cyrilzakka/clinical-trials huggingface dataset:
Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

Primary Objective:

To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen

Secondary Objective:

To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen

The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.

Eligibility Criteria:
Inclusion criteria:

* Male or female subjects, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association
* Body weight between 50.0 kg and 110.0 kg,
* Body Mass Index between 18.0 and 30.0 kg/m2 inclusive
* Stable insulin regimen for at least 2 months prior to study
* Certified as otherwise healthy for Type-1 Diabetes mellitus patient by assessment of medical history and physical examination
* Women of childbearing potential must have a negative pregnancy test and must use a highly effective method of birth control. During the entire study female subjects of child bearing potential must use two independent methods of contraception. The accepted double contraception methods include use of an intra-uterine device or hormonal contraception in addition to one of the following contraceptive options: 1) condom; 2) diaphragm; cervical/vault cap; 3) spermicide.

Exclusion criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness
* More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
* Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
* Participation in a trial with any investigational drug during the past three months
* Symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
* Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days
* Known hypersensitivity to insulin glargine or excipients of the study drug
* Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed and dated
* BMI ≥40 kg/m2 or BMI between 35 and 40 kg/m2, but with a severe disease together with obesity
* Indication for gastric bypass surgery
* Upper digestive endoscopy prior to surgery not showing esophagitis, erosions, ulcers or neoplasia, examination performed up to 30 days before surgery being considered valid
* Helicobacter pylori non-infected patients, diagnosed by tests carried out up to 30 days before surgery

Exclusion Criteria:

* Contraindication for gastric bypass surgery
* Contraindication to use Omeprazole and derivatives
* Patients carriers of gastrinoma or having hypergastrinemia
* Patients contraindicated to perform UDE
* Patients with previous esophagogastroduodenal surgery
BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort

Atopic dermatitis (eczema) is a complicated skin condition. In fact, it represents many different underlying problems. These include abnormalities in the skin barrier, the immune system and the ability to handle different bacteria. Despite many recent gains in the understanding of eczema, a lot needs to be learned. There is little evidence to select between some of the older treatments that are available now. Even the newest targeted therapy does not clear most patients' skin. In order to improve the understanding of eczema, how to treat it now, and to enable discovery of new treatments, the investigators plan to enroll patients into a large study at three centres in Canada (University of Toronto, McGill University and University of British Columbia). The study is called the Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI). In this study, the investigators will collect data on how severe participants' eczema is and what treatments they use. For participants who give permission, the investigators will collect blood and skin biopsy samples to study the mechanisms underlying their disease. The investigators will test to see which form of phototherapy (Broadband or Narrowband Ultraviolet B phototherapy) works best for eczema in a randomized clinical trial. The investigators will also use advanced imaging techniques to visualize the skin.

This trial registry entry, including the description of the treatment arms and outcomes, refer to the nested BROadband vs Narrowband photoTherapy for Eczema clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Atopic dermatitis according to the Hanifin and Rajka criteria.
2. Validated Investigator Global Assessment score of 3 or 4 out of 4
3. Eczema Area and Severity Index (EASI) score ≥7.1
4. Moderate to severe disease as above despite an adequate trial of topical therapy.

Exclusion Criteria:

1. Treatment with phototherapy or oral systemic immune-modulating agents (cyclosporine, methotrexate, azathioprine, mycophenolate) less than 30 days before baseline.
2. Treatment with systemic biologic (dupilumab) or experimental therapeutic less than 90 days before baseline.
3. Current treatment with oral or intramuscular corticosteroids within 30 days prior to baseline. Topical, intralesional or inhaled corticosteroids are allowed.
4. Participating in a clinical trial assessing an investigational agent for atopic dermatitis (topical, systemic or device) within 90 days prior to enrollment.
Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

The goal of this study is to investigate the hemostatic balance in children with acute lymphoblastic leukaemia (ALL) treated according to the ALLTogether1 protocol with focus on the early treatment period including concomitant use of steroids and asparaginase.

The investigators aim to determine if complement proteins or microparticles can be used as clinically relevant predictive or diagnostic biomarkers for thrombosis and if global hemostatic assays can predict bleeding or thrombosis. Characterization of proteins connected to hemostasis before and during ALL treatment may provide pathophysiological insights regarding ALL- and treatment related coagulopathy. The ultimate goal of the study is to minimize the morbidity and mortality related to thrombosis and bleeding complications in children with ALL.

