cyrilzakka/clinical-trials huggingface dataset:
Post-Marketing Safety Study in Japan of Shock and Anaphylaxis After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons in at High Risk of Severe COVID-19

The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19 and explore risk factors.

Data collected from the JDMC Claims Database between May 2021 to November 2021.

Eligibility Criteria:
Inclusion Criteria:

* Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database
* Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and the observation start date is at least 6 months prior to vaccination with the mRNA-1273 vaccine and have underlying diseases. Data period for confirmation of presence/absence of underlying disease is May 2021 to November 2021.

Exclusion Criteria:

* Underlying diseases that were determined undetectable by the pre-screening of JMDC
* Participants who did not consent to the questionnaire.
Safety Study of Nebulized RNS60 to Treat Asthma.

The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in healthy human subjects and in subjects with mild asthma, in a single-dose administration. Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate asthma over a 4-week period.


Eligibility Criteria:
Inclusion Criteria:

For single-dose safety (Groups 1a and 1b):

1. Male or female, aged 18 to 65 years.

2.1. For healthy subjects; clinically considered "healthy" and no diagnosis of asthma.

2.2. For subjects with mild asthma, clinical diagnosis of mild chronic asthma as determined by National Heart, Lung, and Blood Institute's (NHLBI) 2007 guidelines, and who are not regularly using a chronic asthma medication (\< 3 doses/week).

3. Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent.

4. Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry.

For multi-dose safety study (Group 2e):

1. Male or female, aged 18 to 65 years.
2. Patients with clinical diagnosis of mild to moderate asthma, as determined by NHLBI 2007 guidelines, who are not already using a chronic asthma medication.
3. Historical documentation of asthma in the patient's medical record.
4. Men and women of reproductive potential who document use of adequate contraception during the study and for 1 month following the last day of treatment (Day 28).
5. Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry.
6. Subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent.

Exclusion Criteria (for all groups of the study):

1. With a chronic or acute disease that might interfere with the evaluation of RNS60 therapy.
2. Pregnancy or lactation.
3. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated).
4. History of infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV).
5. Infections that require intravenous antibiotic therapy.
6. Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry).
7. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.
8. Treatment with any investigational drugs or therapies within 4 weeks prior to study entry.
9. Any use of antidepressants or other psychiatric medicine in the previous 4 weeks days.
10. Group 1b: Any use of oral, systemic corticosteroids within 2 weeks prior to enrollment. Group 2e: Any use of oral, systemic corticosteroids within 4 weeks prior to enrollment.
Motivational Enhancement Therapy to Improve Treatment Utilization in Pregnant Substance Users - 1

The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard drug abuse treatment among pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy \<30 weeks
* Have not attended drug treatment in past 28 days
* Not needing residential treatment (except detox)
* Not at risk for suicide/homicide
* Have no pending legal charges (except drug treatment)
Optical Nerve Sheath Changes During Head Down Laparoscopy

Patient undergoing laparoscopic radical prostatectomy in steep trendelenburg position are at risk to develop complication from brain edema.

Ultrasound assessment of optical nerve sheath diameter is a simply, non-invasive method to estimate the increase of intracranial pressure. It is unknown how optical nerve sheath diameter changes after prolonged head down position.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective laparoscopic prostatectomy in steep Trendelenburg position
* American Society of Anesthesiologists risk I-III

Exclusion Criteria:

* Age \<18 or \>70 years
* American Society of Anesthesiologists risk \>III
* Assumption of beta-2-blockers, diuretics
* Heart failure with NYHA class ≥ IIb
* Diabetes with ocular (i.e. retinopathy), neurologic (i.e. peripheral neuropathy), or renal complications
* History of cardiac surgery, thoracic surgery, suprainguinal vascular surgery, head surgery, ocular surgery, stroke, hydrocephalus.
The Role of Circadian Rhythms in Cancer-Related Symptoms

Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on cancer survivors' quality of life, and a pressing demand for effective interventions to treat CRS, there is a need for a comprehensive examination of circadian disruption related to cancer and its treatment, and its association with CRS. The study will prospectively examine circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from prior to surgery or chemotherapy to 12 months later. A matched healthy control group will serve as a comparison.


Eligibility Criteria:
Inclusion Criteria:

* Patients with early breast cancer scheduled for surgery and chemotherapy (neoadjuvant or adjuvant) at Aarhus University Hospital (AUH).
* The healthy control group will consist of an age-matched sample of participants with no history of cancer.

