cyrilzakka/clinical-trials huggingface dataset:
SpinChip Hs-cTnI Clinical Diagnostic Performance

During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack.

The purpose of this study is to evaluate the diagnostic accuracy and safety of the SpinChip hs-cTnI test relative to a clinically validated hs-cTnI method.

Cardiac troponins are widely used as a biomarker to aid in the diagnosis of acute myocardial infarction (AMI). These structural proteins are essential in regulating contraction in cardiac muscle cells, and they are sensitive and specific biochemical markers of myocardial damage.

During a heart attack, cardiac muscle cells are injured and release the cardiac marker troponin I (cTnI) into the bloodstream. High-sensitive troponin tests may detect the increase of cardiac troponin in blood within hours after the symptoms of a heart attack has started.

The SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test is a new high-sensitive test for measuring troponin I in blood samples, and the analysis may be performed close to the patient (near-patient test). The results may be obtained within 10 minutes, compared to approximately 1 hour for normal laboratory analysis.

The SpinChip Platform consists of the SpinChip hs-cTnI test and the SpinChip Analyzer and may be used at the emergency department to evaluate patients presenting with symptoms of acute myocardial infarction (chest pain). The test can use blood from finger prick or venous blood samples, either as whole blood or separated into plasma

This study is a multicentre, prospective, observational, non-randomised, open clinical performance study for evaluation of the diagnostic accuracy and safety of the SpinChip hs-cTnI test as an aid in the diagnosis of AMI. Subjects presenting with acute chest discomfort or other symptoms suggestive of AMI will be recruited at the emergency departments (EDs).

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide signed written informed consent
* Subjects ≥ 18 years old
* Subjects presenting at the ED with acute chest discomfort including "pain", "pressure", "tightness", "burning", or "stabbing" and/or other symptoms suggestive of AMI such as upper abdominal pain, left shoulder/arm pain, pain in the jaw, or pain between the scapulae.

Exclusion Criteria:

* Subjects experiencing shock
* Self-reported pregnancy
* Previously included in the study (e.g., in case of a second presentation)
* Patient incapable of judgement, for example due to severe pain
Zinc Supplementation of Imipramine Therapy

Examination of the effect of zinc supplementation on imipramine therapy in major depression.

A placebo-controlled, double blind study of zinc supplementation in imipramine therapy was conducted in sixty, depressed patients fulfilling the DSM-IV criteria for major depression without psychotic symptoms. After a one week washout period, patients were randomized into two groups treated with imipramine and receiving once daily either placebo (n=30) or zinc supplementation (n=30) for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients with fulfilled DSM-IV criteria for moderate or severe depressive episode
* one week washout period without any pharmacotherapy

Exclusion Criteria:

* psychotic symptoms
Pediatric Endotracheal Intubation

We hypothesized that the McGrath MAC EMS is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the McGrath MAC EMS and MIL laryngoscopes in child resuscitation with and without CC.


Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study
* paramedic student

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases
Agreement Between Spectral Domain and Time Domain Optical Coherence Tomography (OCT)

Optical coherence tomography (OCT) is a well-established and safe technique that offers the possibility of visualizing retinal structure and measuring retinal thickness. Time-domain (TD)OCT is considered the "gold standard" technique for retinal thickness measurements. Spectral-domain (SD) OCT has to face the gold standard technique prior to obtain scientific and clinical consensus.

In our study in healthy subjects foveal thickness will be measured with both TD and SD OCT , and the data will be compared to evidence any difference between the two retinal measurements techniques.

The study will be performed at the Ophthalmology Clinic of the University of Chieti-Pescara, Italy. Forty healthy individuals will be enrolled in this study. In the same session in one randomly selected eye of each subject three consecutive measurements of foveal thickness will be performed using both TD OCT and FD OCT. All measurements will be obtained by the same experienced examinator.

Time domain optical coherence tomography images will be obtained from each eye after pupil dilation using the Stratus OCT system (version 4.1. Carl Zeiss Meditec, Dublin, CA).

Spectral domain optical coherence tomography images will be obtained using the HRA-OCT Spectralis unit (Heidelberg Engineering GmbH, Heidelberg, Germany).

All data will be analyzed with the statistical package MedCalc® version 8.1 for Windows (MedCalc®, Mariakerke, Belgium).

