cyrilzakka/clinical-trials huggingface dataset:
Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this non-interventional study to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) and efficacy of edoxaban use in non-preselected patients with NVAF.

Edoxaban was approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the reduction in the risk of stroke and systemic embolism in patients with NVAF, treatment of deep vein thrombosis (DVT) and pulmonary embolism. Edoxaban was approved by the Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 2016) for the prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age at least 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), or treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), following 5 to 10 days of initial therapy with a parenteral anticoagulant.

Real world evidence data of routine clinical practice use of edoxaban up to two years will be collected and evaluated in approximately 2,500 patients, treated by specialized as well as non-specialized physicians in hospital centers.

Eligibility Criteria:
Inclusion Criteria:

* NVAF-patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
* Written informed consent for participation in the study (ICF).
* Not simultaneously participating in any interventional study.

Exclusion Criteria:

* None
Anti-CD33 CAR-T Cells for the Treatment of Relapsed/Refractory CD33+ Acute Myeloid Leukemia

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD33 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.

AML is a rapidly progressing blood cancer and treated by high-dose multi-agent chemotherapy potentially followed by hematopoietic stem cell transplantation. Despite such intensive therapies, which are often associated with considerable toxicities and even death, about 60-70% of AML patients still relapse. Furthermore, the five-year survival rate from AML remains at a dismal 27%. AML is composed mostly of CD33+ leukemic blast cells. Therefore, CD33 is a potential good target by CAR T cells.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent; Patients volunteer to participate in the clinical trial;
2. Diagnosis is mainly based on the World Health Organization (WHO) 2008;
3. Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;
4. Leukemic blast cells express CD33 (CD33 positive by flow cytometry or immunohistochemistry ≥70%);
5. The expected survival period is greater than 12 weeks;
6. ECOG score ≤2;
7. Age 2-60 years old;
8. HGB≥70g/L (can be transfused);
9. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.

Exclusion Criteria:

1. Patients declining to consent for treatment
2. Prior solid organ transplantation
3. One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;
4. History of severe pulmonary dysfunction diseases;
5. Severe infection or persistent infection cannot be effectively controlled;
6. Severe autoimmune disease or congenital immunodeficiency;
7. Active hepatitis;
8. Human immunodeficiency virus (HIV) infection;
9. Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).
Chiropractic Spinal Manipulation for Headache

This is a pilot and feasibility randomized controlled trial to assess the efficacy of chiropractic spinal manipulative therapy in patients with tension-type and cervicogenic headache.

This study is a pilot and feasibility randomized controlled trial that aims to assess the efficacy of 8 treatment sessions of chiropractic spinal manipulative therapy compared to the same number of sham manipulative therapy or placebo interventions for chronic cervicogenic and tension-type headache. The hypothesis proposed is that chiropractic care will reduce the intensity and frequency of both cervicogenic and tension-type headache episodes, when compared to placebo. A sample of 20 participants suffering from cervicogenic or tension-type headache for at least 3 months, aged 18 to 67 will be randomized to receive either 8 sessions of spinal manipulative treatment (2 times per week for a total of 4 weeks) or 8 sessions of a validated sham spinal manipulation. Outcomes will be assessed at baseline, after 4 treatments and at the end of the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* At least 2 episodes per month of cervicogenic or tension-type headache for at least 3 months. Diagnoses will be determined by case history and physical examination according to the International Headache Society criteria (3rd Edition)

Exclusion Criteria:

* Not fulfilling the inclusion criteria
* Having received chiropractic treatment in the previous 12 months
* Diagnosis or frequent symptoms of migraine headaches (symptoms present at least once a month) without an overlapping presentation of cervicogenic or tension-type headache.
* Patients with pathologies affecting the nervous system (MS, tumors, past history of stroke...)
* Contraindications to manual therapy, particularly spinal manipulative therapy (cancer, uncontrolled high blood-pressure, severe cardiovascular conditions)
* Past history of cervical spine surgery
* Pregnancy
* Having being diagnosed with a psychiatric conditions, with the exception of depression and anxiety
Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration

The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.

