cyrilzakka/clinical-trials huggingface dataset:
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102

This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.


Eligibility Criteria:
Main Inclusion Criteria:

* Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
* Age 18 to 70 years (inclusive) at the Screening Visit.
* A diagnosis of lumbosacral radicular pain (sciatica).
* Agrees to follow study-specific medication requirements.
* If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
* Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.

Main Exclusion Criteria:

* Has radiologic evidence of a condition that would compromise study outcomes.
* Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
* Has been diagnosed with insulin dependent diabetes mellitus.
* Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
* Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
* Has a body mass index ≥40 kg/m2.
PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements

The model by which physicians measure the lack of blood flow in the vessels that supply blood to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of the pressure across the vessels that supply blood to the heart. These are known as the coronary arteries. This study involves comparing two FFR wires, the St. Jude Medical Pressure Wire (PW) and the ACIST Navvus Microcatheter (MC) to check the accuracy of the devices. FFR allows real-time estimation of the effects of a narrowed vessel, whereas standard angiography can underestimate or overestimate narrowing, because it only visualizes contrast (the different areas of color) inside a vessel.

Fractional flow reserve (FFR) measurement by pressure wire (PW) under hyperemic conditions has become the invasive gold standard for determining the physiologic extent of cardiac ischemia, and which has been validated in several clinical outcomes studies as a way of optimizing case selection for percutaneous coronary intervention (PCI). More recently a microcatheter (MC)-based sensor measurement of fractional flow reserve has been introduced. Small scale in-vivo comparisons have been performed suggesting the utility of this approach to measure FFR,but these data are limited and have not been independently validated. This non-randomized, prospective study is designed to evaluate the accuracy of MC-based FFR measurement to the PW standard in lesions subjected to FFR assessment in routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient provides signed written informed consent before any study-specific procedure.
3. Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care.
4. Angiographically significant (\>50% visual estimation) stenosis present in at least one native coronary artery.
5. Undergoing FFR assessment for standard clinical or diagnostic indications

Exclusion Criteria:

1. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
2. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
3. Currently participating in another clinical study that interferes with study results.
4. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
5. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
6. High degree A-V block, sinus node disease.
7. Known hypersensitivity to adenosine
MobiCARE™ ECG Monitoring System

Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study

The purpose of the Seers Technology Company Ltd. sponsored study using the mobiCARE™ ECG Monitoring System is to document the variability and interpretability of heart rhythm tracings from the nominal position whereby the mobiCARE™ device is still able to obtain interpretable ECG signals, in a cohort of adults representative of the U.S. population.

Informational data will be collected, such as P-wave amplitude and QRS amplitude and duration to note any morphological ECG signal changes. Human factors (HF) endpoints will be evaluated including: HCP placement according to IFU, subject demonstration of changing electrodes, dexterity for user to perform the task, electrode placement according to skin markings, and the ability of the user to remove and replace the mobiCARE™ device.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults ≥ 18 years of age;
2. Willing and able to provide informed consent;
3. Able to speak and read English fluently;
4. Participant is ambulatory.

Exclusion Criteria:

1. Patients with cardiac pacemaker;
2. Patients with cardioverter defibrillator;
3. Patients with other implantable electric devices;
4. Currently or has a medical history of skin cancer, rash, skin disorder, keloid, and/or any injury in the chest area;
5. Patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient;
6. Patients with known history of life-threatening arrhythmias;
7. Use in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI;
8. Patients with neuro-stimulator, as it may disrupt the quality of ECG data;
9. Critical care patients;
10. Chest pain at the time of presentation for the study.
Magnetic Resonance Cholangiopancreatography Versus Endoscopic Retrograde Cholangiopancreatography in the Approach to Patients With Suspected Biliary Obstruction

