cyrilzakka/clinical-trials huggingface dataset:
Gemcitabine (GFF) in Patients With Pancreatic Cancer

The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).

This open-label, multi center phase II study was conducted to investigate the efficacy and safety of the combination of 5-Fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients (pts) with advanced pancreatic cancer (APC). We consequently started this study after completing the phase I trial accomplished by our CONKO- study group.

Eligibility Criteria:
Inclusion Criteria:

* histological proved pancreatic cancer
* inoperable disease
* informed consent
* adequate bone marrow reserve

Exclusion Criteria:

* under 18 years
* brain metastasis
* lactating woman
* life expectancy under 3 months
PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC

This is a prospective cohort study, where the investigators aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Treatment for HFrEF at the outpatient clinic cardiology.
* Documented reduced ejection fraction of \<40% based on cardiac ultrasound or cardiac magnetic resonance imaging.

Exclusion Criteria:

* Opt-out for the use of routine clinical data for research purposes
Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis

Comparison of Montelukast and Azelastine In treatment of Allergic Rhinitis Allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. The importance of studying this disease can be seen from the high prevalence of this diseas. In addition to the high prevalence, due to the reducing effect of this disease on the economy and academic performance of patients, a great burden is imposed by this disease on the country's health care system.Also finding the best treatment of allergic can help to control of Asthma if exists concurrently.

Inflammation of the nasal mucosa following the release of IgE can be shown as symptoms of runny nose, sneezing, nasal congestion.Many studies have been done in the field of allergic rhinitis to increase the cost-effectiveness of treatment of this complication. Among the treatments for this disease is the use of antihistamine nasal sprays such as Azelastine. Combination therapies such as combining Mometason furoate or fluticasone with Azelastine or Montelukast can also be mentioned. However, there is still a long way to go to find the best drug combination to reduce the economic and human costs to the global health system. Due to the high prevalence of allergic diseases such as allergic rhinitis, finding the best treatment or management of such diseases plays an important role in improving the quality of life and reducing the economic burden on society.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-50years
* Moderate to severe allergic rhinitis

Exclusion Criteria:

* Under any treatment

  * Drug sensitivity
Genomic Opioid Optimization of Dosing and Selections (GOODS) Study

The researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient.

Participants, undergoing total knee replacements, will be randomized into two groups. Both groups will receive pharmacogenomics (PGx) testing preoperatively. The PGx guided group will have their results reviewed by the clinicians during their treatment and the results may guide clinical decisions. The control group results will be sealed until completion of treatment and clinicians will not have access to this information. These participants will undergo standard treatment dosing and medication selection.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary total knee arthroplasty
* Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.

Exclusion Criteria:

* Patients with a current diagnosis of chronic pain
* Patients requiring narcotics for greater than one week prior to surgery
* Patients with chronic kidney disease with a pre-op creatinine greater than 1.5
* Patient preference or need for spinal anesthesia rather than general anesthesia
* Patient planned for robotic surgical approach
Risk and Prevention Study: Evaluation of the Efficacy of n-3 PUFA in Subjects at High Cardiovascular Risk

In the everyday practice cardiovascular prevention in people at high risk is still unsatisfactory and treatments with documented efficacy are generally under-used.

Polyunsaturated fatty acids of marine origin (n-3 PUFA) are the latest more promising strategy to improve prognosis in these patients.

The Risk and Prevention study combines an epidemiological and an experimental approach in order to:

1. Verify the possibility to optimise cardiovascular prevention in subjects at high risk by planning the intervention with patients and setting individual goals (outcome study)
2. Evaluate the efficacy of a long term n-3 PUFA treatment in reducing the incidence of cardiovascular events, through a controlled, randomised, double blind clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Multiple risk factors:

  * diabetes,
  * age =\> 65 years,
  * male sex,
  * hypertension,
  * hypercholesterolemia,
  * smoking,
  * obesity,
  * family history of premature cardiovascular disease;
* Previous manifestations of atherosclerotic disease (ischemic stoke, transient ischemic attack \[TIA\], peripheral artery disease, previous arterial revascularisation procedures, angina pectoris)