Exclusion Criteria:

* Pregnancy
* Shift-work
* Melatonin supplementation
* Insufficient Danish proficiency
* Previous cancer diagnosis except for treated non-melanoma skin cancer
* Confounding diagnosed or suspected psychiatric or medical conditions that might significantly contribute to the CRS or symptoms/diagnoses resembling them (other than those caused by cancer or its treatment) such as seasonal affective disorder.
Elucidating the Genetic Basis of the Pleuropulmonary Blastoma (PPB) Familial Cancer Syndrome

Pleuropulmonary Blastoma (PPB) is a rare lung tumor which develops in childhood. The underlying genetic factors which contribute to the development and progression of PPB are not defined. We are working to identify the genetic factors which may contribute to the development of this rare tumor.

Studies of inherited cancer syndromes have provided unique opportunities to uncover and explain important cellular pathways with broad relevance to both sporadic cancers and human development. This proposal studies the cancer predisposition syndrome originally described as a familial form of pleuropulmonary blastoma (PPB). PPB is a rare, aggressive lung cancer that affects young children. Children with PPB and/or their family members are at increased risk for a number of rare conditions, including Wilms tumor, rhabdomyosarcoma, brain tumors, ovarian tumors and nodular hyperplasia of the thyroid gland. In 2009, we mapped a PPB locus and identified germline, loss of function mutations in one copy of DICER1 as the genetic basis of this syndrome. DICER1 encodes a protein that performs the final critical step in maturation of microRNAs (miRNAs). miRNAs are an important form of gene regulation. The syndrome's varied nature is likely attributable to the various roles of miRNAs during different developmental and/or functional circumstances. This study focuses on defining the full phenotype of this cancer predisposition syndrome including penetrance, expressivity in children and adults, pathologic classification of disease and spectrum of predisposing DICER1 mutations. Improved understanding of the clinical and genetic features of this cancer predisposition syndrome is essential to facilitate early diagnosis when the diseases are most curable, and to create genetic counseling and educational materials to guide medical care.

Eligibility Criteria:
Inclusion Criteria:

* Child or adult diagnosed with pleuropulmonary blastoma, cystic nephroma, embryonal rhabdomyosarcoma of uterine cervix, ovarian Sertoli-Leydig tumor or gynandroblastoma, pineoblastoma, pituitary blastoma, nasal chondromesenchymal hamartoma, medulloepithelioma, Wilms tumor, germline or mosaic DICER1 mutation

Exclusion Criteria:

* child or adult who does not fit inclusion criteria as listed above
Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy

To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo


Eligibility Criteria:
Inclusion Criteria:

1. Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin \< 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT \< 20%) and presence of incomplete reverse remodeling (LVEF \< 40%).
2. Age ≥18 years
3. Obtained informed consent
4. Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)

Exclusion Criteria:

1. Hemochromatosis, iron overload, defined as TSAT \> 45%
2. Hemoglobin \> 15 g/dl at inclusion
3. Known hypersensitivity to injectafer®.
4. Known active infection, CRP\>20 mg/L, clinically significant bleeding, active malignancy.
5. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
6. Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
7. History of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
8. Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
9. Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.
10. Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
11. Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
12. Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).
13. Pregnancy or lactation.
14. Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
15. Planned cardiac hospitalization during study follow-up
Pilot Study of Vitamin D Supplementation in Heart Failure

The purpose of this study is to determine if the methods are feasible for a larger clinical trial.The study will examine the relationship between vitamin D status, quality of life, pain and walking distance of individuals living with heart failure.

This study is being conducted as a pilot project to determine the feasibility of the methods to inform the conduct of a future larger study. This double-blind randomized controlled trial will examine the relationship between vitamin D status, Quality of Life (QOL), pain and functional capacity of individuals living with heart failure (HF) pre and post vitamin D supplementation. The study outcome measures include: the rate of recruitment, retention and compliance with the study procedures. Quality of life will be measured by the EQ-5D™ questionnaire; the Brief Pain Inventory (BPI) will be used to evaluate subject pain. The 6-minute walk test (6MWT) will evaluate functional capacity. Serum 25-hydroxyvitamin D (25OHD) levels will quantify the adequacy of vitamin D dosing to achieve target 25OHD levels.

