cyrilzakka/clinical-trials huggingface dataset:
Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization

Context: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents.

Objective: To determine differences in safety and efficacy between sirolimus and paclitaxel eluting stents.

Design: Randomized controlled, observer-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents

Patients: 1012 patients undergoing percutaneous coronary intervention. The two groups had similar baseline clinical and angiographic characteristics.

Eligibility Criteria:
Inclusion Criteria:

Patients with either stable angina or an acute coronary syndrome were eligible to participate if they had at least one lesion with stenosis of at least 50 percent in a vessel with a reference diameter between 2.25 and 4.00 mm that was suitable for stent implantation.

Exclusion Criteria:

Allergy to antiplatelet drugs, heparin, stainless steel, contrast agents, sirolimus, or paclitaxel; participation in another coronary-device study; and terminal illness.
The Clinical Efficacy of Midline Catheters

The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the Department of Infectious Disease or Department of Heart Disease.
* ≥18 years of age
* Expected requirement for iv. therapy \>5 days from the day of enrolment as evaluated by a specialist in infectious diseases.
* Mentally competency

Exclusion Criteria:

* Lack of patient consent
* Requirement for a CVC before study eligibility screening or anticipation of an absolute indication for CVC inserted within 24 hours of screening
* Personnel for insertion of midline catheter not available
HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy.

Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab.

Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.

All patients will receive IL-2 at 600,000 international units per kilogram (kg) by intravenous bolus (IVB) every 8 hours for up to 14 planned doses with an additional cycle 14 days after the first.

Ipilimumab 3mg/kg IV infusion Q3 weeks up to 4 doses4 doses A 3-6 week interval been the administration of the two drugs to allow for resolution of treatment-related toxicities.

If corticosteroids were required during Ipilimumab administration, a 2-week period from discontinuation of steroid treatment to start of HD IL-2.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years or older
* Confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response
* Meets the requirements for HD IL-2 therapy per Institutional guidelines
* Meets the requirements for ipilimumab therapy per Institutional guidelines
* Treatment naïve or has received only one systemic therapy apart from adjuvant therapy.
* At least 4 weeks since last adjuvant therapy or other cancer treatment
* Willing and able to give informed consent and participate in study procedures as described in the 12PLK02 and 10PLK13 protocols. Patients consented for 12PLK02 will also be asked to participate in the 10PLK13 PROCLAIM registry study.

Exclusion Criteria:

* Patients with known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) or other infectious hepatitis
* Pregnant, nursing or planning to become pregnant
* Untreated brain metastases. (Brain metastases that have been treated, which no longer require corticosteroid therapy and are without progression by MRI at least 6 weeks after definitive therapy are acceptable.)
* Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon are permitted with a minimum 4 week washout)
* Received prior HD IL-2 therapy.
* Received investigational drug within 30 days prior to study dosing. Patients may participate in non-interventional or observational clinical studies, including the 10PLK13 PROCLAIM registry study.
* Concomitant disease or condition that would interfere with the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study.
Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Type 2 Diabetes and Diabetic Nephropathy

The purpose of this study is to determine whether the combination with ramipril and clopidogrel leads to further improvement of endothelial function, reduction of oxidative stress and reduction of vascular inflammation, compared with ramipril monotherapy, in patients with Diabetes Mellitus type 2 and diabetic nephropathy.

* Cardiovascular disease is the leading cause of deaths in diabetic population with diabetic nephropathy.
* Pharmacologic therapy for patients with diabetes and hypertension should be with a regimen that includes either an angiotensin-converting-enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB)
* Diabetic patients at increased cardiovascular risk should receive an antiplatelet agent for primary prevention.

Methods:

An open label,randomized, two period cross-over design study, involving patients with type 2 diabetes and diabetic nephropathy. After a 4 weeks wash out period for ACE inhibitors or Angiotensin receptor blockers (week 0, baseline) 60 patients will be randomized to receive ramipril(10 mg) only or ramipril (10 mg) and clopidogrel (75mg) for 12 weeks exchanging their treatment for a further 12 weeks, after a 2 week wash out period for clopidogrel. Patients will be examined and measurements will be taken at baseline (week 0), and at the end of 12, 14, and 26 weeks.

