cyrilzakka/clinical-trials huggingface dataset:
Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure

Our goal in this study is to investigate the extent of endogenous nitrosation of nornicotine in smokeless tobacco users as a function of nornicotine content in smokeless products. This study will lead to an understanding of the endogenous formation of NNN from nornicotine in humans, and will also investigate the effect of the reduction of nornicotine content in smokeless tobacco on the extent of endogenous NNN formation. The knowledge gained in this study will lead to the development of recommendations for the regulation, or potentially elimination, of nornicotine in smokeless tobacco products in order to minimize exposure to NNN in the users of these products.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult smokeless tobacco users 18-65 years of age, using at least 3 tins of product per week for 6 months;
* Used the same brand for \>80% of their smokeless tobacco use over the course of at least 6 months, and used this brand exclusively for at least two weeks prior to the eligibility screening;
* Not smoking or using any other nicotine or tobacco product in the past 2 weeks (expired CO \< 6 ppm);
* Participants are in good physical health (no unstable medical condition) and good general oral health as determined by the licensed medical professional;
* Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse) as determined by the licensed medical professional;
* Participants who are not taking any medications that affect relevant metabolic enzymes;
* Women who are not pregnant or nursing or planning to become pregnant;
* Participants have provided written informed consent to participate in the study.

Exclusion Criteria:

* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional;
* Vital signs out of range as determined by the licensed medical professional (participants failing for vital signs will be allowed to re-screen once):
* Evident poor oral health (significant gum recession, dental caries, tooth loss) as determined by the general oral health status check;
* Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
* Regular smoking or tobacco use (e.g., greater than once a week) other than oral smokeless tobacco products;
* Currently (within the past 2 weeks) using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers

Healthcare workers and COVID-19 patients may experience psychological distress consequent to the pandemic, and are at particularly elevated risk for experiencing posttraumatic stress disorder (PTSD), based on evidence from previous infectious disease outbreaks. The best-validated treatment for PTSD is exposure therapy. Exposure therapy help patients suffering from PTSD to revisit and overcome their traumatic experiences. Including virtual reality in exposure therapy has a long history in treating PTSD; and has been used to treat military veterans and first-responders following 9/11. The investigators are developing and testing a virtual environment to treat PTSD including sub threshold PTSD symptoms in HCWs who experience occupational related trauma (e.g., working with COVID-19 patients) and COVID-19 patients. An independent evaluator will assess symptoms of PTSD and other psychopathology, using structured clinical interviews and self-report measures with well-established psychometric properties, at baseline, halfway through treatment, after completion of treatment, and at three-months post-treatment. Participants will complete ten ninety minute sessions (in-person or remotely), twice a week for five weeks aimed at mitigating their symptoms of PTSD. Remote participants will receive VR headsets after the baseline assessment and will keep them for the duration of the study. The pilot study will aim to demonstrate the feasibility and the tolerability of the virtual reality intervention in these populations.


Eligibility Criteria:
Inclusion Criteria:

* A COVID-19 patient or any healthcare worker providing medical care or support who experiences occupational-related trauma
* English-speaking
* Age ≥18
* Medically stable
* Diagnosed with PTSD or sub threshold PTSD
* Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
* Stable on psychotropic medication for the prior 60 days

Exclusion Criteria:

* Current significant unstable medical illness such that the participant could not attend sessions regularly or complete assessments
* Patients who in the investigator's judgment pose a current homicidal, suicidal or other risk
* Lifetime or Current diagnosis of schizophrenia or other psychotic disorder
* Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months
* History of motion sickness or seizures
Controlling and Lowering Blood Pressure With The MOBIUSHD™

To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the United States. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system.

Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Office cuff SBP ≥ 160 mmHg measured per protocol instructions (Appendix IV) following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications)

Exclusion Criteria:

* Known or clinically suspected baroreflex failure or autonomic neuropathy
Clinical Assessment of Fish Oil-based Lipid Emulsion Infusions in Critical Patients With Severe Sepsis

The purpose of this study is to determine whether a fish oil-based lipid emulsion, enriched with ω-3 fatty acids, reduce proinflammatory cytokines and mortality rate in critically ill patients with severe sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Li Shin Hospital's ICU with a main diagnosis of severe sepsis.

