cyrilzakka/clinical-trials huggingface dataset:
Effect of Combined Morphine and Duloxetine on Chronic Pain

A double-blind, randomized, and placebo-controlled clinical study examining whether duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), could enhance opioid analgesia and reduce overall opioid use. Positive outcomes will help improve the overall effectiveness of clinical opioid therapy and reduce unnecessary opioid dose escalation.

Subjects will participate in a 10-week study consisting of three phases: Phase I is the dose titration period of 4 weeks, Phase II is the dose maintenance period of 4 weeks, and Phase III is the dose taper period of 2 weeks. Seven office visits (Initial visit/baseline, weeks 1, 3, 5, 7, 9, and end of week 10) and four follow up phone calls (weeks 2, 4, 6, and 10) will be used to collect data. Since this is a prospective study, we will be able to first determine baseline QST and VAS pain score, followed by assessing their longitudinal changes at each office visit. To assess OIH, QST will be performed at each office visit before subject takes the next dose of the study drugs. We will also measure plasma morphine concentration during the titration and maintenance phase to help validate morphine intake.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18-70 years old.
2. Subject has chronic neck or back pain for at least 3 months.
3. Subject has a VAS ≥ 5.
4. Has not taken duloxetine in the last 3 months.
5. Has not taken an opioid in the last 3 months, but has taken one in the past without sufficient pain control OR has never taken opioids but has failed at 3 (or more) non-opioid treatments.

Exclusion Criteria:

1. Subject has major psychiatric disorders requiring recent hospitalization (within 3 months) such as major depression, bipolar disorder, schizophrenia, anxiety disorder, or psychotic disorder.
2. Subject is using illicit drugs detected by urine toxicology/drug screen.
3. Subject is pregnant or lactating/breast feeding.
4. Subject is allergic to morphine or duloxetine.
5. Subject is on an antidepressant including serotonin-norepinephrine reuptake inhibitors (SNRI), selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant.
6. Subject has a history of suicidal attempts or current suicidal ideation.
7. Subject takes monoamine oxidase inhibitors, antipsychotics, triptan drugs such as sumatriptan, lithium, linezolid, tramadol (Ultram), St. John's Wort, central nervous system (CNS) stimulants such as amphetamine, methylphenidate, methamphetamine, phentermine, diethylpropion, sibutramine, cocaine, or thioridazine.
8. Subject has uncontrolled narrow-angle glaucoma.
9. Subject has sensory deficits on arms or Raynaud's Syndrome.
10. Subject has a pending litigation related to chronic pain condition.
11. Subject is on methadone or suboxone treatment for addiction.
LUMINIST: LUng Cancer Molecular Insights Non Interventional Study

The recent development of therapies targeting specific biomarkers mutations is changing the standards of care and prognosis of patients with advanced NSCLC, but very few data are currently available on those emerging biomarkers. In addition, the correlation of biomarkers with patients' clinical outcomes in a standard of care setting is poorly understood. This study aims to address that need.

The LUMINIST study will enrol patients who are ineligible for the SELECT-1 (NCT01933932) or SELECT-2 (NCT01750281)RCTs. Within this NIS patients will be followed longitudinally for treatment information and outcomes. The final dataset will enable linkage at the individual patient level of the clinical information datasets collected within LUMINIST to the exploratory biomarker data generated from samples collected as part of SELECT-1 screening. This will enable the examination of various molecular markers in patients with v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type and some KRAS mutation positive (KRAS+) patients. The LUMINIST study aims to enable the investigation of various molecular segments in NSCLC, based on patient consent and where permitted by local legislation, some of which have not yet been discovered. The availability of a longitudinal dataset of clinical information linked to tumour samples will be a valuable tool to readily assess the clinical utility of potential new biomarkers. The determination of current standards of care and outcomes in future molecular segments of interest will provide valuable new insights to the scientific community.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent from the patient or next-of-kin for deceased patient at study entry, where this is mandated by local regulations
2. Female and male adults (according to each country regulations for age of majority)
3. Patients who are not eligible or choose not to enter selumetinib SELECT-1 or SELECT-2 trials
4. Patients with confirmed histological diagnosis of NSCLC

