cyrilzakka/clinical-trials huggingface dataset:
Comparison of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer

Background: Sealers have been concerned with obturation. However, studies for assessing the effectiveness of endodontic treatment of sealer based on Calcium Silicate have been not much.

Objective: This study aimed to assess the effectiveness of endodontic treatment of sealer based on Calcium Silicate Methods: A prospective, single-blind, clinical trial was conducted from June 2020 to December 2020 with 42 irreversible pulpitis teeth by one clinician. The postoperative pain was assessed after root canal treatment using sealer based on Calcium Silicate and sealer based on Epoxy resin after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days and inconvenient symptoms were assessed after 7 days, 3 months and 6 months. t-test, Mann-Whitney and Wilcoxon analysis were applied.

Key words: obturation, sealer based on Calcium Silicate and sealer based on Epoxy resin


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* teeth diagnosed with irreversible pulpitis by electrical and thermal tests (+)
* had clinical symptoms like continuous or spontaneous pain, teeth exposed to sudden temperature changes, especially cold stimuli, causing sharp pain and persisting after stimulus removal
* these teeth must have healthy periodontal tissue and sufficient clinical teeth crown for isolation with a rubber dam

Exclusion criteria:

Patients with:

* Pregnant
* Have a systemic disease requiring antibiotics or have an allergic reaction
* Have maxillofacial pathology, cellulitis, occlusal trauma, and temporomandibular disorders, have endodontic periodontal lesions, periodontal abscesses
* Have taken a previous pain reliever within 24 hours

Tooth:

* Roots internally or externally resorbed, cracked or broken
* Have had failed endodontic treatment, or the root canal cannot be controlled for leakage
* No opposing teeth
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD

A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.

A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of \<0.70.
* FEV1 must be \<80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).

Exclusion Criteria:

* Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
* Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

The study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.

Eligibility Criteria:
Inclusion Criteria (abbreviated list):

* Relapsed follicular B-cell lymphoma
* One or more previous therapies for non-Hodgkin's
* At least one measurable tumor by CT scan or MRI
* Additional criteria to be determined at screening visit

Exclusion Criteria (abbreviated list):

* Rituximab refractory (less than 6 months from last treatment with rituximab to relapse)
* Currently receiving treatment for another cancer
* Infection currently being treated
* Active Hepatitis B
* History of HIV infection
* Pregnant
* Additional criteria to be determined at screening visit
Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)

Regorafenib in third-line treatment of metastatic colorectal cancer(mCRC) significantly prolongs the survival of patients, and its advancement has a sensitizing effect on postline chemotherapy and thus improves the prognosis of patients. Therefore, the present study was designed to include patients who achieved stable disease/partial response(SD/PR) after 3 months of second-line therapy and advance regorafenib to investigate the role of advance regorafenib in prolonging progression-free survival, prolonging the efficacy of overall survival, safety, and quality of life in patients with mCRC compared with standard second-line and third-line therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed metastatic colorectal cancer who have measurable metastatic disease according to the Resolute Efficacy Criteria for Solid Tumors (RECIST) version 1.1.
* Received standard second-line therapy, achieved stable disease(SD) and above by recist1.1 tumor assessment and maintained for 3 months.
* Eastern Oncology Collaborative Group(ECOG) physical status of 0 or 1 at trial entry and life expectancy ≥ 3 months.
* No bone marrow suppression and normal heart, lung, liver and kidney function.
* Voluntary participation in research.

Exclusion Criteria:

* Concurrent primary tumors of other types.
* MSI-H/dMMR type mCRC patients.
* Heart, liver, kidney, bone marrow insufficiency or mental abnormalities.
* Intolerant to treatment methods
* Concurrent participants in other clinical trials.
* Pregnant or lactating women.
* Patients deemed unsuitable for study participation by the remaining investigators.
A Study to Assess Mitomic Prostate Test for Prostate Cancer Screening

To evaluate the diagnostic accuracy of the Mitomic Prostate Test (MPT) comparing to prostate biopsy within the intended use population.

