cyrilzakka/clinical-trials huggingface dataset:
Silver Diamine Fluoride Gel: Case Series

A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Eligibility Criteria:
Inclusion Criteria:

* At least one active caries lesion Good general health by parent report

Exclusion Criteria:

* Unable to cooperate with exam or procedure
Evaluation of MRI for Prostate Cancer

The objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer.

The objective of this study is to evaluate of the potential of endorectal 3T MRI for the staging of prostate cancer before prostatectomy or recurrence of prostate cancer after prostatectomy

Eligibility Criteria:
Inclusion Criteria:

* Age of patients: up to 80 years.
* Men scheduled for radical prostatectomy due to prostate cancer or men post radical prostatectomy with suspicion of recurrence.
* Patients who are able and willing to give consent and able to have an MRI examination.

Exclusion Criteria:

* Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Dotarem)
* Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hr.)
* Any rectal pathology preventing probe insertion, (as active proctitis, active ulcerative colitis, fissure ani)
* Any spinal pathology that prohibits maintaining supine position for an hour
* Patients with documented myocardial infarction within one month of protocol entry, and patients with cardiac pacemakers
* Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
Assessment of the Effect of Age on Duration of Analgesia From Single-shot Femoral Nerve Blocks

Cohort study to examine the effect of age on duration of analgesia in patients receiving single-shot femoral nerve block prior to surgery, by postoperative phone follow-up questionnaire.

The purpose of this study is to find out how differences in age can affect the duration of pain relief from a femoral nerve block. Complete recovery after leg surgery involves healing of tissues at the surgical site, recovery of muscle strength and range-of-motion. Some pain is normally experienced after leg surgery. At the hospital, pain is usually treated with pain medicines, and/or a nerve block procedure. A nerve block involves injecting a local anesthetic beside the nerves to numb the nerves that supply feeling to the knee joint and surrounding tissues. The choice as to whether a participant has a nerve block or not is made by the participant and their surgeon and is not determined by this research study. The study aim is to find out how long a nerve block can relieve postsurgical pain, and whether that duration is affected by the age of the participant.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \>18 years)
* American Society of Anesthesiology physical status 1-3
* Having ambulatory surgery, who have received a single-shot femoral nerve block
* Able to read and understand English
* Have access to a phone after surgery

Exclusion Criteria:

* Pediatric patients (age \<18 years)
* American Society of Anesthesiology physical status \>3
* Unable to read and understand English
* Unable to have access to a phone after surgery
Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion

The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.


Eligibility Criteria:
Inclusion Criteria:

Clinical inclusion criteria:

* Age ≥18 years
* Angina pectoris, equivalent symptoms, and/or positive stress test
* Viable myocardium subtended by chronic total occlusion
* Negative pregnancy test in women with childbearing potential

Angiographic inclusion criteria:

* Chronic total occlusion defined as Thrombolysis in Myocardial Infarction flow 0 with an estimated duration ≥3 months
* Successful wire passage and assumption of successful stent/scaffold deployment
* Target reference vessel diameter 2.5 - 4.0 mm

Exclusion Criteria:

Clinical exclusion criteria:

* Limited long-term prognosis with a life-expectancy \<12 months
* Contraindications to antiplatelet therapy
* Known allergy against cobalt chrome, everolimus, or polylactic acid

Angiographic exclusion criteria:

* Target lesion located in the left main trunk
* Target lesion located in a coronary bypass graft
* Bifurcation lesion with planned two-stent strategy
* Indication for coronary artery bypass grafting
Smoking Cessation Study

The primary outcome of this study is to determine the true incidence of smokers among patients undergoing joint replacement and secondly, what percent are able to quit smoking before surgery under a structured cessation program with carbon monoxide breath testing. The investigators hypothesize that self-reported smoking status is underreported and that routine carbon monoxide breath testing will improve abstinence rates at the time of surgery.

