cyrilzakka/clinical-trials huggingface dataset:
Acute Microvascular Changes With LDL Apheresis

Severe hypercholesterolemia produced by conditions such as heterozygous familial hypercholesterolemia is associated with multiple complications including premature atherosclerotic disease. There is evidence that microvascular perfusion, particularly flow reserve, in critical organs is limited due to abnormalities in plasma viscosity, abnormal RBC deformability, and an imbalance between vasodilators and vasoconstrictors. There is little is currently known about acute changes in microvascular blood flow and microvascular rheology that occur in response to plasmapharesis which is used in some patients to lower critically elevated cholesterol levels. Our research group has pioneered CEU methods for assessing myocardial and skeletal muscle perfusion, and has previously demonstrated in pre-clinical models that acute hyperlipidemia produces a reduction in microvascular RBC transit rate. In this study, the investigators will assess acute changes in microvascular perfusion in patients undergoing clinically-indicated plasmapharesis.

Subjects who are scheduled to have planned apheresis treatment for severe hypercholesterolemia will be recruited into the study. They will undergo a screening evaluation, including a medical history, physical examination, ECG, and limited echocardiogram to evaluate for exclusion criteria. Before the apheresis procedure, blood samples will be obtained for plasma markers of inflammation, erythrocyte deformability, and plasma viscosity. Contrast enhanced ultrasound perfusion imaging will be performed to evaluate blood flow in the myocardium at rest, as well as in the forearm skeletal muscle before and after mild isometric exercise (50% maximal grip, 0.2 Hz). Flow mediated vasodilation will be performed. The subjects will then undergo their planned apheresis procedure. Within 2 hours of completion of apheresis, blood collection and CEU will be repeated. Plasma lipids will be available as part of the standard apharesis protocol.

Eligibility Criteria:
Inclusion Criteria:

* hypercholesterolemia (LDL \>200 mg/dL)
* clinically-indicated aphersis for hyperlipidemia
* age \>18 y.o.

Exclusion Criteria:

* pregnant or lactating females
* hypersensitivity to ultrasound contrast agents
* evidence for right to left or bidirectional shunt
* on anticoagulants
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System

The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates and Screws System (implants and instrumentation) when used to stabilize diaphyseal, proximal humerus and proximal tibia fractures.

The primary objective is the assessment of performance by analyzing fracture healing.

The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.

The Zimmer® Plates and Screws System consists of temporary internal fixation devices comprised of plates and screws that provide management of fractures through interfragmentary compression and bone plating. In this study, the focus is on the Zimmer® Plates and Screws System used to stabilize diaphyseal, proximal humerus and proximal tibia fractures.

One site will be involved in this study. The aim is to include a maximum of 112 consecutive series cases who received the Zimmer® Plates and Screws System at the Istituto Ortopedico Rizzoli (Bologna, Italy) between 2008 and 2018. All potential study subjects will be required to participate in the Informed Consent process.

Baseline data from the preoperative, intraoperative, immediate post-operative and last consultation visit at minimum 6 months post-operative will be available in medical notes and collected retrospectively. During a follow up phone call the subject will be asked to complete questionnaires and a clinical assessment of the fracture healing. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected over the phone.

Eligibility Criteria:
Inclusion Criteria:

Patients having received one of the plates belonging to the Zimmer® Plates and Screws System, designed for temporary internal fixation to stabilize fractures during the normal healing process. In this study we will collect data specifically on Zimmer® Plates and Screws System plates belonging to the Diaphysis, Proximal Humerus and Proximal Tibia groups.

Exclusion Criteria:

* Off-label use
* Patients under the age of 18
* Prisoners
* Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
* Infection
* Metal sensitivity or intolerance
* Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation
* Sternal or spinal fractures
* Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures
* Patients with inadequate soft tissue coverage at the implant site
An Algorithm Driven Sepsis Prediction Biomarker

A sepsis early warning predictive algorithm, InSight, has been developed and validated on a large, diverse patient cohort. In this prospective study, the ability of InSight to predict severe sepsis patients is investigated. Specifically, InSight is compared with a well established severe sepsis detector in the UCSF electronic health record (EHR).


