cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS)

The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of HDA-RRMS as defined by clinical or radiological features
* Treatment initiation with cladribine tablet monotherapy on or after 22 August 2017 and at least 3 years before enrolment
* Completion of Year 1 treatment of cladribine tablets (Week 1 and Week 2 treatment, per recommended dose in Year 1: 1.75 milligrams per kilogram \[mg/kg\] body weight, cumulatively)

Exclusion Criteria:

* Received cladribine tablet treatment within an interventional clinical trial during the study period
* Received treatment with any investigational therapy for RRMS in the 6 months prior to cladribine tablet treatment initiation
To Discuss the Best Mode for Taking Lapatinib Under the Influence of the Diet

Food can make a big difference on the bioavailability of lapatinib in breast cancer patients,and fatty food can increase the lapatinib bioavailability.By examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib,emptiness or taken with fatty food,discuss the best mode of taking lapatinib with fatty food.

Metastatic breast cancer is the leading cause of cancer-related death among women worldwide ,those overexpress the HER2 are associated with a higher risk. Lapatinib is approved for use to treat advanced metastatic breast cancer. The pharmacokinetic parameters of lapatinib have been characterized previously.It can reach steady state concentration after 6 or 7 days oral dosing, but the bioavailability is very different between different patients. The effect of food on lapatinib pharmacokinetics in humans was first examined in 19 healthy participants who were given single 100-mg doses with a high-fat breakfast. Food caused a 60% increase in the relative bioavailability of lapatinib.Another test showed that the bioavailability of lapatinib was 3 times more in low-fat diet than in emptiness.

Some investigators think that it can change the mode for taking lapatinib with food or without food to enhance the absorption.It may decrease the oral dose but the lapatinib can reach the same steady state concentration,so it can achieve maximum economic benefits.

By continuous change for lapatinib and fat diet, The change of lapatinib pharmacokinetic is lack of discussion. If the adverse reactions increase since the absorption of lapatinib increase, the existing research data are still lacking.

The trial By examine the steady blood drug concentration in the same individual at different treatment mode for lapatinib, emptiness or taken with fatty food, discuss the best mode of taking lapatinib with fatty food.

Eligibility Criteria:
Inclusion Criteria:

1. Advance breast cancer with her2 positive
2. The patients are ready to use or using lapatinib for tumor treatment, and plans to keep the treatment for at least a month
3. The ECOG score is 0 to 2
4. hemoglobin≥ 9 gm/dL
5. serum albumin concentration is normal
6. ALT / AST / bilirubin\<1.5UL
7. creatinine clearance rate≥ 40 mL/min
8. signed ICF

Exclusion Criteria:

1. Pregnancy or Pregnancy
2. Stomach absorption dysfunction
3. Difficulty in taking fatty food
4. Severe heart disease or medical condition
New Devices to Measure the Intracuff Pressure

Over the past 5 years, there has been a change in clinical practice with the use of cuffed instead of uncuffed endotracheal tubes in infants and children. Two manufacturing companies have recently introduced syringe-like devices to the market which allow the measurement of the intracuff pressure. This study proposes to prospectively compare the intracuff pressure from these devices with the gold standard technique (manometer).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or younger, undergoing a procedure requiring endotracheal intubation with a cuffed ETT.

Exclusion Criteria:

* None
Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient

The purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c ≤7.0% on ≤ 2 non-insulin agents at home.

The current professional organization guidelines recommend insulin as the preferred treatment for hospitalized patients. It is recommended that most critically ill patients should receive insulin infusion therapy and non-critically ill patients should receive basal bolus insulin therapy in the hospital.

The study will test the hypothesis that treatment with saxagliptin is non-inferior to treatment with basal bolus insulin in this group of patients during their hospital stay. The study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)

The primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as compared to the control group

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness.
* Written informed consent.

