cyrilzakka/clinical-trials huggingface dataset:
Determination of Normal Reference Values of CRP, Procalcitonin, and Lactate Levels for the Nanōmix eLab® System

The main objective of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay.

The purpose of this clinical study is to determine the normal reference range of the Nanōmix eLab® (eLab) C-Reactive Protein, Procalcitonin and Lactate Assay, whereby collected blood samples are used to characterize the distribution of C-Reactive Protein (CRP), Procalcitonin (PCT), and Lactate (LAC) in a population of healthy subjects. Approximately 4 mL of whole blood will be collected by venipuncture from normal healthy volunteers and tested with the eLab C-Reactive Protein, Procalcitonin, and Lactate assay within 30 minutes of collection. Following the whole blood test, the sample will be spun down to plasma and a plasma sample will be tested on the eLab with the eLab C-Reactive Protein, Procalcitonin, and Lactate assays within 30 min of the whole blood test. Demographic and health information will also be collected from each participant by having them complete a questionnaire. The test results will be collated to establish the normal range (2.5 - 97.5th percentile) for each analyte. The remaining plasma will be frozen and stored at -80° C.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Must have provided written informed consent
* Must self-report as being in good health

Exclusion Criteria:

* Under the care of a physician and currently receiving any therapy
* Obesity (BMI \> 35)
* Have had outpatient surgery or been hospitalized in the last 3 months for any reason
* Known to be pregnant or nursing
* Engaged in exertion resulting in an estimated HR\>120 bpm for \> 5 minutes in the last 4 hours
Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia

This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication.

Dabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigratran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it.

This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119).

If positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.


Eligibility Criteria:
The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:

Inclusion Criteria:

* Patient is taking an oral Xa inhibitor for: stroke prevention in atrial fibrillation, treatment or secondary prevention of deep venous thrombosis or pulmonary embolism, prevention of VTE in patients who have undergone elective total hip or total knee replacement surgery provided there are 30 or more days of planned treatment remaining at the time of enrolment.

Exclusion Criteria:

* Active bleeding (allowing up to 5 days from the index blood culture to randomize in the event anti-thrombotic therapy is resumed)
* Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days
* Pregnancy
* Known use of dabigatran within last month
* Allergy to dabigatran
* Concomitant use of amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor
* eGFR \< 30mL/minute calculated by Cockcroft-Gault equation using adjusted weight \[if acute kidney injury can allow for up to 5 days from index blood culture to allow for recovery\]
* Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)
Dynamic Gait Index in Children With Dyslexia

The aim of the present study is to investigate reliability in dyslexic children and compare it with healthy peers.

Assessments methods are very important for the detection and treatment of such problems and there is a need for studies that can be applied for the dyslexia group. However fewer attempts have been made to demonstrate the reliability of balance impairments tools in dyslexic children. The DGI is a test that has been used a lot lately because of its minimal requirement for space and equipment, as well as its ability to be used with different patients' groups. The aim of the present study is to investigate reliability in dyslexic children and compare it with healthy peers.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of dyslexia by Child and Adolescent Psychiatry
* Intelligence quotient (IQ)\> 85 results of WISC-R
* Age between 8 - 14
* Able to understand the commands given
* Volunteer to study

Exclusion Criteria:

* Having cognitive disorder
* Having neuromuscular disorder
* Having skeletal anomaly
* Having visual or hearing problems
Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy

To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy.

A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both, intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* physical status I, II and III according to the criteria of the American Society of Anesthesiology (ASA)
* patients who are going to undergo diagnostic colonoscopies
* patients who signed the informed consent

Exclusion Criteria:

* Allergy or hypersensitivity to some of the reference drugs in the study
* patients with proven liver disease
* suspicion or confirmation of pregnancy
* antecedent or risk of malignant hyperthermia
* fasting less than 8 hours
* patients with psychic disorders or mental incapacity that make it difficult to understand their participation in the study
* patients who have acute illnesses that compromise their health for which the study cannot be performed
Novel Approach to Surveillance of Gastric Lesions

This will be a pilot study investigating the feasibility of using pressurized irrigation of the stomach mucosa to obtain gastric aspirate cell samples for analysis and identification of premalignant lesions of the stomach.

