cyrilzakka/clinical-trials huggingface dataset:
EXCEL: Change in Cardiometabolic Disease Risk Factors During an Interactive Fitness Program

Childhood obesity has increased in prevalence over the past several decades and is predictive of adult type 2 diabetes and cardiovascular disease (CVD). Recent studies of children and youth suggest that exercise reduces cardiometabolic risk factors. Minimal data are available, however, on the effects of "exergaming" , interactive technology- mediated approaches to increasing physical activity in children and youth. This project involves a partnership between UMass Boston/GoKids Boston and Children's Hospital Boston featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, nursing, prevention and behavioral sciences and exercise physiology and is designed to examine the effects of exergaming on moderate or vigorous physical activity (MVPA) indices of adiposity, risk factors for cardiometabolic disease and self-competence in Boston Public School children. It is hypothesized that participation in the EXCEL/exergaming intervention for 60 minutes, three times per week for 12 weeks will significantly increase MVPA (as measured by accelerometers), pre- to- post intervention and compared to an Advice only (Nutrition Education) group.Results of this pilot study will guide and inform a larger study of exergaming in children from the Boston Public Schools.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in grades 3-5
* able to attend GoKids and school-based weekly educational sessions for 12 weeks and complete baseline and follow-up testing
* informed consent from a parent or legal guardian and written assent from the child
* English speaking child
* free from medical conditions that would prohibit exercise as indicated by permission to participate in school physical education, and by review of screening questions with clearance from primary care provider as necessary.

Exclusion Criteria:

* abnormalities on screening/baseline evaluation that could pose a significant risk for exercise
* illness that would limit participation
* plans to move out of the area or change schools in the next 6 months
COVID-19 Tests With Saliva Specimens

Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.


Eligibility Criteria:
Inclusion Criteria:

* Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and

  * Is able to give informed consent
  * Is able to understand oral or written instructions, and
  * Is able to mentally and physically perform self-collection of saliva using the provided collection device.

Exclusion Criteria:

* - Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Employees of Paradigm lab and the assisted living facilities involved in the study
* Members of other vulnerable populations
Bioequivalency Study of Zolpidem Tartrate Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Zolpidem or any comparable or similar product.
Tamoxifen Following Combination Chemotherapy in Treating Women With Operable Invasive Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination chemotherapy with hormone therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without tamoxifen in treating women with stage I or stage II breast cancer that can be surgically removed.

OBJECTIVES: I. Assess the disease-free and overall survival produced by adjuvant tamoxifen given after postoperative chemotherapy with cyclophosphamide/methotrexate/fluorouracil (CMF) vs. adjuvant CMF alone in women with primary breast cancer.

OUTLINE: This is a randomized study. Patients are stratified by age and by participating institution. All patients undergo surgical resection with local radiation therapy, as appropriate. Within 4 weeks of surgery, patients receive cyclophosphamide, methotrexate, and fluorouracil (CMF) every 3 weeks for 6 courses. Radiotherapy is given within 4 weeks of completion of CMF. Before beginning the last course of CMF, patients are randomized to receive either oral tamoxifen daily for 5 years or no further therapy. Patients are followed every 6 months for 5 years, then yearly. Hormone therapy is prohibited except as specified above and except for short-term hormone replacement therapy for severe unresponsive menopausal symptoms.

PROJECTED ACCRUAL: Approximately 2,000 patients will be required. Data on patients entered in Scotland as part of this study will be pooled with data from the EORTC-10901 study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer with palpable, unilateral, invasive disease Bilateral mammography required within 1 year prior to randomization TNM Stage T1-3, N0-1, M0 disease for which adjuvant chemotherapy is considered an essential part of initial therapy No prior pure in situ carcinoma in either breast No concurrent in situ carcinoma only No Paget's disease of the nipple without underlying invasion No evidence of distant disease, e.g.: No ipsilateral supraclavicular node enlargement unless proven benign Hormone receptor status: Any status

PATIENT CHARACTERISTICS: Age: Not specified Sex: Women only Menopausal status: Pre- or postmenopausal Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious unrelated illness No prior invasive malignancy at any other site except adequately treated nonmelanomatous skin cancer No pregnant or nursing women Adequate contraception required

