cyrilzakka/clinical-trials huggingface dataset:
Comparison of Intracoronary Versus Intravenous Abciximab in ST-segment Elevation Myocardial Infarction (CICERO)

The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists of primary percutaneous coronary intervention (PCI) including thrombus aspiration and stenting. There is, however, still a high incidence of impaired post-procedural myocardial perfusion, which is associated with poorer clinical outcomes. Intravenous (IV) administration of the glycoprotein IIb/IIIa inhibitor abciximab during primary PCI plays an important role in the treatment of patients with STEMI. With higher local drug concentrations, abciximab may have additional anti-platelet, anti-thrombotic and anti-inflammatory features. These possible benefits may be obtained by intracoronary (IC) administration of abciximab. Recent small- to medium-scaled studies have suggested that IC administration of abciximab instead of the (IV) route is associated with improved post-procedural myocardial perfusion and a clinically relevant reduction of major adverse cardiac events.

Because of the limited number of patients included in these studies, a larger randomized clinical trial is needed to evaluate the effect of IC abciximab in patients with STEMI. Furthermore, the combined strategy of PCI with thrombus aspiration and IC use of abciximab has not been investigated.

Therefore, the investigators intend to evaluate the effect of IC bolus administration of abciximab compared to IV bolus administration on post-procedural myocardial perfusion as assessed by the extent of ST-segment elevation resolution in patients with STEMI undergoing primary PCI. The study is a single-center, prospective, randomized trial with blinded evaluation of endpoints.

Eligibility Criteria:
Inclusion Criteria:

a diagnosis of STEMI defined by

* chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
* time from onset of symptoms of less than 12 hours
* ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads

Exclusion Criteria:

* rescue PCI after thrombolytic therapy
* need for emergency coronary artery bypass grafting
* presence of cardiogenic shock
* known existence of a life-threatening disease with a life expectancy of less than 6 months
* inability to provide informed consent
* contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensive or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins)
Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty

Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions.

Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.

The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.


Eligibility Criteria:
Inclusion Criteria:

* Patients candidate for unilateral primary total knee arthroplasty

Exclusion Criteria:

* Existing orthopaedic metal implants
* A history of hypersensitivity to metals
* Preoperative patch-test positivity to Co, Cr, Ni and Ti
* Malignancies
* Renal insufficiency
* Severe illnesses that would impair participation in this study
Vaporization as a Smokeless Cannabis Delivery System

A study to evaluate the use of a vaporization system as a smokeless delivery system for inhaled marijuana.

Our primary objective is to evaluate the use of a vaporization system ( the Volcano) as a smokeless delivery system for inhaled marijuana. We will compare plasma levels of delta-9-tetrahydrocannabinol (THC), cannabinol, cannabidiol, and metabolites, including 11-OH-THC, in healthy volunteers after smoking \~400 mg each of approximately 1.8, 3.5, and 7% THC marijuana cigarettes (using the Foltin puff procedure) to those obtained when the same individuals inhale the vaporization product of the rest of the marijuana from the identical cigarette processed through the Volcano device. In addition to plasma levels, we will also compare the THC concentrations over an 8-hour time period, the subjective high experienced by the patients, and clinical evidence of cannabis effect by evaluating conjunctival hyperemia and heart rate. We will also compare the tolerability of the two methods of ingestion, and we will monitor expired carbon monoxide to evaluate whether the vaporizer reduces exposure to respiratory toxins.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-45 years Current history use of marijuana. Subjects must have smoked marijuana within the past 30 days but an amount totaling less than 10 marijuana cigarettes or the equivalent.

All men and women in this study must agree to use adequate birth control during the study. Acceptable barrier birth control methods are a male condom, female condom, diaphragm, or intra-uterine (IUD).

All women of reproductive potential (who have not reached menopause or undergone hysterectomy, oophorectomy,or tubal ligation) must have a negative urine B-HCG pregnancy test performed 48 hours before initiating the protocol-specified medication.

Able to understand and follow the instructions of the investigator and research personnel.

Able and willing to provide informed consent.

Exclusion Criteria:

* Severe coronary artery disease, uncontrolled hypertension, cardiac ventricular conduction abnormalities, or orthostatic mean blood pressure drop greater than 24mm/Hg, severe chronic obstructive pulmonary disease.

