cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma

Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.

Patients with ankle trauma frequently present in the emergency department. In many institutions radiographies of the ankle and foot are obtained in most of these patients, although significant fractures occur only in 15%. Therefore clinical decision rules were developed to clinically rule out significant ankle fractures, thereby reducing the number of radiographies resulting in significant time and cost savings.

Up until now the Ottawa Ankle and Foot Rules are the only clinical decision rules for ankle trauma that are widely accepted. They have a high sensitivity for the detection of fractures but a relatively low specificity. This led to the development of alternative clinical decision rules claiming equally high sensitivity but improved specificity. These alternatives have mostly not been replicated nor have they been directly compared.

This is what the researchers want to do in this study: compare different clinical decision rules regarding sensitivity and specificity. Radiographies of ankle and foot made for every patient are used as the gold standard for the detection of fractures.

Different clinical decision rules will be compared in a pediatric (5-15 years) and an adult population (from 16 years onwards). The researchers consider a clinical decision rule acceptable of it has a sensitivity of at least 95% and a specificity of at least 25%.

Eligibility Criteria:
Inclusion Criteria:

* Pain due to blunt trauma to the ankle
* Must be at least 5 years old

Exclusion Criteria:

* Skin defects in the injured area
* Time of trauma \> 72 hours before presentation
* Multiple significant injuries making clinical examination impossible
* Clinically obvious fracture
* Re-evaluation
* Referred with radiography
* Result of radiography already known to investigator
* Glasgow Coma Scale \< 15
Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer

This phase II trial examines letrozole in patients with newly diagnosed hormone receptor-positive HER2-negative invasive breast cancer that can be removed by surgery (operable). Letrozole is in a class of medications called nonsteroidal aromatase inhibitors. It works by decreasing the amount of estrogen produced by the body. This can slow or stop the growth of some types of breast cancer cells that need estrogen to grow.

PRIMARY OBJECTIVE:

I. To comprehensively evaluate differences in tumor microenvironment subpopulations in aromatase inhibitor (AI)-sensitive versus (vs.) AI-resistant hormone receptor (HR)+ breast cancer.

SECONDARY OBJECTIVES:

I. To assess the effects of estrogen deprivation on the systemic immune response.

II. To assess the effects of estrogen deprivation on tumor immune microenvironment.

OUTLINE:

Patients receive letrozole orally (PO) once daily (QD) for 2-8 weeks prior to surgery in the absence of disease progression or unacceptable toxicity. Patients then undergo collection of blood and tissue samples.

Eligibility Criteria:
Inclusion Criteria:

* SCREENING:
* Female \>= 18 years
* Postmenopausal and suitable to receive aromatase inhibitor as per physician's discretion
* Histologically confirmed un-resected operable invasive adenocarcinoma of the breast ≥ 0.5 cm with estrogen receptor (ER) and/or progesterone receptor (PR) positive ≥ 10%, and no human epidermal growth factor receptor 2 (HER2) amplification or overexpression
* Patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included
* Willing and able to provide research tissue samples
* Willing and able to provide research blood samples

Exclusion Criteria:

* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids

  * NOTE: Must be off systemic steroids at least 14 days prior to pre-registration. However, topical steroids, inhalants or steroid eye drops are permitted
* Known history of active autoimmune disease that has required systemic treatment within =\< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration

  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded
Nicotine Mouth Film for Craving Relief.

Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.


Eligibility Criteria:
Inclusion Criteria:

* BMI within the range of 19-35 kg/m2;
* Current cigarette smokers who have smoked regularly daily for at least a year,
* Participants who smoke their first cigarette more than 30 minutes after waking up

Exclusion Criteria:

* Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
* Any participant whose CO level rises during the sequestration period (i.e., the subject's two expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.
"The Effect of Reduced Fluid Load After Cardiac Surgery"

The purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with expected long-CPB-time.

Expected beneficial effects are improved organ function for heart and lungs.

Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.

Our group has experience with the use of hypertonic saline/colloids in several experimental studies (pigs). In these animal studies we have used hypertonic saline/colloids both as an infusion during CPB or as an additive to CPB-prime. Both administration methods resulted in significant reduction in fluid loading due to better intravascular volume preservation.

One clinical study from our group observed reduced fluid load and an improved cardiac index when an infusion of hypertonic saline/colloids was used during cardiac surgery. Patients included in this study had a normal left ventricular function and no co-morbidity.

The planned study includes patients with combination procedures, both aorta coronary bypass and valve implantation, and expected long CPB-time.Time spent on CPB is a individual risk factor negatively associated with increased mortality and morbidity. The investigators believe high-risk patients will have even more benefit of reduced fluid loading. Their tolerance for hypovolemia is lower and the incidence for hemodynamic instability first hours postoperatively is greater.

The patients will be randomized to receive either a continuous infusion of hypertonic saline/colloids or acetated Ringer's solution during CPB. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.