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the participating units will be eligible.

Exclusion Criteria:

* All patients younger than 18 years of age will be excluded.
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)

The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.

Prospective, multicenter, observational study to evaluate the Merit WRAPSODY™ Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft (The WRAP Registry)

Eligibility Criteria:
Inclusion Criteria:

1. Subject provides written informed consent for study participation.
2. Subject is male or female, with an age ≥ 18 years at date of enrollment.
3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 24 months.
4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon
5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
6. Subject has stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System in accordance with device instructions for use.

Exclusion Criteria:

1. Subject has a planned surgical revision of access site.
2. Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
3. Subject has an uncorrectable coagulation disorder.
4. Known hypersensitivity to nickel titanium alloy.
5. Subject's hemodialysis access is anticipated to be abandoned within 6 months.
6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
7. Full expansion of a Percutaneous Transluminal Angioplasty (PTA) balloon cannot be achieved during predilatation.
8. Device would be placed in the Superior Vena Cava
9. Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.
Pharmacokinetic Interaction Between Midazolam and ID-082 in Healthy Subjects

A clinical study in healthy male subjects to investigate whether the administration of ID-082 can affect the fate in the body (amount and time of presence in the blood) of midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in the local language prior to any study-mandated procedure;
* Healthy male subjects aged 18 to 45 years (inclusive) at screening;
* Male subject with a female partner of childbearing potential or a pregnant partner must agree to use a condom from screening, during the study, and for at least 3 months after last study treatment intake;
* Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at screening;
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria:

* Contraindication or known hypersensitivity to ID-082, midazolam or drugs of the same classes, or any of their excipients;
* Modified Swiss Narcolepsy Scale total score \< 0 at Screening or history of narcolepsy or cataplexy;
* History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment;
* Known hypersensitivity or allergy to natural rubber latex;
* Known hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency;
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).


Eligibility Criteria:
Inclusion Criteria:

* Aged greater than 18 years
* Male or female patients with a documented history of PLE diagnosed or confirmed by a photodermatologist or photobiologist, with a history of PLE related pruritus symptoms.
* Recurrent PLE episodes that occur at least once a year (as evidenced by PLE related pruritus symptoms) developing in their own country (to exclude patients affected only when traveling to sunnier climates)
* Written informed consent prior to the performance of any study-specific procedure
* Are willing and able to comply with the conditions specified in the protocol and study procedures in the opinion of the Investigator

Exclusion Criteria:

* Currently requiring treatment with systemic immunosuppressive agents
* Documented history of other photosensitivity conditions which may be confused with PLE or interfere with the assessment of PLE episodes
* Solarium use in the three months prior to study involvement and throughout the duration of the study
* Use of immunosuppressive medications, drugs that cause hyperpigmentation or any other treatment that in the opinion of the Investigator may interfere with this study
* Documented presence (\> 1 in 320) of Anti-Nuclear Antibody (ANA) and/or positive Extractable Nuclear Antibody (ENA); historical results from the 3 years prior to randomisation are acceptable if available
* In the opinion of the Investigator, any evidence of clinically significant organ dysfunction, or any clinically significant deviation from normal in clinical or laboratory parameters
* History of drug or alcohol abuse (in the last 1 year)
* Female who is pregnant (confirmed by positive serum beta-Human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating
* Female of child-bearing potential (pre-menopausal, not surgically sterile) that is not using or is not willing to use adequate contraceptive measures (e.g. oral contraceptives, condoms, diaphragm plus spermicide, intrauterine device)
* Sexually active men with partners of child bearing potential not willing to use barrier contraception during the trial and for a period of three months thereafter
* Participation in a clinical trial with another Investigational Medicinal Product (IMP) within 30 days prior to the Screening visit or during the study
* Hypersensitivity to afamelanotide or any of its components
Mobile Application to Assist Adherence to Oral Anticancer Agents and Symptom Management

The use of oral anticancer agents (OAAs) in cancer treatment has increased especially in the last two decades. The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.The aim of this study is to explore how a Smartphone mobile application can help improve the cancer treatment process in people who are used oral anticancer agents. This study will be done a randomized-controlled trial to test the intervention.

