncture in NAS infants who require pharmacologic therapy. We intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. We plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.

Objectives:

Primary: To establish feasibility of a protocol for auricular acupuncture in infants suffering from NAS admitted to the NICU receiving pharmacologic therapy.

Secondary: In infants suffering from NAS admitted to the Neonatal Intensive Care Unit (NICU) receiving pharmacologic therapy:

1. Determine parent and staff acceptability of auricular acupuncture
2. Determine infant tolerance to auricular acupuncture
3. Evaluate the effect of auricular acupuncture on individual items of the Modified Finnegan Neonatal Abstinence Severity score associated with sympathetic nervous system responses
4. Evaluate the effect of auricular acupuncture on time to return to birth weight

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
2. Admitted to NICU with diagnosis of NAS requiring pharmacologic therapy
3. Parents give written consent within 72 hours of infant receiving first dose of methadone

Exclusion Criteria:

1. Helix or antihelix of ear is deformed and needle is unable to be placed
2. A suspected or confirmed genetic or metabolic syndrome
3. Custody retained by the Department of Children and Families
4. Any skin condition involving the ear(s)
5. Suspected or documented infection at the time of enrollment
Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 \& 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity \& safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female aged 60 years or older at the time of the first vaccination.
* Written informed consent obtained from the subject

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
* Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
* Previous vaccination against HZ.
* History of herpes zoster (Shingles).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.
* History of or current drug and/or alcohol abuse.
Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses.

Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.


Eligibility Criteria:
Inclusion Criteria:

* Women with cervical dysplasia been referred to conisation.
* Women invited to cervical screening program and with only normal smear and normal smears in their history.

Exclusion Criteria:

* Women not performing the tampon self-test before conisation.
* Women not performing the tampon self-test at least 3 month after having a normal PAP-smear taken.
Factors Associated With Recurrent Falls in Stroke Patients

The goal of this observational study is to learn about the recurrent falls in patients with acute stroke. The main question\[s\] it aims to answer are:

* what is the frequency of recurrent falls
* which factors are associated with recurrent falls in patients with acute stroke.

Participants will be evaluated in terms of

* frequency of recurrent falls within the six months after stroke
* fear of falling
* the stroke severity (Canadian Neurological Scale),
* ambulation level (Functional Ambulation Classification),
* functional disability (Functional Independence Scale)
* Postural control and balance
* functional status (Modified Rankin Scale)

Falling is common in stroke patients both in the hospital and at home after discharge. As a result, physical problems such as fractures and psychological problems such as fear of falling, limitation of physical activity and social isolation occur. Identifying the factors that cause falls after stroke will contribute to the recovery process by preventing complications by taking the necessary precautions and increasing the patient's participation in rehabilitation. This study was planned to determine the frequency of falls in patients with acute stroke and to determine the risk factors associated with recurrent falls within the first six months after stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Having an acute stroke over the age of 18
2. To have a cognitive situation to understand and answer questions

Exclusion Criteria:

1. Patients with bilateral hemiplegia
2. Patients without motor involvement
3. Those with a history of stroke
4. Patients with severe cognitive impairment
5. Patients in need of intensive care
The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification

Both Coronary Artery Calcification (CAC)and its annual progression are a strong predictors of cardiovascular events. The development of arterial calcification results from imbalance between calcification promoting and inhibiting factors. An important inhibitor of calcification is Matrix Gla Protein (MGP): a protein present in the vascular wall where it is synthesized by Vascular Smooth Muscle Cells (VSMC). MGP requires Vitamin K-mediated carboxylation to function properly. Deficiency of Vitamin K has been demonstrated to cause arterial calcification and a diet containing large amounts of Vitamin K2 was associated with lower CAC and cardiovascular risk. In animal studies, active supplementation of Vitamin K2 caused regression of existing arterial calcification. Therefore, the aim of this randomized, double-blind, placebo-controlled clinical trial is to investigate whether daily supplementation of Vitamin K2 (Menaquinone-7) to patients with established CAC will lead to a decreased progression-rate of CAC after 24 months of follow-up in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality
* Baseline Agatston calciumscore 100 - 400

Exclusion Criteria:

* Baseline-scan of insufficient quality
* Heart rate greater than 70 beats per minute during first scan.(despite adequate treatment with metoprolol)
* Chronic or paroxysmal Atrial Fibrillation
* Presence or scheduled coronary revascularization procedure
* History of myocardial infarction or stroke.
* Presence of Diabetes Mellitus.
* Known kidney disease or a Glomerular Filtration Rate (GFR)MDRD \< 60 ml/min/1.73m2
* Malignant disease (exception: treated basal-cell or squamous cell carcinoma).
* Use of Vitamin K antagonists.
* A life-expectancy \< 2 years
* Pregnancy or wish to become pregnant in the near future.
A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

