cyrilzakka/clinical-trials huggingface dataset:
Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study)

This is a single cohort, prospective post approval study conducted on patients with COPD in Canada. The study will enroll patients that have not responded to their current treatment of tiotropium alone, or who are on the fixed dose combinations fluticasone propionate/salmeterol. Only patients for whom the physician has decided to change treatment due to lack of efficacy will be eligible to be enrolled in the study.

Also will evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed and treated for moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease according to physician's assessment
* Smoking history of \> 10 pack - years.
* On-going treatment with tiotropium or fixed dose combination of LABA/ICS, specifically combinations fluticasone propionate/salmeterol for a minimum of three months but demonstrating persistence of symptoms indicating change of treatment to combination therapy \*\*using a CAT score \> 10.
* Treatment with QVA149 is indicated as per the product monograph and appropriate for the patient as per the judgment of the treating physician.
* Patient has signed informed consent agreeing to participate in the study and undergo the study treatments and allowing the use of their data for the purposes of the study.
* Patient is expected to be available for 16 weeks after study enrolment

  * Assessed as per routine care or as documented in the patient's chart. \*\* As determined and decided by the treating physician prior to enrolment of the patient in the study.

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.

* Patients not willing to sign an informed consent.
* Patient on maintenance treatment including triple therapy (LABA +LAMA+ICS) for COPD
* Patients with a diagnosis of asthma or history of asthma.
* Patients who have had two or more moderate to severe exacerbations during the last 12 months prior to study enrolment. A moderate COPD exacerbation is defined by requirement for treatment with systemic corticosteroids or antibiotics or both. A severe COPD exacerbation is defined by hospitalization, including an emergency room visit of longer than 24 h.
* Patients who had an exacerbation within the previous 6 weeks to enrolment.
* Patients who as per physician clinical judgment will require ICS treatment co-administered with QVA149 during the study period.
* Patients with other chronic respiratory conditions that may affect the outcome of treatment including but not limited to lung cancer.
Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing

Erythritol is a natural sugar alcohol (a four-carbon polyol) produced by the reduction of erythrose. It is considered safe as food additive and has many of the functional properties that are important for subgingival debridement. Current evidence includes no prospective studies comparing the outcomes of a low abrasive erythritol air-polishing as an adjunctive therapy to conventional titanium and ultrasonic debridement of patients in a maintenance program with peri-implantitis. Thus, the main purpose of this randomized, single-masked controlled trial (RCT) is to assess whether low abrasive erythritol air-polishing has an adjunct effect to conventional non-surgical treatment of peri-implantitis.

This RCT will enroll subjects among patients in need for non-surgical treatment of peri-implantitis at a private dental clinic in Stavanger, Norway. Forty patients diagnosed with peri-implantitis on at least one implant will be randomly allocated by tossing a coin into test or control group. Patients with cement-retained and screw-retained supraconstructions will be included.

Treatment of peri-implantitis will be performed by one operator (AS) at baseline, 3-, 6-, 9- and 12-month follow-up visits. Local anesthesia will be used when needed. In the test group, implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit.

In the control group, implant with peri-implantitis will be debrided with titanium curette and ultrasonic device only. Test and control debridement will be performed without time limit. The treatment will continue until the operator is judging the implant surface to be free for supra- and subgingival deposits.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 20 - 85 years who have received one or more dental implant(s) being in successful function for more than 12 months and restored with an optimal supraconstruction
* Diagnosed with peri-implantitis based on the following criteria:

  * Bleeding and/or suppuration upon gentle probing
  * Increased probing depths (PD) compared with previous examinations or PD of ≥ 4 mm in at least one site around the implant
  * Crestal bone level (CBL) loss ≥2 mm compared with baseline registration

Exclusion Criteria:

* Surgical treatment of peri-implantitis the last 6 months
* Supportive periodontal therapy within 3 months
* Use of systemic antibiotic within 6 months
* A history of non-compliant behavior
* Inflammation around implant without evidence of bone loss
* Periapical peri-implantitis
* Subjects with implant fracture, ceramic implants, or detectable subgingival cement
* Any current medical condition affecting the use of the abrasive air-polishing device.
* Subjects with diabetes mellitus, cancer, HIV/aids, acute infections, liver or kidney dysfunction/failure,
* Current pregnancy or breastfeeding
Low-cost, Noninvasive Method to Assess Pulpal Vitality

The purpose of this research study is to find a new way of using light to measure the blood flow within the tooth.

The researcher develop dental Laser Speckle imaging system tool that can use for exam condition of the tooth. This device is reliable method to provide information to dentists and endodontists during oral examination.