The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Willing to give informed consent, make the required study visits and follow instructions;
* Newly diagnosed with exudative age-related macular degeneration (AMD);
* Presence of primary juxta- or subfoveal choroidal neovascularization (CNV) secondary to AMD (study eye);
* Best-corrected visual acuity (BCVA) in study eye as specified in protocol;
* No vision-threatening ocular condition other than AMD, in the opinion of the Investigator;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* History or current evidence of macular or retinal disease other than exudative AMD (study eye);
* Any evidence of fibrosis or scarring within the CNV (choroidal neovascularization)lesion (study eye);
* Any evidence of vitreous hemorrhage (study eye);
* History or evidence of surgery (study eye), as specified in protocol;
* Any active systemic infection or ocular/intraocular infection or inflammation in either eye;
* A history or current medical diagnosis of glaucoma or ocular hypertension (study eye), as specified in protocol;
* History or current evidence of a medical condition that may in the opinion of the Investigator preclude the safe administration of test article, adherence to the scheduled study visits, safe participation in the study or affect the results of the study
* History of severe or serious hypersensitivity to any component of the investigational product, reference product or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator;
* Females of childbearing potential may not participate in the study if pregnant, lactating, or not using adequate birth control methods for the duration of the study;
* Participation in any ocular or non-ocular investigational study within 30 days of screening;
* Has received any approved or investigational therapy for AMD in the study eye with the exception of vitamins;
* Other protocol-defined exclusion criteria may apply.
Nutritional Quality of Egg Proteins and Effect on Satiety

The project aims to precisely quantify the postprandial amino acid utilization of egg proteins in vivo in humans, and also to assess their satiating power, in relation with nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an egg test meal. The second one is a cross over design performed on 30 volunteers to compare the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 25

Exclusion Criteria:

* Allergy to egg or milk protein
* Digestive or metabolic pathology
* Positiveness to HIV, Hepatitis B and C
* Smokers
Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether surgery and hepatic arterial chemotherapy are more effective than surgery alone in treating patients with liver cancer that has spread to the portal vein.

PURPOSE: This randomized phase III trial is studying surgery and hepatic arterial chemotherapy to see how well they work compared to surgery alone in treating patients with liver cancer that has spread to the portal vein.

OBJECTIVES:

* Compare the efficacy of surgical resection with vs without postoperative hepatic arterial chemotherapy in patients with hepatocellular carcinoma and portal vein tumor thrombus.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to grade of portal invasion and Child-Pugh classification. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo macroscopic curative resection. Within 28 days after surgery, patients without post-surgery complications undergo hepatic arterial infusion comprising fluorouracil and cisplatin on days 1-5, 8-12, and 15-19. Treatment continues for 6 months.
* Arm II: Patients undergo macroscopic curative resection.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed hepatocellular carcinoma (HCC) with portal vein tumor thrombus
* Tumor thrombus in the main trunk or first branch of the portal vein
* No apparent distant metastases on chest CT scan and bone scintigraphy within the past 6 weeks
* No pleural effusion or ascites

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Neutrophil count \> 1,000/mm\^3
* Platelet count \> 50,000/mm\^3
* Hemoglobin \> 8 g/dL

Hepatic

* Bilirubin \< 2 times upper limit of normal (ULN)
* ALT and AST \< 4 times ULN

Renal

* Creatinine normal

Cardiovascular

* No severe heart disease
* No cardiac effusion

Other

* No other malignant disease
* No high risk for esophageal varices rupture
* No allergy to fluorouracil or cisplatin

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior hepatic arterial chemotherapy
* No prior systemic chemotherapy for HCC

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Intrathecal Morphine for Inguinal Hernia Repair.

The aim of this study was to compare the effects of two different doses of intrathecal morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block regression times, postoperative analgesia and the severity of side effects, for inguinal hernia repairs.