Exclusion Criteria:

1. Involved in the planning and/or conduct of this study (applies to both AZ staff and/or staff at the study site)
Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil

Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and women
* Age ≥ 25 and ≤ 75 years old
* Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
* Total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/L
* 10-year CVD risk equal or lower than 10% according to "SCORE"
* Blood pressure, heart rate, hematological parameters, clinical chemical parameters within normal reference ranges
* Informed consent and biobank consent signed
* Willing to comply to study protocol during study
* Agreeing to be informed about medically relevant personal test-results by a physician
* Not smoking
* Accessible veins on the forearm
* Habitually consuming spreads

Exclusion Criteria:

* Pregnant or having the wish to become pregnant, or lactating
* Use of prescribed medication which may interfere with study measurements
* Use of antibiotics in the 3 months before screening or during the study
* Use of any medically- or self-prescribed diet with the purpose to reduce weight
* Intolerance for gluten or lactose
* Reported food allergy
* Having bleeding disorders
* Recent blood donation
* Excessive alcohol consumption
* Strenuous exercise
* Reported weight change ≥ 10 % of body weight or use of prescribed weight reduction drugs
* Recent participation in another nutritional or medical trial
* Participation in night shift work
Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation

To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration

The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.

The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.

The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.

Eligibility Criteria:
Inclusion Criteria:

* documented atrial fibrillation in the 12-lead ECG or Holter ECG
* Paroxysmal symptomatic atrial fibrillation
* Ineffectiveness of antiarrhythmic medication ( at least 1 medication )
* Age 18-75 years
* left atrial diameter \<60 mm ( Transesophageal Echocardiography, parasternal )
* A signed consent form

Exclusion Criteria:

* Reversible etiology of atrial fibrillation
* Pregnancy
* Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
* Intracardiac thrombus
* Contraindication to anticoagulation
* Thromboembolic event in the last 6 months
* Previous left atrial ablation
Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients

The study evaluates the efficacy of heart function improvements in type 2 diabetes and heart failure patients with exenatide, and also investigates the mechanisms of exenatide improving heart function.

The study enrolls 234 patients with type 2 diabetes and heart failure. The patients have an New York Heart Association (NYHA) functional class of II to IV, are randomly assigned to 2 groups. One group use exenatide , the other group is control group and each group has 117 patients. At the baseline, the 3rd day, the 28th day patients are required to complete the heart failure examination: plasma N-terminal pro-B-type natriuretic peptide(NT-proBNP), 6-min walking distance, echocardiographic measures, patient quality of life(MLHFQ). At the end of 4-week follow-up, we evaluate the efficacy of heart function improvements after treatment with exenatide and also investigate the mechanisms of exenatide improving heart function .

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed Type 2 diabetes mellitus
2. HbA1c 7%-10% and Fasting plasma glucose(FBG) \<10mmol/L
3. Age 18-65 years
4. NT-proBNP level≥ 450 pg/ml
5. Left ventricular ejection fraction (LVEF)\<40%

Exclusion Criteria:

1. Uncorrected primary vascular disease
2. congenital heart disease
3. Left ventricular outflow obstruction
4. Myocarditis
5. Aneurysm
6. uncontrolled severe arrhythmia
7. cardiogenic shock
8. unstable angina, or acute myocardial infarction
9. Severe primary hepatic, renal, or hematologic disease
10. Cr\>194.5 mmol/l or K+\>5.5 mmol/l
11. Systolic blood pressure (SBP) ≥180mm Hg or diastolic blood pressure (DBP) ≥110mm Hg
12. Alanine aminotransferase (ALT) \>3 times the upper normal limit
13. Patients were likely to undergo coronary artery bypass graft surgery during the following 4 weeks
14. Patients had undergone or were likely to undergo cardiac resynchronization therapy
15. Pregnant or lactating known
16. Suspected to be allergic to the study drugs
17. Use dipeptidyl peptidase-4 (DPP-4) or glucagon-like peptide-1 (GLP-1) drug in 3 months
18. Hyperthyroidism and Hypothyroidism
19. Tumor
20. Received another investigational drug within 30 days prior to randomization
21. Severe mental health condition or other uncontrolled systemic disease.
Trial Evaluating Combined Chemotherapy in Patients With Metastatic Pancreatic Adenocarcinoma

