cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®

This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.

This is a proof-of-concept, open label study, to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy of 2.5 mg AIR DNase TM administered once daily for 28 days via inhalation to Cystic Fibrosis subjects who have previously been treated with Pulmozyme®.

This multicenter study will be conducted in approximately 10 sites and will enroll up to 15 subjects.

Eligibility Criteria:
Main Inclusion Criteria:

1. Age ≥ 12 years of age (inclusive) at the time of screening
2. Weight ≥ 36 kg
3. Prior confirmed diagnosis of CF
4. At least 4 months treatment with Pulmozyme® prior to screening.
5. The subject is medically stable for at least one month prior to the screening visit.
6. Stable inhaled regimen of either: antibiotics, steroids, hypertonic saline at least four months prior to screening visit.
7. FEV1 of \>40% and \<90% and FVC ≥ 40% of predicted normal for age, gender, and height at screening .
8. Female and male subjects whose co-partners are of child bearing potential must agree to use two medically acceptable methods of contraception, not including the rhythm method.
9. Be willing and able to adhere to the study visit schedule and other protocol requirements
10. Be willing and able to provide voluntary written informed consent

Main Exclusion Criteria:

1. Has a history of lung transplantation.
2. Female subjects who are pregnant or lactating.
3. History of severe or unexplained adverse reactions during aerosol delivery of any medicinal product.
4. History or presence of hypersensitivity or reaction to inhaled proteins.
5. Participation in another clinical trial within 60 days prior to screening.
6. Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's safety or compliance with the requirements of the study.
7. Have positive serology for human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infection.
Ultrasound Examination Versus Palpation to Locate the Cricothyroid Membrane

Anesthesiologists get a course on localizing the cricothyroid membrane on a human using ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.

The ability to localize the cricothyroid membrane on patients before airway management is crucial in order to be able to follow the difficult airway algorithms.

Studies have show a high failure rate when anesthesiologists rely on palpation.

In this study Anesthesiologists get an e-learning course, get literature to study , and get a theoretical course and a hands-on course in using ultrasound for localizing the cricothyroid membrane. . Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.

Eligibility Criteria:
Inclusion Criteria:

* being an anesthesiologist attending our airway management course

Exclusion Criteria:

* unwillingness to participate
Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study

In this pilot study the investigators propose the intraoperative use of a high-resolution PET-CT imaging system which can assess resection margins and lymph node status in the operating room. This will allow for a faster and stepwise assessment (estimated to be under 10 minutes per specimen), enabling the surgeon to decide on subsequent surgical steps after each previous assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older.
* Patient with suspected or confirmed lung malignancies
* Patient is indicated to undergo thoracic surgery.
* Patient is estimated to be compliant for study participation by the investigator.
* Patient has freely given his/her informed consent to participate in this study.

Exclusion Criteria:

* Patient has general or local contra-indications for thoracic surgery.
* Patient has active infection.
* Blood glucose level over 200 mg/dL on the day of surgery.
* Pregnancy or lactation.
* Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year
Bedside Testing of CYP2C19 Gene for Treatment of Patients With PCI With Antiplatelet Therapy

Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary intervention (PCI) with stent implantation and during one year after PCI, to prevent atherothrombotic complications. However, clopidogrel is ineffective in certain patients due to genetic mutation in CYP2C19 gene a specific enzyme in the liver required for metabolism of clopidogrel. Therefore, the purpose of this study is to test these patients genetically at bedside and prescribe an alternative drug such as Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight \< 60kg) if they are carriers of the allele 2 or 3 of the mutated gene.

Clopidogrel is crucial as antiplatelet treatment in patients undergoing percutaneous coronary intervention (PCI) with stent implantation and during one year after PCI, to prevent atherothrombotic complications. Clopidogrel is converted into its active metabolite by Cytochrome P2C19 (CYP2C19). However 30 % of the Saudi population is carrier of the non functional CYP2C19\*2 or \*3 alleles having an impaired CYP2C19 capacity, resulting in decreased effectiveness of Clopidogrel. These patients have a 42% higher risk for major cardiovascular events (MACE) compared to non carriers. Further 50 % of the MACE occurs in the first 48 hours. Therefore Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight \< 60kg) whose actions are not dependent on conversion by CYP2C19 may be an alternative only in carriers of the non functional CYP2C19\*2 or \*3 alleles. This might be cost effective and prevent patients form MACE. Therefore the objective of this study is to assess the efficacy, complication free survival, safety and cost-effectiveness of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel or prasugrel (or Ticlid). All participants will be followed for one year using follow up questionnaires.

Eligibility Criteria:
Male \& female age 18-70 years

Inclusion Criteria:

* Patient presents with acute myocardial infarction of more than 30 minutes and less than 12 hours
* Patient eligible for PCI

Exclusion Criteria:

* Life expectancy of less than one year
* Previously Known genotype
* Receiving chemotherapy for malignancy
* On dialysis or receiving immunosuppressive therapy or have autoimmune disease
* Hepatic impairment
* History of bleeding diathesis
* Receiving vitamin K antagonist therapy
* Confirmed hypertension
* Out of normal range platelet count
* History of major surgery
* Severe trauma or fracture
* Pregnancy and lactation
* Concomitant use of simvastatin, cytochrome P450 3A4 inhibitors or inducers
* Hypersensitivity to clopidogrel or ticagrelor or prasugrel
ECG-guided Immediate Primary PCI for Culprit Vessel to Reduce Door to Device Time

No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by PCI for the treatment of ST segment elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D) time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy time, cumulative air kerma(CAK) and dose area product(DAP).


Eligibility Criteria:
Inclusion Criteria:

* Patient must be \> 18 years of age
* Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI
* Symptoms ≥ 30 min and ≤12 hours
* Patient and treating interventional cardiologist agree for randomization
* Patient provides written informed consent
* Diagnostic and therapeutic intervention performed through transradial artery approach
* Palpable radial artery.

Exclusion Criteria:

* Concurrent participation in other investigational study
* Current platelet count \<100 x 10\^9cells/L or Hgb \<10 g/dL
* Absence of radial artery pulsation
* Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
* Uncontrolled hypertension
* Prior CABG surgery
* Fibrinolytic therapy for current MI treatment
* patient have a life expectancy of \<180days
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)

This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active moderate to severe rheumatoid arthritis (RA)
* On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
* Oral corticosteroids must have been at stable dose of \</= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
* Body weight \</= 150 kg

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry
* Rheumatic autoimmune disease other than RA
* Functional class IV according to American College of Rheumatology (ACR) classification
* Prior history of or current inflammatory joint disease other then RA
* Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
* Treatment with any biologic drug that is used in the treatment or RA
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Known active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency
* Positive for HIV
Safety, PK and PD Study in Healthy Male Japanese Subjects

Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects


Eligibility Criteria:
Inclusion Criteria

* Men aged 20 to 45 years at the time of obtaining informed consent.
* Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (ADME) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).
Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance in Healthy Male Cyclists

Research Plan

Eleven trained cyclists have completed 4 cycling performance trials, before and after 4 weeks of fish oil supplementation and before and after 4 weeks of placebo with a 4 week washout between supplementation periods. During the performance trials blood, expired air and heart rate were collected. The blood samples have been used to investigate the production of inflammation resulting from the cycling performance test. Inflammation has been assessed using enzyme-linked immunosorbent assay for IL-6, which is an inflammatory cytokine. Work done from the cycling performance will be analysed to investigate whether there is a relationship with power and inflammation and whether this is modulated by fish oil supplementation.

Specific Aims

1. Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following high intensity cycling.
2. Is a modulation of the inflammatory response connected to cycling performance.

Hypotheses

1. Four weeks of n3-PUFA supplementation will reduce the inflammatory response
2. A reduction in inflammation will improve cycling performance

Anticipated Outcomes

A high level of cycling performance, indicated by a high average power, will be associated with high levels of systemic inflammation. n3-PUFA supplementation will decrease the level of inflammation and consequently cycling performance will be improved.


Eligibility Criteria:
Inclusion Criteria:

* recreationally trained male cyclists

Exclusion Criteria:

* History of coagulation/bleeding disorder
* History of metabolic disease
* Serious allergy
* History of heart disease
* Regular use of anti-inflammatory drugs
* Vitamin or fish oil supplementation over the past 6 months
* Known to have blood-borne virus
* Females
An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan

Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1. Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet needs that may accompany traditional proton pump inhibitors, with two separate pH-depended release phases, the first in the proximal duodenum and the second in the more distal small intestine. This dual release system extends the plasma concentration and pharmacodynamics effects beyond those of single-release PPIs, allowing for dosing at any time of the day without regard to meals 1. A study conducted by Fass et al. has shown that the use of dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and consequently improving work productivity, sleep quality and quality of life 2.

Because of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove beneficial in optimizing the management of GERD and the associated burdens that often surface after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep quality.

To investigate the efficacy and quality of life improvement of Dexlansoprazole 60mg taken once daily at Iftar time in patients with known symptomatic heartburn exacerbated in Ramadan and who are not on daily treatment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18-75 years old
* Fasting in Ramadan
* No daily PPI use
* Individuals willing to sign consent form
* Patients owning a smartphone and able to use a smartphone application

Exclusion Criteria:

* Known erosive GERD on PPI
* Pregnant females
* Prior gastric surgery
* Long standing diabetes mellitus (≥10 years of disease)
* Frequent NSAID use (\>3x/week)
* Morbid obesity (BMI\>35)
* History of recent (\<6 months) upper GI bleeding
* Patients who do not own a smartphone or who cannot use a smartphone application
* Known allergy to PPIs
* Known history of poor compliance or adherence and active psychological problems which might impact adherence
Predictability of Echographic Excursion of the Diaphragm for Intubation in COPD- Patients With Acute Respiratory Failure in ED

The investigators seek to evaluate if the ultra-sound measure of the diaphragm expansion is predictive of admission into an ICU and/or intubation for patients with COPD.