To determine the clinical performance of a blood-based test for clinically significant (CS) prostate cancer (PCa) (grade group ≥ 2) intended for use in men with prostate serum antigen levels in the 'grey zone' (PSA \< 10 ng/ml). The test quantifies a previously described 3.4 kb mitochondrial DNA (mtDNA) deletion.

Eligibility Criteria:
Inclusion Criteria:

* Men of screening age (≧45) who are scheduled for prostate needle biopsy due to suspicion of prostate cancer and have a total PSA \< 10ng/ml within the previous 3 months.
* Extended Sextant biopsy pattern that must include a minimum of 12 cores. MRI targeted biopsy preferred where available.
* Age, total PSA, biopsy pathology, prostate medication history, and ethnicity data must be available;
* The index biopsy must occur following and within 16 weeks of blood draw.

Exclusion Criteria:

* Subject does not undergo their prostate biopsy within 16 weeks of collection of pre-biopsy blood sample;
* Previous diagnosis of prostate cancer;
* Prostate biopsy within the previous 3 months;
* Men with a total PSA\>10ng/ml within the previous 3 months;
* Provides less than the required amount of blood;
* Considered incompetent to provide informed consent;
* Does not understand and read language of informed consent;
* Age, total PSA, biopsy pathology information, medication history or ethnicity data unavailable;
* Males who are not of screening age (\<45);
* Subjects whose classification as cancer positive or negative is undetermined following biopsy due to suspicious results such as Atypical Suspicious Acinar Proliferation (ASAP);
* Blood collected after index biopsy.
* Subject is taking antibiotics at the time of blood collection or has taken antibiotics within the 2 weeks prior to blood collection.
Phase Ia/Ib Study of RS-0139 in Patients with a Recurrent, Locally Advanced or Metastatic Solid Tumors

This study designed as a multicenter, open label, two-step study to determine the optimum dose, pharmacokinetics, and the safety of RS-0139 in patients with a recurrent, locally advanced or metastatic solid tumors. The research is planned as a two-step study (Phase Ia and phase Ib) and accelerated titration design (ATD) is used.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have consented to participation in the trial.
* Patients of both sexes aged between 18 and 75 years.
* Patients with relapsed or refractory solid tumors who have failed available standard therapy or are not candidates for standard therapy.
* Patients who are willing to provide fresh or archival biopsy material before their participation to identify the integrin expression levels (for Phase Ib only).
* Patients who completed the previous treatments 21 days before the first dose of the study drug.
* Patients who have at least three months of life expectancy.
* Patients with ECOG performance score 0 to 1.
* Patients with adequate organ function defined as:

  * Hemoglobin ≥10 mg/dl
  * Neutrophil ≥1,500/µL
  * Platelet ≥100,000/µL
  * Creatinine ≤1.5xULN or creatinine clearance ≥60mL/sec/1.73m2
  * Total bilirubin ≤ 1.5xULN
  * AST/ALT ≤2.5xULN; for patients who have confirmed liver metastasis: AST/ALT ≤5xULN.
  * Prothrombin time ≤1.5xULN (in case of no anticoagulant treatment).
  * Normal levels of serum magnesium and potassium concentrations

Exclusion Criteria:

* Patients with active and/or uncontrolled central nervous system (CNS) metastasis.
* Patients who have interstitial lung disease or interstitial pneumonia.
* Patients who have serious cardiac dysfunction.
* Patients who have insufficient target organ function.
* Patients with positive tests for HAV, HBV, HCV or HIV.
* Patients who experienced grade 3 or higher toxicity related to the previous docetaxel treatment.
* Female patients who are pregnant or breastfeeding.
* Male patients with pregnant female partners.
* Patients enrolled in another clinical trial at the same time or recently completed an investigational drug study and received the last dose of an investigational drug within 30 days or five half-lives (whichever is longer).
* Patients who have serious medical conditions such as uncontrolled infection or untreated wounds.
* Patients who have bone marrow transplantation history.
* Patients who have hypersensitivity to docetaxel, components of RS-0139 and/or other taxanes.
* Patients taking inhibitors or inducers of CYP3A4, including grapefruit juice and OTC medications such as St. John's Wort.
* Patients who, in the judgment of the PI, are likely to be non-compliant or unable to cooperate.
* Patients who cannot be contacted in case of emergency.
* Patients who are the PI or sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved in conducting the study.
Effects of Exercise on Young Adult Women With ACEs: an Integrative Pilot Study

