cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants

Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kg/m\^2, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital sign measurements, and clinical laboratory evaluations as assessed by the investigator or designee
* Female participants must be of non-childbearing potential (surgically sterile or postmenopausal)

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
* Evidence of any infections (bacterial, viral, fungal, parasitic, COVID-19) within 4 weeks prior to the first dose of study drug, as determined by the investigator or designee
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator or designee
* History or presence of an abnormal ECG prior to the first dose of the study drug that, in the opinion of the investigator or designee, is clinically significant
* Abnormal liver function tests, as defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin \>upper limit of normal (ULN) range
* Positive hepatitis panel and/or positive human immunodeficiency virus test

Note: Other protocol defined Inclusion/Exclusion criteria apply
Skeletal and Dental Changes with Hyrax-type Rapid Maxillary Expander Anchored to Permanent Versus Deciduous Molars

The aim of the study is to compare the skeletal and dental maxillary expansion obtained with an Hyrax tooth-borne expander anchored either on the 2nd deciduous molars (V) or on the 1st permanent molars (6)

The aim of the study is to compare the skeletal and dental maxillary expansion obtained with an Hyrax tooth-borne expander anchored either on the 2nd deciduous molars (V) or on the 1st permanent molars (6).

The main objective is to compare at the skeletal level the distance between the cephalometric points, right jugal (RJ) and left jugal (JR) (maxillary base).

The secondaries objectives are performed at the dental level by measuring the distance between the maxillary first molars mesio-palatal cusp and the cuspids cups. Molar derotation is also assessed

Eligibility Criteria:
Inclusion Criteria:

* Patient coming to the dental clinic for a first orthodontic consultation in mixed dentition
* Patient aged 6 to 12 years
* Patient with a transverse maxillary deficiency requiring rapid maxillary expansion
* Presence of 1st permanent molars "6" and 2nd deciduous "V" molars with sufficient root length

Exclusion Criteria:

* Syndromic patients (all syndromes combined: cleft lip, etc.)
* Patient with V or 6 with decays (or with major root resorption)
* Patient with oral hygiene non compatible with orthodontic treatment
* Failure to obtain informed written consent
* No affiliation to a French national medical health system
* Patient with a legal protection measure
Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.


Eligibility Criteria:
Inclusion Criteria:

* English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
* Scheduled or unscheduled cesarean delivery under spinal anesthesia
* Height: 5 feet-5 feet 11 in.

Exclusion Criteria:

* Laboring women needing an emergency cesarean delivery

  * Subjects less than 18 years of age
  * Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section
  * Allergy to ondansetron, or metoclopramide
  * Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)\>160mmHg, diastolic blood pressure (DBP)\>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
  * Severe Cardiac disease in pregnancy with marked functional limitations
  * Diabetes type I
  * Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
  * Morbid obesity (body mass index (BMI)\>45)
  * Inclusion in another anesthetic study involving drug administration
Frequency of Metabolic Dysfunction Associated Fatty Liver Disease in Patients With Acute Coronary Syndromes

Aim of the research is to assess frequency of MAFLD among patients with acute coronary syndromes (ACS).

Hepatic manifestation of metabolic syndrome (MS) is known as Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD). MAFLD could be complicated by serious events as steatohepatitis, cirrhosis and malignant liver. The characteristics histological findings in those patients are macrovesicular steatosis. The prevalence of MAFLD has doubled over the last 20 years.

Globally, based on many reported studies, it's well-known that in 25-28% of deaths in patients with Metabolic Dysfunction Associated Fatty Liver Disease (MAFLD) , coronary artery disease (CAD) is accused to be the leading cause.

Patients with MAFLD are known to have more complex coronary artery disease in angiography. But the effect on clinical outcome and mortality is not known. Furthermore, the impact of MAFLD on acute coronary syndrome (ACS) is not clear. Moreover, in patients with metabolic syndrome the presence of MAFLD would be associated with severe form of CAD as noticed by angiography where there was increased in number of affected vessels and multivariate regression analysis found that MAFLD as the only independent factor affecting coronary score.

The SYNTAX score was prospectively developed for the SYNTAX trial to grade the anatomical complexity of coronary lesions in patients with lt main coronary arterty (LM) or three-vessel disease . It was found to be an independent predictor of long-term major adverse cardiac and cerebrovascular events (MACCE) and of death.