Eligibility Criteria:
Inclusion Criteria: type 2 diabetes patients with diabetic nephropathy in the range of micro- or macroalbuminuria and

* HbA1c(glycosylated haemoglobin A1c \<7%
* Blood pressure ≤130/80 mmHg
* LDL (Low Density Lipoproteins) \<100 mg/dl
* Informed consent

Exclusion Criteria:

* patients with diabetic nephropathy and estimated GFR \<30ml/min with Modification of Diet in Renal Disease equation (MDRD equation)
* baseline potassium \> 5.2 meq/L
* patients with nephrotic proteinuria defined as albumine to creatinine ratio (ACR)\> 3.5 g/g or as proteinuria \>3.5 g per 1.73 m2 per 24 hours
* history or evidence of non-diabetic kidney disease
* history of stroke, peripheral artery disease, coronary artery disease
* history or evidence of a secondary form of hypertension
* history of severe hepatic failure, malignancy, severe endocrinopathy,autoimmune disease or chronic inflammatory disease
* any known bleeding or platelet disorder or platelets \<100.000/μL
* heart failure in New York Heart Association(NYHA) functional class II-IV
* inability or unwillingness on the part of the patient to sign the Patient Consent Form
* known hypersensitivity to ramipril or to clopidogrel
* Women of child-bearing potential
* use of oral anticoagulants or other antithrombotic treatment
* use of glitazones
* patients receiving statins should be on a stable dose of at least 3 months prior to study initiation and dose should be constant during the study
* any surgical or medical condition which in the opinion of the investigator may expose the patient to a higher risk in participation in the study
Immune Response to Vaccination Against Covid-19, a Follow up Study

The study investigates the immune response after vaccination in individuals with and without pre-existing immunity to Coronavirus disease (COVID) -19. The participants are followed and sampled up to 4 years after vaccination. Blood samples are collected at different timepoints to analyze immune response.

The aim is to investigate the level of specific antibodies to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) yearly, up to 4 years after vaccination.

The main objective is to investigate if the antibody development to SARS-CoV-2 S protein differ after vaccination in those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals.

The secondary objective is to improve the understanding of the cellular and serological immune response after vaccination against COVID-19 in these groups.

Individuals with and without pre-existing immunity to COVID-19 are included in the study. They are included after informed consent at sites where they receive vaccines against COVID-19 within the national and regional vaccine campaign.

The study includes all approved COVID-19 vaccines with marketing authorization in Sweden.

Persons are enrolled after the first or second dose of vaccination and followed 4 years after vaccination. Blood is collected at inclusion and 3 months, 6 months, 1 year, 2 years, 3 years and 4 years after vaccination to assess the immune response.

Data on sex, age, body mass index, medical history and concomitant medication is collected.

The study is a follow-up study after vaccination and approved by the Swedish Medical Products Agency (EudraCT 2021-000683-30). Regular monitoring of the study is performed by the Clinical Trial unit at Umeå University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Consents to participate in the study
* Age ≥ 18 years

Exclusion Criteria:

* Age \<18 years
* Incapable of giving informed consent
* Contraindication to vaccination
* Severe disease
* Ongoing treatment that is judged to affect the vaccine response (Does not include Rituximab which is allowed after individual consideration). Steroids \> 15 mg orally per day.
The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries

Ondansetron is a medication routinely given to mothers having cesarean deliveries to help prevent and treat nausea and vomiting. The investigators are studying the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

Spinal anesthesia is a routine anesthetic technique for elective cesarean deliveries. Although this provides safe and effective surgical anesthesia, it is not without side effects, including both hypotension and bradycardia. The incidence of hypotension following spinal anesthesia has been estimated to be as high as 80% in an obstetric population. A number of factors are also likely involved in the development of hypotension and bradycardia, including the Bezold-Jarisch Reflex (BJR).

Two human studies with spinal anesthesia, one in an obstetric population, have demonstrated ondansetron's ability to presumably attenuate the BJR and better prevent hypotension by antagonism of 5-HT3 receptors. Maintenance of blood pressure and heart rate are vitally important, as they are required for adequate perfusion of the fetus prior to delivery.

The investigators plan to investigate the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

Ondansetron is classified as a Pregnancy Category B drug by the FDA, meaning that no adverse fetal effects have been demonstrated in animal studies, but that there is a lack of well controlled studies in pregnant humans.

Eligibility Criteria:
Inclusion Criteria:

* Elective CD under spinal anesthesia
* Fluency in English

Exclusion Criteria:

* Contraindication to spinal anesthesiA
* Allergy to ondansetron
Novel Classification of Adult-onset Diabetes and Its Association With Common Microvascular Complications in Upper Egypt

Aim of our work:

First aim: Classify patients with adult-onset diabetes according to the novel classification into new subgroups, depending on multiple variables related clinically to those patients.