Several pediatric oncology centers in Sweden will be participating in this study, which will enroll approximately 100 pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Lymphoblastic Leukaemia (ALL) in Sweden
* Age 1-17.99 years at diagnosis
* Planned/Initiated treatment for ALL according to the ALLTogether1 protocol
* Signed informed consent from parents and patients (from 12 years - voluntary if \<15 years)

Exclusion Criteria:

* Other underlying diseases which according to examiner's clinical assessment may increase the risk of bleeding or thrombosis and which are expected to lead to adaption of the therapy protocol for ALL (e g APS, moderate/severe v Willebrand disease, haemophilia)
* Patient not treated according to the ALLTogether1 protocol (including patients with BCR::ABL1, mixed phenotype acute leukaemia - MPAL)
Implementation and Evaluation of the Graded Repetitive Arm Supplementary Program (GRASP) for People With Stroke

The goal of this clinical trial is to compare the effect of the Graded Repetitive Arm Supplementary Program (GRASP) with the usual care on upper extremity function in individuals with stroke.

The main questions it aims to answer are:

* Compare the effectiveness of the GRASP program delivered by train occupational therapists
* Explore the patients' and therapists' experiences of the GRASP program using interviews and surveys

Stroke participants will receive either the GRASP program or Usual Care for four weeks (3 sessions/week). Stroke participants will be evaluated before, immediately after, and 3 months after the intervention. Therapist participants will be trained for the delivery of the GRASP program. Interviews and surveys/questionnaires will be administered to understand patients' and therapists' perspectives on the implementation of the GRASP program.


Eligibility Criteria:
Inclusion Criteria:

* 1) are aged 20 years or older, 2) stroke onset \> 3 months, 3) have upper extremity hemiparesis due to the first-ever stroke, (4) have some voluntary movement in the affected UE, including the ability to lift the affected arm to chest level and hold for 5 seconds, some ability to extend the affected wrist, and some ability to grasp and release an object such as a cup handle, and 5) are able to follow 2-step instructions.

Exclusion Criteria:

* 1) orthopedic conditions affecting the arm/hand or other neurological conditions, 2) severe pain that prevents movement in the affected arm and hand, and 3) unstable medical status.
A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine

The purpose of this study is to evaluate the pharmacokinetics of a single dose of intranasally administered esketamine in participants with impaired renal function when compared to participants with normal renal function.

This is an open-label (all people know the identity of the intervention), single-dose, single-center, parallel group study to characterize the pharmacokinetics and safety of a single 28 milligram (mg) dose of esketamine in both participants with varying stages of renal impairment and healthy participants. A total of approximately 32 medically stable men and women with varying degrees of renal function impairment or no renal impairment will be enrolled. The study consists of a Screening period of up to Days -21 to -2, open label phase of Days -1 to 4, and end-of-study (11 plus \[+\] or minus \[-\] 2 days after final dose). The participants will be assigned to 1 of 4 groups (8 participants per group) based on creatinine clearance (CLCR,m). Safety and tolerability will be assessed from the time of consent until the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
* For women of childbearing potential, must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening; and a negative urine pregnancy test on Day minus (-) 1
* Comfortable with self-administration of intranasal medication and able to follow instructions provided
* Hemoglobin concentration of greater than or equal to (\>=) 10 grams per deciLiter (g/dL) (Only for cohorts 1, 2, and 3)
* Platelet count of \>= 50,000 counts/microliter (Only for cohorts 1, 2, and 3)

Exclusion Criteria:

* Current or previous diagnosis of psychotic or major depressive disorder (MDD) with psychosis, bipolar or related disorder, intellectual disability, borderline personality disorder, or antisocial personality disorder
* A lifetime history of cerebrovascular disease including stroke or transient ischemic attack, aneurysmal vascular disease
* Unstable coronary artery disease or myocardial infarction in the last 12 months or any unstable angina requiring revascularization procedure, hemodynamically significant valvular heart disease, or New York Heart Association Class III-IV heart failure
* Has had a renal transplant or diagnosis of systemic lupus erythromatosus or renal carcinoma
* Has a nasal piercing
* Participant requires dialysis (Only for cohorts 1, 2, and 3)
Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults

Spinal surgery often involves multiple segments. The trauma of surgery is large, the duration of postoperative pain is long, and the pain is severe. Therefore, the use of opioids in perioperative period is large. Although the application of \* large amounts of opioids can effectively inhibit pain, it will delay the recovery of urine retention, sedation, respiratory depression and gastrointestinal function. The delayed recovery of gastrointestinal function will increase the postoperative complications, and then increase the length of hospital stay and the cost of patients. Therefore, reducing the dosage of opioids to promote the recovery of gastrointestinal function has become the research direction. Intravenous lidocaine has been proved to be effective in reducing the dosage of opioids during the perioperative period of gastrointestinal surgery and promoting the recovery of postoperative gastrointestinal function. However, there are few studies on the application of lidocaine during the perioperative period of spinal surgery, especially the impact on postoperative gastrointestinal function. In this study, a multicenter, randomized, double-blind, controlled study was conducted to explore the effect of perioperative lidocaine on the recovery of gastrointestinal function after adult lumbar surgery. We hypothesized that lidocaine could shorten the recovery time of gastrointestinal function after lumbar surgery


Eligibility Criteria:
Inclusion Criteria:

1. age 60 to 80;
2. ASA physical status score of I, II or III;
3. Scheduled to undergo a posterior lumbar surgery;
4. Ideal body weight≤80 kg;

Exclusion Criteria:

1. Those who are refused to be included;
2. Those who are allergic to the drugs used in this study;
3. Emergency operation
4. Degree II or III atrioventricular block
5. heart failure
6. History of ALS, preexcitation or active dysrhythmia
7. Severe liver injury (bilirubin \> 1.46 mg/dl)
8. Severe renal injury (creatinine clearance \< 30 ml/min) or Renal failure
9. History of epilepsy
10. History of porphyria
11. Preoperative hypotension (SBP\< 90mmHg)
12. Drug contraindications of NSAIDs
13. Allergic to anaesthetic
The Effect of Nurse Practitioner Led-Care on Quality of Life in Patients With Atrial Fibrillation

Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms as well as increases the person's risk of stroke and heart failure. With an ageing population, increasing rates of AF and limited access to specialists, new methods of care, like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide sustainable care.

The objective of the project is to evaluate the effect of Nurse Practitioner-led care in people with AF on their quality of life.

The Canadian Healthcare system is overwhelmed, with increasing costs and wait times. Contributing to these issues, is AF is the most common arrhythmia accompanied with costly complications including stroke and heart failure. Currently family or emergency room physicians ask general cardiologists or specialized cardiologists, to provide care to patients with AF. Unfortunately, there is limited access to their services. NP's are nurses who have taken extra education at University to treat patients and prescribe medications. This research project involves an NP who has specialized training in AF patient management.

By utilizing an NP to provide care for patients with AF, the investigators hope to improve patient's quality of life and satisfaction with care. This may also reduce complications of AF.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Documented non valvular atrial fibrillation
* Able to provide informed consent
* Able and willing to complete the study questionnaires on own or with assistance

Exclusion Criteria:

* Referral is for atrioventricular node ablation or pulmonary vein isolation.
* Patients who have failed antiarrhythmic medications
* Patients with moderate to severe mitral or aortic valvular heart disease
* Clinically unstable atrial fibrillation
* Cannot or unwilling to attend follow-up appointments
The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer

Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis, even though the first line chemotherapy showing about 70% response rate. Most of the patients will relapse with in 6 months after the chemotherapy and the following therapy such as second line chemotherapy have a very limited efficacy to these patients. Currently, there is no standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).

As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases report in the patients with SCLC, the aim of this clinical trial is to investigate the efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive disease and failed to first line/ second line chemotherapy.

Primary end point: Objective Response Rate(ORR)

Secondary end point:

Progression Free Survival(PFS), Overall Survival(OS), Side effects according to Common Terminology Criteria for Adverse Events(CTCAE) version 4.0 Quality Of Life(QOL) etc.