Exclusion Criteria:

* Age of ﹤15 years
* Pregnancy
* Patients treated with immunosuppressive drugs or the equivalent of hydrocortisone more than 300 mg daily
* Plasma triglyceride concentration of more than 400 mg/dl
* Infection with human immunodeficiency virus
* Anticipated rapid fatality from irreversible underlying disease or malignancy
* Severe hemorrhagic disorders
* Acute myocardial infarction
* Recent stroke (within 3 month)
* Suspected or proven pulmonary embolism
* Cirrhotic liver and/or acute hepatitis ( elevation of serum GOT or GPT \> 5 times of normal upper limit)
* Chronic renal failure (Cr \>3.5 mg/dl upon admission) or end stage of renal diseases
* Allergic reactions against fish or egg proteins.
A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Any condition possibly affecting drug absorption.
* A positive urine drug screen.
* Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to artesunate or its derivatives.
The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals

We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

1. Men
2. Ages 18 to 40 years.
3. Body mass index less than or equal to 30 kg/m2

Exclusion Criteria:

1. History or clinical signs of heart, lung, kidney, or endocrine organ disease.
2. Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
3. Abnormal screening of the urine regarding: albumin and glucose
4. Malignant disease.
5. Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
6. Alcohol abuse.
7. Smoking.
8. Drug use or abuse.
9. Known intolerance or allergy to dihydralazine
10. Blood donation within 1 month of the start of the study.
Procedural Simulation for Difficult Airway Training in Anesthesiology Resident Education Program

Difficult airway management is a crucial point that may influence outcomes of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. Investigators included this workshop to a state education program of anesthesiology resident in second year and compared to their homonym in another state where no specific organized workshop is integrated to the education program.

Difficult airway management is a crucial point that may influence outcome of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. The investigators included this workshop for smal groups of 6-10 anesthesiology resident from Rhône Alpes Auvergne french state. Participants were ask to fill out a questionnaire about their specific knowledge and experience of several devices usable in difficult airway management situation. The workshop was a small briefing as an introduction to the workshop and then small workshop of 20-45 min for specific procedural use of different devices for difficult airway management : Eischmann guide, LMA, supraglottic devices, fiberoptic with spontaneous breathing, cricothyroidotomy, jet ventilation, percutaneous tracheotomy... Investigator will compare at 6 month the incidence of use of the difficult airway devices between resident from rhone alpes auvergne following the workshop and resident from Montpellier that did not follow specific organized workshop.

Eligibility Criteria:
Inclusion Criteria:

* Residents in 2nd year of anesthesiology residency in Rhones alpes auvergne and in Nîmes

Exclusion Criteria:

* Exclusion demand from the participant
Effect of Alpha-Lipoic Acid Supplementation on the Incidence of Postoperative Atrial Fibrillation in Cardiac Surgery Patients

ALA is administered orally since it is without difficulty absorbed in the stomach. ALA goes through the blood brain barrier and does not show toxic effects and actions at doses used for prophylactic and therapeutic purposes. This has encouraged us to use an efficient anti-oxidant and anti-inflammatory agent, alpha-lipoic acid (biochemical) as a relevant option to prevent POAF.

Investigators computed on the basis of findings from a prior study found the incidence of POAF after cardiac surgery of about 25% . Assuming a slightly lower alpha-lipoic acid' effect to previous study. If the true relative risk of AF for experimental subjects relative to controls is 0.5 , with α equivalent to 0.5 and power (1 - β) is 0.8, the estimated sample size is 152 experimental subjects and 152 control subjects in order to be able to reject the null hypothesis that this relative risk equals 1 with probability (power) of 0.8. investigators used the uncorrected chi-squared statistics to evaluate this null hypothesis. STATA software version and taking into account a possible dropout of 15%, the total sample size was: 304 + 0.15 (304) × 2 = 350 subjects of which there will be 175 controls and 175 experimental subjects %, assuming an enrolment ratio of 1:1.

Eligibility Criteria:
Inclusion Criteria:

* I
* Male or female patients above 18 years of age who are scheduled for cardiac surgery.