PRIOR CONCURRENT THERAPY: No prior tamoxifen and not currently receiving tamoxifen
Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

The purpose of this study is to investigate changes in new plasma stroke biomarker panel in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Elective cardiac surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

* Patients undergoing emergent procedures
* Patients with preoperative mechanical support
Bringing South African Men Into HIV Counseling and Testing and Care

This clinical trial seeks to determine if male-centered recruitment increases men's testing for HIV and whether or not individualized introduction to clinics increases male engagement in treatment for HIV. The study is being conducted in rural KwaZulu Natal.

This study combines structural and individual level interventions for HIV and integrates the two to address the study's objective of identifying South African men in KwaZulu Natal with HIV and maintaining those diagnosed with HIV in care to the point of viral suppression.

The cluster-randomized design will randomize 8 communities to intervention or control to test the hypothesis whether male-centered mobilization and testing increases the population-level percentage of men who have been tested within the past 12 months by more than 10 absolute percentage points.

The individually randomized design will test whether individualized case management will effectively link HIV-positive men to treatment to the point of viral suppression.

The study will also examine the incremental cost-effectiveness of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Men residing in the target communities

Exclusion Criteria:

* Men outside of the target communities
* Men who report being tested and HIV+
Down-titration of Steroids in Patients With Difficult Asthma With no Bronchial Hyperreactivity

An 8 week 'real-life' inhaled corticosteroid (ICS) dose reduction study in patients with severe asthma without evidence of bronchial hyperactivity.

We aim to describe the proportion of patients with severe asthma, but without objective evidence of active disease, who can successfully be reduced in ICS dose for a period of 8 weeks. This is also intended as an exploration of the methodology and feasibility of step-down studies with this patient group, to act as a pilot for future projects.

This study enrolled patients from the SATS severe asthma study, in which they had undergone systematic investigation for comorbidities, triggers and barriers to good asthma control.

After baseline investigations, the patient's ICS dose is halved (or as close as possible to, but not below, 50%). Patients continued on the same inhaled steroid drug and device. Patients taking a combined ICS/LABA inhaler halve the dose of this, as per usual clinical practice. Other asthma medicaitons are continued unchanged.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma for at least 6 months
* Fulfill ERS/ATS giudelines for severe asthma
* Stable dose of ICS for at least 4 weeks
* Able to carry out study procedures
* Negative metacholine provocation test at screening
* Negative reversibility to beta agonist at screening
* FeNO under 50 ppb

Exclusion Criteria:

* Treatment with prednisolone, methotrexate, ciclosporin, omalizumab or nucala in the last 6 months
* FEV1 under 70% of predicted
* Acute upper or lower airway infection requiring antibiotics in the last 4 weeks
* Exacerbation of asthma requiring prednisolone in the last 6 months
* Current smoking
* Pregnancy or breastfeeding
* Other clinically significant lung disease
* Current participation in another interventional study
Perforator Pedicled V-Y Advanced Flaps for Coverage in the Lower Limbs

Repair of soft tissue defects with hardware exposing in the lower limbs was considered as a severe challenge for plastic surgeons in reconstructive surgery. The purpose of the paper was to investigate the clinical effect of perforator pedicled V-Y advanced flap for repairing soft tissue defects with hardware exposing in the lower leg .

The various causes of the lower leg defects always consist of trauma, infection, tumors etc. Flaps are often used to cover the wounds when the bones and tendons are exposed to the body surface. However, flap coverage at the lower leg was considered a severe challenge due to the difficult anatomy and paucity of soft tissue1. Reconstruction and esthetic aspects of defect should be systemically considered .Common skin flaps include the peroneal perforator flap, the medial sural artery perforator flap2-8and muscle flaps. However, common skin flaps have a disadvantage of reversing of the pedicle which may be a reason of necrosis. A split thickness skin graft was usually applied to cover close secondary wound at the donor site. The aim of this paper was to investigate the clinical effect of V-Y advanced flaps based on septocutaneous and musculocutaneous perforator in the repair of soft-tissue wounds in the lower limbs.