Exclusion Criteria:

* Contraindications (known allergies to n-3 PUFA) or indications (previous myocardial infarction) for the treatment with n-3 PUFA
* Serious comorbidity with an unfavourable prognosis over the short term
* Expected non compliance over a long period of time
* Pregnancy
Identification of Serum and/or Plasma Biomarkers for the Diagnosis Prognosis and/or Prediction of Invasive Mycosis in Neutropenic Patients

The aim of the present work is to study the protein expressions profiles of neutropenic patients (with a high risk of invasive mycosis) who developed - versus who did not develop invasive mycosis (principally aspergillosis and candidosis) in order to identify biomarkers for the diagnosis, prognosis and /or prediction of invasive mycosis.


Eligibility Criteria:
Inclusion Criteria:

* - Patients with malignant haemopathy who received chemotherapy likely to lead to severe neutropenia (PN\<500/mm3) for a foreseeable period of 10 days.
* Patients aged 14 years or older (no upper age limit)
* Patients with malignant haemopathy who received an autologous marrow graft.
* Patients with severe idiopathic medullar aplasia (PN\<500/mm3) who need to be hospitalised for at least 10 days consecutively (with or without immunosuppressant treatment).
* Patients who have provided written informed consent to participate in this study.

Exclusion Criteria:

* Patients who received an allograft of marrow or hematopoietic stem cell transplant (given that these patients carry a risk of aspergillosis, which in most cases appears after medullar recovery, they will not be included in the study).
* Patients who received an autologous hematopoietic stem cell transplant (given that the duration of the neutropenia is often less than 10 days).
* Patients who do not meet the inclusion criteria
* Persons not covered by the national Health Insurance Agency
Mental Health Services for Toddlers in Foster Care

Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior and biology, and are at risk for a host of mental health problems. Critical issues for toddlers straddle the challenges of infancy and preschool years. In particular, toddlers in foster care face significant challenges in forming new attachment relationships and developing behavioral and biological regulatory capabilities. This project will assess the effectiveness of an intervention that targets these issues. Attachment and Biobehavioral Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide nurturing care so that children develop secure, trusting relationships; and supporting children when they become overwhelmed that enhance children's ability to regulate behavior and biology. This intervention's effectiveness will be assessed in a randomized clinical trial.

This study assesses the efficacy of a 10-session intervention for young children in the foster care system. Children are randomly assigned to the experimental condition (ABC-T) or to a treatment control (DEF). In the Attachment and Biobehavioral Catch-up for Toddlers (ABC-T) condition, children's foster parents receive an intervention that focuses on nurturance, following children's lead, and helping children settle when they become overwhelmed. In the Developmental Education for Families (DEF) intervention, children's foster parents receive an intervention that focuses on enhancing children's cognitive and motor skills. Both of the interventions are provided in families' homes for 10 sessions of about 60 minutes duration. Outcomes include attachment (assessed in the Preschool Strange Situation), cortisol production (assessed diurnally), child behavior problems (assessed through laboratory procedures that stress children), and through psychiatric interviews.

Eligibility Criteria:
Inclusion Criteria:

* 2 -3 years of age, in foster care

Exclusion Criteria:

* Not in foster care
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients

The study will be investigating pharmacokinetics, safety and efficacy in patients less than 12 years of age with severe hemophilia A that have been previously treated with Factor VIII products ( including blood products).


Eligibility Criteria:
Inclusion Criteria:

* Male subjects less than 12 years of age with a documented history of severe hemophilia A (FVIII:C less than 1%).
* Subjects who are less than 6 years of age must have had at least 50 Exposure Days (EDs) to prior FVIII products (including blood products).
* Subjects who are equal to or greater than 6 years of age must have had greater than 150 EDs to prior FVIII products (including blood products).