While the available data clearly support a role of MAFLD in initiating and progression of CAD in non-diabetic patients is still to be searched. MAFLD might play a part in the pathogenesis of CAD through the overexpression and systemic release of several inﬂammatory, hemostatic and oxidative-stress mediators or via contributing to whole-body insulin resistance and atherogenic dyslipidemia.

Based on the lack of studies that discussed the effect of MAFLD on patients with ACS ,we designed this study trying to asses the effect of MAFLD on the severity of ACS.

Eligibility Criteria:
Inclusion Criteria:

Any Patient above the age of 18 years old presented with acute coronary syndromes {myocardial infarction (MI), non-ST elevation myocardial infarction (NSTEMI), unstable angina} underwent coronary angiography within admission.

Exclusion Criteria:

1. Patients refused to participate.
2. Patients with history of alcohol or drug abuse.
3. Patients have hepatitis C or hepatitis B infection.
4. Patients have primary or secondary hepatic malignancies
5. Pregnant women.
Registry Type Study to Monitor for Adverse Drug Reactions to Fedoruk Manufactured [F-18]-Fludeoxyglucose

This is a single-centre, open-label, non-randomized clinical trial designed to monitor the occurrence of adverse events associated with \[F-18\]-FDG Injection manufactured by the Fedoruk Centre. \[F-18\]-FDG Injection used in this clinical trial will be identical to commercial \[F-18\]-FDG that is already used at Royal University Hospital (RUH).

This study will document the use of Fedoruk-manufactured \[F-18\]-FDG Injection (citrate formulation) in patients referred for \[F-18\]-FDG PET or PET/CT imaging at Royal University Hospital (RUH) in Saskatoon, SK. This investigational agent is produced using procedures, raw materials, equipment and quality standards that are equivalent to commercially-approved \[F-18\]-FDG Injection (Glucovision®, manufactured by the CPDC in Hamilton ON).

This is a single-centre, open-label, non-randomized study to monitor for adverse drug reactions among subjects administered Fedoruk-manufactured \[F-18\]-FDG Injection. Eligible subjects are those who would normally be referred by their physician for \[F-18\]-FDG PET or PET/CT imaging at RUH in Saskatoon, SK.

The primary goal of this study is to permit immediate access, with appropriate regulatory and REB oversight, to Fedoruk-manufactured \[F-18\]-FDG Injection pending commercial approval.

Monitoring for adverse drug reactions, during and after subjects are administered Fedoruk-manufactured \[F-18\]-FDG Injection, will support the primary objective of this study. Based on the well-established safety profile of \[F-18\]-FDG and the comparability of Fedoruk-manufactured \[F-18\]-FDG Injection to commercially-approved \[F-18\]-FDG Injection (Glucovision®), it is not expected that any ADRs will be observed.

Eligibility Criteria:
Inclusion Criteria:

* Referred by treating physician to receive \[F-18\]-FDG and PET or PET/CT imaging;
* Meets all current local clinical criteria for receiving \[F-18\]-FDG and PET or PET/CT imaging;
* Ability to understand and the willingness to sign, or (in the case of paediatric patients) a parent/guardian who understands and is willing to sign, a written informed consent document;

Exclusion Criteria:

* Pregnant women; all women of child-bearing potential will have a confirmed negative urine pregnancy test prior to administration of \[F-18\]-FDG Injection;
* Subjects unwilling or unable to stop breast feeding for 24 hours;
* Subjects who are medically unstable, based on the Principal Investigator's assessment
Amniotic Membrane as an Adjunct Treatment for Hallux Rigidus

The purpose of this study is to determine whether patients undergoing a dorsal cheilectomy procedure with implementation of amniotic membrane tissue results in improved clinical and functional outcomes compared to a standard dorsal cheilectomy procedure.

Specific Aim 1:

To compare American Orthopedic Foot and Ankle Society (AOFAS) scores between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.

Hypothesis 1: Clinical and functional outcomes, as measured by the AOFAS , in the patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior to those without.

Specific Aim 2:

To compare range of motion between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.

Hypothesis 2: Patient to undergo dorsal cheilectomy and implantation of amniotic membrane tissue will demonstrate less postoperative stiffness as measured from the pre-and postoperative radiographs.