In additional to routine oral exam the researcher can use the Laser Speckle imaging system probe with low-level light shine to the problematic tooth to collect blood flow information.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 30.
* Have one or more teeth requiring endodontic treatment.

Exclusion Criteria:

* Participation in other study within 3 months of enrollment in this study,
* Pregnant Women.
Deprescribing of Diabetes Regimens in Long Term Care Residents with Alzheimer's

Objectives To 1) examine the ability of the STRIDE (Simplification of Treatment Regimens and Individualized Diabetes Education) educational program to increase deprescribing of high hypoglycemia risk glucose-lowering medications (HRMs) among long term care facility (LTCF) residents with ADRD, 2) assess key implementation constructs (secondary outcomes) of the STRIDE program, including acceptability, appropriateness, and feasibility, and 3) validate the primary HRM use outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* Clinical staff at the LTCF (MDs, PAs, NPs, clinical pharmacists) - (Targeted providers for STRIDE program)
* Clinical staff that participated in the STRIDE program (Providers doing stakeholder exit interviews)

Exclusion Criteria:

* Consistent with the pragmatic nature of the trial, there are no exclusion criteria.
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.

* Healthy male and female subjects in the ≥12 and \<16 weeks of life at the time of the first vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parents/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion Criteria:

The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination).
* Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
* History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of seizures or of any neurological disease at study entry.
* Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
* Acute disease at the time of enrolment.
Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes

This study is conducted in Asia. The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.

Exclusion Criteria:

* Currently treated with NovoMix® 30
* Subjects who are unlikely to comply with protocol requirements
* Previously enrolled in this study
* Hypersensitivity to biphasic insulin aspart or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial

This trial will compare two strategies for patients with Heart Failure, Left Ventricular systolic dysfunction, and intermediate QRS durations. The control group is conventional CRT. The experimental group is LVendo CRT

Patients randomized to the Conventional CRT will receive a CRT device with or without ICD. Device implantation will be performed within 10 working days of randomization.

Patients randomized to LV endocardial CRT will receive a CRT device with or without ICD, placed in the same time frame and will have RA and RV leads implanted as the conventional CRT group. The device will be implanted in a facility that has the capacity to perform trans-atrial septal puncture with ultrasound guidance. The LV lead will be placed using a trans-atrial septal approach using a specially designed puncture tools and LVendo delivery tool kits specifically designed for this study

Eligibility Criteria:
Inclusion Criteria:

* Patients with NYHA Class II or III or ambulatory IV HF symptoms
* Optimal HF Medical Therapy of at least 3 months (2009 ACCF/AHA, ESC 2012)
* LVEF less than or equal to 35%
* Sinus rhythm (can have paroxysmal atrial fibrillation)
* QRS morphology is non-RBBB
* QRS durations more than or equal to 120 ms, but less than 150 ms
* Patients are able to receive chronic oral anticoagulation
* Patients with pacemaker or ICD that meet the above criteria may be upgraded to CRT-D or CRT-P

Exclusion Criteria:

* Planned Atrial Fibrillation Ablation within 12 months
* Patients with mitral or tricuspid prosthetic valve that precludes the placement of an LV lead transvenously or trans-septally
* Patients with RBBB
* Patients with LV thrombus
* Patients with permanent atrial fibrillation
* Patients with contraindications to oral anti-coagulation
* In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
* Acute coronary syndrome (including MI) \< 4 weeks
* Coronary revascularization (CABG or PCI) \< 3 months
* Uncorrected or uncorrectable primary valvular disease
* Restrictive, hypertrophic or reversible form of cardiomyopathy
* Severe primary pulmonary disease such as cor pulmonale
* Expected to undergo cardiac transplantation within one year (status I)
* Patients with a life expectancy of less than one year from non-cardiac cause.
* Patients included in other clinical trials that will affect the objectives of this study
* Those unable or unwilling to provide informed consent
* Those with a history of noncompliance to medical therapy
A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers

This study aims to establish a novel approach assisting the rational development of analgesic and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether proteins mediating inflammation and pain can be detected in an experimentally induced inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected from the inflamed skin site via small porous catheters. We wish to establish the expression pattern of different proteins and correlate it with various tests assessing pain.


Eligibility Criteria:
Inclusion Criteria:1. Age between 21-60. 2. Skin type II or III according to the classification of Fitzpatrick (II: fair skin, always burns, sometimes tans, III: medium skin, sometimes burns, always tans).\&#xA; Exclusion Criteria:1. History of a significant systemic disease, a dermatological disease, bleeding disorder, or chronic pain.