Exclusion Criteria:

* For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor titer greater than ULN for the testing laboratory at the time of screening.
* Any other bleeding disorder in addition to hemophilia A.
* Treatment with any investigational drug or device within 30 days before the time of signing the parental informed consent/assent form.
* Major surgery planned to occur during the course of the study.
* Regular (e.g., daily; every other day) use of agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDS).
* Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous immunoglobulin \[IVIG\], routine systemic corticosteroids), or currently receiving immune tolerance induction (ITI) for inhibitor treatment.
* The subject is receiving treatment for HIV or hepatitis infection (unless the subject is on a stable antiviral regimen \[i.e., consistent treatment regimen for at least 3 months before the parental informed consent/assent form is signed\]).
* Platelet count less than 100,000/µL.
* Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international normalized ratio (INR) equal to or greater than 1.5.
* Known hypersensitivity to hamster protein.
Preventing Substance Use and Risky Behavior Among Rural African American Youth

The Rural African American Families Health (RAAFH) Project is a federally funded research study designed to evaluate the effectiveness two prevention programs designed for rural African American families. One program, FUEL, helps teens develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The sessions deal with goal setting, peer pressure, and staying in school.


Eligibility Criteria:
Inclusion Criteria:

* African American student in 10th grade
* Agree to randomization and assessment
* Resides in targeted county
* Target and parent speak English

Exclusion Criteria:

* Active psychoses
The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients

In kidney transplant patients atherosclerosis process is accelerated even in asymptomatic patients. This is mainly the consequence of immunosuppressive therapy. Dyslipidemia is treated with statins in low doses only as high doses can lead to rhabdomyolysis and are therefore contraindicated. As second lipid lowering agent most commonly ezetimibe is used. The investigators hypothesise that ezetimibe as a second lipid lowering drug in kidney transplant patients lowers LDL cholesterol for additional 10 per cent.

In addition to observing the lipid profile the investigators intend to look for other pathophysiological effects of ezetimibe, such as its influence on oxidative stress, endothelial function and inflammatory biochemical markers.

Eligibility Criteria:
Inclusion Criteria:

LDL \> 2.5 mM, Already treated with statin, Stable renal function of various GFR, Men or women older than 18 years, Signed informed consent.

Exclusion Criteria:

Acute heart disease or any heart disease in the last 3 months, kidney graft failure, active systemic inflammatory disease, active malignant disease, chronic diarrhea and malabsorption, transaminases increased \> 3 fold, creatin kinase increased \> 5 fold, hypersensitivity reactions, active peptic ulcer disease.
A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects.

SSS11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kDa PEG molecules. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SSS11 administered intravenously in healthy volunteers.

Objectives:

Primary:

• To assess the safety, tolerability of single dose SSS11 in healthy subjects

Secondary:

• To assess the pharmacokinetics, pharmacodynamics and immunogenicity of SSS-11 in healthy subjects

Enrollment and Number of Arms (planned):

40 subjects will be assigned into 5 dosing cohorts (1.5, 3, 6, 12 and 24mg) with 5-10 subjects each.

Original primary outcome Measures:

Safety: Physical exam，ECG，Clinical laboratory tests，AE，SAE Tolerance assessment：MDT，DLT

Original secondary outcome Measures:

pharmacokinetics: Cmax, Tmax, AUC, CL, Vd, t1/2 pharmacodynamics: level of serum uric acid Immunogenicity ：anti-SSS11, anti-uricase and anti-PEG antibodies

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18-45 years of age at time of consent; 2. Subjects are in good health, without any clinical significant symptoms or laboratory test; 3. Having a body mass index between 19 and 28 kilogram per meter square (kg/m²); 4. Capable of giving written informed consent 5. Understanding and being willing to comply with the requirements of protocol, participate to complete the study; 6. Having recovered if received a surgery before . Exclusion criteria：

