cyrilzakka/clinical-trials huggingface dataset:
Polyuria Associated With Dexmedetomidine in Operating Room

Dexmedetomidine is an a2-adrenergic receptor agonist drug, widely used in intensive care for the sedation of patients on mechanical ventilation, as well as in the operating room during invasive procedures and during general anesthesia. It also has anti-inflammatory properties and reduces the need for opioids and benzodiazepines, which leads to a lower incidence of delirium associated with these drugs.

Among the frequent adverse effects associated with the administration of dexmedetomidine we can find bradycardia and hypotension, while some studies carried out in animals have shown that it can increase the diuretic rate.

Polyuria related to pharmacological agonism of a2-adrenergic receptors has been described in vitro and in studies performed in animal models, and is believed to be the result of functional antagonism of arginine vasopressin. Despite its widespread use as a sedative and adjunctive anesthetic, there are very few reports in the literature of dexmedetomidine-related polyuria in humans.

Currently there are no reports in the literature on the incidence of polyuria induced by the intraoperative administration of dexmedetomidine.

This is a prospective, observational study designed to determine the incidence of polyuria, defined as urine output greater than 150 ml/h or 3 ml/kg/h, associated with the administration of dexmedetomidine during the intraoperative period.

The investigators will prospectively and consecutively study all patients scheduled for high complexity surgery under general anesthesia for a period of 4 months.

The diuretic rate will be quantified in ml/hour. A urine sample will be taken two hours after the start of surgery to assess sodium and urinary density, and an arterial blood sample will be taken to determine serum sodium.

Hydration will be recorded in milliliters per hour, detailing the type of solution used.

All data obtained will be captured in a RedCap data collection form.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Scheduled surgery
* Dexmedetomidine in boluses and/or continuous infusion during intra-operative period
* Patients who require arterial line and urinary catheter

Exclusion Criteria:

* Chronic renal disease.
* eGFR \< 60 ml/min/1.73m2 for more than 3 months of evolution.
* Emergency or unscheduled surgeries.
* Central nervous system disease at the sellar or suprasellar level.
* Patients receiving diuretics.
* Liver cirrhosis.
* Adrenal gland disease.
Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay

Blood samples from a total of 200 women in two cohorts will be collected and analyzed by TM-B1 assay, which is based on TBIA (Total Biochemical Infrared Analysis) to confirm the presence of cancer. These two cohorts will yield 75 healthy women with no pathological findings, 75 women diagnosed as having benign breast tumor and 50 women diagnosed as having breast cancer.

Prospective, two arms, observational, blinded, cohort study enrolling 200 women which intended to validate the cut-off points between women with malignant tumors, benign tumors, and women without tumors (controls) and to validate the sensitivity and specificity of TM-B1 for the detection of an invasive breast tumor.

Two cohorts will be tested with TM-B1. The cohorts will differ in the percentage of women that are expected to yield a positive finding for breast cancer. Any finding in TM-B1 will not influence medical standards of care.

Eligibility Criteria:
Inclusion Criteria:

Screening Population:

* Subject signed the informed consent.
* Subject is aged 25 years and older.
* Subject is presenting for routine screening or diagnostic XRM and / or breast US.

Breast Cancer Population

* Subject signed the informed consent form.
* Subject is aged 25 years and older.
* Subject was diagnosed with a malignant breast tumor, and has not yet started treatment.

Exclusion Criteria:

All Subjects:

* Subject has been diagnosed with any type of malignancy apart from breast cancer.
* Subject has been previously treated for breast cancer.
* Subject underwent any surgery within the previous year (apart from benign nevus removal).
* Subject was treated for benign tumor within the previous year (e.g. polyps or cysts).
* Subject has an active infection or inflammation from any type of infection (bacterial or viral) as determined clinically at screening.
* Subject is currently taking medications related directly to, or that can affect, the immune system such as steroids.
* Subject has any type of active autoimmune disease such as lupus or rheumatoid arthritis.
* Diagnostic drugs (e.g. contrast materials) were injected or given orally to subject within the last 7 days prior to sample collection for TM-B1 analysis.
* Subject has been taking any investigational drug which influence her health status within 30 days prior to sample collection for TM-B1 analysis.
* Subject is not feeling well at the time of blood collection for TM-B1 analysis due to suspected bacterial or viral infection or subject has symptoms such as high fever, diarrhea, headache, vomiting, dizziness etc.
* Subject is pregnant, lactating, or undergoing fertility treatment.
* Subject has participated in this study, in another cohort, and the TM-B1 test was performed.