Exclusion Criteria:

* Admitted to or expected to require admission to ICU
* Patients with a history of diabetic ketoacidosis or hyperosmolar state
* HbA1c \>7.5% at the time of admission or within 3 months before admission
* Insulin requiring before admission
* Unable to take oral food or medications
* Systemic steroid use
* Pregnancy or breastfeeding
* Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
* History of pancreatitis or active gallbladder disease
* End stage renal disease on dialysis
* Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
* Subject unable to give informed consent
Clinical Profiles and Outcomes of Acute Aortic Dissection in the Chinese Patients

Clinical profiles and outcomes of patients with acute aortic dissection have not yet been evaluated in China. The aim of this study is to establish clinical registry of acute aortic dissection in China and to analyze clinical features, managements and outcomes of Chinese patients with acute aortic dissection.

In 1996, the Internation Registry of Acute Aortic Dissection(IRAD) was established to improve clinical diagnosis and treatment of acute aortic dissection. However, most patients from the IRAD are Caucasian. These data were not sufficient to reflect clinical profiles and outcomes of Chinese patients with acute aortic dissection. In China, little is known about clinical features, managements and outcomes of acute aortic dissection involving a large number of patients. The investigators established clinical multicenter registry of acute aortic dissection. Between January 2009 and February 2012, about 2000 were enrolled in the Chinese registry of acute aortic dissection(CRAD) database. The aim of this study is to analyze clinical profiles and outcomes of Chinese patients with acute aortic dissection.

Eligibility Criteria:
Inclusion Criteria:

* Stanford type A dissection
* Stanford type B dissection
* Retrograde Stanford Type B dissection
* Unclassified dissection with primary tear located in the aortic dissection

Exclusion Criteria:

* Aortic aneurysm
* Active infection or active vasculitides
* Myocardial infarction or Cerebral accident within 2 months
* Unwillingness to cooperate wiht study procedures or follow-up visits
Amphotericin-B and Voriconazole for Pulmonary Blastomycosis

All patients with pulmonary blastomycosis requiring mechanical ventilation will have their blood concentrations measured for the antifungal drugs, amphotericin-B and voriconazole; as well as an analysis of the susceptibility of their infecting species of blastomyces. This information will then be analyzed relative to their rate of clinical recovery from this serious fungal infection.

To evaluate six intensively studied patients admitted to medical intensive care with pulmonary blastomycosis requiring mechanical ventilation. Interventionally, all patients will receive continuously infused amphotericin-B (1 mg/kg/d); and then stepped down to oral or i.v. voriconazole once clinically responding. Blood will be sampled for amphotericin-B concentrations for the 3 first days (i.e. one blood sample per day); and when eventually changed over to voriconazole (i.e. generally after a total dose of 1 g has been reached of Amphotericin-B; as per usual practice). Once switched to oral or intravenous voriconazole, at the treating physicians discretion, then blood would once again be sampled for the next 3 days for voriconazole concentrations. MIC's of the infecting blastomyces would also be analyzed. The fungal isolate would be sent off to the Fungus Testing Laboratory at the University of Texas in San Antonio for susceptibility testing.

Clinical response to therapy relative to their initial pharmacokinetic and pharmacodynamic indices for amphotericin-B (i.e. daily free maximal concentration divided by the MIC) would be assessed in these 6 intensively studied patients. Clinical parameters assessed would be 1). time to fever defervescence; 2). time to white cell count resolution, and 3). improvements in respiratory gas exchange (i.e. specifically the rate of rise of the pressure of arterial oxygen (Pa02) divided by the fraction of inspired oxygen (Fi02) delivered through the ventilator (or PF ratio).

Eligibility Criteria:
Inclusion Criteria:

* All adult patients 18 years of age or older admitted to the intensive care units of St. Boniface General Hospital with a diagnosis of acute pulmonary blastomycosis requiring mechanical ventilation.

Exclusion Criteria:

* The patient's data will be excluded if they die within 3 days of hospital admission.
Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea

This study is a non-interventional prospective, multicenter, longitudinal study conducted in France, among a representative sample of public and/or private birth control centers.