The D'Agostino-Pearson test that computes a single P-value for the combination of the coefficients of Skewness and Kurtosis will be used to study the sample distribution.

T-test will be used to compare means between Stratus and Spectralis measurements and orizontal and vertical measurements.

To assess agreement between Spectralis and Stratus OCT foveal measurements the Bland and Altman plots of the agreement in foveal thickness will be used. For both orizontal and vertical foveal measurements the ratio (Spectralis/stratus OCT foveal thickness) will be plotted against the average of the two measurements.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* any systemic or eye disease
* previous ocular surgery or laser treatment
* any systemic or ocular therapy
A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia

Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed informed consent;
* Current DSM-IV-TR diagnosis of schizophrenia;
* Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
* Meets study-specific PANSS criteria;
* Willing and able to cooperate with cognitive testing
* Females are not pregnant, not breast-feeding;
* Females are post-menopausal or surgically sterile or practicing birth control;
* Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control

Exclusion Criteria:

* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
* Diagnosis of schizoaffective disorder;
* Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
* Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
* Current clozapine treatment; suicidal ideation or behavior;
* BMI of 39 or greater; current homicidal or violent ideation;
* Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
* Positive hepatitis or HIV test result;
* Recent clinically significant illness/infection or surgery;
* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
* Visual, hearing or communication disability
Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients - 20

The purpose of this study is to assess the degree in which opioid-dependent outpatients discount the value of an additional maintenance dose of buprenorphine under differing states of opioid deprivation.


Eligibility Criteria:
Please contact site for information.
A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients

The primary endpoint is to evaluate the TFS (time to failure of strategy).

The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combined with or without surgical resection of the primary lesion from the time of randomization to maintenance therapy and reapplication of induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment.

Eligibility Criteria:
Inclusion Criteria:

1. 18\~75 ears old
2. Pathological diagnosis of colon cancer adenocarcinoma
3. No systemic chemotherapy for metastatic tumors
4. ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
5. At least one measurable objective tumor lesions
6. ANC≥1.5\*109/L；PLT≥90\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
7. Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
8. Patients with voluntary participation, and sign the informed consent

Exclusion Criteria:

1. Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
2. With uncontrollable large pleural or peritoneal effusion
3. Alcohol or drug addictions
4. Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
5. With brain metastasis
6. Multiple primary colorectal carcinoma
7. Pregnancy or breast-feeding women
8. There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation.
Assessing Exercise Behavior and Preferences Among Patients and Oncologists

The purpose of this study is to understand the preferences and barriers surrounding exercise of both the patients and oncologists within Indiana University Simon Cancer Center. This information will establish gaps in our current care and provide important information to guide future pilot interventions.

This descriptive, cross-sectional study will survey patients with a current or previous diagnosis of non-metastatic solid tumor malignancy who are being seen at the Indiana University Simon Cancer in Indianapolis, Indiana. Patients with active, incurable disease are excluded. Willing and eligible patients will complete a brief, 14 question survey while seen in the waiting room of the women's or multi-disciplinary clinics. We aim to survey 350 patients over a 12 month period. Patients will fill out the survey at only one point in time and no patient identifiers will be kept.

During COVID-19 restrictions, we will also send out an electronic version of the survey to participants using the email address provided in their Cerner accounts. Responses will be captured by REDCAP and will remain anonymous and not linked to the patients' medical record or personal health information.

The physician survey will be emailed to oncologist/hematologists practicing within IUSCC who see patients at least once per week. Physicians will receive a survey at only one point in time. The survey will be anonymous and no physician identifiers will be kept.

Primary objective Estimate the proportion of patients with curable solid tumor malignancies seen at the Indiana University Simon Cancer Center who are meeting exercise recommendations for cancer survivors (more than 150 minutes per week of moderate or 75 minutes per week of vigorous activity).