Gastric cancer is an important public health concern, accounting for 26,240 new cases in the United States (US) annually. Outcomes are poor, with 5-year survival of 31%, but improve when lesions are detected at early stages amenable to curative therapy. Research has shown that lesions such as atrophic gastritis and gastric intestinal metaplasia are precursors to more advanced lesions such as dysplasia and adenocarcinoma, thus providing a potential target for early intervention. Gastric cancer screening programs have decreased mortality in high-prevalence countries like Japan. However, providers in low-prevalence settings are less experienced at detecting precursor lesions endoscopically on visual inspection. This pilot study will investigate a novel approach to screening for precursor lesions and early detection of gastric cancer by utilizing pressurized irrigation of the gastric mucosa. The study will target patients with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy. Following routine endoscopic evaluation, the investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment. The goal is that this technique will simplify testing for precursor lesions of gastric cancer, making screening more effective in regions of lower prevalence where providers are less experienced with visual identification of such lesions.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy

Exclusion Criteria:

* Personal history of gastric cancer
* Personal history of irritable bowel disease
Intravenous Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer

This is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
* Diagnosed early stage breast cancer and scheduled to receive either adjuvant or neo-adjuvant chemotherapy;
* Willing to receive either intravenous ascorbic acid or normal saline;
* Willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug;
* Negative urine or serum pregnancy test within 2 weeks prior to receipt of study drug;
* Willing to complete all evaluation tools;
* Able to give informed consent to participate in the study; and
* Agree to avoid any additional supplemental ascorbic acid throughout the study.

Exclusion Criteria:

* Diagnosed Glucose-6-phosphate dehydrogenase deficiency;
* Renal insufficiency (Blood Urea Nitrogen \>30 mg/dL, or Creatinine \>1.5 mg/dL);
* Unwillingness or mental incapacity to complete self-reported questionnaires;
* Active smoker; and
* Male sex
Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

This study is to determine if low level vagus nerve stimulation will lead to improvement in heart function, heart rate variation, and in the levels of certain chemical markers of inflammation in study participants' blood.

Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.

Eligibility Criteria:
Inclusion Criteria:

1. Patients (\>50 years) who have received anthracycline-based therapy (a cumulative dose of ≥ 200 mg/m2 Doxorubicin or bioequivalent dose of other anthracyclines) for breast cancer or lymphoma within the last 15-30 days and have \>= 1 of following additional criteria:

* previous chest radiation,
* type 2 diabetes mellitus,
* hypertension,
* current smoking,
* obesity (BMI ≥ 30),
* previous myocardial infarction or
* established atherosclerotic heart disease.

Exclusion Criteria:

1. atrial paced rhythm,
2. history of seizure currently on treatment,
3. history of vasovagal syncope,
4. end stage liver or kidney disease.
Dynamics of Muscle Mitochondria in Type 2 Diabetes Exercise

Insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells for use as energy; it also promotes storage of excess nutrients as fat. Type 2 diabetes occurs when the cells of the body become resistant to the effects of insulin, and this causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the heart. Understanding how insulin resistance occurs will pave the way for new therapies aimed at preventing and treating type 2 diabetes.

Mitochondria are cellular structures that are responsible for turning nutrients from food, into the energy that our cells run on. As a result, mitochondria are known as "the powerhouse of the cell." Mitochondria are dynamic organelles that can move within a cell to the areas where they are needed, and can fuse together to form large, string-like, tubular networks or divide into small spherical structures. The name of this process is "mitochondrial dynamics" and the process keeps the cells healthy. However, when more food is consumed compared to the amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with the ability of insulin to communicate within the cell. This may be a way for the cells to prevent further uptake of nutrients until the current supply has been exhausted. However, long term overload of the mitochondria may cause blood sugar levels to rise and lead to the development of type 2 diabetes.

This study will provide information about the relationship between mitochondrial dynamics, insulin resistance and type 2 diabetes.