Specific Aim 3:

To compare Foot Function Index (FFI) scores between patients undergoing dorsal cheilectomy to patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue.

Hypothesis 3: Clinical and functional outcomes, as measured by the FFI, the patients undergoing dorsal cheilectomy with implantation of amniotic membrane tissue will be superior to those without.


Eligibility Criteria:
Inclusion Criteria:

* Patients presented with an isolated diagnosis of type II hallux rigidus who are candidates for operative management with dorsal cheilectomy.
* Patients over the age of 18 able to consent to participate
* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study

Exclusion Criteria:

* \< 18 years of age
* Patients that use ambulatory assistive devices
* Patients with systemic inflammtory arthritis
* Patient undergoing revision surgery for hallux rigidus to the ipsilateral extremity
* Patients with significant arthritis requiring alternative surgery other than dorsal cheilectomy
Asan Multivessel Registry

The purpose of this study is to evaluate long-term prognoses of patients with multivessel coronary disease treated medically or surgically or percutaneously in real world practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multivessel disease from 1995 in Asan Medical Center
* Age 19 and more

Exclusion Criteria:

* For prospective cohort, not agreeing to participate with written informed consent form
Pilot Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions


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 exemestane or any comparable or similar product.
Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC

The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer.

This is a combined phase 1 and 2 clinical study. The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer. The treatment outcomes will be compared.

Eligibility Criteria:
Inclusion Criteria:

* MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
* Eastern cooperative oncology group (ECOG) performance status of 0-1 or karnofsky performance status (KPS) score is higher than 60.
* Patients have a life expectancy \> 12 weeks.
* Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
* Negative pregnancy test for females of child-bearing potentials.
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
* Signed informed consent form.

Exclusion Criteria:

* Number of T cells is less than 10% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
* Patients with symptomatic central nervous system (CNS) involvement.
* Pregnant or nursing women.
* Known HIV infection.
* Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
* History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previously treatment with any gene therapy products.
* The existence of unstable or active ulcers or gastrointestinal bleeding. Patients with portal vein vascular invasion or extrahepatic, are excluded from this study.
* Patients with a history of organ transplantation or are waiting for organ transplantation.
Transcutaneous Vagus Nerve Stimulation as a Complementary Therapy to Exercise in Chronic Fatigue

Chronic fatigue is enhanced by adapted physical activity (APA) programs. Patients consulting on St Etienne hospital and suffering from fibromyalgia and long Covid benefit from a 4-6 week APA program, with 2 sessions per week. While most patients are improved by these exercise-training programs, for some the benefits remain very modest, and patients describe persistent fatigue. The literature unanimously describes the necessity of longer APA protocols (8-12 weeks, 2-3 sessions/week) for fatigue reduction in fibromyalgia and long Covid. However, it seems difficult to adhere to an optimal program as described in the literature for these fatigued patients. The investigators want to test a device that would both reduce fatigue and improve recovery between APA sessions, in order to gradually reach the recommendations for APA practice. Transcutaneous vagal nerve stimulation (tVNS) seems to be a promising approach. Thus, combining an APA intervention with a tVNS protocol could potentiate the expected and now well-known effect of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Signature of informed consent
* Confirmed diagnosis of fibromyalgia or long Covid (ACR 2016 criteria and persistent symptoms lasting more than 6 months after a positive RT-PCR test, respectively)
* Persistent fatigue after an exercise rehabilitation program (FSS score \> 36)
* Physical inactivity, i.e. \<150 minutes per week of physical activity

Exclusion Criteria:

* Pre-existing atrial fibrillation,
* Left ventricular ejection fraction \<40%
* Severe heart failure
* Recent stroke or myocardial infarction (\<6 months)
* Unilateral or bilateral vagotomy
* Pregnancy or breastfeeding
Role of Dopamine Receptors in Primary Focal Dystonias

Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather rudimentary. A better understanding of neural mechanisms of dystonias is not only an invaluable prerequisite for developing better treatment options but also a step toward better understanding of the complex network of basal ganglia. In this study I will investigate if there is any difference between the dopamine receptors and dopamine in people with dystonia and healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age \>20
* Male or Female
* Any race or ethnicity
* Primary focal dystonia (arm or cranial)
* Ability to give informed consent

Exclusion criteria:

* Family history of dystonia
* Pregnancy (confirmed with negative urine pregnancy test in women of child bearing potential), breastfeeding
* Exposure to radiation therapy
* Any MRI contraindications such as foreign metallic implants, pacemaker, and aneurysm clip etc.
* History of cardiac disease, uncontrolled hypertension, abnormal EKG during screening phase
* History of exposure to any drugs affecting dopaminergic systems within the last 6 months (e.g. dopamine receptor blocking agents, cocaine, amphetamine, tetrabenazine, reserpine, L-dopa, dopamine agonists, as they might affect the dopamine receptor binding or endogenous dopamine).
* Active depression (Beck Depression Inventory_II \>14)
* Cognitive impairment (Mini-Mental State Score \<27)
* CNS active medications such as gabapentin or narcotics, muscle relaxants which might be given for pain in the 3 days prior to study
* History of stroke, seizure, cerebral palsy, generalized dystonia, parkinsonism, inability to hold head still during the scanning time.
Trial of Deforolimus in Combination With Bevacizumab for Patients With Advanced Cancers (8669-010)(COMPLETED)

The purpose of this study is to assess the safety, tolerability, and recommended phase 2 dose of oral ridaforolimus administered in combination with intravenous bevacizumab in patients with advanced cancers.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Advanced or metastatic solid tumor malignancy
* ECOG performance status of less than or equal to 1
* Life expectancy of greater than 3 months
* At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy, or radiotherapy, and the first dose of deforolimus
* Adequate hematological, hepatic and renal function
* Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
* Signed informed consent
* Women of childbearing potential must have a negative serum pregnancy test within 7 days of starting therapy and must use an approved contraceptive method from time of screening until 30 days after the last dose of study drug

Exclusion Criteria:

* Tumor location in close proximity to a major blood vessel
* History of brain metastases, spinal cord compression, or carcinomatous meningitis. Primary brain tumors (for example, glioblastoma) are allowed.
* New brain metastases, spinal cord compression, or leptomeningeal metastases on screening CT scan or MRI
* Hemoptysis or hematemesis within 28 days prior to entering the trial
* Clinical significant unexplained bleeding within 28 days prior to entering the trial
* Uncontrolled hypertension
* Proteinuria at screening
* Clinically significant cardiovascular disease
* Newly diagnosed or poorly controlled type 1 or 2 diabetes
* Active infection requiring prescribed intervention
* Other concurrent illness that, in the Investigator's judgement, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
* Major surgery within 28 days before trial entry, or any incompletely healed surgical incision; minor surgery or procedures within 7 days
* Pregnant or breastfeeding
* Known allergy to macrolide antibiotics
* Known hypersensitivity to any component of bevacizumab
* Concurrent treatment with medications that strongly induce or inhibit cytochrome P450 (CYP3A)
* Known history of HIV sero-positivity
* Any condition in the Investigator's judgement that renders the patient unable to fully understand and provide informed consent and/or comply with the protocol
Comparison of Outcomes Between Biceps Tenotomy and Tenodesis in the Treatment of the Long Head of the Biceps Pathology

The purpose of the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology.


Eligibility Criteria:
Inclusion Criteria:

* patient with chronic refractive bicipital pain

Exclusion Criteria:

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Paclitaxel/Cisplatin/Fluorouracil Followed by Paclitaxel/Cisplatin/Radiotherapy and Esophagectomy for Esophageal Cancer

We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.

We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.in order to test this hypothesis, we thus propose this phase II clinical study to verify the role of "response to one-cycle induction chemotherapy"in the prediction of pathologic complete response rate to CCRT and tje outcomes for patients with loco-regional esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven esophageal cancer
* Locally advanced diseases T3 N0-1 M0; T1-3 N1 M0; T1-3 or N0-1 M1a
* Age ≥ 18 years old
* ECOG ≤ 2
* Creatinine \< 1.5 mg/dl AST, ALT \< 2.5 x upper normal limits Bilirubin \< 2.0 mg/dl
* WBC \> 4,000/μl or ANC\>2,000/μl
* Platelet \> 100,000//μl
* Informed consent

Exclusion Criteria:

* Invasion to surrounding organs (T4 disease)
* Distant mets (except M1a)
* Prior thoracic irradiation
* Presence of other squamous cell carcinoma of aerodigestive way
* Symptomatic co-morbid diseases
* Previous malignancy