1. Allergic condition or having the history of allergic reactions to any drugs, pegylated products, or more than two substances;
2. Use of any medicine within 4 weeks or shorter than 5 half-lives;
3. Use of any medicine within 12 weeks, which is harm to any organ;
4. Participated in any other clinical trial within 12 weeks;
5. History of blood donation within 12 weeks;
6. History of glucose-6-phosphate dehydrogenase deficiency;
7. History of catalase deficiency;
8. Any significant disease, including but not limited to the following: digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatry system, hematological system, immune system, metabolic system abnormity.
9. Abnormal significance clinical laboratory tests within 2 weeks such as routine blood test and urinalysis, blood chemistry, ECG.
10. Positive serology for hepatitis B surface antigen , or antibodies to hepatitis C, or HIV and syphilis;
11. Pregnancy, planning pregnancy, or breastfeeding;
12. Positive pregnancy test;
13. Male subject without effective contraception or his partner intend to be pregnant within 6 months;
14. History of mental disorder or disabilities legally;
15. History of alcohol abusing during the last 6 months;
16. More than 5 cigarettes per day during the last 6 months;
17. Positive drug abuse or alcohol test;
18. More than 1L of strong tea, coffee or caffeine drink per day;
19. Can't understand the content of informed consent form ;
20. Any condition, which investigators consider, is not fit for the trial
Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent;
2. Male and female patients on diet and exercise regimen who are drug-naïve;
3. HbA1c \>= 7.0% and \<= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c \> 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
4. Age \>= 20 (Japan); Age \>= 18 (countries other than Japan);
5. BMI \<= 45 kg/m2 at Visit 1 (screening);
6. Signed and dated written informed consent by date of Visit 1

Exclusion criteria:

1. Uncontrolled hyperglycaemia;
2. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
3. Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
4. Impaired renal function (eGFR\<50 ml/min);
5. Bariatric surgery within the past two years or other GI surgeries;
6. Medical history of cancer;
7. Contraindications to sitagliptin;
8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
10. Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
11. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
12. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
13. Alcohol or drug abuse;
14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Imaging Characteristics of Breast Cancer in Women Under 40 Years of Age

To evaluate if there is any imaging characteristic of breast cancers in women younger than 40 years of age.

In Western countries, breast cancer is the most commonly diagnosed cancer in women and breast cancer screening using mammography has reduced breast cancer mortality by 18-29%. In Taiwan, breast cancer is the second most common cancer in women and the Bureau of Health Promotion, Department of Health has started breast cancer screening using mammography in women between 50 and 69 years old since 2002, between 40 and 49 years old since early 2004. However, young women at 20 to 39 years of age have never been enrolled in the mass screening mammography program because of their relatively young age and mammographic findings of breast cancer in young women were seldom reported.Some authors found out that breast cancer in young women is more advanced and more often presents with a mass, has higher grade, more extensively proliferating and vessel invading disease when compared with those in older age groups. Most intraductal carcinomas (\>80%) present as clustered microcalcifications on mammograms, and the sensitivity of mammography can be reduced in younger, denser breasts. Given these, mammography seems not to be a proper diagnostic tool for breast cancer women at a younger age. However, this presumption needs to be clarified since there are neither definite documented facts regarding breast cancer manifestation of young women on mammograms, nor documented sensitivity and false-negative rate of mammography in detecting of breast cancer among young women, at whom mammography is seldom used to be a diagnostic imaging tool. Our study is conducted to analyze the mammographic findings of breast cancers in young women between 20 and 39 years of age, regarding tumor size, location, major finding type, pathology type and grade. We will compare all of the above issues between younger age group and older age groups (40 to 49 and 50 to 69 years old).The breast ultrasound findings of the breast cancer among young women will be also compared with their corresponding mammographic findings, regarding the sensitivity, specificity, false-negative rate and accuracy.

Eligibility Criteria:
Inclusion Criteria:

* 20-39 years women with breast cancers

Exclusion Criteria:

* pregnant women
Clinical Effects of Soluble Dietary Fiber Supplementation

The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation.

Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time, constipation symptoms and fecal bacterial population in two groups.

Eligibility Criteria:
Inclusion Criteria:

* All patients(age≧18y)
* Admitted for slow-transit constipation were considered eligible

Exclusion Criteria:

* Mental disorders
* Cancer
* Inflammatory bowel disease