This study looks at patients who have been referred to our clinic for a potential hip and knee joint replacement surgery. Once it has been determined that the patient requires surgical replacement of either their hip or knee and is placed on our surgical waitlist, the patient will be asked if he or she would like to participate in the study. The investigators would ask all patients, both self-declared smokers and non-smokers, to participate. This study would include completing a smoking history questionnaire and a noninvasive carbon monoxide breath test. While smoking status is already assessed in the McGill University Health Centre preoperative questionnaire, the investigators intend on expanding these questions in study participants to better quantify their nicotine exposure.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-85 who require a primary total hip or knee replacement
* Any gender
* Smokers and non-smokers
* Osteoarthritis, rheumatoid arthritis, avascular necrosis

Exclusion Criteria:

* Patients who require revision surgery
* Previous fracture to affected area
* Emergency surgery
* Patients who do not understand, read or communicate in either French or English
SIB-Time Web-application Tool for Typically Developing Siblings

In the United States, over 32.7 million people have special health, developmental, and mental health concerns. Most of these people have typically developing brothers and sisters. Across the lifespan, siblings share high levels of involvement in each other's lives, and also many of the concerns that parents of children with special needs experience, including isolation, a need for information, concerns about the future, and caregiving demands. Brothers and sisters also face issues that are uniquely theirs including emotions (resentment, worry, embarrassment, guilt), peer issues, and family communication challenges. The team of researchers, developers, and consultants built and tested an assistive media enhanced web-application tool for developing knowledge, skills, and routines for attending to TD siblings' (ages 3-5) social-emotional health and well-being.

The investigators conducted a 4-week intervention to assess the English/Spanish, media-enhanced SIBTime web-application tool in terms of its relevance, acceptability, cultural appropriateness, and potential for efficacy to deliver a family-based intervention. The test used a within subjects pre-post design to detect changes in parent self-efficacy, family cohesion, and knowledge, and parent rating of sibling-parent relationship. Additionally, the investigators collected a post-test evaluation of consumer satisfaction and recommendations for modifications to the program.

Eligibility Criteria:
Inclusion Criteria

* Be the primary parent/guardian of a child with a disability
* Also be the primary parent/guardian of a typically developing child, 3-5 years old
* Speak English or Spanish
* Have access to a computer, tablet, or smartphone

Exclusion Criteria

• N/A
Transcutaneous Bilirubinometry in Neonates

Objective: To assess the accuracy of transcutaneous bilirubin (TcB) measurements in neonates, in relation to gestational age (GA), time (postnatal hour) and site (forehead, sternum, knee) of measurements.

Hypothesis: Using (or combining) different sites for TcB determination might improve the accuracy of TcB in relation to the time of measurement and the GA of the neonate.

Methods: The study will include neonates \>32 weeks' gestation cared for in the well-baby nursery and NICU of the University Hospital of Patras, from September to December 2011. Data such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding, and extension of jaundice, will be collected.

TcB measurements will be performed using the BiliCheck bilirubinometer (according to the standard protocol) at 3 different sites: forehead, sternum and knee. Total serum bilirubin (TSB) values will be obtained using the heel stick technique, and measurements will be performed by a direct spectrophotometric device (Unistat bilirubinometer, Richert, Depew, NY). The accuracy of the device has been validated previously. TSB measurements will be performed within 5 minutes of the TcB measurements.

At each occasion TcB measurements (3), the corresponding TSB value, the time of measurement (postnatal hours), and the actual weight will be noted.

Statistics: The agreement between TcB and TSB values will be assessed using the Bland-Altman % method. The independent and joint effects of GA and time of measurement on bias will be evaluated by multivariate regression analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Born at the University Hospital of Patras
2. GA \>32 weeks
3. Parental consent to participate

Exclusion Criteria:

1. Under phototherapy
2. Congenital infections
3. Chromosomal abnormalities
4. Congenital abnormalities
5. Hepatic dysfunction
A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies

The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory B-cell malignancies. Co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffused Large B Cell lymphoma (DLBCL)


Eligibility Criteria:
Inclusion Criteria:

