cyrilzakka/clinical-trials huggingface dataset:
Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia

Introduction: The etiology/pathophysiology of preeclampsia remains an enigma. Cellular immunity is a key factor in the etiology of late-onset preeclampsia (L-PrE). Presepsin is split out from the phagocytes membranes after phagocytosis. To investigators knowledge, this is the first study in literature to investigate maternal blood concentrations of presepsin in preeclampsia and healthy pregnant women.

Methods: The investigators examined maternal plasma interleukin-6, presepsin and pentraxin-3 concentrations in pregnant women with (n=44) and without L-PrE (n=44). These three inflammatory markers concentrations measured using enzyme-linked immunosorbent assays were compared.

This observational case-control study was designed at Cengiz Gokcek Women's and Children's Hospital, Gaziantep, Turkey, in the Department of Obstetrics and Gynecology between June 2018 and January 2019. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (Reference number: 2018/393). The study strictly adhered to the principles of the Declaration of Helsinki. All subjects included in the study gave oral and written informed consent. Eighty-eight women were enrolled in the study in two groups. All participants will gave their oral and written informed consent before their inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* preeclampsia healthy pregnancy

Exclusion Criteria:

1. pregnant women with any systemic condition (such as chronic hypertension, inflammatory and rheumatic diseases),
2. using any kind of medication throughout pregnancy (such as acetylsalicylic acid, corticosteroids or heparin),
3. pregnant women who had fever at the time of the first admission,
4. concurrent infections (urinary tract infection, cervicitis, etc.),
5. pregnancies complicated with premature membrane rupture or chorioamnionitis,
6. history of medication for PE treatment at the time of the first admission,
7. patients who had fetal congenital abnormalities or genetic syndromes,
8. drug user,
9. multiple gestations,
10. active labor.
Teaching Harm Reduction in a Hospital Setting: A Peer-led Intervention

The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of harm reduction services to be delivered in the hospital setting, called the THRIVE intervention.

The main question it aims to answer is: Will participants receiving the THRIVE intervention have a reduced risk of self-reported non-fatal overdoses OR skin/soft tissue infections compared to participants receiving enhanced usual care?

Researchers will compare the THRIVE model to enhanced usual care to see if the THRIVE model helps participants reduce their number of self-reported non-fatal overdoses OR skin/soft tissue infections.

Intervention participants will:

* Receive one in-person session from a peer support specialist while in the hospital
* Receive weekly text messages from the peer support specialist for a 12-week period
* Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
* Complete a baseline, 3-month, and 6-month assessment with Research Assistants

Enhanced usual care participants will:

* Receive a handout with harm reduction education and resources in their local area
* Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6
* Complete a baseline, 3-month, and 6-month assessment with Research Assistants


Eligibility Criteria:
Inclusion Criteria:

* Participants who are: a) admitted to University of Pittsburgh Medical Center (UPMC) Shadyside Hospital, UPMC Presbyterian-Montefiore Hospital, UPMC Mercy Hospital for inpatient or observation status, or b) seen in the Emergency Department setting at UPMC Presbyterian-Montefiore Hospital and UPMC Mercy Hospital.
* Participants must have a current diagnosis of Opioid Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
* Participants must be at least 18 years of age on day of admission.
* Participants must be able to speak and read English.

Exclusion Criteria:

* Participants diagnosed with dementia and/or cognitive impairments.
* Participants with acute psychiatric complications, such as schizophrenia with acute psychosis, acute mania, or suicidal ideation (which may impact the ability of a participant to consent and actively participate in treatment).
* Participants who are pregnant or lactating at onset of study.
* Participants who cannot read or speak English.
AZD Single Ascending Dose Study In Healthy Japanese Subjects

This is a single centre, open label, non-randomised study to access the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male and females of non-childbearing potential aged ≥20 to ≤ 45 with suitable veins for cannulation or repeated venepuncture.
* Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
* Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
Vouchers vs. Prizes for Methadone Patients - 1

The purpose of this study is to compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus voucher CM for abstinence, defined by negative breath and urinalysis test results, or (c) standard treatment plus prize CM for abstinence, defined by negative breath and urinalysis test results. Urine and breath samples are collected 3x/week during Weeks 1-3, 2x/week during Weeks 4-6 and 1x/week during Weeks 7-12. Follow-up interviews are conducted 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.