Exclusion Criteria:

* Any urgent or emergency surgery.
* Poor Left ejection volume (EF \< 30%).
* Intake of steroids or any antiarrhythmic drugs except beta blockers during the last month before surgery
* Unable or unwilling to provide informed written consent.
* Pregnancy or lactation
* Known hypersensitivity to the study drug.
* Current treatment with antioxidants or alpha-lipoic acid for any indication.
* Infection or inflammatory disease except coronary artery disease.
* Left atrium size \>70 mm.
Clinical Trial of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years(COVID-19)

This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy residents aged 3 to 17 years at the time of consent
* Subjects and/or their guardian agree to sign the informed consent forms voluntarily.
* Be able to comply with study requirements/procedures.
* Axillary temperature ≤ 37.0℃

Exclusion Criteria:

* Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
* Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
* Subjects with history of SARS virus infection by self-reported;
* Positive in throat swab through RT-PCR;
* History of vaccination of various COVID-19 vaccines or positive in SARS-CoV-2 antibody test;
* Positive urine pregnancy test for females with menarche
* With abnormal indicators, such as blood biochemistry, blood routine, urine routine, thyroid function and coagulation function which might show clinical meaning, before administration;
* History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;
* History or family history of convulsion, epilepsy, encephalopathy or mental illness;
* Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
* Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;
* Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
* History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
* Subjects receiving anti-TB treatment;
* Subjects receiving other research drugs within 6 months before vaccination;
* Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
* Subjects receiving blood products within 3 months before administration;
* Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
* Subjects vaccinated with other vaccine within 7 days before vaccination;
* The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies

The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.

Study Design: This is a single center Phase 2 study of myeloablative (MA) and nonmyeloablative (NMA) conditioning, transplantation of partially HLA-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (Cy) in patients with hematologic malignancies including:

1. Acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and Burkitt's lymphoma in remission.
2. Relapsed lymphoma, including marginal zone B cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or Hodgkin lymphoma.
3. Myelodysplastic Syndrome (MDS)
4. Blastic plasmacytoid dendritic cell neoplasm

Primary Objective:

The primary objective is to determine overall survival 180 days after transplantation involving Myeloablative and Non myeloablative conditioning, HLA-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant Cyclophosphamide as GVHD prophylaxis.

Secondary Objectives:

Secondary objectives include estimating overall and progression-free survival at 100 days, 180 days, and one year after transplantation, treatment-related mortality, incidence of neutrophil and platelet recovery or engraftment, incidence of graft failure, cumulative incidence of acute and chronic Graft versus Host Disease (GVHD), incidence of infections, and cumulative incidence of relapse/progression. The investigators will also examine the amount of time to transplant (day of unrelated search initiation to day 0).

Eligibility Criteria:
Inclusion Criteria:

1. Age: Subjects 18-70 years old.
2. Donor must be 18 years of age.
3. HLA typing will be performed at high resolution. A minimum match of 5 out of 10 is required.
4. Patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
5. Acute Leukemias.

   * Acute Lymphoblastic Leukemia in high risk 1st complete response (CR1)
   * Acute Myelogenous Leukemia in high risk 1st complete response (CR1)
   * Acute Leukemias in 2nd or subsequent Complete Response (CR)
   * Biphenotypic/Undifferentiated Leukemias in 1st or subsequent Complete Response (CR).
6. Burkitt's lymphoma: second or subsequent Complete Response (CR).
7. Lymphoma
8. Patients with adequate physical function
9. Performance status: Karnofsky score 70-100%.

Exclusion Criteria:
Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory CD30-positive malignancy
* Adequate organ function
* ECOG performance status \<2

Exclusion Criteria:

* Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)
* Current diagnosis of primary cutaneous ALCL
* Acute or chronic graft-versus-host disease
* Prior hematopoietic stem cell transplant within specified timeframe
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis

To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

1. Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
2. 18 yrs of age or older
3. Read and sign informed consent
4. Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control.

Exclusion Criteria:

1. History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
2. Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection.
3. Impairment of sense of tast or smell (self reported)
4. Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
5. Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
6. Patients w/a severe impairment of nasal breathing
7. Anatomic abnormalities of as identified by nasal examination
8. History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.
9. History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.