The aim of the study is to assess, in real-life settings, the success rate of the protocol Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* Adult women (≥ 18 years old) with confirmed intra-uterine pregnancy consulting for medical termination of pregnancy
* Patients for whom the physician decides to use a Mifegyne 600 mg and prostaglandin analogue combination for medical abortion
* Patients agreeing to participate in the study after having been informed orally by the physician and given the information sheet
* Informed patients accepting the computer processing of their medical data and their right of access and correction

Exclusion Criteria:

* Patients with known hypersensitivity to mifepristone
* Patients with known hypersensitivity to prostaglandin analogues (misoprostol or gemeprost).
* Patients with severe and progressive disease
* Patients with ectopic pregnancy
Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years and older
* diagnosis of choledocholithiasis
* indication for ERCP procedures
* willingness to participate in the study
* the ability to sign the informed consent

Exclusion Criteria:

* presence of acute pancreatitis or other inflammatory diseases at admission
* pregnancy
* contraindication for NSAID administration
* recent episode of upper digestive bleeding (less than one month)
* hypersensibility to antioxidants hypersensibility to antioxidants
* the necessity of a prophylactic pancreatic stent insertion
* patients' disapproval to take part in the study
Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery

The study aims to compare the incidence of side effects caused by Oxycodone and Hydromorphone.

Nausea and vomiting in the post-operative period is considered strongly undesirable by patients and has adverse effects on recovery from outpatient procedures, contributing significantly to delays in discharge from recovery. A know major contributor to the occurrence of post-operative nausea and vomiting is the use of opiate medications which are the cornerstone of post-operative pain management. The investigators hypothesize that the occurrence of this side-effect is different between patients prescribed oxycodone and those receiving hydromorphone for acute pain management after total hip replacement surgery. This investigation is a randomized, double-blind, head-to-head comparison to equipotent administration of oxycodone vs. hydromorphone to determine whether such a difference exists.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status Classification System 1-3
* Age 18-85 years
* Patients undergoing hip replacement surgery under spinal anesthesia

Exclusion Criteria:

* patient refusal
* contraindication or refusal of spinal anesthesia
* inability to provide informed consent
* history of dementia
* intolerance or allergy to oxycodone or hydromorphone
* chronic opioid use or chronic pain disorder
* pregnancy
* history of drug addiction
* history of major psychiatric illness
Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases

Type 2 diabetes is common in ethnic and, minority groups in developing and developed countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya preparation and green tea infusates in latent diabetes (individuals newly diagnosed as diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation end-products which play a role as proinflammatory mediators in gestational diabetes can accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction with high-affinity receptors located on monocytes and macrophages can enhance the production of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial, mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of cardiovascular complications. The clinical markers include C-reactive proteins (inflammation indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides, and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of diabetic nephropathy. A second phase of the study is expected to commence after the first 16 weeks in order to assess the ability of the dietary factors to modulate atheroma formation and the integrity of drug therapy (upon commencement of treatment)on the prognosis of diabetes. This will be expected to last up to 3 years.


Eligibility Criteria:
Inclusion Criteria:

Individuals at risk of diabetes 35-65 years of age male or female

Exclusion Criteria:

* Smokers or those who have stopped smoking 6 months before the study
* Daily alcoholic intake exceeding 4 standard drinks
* Post menopausal women currently under hormone replacement treatment
* Hypertension (\>140/90 mm Hg)
* individuals outside the age range 35-60
Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy

RATIONALE: Gathering information about cognitive function over time in postmenopausal women with breast cancer may help doctors learn about the long-term effects of aromatase inhibitor therapy and plan the best treatment.

PURPOSE: This clinical trial is studying cognitive function in older postmenopausal women with stage I, stage II, or stage III breast cancer receiving hormone therapy and in healthy volunteers.

OBJECTIVES:

* Explore the impact of treatment with an aromatase inhibitor on the cognitive function of postmenopausal women with stage I-III breast cancer vs in cancer-free, age-matched healthy volunteers.

OUTLINE: Patients receive adjuvant anastrozole or letrozole in the absence of disease progression or unacceptable toxicity.