GATE 1 is an open-label, non-comparative, multicentric study evaluating the efficacy and tolerance of the combined use of Gemcitabine, Trastuzumab and Erlotinib as a first-line chemotherapy in metastatic pancreatic cancer patients.

The patients will be treated intravenously with Gemcitabine at a dose of 1000 mg/m2 for 30 min. For the first eight weeks, Gemcitabine will be administered once weekly for 7 weeks followed by one week of rest. Subsequently, Gemcitabine will be administered once weekly for three weeks followed by one week of rest.

Trastuzumab will be administered once a week at a dose of 4 mg/kg over 90 min. at D1 and then at 2 mg/kg over 30 min. for the subsequent infusions.

Erlotinib will be administered orally at a dose of 100 mg/day from C1D1.

The patients will be subjected to research for the EGFR, HER2 and KRAS status.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic pancreatic adenocarcinoma confirmed by histology
* Tumor sample available
* Measurable lesion according to RECIST criteria
* Performance status ≥ 1
* Life expectancy \> 3 months
* Hematology: Hb ≥ 9g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
* Renal function: creatinine ≤ 1.5 x ULN
* Hepatic function: total bilirubin ≤ 2.5 x ULN, transaminases ≤ 5 x ULN
* Left ventricular ejection fraction (LVEF) ≥ 50%
* At least a 6-month delay between the end of any previous gemcitabine-based chemotherapy and diagnosis of metastases
* Social security
* Informed consent obtained prior to inclusion.

Exclusion Criteria:

* Non metastatic advanced local disease
* Presence of cerebral metastases or symptomatic leptomeningeal carcinomatosis
* Others cancers except BBC and cervical cancer receiving curative treatment
* No previous treatment by Erlotinib or Trastuzumab
* Known severe hypersensitivity to Erlotinib, Trastuzumab, murine proteins or Gemcitabine
* Presence of significant co-morbidities
* Concomitant treatment with other experimental products or other anticancer therapies
* Breastfeeding or pregnant female, or patient of reproductive age not using adequate contraception
* Legal incapacity or limited legal incapacity
Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine

This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. All the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.

The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and Treatment of Dyslipidaemia in Adults (2016, revision edition).

Eligibility Criteria:
Inclusion Criteria:

1. Meet at least three of the requirements below; 1) Fasting Plasma Glucose \> 6.1 mmol/L or 2-hour Postprandial Blood Glucose \> 7.8 mmol/L or diagnosed as type 2 diabetes mellitus; 2) Body Mass Index \> 25 kg / m2; 3) Total Cholesterol \> 5.2 mmol / L; Or Triglyceride \> 1.70 mmol / L; Or Low-Density Lipoprotein \> 3.12 mmol / L; Or High-Density Lipoprotein \< 1.04 mmol/L. 4) Systolic blood pressure \> 130 mmHg or Diastolic blood pressure \> 85 mmHg or diagnosed as hypertension;
2. Received 6 months of continuous Chinese herbal medicine treatment;
3. During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before.
4. During the period of receiving Chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution.
5. Aged 18 to 80 years at the time of their consent;
6. Signed informed consent.

Exclusion Criteria:

* Patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.
Effectiveness of Interfaces Program to Promote Work Ability of People With Disabilities

the objectives of the study is to Evaluate the effectiveness of "The Interfaces Program" to promote person's components, performance and improving the work environment of people with disabilities.