2. Consumption of analgesic drugs. 3. Hypersensitivity to sunlight.
The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed

Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).

The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH).

This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.

Eligibility Criteria:
Inclusion Criteria:

* All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age

Exclusion Criteria:

* Ulcerative esophagitis,
* Mallory Weiss tear,
* Bleeding gastric or duodenal ulcers,
* Bleeding from gastric varices or portal hypertensive gastropathy and
* Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.
A Study to Evaluate if AC-084 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects

The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults

The study is designed in three parts, A, B and C

Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose

Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose

Part C: single-center, open-label, single dose in CYP2C9 poor metabolizers

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in the local language prior to any study-mandated procedure
* Healthy male subjects for Part A, healthy male and female subjects for Part B and Part C aged between 18 and 55 years (inclusive) at screening
* No clinically significant findings on physical examination at screening
* Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at screening
* CYP2C9 poor metabolizers (Part C)

Exclusion Criteria:

* History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed)
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
* Treatment or substances known to induce CYP enzyme drug metabolism within 30 days prior to first study treatment administration
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
* Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of their excipients
* For Part A and Part B, CYP2C9 poor metabolizers enrolled in a cohort to be dosed with single or multiple dose of 500 mg or higher of ACT-774312 (confirmed by genotyping before enrollment)
Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

The purpose of this study is to evaluate the effect of a single dose of etomidate for patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB adrenocortical responsiveness, on requirements of hemodynamic support, and on use of intensive care resources.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients undergoing elective

  * coronary artery bypass graft (primary or re-operation)
  * mitral valve reconstruction/replacement for mitral valve regurgitation
* Age between 18 and 80 years (extremes included)
* Subject itself has signed the informed consent
* No clinically relevant deviation from the laboratory's reference range of biochemistry, hematology, or urinalysis testing

Exclusion Criteria:

* Participation in another ongoing interventional trial
* Known adrenocortical insufficiency
* Use of etomidate or propofol within 1 week preoperatively
* Use of glucocorticoids within 6 month preoperatively
* Known sensitivity to etomidate, propofol, or emulgator
* Severe hepatic dysfunction (bilirubin \> 3mg/dl)
* Severe renal dysfunction (plasma creatinine \> 180mikromol/l)
* Sepsis, endocarditis or other chronic inflammatory disease
* Manifest insulin-dependent diabetes mellitus
* Positive HIV serology
* Hemodynamically significant carotid stenosis requiring treatment
* Serious illnesses: endocrine, neurological, psychiatric, metabolic disturbances
* Pregnancy or breast-feeding female; females will be subject to pregnancy testing
* Requirement of rapid sequence induction
* Emergency surgery
* History of asthma
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.


Eligibility Criteria:
* Inclusion Criteria

  * Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
  * Female participants must agree to contraception requirements.
* Exclusion Criteria

  * Participants must not have developed a new condition, including cancer in the originator study.
  * Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
  * Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
  * Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

This is a prospective observational cohort study of haploidentical transplantation with post-transplant cyclophosphamide for acute leukemias using reduced intensity conditioning for acute myeloid leukemia (AML) and myeloablative conditioning for acute lymphoblastic leukemia (ALL).

Hematopoietic stem cell transplantation (HSCT) is the most effective treatment for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), with the lowest rates of relapse.

Fertility rate in Brazil is falling, and only 25% of people born today will have a matched sibling donor. On the other hand, currently donor non-related to about 50% of patients enrolled in Brazilian Receptor Registry (REREME). Consequently, at least 35% of patients won't have a matched donor.

The haploidentical transplantation is defined as a partially matched hematopoietic cell transplantation, using a partially matched family donor (parent, sibling or child). Haploidentical transplantation activity is growing worldwide, with results comparable matched unrelated donors.

The objective of this study is to test the feasibility of haploidentical transplantation with post transplant cyclophosphamide for acute leukemias in a Brazil.

Eligibility Criteria:
Inclusion Criteria:

* Acute lymphoblastic leukemia or acute myeloid leukemia

Exclusion Criteria:

* Severe comorbidities
* Second transplant
Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.

This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label phase. The following procedures are used: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, quality of life and compliance. 93 centres in 11 European countries (Finland, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine, UK) will be involved

Eligibility Criteria:
Inclusion Criteria:

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia

Exclusion Criteria:

* Medical conditions that would confound the efficacy evaluation
* Medical conditions in which it would be unsafe to use an alpha-blocker
* Use of concomitant drugs that would confound the efficacy evaluation
* Use of concomitant drugs that would be unsafe with this alpha-blocker