Eligibility Criteria:
Inclusion criteria:

* age \> 18 years
* current DSM-IV diagnosis of cocaine dependence
* maintained on a stable dose of methadone for \>1 month
* willing to sign informed consent
* English speaking

Exclusion criteria:

* serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, or substantial suicide risk) on the basis of history or medical examination
* dementia (\<23 on the Mini Mental State Exam)
* in recovery from pathological gambling as determined by DSM-IV criteria
AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged ≥18 years old.
* Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines1.
* Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
* Signed and dated informed consent.

Exclusion Criteria:

* Class IV of NYHA (ambulatory or not).
* Allergy to contrast media used for imaging during cardiac catheterization.
* Severe Renal Failure (clearance of creatinine according to Modification of diet in renal disease formula (MDRD) \< 30ml/mn/m²).
* Previous failure of catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
* Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
* Vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
* Known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known failure rate \< 1%.-
Effect of Aspirin Vs Omega 3 Fatty Acid After Scaling and Root Planing in Type II Diabetic Patients With Chronic Periodontitis

The main aim and objective of this study is to compare the effectiveness of low dose aspirin vs omega 3 fatty acids as adjuvants to non-surgical periodontal therapy and also to evaluate the levels of pentraxin 3 and glycosylated haemoglobin in diabetic patients with chronic periodontitis

There is an established bi-directional relationship between diabetes mellitus and periodontitis. Periodontitis causes systemic inflammation by the entry of oral pathogens and their virulence factors that adversely affect diabetic control in terms of elevated HbA1c levels.

Host modulatory therapy (HMT) is a strategy prescribed as an adjunct to conventional periodontal treatment by downregulating inflammation and promoting protective or regenerative responses. Different drugs have been evaluated as HMT including NSAIDS, Doxycycline, Bisphosphonates.

Aspirin has the unique position as HMT drug. It inhibits prostanoid production and induces 15- epi- lipoxins which are bioactive than native lipoxins.

Omega 3 fatty acids including Docosahexaenoic acid and Eicosapentaenoic acid due to their anti-inflammatory, antithrombotic, hypolipidemia and vasodilator effect, reduce the inflammatory mediators to levels of healthy tissues.

Pentraxins(PTX3) are classic acute phase proteins. They are a superfamily of evolutionarily conserved proteins considered to be the markers of acute phase inflammation. PTX3 is also known as TNF stimulated gene. It is produced abundantly in periodontal tissue by neutrophils, fibroblasts, monocytes and epithelial cells. The plasma levels of PTX3 is raised in inflammatory conditions. Hence it is taken as a biomarker.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type II Diabetes
* Patients with Chronic periodontitis.
* Clinical attachment loss ≥ 4 mm
* Probing depths ≥ 5mm.
* 14 teeth should be present
* Diabetic patients having HbA1C levels ≥ 6%

Exclusion Criteria:

* Pregnant and lactating women
* Smokers
* Patients with any auto immune or systemic disorder other than type II Diabetes
* Use of Medicines or antibiotic 3 months before
* History of periodontal treatment within 12 months
* Suspected intolerance to Aspirin
Correlation Between Muscle Strength and Thickness in Critically Ill Patients

Mechanical ventilation (MV) is associated with adverse outcomes in ventilated patients, and impact of MV-induced diaphragm changes are still unclear.

The objective of this prospective observational study is to assess muscle thickness and strength, specifically in limb muscles such as the quadriceps, among critically ill patients who undergo extended mechanical ventilation during their Intensive Care Unit (ICU) stay.