The purpose of this study was to compare spinal anesthesia with low dose heavy bupivacaine combined with 0.1 mg or 0.4 mg of morphine in inguinal hernia repair surgeries. Anesthesia onset time (sensory and motor blocks) as well as postoperative recovery (first mobilisation, first voiding) time were compared. Also the postoperative pain management and side effects (nausea, vomiting and pruritus) were assessed.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiology physical status I-II patients
* aged 18-65 years
* undergoing elective unilateral open inguinal hernia repair surgery

Exclusion Criteria:

* contraindications to spinal anesthesia
* central or peripheral neuropathies
* severe respiratory or cardiac diseases
* chronic analgesic use
* history of substance abuse
* allergy to local anesthetics
Hypermetabolism in the Elderly Lung Cancer Patient

Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer.

During aging, among other physiological modifications, inactivity and insulin resistance cause a progressive muscle loss associated with a decrease in resting energy expenditure (REE). In cancer, loud inflammation background also provokes a decrease in muscle mass as well as in fat mass. However, previous studies reported an increased REE, termed hypermetabolism, probably linked to inflammation.

Data concerning response to aggression in the elderly patient is scarce and even inexistent when it comes to cancer. The investigators hypothesize that the mitochondrial dysfunction that comes with aging and that decreases the ATP rendering per unit of energy-producing nutrient oxidized increases the amount of nutrient to be consumed in order to sustain to energy needs. Therefore, in this situation, elderly patients could have a higher rate or degree of hypermetabolism than younger patients.

The primary objective of this study is to assess the effect of aging on the metabolic response to cancer assessed by resting energy expenditure measured by indirect calorimetry corrected by whole body fat free mass calculated from single slice CT imaging at the third lumbar vertebra.

The secondary objective of this study is to point out some inflammatory or endocrine determinants of these energy metabolism changes in the cancer patient.

Non-small cell lung carcinoma seems to be a relevant choice for this study because it is frequently associated with cachexia and the literature reports a high rate of hypermetabolism in this cancer.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung carcinoma

Exclusion Criteria:

* Imbalanced Diabetes
* Imbalanced dysthyroidia
* Surgery within two month prior inclusion
* Any chronic auto-immune or inflammatory disease
Intermittent Fasting in Multiple Sclerosis

This is a randomized controlled trial that will test the effects of intermittent fasting (IF) in subjects with relapsing-remitting MS (RRMS). The goal of this clinical trial is to acquire objective evidence regarding whether an IF diet has beneficial effects in MS patients.Two dietary regimens, IF and western diet, will be compared in a randomized, controlled, single-blinded 12 week trial in RRMS patients. This is a single-center study.

RRMS patients will be enrolled in a randomized, controlled, single-blinded 12 week trial in which IF will be compared to a standard western diet. Patients will be recruited at the John L. Trotter MS center and randomly assigned to either a standard western diet or an IF diet (1:1). Enrolled subjects will complete a clinical and laboratory assessment before starting the diet (baseline), at week 6 and at end of the study (week 12). The primary outcome will be leptin at week 12 measured in the peripheral blood. Secondary outcomes will be: 1) peripheral blood metabolic profiling; 2) anthropometric (body mass index and waist circumference) and total body fat measures; 3) gut microbiota richness and composition.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RRMS (2010 Mc Donald criteria).
* EDSS \<6.0 and disease duration ≤ 15 years.
* On an injectable therapy for MS, glatiramer acetate (GA) or beta-interferon (beta-IFN) for at least 3 months prior to the study and with no anticipated changes of the medication for the 12 week study duration.
* Age ≥18 years.
* BMI \> 22 and \< 35 kg/m2 with stable weight in the 3 months prior to screening.