* Must have histologic or cytologic confirmation of chronic lymphocytic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, or Multiple Myeloma and have relapsed following prior treatment or been refractory to prior treatment
* Must have progressed or been refractory to, at least one prior standard therapy, including radiation, immunomodulatory agents (eg, lenalidomide), immunotherapy, cytotoxic chemotherapy, and select antibody (anti-CD20, alemtuzumab, or anti-CD30) therapy.
* Must be more than 100 days post autologous transplant

Exclusion Criteria:

* Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease (controlled CNS metastases are allowed)
* Known or suspected autoimmune disease
* History of allergy to anti-PD-1 or anti-PD-L1 antibody therapy or to other monoclonal antibodies or related compounds or to any of their components

Other protocol-defined inclusion/exclusion criteria apply
Auditory Deficits in Congenital Amusia (AMUSIE CONGENITALE)

The project studies auditory deficits in congenital amusia at the behavioral and neurophysiological levels.

The auditory processes investigated are pitch discrimination, short-term memory, sound-induced emotions. To characterize auditory deficits in the amusic population, neuropsychological assessments are combined with neurophysiological markers (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging: MRI).


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 70 years' old
* French
* Compatibility IRM / MEG (no metal in the body)
* Motivation to participate effectively in the project
* No neurological or psychiatric history
* No severe hearing loss
* Informed consent to participate in the study
* For Amusic participants: participant diagnosed amusic by the MBEA (Montreal Battery of Evaluation of Amusia)
* For Control participants: matched in age, sex, education, music education, laterality, non-amusic (controlled with the MBEA)

Exclusion Criteria:

* Age below 18 or above 70
* Non-Francophone volunteers.
* MRI scanning not possible: artificial cardiac pacemaker, insulin pump, metallic prosthesis, intra-cerebral clip, claustrophobia
* MEG acquisition not possible: large heads, neurostimulator, metal in the head or the body.
* Pregnant or breast-feeding women
Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer

Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies.

However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments.

This study is undertaken to build specific molecular signatures to predict the effects of neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Untreated cervical cancer with FIGO stage Ib-IIb
* Measurable lesions
* Possible to radical hysterectomy
* Age: 18 and older
* Karnofsky Performance Status≥ 70.
* WBC \> 3,000/mm³, Hb \> 9.0g/dl, Platelet \> 100,000 /mm³, SGOT/SGPT \< 60 IU/L, T-Bil \< 1.5 mg/dL, Cr \< 1.2 mg/dL, PaO2 \> 80 torr, normal ECG
* Written informed consent

Exclusion Criteria:

* Previous history of cancer
* Patients with previous treatment
* Patients without information of clinical risk factors
* Patients who have active infection
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of SLE by ACR criteria.
* Active SLE disease.
* Autoantibody-positive.
* On stable SLE treatment regimen.

Key Exclusion Criteria:

* Pregnant or nursing
* Have received treatment with any B cell targeted therapy.
* Have received treatment with a biological investigational agent in the past year.
* Have received IV cyclophosphamide within 180 days of Day 0.
* Have severe lupus kidney disease.
* Have active central nervous system (CNS) lupus.
* Have required management of acute or chronic infections within the past 60 days.
* Have current drug or alcohol abuse or dependence.
* Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Iron Overload in Patients Undergoing Donor Stem Cell Transplant

RATIONALE: Learning about the effect of excess iron in the liver of patients undergoing donor stem cell transplant may help doctors plan treatment.

PURPOSE: This study is investigating the effects of iron overload in patients undergoing donor stem cell transplant.

OBJECTIVES:

Primary

* Determine the impact of pre-transplant iron overload (defined as liver iron concentration \[LIC\] above normal \[\> 1.8 mg/g\] on an MRI of the liver measuring tissue proton transverse relaxation rates \[R2 MRI\]) on the probability of 1-year overall survival of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).