The primary inquiries this study seeks to address are:

* Is there an association between muscle thickness and strength in the limbs of critically ill patients undergoing prolonged MV?
* How much thickness and strength variation can be expected in respiratory and limb muscles in critically ill patients undergoing prolonged MV?

The methodology for measuring the thickness of the diaphragm and quadriceps involves the use of bedside ultrasound. In terms of diaphragmatic assessment, to ensure consistency over multiple timepoints, the areas of the lower limbs evaluated (Quadriceps thickness, Qthick and Cross section area, CSA) will be marked on the skin using a dermatographic pen during the peripheral assessments.

Muscle strength in the limbs will be assessed utilizing the Medical Research Council (MRC) Score, specifically in patients who are awake and cooperative (RASS 0 +/- 1). Additionally, a dynamometer will be employed for the precise measurement of quadriceps strength, serving as the gold standard.

The timeline for data collection during the observational period is structured as follows:

T1: 48-72 hours from the start of invasive MV after intubation T2: At the initial trial in pressure support mode. T3: Immediately prior to extubation. T4: Before discharge from the Intensive Care Unit.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Intubated patients on mechanical ventilation presumably for 48 hours;
* Informed consent

Exclusion Criteria:

* Contraindication (absolute or relative) to assessment: acute bleeding, multiple fractures or trauma, spinal instability;
* Hemodynamic instability during assessment;
* ICU admission due to thoracic surgery, including lung transplant patients;
* History of preexisting neuromuscular diseases;
* History of preexisting functional impairment;
* Pheripheral Neural disease;
* Cervical spine injury;
Lean Seafood Intake and Postprandial Metabolism

Despite numerous studies of meal components in humans, little is still known about how different meals influence on metabolism. The purpose of this study is to a gain knowledge of how a balanced test meal with either lean seafood (example:cod) or meat as the main protein source will:

1. affect the postprandial metabolism acutely (test-meal at beginning of the study)
2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period)
3. affect gut microbiota composition


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Caucasian

Exclusion Criteria:

* Smoking
* Diabetes
* Hysterectomy
* Abnormal bleeding last 6 months
* Use of medication that affects lipid and glucose metabolism
* Large (\>10%) alteration in body-weight the last 6 months
* Chronic, metabolic or acute disease or major surgery within last 3 months
* Dietary incompatibility with calcium supplementation and/ or seafood consumption (allergy, intolerance, dislike)
Machine Learning Models for Predicting Unforeseen Hospital Admissions or Discharges After Anesthesia

Unexpected hospital admissions after ambulatory surgery not only bring discomfort to patients but also causes a decrease in the efficiency of the healthcare system. In addition, unanticipated patient's orientation carry the risk of unsuitable post operative orders. The hypothesis of this project is that artificial intelligence models will outperform traditional models in predicting which patients will require hospital admission after ambulatory surgery or unforeseen hospital discharge after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing anesthesia for a therapeutic or diagnostic procedure

Exclusion Criteria:

* Incomplete informatic data
* Error in the encoding system
Phase I/IIa Study of FIXFc in Hemophilia B Patients

The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.

This study was previously posted by Syntonix Pharmaceuticals, Inc. In January, 2007, sponsorship of the trial was transferred to Biogen Idec. In February, 2017, sponsorship of the trial was transferred to Bioverativ.

Eligibility Criteria:
Key Inclusion Criteria:

1. Are previously treated (PTPs) with severe (\<2 IU/dL endogenous FIX level) hemophilia B and at least 150 prior documented exposure days to other FIX products.
2. Have no prior history of or currently detectable inhibitor defined as \> 0.6 Bethesda units by the local lab. A family history of inhibitors will not exclude the patient.
3. No prior history of an allergic reaction or anaphylaxis associated with any FIX or IVIG administration.
4. No concurrent autoimmune disease.
5. At least 7 days since their last dose of FIX (wash-out period).
6. Certain laboratory testing criteria and other protocol-defined criteria may apply.
7. HIV negative or if HIV positive with a CD4 count ≥ 200 cells/mm3. HIV patients are allowed to receive protease inhibitors per the discretion of the Investigator.