Breast Cancer Population only:

* The subject's tumor has been surgically removed before sample collection for TM-B1 analysis.
Tobacco Use and Uptake of COVID-19 Vaccinations

This is an observational study of participants in two general population health surveys (FinSote 2018 and 2020) who are followed up for their COVID-19 vaccinations or end of follow-up. The primary objective is to examine the association between tobacco use and COVID-19 vaccine uptake and between-dose spacing.

Most high income countries have rolled out COVID-19 vaccinations, with the promise of reducing incident COVID-19 infections and preventing hospitalizations and deaths. A high vaccination coverage is crucial for several reasons: (i) to reduce the number of new COVID-19 cases, (ii) to diminish selective pressures leading to the emergence of new variants of concern, (iii) to prevent severe COVID-19 outcomes, such as hospitalizations and deaths, and (iv) to potentially reduce the risk of post-acute COVID-19 symptoms.

Smokers are at higher risk of COVID-19 hospitalizations and deaths and might thus benefit greatly from high vaccination coverage. However, evidence suggests that they may be less likely to be vaccinated, as smokers are less likely to adhere to preventive measures in general and have lower adherence to other vaccines. Reports of a protective role of smoking on the risk of COVID-19 infection might have also reduced the perceived risks from being infected.

Evidence regarding tobacco use and COVID-19 vaccine hesitancy is mixed. Some studies have shown greater mistrust in COVID-19 vaccine benefits and greater vaccine hesitancy and lower vaccine acceptance compared to non-smokers, while other studies have reported no differences by smoking status or lower levels of vaccine hesitancy in smokers compared to non-smokers. Few studies have examined the relationship between tobacco use and vaccine uptake, showing that smokers had higher odds of being vaccinated. These studies, however, are not representative of the general population and relied on self-reported vaccination status, resulting in higher risk of selection and information bias.

The investigators will expand current knowledge by examining two forms of tobacco use in Finland -smoking and smokeless tobacco use (snus)- and by analysing the spacing between vaccine doses. The study will use data from nationally representative surveys in Finland linked to vaccination registries, which reduces the risk of selection and information bias.

Eligibility Criteria:
Inclusion Criteria:

* Permanent residents of Finland
* Registered in the Population Register at the moment of sampling
* Aged 20 and over
* Participated in the FinSote surveys in 2018 or 2020
* Provided consent for register linkage

Exclusion Criteria:

* Temporary residents in Finland or tourists
* Age less than 20 years old
* Did not participate in FinSote surveys in 2018, 2019 and 2020
* Did not provide consent for register linkage
Comparison Between Low Dose and High Dose Intra-articular Tranexamic Acid in Total Knee Arthroplasty

The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritic knee who underwent primary total knee arthroplasty

Exclusion Criteria:

* Abnormal coagulation or bleeding disorder
* Allergy to tranexamic acid
* History of thromboembolism or ischemic heart disease or cerebrovascular accident
* chronic kidney disease stage 3-4
Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support

Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. There are many studies demonstrating that vaginal progesterone is equally efficacious and better tolerated compared to intramuscular progesterone for luteal phase support in IVF cycles. Conversely, although different studies showed that subcutaneous progesterone is equally efficacious compared to vaginal progesterone, patient use satisfaction and compliance were less studied with few evidences are available, that may guide the choice of vaginal progesterone instead of subcutaneous progesterone and other way around. Considering the paucity of published data about the patient's preference and use satisfaction about subcutaneous progesterone, the investigators will conduct a prospective randomized study aimed to compared adverse effects rates, impact on quality of life, use satisfaction and administration preference in women undergoing luteal phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles, that may guide the choice for luteal phase support in IVF cycles.


Eligibility Criteria:
Inclusion Criteria:

* Infertile women candidate to undergo fresh IVF cycles

Exclusion Criteria:

* day-3 follicle-stimulating hormone (FSH) levels over 15 IU/L
* clinically relevant systemic disease (e.g., uncontrolled thyroid and adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, cancers)
* hypersensitivity to any of the study drugs
* contraindications to use the study drugs
* surgical or medical condition that would interfere with absorption, distribution, metabolism, or excretion of the study drugs
Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

Primary Objectives:

* Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates.
* Phase 2: To evaluate the efficacy of isatuximab in desensitization of participants awaiting kidney transplantation.