The main objective of this study is to assess the effectiveness and costs of magnetic resonance cholangiopancreatography (MRCP) and compare it to endoscopic retrograde cholangiopancreatography (ERCP) in the work up of patients with suspected bile duct obstruction on ultrasound. The investigators do not anticipate that a universal recommendation for a given diagnostic test (MRCP versus ERCP) will be applicable in all patients presenting with bile duct obstruction. Rather, the investigators hope to provide quantitative and comparative data relevant to the different clinical situations likely to be encountered in practice, in order to assist physicians in choosing the appropriate diagnostic modality. More specifically, the investigators feel that patients with intrahepatic or hilar obstruction (particularly those with malignant conditions), and those with partial common bile duct (CBD) obstruction (to rule out suspected choledocholithiasis) will benefit most from this new technology and the avoidance of an unnecessary ERCP to further determine the biliary anatomy.

The approach to investigation and management of intermediate-risk biliary obstruction is controversial. Both magnetic resonance cholangiopancreatography(MRCP)and endoscopic retrograde cholangiopancreatography (ERCP) are used interchangeably in practice, with little literature to support the efficacy of one versus the other.

The purpose is to assess the effectiveness of MRCP compared to ERCP in the initial work-up of patients at intermediate risk of suspected biliary obstruction following initial clinical assessment and ultrasonography.

A randomized medical effectiveness study was conducted across three tertiary care hospital sites. Patients at intermediate risk of biliary obstruction were randomized to either ERCP or MRCP based on level of obstruction as seen by ultrasound (US).

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Elevated bilirubin (\>30 umol/L)
* CBD dilatation on ultrasound: greater than 7 mm wide with gallbladder in situ, or 10mm wide in patient post-cholecystectomy
* Suspected or detected gallstone on ultrasound

Exclusion Criteria:

* Low probability of biliary tract disease
* Active cholangitis
* Bilio-pancreatic pathology identified on ultrasound or CT scan
* Any clinical condition precluding MRCP or ERCP: severe cardio-respiratory disease, pregnancy, significant coagulopathy (INR over 1.5)
* Presence of Roux-en-Y bilio-enteric anastomosis
* Any metallic implant making ERCP or MRCP hazardous
* ERCP or MRCP performed within 6 months prior to study inclusion
Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion

The aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management.

This study will involve 124 adult patients who are breathlessness with pleural effusions. They will be recruited from a single UK centre over an 18-month period.

After being informed about the study, all patients giving written informed consent will undergo a baseline assessment when they first come to have their fluid drained. The investigators will record information about them and their disease. The investigators will take measurements of their breathlessness, their breathing muscles, and the electrical activity from the brain to those muscles. These will be taken at the start and end of drainage, as well as 1 day and 7 days after. The investigators will use this information to look for links between the effect of pleural effusions and its removal on the electrical activities of the breathing muscles and patients' breathlessness.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above
* Has a unilateral pleural effusion AND

  1. require thoracocentesis OR
  2. chest drain insertion (main study only) OR
  3. has an IPC in situ (main study only)

Exclusion Criteria:

* Inability to consent
* Any contraindications to the proposed pleural procedure
* Haemodynamic or clinical instability that precludes from the safe completion of required pre-procedural measurements
* Inability to identify surface landmarks for surface EMG electrode placement
* Past medical history of diaphragmatic paralysis (diaphragm sub study only)
A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy participants of non-child bearing potential
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)
* Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion Criteria:

* Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Instillations of Loteprednol Etabonate Ophthalmic Gel

This will be a single-center, single-arm, open label PK clinical study of loteprednol etabonate (LE) ophthalmic gel, 0.38% conducted at one clinical center in the United States (US), with the goal of enrolling approximately 15 healthy normal subjects in the treatment period

Eligibility Criteria:
Inclusion Criteria:

1. Are able to read, understand and provide written informed consent on an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
2. Be a non-smoking male or female at least 18 years of age on the date the ICF is signed and with the capacity to provide voluntary informed consent.
3. Be in general good health and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or place the subject at increased risk during the study.
4. Be willing/able to return for all required study visits and follow instructions from the study Investigator and his/her staff.
5. Are able to self-administer eye drops or have a clinical staff member deliver the single dose of investigational product (IP) on specified study days.

