cyrilzakka/clinical-trials huggingface dataset:
Pain Following One-visit Versus Two-visit Root Canal of Necrotic Teeth Using Protaper Next

To evaluate the incidence and severity of postoperative pain after root canal therapy of necrotic teeth in one appointment versus two appointments using Protaper next instrument.

The key to endodontic success was described as the debridement and neutralization of any tissue, bacteria, or inflammatory products within the root canal system.

Endodontic treatment used to take multiple visits to complete, with one of the main reasons for this being that it required a considerable amount of time to complete the treatment.

The single-visit treatment was bought back in the 1950s by Ferranti, who advocated the use of diathermy for pulpal disinfection and hydrogen peroxide for irrigation.

The use of contemporary endodontic techniques and equipment, such as use of rubber dam, magnifying devices, electronic apex locators, engine-driven rotary nickel titanium files, and so forth, not only increases the success rate of endodontic treatment but also, shortens the time needed for the treatment. Endodontic treatment may therefore be completed in a single visit.

It is generally agreed upon that the prepared canals can never be sterile before obturation, no matter how potent the antibacterial irrigants or intracanal medications are. There are currently two measures to reduce bacterial persistence and reinfection in the canals. We can either dress the canals with antibacterial agents in multiple visits or immediately obturate the canals, to reduce the space for bacterial colonization, in a single-visit approach. Calcium hydroxide is the most commonly used intracanal medicament, however its efficacy towards Enterococcus faecalis is questionable.

Eligibility Criteria:
Inclusion criteria:

* Medically free patients.
* Patient's age above 18 years old.
* Teeth diagnosed clinically with necrosis.
* Positive patient's acceptance for participation in the study.
* Sex includes both male and female.
* Patients who can understand visual analogue scale.
* Patients able to sign informed consent.

Exclusion criteria:

* Pregnancy or lactation.
* Medically compromised patients.
* Patient with multiple teeth that required treatment in the same quadrant to eliminate the possibility of pain referral.
An Internet-based Behavioral Weight Loss Program for HIV+ Patients

The goal of this project is to determine whether an Internet-based weight loss program will lead to weight loss and improvements in cardiovascular disease risk factors in people living with HIV.

The goal of this project is to provide an empirically validated weight loss program to HIV+ patients and evaluate its efficacy for weight loss and improvements in cardiovascular disease risk factors. Investigators will conduct a randomized pilot study with 50 overweight or obese patients who are HIV+, are recruited from the Miriam Hospital Immunology Center, and are interested in losing weight. These patients will be randomly assigned to a 12 week behavioral weight loss program delivered via the Internet or to a 12 week education only control group (also Internet based). Primary aims of this study are 1) to determine whether an Internet program is appropriate for this patient population, assessed by the success of recruiting 50 patients for the trial and their level of adherence over the 12 weeks, 2) to compare weight losses at the end of the 12 week program for program for patients randomized to the Internet behavioral weight reduction program (WT LOSS) relative to the Internet education program (CONTROL), 3) to compare the efficacy of the WT LOSS program relative to CONTROL for improving lipids (total cholesterol, HDL, LDL, triglycerides), metabolic measures (fasting blood sugar, insulin), and inflammatory markers (IL-6, C-reactive protein, adiponectin), and 4) to compare the changes in dietary intake and physical activity from baseline to 12 weeks in the WT LOSS and CONTROL conditions. Investigators will also store blood for later analysis of other adipokines (leptin) and biomarkers of microbial gut translocation (e.g., sCD14). These will provide important pilot data for future NIH funding related to both the implementation of weight loss programs and the effect of weight loss on the co-morbidities in this population.

Eligibility Criteria:
Inclusion Criteria:

* Recruited from the Miriam Hospital Immunology Center
* HIV+ with a CD4 count \>200 and an undetectable viral load
* BMI greater than 27 kg/m2
* No health problems that make weight loss or unsupervised exercise unsafe
* English speaking
* Have access to a computer and the Internet

Exclusion Criteria:

* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Active substance abuser
* Currently pregnant or intend to become pregnant in the next 6 months
* Planning to move outside of the state within the next 6 months
* Have participated in a study conducted by the Weight Control \& Diabetes Research Center in the past 2 years
Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone

All patients who were alive at the end of the dexamethasone treatment trial conducted by Oxford University CLinical Research Unit from 2001-2005 (n=340) will be eligible to participate in this long-term follow-up study.