Second aim: To identify the association between the new classification subgroups and the presence of common microvascular complications (retinopathy, nephropathy, and neuropathy), which can help in the early prediction of these complications and their early management.

We will conduct an observational cross-sectional study and cluster analysis for patients from different Diabetes clinics and tertiary centres located in different governorates in Upper Egypt. Our participants in this study will be divided into two groups:

1. The first group will be as a prospective group, All necessary examinations and investigations will be performed for every patient of this group during their clinic visit at the time of registration to this study.
2. The second group will be the retrospective group. Data for those patients will be collected from electronic records and/or paper records in collaboration with different diabetes centres and clinics scattered in Upper Egypt governorates. We will collect clinical and lab data as much as we can. All available data for this group at end of this study will be used in the clustering of this group.

Then we will use the above data from both groups to classify diabetic patients to the new clusters and to find the association between those clusters and the incidence of microvascular complications.

Eligibility Criteria:
Inclusion Criteria:

* Adult-onset DM type 2 diagnosed patients according to current ADA recommendations, aged \<18 years old and within 3 years from the time of diagnosis.

Exclusion Criteria:

* 1- Patients diagnosed with Gestational DM or rare types of diabetes like monogenic diabetes types, such as maturity-onset diabetes of the young (MODY), diabetes secondary to steroid use, cystic fibrosis, hemochromatosis, and pancreatic diabetes according to ADA criteria.

  2- Patients diagnosed with non-diabetic kidney diseases, such as chronic glomerulonephritis, vasculitis, polycystic kidney disease, and renal cancer or patients with a transplanted kidney were excluded from the analysis for diabetic kidney disease.

  3- Patients diagnosed with retinopathy due to non-diabetic causes or diagnosed with neuropathy due to non-diabetic causes will be excluded from the analysis for diabetic retinopathy and neuropathy, respectively.
Treatment Study for Problematic Gaming and Gambling

The aim of the study is twofold: 1) to evaluate an Relaps Prevention(RP) treatment for Problematic Gaming (PG) and Internet Gaming Disorder (IGD) patients recruited from child and youth psychiatry (CAP) clinics and 2) to test whether the quality of parent-child relationships plays role in the effect of RP treatment and vice versa - whether the RP treatment has a spillover effect on the quality of parent-child relationships.

This study is a two-arm, parallel-group, single-blind, early-stage Randomized Clinical Trial (RCT) with embedded qualitative components. Participants will be randomized in a 1:1 ratio to either intervention or control, with a total of 162 participants (81+81) in the trial. The primary outcomes are measures of gaming and gambling behavior pre- and post-intervention, and the secondary outcomes include child ratings of parent-child communication, including parental knowledge, control and solicitousness about child gaming, as well as child disclosure and secrecy related to gaming.

Preliminary analyses will be conducted with regression analyses, paired sample t-tests and ANOVAs and performed in Mplus. In addition to the RCT, the study will be supplemented with a qualitative component with semi-structured individual interviews to capture participants' and clinicians' experiences of the treatment, as well as attitudes about parent-child relationships and parenting needs in carers whose children completed the RP treatment. The qualitative data will be analyzed with thematic analysis.

Eligibility Criteria:
Inclusion criteria

* age 12-18
* over cut-off on GASA
* over cut-off on CLiP

Exclusion criteria

* not being able to speak Swedish
Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy

Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow for better analysis of local and global activity of the cerebral cortex, as compared with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first clinical service in France equipped with such a system.

Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential information (in the form of "connectivity graphs") on cortical networks, either dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and during seizures.

So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et al., 2010). However, since each method is highly sensitive to the type of model that is assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al., 2006), none of them has yet demonstrated its effectiveness.


Eligibility Criteria:
Inclusion Criteria Patients:

* Being more than 18 years old,
* Having a chronic partial epilepsy resistant to medical treatments well administered and well followed in the course of pre-surgical assessment.

Inclusion Criteria Healthy Volunteers:

* Being French native speaker,
* Being more than 18 years old,
* Being right-handed.

Exclusion Criteria Patients:

* All patients for whom a preoperative surgical exam is not suitable,
* Any patient with psychiatric disease or intellectual disorder such that informed consent could not be obtained,
* Any patient with no abnormal EEG during intercritical phases,
* All patients presenting psychiatric, neuropsychological or developmental difficulties in addition to epilepsy,
* Adult persons subject to legal protection (judicial protection, temporary guardianship/guardianship, administrative supervision), persons deprived of their liberty and pregnant or lactating women.