Exclusion Criteria:

* History of any chronic disease process (excluding MS) that could interfere with interpretation of results.
* Diagnosis in the past of an eating disorder (anorexia, bulimia, or binge eating).
* Relapsing at the time of enrollment.
* On corticosteroid treatment (oral or intravenous) in the past month. Nasal corticosteroid treatments are allowed.
* Diagnosis of diabetes or at time of OGTT (fasting glucose \>126 mg/dl or \> 200 mg/dl at 2 hours with a load of 75 g of glucose
* History of food allergies or food intolerance that would interfere with the study.
* History of antibiotic treatment within the past 3 months prior to enrollment
* Use of anticoagulant drugs (like Warfarin or Coumadin) that need to monitor their intake of vegetables containing high levels of vitamin K.
* Currently on a special diet and not willing to stop at least one month prior to enrollment
* Currently taking omega 3/fish oil supplements and not willing to stop administration one month prior to enrollment
* Currently pregnant or plan to become pregnant within 6 months
* Current tobacco or e-cigarette smoker
TACTICS (Targeting Adherence to Cholesterol-lowering Therapy to Improve Control Study)

Background:

This is a randomized controlled trial (RCT) of two novel behavioral interventions to enhance treatment adherence and improve low-density lipoprotein cholesterol (LDL) in diabetes. Among adults with diabetes, high LDL greatly increases their risk for cardiovascular disease (CVD). Despite the proven efficacy of LDL control(\<100 mg/dL) in preventing CVD, the control rate is low. Poor adherence to treatment(diet, exercise and medication) is the main reason for this poor control.

Aims: This study will test two telephone-delivered interventions, a Transtheoretical stage-matched intervention (SMI) and a Prospect theory-based framing effects intervention (FEI). The investigators hypothesize that both SMI and FEI will be more effective in improving LDL control than an attention placebo intervention (API) at 6 months. SMI and FEI will also be more effective in increasing adherence to medications, diet and exercise than API at 6 months.

Methods:

The investigators will recruit 246 adults with diabetes and high LDL despite being on medications. Key outcomes are adherence to diet, exercise and medication, and LDL control. The interventions will be standardized and fidelity of intervention maintained. Using a blinded RCT the investigators will test the effect of SMI and FEI compared to API on LDL control and adherence. All analyses will be intent to treat.

Significance:

This project will provide important information to improve diabetes-related behavior and lead to the implementation of novel interventions for lowering LDL in primary care settings among adults with diabetes. It may also provide the scientific rationale to use such approaches to control other risk factors in diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Adults with diabetes
* LDL greater than or equal to 100
* Cholesterol-lowering drug therapy for \> 6 months
* A working telephone
* At least 2 primary care visits in the past 1.5 years

Exclusion Criteria:

* Poor short-term survival (\< 1 year)
* Inability to understand English
* Recent major surgery (\< 3 months)
* Patients temporarily in the area
* Inability to provide consent
Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor

This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid tumor. Subsequently, an expansion part will further evaluate the biomarker, safety, pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.

This trial is designed to determine the safety, tolerability, maximum tolerated dose and recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle) to subjects with advanced solid tumor in the dose escalation part so that biomarkers, efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose escalation design for a small sample size.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically and/or cytologically confirmed advanced solid tumor
2. Patients who were refractory to standard therapy or for which there are no standard treatment options available
3. Age 20 to 80 years at the time of informed consent
4. Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
5. Patients informed of the diagnosis of advanced solid tumor who are fully informed about the content of the study by the investigator or subinvestigator using the specified written consent form and other written explanation, and give written consent to participate in the study of their free will
6. Patients who are able to take oral medication

Exclusion Criteria:

1. Patients with symptomatic brain metastases
2. Patients who have not recovered from any prior therapy related toxicity deemed to be clinically significant at study entry, except for the test item defined in inclusion criteria.
3. Patients with active infections needing whole body therapy
4. Patients with positive hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody
5. Patients with positive human immunodeficiency virus (HIV) antibody
6. Patients with uncontrollable cardiac diseases
7. Patients with uncontrollable pain by analgesic drugs
8. Patients with a history of organ transplantation
9. Patients who have received another IMP
10. Patients who are pregnant, possibly pregnant, or lactating
11. Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial