cyrilzakka/clinical-trials huggingface dataset:
PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

The purpose of the trial is to determine if extended-release dipyridamole + aspirin \[Aggrenox, Asasa ntin\] is superior to clopidogrel \[Plavix\], and if telmisartan \[Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan\] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.


Eligibility Criteria:
Inclusion criteria:

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors:

* Diabetes mellitus
* Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)
* Smoker at time of qualifying stroke
* Obesity (BMI\>30; BMI=weight (kg)/\[height (m)\]2)
* Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke)
* End-organ-damage (retinopathy, LVH, or microalbuminuria)
* Hyperlipidemia

Exclusion criteria:

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.
A Genotype Stratification Study for Pharmacokinetics and Pharmacodynamics of Amitriptyline in Healthy Male Subjects

A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline, 25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and cytochrome P450 2C19 genotypes, and serial blood sampling will be done for plasma concentrations of amitriptyline, nortriptyline, and their metabolites. Various pharmacodynamic markers related to the adverse event of amitriptyline will be measured serially during the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer, age 19\~45 years
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
* Voluntarily signed the informed consent form

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
* History of relevant drug allergies or clinically significant hypersensitivity reaction.
* Smoked more than 10 cigarettes a day for past 3 months
* Not eligible due to other reasons including laboratory results
Microvascular Changes in OCT-angiography in Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.

The objective of the study is to evaluate the differences in the retinal microcirculation measured by OCT-Angiography in patients with type 1 diabetes between the diagnosis of the disease and after 3 months of insulin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 1 Diabetes at diagnosis of the disease (less than 7 days after diagnosis)
* Age equal to or greater than 18 years
* Signature of the informed consent by the patient / legal guardian.

Exclusion Criteria:

* Metabolic situation of ketosis or ketoacidosis, according to clinical criteria established in the protocol of the Endocrinology and Nutrition Service. The patient will be a candidate once the ketonemia is absent (value \<1 mmol / L).
* Previous diagnosis of dyslipidemia and any previous lipid-lowering treatment
* Previous diagnosis of hypertension and any previous hypotensive treatment
* Previous diagnosis of any form of cardiovascular disease, including heart failure.
* Previous kidney disease, and presence of advanced kidney failure (estimated glomerular filtration rate \<60 ml / min)
* Presence of diabetic retinopathy identifiable by conventional eye fundus or retinography, or other concomitant retinal vascular pathology (hypertensive retinopathy, venous occlusion, arterial obstruction, etc.)
* History or presence of retinal pathology that may alter its structure and / or the validity of the measurements (retinal detachment, epiretinal membrane, high myopia -understood as an axial length greater than or equal to 26mm measured by "IOL Master" biometry-, neovascular membrane, choroidal tumors, etc.)
* History of posterior uveitis or retinal vasculitis
* Glaucoma and neuro-ophthalmological pathology that can alter the neuroretinal structures.
* Refractive media opacity that prevents a correct acquisition of images and, therefore, their evaluation
* Dementia or intellectual disability that prevent proper collaboration when acquiring images
Rituximab Treatment in Sjogren's Syndrome

This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.

Study design:

phase II trial

Study objective:

evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS

Number of participating centres:

1

Duration:

follow-up 48 weeks

Study medication:

2 infusions on day 1 and day 15 rituximab infusions (1000 mg) or placebo infusions intravenous infusion of 100 mg of methylprednisolone before infusion of rituximab (or the placebo for rituximab), together with 60 mg per day of oral prednisone on days 2, 3, 16 and 17, 30 mg per day on days 4, 5, 18 and 19 and 15 mg per day on days 6 and 20

Primary objective/endpoint:

stimulated salivary gland function (stimulated submandibular/sublingual and parotid saliva)

Secondary objectives/endpoint:

Functional parameters Laboratory parameters Subjective parameters Histological/Molecular parameters

Number of subjects:

30 patients with primary SS (20 patients rituximab treatment, 10 patients placebo)

Eligibility Criteria:
Inclusion Criteria:

* Stimulated whole saliva secretion ≥ 0,15 ml/min
* Male or female \> 18 years
* Primary SS according to the revised European - U.S. criteria(22)
* Positive autoantibodies (IgM-Rf \> 10 and SS-A and/or SS-B)
* Parotid gland biopsy (paraffine material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago)
* Use of reliable method of contraception during the study
* Written informed consent

Exclusion Criteria:

* The presence of any other connective tissue disease
* Preceding treatment with anti-TNF or other monoclonal antibodies
* Use of prednisone, hydroxychloroquine less than 1 month ago
* Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than 0,5 year ago
* Serum creatine \> 2.8 mg/dl (250 micromol/l)
* ASAT or ALAT outside 1.5 x upper normal range of the laboratory
* Hb \< 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
* Neutrophil granulocytes less than 0.5 x 109/l
* Platelet count less then 50 x 109/l
* Positive pregnancy test or breast-feeding
* History of alcohol or drug abuse
* Serious infections
* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study
* History of any malignancy with the exception of completely resected basal cell carcinoma of the skin
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* pancreatic cancer, surgically unresectable or with metastases;
* no previous chemotherapy (except concomitant with radiotherapy);
* ECOG 0-2.

Exclusion Criteria:

* pancreatic cancer without histologic or cytologic confirmation;
* surgical resection possible;
* previous chemotherapy not concomitant with radiotherapy;
* ECOG 3-4.
Hypoxia at Multiple Wavelengths of Light

The purpose of the study is to assess the effect of progressive, incremental hypoxia at multiple wavelengths of light.

No additional information is required.

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 35 years of age
* Is American Society Anesthesiologist status 1
* Has a BMI between 18 and 30

Exclusion Criteria:

* Currently taking any medications other than birth control pills
* Has participate in an investigational drug study within one month prior to the start of the study
* Fails the Allen's Test to confirm patency of the colateral artery
* Subject is female with a positive pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study termination
* Has a positive urine continine or drug test
* Has an reported allergy to Lidocaine
* Has anemia or other hemoglobinopathy
* Has a room air saturation less than 95% by pulse oximetry
* Has an abnormal EKG
* Has an abnormal pulmonary function test via spirometry
* Is intolerant to a breathing mask apparatus
* Has a COHb greater than 3%, or MetHb greater than 2%
* Has another condition, which in the opinion of the principle investigator would not be suitable for participation in the study
* Is unwilling or unable to provide informed consent or comply with the study procedures
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement

This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.


Eligibility Criteria:
Inclusion Criteria:

* Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
* Required treatment of paravalvular leakage due to heart failure or hemolysis
* There is a formal agreement of heart team as following

  * predicted high-risk (STS score ≥8 OR Logistic EuroSCORE ≥20% OR operative mortality is ≥15%)
* Inoperable status due to old age or frailty
* Written consent

Exclusion Criteria:

* Risk of valve embolization because of valve dehiscence or instability
* Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram), or chest pain/discomfort)
* Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal echocardiographic study
* Life expectancy less than 6 months due to non-cardiac disease
* Pregnant or breastfeeding
The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury.

Venous thromboembolic (VTE) prophylaxis in trauma patients is a critical clinical problem. Patients with traumatic brain injury usually have effective VTE prophylaxis withheld secondary to concerns of exacerbating intracranial hemorrhage. This study examines the safety and efficacy of early administration (within 24 hrs of admission) of low molecular weight heparin to this patient population with very high VTE risk.

Eligibility Criteria:
Inclusion Criteria:

* Blunt traumatic brain injury (Marshall II-V)
* Stable 6 hr. head CT
* Stable hemoglobin

Exclusion Criteria:

* Premorbid coagulopathy
* Pregnancy
* \< 18 y.o.
* Need for therapeutic anticoagulation
* Heparin allergy
CLL-1/CD33 Targeted LCAR-AMDR Cells in Patients With Relapsed or Refractory Acute Myeloid Leukemia

This is a prospective, single-arm, open-label, single dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-AMDR cells in subjects with relapsed/refractory Acute Myeloid Leukemia who received adequate standard therapy.


Eligibility Criteria:
Inclusion Criteria:

1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF)（For minors, the guardian shall also provide written informed consent ）; Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
2. Age 14-60 years;
3. ECOG score: ≤2;
4. Relapsed/refractory AML must meet one of the following conditions:

   1. Twice or more relapse;
   2. Newly diagnosed AML patients who failed after 2 cycles of standard chemotherapy;
   3. Relapse within 12 months after CR, or relapse after 12 months with CR but failed to respond to conventional chemotherapy;
   4. Persistent extramedullary leukemia.
5. Meet the requirements of allogeneic HSCT
6. Expected survival ≥ 3 months;

Exclusion Criteria:

1. Subject with APL/AML-M3:t(15;17)(q22;q12)
2. Received any of the following treatments:

   * Previous allo-HSCT(Subjects who received allo-HSCT for more than 6 months, have stopped immunosuppressive drugs and have no active GvHD are not included in the exclusion criteria)
   * Previous gene therapy
   * Previous anti CD33/CLL1 therapy
   * Previous any target CAR-T cells therapy
3. Prior antitumor therapy with insufficient washout period;
4. CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission;
5. HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive;
6. Pregnant or breast-feeding women;
Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release

Characterize the steady-state pharmacokinetics of morphine after oral administration of Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to compare their pharmacokinetics to that of AVINZA.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to morphine sulfate or any comparable or similar product.
A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal Test

The purpose of this study is to collect whole blood samples from women with viable pregnancies of at least 10 weeks gestation (at any risk for fetal chromosomal anomaly) for future testing with an investigational noninvasive prenatal test(s) (NIPTs), and to establish clinical truth compared to a clinical reference standard.

This is a prospective, multi-center specimen collection study; each subject's treatment, management, or medical care will not be determined by the study protocol.

Women 18 years of age or older with a viable pregnancy of at least 10 weeks gestation will be enrolled. A whole blood sample will be collected from each subject.

Subjects will be followed until data or specimens used to establish the clinical reference standard are collected, and pregnancy outcome and birth information is collected (if applicable). If cytogenetic test results from standard-of-care procedures are not available and pregnancies end in live births, a neonatal buccal swab specimen will be collected.

Maternal specimens will be processed to plasma and stored for future testing with an investigational NIPT(s). There will be no investigational NIPT results nor centralized CMA LDT results generated under this protocol.

Cytogenetic results from standard-of-care procedures and microarray results will be used to classify the clinical status of subjects according to the clinical reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Has a viable pregnancy of at least 10 weeks, 0 days gestation at the time of maternal specimen collection (singleton or multiple pregnancy acceptable),
* Be 18 years of age or older at enrollment, and
* Is willing and able to provide documentation of informed consent.

Exclusion Criteria:

* Has a prior NIPT result from the current pregnancy,
* Had an invasive prenatal diagnostic procedure (eg, CVS, amniocentesis) in the current pregnancy before maternal specimen collection,
* Has a history of transplant or malignancy,
* Had a transfusion of blood or blood components up to 8 weeks before maternal specimen collection,
* Had preimplantation genetic screening for the current pregnancy (for in vitro fertilization patients only), or
* Has already participated in the study (enrolled previously)
Bedside Ultrasound in Detection of Pneumothorax Post Transthoracic Lung Biopsy

Currently chest X-ray (CXR) is the modality used to assess for pneumothorax after transthoracic lung biopsy at the Ottawa Hospital. Recently bedside Ultrasound (US) has become a useful rapid imaging modality to assess chest for pneumothorax in emergency rooms with reported sensitivity, specificity and diagnostic accuracy were 88%, 97% and 97%, respectively (ref. 2).

Our team will be comparing the diagnostic accuracy of US to CXR in diagnoses of pneumothorax post transthoracic lung biopsy.

The purpose of the study is to compare the diagnostic accuracy of US to CXR post-biopsy to confirm the presence of a pneumothorax.

Hypothesis:

US have sensitivity and specificity equal or better than CXR to exclude pneumothorax after transthoracic lung biopsy.

Clinical relevance:

Pneumothorax is a well-known complication of image-guided transthoracic biopsy of lung lesions. The incidence of pneumothorax in patients undergoing TTNB has been reported to be from 9% to 54% (ref. 3). Most of the time, the pneumothorax is small and requires no further intervention other than observation and a repeat CXR to ensure stability or resolution of the pneumothorax. In small group of patients with detected pneumothorax after biopsy, the pneumothorax is either large or becomes larger (more than 2 cm width at the level of the hilum) during observation. In these cases, a small pleural drainage catheter will be inserted to prevent the lung from collapsing. The catheter will be removed in 2 days. Detection of pneumothorax post biopsy is important to prevent possible lung collapse after discharge and currently is done by obtaining a CXR, 30 minutes after the biopsy.

Obtaining a CXR, requires moving the patient on stretcher to the X-ray room, bringing the patient to upright position, patient holds breath. An X-ray technologist obtains the CXR which will be reviewed by a Radiologist when it becomes available on work station. Then the Radiologist revisits the patient and orders the discharge.

Detection of pneumothorax by US is feasible and compare to current practice with CXR, is faster and do not need moving and repositioning the patient, therefore, more convenient. It can be easily performed at the time of clinical assessment prior to discharge.

Study design/ Methodology:

* All patients coming for lung biopsy will be invited to participate in this study. Information about the one additional US at the time of their biopsy and routine CXR will be explained to the patient by either thoracic radiology fellow or staff radiologist.
* For those who agree to participate, informed Consent will be obtained by the same people mentioned above.
* There will be no change in clinical assessment or decision to discharge the patient after biopsy.
* US will be performed by a trained staff radiologist or thoracic fellow.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are booked and coming for image-guided transthoracic biopsy of a lung lesion to the Ottawa Hospital, General Campus, will be consented and those who agree to added US will be included

Exclusion Criteria:

* Other patients.
Videolaryngoscopic Intubation Using Macintosh vs.Hyperangulated Blades in Patients With Expected Difficult Intubation

Videolaryngoscopy-guided intubation has become widespread as a means of preventing major complications relating to airway management by improving the glottic view, increasing the first attempt success rate, likely reduce rates of hypoxemic events, while reducing the rate of airway trauma. However, as randomized controlled studies in patients with anticipated difficult intubation undergoing ear nose and throat (ENT) or oral and maxillofacial (OMF) surgery are lacking, it is still unknown if hyperangulated blades improve glottic view and if their use translates into faster intubation. The primary aim of this randomized controlled trial is to compare the percentage of glottic opening (POGO) between hyperangulated blades and Macintosh blades in patients with expected difficult intubation undergoing ENT or OMF surgery who require transoral tracheal intubation. Secondary aims are to compare secondary outcome measures such as time variables, indicators for difficult and successful intubation, number of attempts, view conditions, difficult airway classifications and adverse events between both blade types.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring general anesthesia with transoral tracheal intubation for elective ear, nose and throat or maxillofacial surgery
* Expected difficult intubation
* Age ≥ 18

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Planned awake tracheal intubation (without deep anesthesia or neuromuscular blocking agents)
* Required transnasal tracheal intubation (e.g. for surgical reasons)
* Special tubes required for surgical reasons ( e.g. double lumen tube)
* Denial of consent