Secondary Objectives:

* Phase 2: To characterize the safety profile of isatuximab in kidney transplant candidates.
* To characterize the pharmacokinetic (PK) profile of isatuximab in kidney transplant candidates.
* To evaluate the immunogenicity of isatuximab.
* To assess the overall efficacy of isatuximab in desensitization of participants awaiting kidney transplantation.

The study had a screening period of up to 28 days, a treatment period of up to 12 weeks, a site visit FUP of up to 26 weeks, and an extended follow-up (FUP) until study cut-off.

The study duration involved site visit per participant (i.e., screening, treatment, site visit FUP was approximately 42 weeks.

The study duration included extended FUP per participant was approximately 97.7 weeks (depending on when the participant was enrolled).

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of chronic kidney disease (CKD) and active candidate on the kidney donor waitlist at the time of screening.
* Body mass index (BMI) \</=40 kg/m\^2.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent.

For Participants in Cohort A: active candidates on the kidney waitlist with living donor.

For Participants in Cohort B: active candidates on the kidney waitlist with no living donor cleared for donation.

Exclusion criteria:

* Significant cardiac dysfunction.
* Known active, recurrent, or chronic infection.
* Active lupus or uncontrolled diabetes.
* Prior treatment with rituximab within 6 months from SAR650984 administration.
* Inadequate organ and bone marrow function at screening.
* Pregnant or breastfeeding women or women who intend to become pregnant during participation in the study.
* Known intolerance or hypersensitivity to any component of SAR650984 or pre-medications.
* Participants who were not suitable for participation as judged by the Investigator.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study of Placental Function in Healthy and Pathological Pregnancies

The purpose of this study is to establish a tissue and data repository consisting of samples of human placentas, umbilical cord blood, and maternal blood, collected at the time of delivery. Specimens will be used in cellular, molecular, and functional studies to learn more about changes in placental structure and function, which can result in serious pregnancy complications and determine life-long health by programming the fetus for future metabolic and cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women delivering at term
* Women with pregnancy complications such as:

  * pre-term birth,
  * intrauterine growth restriction,
  * diabetes, and
  * obesity.

Exclusion Criteria:

* Women:

  * under stress,
  * experiencing pain of labor.
* Pregnancies complicated by other pathologies.
Feasibility of High Frequency QRS Analysis in Patients With Acute Myocardial Infarction

The primary objective of this study is to characterize the morphological patterns of high frequency QRS components (HFQRS) in patients with acute myocardial infarction (AMI), including STEMI and NSTEMI, compared to patients without AMI.

Chest pain is one of the leading reasons of hospital emergency department (ED) visits worldwide. In the US, approximately 6 million people annually undergo evaluation in the ED for acute chest pain. Despite the wealth of knowledge available about acute coronary syndrome (ACS), this condition continues to be among the most difficult to predict or diagnose. Misdiagnoses may lead to discharge of patients with ACS, who should have been admitted as well as costly unnecessary hospitalizations of patients who do not have ACS.

More than 2/3 of the patients with ACS have unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). Conventional ECG has low sensitivity of less than 50% in diagnosing these conditions. As the initial ECG in the ED is often non-diagnostic in ACS patients, the diagnosis of ST-elevation myocardial infarction (STEMI) during its early stages may also be difficult.

Analysis of high-frequency QRS components (HFQRS), which quantifies changes in the depolarization phase of the cardiac cycle, has been previously reported to be a sensitive method for detection of demand ischemia. Preliminary studies have shown that HFQRS-derived indices can also identify supply ischemia caused by prolonged balloon occlusion, and transient ischemic episodes in patients with chest pain.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 years (men and women)
* Time from onset of chest pain ≤ 12h
* AMI confirmed by biomarkers
* Clinical or electrocardiographic evidence of ischemia during recording
* Signed an informed consent

Exclusion Criteria:

* Prior MI
* Prior CABG
* pre-excitation syndrome (e.g. WP)
* Atrial Fibrillation or significant ventricular arrhythmia
* BBB, intraventricular conduction delay or QRS duration \> 120 ms
* Implanted pacemaker or defibrillator
* Left-ventricular hypertrophy
Exercise During Active Surveillance for Prostate Cancer

The broad goal of the Exercise During Active Surveillance for Prostate Cancer (ERASE) trial is to examine the effects of exercise in prostate cancer patients undergoing active surveillance.