Exclusion Criteria:

1. Have a history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject, confound the result(s) of the study, or preclude study treatment or follow-up.
2. Have any current disease or medical condition that requires medicinal therapy.
3. Have a history of drug or alcohol abuse in the last 6 months.
4. Have a positive urine screen for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine (or cocaine metabolite), cannabinoids, methadone, methamphetamine, opiates and/or phencyclidine.
5. Are known to have a prior positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus types 1 and 2.
The Feasibility Study for Real-time Remote CT Reading for Suspected Acute Appendicitis Using iPhone

1. Purpose

   - The investigators aim to evaluate the feasibility of iPhone based remote control system as a real-time remote CT reading tool for suspected appendicitis under 3G network and the suboptimal illumination.
2. Methods

   * A total of 120 abdominal CT examinations; sixty had no findings of appendicitis, while the other sixty showed signs of acute appendicitis, were selected. The 16 raters reviewed these images using an LCD monitor of the PACS workstation and also an iPhone which was connected to the PACS workstation via remote control system, grading the probability of presence of acute appendicitis on each examination by a five Likert scale.
   * The investigators will compare the diagnostic performance between two devices.

The 16 raters were randomly divided into two groups

* The raters in group one reviewed the CT examinations numbered from one to 60 using LCD monitor and reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit
* The other group firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor.
* They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.
* The raters were instructed to rate the likelihood of the presence or absence of appendicitis in each case using a five-Likert scale (1 = obvious no appendicitis, 2 = unlikely appendicitis, 3 = unsure, 4 = likely appendicitis, 5 = obvious appendicitis).

Eligibility Criteria:
Inclusion Criteria:

* Board certified emergency physicians with a clinical experience of 5 years and over.

Exclusion Criteria:

* Corrected eyesight \< 20/30
* Color weakness or blindness
RMT in Patients With Spinal Cord Injury

Spinal Cord Injury (SCI) is an involvement of the spinal cord, a nerve cord protected by the spine and extends from the base of the brain to the lumbar region. The spinal cord lesion causes complete or incomplete paralysis of voluntary mobility and absence, partial or total, of any sensitivity below the affected area; In addition, it also involves the lack of control over the sphincters of urination and intestinal evacuation, disorders of sexuality and fertility, alterations of the Vegetative Nervous System and risk of suffering other complications not less important as: bedsores, spasticity, kidney processes, ...

The cervical and dorsal cord injury severely affects respiratory function due to paralysis and deterioration of the respiratory muscles. Several types of respiratory muscle training (RMT) have been described to improve respiratory function for people with SCI in the literature.

Despite the relatively small number of studies included in this review, the meta-analysis of the pooled data indicates that RMT would be effective in increasing respiratory muscle strength and also lung volumes for people with SCI.

More research is needed to obtain functional results after EMR, such as dyspnea, cough efficacy, respiratory complications, hospital admissions due to respiratory complications and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute spinal cord injury from C5 to T11 (AIS A-B)
* No tracheotomy user or invasive mechanical ventilation.
* Age between 18 years - 75 years.

Exclusion Criteria:

* Not wanting to participate in the study.
* Not meet inclusion criteria
* Cognitive or psychiatric disorder that does not allow you to participate in the study.
Effect of Thiazolidinedione Treatment Vascular Risk Markers

The purpose of this study is to examine the effects of two diabetes medications, rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2 diabetes.