All eligible and consenting patients will undergo an assesment consisting of a simple questionnaire, a clinical examination and a blood test. Data collected will focus on survival, neurological disability and tuberculosis relapse. Data will be collected in individual case record forms and entered into a computer database.


Eligibility Criteria:
Inclusion Criteria:Patients were alive at the end of the dexamethasone study (n=340) will be eligible to participate in this long-term follow-up study Informed consent

Exclusion Criteria:

Patients without informed consent
Effects of Physical Therapy in Pain and Posture of Fibromyalgia Patients

The aim of this study is to compare the effects of two physiotherapeutic treatments of fibromyalgia: global postural reeducation associated with cognitive behavioral therapy and segmental muscle stretching exercises associated with cognitive behavioral therapy.

Fibromyalgia is characterized mainly by chronic widespread pain. Segmental muscle stretching therapeutic exercises reduce the shortening of myofascial structures and recover the body flexibility. It is indicated for the treatment of chronic pain caused by osteo-myo-articular dysfunction. The pain behavior may be defined as the adoption of body postures and attitudes that a person communicates his/her pain. In this way, the global postural reeducation - a method of muscles chains stretching exercises - could be an important intervention. In addition, negative thoughts and dysfunctional beliefs are usual in situations of chronic pain, compromising the health recovery process. As part of a pain catastrophizing-related therapeutic approach, physiotherapist may help patients with chronic pain to develop positive, realistic and hope attitudes as based on the cognitive behavioral therapy model.

Eligibility Criteria:
Inclusion Criteria:

* Patients with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria and the presence of at least 11 of 18 tender points.

Exclusion Criteria:

* Presence of joint deformities
* Independent walking disability
* Making another physiotherapeutic treatment at the same time.
Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis

The purpose of this study is to determine whether teplizumab is safe when administered subcutaneously (by needle under the skin) in subjects with psoriasis. The study will also evaluate how long teplizumab stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it improves psoriasis.

This study will test the hypotheses that therapeutic modulation of T-cell function by teplizumab is well tolerated in subjects with moderate or more severe psoriasis, and that this treatment ameliorates the immunopathology of psoriasis. This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) administration for 6 days. Once the SC maximum tolerated dose is identified, this dose will be administered to a cohort of subject by intravenous for comparison of PK and PD.

Eligibility Criteria:
Inclusion Criteria:

* Chronic plaque psoriasis that has been present for more than 6 months and involves at least 10% Body Surface Area (BSA).
* Baseline LS-PGA score of moderate or greater severity.
* Weight \<= 125 kg (276 lb) and a BSA \<= 2.5 m\^2.

Exclusion Criteria:

* Clinically significant flare of psoriasis during the 12 weeks before enrollment.
* Guttate, erythrodermic, palmoplantar, or pustular (von Zumbusch) psoriasis
* Orally administered systemic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks before enrollment.
* Prior administration of a biologic agent/monoclonal antibody within 12 weeks before enrollment or 5 half-lives of the agent, whichever is greater.
* Prior otelixizumab, OKT®3, or teplizumab.
* Treatment within the last 30 days with a non-biologic drug or device that has not received regulatory approval for any indication at the time of study entry or are unwilling to forgo experimental treatment other than teplizumab during this study.
* Treatment with live vaccine within 8 weeks before enrollment or during study; vaccination with an antigen or killed organism during the study, within 8 weeks before enrollment, or 8 weeks after dosing.
* Evidence of active infection.
* Positive IgM test for hepatitis A.
* History of or positive test for hepatitis B, C, or D.
* History of or positive test for HIV.
* Are immunocompromised, have had recent or current serious systemic or local infection, clinical or radiological evidence of active tuberculosis, or evidence of latent TB infection.
* History of chronic liver disease, peripheral vascular disease, cerebrovascular disease, cardiovascular disease, or epilepsy.
* Current serious or unstable illnesses or allergies.
* Clinically significant laboratory abnormalities.
* Presence of serological reactivity to teplizumab (in subjects previously treated with therapeutic antibodies).
* Clinically significant ECG abnormalities.
Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology As Reference

This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.