A convenience sample of 40 subjects (20 per treatment group) will be prospectively recruited from the Royal Columbian Hospital (RCH) Heart Function (HFx) Clinic. Subjects will be randomized to receive either vitamin D3 (cholecalciferol) or a matching placebo at a dose of 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks. Subjects will have their 25OHD levels measured, self-administer the EQ-5D™ and BPI questionnaires and perform the 6MWT at the study entry and again at the completion of the study (12 weeks after entry).

Descriptive statistics (mean, standard deviation and proportion as appropriate) will be used to describe the data. The feasibility of all study procedures will be reported by percentage and compared to the standard set by the team of 80%.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* New York Heart Association functional Class II or III symptoms
* Ability to communicate in English or through a translator
* Competent to sign the informed consent

Exclusion Criteria:

* Co-morbidity that would negatively impact quality of life (e.g. severe arthritis, or fibromyalgia)
* Co-morbidity that would negatively impact vitamin D metabolism (glomerular filtration rate-15-29%, significant liver dysfunction
* On a pharmaceutical agent that could lower Vitamin D levels (e.g. glucocorticoids, anticonvulsants)
* Taking \>600 IU vitamin D (cholecalciferol or ergocalciferol) daily
* Moderate or severe cognitive impairment
* Contraindication to vitamin D supplementation: history of hypercalcemia or conditions that increase the risk of hypercalcemia (sarcoidosis, tuberculosis or lymphoma)
* Wheelchair bound (ambulation is a component of the QOL questionnaire
PET/MRI to Stage Prostate Cancer Patients

The main goal of this phase II clinical trial is to define a novel approach of staging prostate cancer (PCa) patients by using a fully integrated positron emission tomography/ magnetic resonance imaging (PET/MRI) system with 68Ga-prostate specifica membrane antigen (PSMA) and 68Ga-RM2 (bombesin antagonist).

50 patients with biopsy proven PCa will be studied by PET/MRI with 68Ga-PSMA and with 68Ga-RM2 and then will undergo prostatectomy and pelvic lymphadenectomy.

This is a prospective monocentric open study (Phase II study). The study will include 50 consecutive PCa patients who will be recruited in the first 36 months of the study. All clinical and pathological variables available at the time of PET/MRI will be recorded for each patient and all patients will take a blood sample before the first PET/MRI study. All patients will undergo 68Ga-PSMA and 68Ga-RM2 PET/MRI studies at San Raffaele Hospital in two different days (\> 48 hours between the two studies) and within one month from each other.

Then, patients will undergo surgical intervention (prostatectomy and pelvic/retroperitoneal lymphadenectomy) and the surgically removed prostate will be fixated and processed. Ex-vivo 3T-MRI study will be performed on the processed specimen (prostate gland) and afterwards, the prostate will be examined by a dedicated pathologist. Spatial coregistration of in vivo, ex-vivo and histopathological images will be performed so that the annotation (dominant tumor lesion) made by the pathologist will be translated onto in vivo PET/MR images and semi-quantitative and radiomic features will be extracted from PET and mp-MRI images

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years-old
* Biopsy proven high-grade PCa referred to prostatectomy and pelvic/retroperitoneal lymphadenectomy.
* Willing to provide a signed informed consent

Exclusion Criteria:

* Age \< 18 years-old
* Inability to complete the needed imaging examinations (i.e. severe claustrophobia)
* Any additional medical condition that may significantly interfere with study compliance
* All the contraindications for MRI study (i.e. pacemaker)
* Evidence of metastatic disease on conventional imaging contraindicating the surgical procedure
Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease

Protein-calorie malnutrition is frequently observed in patients with advanced liver cirrhosis. There have been continued interests in potential benefits of long-term oral branched-chain amino acid supplement in improving severity of liver disease. However, there are limited evidences in literature. The aim of this study is to evaluate the efficacy of oral branched-chain amino acid in patients with advanced liver cirrhosis.

This study is a multicenter retrospective cohort study involving thirteen centers in Korea nation-wide. The inclusion criteria are liver cirrhosis patients with Child-Pugh score 8 to 10. The major exclusion criteria are abnormal serum creatinine level, and hepatocellular carcinoma with viable tumor. The investigators analyzed improvement of Model for End-Stage Liver Disease score, Child-Pugh score, incidence of cirrhosis-related complications, and event free survival.