Diabetes is a common disease in the United States, affecting over 10 million Americans. Vascular disease, including heart attack and stroke, affects many diabetic patients and will cause the death of three-fourths of these patients. Because the majority of diabetic patients will suffer complications or death from vascular disease, we will explore treatments that have the potential to reduce or prevent vascular disease in type 2 diabetes patients. Our study will examine the effects of two diabetes medications, rosiglitazone (ROSI) and pioglitazone (PIO), on markers of vascular disease in 20 subjects with type 2 diabetes. It is thought that these two medications will reduce the risk of vascular disease by affecting the platelets and proteins that that regulate the processes involved in clot formation. One-half of the subjects enrolled in our study will take ROSI and the other half will take PIO. We will measure the clumping ability of these subjects' platelets before, during, and after three months of treatment with ROSI or PIO. We will measure the blood concentrations of several proteins (fibrinogen, PAI-1, CRP, adiponectin, and leptin) before and after treatment with the study drugs. These experiments will give us information about any beneficial effects of ROSI and PIO on the clot-forming ability in diabetes patients. We expect that treatment with ROSI and PIO will result in improvement of the disturbed clot-forming processes that predispose diabetic patients to vascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of all races
* Age 40-65 years
* Diagnosis of type 2 diabetes
* hemoglobin A1C ≥ 7%
* eligible whether or not currently taking antihyperglycemic medications

Exclusion Criteria:

* History of rosiglitazone or pioglitazone use in the previous 3 months
* Known diagnosis of peripheral vascular disease or cardiac failure
* Recent history (within past 6 months) of ischemic stroke, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery
* Active liver disease or elevated serum transaminases (ALT \>2.5x upper limit of normal)
* Current therapy with oral anticoagulants (warfarin, heparin, low molecular weight heparin), clopidogrel, or immunosuppressive agents
* Pregnancy or breastfeeding
* Any other condition, in the opinion of the investigator, that renders the subject unable to complete the study, that interferes with optimal participation in the study, or that produces significant risk to the subject
Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly

This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 65-85 years with a body mass index (BMI) of 18-28 kg/m2
* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations including hematology (blood cell count, hemoglobin, and platelet count), liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin), serum creatinine, blood glucose and urinalysis

Exclusion Criteria:

* If they had clinically relevant disorders
* Past history of diabetes or clinical findings to suspect diabetes
* Abnormal clinical laboratory values (i.e., platelets ≤ 75,000/mm3, hemoglobin ≤ 9 g/dL, neutrophils absolute ≤ 1000/mm3, fasting glucose \> 126mg/dL, creatinine ≥ 1.5 mg/dL, or AST, ALT \> 3 × upper limit of normal)
Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection

Bowel cancer can arise from polyps, which can become cancerous. Polyps are little outgrowths within the lining of the bowel (similar to skin warts). Depending on their size and their potential to become cancerous, they can cause bleeding. However, it is not known which polyps harbour cancerous potential. Therefore, at present all patients undergo a colonoscopy (camera examination of the large bowel) in order to identify and remove any polyps. However, not all patients who undergo a colonoscopy will have polyps. Moreover, colonoscopies are invasive and disruptive to patients, as they require bowel preparation. The aim of this study is to evaluate non-invasive stool and urine tests to identify patients who are at risk of polyps and if the polyps have the potential to become cancerous. This in turn, will significantly reduce the number of 'unnecessary' polyp surveillance colonoscopies with resultant benefits to both patients and the National Health Service (NHS).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are on a polyp surveillance programme and will be undergoing colonoscopy examination for polyp surveillance OR Patients who will be undergoing elective polypectomy through specialised polyp multi-disciplinary meetings.

Exclusion Criteria:

* Participants who are unable to attend colonoscopy
* Under 18 years old
* Unable to provide informed consent for themselves to take part in this study
Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)

This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary purpose is to assess the safety and tolerability of extended administration of polyethylene glycol (PEG) interferon alfa-2b in participants with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Had a response of stable disease or better in PEG interferon alfa-2b base study C/I97-188 (MK-4031-006).
* Has a Performance Status of 0 (normal activity), 1 (symptoms, but fully ambulatory), or 2 (symptomatic, but in bed \<50% of the day).
* Is enrolled within two weeks of completing their last dose of PEG Interferon alfa-2b on the previous study and has not have received any other therapy during this period.

Exclusion Criteria:

* Discontinued prior to completing PEG interferon alfa-2b base study C/I97-188 (MK-4031-006).
* Is pregnant or nursing.