Eligibility Criteria:
Inclusion Criteria:

1. people age: among 5-80years,
2. tolerate general anesthesia.
3. The perforating vessel is fine.

Exclusion Criteria:

1. patients age :\<5years,\>80years
2. can not tolerate general anesthesia.
3. The perforating vessel is damaged -
An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida

The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection.
* Male or female ≥ 16 years of age.
* Expected hospitalization for at least fourteen (14) days.

Exclusion Criteria:

* Pregnancy or breast feeding or planning to become pregnant during the study.
* Recent treatment with one of the study drugs over the last 30 days.
* Allergy to either study drug or to this class of drugs.
* Significant liver dysfunction.
* Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients

This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 20 years old and \< 75 years old.
* Patient who was eligible and able to participate in the study and accepts to enter the study by signing written informed consent.
* Patient with fasting LDL-C \> 100 mg/dL. The concentration of LDL-C is obtained from laboratory examination.
* Patient with at least one of the following description (NCEP ATP III guideline).
* Female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.

Exclusion Criteria:

* Patient who has participated in other investigational studies within 3 months.
* Patient took medication and natural health foods known to alter blood lipid profiles within 4 weeks.
* Patient is taking any medication or food that is prohibited by the study.
* Patient taking Amiodarone will be excluded from this study (due to long half life of this medication).
* Patient is diagnosed with type 1 DM or has been using insulin/insulin analog medication.
* Patient with a history of multiple drug allergies or with a known allergy to HMG-CoA reductase inhibitors.
* Patient with TG \> 400 mg/dL.
* Excessive obesity defined as BMI above 35 kg/m2.
* Cerebral vascular disease (including cerebrovascular hemorrhage or ischemia, transient ischemic attack) diagnosed within 3 months.
* Myocardial infarction, heart failure (NYHA class III or IV), gross cardiac enlargement (cardiothoracic ratio \> 0.5), significant heart block or cardiac arrhythmias within 3 months; history of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia, pacemaker or implantable cardiac device were not eligible for this study.
* Patient with advanced renal disorder (Serum creatinine levels ≥ 2 mg/dL and BUN ≥ 25 mg/dL).
* Patient with advanced hepatic disorder (AST or ALT level ≥ 100 IU/L)
* Patient with CK level \> 5 × ULRR at any time point between Visit 1 and Visit 2.
* Patient with poorly controlled diabetes mellitus (HbA1c \> 9.0%) or patient with severe hypertension (\> 180 mmHg for systolic or \> 120 mmHg in diastolic blood pressure).
* Patient with hypothyroidism, hereditary muscular disorders, family history of the above or history of drug-induced myopathy.
* Patient has significant alcohol consumption (\> 65 mL pure alcohol) within 48 hours before Visit 2.
* Any major surgery within 3 months prior to Visit 2.
* Female patient who is lactating, being pregnant or plans to become pregnant.
* Patient with conditions judged by the investigator as unsuitable for the study.
Whole Milk Intake and Cardio-metabolic Risk Factors

Milk is the source of high-quality protein, calcium, and other vitamins and minerals. Epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome, T2DM, hypertension and obesity, which are independent risk factors of cardiovascular disease. However, milk contains disaccharide lactose, which may cause gastrointestinal problems in those adults with poor digestion. Recent studies have shown that subjects with intolerance to lactose tend to reduce their consumption of milk. Actually, consumption of 12g lactose (240ml milk) per day produces negligible symptoms in lactose intolerant. Furthermore, a dairy-rich diet could improve lactose intolerance because of colonic adaption to it. Lactose maldigestion would not be a restricting factor in milk intake. In general, the undigested lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide, and short-chain fatty acids (SCFA: acetate, propionate, and butyrate). The SCFAs may have beneficial effects on human glucose and lipid metabolism, and the lactose fermentation may change the intestinal flora profile. But there are few studies evaluating effect of milk intake on health of people with lactose malabsorption or intolerance.This trial intend to study the effect of whole milk on cardio-metabolic risk factors of healthy person with or without lactose maldigestion.