History of renal or hepatic failure. Evidence of hepatic, hematological or renal dysfunction based on judgement of physician.

Active substance abuse. Marijuana dependence as defined in DSM-IV code#304.30. Any psychiatric dysfunction that would, in the opinion of the study investigator, interfere with a participant's ability to comply with the study protocol.

Use of tobacco within the past 30 days. Subjects taking medications which may be vulnerable to drug-drug interactions such as those metabolized by the cytochrome P450 enzyme system.

Blood donation in the past 30 days. Use of smoked marijuana within 48 hours of GCRC admission. Women who are pregnant or breast-feeding may not take part in this study. Unable to read or speak English.
App for Pregnancy Smoking Cessation With Peer Support

The objectives of this project are to develop, implement, and test the feasibility and effectiveness of an artificial intelligence adaptive mobile pregnancy tobacco cessation app-based intervention using deep tailoring and a self-nominated support person, and to build mHealth research capacity in Romania. The central hypothesis is that the intervention will show evidence of feasibility and effectiveness in increasing positive support, pregnancy cessation, and postnatal abstinence. The intervention is grounded in Self-Determination Theory (SDT) and Motivational Interviewing (MI), a counselling style that is effective in assisting people to quit smoking. The app will be novel in its use of the unique functionality of smartphones, use of reinforcement learning (RL) and deep tailoring to continuously adapt the intervention, the emphasis on increasing positive support, and the use of the app by both smoker and support person. The long-term goal of the research program is to use mHealth for smoking cessation leveraging the unique functionality of smartphones and to continue building mHealth research capacity and developing research networks in Central and Eastern Europe (CEE) and other LMICs.

Aim 1 (R21 phase). Develop and test the feasibility and acceptability of the SFT2.0 app-based mobile smoking cessation intervention with a support person during pregnancy and postpartum in Romania. Through a user-centered and iterative design the investigators will enhance the SFT1.0 app, deepen the tailoring, incorporate RL, expand the app for use by any support person, and test the intervention including the app and MI video counseling in a series of usability studies and a 12-week open trial (n=20).

Aim 2 (R33 phase). Test the SFT2.0 app-based smoking cessation intervention in a hybrid effectiveness and implementation randomized controlled trial. The investigators will randomize 375 pregnant smokers and their support persons to i) a fixed arm, including the SFT2.0 app for both, and fixed pre- and postnatal MI counseling; ii) an RL-adaptive arm, with the app continuously optimizing as-needed MI counseling; or iii) control group.

Aim 3 (R21 and R33 phases). Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.


Eligibility Criteria:
Inclusion Criteria:

* age\>=18
* pregnant
* user of regular cigarettes
* availability of Android phone with broadband data

Exclusion Criteria:

-
Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

The purpose of this study is to determine if the combination of aspirin plus clopidogrel is more effective than aspirin alone in preventing another heart attack, chest pain, stroke or death in people who have already had a heart attack that was treated with fibrinolytic therapy.


Eligibility Criteria:
Inclusion Criteria:

* STEMI within 12 hours of randomization
* Planned treatment with a fibrinolytic agent and aspirin

Exclusion Criteria:

* Intention of performing coronary angiography within 48 hours of fibrinolysis
* Treatment with clopidogrel or ticlopidine within 7 days prior to enrollment, or planned treatment with clopidogrel or ticlopidine.
* Contraindication to fibrinolysis
* Planned use of a glycoprotein IIb/IIIa inhibitor
* Prior CABG
* Evidence of cardiogenic shock or acute pulmonary edema requiring intubation or an intraaortic balloon pump
* Known renal or hepatic insufficiency
Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)

Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading adenomas

Rationale:

Conventional EMR is well-established for the resection of lateral-spreading adenomas and has been shown to be highly efficacious with adjuvant STSC. Cauterisation-related complications occur relatively frequently and while endoscopically treatable, still carry morbidity not seen in current cold snare polypectomy data.

Cold snare polypectomy has an excellent safety profile for smaller polyps, without cauterisation-related adverse events. Limited data on cold EMR for large adenomatous laterally-spreading lesions shows minimal complications. Efficacy, however, is yet to be evaluated in prospective randomised trials. Observational data demonstrates recurrence rates exceeding conventional EMR. Since STSC causes significant reduction in recurrence in conventional EMR, the safety and efficacy of this adjuvant technique, when compared to isolated cold snare EMR, has theoretical advantages in both safety and efficacy.