The ERASE Trial will be a phase II randomized controlled trial. A total of 66 men with low- or intermediate-grade clinically localized prostate cancer undergoing active surveillance will be randomized to either a 12-week of supervised high-intensity aerobic interval training or usual care. The primary outcome will be peak oxygen consumption (VO2peak) as a measure of physical fitness. The secondary outcomes include tumour-related biomarkers, fear of cancer progression, quality of life, and psychological distress. Exploratory outcomes will include indicators of cancer progression including prostate-specific antigen. Based on this sample size, our study has 80% power with a two-tailed alpha \<0.05 to detect a clinically meaningful effect of 3.5 ml/kg/min on our primary outcome of VO2max. This power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are at least moderate (i.e., a standardized effect size of d=0.60).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* diagnosed with low or favorable intermediate grade localized PCa defined as PSA less than 10, Gleason Score 3+3 or 3+4 with low volume, and digital rectal examination (DRE) of T1C or T2A
* initiating or continuing active surveillance with no plans for treatment for prostate cancer in the next 6 months (e.g., radical prostatectomy, radiotherapy, or androgen deprivation therapy)
* screened for medical clearance for exercise testing and participation in vigorous aerobic exercise
* residing in a commutable area near Edmonton, Alberta
* willing to commute to the Behavioural Medicine Fitness Centre three times per week to attend a 12-week supervised high-intensity aerobic interval exercise program

Exclusion Criteria:

* having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise (e.g., known cardiac disease or uncontrolled hypertension)
* having contraindications for cardiopulmonary stress and/or physical fitness tests
* currently participating in a structured, vigorous exercise program.
Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects

According to the relevant provisions of bioequivalence test, nifedipine sustained-release tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release pharmaceutical Co., Ltd. were compared with Adalat ® GITS (reference preparation, R, 30mg / tablet) produced by Bayer Pharma AG to evaluate the bioequivalence of single dose in healthy subjects under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female aged 18-45.
* The body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
* The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
* The subjects have no family planning within 3 months and could select contraceptive method.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

* Being allergy to the study medications, smoking, alcohol abuse.
* Participation in another clinical trial within 3 months.
Brief Religious Alcohol Intervention

This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 29 years old
* Have had a binge episode (4/5 drinks on one occasion for women/men) at least once in the past month
* UH students

Exclusion Criteria:

* Participants who are currently enrolled in treatment for alcohol or other substances
* Participants who have been diagnosed with and/or treated for verbal learning disabilities
Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance

Microparticules (MPs) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with merging role in pathophysiology of immune and cardiovascular diseases. MPs have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators. This a prospective observational study of circulating MPs and blood coagulation in septic shock patients admitted in medical intensive care units (ICUs) of four tertiary hospitals at baseline (D1, D2, D3, D4, D7).


Eligibility Criteria:
Inclusion Criteria:

* Septic shock (patients)
* Without septic shock (control)
* Informed consent

Exclusion Criteria:

* Class IV heart failure
* Child-plugh grade C cirrhosis
* Cancer under active treatment
* BMI\>35kg/m2
* Moribund patient
* DNR decision
Retrospective Investigation of the Impacts of Prognosis for Nasopharyngeal Carcinoma Patients

To investigate whether the additional induction chemotherapy (IC) to concurrent chemoradiotherapy (CCRT) was able to improve overall survival (OS) and disease-free survival (DFS), and to clarify if stage-specified chemoradiotherapy regimens benefit the most for locoregionally advanced NPC.

Data of patients firstly diagnosed NPC from Jan 1st, 1998 to Jun 1st, 2013 were downloaded from Department of Medical Information, Sun Yat-Sen University Cancer Center. Patients were excluded if they had stage I or II disease, no complete medical records, received treatment previously, or without concurrent chemoradiotherapy. Follow-up data is updated on October 1st, 2015.The propensity score-matching (PSM) method was adopted to balance observed covariates between both groups. Propensity scores reflect the conditional probability that is intended to be uniform between patients received CCRT and IC+CCRT based on their baseline characteristics. Matching was performed based on nearest-neighbor matching, and comparing between CCRT and IC+CCRT patients were matched within their respective risk groups.

Eligibility Criteria:
Inclusion Criteria:

1. firstly diagnosed NPC in SYSUCC from Jan 1st, 1998 to Jun 1st, 2013;
2. with complete medical records;
3. received radical RT.

Exclusion Criteria:

1. distant metastasis patients at first diagnosis,
2. recurrent patients,
3. not finishing radiotherapy, missing medical data, death during RT, stage I or II disease,received treatment previously, or without concurrent chemoradiotherapy were excluded.