Background: The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.

Objective/Hipothesis: The purpose of this study is to explore the effectiveness of a mobile application on treatment adherence and symptom management in patients using OAA. The following hypotheses (H) will teste in this study:

H0a: A mobile application developed for patients using OAA has not increased treatment adherence.

H1a: A mobile application developed for patients using OAA has increased treatment adherence.

H0b: A mobile application developed for patients using OAA has not decreased the frequency and severity of symptoms.

H1b: A mobile application developed for patients using OAA has decreased the frequency and severity of symptoms.

Study Design: The investigators will recruit and randomly assign 100 patients from the two cancer care sites who have recently been prescribed oral anticancer agents to receive either the mobile app intervention or standard care. Participants will be stratified by age and anticancer treatment ( i.e. simple and complex) regimen. Patients will be follow 6 months. Medication adherence, symptom severity will serve as primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Using OAAs for cancer treatment and taking at least one cure
* Taking OAAs for at least six months
* Knowing the diagnosis
* Communicating verbally
* Scoring less than three on the Eastern Cooperative Oncology Group (ECOG) scale
* Having a smartphone with IOS or Android software
* Actively using the smartphone
* Consenting to download the mobile application on one's mobile phone
* Volunteering to participate in the research.

Exclusion Criteria:

* Participation in a similar study aimed at increasing treatment adherence
* Having physical, cognitive, or memory-related problems that significantly impair one's daily activities
* Having a smartphone with Windows or Blackberry software.
A Positive Psychology Intervention for Fibromyalgia Patients Using ICT´s

This study is aimed to test the efficacy of a Positive Psychology Intervention (Best Possible Self, BPS) over optimism, future expectancies and positive affect at mid-term, in comparison to a control group, in fibromyalgia patients. The principal hypothesis is that the BPS intervention will enhance significantly the levels of optimism, positive future expectancies and positive affect in comparison to the Control group at short and mid-term.

Previous studies have demonstrated the effects of positive psychological factors in pain adjustment. Specially, optimism has been linked to lower pain sensitivity, better physical functioning, less psychological distress and pain catastrophizing. Until recently, the beneficial effects of optimism on pain have been studied mostly in correlational studies or in experimental interventions in laboratory settings. To address the gap between research and clinical practice, the aim of this study is to test the efficacy of the Best Possible Self intervention (BPS) using Information and Communication Technologies (ICTs) with fibromyalgia patients.

BPS is a guided imagery exercise that requires participants to envision themselves in the future, achieving desired goals in different areas of their lives. This exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population (Meevissen, Peters \& Alberts, 2011; Sheldon \&Lyubomirsky, 2012; Peters, Flink, Boersma \& Linton, 2010). Taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study in order to replicate the findings about the effects of BPS on optimism, mood and affect in a chronic pain population. The exercise will be applied through a Positive Technology system and the effects will be analyzed during four months. The design employed in this study is similar to the used in other studies (Meevissen et al, 2011; Renner, Schwarz, Peters \& Huibers, 2014; Sheldon \& Lyubomirsky, 2006).

Eligibility Criteria:
Inclusion Criteria:

* Patients have to fulfill the American College of Rheumatology criteria for primary FMS.
* Sign a consent form stating their willingness to participate

Exclusion Criteria:

* Presence of another severe physical illness
* Presence of severe psychological disorders
* Be currently involved in another psychological treatment
The Effect of High Dose Parenteral Ascorbic Acid On Microcirculation In Sepsis

The purpose of this study is to evaluate the effect of high-dose ascorbic acid on microcirculation in sepsis.