The traditional view of mitochondria as isolated, spherical, energy producing organelles is undergoing a revolutionary transformation. Emerging data show that mitochondria form a dynamic networked reticulum that is regulated by cycles of fission and fusion. The discovery of a number of proteins that regulate these activities has led to important advances in understanding human disease. Data show that activation of dynamin related protein 1 (Drp1), a protein that controls mitochondrial fission, is reduced following exercise in prediabetes, and the decrease is linked to increased insulin sensitivity and fat oxidation. The proposed research will test the hypothesis that mitochondrial dynamics is a key mechanism of insulin resistance in type 2 diabetes. The experimental approach harnesses innovative molecular and cellular tools, interfaced with physiologically significant human studies to obtain meaningful data on insulin resistance, and has the potential to generate insights that will lead to new diabetes therapies for future generations.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Body Mass Index (BMI) between 25 and 50 kg/m2
* HbA1C \< 10%
* Sedentary

Exclusion Criteria:

* Evidence of type 1 diabetes or requiring insulin therapy
* BMI \>50 kg/m2
* Smoking
* Active pregnancy
RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood

The purpose of this study is to investigate the efficacy of an evidence-based smartphone application (app) for the management of mood compared to treatment as usual alone among 135 women who have been discharged post-delivery from Labor and Delivery at Stanford Children's Health - Lucile Packard Children's Hospital. Using psychometrically validated surveys for depression, postpartum depression, and anxiety, this study will evaluate whether the smartphone app has a differential effect on the mental health of postpartum women as compared to treatment as usual.

The intervention is a cognitive behavioral therapy (CBT) based automated conversational agent available as a mobile device smartphone application. When a user logs in with the app, it asks questions about that user, such as how they're feeling, and the user is able to type their response, similar to texting or messaging. The app is then available for use by the user anytime (24 hours per day 7 days per week), and will check in with the user to encourage mood tracking followed by tailored delivery of CBT-based tools and other general psychoeducation. This smartphone app interacts with conversational tones, and offers empathy and behavioral pattern insight to users. The app's artificial intelligence becomes more specific to a user over time, based on conversations. The app allows patients are able to immediately process and receive empathy for significant events and removes barriers traditionally limiting treatment access (cost, stigma, health care system navigability, and lack of childcare or transportation).

Eligibility Criteria:
Inclusion Criteria:

* Postpartum day 0-7 after delivery
* Medically stable and cleared for discharge
* Owns smartphone
* English-speaking (because all intervention materials are in English)

Exclusion Criteria:

* Neonatal demise this admission
* Intrauterine fetal demise this admission
The Effect of Neuro Linguistic Programming on COVID-19 Fear in Kidney Transplant

The study was conducted experimentally to evaluate the effect of neurolinguistic programming on COVID-19 fear in kidney transplant patients.

The study was conducted experimentally (prospective randomized single-blind clinical trial model) to evaluate the effect of neurolinguistic programming (NLP) on fear of Covid-19 in kidney transplant patients.

The study was carried out between June 2021 and October 2021. Personal Information Form and Fear of COVID-19 Scale (FCV-19S) were used to collect data. The data obtained from the research were evaluated with SPSS 25.

According to the calculation made using G\*power 3.1 software, the sample size was determined as 74 (each group 37) with an effect size of 0.80, a margin of error of 0co.05, a confidence level of 0.95, and a population representation of 0.95. Simple random sampling method, one of the probability sampling methods, was used to determine the participants. Single-group columns between 1 and 300 were created using the Random Integer Generator method, which located in the Numbers sub-heading of the random.org website for the participants who met the sample selection criteria. Participants were randomly assigned to numbers 1 and 2, considering the numbers 1 and 2 in the column. The number of the experimental or control group was determined by drawing lots at the beginning of the research

Eligibility Criteria:
Inclusion Criteria:Patients who could communicate verbally, had no hearing problems, had a high or moderate fear of Covid-19 (20 or more), and had not applied NLP before were included in the study.