Eligibility Criteria:
Inclusion Criteria:

1. Obtain of informed consent.
2. Male or female aged 18 years and over.
3. Histologically or cytologically confirmed small cell lung carcinoma.
4. Extensive disease before receive nab-paclitaxel.
5. Failed to previous chemotherapy, but the previous paclitaxel chemotherapy is not allowed.
6. World Health Organization (WHO) performance status (PS) of 0 to 2.
7. Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
8. Heart index values is in the range, as defined below, within two weeks of randomization:

   * Absolute neutrophils count(ANC)≥2.0×109/L
   * Platelets≥100×109/L
   * Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT) ≤2.5×ULN(≤5×ULN if liver metastases)
   * Creatinine clearance≥60ml/min
9. Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) criteria with at least one measurable lesion not previously irradiated.
10. Life expectancy ≥12 weeks.

Exclusion Criteria:

1. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
3. Known severe hypersensitivity to nab-paclitaxel or any of the excipients of these products.Known severe hypersensitivity to pre-medications required for treatment with nab-paclitaxel doublet chemotherapy.
4. Prior treatment with paclitaxel.
5. Pregnant or lactating woman.
6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
7. Life expectancy of less than 12 weeks.
Magnesium Associated With Morphine for Cancer Pain Relief

This study is an evaluation of the analgesic effect of magnesium associated with morphine in patients with cancer pain.

The study is prospective, randomized, double-blind. The patients will be allocated into two groups. After approval by the Ethics Committee and signed informed consent, 40 patients, aged \> 18 years of both genders with cancer pain, will be studied.

The patients in group 1 (n = 20) will receive a dose of magnesium sulfate (65 mg) po twice daily. Patients in Group 2 (n = 20) will receive placebo twice a day. The Mg and placebo capsules are identical. Everyone will receive morphine as needed.

Will be recorded: tumor location, factors which worsen the pain, quality of pain. Pain intensity will be assessed by numerical scale from zero to 10 at T0 (first visit) and after 1, 2, 3. and 4wk.

The patient will note the intensity of pain and side effects at home. Functional performance assessment will bes done by the Karnofsky Performance Status Scale. Quality of life will be assessed by the QLQ-c30.

Eligibility Criteria:
Inclusion Criteria:

* After approval by the Ethics Committee and signed informed consent,
* 40 patients, \> 18 years, with cancer pain, and taking morphine (third step of the analgesic ladder recommended by WHO) were studied

Exclusion Criteria:

* Were excluded from the study patients with hypersensitivity to drugs and pregnant
Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* ≥18 years old, diagnosed with persistent or chronic ITP

Exclusion Criteria:

* Secondary immune thrombocytopenia
* Drug induced thrombocytopenia
EARLY-MYO-SEPSIS Registry

The diagnosis and pathophysiology of sepsis-induced cardiac dysfunction remain unknown. This registry is to evaluate characteristics of sepsis patients by multi-modalities imaging, including echocardiography, cardiovascular magnetic resonance imaging in 300 patients in 5 sites. Subjects will be followed up to 2 years.

Approximately 20-30 million patients worldwide suffer from sepsis every year, which is increasing at the rate of 8% to 13% per year. It is possible that sepsis progress to multiple organ dysfunction in the early stage, with a fatality of 30% to 60%. Myocardium is one of the most vulnerable tissue under the abnormal 'inflammation storm'.Cardiac dysfunction is one of the important predictors for mortality of sepsis.Patients with myocardial depression have an apparently higher mortality rate (70%) as compared with septic patients without cardiac impairment (20%).

Although several trials had explored the diagnosis and treatment of sepsis-induced cardiac dysfunction, the effective characteristic depict and effective therapy remain incompletely understand.

This is a prospective, multi-center, non-randomized, observational registry study of sepsis patients that undergo multi-modality imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patiants meets the criteria of Sepsis 3.0 as below:
* Sepsis is a lifethreatening organ dysfunction caused by a dysregulated host response to infection
* 1 patients in ICU：
* 1.1 have at least one organ dysfunction
* 1.2 SOFA score ≥2
* 2 patients not in ICU
* 2.1 have at least one organ dysfunction
* 2.2 SOFA score or qSOFA score ≥2

Exclusion Criteria:

* 1. Patient who is unable to comply with the follow-up schedule.
* 2. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
* 3. Patient has a life expectancy of less than 6 months due to any condition