Secondary

* Determine the impact of pre-transplant iron overload on the composite endpoint of non-relapse mortality and complications (e.g., serious infections, hepatic veno-occlusive disease, or organ failure) within 1 year after allogeneic HSCT.
* Determine the impact of pre-transplant iron overload on the 1-year cumulative incidence of acute or chronic graft-vs-host disease in patients with acute leukemia or myelodysplastic syndromes undergoing allogeneic HSCT.
* Determine the impact of pre-transplant iron overload on the 1-year probability of overall survival and non-relapse mortality in patients undergoing allogeneic HSCT.
* Determine the prevalence of pre-transplant iron overload in adult patients undergoing allogeneic HSCT.
* Determine the correlation between pre-transplant ferritin levels and LIC on R2 MRI.
* Compare the longitudinal measures of serum ferritin levels after allogeneic HSCT in patients with iron overload vs those without iron overload.
* Estimate the cumulative incidence of iron overload at 1 year after allogeneic HSCT.

OUTLINE: Patients undergo blood sample collection to measure serum ferritin levels at baseline (pre-transplant) and then at 3, 6, 9, and 12 months after transplant. Patients with serum ferritin \> 500 ng/mL also undergo an R2 MRI at baseline (pre-transplant) and at 12 months after transplant to determine liver iron concentration. Patients with serum ferritin \> 500 ng/mL at 12 months after transplant also undergo an R2 MRI.

Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo allogeneic hematopoietic stem cell transplantation using either myeloablative or reduced-intensity conditioning

  * Any diagnosis allowed
* Not pregnant
* Weight ≤ 350 lbs
* Must be able to give written informed consent indicating the investigational nature of the study and its potential risks.

Exclusion Criteria:

* Claustrophobia
* Other contraindication for MRI (e.g., cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, or implanted drug infusion device)
Risk Factors of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin

Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been proved to be effective in reducing the incidence of PEP. It has been widely used to prevent PEP in patients, especially those with potentially high risks of PEP. However, rectal indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients receiving rectal indomethacin remains unclear. The aim of the study was to identify potential risk factors in high-risk patients whose received administration of prophylactic rectal indomethacin after ERCP.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing diagnostic or interventional ERCP
* Receiving administration of rectal indomethacin(100mg) after ERCP
* High risk patients determined at the discretions of endoscopists

Exclusion Criteria:

* Dose other than 100mg
* Acute pancreatitis within 3 days before ERCP
* Average risk patients at the discretions of endoscopists
* Using NSAIDs within 7 days before ERCP
* Without cannulation attempts
* Administration of rectal indomethacin before or during ERCP
Teres Major Muscle and Subacromial Impingement Syndrome

There is not a clear understanding of the origin of symptoms perceived by patients with impingement of the soft tissue structures of the subacromial space. Tendinopathy, tendon rupture or other pathologies, are present in asymptomatic subjects and subjects with symptoms and structural integrity can also be found.

Patients diagnosed with subacromial impingement syndrome frequently have myofascial trigger points in the teres major muscle. Travell and Simons reported that the symptoms caused by trigger points in this muscle are similar to those experienced by patients diagnosed with impingement syndrome, but a literature search provides few results regarding relationship between subacromial impingement syndrome and presence of myofascial trigger points in the teres major muscle.

This study aims to provide evidence of the results that can be obtained with a specific approach of teres mayor muscle by two manual techniques, Trigger Point Pressure Release and Diacutaneous Fibrolysis, in subjects with subacromial impingement syndrome, a condition that still representing both a diagnostic and therapeutic challenge. Secondary objective is to compare the outcomes between both techniques to select for each patient the most appropriate to their needs and characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and over
* Clinical diagnosis of Subacromial Impingement Syndrome.
* Detectable trigger points in teres major muscle.
* Sign informed consent form.

Exclusion Criteria:

* Diacutaneous Fibrolysis contraindications
* Previous shoulder surgery (\<1year)
* Language barriers or cognitive issues that limit their ability to provide informed consent and participate in research.
* Patients with a pending litigation or court claim.
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.


Eligibility Criteria:
Inclusion criteria:

* provided written informed consent.
* Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
* Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
* Sleep efficiency \<85% OR Latency to persistent sleep \>20 minutes.

Exclusion criteria:

* Secondary RLS
* Primary sleep disorder
* Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
* Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
* Use of any prohibited medication.