Key Exclusion Criteria:

1. Presence of a major bleeding episode on Day 1 of study.
2. Any coagulation disorder in addition to hemophilia B.
3. A patient currently on a dose and regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the study period.
4. A positive d-dimer at screening.
5. Documented history of liver cirrhosis.
6. Positive for HBsAg and/or positive for hepatitis C antibody, and/or HIV positive with an ALT or AST greater than 5 times upper limit of normal.
7. Certain prior illnesses and other protocol-defined criteria.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Pelvic Pain Education and Skills Training for Women Veterans

The goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans, and 3) identify appropriate pain-related treatment outcomes for the larger randomized trial.

Participants will be randomly assigned to participate in either the ACT condition or treatment as usual condition, complete three surveys (before, after, and 3-months after first survey), and complete a phone interview (if assigned to the ACT condition).

Researchers will compare the ACT condition and treatment as usual condition to see if there are meaningful differences in health outcomes. Due to the small sample size and pilot nature of this study, significance testing will not be performed.

Chronic pelvic pain (CPP) is a debilitating pain condition that disproportionately affects women veterans (30% vs. 16% of nonveteran women vs. 3% of men). Pain intensity and disability are further exacerbated by psychosocial factors (such as depression, anxiety, posttraumatic distress) that may not be fully addressed through pharmacological and surgical interventions. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are identified as first-line nondrug treatments for pain conditions. Given the multifactorial nature of CPP, ACT may be of particular benefit to these patients as it provides a unified (transdiagnostic) approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Specifically, ACT targets core psychological and behavioral factors (e.g., avoidance) that underlie many psychiatric and medical conditions. Several meta-analyses show ACT is effective, even when compared to active interventions such as Cognitive-Behavioral Therapy.

In this pilot study, researchers will examine the feasibility and acceptability of conducting a larger randomized controlled trial to establish the efficacy of a brief ACT group treatment for women veterans experiencing pelvic pain. This pilot study builds on previous work adapting an empirically supported one-day ACT workshop to the specific needs of women veterans based on their feedback.

Eligibility Criteria:
Inclusion Criteria:

* Served in US Armed Forces
* Self-identify as female/woman
* Have a diagnosis of chronic pelvic pain (CPP)
* Endorse moderate to severe pain (worst pain score ≥ 4 on Numeric Rating Scale \[NRS\]) AND pain-related distress (score ≥ 80 on Pelvic Floor Distress Inventory \[PFDI-20\])
* Be stable on mood and pain medication for four weeks and not scheduled for medical tests or procedures that might influence pain-related outcomes (e.g., surgical interventions, nerve block treatments)

Exclusion Criteria:

* Cognitive impairment
* Uncontrolled bipolar or psychotic diagnosis
* Active suicidal or homicidal ideation
* Receiving concurrent psychotherapy or who have received Acceptance and Commitment Therapy (ACT) within the past year
Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation

The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN therapy without instillation in the treatment of infected surgical wounds. Investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus Amukine Med 0.5%.


Eligibility Criteria:
Inclusion Criteria:

* Patients with infected surgical wounds.
* Patient age greater than or equal to 18 years.
* Patients who have given informed consent to the enrollment in the trial and to the processing of personal data.

Exclusion Criteria:

* Patients unable of consent.
* Patients affected by serious medical conditions that, according to the investigator's opinion, represent a contraindication to the study participation.
* Patients affected by wounds with exposition of blood vessels, sutures, organs or nerves and open wounds in mediastinum or abdomen.
* Patients with malignancy at the wound.
* Patients with untreated osteomyelitis.
* Patients with enteric and unexplored fistulas.
* Patients with necrotic tissue and eschar.
* Immunocompromised patients or in treatment with corticosteroids.
* Suspected or known allergic diathesis to the product of medication.
* Patients with coagulation disease.