This prospective pilot study evaluates the comparative and additive diagnostic performance of Magnetic Resonance Elastography (MRE) and corrected-T1 (cT1) for the detection and staging of fibrosis and inflammation in Nonalcoholic Steatohepatitis (NASH), using histology as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects of any gender and any ethnic group with known or suspected NASH
* Subject is willing and able to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, and research MRI exam), and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images and clinical or research biopsy results
* Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents
* Subject has had or is expected to have a clinical or research biopsy within 150 days of the MR exam

Exclusion Criteria:

* VA subject
* \< 18 years of age
* Subject does not have a physician and does not wish to be contacted about possible incidental findings
* MRI contraindication(s)
* Subject knows that she is pregnant or states she is trying to become pregnant
Mechanisms of Disease Severity in Multiple Sclerosis: an Integrative Multimodal Study

This study will identify a combination of disease severity markers (genetic, immunology, epigenetic, imaging) associated with disease severity and progression in a cohort of patients with multiple sclerosis.

The heterogeneity of multiple sclerosis evolution relies on several pathophysiological mechanisms including neuroinflammation, neurodegeneration and remyelination and repair mechanisms.

The study will identify markers of disease severity in a longitudinal cohort of patients with multiple sclerosis who are siblings (both siblings having multiple sclerosis) including: biological markers (genetic, immunological and epigenetic markers, advanced MRI markers). An integrative model to predict disease progression will be proposed based on multimodal markers.

Eligibility Criteria:
Inclusion Criteria:

* Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria)
* Sibling having Clinically isolated syndrome or Multiple sclerosis (2010 Mc Donald criteria) willing to participate to the study
* Affiliated to the French social security or equivalent

Exclusion Criteria:

* Cyclophosphamide, mitoxantrone or methylprednisolone infusion within one month before inclusion
* Multiple sclerosis relapse within one month before inclusion
* Concomitant severe or uncontrolled disease
ADT Exercise Trial and Economic Analysis

Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but has many side effects. Researchers have shown that exercise, specifically one-on-one supervised exercise improves many of the side effects of ADT. However, exercise programs for men on ADT are not widely available. More questions need to be answered in order for exercise programs to become part of PC treatment. First, can programs that require fewer resources, such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do exercise-related benefits continue beyond the structured exercise program? And what makes people continue exercising? Third, which exercise program is most cost-effective?

In this study, the investigators will compare: (a) group supervised in-centre and (b) home-based supported exercise programs to see which program is most effective for men with PC on ADT. The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective.

Participants (men with PC on ADT) will be recruited from one of the following cancer centres: Princess Margaret Cancer Centre in Toronto, the Tom Baker Cancer Centre in Calgary, the Southlake Regional Health Centre in Newmarket, and Scarborough and Rouge Hospital - Centenary Site in Scarborough. When a patient agrees to participate, patient will be randomly placed in 1 of 2 exercise programs. All programs will include the same type of exercises (aerobic, resistance and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as tolerated) for the length of the program (6 months). The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue and different physical measures before, during, and after the exercise program.

Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial and more financially responsible. This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment.