The safety and efficacy of these two techniques will therefore be compared in a randomised controlled trial.

Hypothesis:

Cold snare EMR of 15-40mm lateral-spreading adenomas with adjuvant STSC is expected to be superior regarding complete resection and adenoma recurrence rates as compared to cold snare EMR.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing colonoscopy who is older than 18 years of age, has a written consent for trial participation and has at least one laterally spreading lesion meeting the following description:
* Localisation in the colon or rectum
* Benign adenomatous surface features (Kudo III / IV, Japan NBI Expert Team (JNET) 2a)
* Granular or non-granular topography
* Paris classification 0-IIa/IIb +/- Is
* If present, sessile component may be no greater than 10mm in size.
* Polyp size ranging from 15 to 40mm

Exclusion Criteria:

* Current use of antiplatelet (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines.
* Known bleeding disorder or coagulopathy.
* Pregnancy
* History of inflammatory bowel disease
* Previously attempted or otherwise non-lifting lesions
* Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3) or concurrent colorectal cancer
* Lesions involving the ileocaecal valve (ICV), appendiceal oriface or anorectal junction (ARJ)
TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty

Study 1 is to determine if muscle strength and dynamic and postural stability are compromised in patients with severe hip or knee Osteoarthritis (OA) and in patients after THA and TKA.

Study 2 is to quantify the effect of THA and TKA on muscle strength and dynamic and postural stability.

Postural stability is defined as the ability to maintain the body's centre of gravity within the limits of stability as determined by the base of support. It is further divided in static and dynamic stability involving the ability of maintaining a base of support while standing or completing a functional Task. The importance of postural stability is accepted as a factor predicting falls and affecting the ability to perform activities of daily living.

Despite of reported strength deficits and the importance of balance, to date the potential contribution of strength deficits in patients before and after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA) to compromised balance ability is unknown. Furthermore, the role of preoperative muscle function on functional outcome of THA and TKA is poorly understood. A correlation between compromised preoperative muscular function and postoperative outcome would suggest that preoperative physical therapy may be critical for preserving the muscular status and may help explain reported poorer outcome after late treatment when muscular function has already deteriorated.

The project includes two studies differing in design and primary and secondary objectives but with overlapping patient populations.

Study 1 will include all five groups, and there is only one visit by the participant (visit A).

Study 2 will include only patients from groups 3 and 4. Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3). Visit 1 will be identical to visit A in study 1 in these two patient groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an unilateral THA or TKA, which they received for the treatment of osteoarthritis (Patient groups 1+2)
* Patients diagnosed with unilateral OA of the knee or hip planned for a treatment with THA or TKA (Patient groups 3+4)
* Age ≥ 30 years (Healthy control group)

Exclusion Criteria:

* Body mass index \> 35kg/m2
* Use of walking aids
* Neuromuscular disorders affecting gait
* Inability to follow procedures due to psychological disorders or dementia
* Diagnosed hip or knee OA (Healthy control group)
* Current pain in the lower extremities or lower back (Healthy control group)
* Rheumatoid Arthritis (Healthy control group)
* Previous corrective osteotomy (Healthy control group)
* Regular intake of pain medication (more than 4 times per week) (Healthy control group)
Periodontal Phenotype Study (Tooth Extraction)

The purpose of this trial is to determine the correlations between various tissue dimensions and the changes that occur following a single-tooth dental extraction in human adults.

65 adult subjects who are in need of dental extractions will be recruited. Clinical measurements will be gathered prior to and immediately following the single tooth extraction. There will be a 2-week post-operative visit to assess healing and a 14-week follow-up for photographic documentation and clinical measurements of the extraction area.

Periodontal phenotype, also known as periodontal biotype, has been recognized as one of the key factors that may potentially impact the outcome of a variety of esthetic restorative procedures. With the increasing esthetic demand of patients in the context of tooth replacement therapy in the anterior esthetic zone, the ability to determine the prognostic value and the influence on treatment outcomes of this parameter has become a critical component of contemporary treatment planning. Periodontal phenotype encompases "bone morphotypes, shapes of the teeth, morphologic characteristics of the gingiva and the periodontium".