Eligibility Criteria:
Inclusion Criteria:

* Aged above 18 years of age
* Able to give informed connect

Exclusion Criteria:

* Unwilling to trial dietary intervention
* Pregnancy
* Known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease.
* Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on.
* Evidence of drug or alcohol abuse
Calcium Administration in Life-saving Management During Massive Hemorrhage

This study evaluates the feasibility of conducting a larger study on the impact of treating massive hemorrhage with calcium in trauma patients. Patients undergoing the Massive Hemorrhage Protocol (MHP) will be randomly assigned to receive either calcium gluconate or placebo drug after every 4 packs of units of RBCs received during the MHP.

The treatment of hemorrhage with blood products has been well studied, however very little literature exists on the administration of specific electrolytes such as calcium. Citrate is added to blood products to prevent coagulation by chelating free calcium. This process reduces serum calcium and can lead to hypocalcemia, especially in trauma patients who have altered metabolism, hypovolemia, and receive large quantities of blood products. The majority of trauma patients have hypocalcemia upon arrival at the hospital. Serum hypocalcemia in trauma patients matters because calcium is crucial for bleeding control due to its contributions to platelet function, coagulation, and vasoconstriction. Calcium is also essential for other physiological functions during trauma, such as heart and smooth muscle contractility. It is likely due to these key roles that the literature demonstrates hypocalcemia's association with increased mortality, bleeding, blood transfusion requirements, and coagulopathy.

The primary objective of our proposed trial is to assess the feasibility of conducting an interventional calcium trial on patients undergoing the Massive Hemorrhage Protocol (MHP). Feasibility will be evaluated through the recruitment of patients, adherence to protocol, as well as assessment of any protocol violations that occur during the trial. Secondary objectives of our trial include analyzing the effect calcium supplementation has on patient ionized calcium (iCa) level, total blood product transfused, hemodynamic instability, ICU mortality, and hospital mortality.

The investigators will complete a single-centre, double-blinded randomized control feasibility trial. Both trial arms will receive study drug in accordance with Ontario's Massive Hemorrhage Protocol (MHP). After every 4 units of RBCs, the treatment group will receive 3g of calcium gluconate and the control arm will receive saline placebo. Results will be assessed for feasibility to inform the development of a larger trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult trauma patients undergoing the MHP at Victoria Hospital, London, Ontario

Exclusion Criteria:

* Under the age of 18
* Pregnant
Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance

Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed ovarian tissue, with the aim to conceive.

Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine monitoring, IVF.

Main Outcomes expected:

Endocrine profile IVF results, pregnancy rates following transplantation of ovarian tissue live-births rates following transplantation of ovarian tissue cancer disease recurrence

Eligibility Criteria:
Inclusion Criteria: infertile patients who stored ovarian tissue to preserve fertility prior to potentially sterilizing cancer treatments

-

Exclusion Criteria:

* active disease, fertile patients post cancer treatment
Effects of Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents

The purpose of study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents.

In the study, ET cuff pressure control will be provided with pilot balloon fingers (Control Group), intermittent with a manometer (Study Group 1) and continuously with a smart cuff manager (Study Group 2).

To assess the effect of different ETT cuff pressure control on microaspiration of the stomach contents, the pepsin level will be measured during deep tracheal secretions. The samples will be examined in the first four hours after intubation, all secretions collected up to the 24th hour of intubation after first sample intake and all secretions collected between 24-48 hours after intubation. Pepsin level will be considered as positive for cut-off point. In addition, the effect of different ETT cuff pressures control on the incidence of VAP will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering of the patient or relatives who will participate in the study,
* Patients who require mechanical ventilation support with endotracheal tube supply for 48 hours.

Exclusion Criteria:

* Patients who are contraindicated in giving a semi-fowler position,
* Patients with enteral nutrition contraindications,
* Patients connected to mechanical ventilators for more than 48 hours,
* Patients with tracheostomy,
* Patients admitted to ICU for gastroesophageal reflux disease, aspiration pneumonia or suspicion,
* Nasal endotracheal intubation.