cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis

This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide written informed consent
* Body mass index 18.5 to 35.0 kg/m2
* Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
* Global Functional Class I, II, or III according to ACR 1991 revised criteria
* Stable use of \>/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for \>/= 4 weeks prior to Day 0, including:

  1. Methotrexate (MTX) 7.5 - 25 mg/week
  2. Hydroxychloroquine (HCQ) \</= 400 mg/day
  3. Sulfasalazine (SSZ) 1,000 - 3,000 mg/day
  4. Leflunomide 5 - 20 mg/day
  5. Azathioprine 150 mg/day or 2 mg/kg/day
  6. Combinations of MTX, HCQ, and/or SSZ allowed

Exclusion Criteria:

* Prior to Day 0, use of

  1. Abatacept
  2. Rituximab within 6 months
  3. Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months
  4. Etanercept or Anakinra within 28 days
  5. Immunoglobulin or blood products within 28 days
* Evidence of any active or recent infection including ongoing, chronic infectious disease such as chronic renal infection or chronic chest infection with bronchiectasis or sinusitis
* History of systemic autoimmune disease other than Rheumatoid Arthritis
* History of allergic reactions to other protein therapeutics such as monoclonal antibodies or fusion proteins
* History of anaphylaxis or allergic diathesis
* Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
* Evidence of active or latent tuberculosis
* Vaccination wtih live attenuated viruses within the 2 weeks prior to Day 0
* Evidence of infection with hepatitis B virus, hepatitis C virus, human immunodeficiency virus 1 or 2, or active infection with hepatitis A
* Pregnant or breastfeeding women
Intervention to Prevent Fall Injuries to Young Children in the Home

Currently, six Public Health Units (PHUs) in Southwestern Ontario are taking part in the developed and implementation of a social marketing intervention campaign aimed at lowering the incidence of falls to children in the home; City of Hamilton - Public Health Services (Control), Durham Public Health, Haldimand-Norfolk Health Unit, Niagara Region Public Health, Wellington-Dufferin-Guelph Public Health and Windsor Public Health (Control). This campaign is based on community-based intervention research and 'best practices' for improving parent attitudes and behaviours toward child safety. The campaign will focus on increasing parents' awareness and knowledge of fall injuries, positively impact parental attitudes to motivate them to want to implement strategies to reduce fall risks, and increase parental safety practices that would counteract the most common mechanisms that contribute to home falls for children at these young ages. The campaign will run from September 2013 through August 2014. The PHUs' social marketing campaign will strategically disseminate different materials to their respective communities: printed materials (posters, pamphlets), video modules about parenting safety, safety information through an e-Health website, and direction communication with parents through Family Health Team practitioners.

The proposed research project will request archival data from Canadian Institute of Health Information (CIHI), specifically from their National Ambulatory Care Reporting System (NACRS), on frequency of falls in the home to determine the extent to which the social marketing campaign is effective. Comparing pre-, during and post-intervention levels in the PHU communities will determine if and which social marketing strategies were effective. Additionally, random digit dialing will be used to assess pre vs post parental fall related attitudes, behaviors and intervention exposure. This evaluation will provide the first ever test of a community level intervention to reduce childhood falls in the home in Canada and will provide valuable information about what constitutes 'best practices' for preventing falls in the home among children 1 through 4 years of age.


Eligibility Criteria:
Inclusion Criteria:

* must be a parent or primary care giver of a child 1 through 4 years of age
* must live in one of the designated communities (by postal code)

Exclusion Criteria:

-
Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm

The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit.

Electrical storm (ES), defined as three or more sustained or treated ventricular arrhythmias in a 24-hour period, is a life-threatening condition that is associated with significant short- and long-term mortality. Autonomic dysfunction from increased sympathetic tone and the catecholamine surge from defibrillator shocks can precipitate recurrent ventricular arrhythmias and exacerbate ES. Although the mainstay of treatment are anti-arrhythmic drugs, sedative agents and procedures are commonly used to decrease sympathetic tone. These therapies have been studied in refractory ES but the benefit of early sedation remains unclear.

Alpha-2 agonism with dexmedetomidine can provide conscious sedation without the need for mechanical ventilation. Dexmedetomidine has been found to reduce ventricular arrhythmia events in non-ES patients in the intensive care unit and in the peri-operative period. Its antiarrhythmic properties are thought to be due to catecholamine suppression, prolonging electrical refractory periods, and increasing vagal tone. Its rapid onset and favorable safety profile render alpha-2 agonism with dexmedetomidine a potentially valuable therapy for patients with ES.

This study is a multi-centre, double-blinded, placebo-controlled, randomized trial that will evaluate the effectiveness of dexmedetomidine in the acute treatment of ES. Consecutive patients admitted to an intensive care unit will be randomized to receive dexmedetomidine or placebo at the time of presentation. The study drug will be titrated to a maintenance dose and continued for 48 hours before being weaned.

Eligibility Criteria:
Inclusion Criteria:

- All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment.