This is an open-label, multi-center study in which adalimumab (D2E7) is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies. Patients must have active disease despite standard anti-rheumatic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years or older
* ACR criteria for diagnosis of RA for at least 3 months.
* Active RA as defined by DAS28 \>= 3.2 at study entry.
* Unsatisfactory response or intolerance to prior DMARDs.
* A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment.
* Use of reliable method of contraception e.g. IUDs, condoms, or hormone (oral, implantable, or injectable) contraceptives by all female patients of childbearing potential. Male patients with procreative capacity should also ensure that effective contraception is used during the study and for 70 days after study completion

Exclusion Criteria:

* Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil.
* Prior treatment with intravenous immunoglobulin or any investigational agent within 30 days, or 5 half lives of the product, whichever is longer.
* Prior treatment with investigational biologic therapy (e.g. anti CD4)
* Treatment within the last 2 months with approved biologic therapy (eg etanercept, infliximab, anakinra)
* Prior treatment with total lymphoid irradiation
* History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma.
* History of or current acute inflammatory joint disease of origin other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
* History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months) and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
* Positive serology for hepatitis B or C indicating active infection
* History of positive HIV status.
* Persistent infection, or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
* Female subjects who are pregnant or breast-feeding.
* History of clinically significant drug or alcohol abuse in the last year.
* Previous diagnosis or signs of demyelinating diseases
* History of active tuberculosis (TB), histoplasmosis or listeriosis.
* Signs of previous TB infection (chest X-ray signs or positive PPD skin test). The diagnosis of previous TB infection will be based on chest X-ray signs and on PPD skin test.
Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis

Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of life and increased economic burden. Current research has focused on expensive, invasive treatments, whereas inexpensive conservative treatments have received less attention. One such treatment is the use of orthotics to reduce pain and increase function in people with knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and contradictory, and could benefit from more research taking into account foot posture. This study aims to compare the use of two orthotics designs in people with knee OA.


Eligibility Criteria:
Inclusion Criteria:

i) age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)

ii) medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment

iii) pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.

Exclusion Criteria:

i) low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response

ii) knee surgery or intra-articular corticosteroid injection within the previous six months

iii) current or recent (within 4 weeks) oral corticosteroid use

iv) any muscular, joint or neurological condition affecting lower limb within the past 6 months

v) ankle/foot pathology or pain that precludes the use of orthotics

vi) current use of foot orthotics

vii) use of footwear unable to accommodate an orthotic

viii) unable to walk without a gait aid

ix) inability to speak English or have a family member present to translate (required for the validity of the questionnaires)
Stroke Risk in the NAS-NRC Twin Registry

To investigate stroke risk using the National Academy of Sciences Twin Registry.

BACKGROUND:

The epidemiology and common risk factors for cerebrovascular disease have been well documented by cross-sectional and longitudinal population surveys. These studies have generally involved unrelated individuals with little information on family history. Despite a significant role in cardiovascular risk, few studies have investigated familial contributions to stroke risk, and its importance was unknown. Recognition of the importance of hereditary influences on vascular disease of the heart has contributed, in large part, to the current emphasis on the molecular biology of vascular disease and a more balanced view that recognized both genetic and environmental influences on coronary artery disease. Twin studies represented a simple and uniquely powerful tool for analyzing genetic and environmental contributions to complex human phenotypes. Studies of cardiovascular risk have shown the importance of heritable factors, and it was hypothesized that similar genetic factors played a role in development of stroke.

With improved understanding of stroke risk factors (both genetic and environmental), early prevention measures can begin in high risk groups as early as childhood, an approach already applied to cardiovascular disease. Demonstration of a significant heritable risk for stroke should also prompt and help direct, further investigation into the molecular mechanisms of the genetic influences on stroke and may identify new approaches for stroke prevention and treatment, as it has for cardiovascular disease.

DESIGN NARRATIVE:

The twins have been surveyed periodically over the past two decades, most recently in 1985. Information obtained included questions on vascular risk factors, myocardial disease, and stroke. An analysis was made on an estimation of heritable risk. A comparison was made between monozygotic (MZ) and dizygotic (DZ) twins. If genes influenced the prevalence of stroke, there should have been more MZ twin pairs with stroke. Measures of concordance and heritability were used to estimate the size of the genetic contribution. Secondary analyses focussed on compound risk factors (e.g. hypertension and diabetes), less well documented risk factors (e.g. diet and personality), and the heritability of individual stroke risk factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria