cyrilzakka/clinical-trials huggingface dataset:
Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB

The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy daily (QD). This is an open labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, \<40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or HBsAg positive \> 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc
* Age \< 40 years old
* HBeAg positive
* HBV DNA \> or = to 10\^7 copies/mL by Abbott real-time PCR
* ALT \< or = to 1 ULN
* Willing and able to provide written informed consent
* No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection)
* Is willing and able to comply with the study drug regimen and all other study procedures and requirements
* Is willing and able to provide written informed consent before any study assessment is perform

Exclusion Criteria:

* Decompensated liver disease defined as direct (conjugated) bilirubin \> 1.2 × ULN, PT \> 1.2 × ULN, platelets \< 150,000/mm3, serum albumin \< 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g. ascites, jaundice, encephalopathy, variceal hemorrhage).
* Received interferon (pegylated or not) therapy within 6 months of the screening visit
* α-fetoprotein \> 50 ng/mL
* Evidence of hepatocellular carcinoma (HCC)
* Co-infection with HCV (by serology), or HIV,
* Significant renal, cardiovascular, pulmonary, or neurological disease.
* Received solid organ or bone marrow transplantation.
* Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
* Has proximal tubulopathy.
* Use of other investigational drugs at the time of enrollment, or within 30 days
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* Is pregnant or breastfeeding.
* Is a women of child-bearing potential (WOCBP)unless post-menopausal or using one or more acceptable method of contraception.
* Patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
* Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
* Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir.

Other protocol-defined inclusion/exclusion criteria may apply
Accuracy of IVCCI as a Measure of CVP

The primary aim of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI.

Hemodynamic monitoring is important in the management of patients in the intensive care unit (ICU) Assessment of the intravascular volume, infusion of fluids or vasoactive drugs and maintenance of an adequate systemic perfusion is essential for reduction of the risk of organ failure and/or mortality.

The use of CVP through central venous catheter is a gold standard method that is extensively used in the ICU as it reflects the filling pressure of the right ventricle (RV) and RV preload.

Central venous cannulation has significant complications such as pneumothorax, hemothorax, arterial puncture, catheter malposition, cardiac arrhythmias, venous embolism, subcutaneous hematoma, and catheter related infection, and it is difficult to use this method in an emergency situation as it requires skilled personnel.

Measurement of IVC index by bedside ultrasound is widely used to assess the intravascular volume in adult patients and has the advantage of being non-invasive, rapid, and reliable for assessing the volume status.

Besides, related measures such as IVC diameter, IVC collapsibility, and IVC to aorta (AO) diameter have been applied clinically to assess the volume status and have been related to CVP.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years.
* Sex: Both sexes.
* BMI: \<35
* Patient in whom central venous cannulation is needed for management.
* Spontaneously breathing patients.

Exclusion Criteria:

* Patients with increased intra abdominal pressure.
* Patients who not able to lie supine.
* Patients on mechanical ventilation.
Outcomes of Robotic Total Hip Arthroplasty

The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.

The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 20 to 75 years of age
* Subjects requiring primary total hip replacement
* Contralateral hip should be relatively free from arthritis for comparison purposes, specifically with less than a grade of 2 on the Kellgren-Lawrence Scale.
* Subjects diagnosed with osteoarthritis or traumatic arthritis
* Subjects with avascular necrosis
* Subjects who demonstrate the ability to return for follow-up for the next 10 years

Exclusion Criteria:

* Subjects with difficulty understanding protocol for any reason
* Subjects with a limited life span
* Subjects with inflammatory hip disease, previous joint infection, or those requiring hip revision surgery
* Female subjects who are pregnant, or who plan to get pregnant while enrolled in the study
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Sirolimus in Healthy Subjects

The purpose of the study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of sirolimus after single dose administration.

Subjects will receive a single dose of sirolimus on Day 1 followed by a 21 day wash-out period (time from sirolimus dosing to isavuconazole dosing). On Days 22 and 23, isavuconazole will be dosed three times daily (TID). On Days 24 through 34, isavuconazole will be administered once daily (QD). All subjects will be administered a single dose of sirolimus on Day 26.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
* Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be within the normal range
* The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests
* The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study

Exclusion Criteria:

* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
* The subject has a history of tuberculosis or exposure to anyone known or suspected to have tuberculosis or any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering study drug to the subject
* The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen, or QuantiFERON®-TB Gold test or is known to be positive for human immunodeficiency virus (HIV).
* The subject has a known or suspected allergy to any of the components of the trial products including prednisone or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reactions
* The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening
* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
* The subject has a recent history (within the last 2 years) of drug or alcohol abuse, or a positive drug and/or alcohol screen
Standardization of Prostatic Resection by Virtual Computational Reconstruction and Computational Flow Dynamics

The enlargement of the prostate is responsible for voiding dysfunction in men, and especially elderly men. The primary surgical treatment for symptomatic benign prostatic hypertrophy (BPH) was transurethral resection of the prostate (TURP).

However, current resection techniques are predominantly experience-based and judgment-based, with little evidence to support the most effective portion of the prostate to be respected. So, the investigators plan through the study to construct a flow diagram to evaluate the amount of tissue needed to be resected to improve voiding flow dynamics.

Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland that develops in men and is a common cause of voiding dysfunction in elderly patients. It is a major public health concern, causing high morbidity and substantial worsening of men's quality of life. (QOL)

Transurethral resection of the prostate (TURP) is the standard surgical therapy for obstructive prostatic hypertrophy. Various techniques have been suggested for the systematic removal of the adenomatous tissue, all based on the principle that the resection should be done stepwise as bleeding is the surgeon's major problem, leading to loss of visual field and disorientation, it is imperative that resection and hemostasis should both be completed in one area of the prostatic fossa before the next area is tackled. With the development of new techniques for prostate resection that decreases perioperative morbidity, larger sizes of the prostate are being resected, and a new category of patients is considered eligible for such an intervention with a large prostate size of more than 80 gm. However, current resection techniques are predominantly experience-based and judgment-based, with little evidence to support the most effective portion of the prostate to be resected to give us the best voiding outcome postoperative. So, the investigators plan through this study to construct a flow diagram to evaluate the amount of tissue needed to be resected to improve voiding flow dynamics.

Eligibility Criteria:
Inclusion Criteria:

* Age: above 50 years old, undergoing an elective endo-urological procedure

Exclusion Criteria:

1. Neurogenic bladder
2. Previous prostate or urethral surgery
3. Associated urethral stricture
Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy

The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting.

Subjects were randomized to apply Biafine® to wounds on one forearm and polysporin (standard of care) to wounds on the other. Medications were applied three times a day for 4 weeks to the areas that have been treated with cryotherapy at the baseline visit.

Eligibility Criteria:
Inclusion Criteria:

* Subject must give written consent.
* Subjects must be \>50 years of age, male or female.
* Subjects must have had cryotherapy treatment of at least one AK's on each forearm in the Dermatology Clinic.

Exclusion Criteria:

* Subjects age \<50 years of age.
* Subjects with known allergy or sensitivity to topical Biafine or polysporin ointment.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for AK while participating in the study.
* Subjects using other topical agent's glycolic acid products, alpha-hydroxy acid products, retinoids and chemical peel agents in the treatment areas while on study.
Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty

This randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD).

In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the patients own cornea. Supine positioning is thought to improve attachment by using the tamponade effect of the bubble. At present, it is unclear how long supine positioning is required. Positioning regimens vary between one hour to over one week. In this trial, the investigators will assess if prolonged supine positioning for 5 days improves graft attachment and long-term outcomes compared to supine positioning for 1 day.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
* Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)

Exclusion Criteria:

* Other corneal diseases (i.e. corneal scars, corneal dystrophies except FECD, corneal inflammation / infection)
* Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, use of contact lenses in past four weeks, anesthetic eye drops)
* Diabetes mellitus with endorgan complications)
* Lack of fixation during corneal tomography
* Bedridden
FENIX™ Continence Restoration System Registry

The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.


Eligibility Criteria:
Inclusion Criteria:

* Individuals being treated with the FENIX™ Continence Restoration System
* Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.
* Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.

Exclusion Criteria:

* Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy \<5 years)
Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100

This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL).
* Evidence of bone metastasis related to prostate cancer on bone scans.
* Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of prostate cancer progression on each agent independently.
* Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.
* Recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable.
* Adequate organ and marrow function.
* Capable of understanding and complying with the protocol requirements and signed the informed consent form.
* Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment.

Exclusion Criteria:

* Prior treatment with cabozantinib.
* Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks.
* Radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization.
* Known brain metastases or cranial epidural disease.
* Requires concomitant treatment, in therapeutic doses, with anticoagulants.
* Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort).
* Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.
* Clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months.
* Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.
* QTcF \> 500 ms within 7 days of randomization.
* Unable to swallow capsules or tablets.
* Previously-identified allergy or hypersensitivity to components of the study treatment formulations.
* Another diagnosis of malignancy requiring systemic treatment within 2 years of randomization.
Buprenorphine Maintenance Dose Schedule and Treatment Setting - 2

The purpose of this study is to evaluate the efficacy of treating opioid-dependent individuals with buprenorphine on a thrice-weekly schedule compared to daily dosing.


Eligibility Criteria:
Please contact site for information.
Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.

Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®


Eligibility Criteria:
Inclusion criteria:

1. Female patients aged \>18 years.
2. Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.

Exclusion criteria:

Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.
Alberta Diabetes and Physical Activity Trial

This project will assess the incremental and cumulative impact of three behavioural intervention strategies for the promotion of physical activity in the adult general population with Type 2 diabetes.

An increasing prevalence of Type 2 Diabetes is associated with the aging population, a significant rise in the prevalence of obesity, and a sedentary lifestyle. In Canada, 4.9-7.0% over the age of 12 and 17% over the age of 64 are estimated to have diabetes, 90-95% of which will be Type 2. Strong evidence supports the importance of physical activity in the management of Type 2 Diabetes. However, current literature lacks clear understanding of best strategies for physical activity behaviour change in this target population. Existing studies employ resource intensive, one-to-one individual and clinically-based approaches with limited theoretical grounding for recommended health behaviour change. Most fail to offer practical, sustainable, economically viable solutions, with documented long-term intervention efficacy. The call to move beyond the clinical focus by including theoretically population-based and "real-life" approaches for the management Type 2 Diabetes remains largely unheeded. The three interventions are: (1) standard print-based physical activity educational materials provided by the Canadian Diabetes Association (CDA); (2) CDA materials + pedometers and a log book + theoretical stage-matched print-based physical activity materials; and, (3) the same as intervention 2 with the addition of a 12-month physical activity telephone counseling protocol.

Eligibility Criteria:
Inclusion Criteria:

\>18 years old, Type 2 Diabetes, Living in the province of Alberta, Can communicate in English.

Exclusion Criteria:

Serious Contraindications to Physical Activity
Can Food Timing Reduce Your Diabetes Risk?

The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants.

Participants will:

* complete 2 inpatient stays
* be provided with test meals
* have frequent blood draws

The investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.

Eligibility Criteria:
Inclusion Criteria:

* Healthy with no acute or chronic medical and psychiatric disorders
* BMI: 18.5-29.9 kg/m2

Exclusion Criteria:

* Smokers, current tobacco or e-cigarette use
* Drug or alcohol dependency
* Pregnant