Exclusion Criteria:

* Refractory shock lasting for more than 30 minutes unrelated to ventricular arrhythmias (VAs), defined as requiring two or more vasopressors
* SCAI class D or E cardiogenic shock
* Cardiac arrest(s) with a no-flow and low-flow total time of greater than 10 minutes prior to recruitment.
* ST-segment elevation myocardial infarction (STEMI)-induced VA with signs of active ischemia.
* Bradycardia with heart rate less than 40 beats per minute, bradycardia-induced ventricular tachyarrhythmia, second degree Mobitz type 2 or greater atrioventricular block in the absence of a pacemaker.
* Pregnancy
* Known dexmedetomidine allergy or intolerance
* Inability to obtain consent from patient or substitute decision maker.
* Patients who have received dexmedetomidine or clonidine during the 24 hours prior to randomization
Radiotherapy Concurrent With Apatinib in Advanced Soft Tissue and Bone Sarcomas of Head and Neck--RASS Study

This is a non-randomized, phase II, open label study of radiotherapy concurrent with Apatinib Mesylate after surgery in patients with advanced head and neck soft tissue and bone sarcomas. The primary purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with head and neck soft tissue and bone sarcomas.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of head and neck soft tissue sarcoma (undifferentiated pleomorphic sarcoma, synovial sarcoma, alveolar soft part sarcoma, clear cell sarcoma, angiosarcoma, epithelioid hemangiosarcoma, solitary fibrous tumor and epithelioid sarcomas) or bone sarcoma (osteosarcoma/high grade bone sarcoma, Ewing sarcoma or dedifferentiated chondrosarcoma) confirmed by central pathology review.
2. Gross total resection, with Invasive cancer seen on microscopic evaluation of the resection margin, or with gross tumor residual, or surgically unresectable and/or refuse surgery.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
4. Adequate hepatic, renal, cardiac, and hematologic function.
5. Patients must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up.

Exclusion Criteria:

1. Evidence of distant metastasis
2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
6. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%
7. Patients who have had prior allergic reaction to Apatinib
Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy

This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.

This Study aims to provide insight into whether the application of Artificial Intelligence (Olympus Endoscopy Computer-Aided Detection (CADe) system) increases the detection rate of adenomatous polyps in screening and / or surveillance colonoscopy procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. 45-80 years
3. Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance

Exclusion Criteria:

1. Lack of informed written consent
2. History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
3. Prior failed colonoscopy

   * multiple historic prior failed colonoscopy due to poor bowel preparation OR
   * a single prior failed colonoscopy due to reasons other than poor bowel preparation
4. Biopsy/anesthesia/sedation contraindications
5. History of radio- and/or chemotherapy
6. Concurrent participation in another competing clinical study
Clinical Features of Smoker Patients With Chronic Obstructive Pulmonary Disease

Smoking is the most important factor in the etiology of COPD. Some of the patients with COPD continue to smoke despite knowing this situation or they cannot quit even if they want.

The aim of this study is; To examine patients with COPD who continue to smoke in terms of perception of dyspnea, exercise capacity, psychological symptoms and quality of life.

The study was designed prospectively. Patients with COPD who apply to the pulmonary rehabilitation outpatient clinic will be included.

The data of patients with COPD who are eligible for PR and have been pre-evaluated will be scanned. Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale will be used in the study. Patients with COPD who smoke will constitute the study group, and those who quit smoking will constitute the control group.

Eligibility Criteria:
Inclusion Criteria:

* Smoker COPD Patients who smoker

Exclusion Criteria:

* Not volunteer to participate the study
Early Loading of Dental Implants: A Prospective Study in the Mandibular First Molar Area

This study will compare tissue healing outcome between early dental implant loading at 4 weeks and conventional dental implant loading at 3 months.

Both loading times are standard of care procedures. The rationale behind early loading is to reduce waiting time so dental implants can be utilized sooner.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older.
2. Willingness to comply with all study requirements.
3. Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
4. Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
5. Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
6. Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
7. Adequate oral hygiene. Full-mouth plaque score (FMPS) (O'Leary et al. 1972) full-mouth bleeding score (FMBS) (Ainamo \& Bay 1975) record as the percentage of surfaces, four per each tooth, patients need to have controlled their periodontal conditions (FMPS 20%, FMBS 20%).

Exclusion Criteria:

1. Pregnant or lactating females.
2. Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
3. History of irradiation in the head and neck area.
4. Smoking.
5. Untreated periodontitis.
6. Alcohol or drug abuse.
7. History of Intravenous Bisphosphonate.
8. Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
9. The use of regenerative procedures in conjunction with implant placement.
10. Presence of residual roots at the implant recipient site.
11. Stomatological diseases.
12. Clinical signs of bruxism.
13. Initial stability at least 30Ncm
The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation

The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal AF (recurrent episodes for at least 2 years, with ≥ 6 episodes over the last 6 months)
* At least one failed antiarrhythmic drug
* Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery

Exclusion Criteria:

Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation or atrial fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation Unwillingness to participate
Energy Supplements to Improve Exercise Tolerance in Metabolic Myopathies

Patients suffering from the metabolic myopathy Glycogen Storage Disease type IIIa (GSDIIIa) have a problem releasing sugar stored in cells that is needed for energy production. This causes several systemic impairments, but only recently have the exercise-related symptoms in the muscles been examined. A previous study showed signs that intravenous infusion of glucose relieves some of these symptoms. The purpose of this study is to investigate in a randomized and placebo-controlled fashion whether oral ingestion of sugar can alleviate muscular symptoms in patients with GSDIIIa.