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 75 years
* Gender: No restriction
* Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless) in the maxillary anterior region (first premolar to first premolar)
* Subjects must be able and willing to follow instructions related to the study procedures
* Subjects must have read, understood and signed an informed consent form

Exclusion Criteria:

* More than 1 mm of recession present on the tooth planned for extraction and inclusion in the study
* Reported allergy or hypersensitivity to any of the products to be used in the study
* Severe hematologic disorders, such as hemophilia or leukemia
* Active severe infectious diseases that may compromise normal healing
* Liver or kidney dysfunction/failure
* Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
* Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or more)
* Subjects with a history of IV bisphosphonates
* Subjects with uncontrolled diabetes, defined as Hba1c \> 7.0
* Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded
* Pregnant women or nursing mothers
* Heavy smokers: Subjects who have smoked \>10 cigarettes per day within 6 months of study onset
* Concomitant medications: Subjects on concomitant drug therapy for systemic conditions that may affect the outcomes of the study will not be included in the study.

NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.

- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).
Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 80 years
* Typical AFL referring for ablation
* No prior history of AF
* Fulfilling the criteria for HF: New York Heart Association (NYHA) function class II or greater; and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) \>125 pg/ml in sinus rhythm or \>365 pg/ml in AFL
* Optimized guideline-directed medical therapy for HF for at least one month
* A minimum of anticoagulation for three weeks
* Sign informed consent

Exclusion Criteria:

* Any AF episodes documented during 48-hour Holter monitoring
* Presence of left atrial thrombus
* HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment
* Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
* Untreated hypothyroidism or hyperthyroidism
* Dialysis-dependent terminal renal failure
* Life expectancy \<12 months due to non-cardiovascular causes.
* Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
* Female under pregnancy or breast-feeding
* Involved in other studies
Possible Relation of Toll-Like Receptors and Nitric Oxide to Chronic Lung Disease

The first objective of this study is to determine if increased expression of one or more members of the toll-like receptor (TLR) family of receptors that are found on inflammatory cells (present in the airway) precede development of chronic lung disease (CLD) of prematurity. The study will also determine if there is a significant correlation between TLRs and the severity of CLD. The second objective of this study is to determine the impact of c-administration of inhaled nitric oxide (INO) on TLR expression in infants at risk of developing CLD or with early CLD.

BACKGROUND:

This study will examine the role of two members in the family of transmembrane receptors, TLRs, found on leukocytes and other cells that are upregulated in response to endotoxin and other stimuli. These substances transfer the signals that propagate inflammation and production of inflammatory cytokines. CLD of prematurity is characterized by early (first week of life) evidence of lung airway inflammation. It is unknown if TLR family members propagate this pathway.

DESIGN NARRATIVE:

This study will involve saving weekly tracheal aspirate fluid samples obtained with routine airway toilet in infants less than or equal to 1250 gm birth weight, who are admitted to a Neonatal Intensive Care unit requiring assisted ventilation via an endotracheal tube. The waste sample will be collected with the cellular contents separated by centrifugation and placed on Trizol reagent after obtaining a cell count. Later extraction and batch analysis of TLR, mRNA, and proteins as well as mRNA and protein for housekeeping genes will be performed. Immunohistochemistry will also be used to semi-quantitate the samples. Samples will be obtained in the first one to two days, and again at the end of the first week of life. In infants who were also participating in the related "Low Dose INO in CLD of Prematurity" study, in which tracheal aspirate samples were collected, when the code is broken to determine who received nitric oxide versus placebo, the second aim of the study will be carried out: to determine the impact, if any, of INO.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight less than 1250 gm
* Requiring assisted ventilation

Exclusion Criteria:

* Moribund condition
* Major pulmonary or cardiovascular associated anomaly
C-reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance

The goal of this study is to determine whether markers of vascular inflammation (such as c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated dilation) in postmenopausal women with glucose intolerance compared to normal controls.


Eligibility Criteria:
Inclusion Criteria:

* healthy postmenopausal women
* ages 40-65

Exclusion Criteria:

* smokers
* diabetes requiring medication
Gastroprotective Agent Utilization and Compliance in Patients > 60 Years Taking Low-dose Aspirin in France

The purpose of this study is to assess in general population low-dose aspirin and gastroprotective agent compliance and reasons for bad compliance


Eligibility Criteria:
Inclusion Criteria:

* French people \> 60 years old, part of Kantar Health Access Sant� panel

Exclusion Criteria: -