The process by which the body responds to stressors to maintain homeostasis is called allostasis and is dependent on the integrated function of the nervous, endocrine, and immune systems. ACEs adversely affect these system, cause allostatic load, and can modify development of allostatic systems. However, the central hypothesis is that exercise can reduce allostatic load by positively augmenting function of each of these three systems. No previous studies have examined the effects of structured exercise interventions in individuals with ACEs. The investigators are studying the effects of 8-weeks of structured resistance and aerobic exercise on biomarkers related to nervous, endocrine, immune, and metabolic function and several clinical outcomes in young adult women with ACEs. The specific aims will test several hypotheses, and are as follows: SPECIFIC AIM 1: Conduct a feasibility study to explore whether progressive, structured exercise can help mitigate the adverse physiological effects of stress and trauma early in life. SPECIFIC AIM 2: Determine whether progressive, structured exercise can help improve health-related quality of life, anxiety, and traits like hope, self-efficacy, or self-control, resilience. SPECIFIC AIM 3: Determine whether the type and timing of exposure to ACEs has a significant influence on the severity of psychopathology and long-term physiological response to ACEs.


Eligibility Criteria:
Inclusion Criteria:

1. provide written and dated informed consent to participate in the study;
2. be willing and able to comply with the protocol;
3. be between the ages of 18 and 29, inclusive;
4. be free from chronic cardiovascular, pulmonary, or musculoskeletal disease as determined by a health history questionnaire;
5. not currently prescribed or taking anti-inflammatory or lipid-lowering medications;
6. have either an ACE score of 0 or 4 or higher;
7. have a BMI between 18.5 and 40.0, inclusive;
8. not enrolled in another clinical trial within thirty days prior to enrollment; and
9. answer no to all questions on the PAR-Q for people aged 15 to 69, which assesses a person's eligibility to engage in exercise without contraindications.
A Phase2 of A-101 Topical Solution in Subjects With Common Warts

The primary objective of this study is to evaluate the effectiveness of A-101 compared to vehicle when applied to 1 common target wart on the trunk or extremities.

The primary objective of this study is to evaluate the effectiveness of A-101 compared to vehicle when applied to 1 common target wart on the trunk or extremities.

The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated warts (Target Warts plus Non-Target Warts), duration of response in all treated warts (Target Warts plus Non-Target Warts), and Safety of A-101.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
* Male or female ≥ 8 years old.
* Subject has a clinical diagnosis of common warts.
* Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
* Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
* Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target and Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
* Subject is willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

* Subject has clinically atypical warts on the trunk or extremities.
* Subject is immunocompromised (e.g, due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
* Subject has a history of Human Immunodeficiency Virus (HIV) infection
* Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to Visit 1
* Subject has a history of sensitivity to any of the ingredients in the study medications.
* Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
* Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
Usage of Skeletal Muscle Relaxants Survey Among Egyptian Dental Practitioners

Pharmacists may also logistically serve as ideal health-care destinations to implement and deliver prevention, early intervention, and referral of oral health services to reduce the incidence of potentially preventable oral conditions including tooth decay, gum disease, and oral cancer. Interprofessional teamwork between pharmacist and dentistry may help to encourage pharmacists to take a more active role in promoting oral health. By providing information and assistance for self-care and the use of over the counter (OTC) products for minor problems on oral health, it can provide better patient care in the Malaysian health-care system

Skeletal muscle relaxants (SMR) are a diverse group of medications that are not chemically related like other drug classes and work through a variety of mechanisms. The term "muscle relaxant" is used to refer to two major therapeutic groups: neuromuscular blockers and spasmolytic. Some of them are working mainly through the central nervous system; they have many adverse effects such as sedation and dizziness that may limit their use.