It has recently been documented how patients with GSDIIIa have a moderate to severely reduced exercise capacity, and that exercise induces muscle pain and cramps. These symptoms are caused by the inability to mobilize skeletal muscle glycogen and are most likely the consequence of a severe energy deficiency within muscles. The study changed the phenotype of GSDIIIa, to include exercise-induced symptoms, which is a typical presentation in other metabolic myopathies. It also documented that exercise capacity was significantly improved while exercise-induced muscular symptoms were relieved by an intravenous glucose infusion. Based on these findings, this study wishes to investigate if oral ingestion of sucrose has the same effects on work capacity on a larger number of patients, in a randomized, placebo-controlled, cross-over setup. Ingestion of sucrose has the potential to be an effective, cheap and easily accessible dietary treatment of muscular symptoms in GSDIIIa.

Eligibility Criteria:
Inclusion Criteria:

* Genetically and/or biochemically verified GSDIIIa.
* 18 years or older.

Exclusion Criteria:

* Clinically significant cardiac or pulmonary disease.
* Pregnancy or lactation.
* Severe mental disorders or participants that are in other ways unable to understand the purpose of the trials.
* Subjects where the investigator assess that it is not possible or very difficult to place an intravenous catheters.
* Other conditions of the joints or skeletal muscle such as arthritis or sprains. If the condition is expected to resolve before the study inclusion period is stopped, the subject may be included at a later time.
* Moderate to severe muscle weakness, where the participants are not expected to complete 10 minutes of cycle-ergometry exercise at 70 % of VO2peak.
* Verified diabetes.
* Participation in other clinical trials that may interfere with the results.
* Medications that may interfere with the results or increase the risk of bleeding.
* Blood-clotting or bleeding disorders.
* Blood donation one month or less prior to inclusion.
Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression

The occurrence of myelosuppression following chemotherapy, including severe neutropenia and hematological toxicity (Grade 3/4), as well as its association with dynamic changes in the gut microbiota, was investigated in conjunction with prophylactic administration of the CDK4/6 inhibitor Trilaciclib prior to the initiation of chemotherapy during radiotherapy for limited stage small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. The histopathology is limited-stage small cell lung cancer.
2. ECOG score 0-2.
3. Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination).
4. It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin.
5. Understand and can sign informed consent

Exclusion Criteria:

1. Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.
2. Active infections require systemic treatment.
3. Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.
4. Combined with other tumors.
5. The current or previous presence of a clinically significant and medically unstable condition, which in the investigator's professional judgment may compromise subject safety, interfere with study evaluation or endpoint assessment, or otherwise impact the reliability of study results.
Treating Pediatric NAFLD with Nutrition

This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children, estimated to be present in 5-10% of all children in the United States. NAFLD is a growing cause of cirrhosis and liver cancer. There is not yet an FDA approved treatment for NAFLD. Guidelines recommend improvement in diet at the first line of treatment; however, there is no consensus as to what that diet should be. General health guidelines recommend nonfat or low fat dairy over whole dairy after age 2. Limited studies have suggested that whole dairy may be better for people with NAFLD.

This study will test the effect of whole dairy on liver fat in children age 10-17 with NAFLD. As a baseline, the investigators will measure liver fat (using MRI) at 2 time points separated by 12 weeks to establish the current amount of liver fat. The children will be instructed to incorporate 2 ½ servings of whole dairy (as milk and/or yogurt provided by the study will provide) into their daily diet. After 12 weeks, the investigators will measure liver fat with MR and labs to assess safety and further evaluate the liver.

Eligibility Criteria:
Inclusion Criteria:

* Age 10 through 17 years
* NAFLD
* ALT of ≥ 40 U/L
* MRI-PDFF ≥ 8%
* Ability and willingness of legal guardian and participant to provide written, informed consent

Exclusion Criteria:

Competing Health Conditions

* Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigator
* Type 1 or Type 2 Diabetes
* LDL-cholesterol \> 160 mg/dL
* Evidence of other chronic liver disease (alcohol liver disease, alcohol related liver disease, hepatitis C, chronic hepatotoxic drug use, mitochondrial diseases, autoimmune liver disease, wilson's disease)
* History of bariatric surgery or planning to undergo bariatric surgery during the study duration
* Participant with a history of conditions affecting digestion and/or absorption

Intervention

* Inability or refusal to consume dairy
* Cow's milk protein allergy
* Lactose intolerance