Eligibility Criteria:
Inclusion Criteria:

* Advanced liver cirrhosis patients with Child-Pugh score 8 to 10

Exclusion Criteria:

* Diagnosis of malignancy (except hepatocellular carcinoma) within 3 years or untreated malignancy
* Major organ failure (heart, lung and kidney) need to admission or medical therapy or dialysis
* Patients already on a waiting list or being considered for major organ transplantation.
* Serum creatinine above upper normal range (\>1.5 mg/dL)
* Patients treating with albumin replacement regularly
* Viable hepatocellular carcinoma or advanced Barcelona Clinic Liver Cancer stage or hepatocellular carcinoma below 6 months life expectancy
* Patients being impossible to secession of alcohol consumption
* Patients being impossible to oral ingestion or oral medication
* Pregnancy or being considered for pregnancy
* Breast feeding
* Amyotrophic lateral sclerosis
* Patients with other metabolic disorder presenting branched-chain ketoaciduria
Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage

The primary purpose of this research is to analyze the cells present in the fluid obtained via ductal lavage from the nipple of a woman with a known diagnosis of breast cancer. A portion of the lavage fluid may be used in future breast cancer biomarkers. Remaining lavage fluid will be used to analyze its biochemical composition, for investigational purposes only.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age
2. biopsy-proven unilateral invasive breast cancer of any histology or ductal carcinoma in situ
3. patient desires or requires treatment with mastectomy
4. any patient who has undergone prior excisional biopsy of their primary breast tumor must have had margins positive for disease, or must have either mammographic or ultrasonographic evidence of probable residual disease in the breast.
5. patients receiving induction chemotherapy remain eligible for participation in the study regardless of tumor response; those with a clinical complete response remain eligible.
6. voluntarily signed informed consent. -

Exclusion Criteria:

1. male gender
2. lobular carcinoma in situ as the only cancerous histology
3. prior margin-negative excisional biopsy of primary breast tumor, with no evidence of residual disease
4. patient being treated with breast conservation therapy inability to understand the nature of the procedure pregnancy and/or active lactation
Developing Standards Skill According to the Learning Curves

The aim of the current study was to develop a criterion in terms of the number of sessions required to achieve mastery in DCS based on the learning curve assessment in real clinical situation.


Eligibility Criteria:
Inclusion Criteria:

* Nursing and midwifery students in Mashhad.
* Before the relevant skills in teaching nursing for the theoretical and practical training
* Employment as student work , etc., is not nursing .

Exclusion Criteria:

* Skills into the clinical environment is not done , or a maximum of three times ( contact skills intravenous line , dry dressing , intramuscular injection ) has done .

Defects or diseases that cause skills to do independent problem , no . ( At the discretion of the instructor )

No sign student proficiency , skills required in this section or elsewhere has done .

Student of psychological ( lack of acute stress , etc.) is ready to perform skills . ( At the discretion of the instructor )
Sedation and Psychopharmacology in Critical Care

Certain methods of sedation increase the duration of respiratory failure. Two strategies, a nursing- implemented sedation algorithm and daily interruption of sedatives, decrease length of mechanical ventilation compared to "conventional care" but have not been compared to each other. The reason certain methods of sedation lead to prolonged respiratory failure is unknown but may be related to altered pharmacokinetics and dynamics that are unique to critically ill patients. Critically ill patients receive substantial doses of sedatives over prolonged periods. The impact of these management strategies on short- and long-term psychiatric complications are unknown. The study seeks to test the central hypothesis that sedation practices impact strongly on outcome of respiratory failure and psychiatric complications. The three specific aims are (1) to compare two sedation strategies (protocol directed sedation and daily interruption of sedatives), (2) to examine the prevalence of psychiatric complications, and (3) to compute the pharmacokinetics of commonly used sedatives and narcotics.

These aims will be achieved by enrolling critically ill patients in a prospective randomized trial comparing the above mentioned sedation strategies, and assessing sedation level as well as delirium throughout the duration of respiratory failure. Sedative plasma levels will be measured, and pharmacokinetics computed. Psychiatric morbidity will be assessed by administration of validated questionnaires.


Eligibility Criteria:
Inclusion Criteria: Patients aged 18 and older undergoing mechanical ventilation via naso- or orotracheal tube -

Exclusion Criteria: Age less than 18, tracheotomy, severe dementia or mental retardation, severe neuromuscular disease or neuromuscular blockade use, institution of mechanical ventilation at another hospital

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