Patients and healthy volunteers undergo cognitive function testing consisting of neuropsychological battery tests and complete self-reported questionnaires (e.g., Squire Memory Self-Rating Questionnaire, and FACT-B Quality of Life Measure) regarding cognitive ability, quality of life, fatigue, and psychosocial status. Patients and healthy volunteers also undergo geriatric assessment at baseline and after 6 months of initiation with aromatase inhibitor therapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Patient diagnosed with breast cancer

    * Stage I-III disease
    * Estrogen receptor- and/or progesterone receptor-positive
    * Planning to start treatment with anastrozole or letrozole
  * Age-matched healthy volunteer (control)

    * No history of breast cancer
    * Not receiving adjuvant aromatase inhibitor therapy

PATIENT CHARACTERISTICS:

* Postmenopausal
* Able to converse, write, and read English
* No claustrophobia (patients participating in the PET scan correlative study)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior hormonal therapy, including estrogen replacement therapy
* No previous treatment with CNS radiation
Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors

This proposed study will assess the effects of different scenarios of PHW policies on smokers' reactions to warnings, attitudes and beliefs, behavioral intentions, and quitting behaviors, with specific aims: 1) to assess the impact of new PHWs covering 50% of cigarette packs, 2) to assess the impact of new larger PHWs covering 85% of cigarette packs, 3) to assess the impact of incorporating quitline information on cigarette packs, and 4) to assess the impact of plain packaging. These aims will be achieved by conducting a five-arm RCT among 1000 adult smokers (n=200 per arm). It includes four intervention groups: 1) branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information, 2) branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information, 3) branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information, and 4) plain pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information. A control group will use branded packs with the current set of 6 PHWs, covering 50% of cigarette packs without quitline information.

Given that the pictorial health warnings (PHW) on cigarette packs need to be renewed, this project will provide highly policy-relevant and timely scientific evidence on the effect of new PHW policies in Vietnam. Additionally, this project would be the first to address the research gap in understanding the effect of adding quitline information to PHWs-a gap not explored in previous studies. With the potential for significant outcomes, the findings will help Vietnamese policymakers enact stronger PHW policies in upcoming years, aiming to increase perceived harms of smoking and foster smoking cessation, ultimately saving millions of lives in Vietnam


Eligibility Criteria:
Inclusion Criteria:

* having smoked at least 100 cigarettes in their lifetime and currently smoking
* aged 18 or older
* fluent in Vietnamese
* smartphone users

Exclusion Criteria:

-
Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).

Oxiris membrane is an efficient tool for inflammatory cytokines adsorption. Cardiac surgery is followed by an inflammatory state mimicking sepsis. The investigators hypothesized that cytokine adsorption by Oxiris® membrane can attenuate the inflammatory response and thus decrease the microcirculation impairment that followed cardiac surgery.

Oxiris membrane is an efficient tool for inflammatory cytokines adsorption. Cardiac surgery is followed by an inflammatory state mimicking sepsis. The investigators hypothesized that cytokine adsorption by Oxiris® membrane can attenuate the inflammatory response and thus decrease the microcirculation impairment that followed cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 18 years old
* Elective cardiac surgery under CPB with an expected CPB time \> 90 minutes (double valve replacement or valve replacement plus coronary arterial bypass graft (CABG))
* Written informed consent from patient or legal surrogates

Exclusion Criteria:

* Missing informed consent.
* Planned CPB hypothermia \<32ºC
* Emergency surgery.
* Acute infective endocarditis.
* Immunosuppressive treatment or steroids (prednisone \> 0.5 mg/kg/day or equivalent).
* AIDS with a CD4 count of \< 200/ μl
* Autoimmune disorder.
* Transplant receptor.
* Advanced Chronic Kidney Disease (CKD 4 or 5).
* Renal replacement therapy (RRT) in the last 90 days.
* Documented intolerance to study device.
* Inclusion in other ongoing study within the last 30 days.
* Pregnancy.
* Coexisting illness with a high probability of death (inferior to 6 months).