Eligibility Criteria:
Inclusion Criteria:

* men with histologically confirmed PC who are starting or continuing on ADT for at least 6 months or who are in an androgen-deprived (or castrate) state for the duration of the intervention
* fluent in English
* able to provide consent
* close to a study centre

Exclusion Criteria:

* already meeting guidelines for moderate to vigorous physical activity (MVPA) - conditions that would interfere with ability to participate
Perioperative Management of Factor Xa Inhibitors

This study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at risk of minor bleeding in actual clinical settings

* Study design This is a multicenter, non-randomized, investigator-initiated prospective cohort study. The study will analyze the bleeding risk and incidence of cardiovascular events according to the discontinuation/resumption of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are prescribed factor Xa inhibitors for stroke prevention and have minor bleeding risk.
* Study population Patients who are over 20 years old, have non-valvular atrial fibrillation, and are taking rivaroxaban, apixaban, or edoxaban (active ingredients), and are facing a procedure defined as having minor bleeding risk.
* Study protocol For patients with non-valvular atrial fibrillation who are prescribed rivaroxaban, apixaban, or edoxaban for stroke prevention and are at risk of minor bleeding, when they visit the prescribing physician (physician A) for consultation and to obtain a medical opinion regarding the discontinuation/resumption of the medication in relation to an invasive procedure, the physician will explain the protocol for discontinuing/resuming the medication and provide a written explanation to ensure that the patient fully understands it.

In addition, the physician in charge of the procedure (physician B) will be notified that the patient has enrolled in this study and will collect information on 1) the type of surgery or procedure performed, and 2) physician B's opinion on the severity of procedure-related bleeding. Thromboembolic and bleeding events will be assessed through patient follow-up 30 days after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Aged \>20 years
* With rivaroxaban, apixaban, or edoxaban
* History of non-valvular atrial fibrillation
* Scheduled minor bleeding risk procedure(s) (dental procedure, cataract/glaucoma surgery, diagnostic GI endoscopy)

Exclusion Criteria:

* Pregnancy
* With rivaroxaban or edoxaban at afternoon
* Mental disorder
* Contraindication to rivaroxaban, apixaban, edoxaban
* Moderate or severe valvular heart disease, or with prosthetic heart valves
* With antiplatelet drugs
* History of systemic embolism or ischemic stroke within the last 12 months
* scheduled therapeutic endoscopic procedure(s)
TRAP Study: Testosterone for Androgen Receptor Polymorphism

To determine whether pretreatment with transdermal testosterone increases the number of cumulus-oocyte complexes (COCs) obtained after ovarian stimulation by more than 1.5 in patients with low ovarian reserve and androgen receptor polymorphism undergoing intracytoplasmic sperm injection (ICSI).


Eligibility Criteria:
Inclusion Criteria:

* Patients with low ovarian reserve according to Bologna criteria: at least two of the following three:

  1. Age equal to or greater than 40 years.
  2. Previous cycle with less than 4 oocytes retrieved.
  3. Low ovarian reserve markers (antral follicle count \<5-7; AMH \<0.5-1.1 ng).
* Carriers of androgen receptor polymorphism: between 22 and 24 CAG repeats.
* Body Mass Index (BMI) less than 32.
* Indication for in vitro fertilization.
* Presence of both ovaries.
* Absence of ovarian cysts.
* Absence of endometriosis.
* Normal karyotype and fragile X study.
* Absence of severe male factor.
* Semen sample from ejaculate.
* Ability to comply with the study protocol.
* To have given written consent.

Exclusion Criteria:

* Non-compliance with instructions or non-formalization of informed consent.
* Concurrent participation in another study.
Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)

This is a Norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with neoadjuvant chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up.


Eligibility Criteria:
Inclusion Criteria:

* borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2015)
* Nx, M0 (UICC 8 th version, 2016)
* cytological or histological confirmation of adenocarcinoma
* age \> 18 year and considered fit for major surgery
* written informed consent
* considered able to receive the study-specific chemotherapy

Exclusion Criteria:

* co-morbidity precluding pancreatectomy
* chronic neuropathy ≥ grade 2
* WHO performance score \> 2
* granulocyte count \< 1500 per cubic millimetre
* platelet count \< 100 000 per cubic millimetre
* serum creatinine \> 1.5 UNL (upper limit normal range)
* albumin \< 2,5 g/dl
* female patients in child-bearing age not using adequate contraception, pregnant or lactating women
* mental or physical disorders that could interfere with treatment of with the provision of informed consent
* any reason why, in the opinion of the investigator, the patient should not participate