Preoperative and postoperative echo cor will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for combination surgery, both elective coronary bypass and valve surgery, with expected long CPB-time, and who after orally and written information agrees to participate in the study.

Exclusion Criteria:

* Age less than 18 years
* Serum-Sodium higher than 145 mmol/l
* Hematocrit less than 30 %
* Estimated GFR less than 60
* BMI more than 30 or BMI less than 18
CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas

Purpose: This study will evaluate the safety of CHOP plus Alemtuzumab in patients with T/NK cell lymphomas and CD-20 negative large B-cell lymphomas who have not had previous treatments. The biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.

Rationale: The drug combination called CHOP, or Cyclophosphamide (Cytoxan), Doxorubicin (Adriamycin), Vincristine (Oncovin), and Prednisone (Deltasone), has been used against different types of lymphoma for many years. Researchers are investigating what other therapies to combine with the CHOP regimen to improve outcomes for patients with lymphoma. The current study combines CHOP with alemtuzumab, a monoclonal antibody used against leukemia. Monoclonal antibodies are a type of immunotherapy used against some types of cancer. They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. Alemtuzumab is designed to target leukemia cells that express a specific protein. The specific protein recognized by alemtuzumab is the CD52 antigen. This antigen, or substance that causes the immune system to create a specific response, is expressed on normal B and T cells, as well as on abnormal T cells characteristic of certain cancers. Alemtuzumab causes the CD52 antigen to bind with B-cell lymphocytes. This study will also assess the theory that alemtuzumab may increase the effectiveness of the chemotherapy agents included in the CHOP regimen.

Treatment: Patients in this study will receive alemtuzumab and CHOP. Alemtuzumab will be given through injections into the skin and CHOP will be administered through intravenous infusions. Patients will receive alemtuzumab alone during the first week of the study. An increasing amount of alemtuzumab will be given during the first week. If patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week, they will be removed from the study. Once the highest dose of alemtuzumab has been achieved, patients will then receive both alemtuzumab and CHOP every three weeks. This schedule will be repeated up to eight times. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* CD-20 Negative
* Previous treatment permitted: radiation, electron beam radiotherapy, PUVA, corticosteroids, IFN, low dose methotrexate, retinoids, Ontak
* CNS disease permitted

Exclusion Criteria:

* Pregnant or Nursing
* prior Alemtuzumab
* history of active Hep C
Circumflex Nerve Blocks Versus Posterior Cord Nerve Blocks in Shoulder Arthroscopy

Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the interscalene approach to the brachial plexus has been employed to manage postoperative pain following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular nerve block (SSNB) was combined with block of the circumflex nerve which comes from the posterior cord of the brachial plexus that usually gives also upper subscapular, thoracodorsal, lower subscapular and radial nerves.

Aim of the work is to compare postoperative analgesic effect of ultrasound guided combined suprascapular and circumflex nerve blocks versus suprascapular nerve and posterior cord blocks at infraclavicular level .

Thirty four patients aged from 18-70 years old, with ASA physical status I-II-III and scheduled for shoulder surgeries will be included in the study. Patients will be randomly allocated using computer-generated table into one of two groups:

* Group circumflex → will undergo ultrasound guided SSN+circumflex.
* Group posterior cord → will undergo ultrasound guided SSN+posterior cord.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II.-III
* Undergoing shoulder arthroscopy.

Exclusion Criteria:

* Patient refusal
* Known allergy to local anesthetics
* Bleeding disorders
* Inability to provide informed consent
Reliability of Sacral Slope, Pelvic Femoral Motion and Cup Ante-inclination on AP Pelvic Radiographs in Healthy Pts

Currently, there are no validated anatomical landmarks that can be used to predict risk of and diagnose abnormal patterns of pelvic motion.This proposed study will measure sacral slope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions, using healthy individuals without a history of spinal and/or lower extremity pathology. All radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability. Determining the reproducibility of these angles between observers will give insight into the potential clinical utility of these measurements in evaluating and treating patients with hip-spine syndrome.

The purpose of this study is to evaluate the mechanics and influence of spinopelvic motion and balance from normal healthy subjects for the purpose of establishing radiographic measurements which are reliable and reproducible and which could give insight into the potential clinical utility of these measurements as future predictors of who may/may not have spinal pelvic issues and in evaluation and treatment of patients with hip-spine syndrome.

This specific objective of this study will be to measure sacral slope, pelvic femoral angle and cup ante-inclination via radiographs in both sitting and standing positions. The radiographs will be evaluated for the three measurements by four individuals with the intent of evaluating inter-observer reliability.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals without major co-morbidities and without spine/hip/pelvis issues including previous injuries or surgeries

Exclusion Criteria:

* no history of spine/hip/pelvis issues
* females who are trying to get pregnant
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.

The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.