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Exclusion Criteria: Patients who wanted to leave voluntarily at any stage after being included in the study, and who had to be hospitalized again for organ rejection or any other reason while the study was ongoing, were excluded from the study.

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Swedish Esophageal and Cardia Cancer Study

The overall objective of this nationwide Swedish project is to identify strategies that can help reduce the suffering and improve the survivorship among patients surgically treated for oesophageal cancer. This objective can be accomplished by a broad research approach that aims to:

1. describe health-related quality of life (HRQL)
2. identify risk factors and preventive actions for poor HRQL

This is a Swedish nationwide, prospective, and population-based cohort including 90% of all patients operated on for esophageal or gastroesophageal junctional cancer in Sweden between 1st April 2001 and 31st December 2005. Detailed clinical data were continuously collected from medical records based on a predefined study protocol to ensure uniformity. The clinical data collected included patient and tumor characteristics, treatment details, and follow-up on complications. Patients were followed up with health-related quality of life (HRQL) questionnaires. The core questionnaire (EORTC QLQ-C30) was used to measure aspects of HRQL and symptoms that are applicable for cancer patient in general, whereas the esophageal cancer-specific module (EORTC QLQ-OES18) measured symptoms common among esophageal cancer patients. HRQL was assessed 6 months, 3, 5, 10 and 15 years after surgery while the 20-year follow-up is ongoing. All questionnaires were self-administered, delivered by mail and up to three reminders were sent if required. Collection of HRQL data was obtained anonymously (patients sent their answers to a central administration and not to the treating department). The all-cause and disease-specific mortality was assessed by linkage to the Causes of Death Registry. Informed consent was obtained from each participant.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are alive and able to participate in the project 6 months following surgery for oesophageal cancer are eligible to participate in the study.

Exclusion Criteria:

* Patients with cognitive impairment, who are unable to complete the measures in Swedish or are too unwell to complete the assessment, are excluded from the study.
Sleep Patterns in Patients Affected by Lymphangioleiomiomatosis

Lymphangioleiomyomatosis (LAM) is a rare and progressive pulmonary disease of unknown etiology that almost exclusively affects women. It is characterised by cystic radiological lung pattern and by the possible presence of angiomyolipomas in other sites or organs. Functionally LAM is associated with airway obstruction or restriction and progressive hypoxemia up to chronic respiratory failure.

There are no studies, so far, which have investigated whether during sleep these patients show changes in the sleep profile and gas exchange and if these changes are related to disease severity. Aim of the study, prospective and pilot, is to evaluate whether the physiological modification of respiratory mechanics during sleep is associated with polysomnographic alterations in LAM.

Lymphangioleiomiomatosis (LAM) is a rare progressive disease that affects primarily lungs with a cystic radiologic pattern and may be associated with angiomiolipomas in the kidneys or in other sites and an increased frequency of meningioma. Patients with sporadic LAM are usually female (incidence around 1/400.000 adult females). LAM associated with tuberous sclerosis may affect male, female and children.

LAM patients are functionally characterized by obstructive or restrictive syndrome that leads patients to hypoxemia and chronic respiratory failure, so that quality of Life (QoL) of these patients is affected by dyspnea. Hypoxemia contributes to the development of secondary pulmonary hypertension (PH) during progression of LAM history, worsening the damage.

The modifications in the neural control of ventilation during sleep in combination with anatomical disposition drive to sleep-related changes in upper airway resistance and physiologic desaturations. In healthy subjects these features are almost completely compensated but, in LAM patients, may lead to airway obstruction and/or pathologic oxygen desaturation that could be managed. So far, none have investigated the changes in sleep architecture and related blood gas exchange in patients with LAM relating these changes with disease severity.

This pilot study investigate if the physiologic modifications of breathing during sleep lead to sleep disorders in LAM patients, measured through abnormalities in polysomnography (PSG) and ih sleep disorders in LAM are associated with respiratory functional abnormalities and disease severity.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of LAM according to current guidelines
* sign of informed consent to participate

Exclusion Criteria:

* the presence of either acute or chronic respiratory failure
* the use of long-term oxygen therapy