Adult patients with septic shock were enrolled within 24 hours following admission to the Central Department of Intensive Care in Lithuanian University of Health Sciences Hospital Kaunas Clinics.

Participants were randomly assigned to a placebo or ascorbic acid group in a 1:1 ratio. They were resuscitated according to Surviving Sepsis Campaign Guidelines. Additionally, they received an intravenous infusion of ascorbic acid either placebo. The dose of ascorbic acid was 200mg/kg/24h divided into four equal parts for 96 hours. Sublingual microcirculatory measurements were obtained, using an incident dark field (IDF) device.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sepsis or septic shock within the first 24 hours after ICU admission.

Exclusion Criteria:

* Age \< 18 years,
* Pregnancy,
* Advanced malignancy,
* History of kidney stone, glucose-6-phosphate deficiency, hemochromatosis, or solid organ transplantation,
* Oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.
Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females

This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with master's level mental health professionals within a juvenile justice setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).

The overall objective of this study is to assess the feasibility and promise of an adapted CHOICES preconception intervention (CHOICES-TEEN) in reducing the risk of HIV, nicotine-exposed pregnancy (NEP), and alcohol-exposed pregnancy (AEP) in adolescent females on intensive community probation. The current study posits that a two-session CHOICES intervention adapted to target multiple bundled health risks-AEP, NEP, and HIV-will be feasible, acceptable, and promising in reducing these risks among females on community-based juvenile probation. This study will: Aim 1: Modify the efficacious CHOICES preconception intervention to target the prevention of HIV, AEP, and NEP. The result will be a two session individual intervention (CHOICES-TEEN) and accompanying therapy manual based on the Transtheoretical Model (TTM) and Motivational Interviewing. Aim 2: Conduct a one-arm feasibility trial with females in the juvenile justice system to assess the promise of CHOICES-TEEN. This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with master's level mental health professionals within a juvenile justice setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk of HIV, NEP, and AEP). This study will inform subsequent Stage II/III behavioral intervention studies and contribute to a missing, fundamental element in the knowledge base - further understanding of the feasibility of targeting bundled health risks in high-risk adolescents, and the potential promise of a gender-specific intervention for this population.

Eligibility Criteria:
Inclusion Criteria:

* Have had vaginal intercourse with a male in the last 90 days
* Inconsistent/ineffective contraception use
* Inconsistent/ineffective condom use
* Drinking at risk levels
* Smoking
* Available for the follow-up period

Exclusion Criteria:

* Pregnant
* Infertile
* Insufficient locator information
* Language other than English
Physiology As Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: the PREDICT Study

The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.

Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximal flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value less than or equal to 0.80 is generally considered to be associated with myocardial ischemia.

FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. this ratio represents the potential decrease in coronary flow distal o the coronary stenosis. Recently, other physiology ratios called non-hyperemic ratios (NHPR) have been developed.

Both types of physiology measures (FFR and NHPR) have been increasingly used in cardiac catheterization laboratories as a diagnostic tool. They provide a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. However, they are underutilized as tools for the assessment of success of coronary interventions.

The PREDICT study is a pilot study which aims to prospectively determine whether post-PCI physiology guidance is associated with better clinical outcomes than standard angiographic guidance.

Eligibility Criteria:
Inclusion Criteria:

* Any patient referred for diagnostic coronary angiography and / or possible PCI in native coronary vessels.
* Successful (\< 30% diameter stenosis and normal TIMI 3 flow post-stenting) and uncomplicated PCI
* All treated lesions stented with drug-eluting stents (except side-branches of bifurcations)

Exclusion Criteria:

* Lesion in saphenous vein or arterial grafts
* Allergy to aspirin, thienopyridines or ticagrelor precluding treatment for 30 days
* Sub-optimal PCI result ( \>30% residual diameter stenosis and/or \<TIMI3 flow) or peri-procedural complications
* Acute ST-Elevation MI (culprit lesion)