Exclusion Criteria Healthy Volunteers:

* The presence of any psychiatric, neuropsychological, and developmental disorder,
* Any uncorrected visual impairment,
* Any trouble or delay in learning to read / speak or write French,
* Being fully bilingual or multilingual
* Medication, treatment and / or substances that may alter or modify brain functions,
* Adult persons subject to legal protection (judicial protection, temporary guardianship/guardianship, administrative supervision), persons deprived of their liberty and pregnant or lactating women.
Antibiotic Prophylaxis in Open Fractures

Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures

Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy

Eligibility Criteria:
Inclusion Criteria:

* male or female \>= 18 years old
* complete an informed consent
* patients are diagnosed with a type II or III open fracture

Exclusion Criteria:

* allergy to beta-lactam antibiotics prior to screening
* prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis
* pregnant female
* inability to provide consent
Combined Effects of Alcohol and Caffeine

The purpose of this study is to investigate the effects of caffeine on the self-administration of alcohol. The study will also examine the combined effects of alcohol and caffeine on behavioral performance, participant ratings of behavioral performance, and self-reported subjective effects.

The purpose of this study is to examine the effects of caffeine on alcohol self-administration. Volunteers will participate in 7 experimental sessions in which they will be given the opportunity to self-administer an alcohol + caffeine or alcohol + caffeine-placebo beverage. The first 6 sessions will involve exposure to the two beverage conditions in mixed order three times each (e.g., A, B, B, A, A, B). The seventh session will be a choice session in which the participant will make a single choice at the beginning of the session about which beverage they will consume that day. In addition to the primary outcomes of quantity of alcohol self-administered and beverage choice, three additional outcomes will be measured including: 1). indirect measures of reinforcing effects (e.g. subjective ratings of liking, well-being, take again); 2). an alcohol-sensitive behavioral measure; and 3). participant ratings of degree of behavioral impairment.

Eligibility Criteria:
Inclusion Criteria:

* Very light or moderate consumer of caffeine (either daily or non-daily).
* Social drinker of alcohol.
* Has experience in lifetime of heavy alcohol consumption.
* Read, write, and speak English fluently.

Exclusion Criteria:

* Serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, uncontrolled hypertension, and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis), or hematologic disease.
* Parkinson's disease, seizure disorder, or history of significant head trauma.
* Current psychiatric illness
* Pregnant or nursing women or women who are not using an effective means of birth control.
Infantile NO Replenishment as a New Therapeutic Possibility

Case-control study of inhaled Nitric Oxide (iNO) treatment of full-term and preterm infants. The main objective of this study is to investigate the association between premature birth and its later comorbidities (neuroendocrine, metabolic, cognitive, etc) with iNO treatment and the maturation of the HPG axis during minipuberty.

In preterm infants, inhaled NO (iNO) is routinely used to treat respiratory failure and pulmonary hypertension, while preclinical studies have shown that it markedly increases NO concentrations in the brain. Animal and human studies have shown that NO deficiency may jeopardize the establishment of a mature and functional HPG axis whereas it is also associated with a series of comorbidities affecting the overall brain development (e.g. sensory, fertility and cognitive functions). Prematurity has been associated with a series of non-communicable diseases of major importance in public health, including neurodevelopmental impairments, metabolic abnormalities (e.g. obesity, type 2 diabetes mellitus, impaired glucose tolerance) and cardiovascular disease. This study aims to evaluate the associations between altered minipuberty in preterm infants and the later development of multi-comorbidities (mental and non-mental disorders), and identify the possible implication of the NO pathway as a causative mechanism.

Specific objectives :

1. Assess the efficiency of NO replenishment therapy (i.e. role of NO pathway) as a therapeutic against alterations of minipuberty resulting from preterm birth.
2. Assess the efficiency of NO replenishment therapy (i.e. role of NO pathway) as a therapeutic against the multi-comorbidities (mental and non-mental disorders) related to altered minipuberty as a result of preterm birth.

Eligibility Criteria:
Inclusion Criteria:

* Preterm (GA\<37 weeks) or full-term (≥37 weeks of gestation) infants
* Requiring respiratory support
* Admitted to Neonatal Care Unit

Exclusion Criteria:

* Severe congenital anomalies
* Suspected major chromosomal anomalies
* Infants judged by the physician as nonviable