People with disabilities experience many barriers in trying to integrate into the competitive market. The barriers may be result of the unique characteristics of the individual (characteristics of the disability, occupational history, work self-efficacy, etc.), the characteristics of the occupation and occupational performance (characteristics of the job and the job demands) and environmental barriers (accessibility, discrimination, stigma and lack of opportunities, etc.). The main response to the integration problems of people with disabilities in the world of work is supported employment service. Supported employment focuses primarily on placement of the individual and do not relate to barriers relating to the individual's ability to develop a career.

The present study examines the effectiveness of a new intervention program "The interfaces program " aiming to promote career development process among people with disabilities working in the competitive market. The program presents an integration of the Person-Environment-Occupation-Performance (PEOP) model and lead career development theories. The ultimate goal of this study is to examine the effectiveness of the "interfaces program" by examining its impact on the promotion of objective and subjective measures among people with disabilities who work and receive supported employment services.

Eligibility Criteria:
Inclusion Criteria:

* psychiatric or physical disability
* 12 years of educations minimum
* at least 26 score on the Montreal cognitive assessment ( MOCA)
* working at least 3 month in the open market

Exclusion Criteria:

* autistic spectrum disorder (ASD)
* Developmental Cognitive Disability
* alcohol or drags comorbidities
Expression Profiles of Integrin αDβ2 on Neutrophils in Sepsis

In this research study we want to learn more about the characteristics of neutrophils that are present in the blood and secretions from a breathing tube of patients with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in the lungs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood and secretions from the breathing tube of patients with sepsis so that they can work to develop therapies to prevent these cells from being harmful.


Eligibility Criteria:
Case Inclusion Criteria:

* sepsis patient in the ICU with a breathing tube

Control Inclusion Criteria:

* scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure
* Plan to have endotracheal tube for planned procedures.

Exclusion Criteria:

* On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases (oncology patients, patients with transplantation)
A Phase Ib Study of Panobinostat (LBH589) in Combination With 5-Azacitidine for Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML) Patients

The purpose of this study is to confirm the safety and tolerability of oral panobinostat (PAN) in combination with a fixed dose of 5-Azacitidine (5-Aza) in adult Japanese patients with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

1. Japanese patients who are candidates for treatment with 5-Aza and present with one of the following:

   * intermediate-2 or high-risk MDS according to the International Prognostic Scoring System (IPSS). OR
   * AML with multilineage dysplasia and maximum of 30% blasts (former RAEB-T according to FAB) OR CMML
2. Patient has an ECOG performance status of ≤ 2
3. Patients must have the following laboratory values unless elevations are considered due to MDS or leukemia: AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN; serum creatinine ≤ 1.5 x ULN; serum bilirubin (total and direct) ≤ 2 x ULN; electrolyte panel without clinically relevant abnormalities

Exclusion Criteria:

1. Patient who is planned for or has history of hematopoietic stem-cell transplantation (HSCT)
2. Patients with relapsed/refractory AML
3. Patient is receiving concurrent anti-cancer therapy
4. Patient has received prior treatment with deacetylase inhibitors (DACi)
5. Patient has received prior treatment with 5-Aza or 6-aza-2'-deoxycytidine (decitabine)

7. Patient has shown suspected hypersensitivity to 5-Aza or Mannitol 8. Patients with impaired cardiac function 9. Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pontes if such treatment cannot be discontinued or switched to a different medication prior to starting study treatment 10. Patients with clinical evidence of relevant mucosal or internal bleeding 11. Patient has any other concurrent severe and/or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) age 18-55, BMI 18-35

Exclusion Criteria:

* pregnancy
* significant diabetes complications
* liver disease, cirrhosis
* cardiac disease
* neurological disorder
* autonomic neuropathy
* kidney disease
* lactose intolerance