Every patient coming to the ER with shortness of breath and a known or suspected COPD, will undergo standard of care associated with a diaphragm ultrasound.

The investigators will then gather, through the internal databases of the recruiting hospitals, information about admission into ICU and/or intubation.

The investigators think that this technique will help improve early detection of COPD patient requiring mechanical ventilation, using ultrasound, a non invasive technique.

Inclusion of every lawful age patient presenting to the ER with inclusion criterias

The patient must not have exclusion criteria and must have received the information and consent sheets to be signed jointly

Then, the investigators perform an online randomization for the first and second operator and the side (left/right) from which they start the ultrasound assessment.

The investigators then assess diaphragmatic excursion measurements in spontaneously ventilated patient at 45 ° proclive position for each hemi-diaphragm, with the 2 operators blinded to each other, for 3 consecutive respiratory cycles and save the images.

The date of inclusion is then reported in the register.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous ventilation at arrival to the ER
* With Respiratory Failure defined by at least of the following criterias :

  * Respiratory frequency \> 25 and/or clinical signs of respiratory failure
  * Hypoxia with a WpO2 \< 90%
  * Hypercapnia \> 45mmHg with a respiratory acidosis

Exclusion Criteria:

* Known diaphragmatic dysfunction
* Necessity of immediate intubation leaving no time for ultrasound measurements of diaphragmatic excursion
* Unable to provide informed consent
* Evolutive or degenerative neurological disease that could affect diaphragmatic function
* Intracranial Hypertension
* Haemodynamic instability
* Acute heart failure
* Pregnant or Breastfeeding
A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis

Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of secretions, especially in the lungs. By adulthood, the majority of patients with CF will have a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung infections. This usually results in worsening respiratory symptoms and often an acute deterioration in their lung function. They are usually treated with antibiotics that target the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous infusions several times a day. This study aims to compare the standard method of giving these antibiotics with a different strategy of giving these antibiotics to see if this can improve the outcomes of treatment of these infections and reduce the amount of Pseudomonas aeruginosa in the lungs of these patients. This strategy consists of giving the same antibiotics continuously, to ensure there is always enough antibiotic in the bloodstream and the lung to be able to kill the bacteria.


Eligibility Criteria:
Inclusion Criteria:

1. Patients \>= 18 years of age,
2. Pseudomonas aeruginosa isolated in sputum within the last 12 months,
3. has an acute infective exacerbation, defined by international standards of 2 or more of the following in the last 2 weeks:

   * change sputum volume or colour,
   * increased cough,
   * increased dyspnoea,
   * increased malaise, fatigue or lethargy,
   * anorexia or weight loss,
   * decrease in pulmonary function by 10% or more, or
   * new radiographic changes

Exclusion Criteria:

1. patients \< 18 yrs of age,
2. patients that do not meet the criteria for an acute infective exacerbation,
3. concurrent pulmonary embolism, significant haemoptysis, pneumothorax, or respiratory failure,
4. impaired renal function with an estimated creatinine clearance \< 60 mls/min,
5. patients allergic to ß-lactam antibiotics,
6. aminoglycoside contra-indicated,
7. intravenous antibiotics in the last 2 weeks, prior to this admission,
8. received more than 24 hours of intravenous antibiotics in this admission,
9. previous lung transplantation,
10. pregnancy or lactation, or
11. inability to consent.
Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.

OBJECTIVES:

Primary

* Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer.

Secondary

* Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1. Patients undergo tumor resection on day 0.

After completion of study treatment, patients are followed periodically for 6 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus

  * Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0)
  * Stage I-III disease
* No known distant metastases
* No cervical-esophageal tumors (upper border \< 18 cm from the incisor teeth)
* No supraclavicular metastases

PATIENT CHARACTERISTICS:

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Adequate bone marrow function

Hepatic

* Adequate hepatic function
* No unstable or uncompensated hepatic disease

Renal

* Creatinine ≤ grade 2 by Common Toxicity Criteria
* Adequate renal function
* No unstable or uncompensated renal disease

Cardiovascular

* No unstable or uncompensated cardiac disease

Pulmonary

* No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes
* No unstable or uncompensated respiratory disease

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No known hypersensitivity to gefitinib or any of the excipients
* No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix
* No evidence of severe or uncontrolled systemic disease
* No other significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Endocrine therapy

* Concurrent stable-dose steroids allowed

Surgery

* Recovered from any prior oncologic or other major surgery

Other

* More than 30 days since prior nonapproved or investigational drug
* No prior therapy for this or any other malignancy
* No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)