Eligibility Criteria:
Inclusion Criteria:

* 14 to 30 years of age
* Willing to participate in follow-up for at least two years
* Acute, first-time, traumatic, isolated anterior dislocation of the shoulder

Exclusion Criteria:

* Previous instability of the affected shoulder
* A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder
* Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments
* Incompetent or unwilling to consent
* A medical condition making the patient unable to wear a sling
* Significant associated fracture (Exception Hill Sachs of \>20% or bony Bankart lesions\>10%)
* Neurovascular compromise of the affected limb
* Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
Characterizing MyMood Patterns of Use

MyMood is an electronic mood-charting tool available to the general population of Sunnybrook Health Sciences Centre (SHSC). This project aims to characterize duration and frequency of use of MyMood by users characteristics and determine if there is any significant variability in duration and frequency of use attributable to users' age, sex, self-reported diagnosis of a mood disorder, and/or prior treatment.

Mental Health Telemetry (MHT) is a software platform developed at Sunnybrook for collecting real-time self-report symptom-rating questionnaire data using patients' cell phones or other portable, Internet-enabled devices. MHT has previously been used in several funded clinical research studies. The mood-disorders-specific version of MHT, which we have named MyMood, collects information on a variety of items including symptom severity, medication adherence, ER visits / hospital admissions, sleep, relationships, and life events. In our previous project, we made MyMood available to the general population of SHSC by integrating it into Sunnybrook's MyChart personal health record system and collected feedback from users, using the feedback to refine MyMood. In the current project, we aim to characterize long-term patterns of MyMood usage, examining how duration and frequency of use are affected by demographic and clinical characteristics of users (age, sex, present / reported diagnosis of a mood disorder, and/or prior treatment).

Please note that the _only_ route for entry into this study is self-referral: interested individuals who have signed themselves up for MyChart can choose to begin using MyMood on their own. There is no reason to contact the study team regarding recruitment.

Eligibility Criteria:
Inclusion Criteria:

• Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal

Exclusion Criteria:

• n/a
Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks

The aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a computer-based telecommunication system that will monitor, educate and counsel African American adults with hypertension on adherence to medication, diet, and exercise. The primary hypotheses are:

1. TLC-HTN-AA use will improve medication regiment adherence
2. TLC-HTN-AA will improve adherence to 3 healthy diet recommendations
3. TLC-HTN-AA will improve levels of regular exercise
4. Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group


Eligibility Criteria:
Inclusion Criteria:

* a patient with a primary care provider at one of Boston Medical Center's Adult Primary Care Medical Practices or one of three HealthNet health centers participating in the study
* have a physician diagnosis of hypertension
* be African American by self-report
* be 35 years of age or older
* be prescribed at least one medication for hypertension
* have poorly controlled blood pressure
* be non-adherent to at least one hypertensive medication
* understand spoken English
* have a home telephone

Exclusion Criteria:

* patients for whom a medication, diet or exercise regiment adherence improvement or maintenance program would be inappropriate
* patients with a terminal illness
* patients with severe medical or psychiatric illness
* patients with cognitive difficulty
The Effect of Polymorphism of the GUCY1A3 rs7692387 Gene on Cardiovascular Events After Coronary Artery Bypass Grafting.

Polymorphism in the GUCY1A3 gene worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. Studies have shown the association of the GUCY1A3 gene with the risk of coronary heart disease and its complications, with ischemic stroke

Acetylsalicylic acid is indicated for the prevention of cardiovascular complications after CABG. Class I. The level of evidence A. ECS recommendations, Russian recommendations of cardiologists. However, the main problem of CABG remains thrombotic and thromboembolic complications in the immediate and long-term postoperative period, despite taking acetylsalicylic acid. According to various sources, the resistance to ASA among the population ranges from 5 to 45%. Resistance to ASA is primarily associated with genetic factors: the presence of polymorphisms of genes encoding platelet receptor proteins, and the functional activity of soluble guanylate cyclase (rCC), the synthesis of which is controlled by the GUCY1A3 gene. Studies have shown a link between the GUCY1A3 gene and the risk of coronary heart disease and its complications. The presence of polymorphism in the GUCY1A3 gene significantly worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. At the same time, acetylsalicylic acid cannot provide effective prevention of thrombotic and thromboembolic complications.

Eligibility Criteria:
Inclusion Criteria:

* Stable ischemic disease 2- 4
* CABG

Exclusion Criteria:

* the need to take any anticoagulants
* thrombocytopenia
* allergy to aspirin.
Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting

This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with alveolar ridge cleft
2. Males and females 7-14 years of age.
3. Patients with adequate oral hygiene.
4. Compliance with all requirements in the study and signing the informed consent.

Exclusion Criteria:

1. Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%).
2. Patients with systemic disease affecting bone healing.
3. Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications).
4. Patients with history of intravenous and/or oral bisphosphonate use.
5. Pathologic lesions or acute infection in the area of defect.
6. Patients with poor oral hygiene that are not amenable to motivation and improvement.

8. Vulnerable patients.