Secondary objectives

* Assess patients' perceived barriers to exercise during cancer survivorship
* Assess patients' preferences for receiving exercise recommendations
* Assess oncologists' perceived barriers to making exercise recommendations
* Assess oncologists' preferences for exercise and physical activity resources that could be provided by the cancer center

Eligibility Criteria:
Inclusion Criteria:

* Physician survey Any oncologist/hematologist practicing within IUSCC regularly providing care for patients with solid tumor malignancies (seeing patients one or more days per week in the multidisciplinary or women's clinics with solid tumor malignancies). Physicians providing care only for hematologic (multiple myeloma, leukemia, lymphoma, transplant) or benign disorders will be excluded.
* Patient survey

  1. Patients with a current or previous diagnosis of stage 0-III or curable solid tumor
  2. Patients receiving any component of their medical oncologic care at IUSCC
  3. Age ≥ 18 years
  4. Able to read and write English

Exclusion Criteria:

1. Metastatic disease at the time of study participation
2. Inability to complete the survey
Using an Online Patient Monitoring System to Improve Care for Children With Chronic Conditions

TriVox Health is an online system designed to make it easy for healthcare providers to monitor patients' disease symptoms and functioning over time and in between in-person visits (http://www.youtube.com/watch?v=VR1vcbx0Ef4). Using combined quality improvement and randomized clinical trial methods, we will evaluate the impact of TriVox on the health outcomes, patient/family experience of care, and healthcare utilization for children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD), asthma, autism, depression, and epilepsy.

TriVox Health is a web-based patient management and monitoring system designed to track patients' disease symptoms and response to therapy over time. TriVox Health enables clinics to use electronic surveys to gather data remotely from multiple responders, including patients, parents/guardians, school personnel and ancillary providers, and view the responses in a timely manner via graphical, tabular, and narrative summary formats.

This quality improvement (QI) initiative will implement TriVox as the standard of care for all patients who receive care for ADHD, asthma, autism, depression, and epilepsy within seven ambulatory specialties at Boston Children's Hospital. Patients and families will use TriVox to report on patient health status and will complete clinically-reTriVoxlevant questionnaires at routine intervals. Providers will use the information collected through TriVox to inform their clinical care of the patient/family.

To evaluate the effectiveness of TriVox, we will conduct a 24-month phased, cluster randomized controlled trial (RCT) where we randomize providers to "active" vs. "delayed-start" to TriVox use, with patients clustered by provider (within specialties) for analytic purposes. Delayed-start providers will crossover to active TriVox use after 12 months. Patients/families will complete additional surveys in order to assess the system's actual or potential effects on patient/family-provider interactions, healthcare utilization and costs.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with clinical diagnosis of ADHD, asthma, autism, depression, and/or epilepsy
* Patient receives care for these diagnoses from providers in participating ambulatory clinics (Primary Care, Adolescent Medicine, Developmental Medicine, Neurology, Psychiatry)
* Patient's primary caregiver enrolled in TriVox

Exclusion Criteria:

* None
A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.


Eligibility Criteria:
Inclusion Criteria:

* Japanese with male or female aged ≥ 20
* Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week
* Patient receiving treatment for itch
* Patient has a baseline NRS score \> 4

Exclusion Criteria:

* Patient has pruritus cause other than CKD or its complications
* Patients has hepatic cirrhosis
* Patient has a known history of allergic reaction to opiates
"SCRIBBLE" Spinal Cord Injury Blood Biomarker Longitudinal Evaluation

Prospective, single center study designed to assess blood biomarkers for classifying injury severity and predict neurologic recovery in traumatic spinal cord injured (SCI) patients.

Study will also establish the accuracy of point to care devices for SCI blood biomarkers and support the biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

This single center study at Vancouver General Hospital (VGH) will enroll patients with acute traumatic cervical and thoracic SCI who will have blood samples obtained daily for the first week post-injury. They will then have follow-up neurologic assessments at 6 and 12 months post-injury. The specific aims of the study are to:

1. Validate serum Neurofilament Light Chain (NF-L) and Glial Fibrillary Acidic Protein (GFAP) as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery.
2. Establish the relationship between serum and plasma levels of NF-L and GFAP.
3. Establish the accuracy of point-of-care devices for measuring GFAP.
4. Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).

Eligibility Criteria:
Inclusion Criteria

SCI Participants. Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as "SCI participants":

* Male or Female ≥ 19 years of age
* Blunt (non-penetrating) traumatic spinal cord injury
* Baseline neurologic impairment deemed "complete"(AIS A) or "incomplete" (AIS B, C, D)
* Bony spinal level involvement between C0 and L1 inclusive
* Ability to have initial blood sample drawn within 24 hours of injury
* Have either an arterial line, central line, or intravenous line for collecting blood samples
* Able and willing to provide informed consent

Non-SCI Spine Trauma Control Participants. Patients who suffer a fracture or dislocation of their spinal column without neurologic injury who meet the following inclusion criteria are eligible for admission into the study as "Non-SCI Spine Trauma Control Participants":