Pharmacists may also logistically serve as ideal health-care destinations to implement and deliver prevention, early intervention, and referral of oral health services to reduce the incidence of potentially preventable oral conditions including tooth decay, gum disease, and oral cancer. Interprofessional teamwork between pharmacist and dentistry may help to encourage pharmacists to take a more active role in promoting oral health. By providing information and assistance for self-care and the use of over the counter (OTC) products for minor problems on oral health, it can provide better patient care in the Malaysian health-care system

Eligibility Criteria:
Inclusion Criteria:

* academic dental practitioners in Egypt
* nonacademic dental practitioners in Egypt

Exclusion Criteria:

* Age less than 20 or more than 60
* Non-dental
Prophylactic Versus Therapeutic Dose Anticoagulation In COVID-19 Infection at the Time of Admission To Critical Care Units

This is a multi-center, retrospective, study to determine if therapeutic dose anticoagulation (High dose group) improves inpatient mortality in severely ill patients with COVID-19 compared to prophylactic dose anticoagulation (Low dose group). The study involved 704 individuals who were admitted to Beaumont Health System (BHS) from March 10th to April 15th, 2020.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* positive reverse transcription-polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens.
* Intensive care unit (ICU) patient or Step-down unit (SDU) patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula.
* peak d-dimer levels exceeding 1,000 mcg/mL at any time during admission.

Exclusion Criteria:

* Hospital length of stay less than 5 days.
* Hemorrhage before ICU/SDU admission.
* Treatment with an anticoagulant other than low molecular weight heparin or unfractionated heparin.
* Constant treatment with the same dose of anticoagulant for less than 5 days.
Regular Use Tiotropium and Tolerance to Bronchoprotection in Mild Asthma

The study will assess if regular use of tiotropium (i.e. daily) results in loss of bronchoprotection against methacholine induced bronchoconstriction in those with mild asthma.

A single dose of an inhaled muscarinic antagonist will protect against methacholine induced bronchoconstriction and increase the dose of methacholine required to cause bronchoconstriction about 4 doubling doses. Beta agonist bronchodilators also shift the dose response curve to the right but the protection against methacholine induced bronchoconstriction is lost (i.e. tolerance develops) with regular use. This study will determine if bronchoprotection is lost following regular use of tiotropium.

This will be a randomized, double-blind placebo controlled study to assess the development of tolerance following regular use of tiotroium in a population of mild asthmatics.

Tiotropium will be administered at the clinically recommended dose (5mcg/day) for a total of 8 days. Methacholine challenges will be performed at baseline (pre-treatment), at one hour post first dose and on day 8, one hour after the final dose. The same will dosing schedule and assessments will occur with an identical placebo inhaler.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of asthma
* asthma is currently well controlled using only occasional bronchodilators
* baseline lung function (FEV1) is greater than 65% of the predicted value
* exhibit bronchoconstriction to inhaled methacholine at a dose of 200mcg or less

Exclusion Criteria:

* women who are pregnant or breastfeeding.
* diagnosis of another lung condition or medical condition that would pose a risk to the participant if enrolled in the study
* current smokers of nicotine products (e.g., cigarettes).
* users of cannabis or other inhaled recreational products (e.g., e-cigarettes or other vaping products) on a daily basis
* respiratory infection within 4 weeks of entering the study
* use of any anticholinergic agent within 30 days prior to the beginning of the study (e.g., ipratropium or the study treatment tiotropium).
* known hypersensitivity to tiotropium bromide or components of tiotropium formulation (e.g., benzalkonium chloride), to atropine or its derivatives.