* Male or Female ≥ 19 years of age
* Traumatic spinal fracture between C0 and L1 without spinal cord injury
* Collection of initial blood sample within 24 hours of injury
* Have either an arterial line, central line, or intravenous line for collecting blood samples
* Able and willing to provide informed consent

Exclusion Criteria

Patients who fulfill any of the following criteria are not eligible for admission into the study:

* Penetrating spinal cord injury (e.g. gunshot, stab)
* Spinal cord injury with sensory deficit only (i.e. no motor deficit)
* Spinal injury below L1
* Isolated radiculopathy without fracture
* Isolated cauda equina injury
* Pre-existing thromboembolic disease or coagulopathy (disorders related to blood clotting), such as haemophilia or von Willebrand's disease
* Have any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair their ability to receive treatment
Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome

The recent dramatic increase in obesity has been linked to a reduction of dietary fibre intake. We hypothesized that supplementing the diet of overweight and obesity adults with pulse fibre will improve their metabolic status, chiefly defined as greater weight loss. Other metabolic health improvements may include improved glucose control and reduced inflammatory markers.

The main objective of our study is to assess the effects of pulse fibre supplementation on weight loss in an overweight and obese adult population.

Primary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre on weight loss supported by body composition measures.

Secondary objective - To measure glucose control and appetite regulation in overweight and obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use of plasma HbA1c and an oral glucose tolerance test (OGTT).

Tertiary objective - To examine mechanisms of action of pulse fibre supplementation by determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics and fecal short-chain fatty acid and bile acid concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18 - 70 years
* BMI 25 - 38 kg/m-2
* Stable body weight for at least 3 months prior to the study

Exclusion Criteria:

* Concomitant use of any weight loss medication, diet or exercise regime
* Use of corticosteroids, anti-depressants, anti-epileptic medications, lipid lowering medication, diabetes medications
* Previous bariatric or other intestinal surgeries
* Pregnancy or lactation
* Weight loss \> 3 kg within preceding 3 months to enrollment
* Use of bulk laxatives or probiotics/prebiotics supplements
* Antibiotic use in the past month
* Clinically significant cardiovascular or respiratory or liver disease
Effects of Lovastatin on Human Platelet Proteome

The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize the cell signalling modifications induced by Lovastatin. Furthermore, the current study aims to characterize the biological and inter-individual variation of platelet's proteome as measured by liquid chromatography-tandem mass spectrometry. Lastly, the exploration of changes induced by Lovastatin on the platelet's proteome may allow the discovery of modifications relative to the effects of statins on hemostasis and the lipid profile.


Eligibility Criteria:
Inclusion Criteria:

* Being an individual age 18 to 40.
* If applicable, female participants susceptible of becoming pregnant consent to use a highly efficient contraception technique AND an efficient contraception technique during the clinical trial and at least 3 months following ending the consumption of Lovastatin.
* Being able to read and understand French.

Exclusion Criteria:

* Having a known history of dyslipidemia.
* In regard of the lipid profile at the first visit, patients that are not comprised between the 5th and the 95th percentile for LDL, HDL or Total cholesterol will be excluded.
* Having a history of hypersensitivity to Lovastatin, to one of the components of this product or to any other statin.
* Being affected by mental retardation.
* Pregnancy or suspicion of pregnancy.
* Having an excessive alcohol consumption (a maximum of 3 drinks a day during the trial will be accepted).
* Planning to perform unusual and very intense physical exercises during the study (ex: running a marathon or an Iron Man).
* Having a history of myopathy, myalgia or elevated creatine kinase (CK).
* In regard of the biochemical tests performed at the first visit, individuals having CK levels three times (or more) superior to the upper normal limit will be excluded.
* Having a personal or family history of hereditary muscular diseases.
* Having a history of renal or hepatic pathology.
* Taking one of the following drugs : any hypolipemic drug, any cytochrome P450 isoform 3A4 inhibitor (itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, erythromycin, clarithromycin, telithromycin, nefazodone and products containing cobicistat), ACE inhibitors, danazol, verapamil, diltiazem, cyclosporin, amiodarone, colchicine, fusidic acid (IV or oral).
* Having a history of hypothyroidism.
* Having had a surgical intervention shortly before the beginning of the clinical trial.
* Suffering from any other acute medical condition.