cyrilzakka/clinical-trials huggingface dataset:
Impact of Oral Magnesium on Neuropathic Pain

Use lay language.

The aim of this study is to evaluate on pain scores (neuropathic pain questionnaire and pain numeric scale) and on quality of life, the effect of oral magnesium intake on patients with neuropathic pain comparing with patients receiving placebo,. The study drug will be taken during 4 weeks.

Protocol description

Visit D0

* patient inclusion after informed signed consent
* clinical exam
* blood sampling (magnesium dosage)
* questionnaires (neuropathic pain and quality of life)
* daily self-evaluation on neuropathic pain scale (Week0 to Week5)

D8 : first intake of study drug (magnesium or placebo)

Visit Week5:

* questionnaires (neuropathic pain and quality of life)
* blood sampling (magnesium dosage)
* clinical exam

Eligibility Criteria:
Inclusion Criteria:

- neuropathic pain

- informed signed consent

Exclusion Criteria:

* magnesium intake contra-indication
* severe renal insufficiency
* quinidine intake
* concomitant treatment change 2weeks before inclusion
* evolutive pathology
HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain

The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.

This study will include patients with chronic low back pain. The main question it aims to answer is:

How do rationales influence the effects of open-label placebos?

Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.


Eligibility Criteria:
Inclusion criteria are:

* chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over)
* at least 18 years old
* English speaking
* have a smartphone or computer with video access
* the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate)

Exclusion Criteria

* Have chronic pain because of a cancer diagnosis
* Over 89 years of age
* Suspect an allergy to any placebo ingredient
* Currently receiving worker's compensation.
Evaluation of the Role of Brain Natriuretic Peptide in Acute Coronary Syndrome .

The measurements of the natriuretic peptide are useful and beneficial for risk stratification irrespective of the cause during admission time or during hospital stay course. the aim of the study is to Assessment of the role of Brain natriuretic peptide in diagnosis of acute coronary syndrome . Evaluation of the relation of Brain natriuretic peptide to the severity and occurrence of complications in acute coronary syndrome .

Ischemic heart disease (IHD) is regarded as one of the important leading causes of disability and death across the globe.

Acute coronary syndrome (ACS) applies to a variety of events reporting ischemia, ranging from stable angina without myocardial necrosis to ST -segment elevation myocardial infarction (STEMI). The need for prevention and detection of coronary vascular disease as early as possible by using newer and more cost effective tools is suggested . For risk stratification in patients with ACS, serial ECG monitoring and cardiac biomarkers measurement are needed as part of the diagnostic workup. B-type natriuretic peptide is synthesized as a high molecular weight precursor pro-brain natriuretic peptide (BNP) which is cleaved to release BNP and the amino-terminal fragment, N-terminal pro (NT-pro) BNP. Both peptides are released from the cardiac ventricles in response to the increased wall stress and hence its levels may indicate ventricular strain BNP is believed to have its role as natriuretic hormone and vasodilation. Among other effects are inhibition of the Renin Angiotensin-Aldosterone system(RAAS), and sympathetic nervous system. After an ischemic occurrence, BNP levels peak in 14 to 40 hours .

Eligibility Criteria:
Inclusion Criteria:

* patients with acute coronary syndrome.

Exclusion Criteria:

* Patients with previous MI
* Eection fraction (EF) less than 30%
* Patients having cardiomyopathy
* Patients having renal, liver, malignant, infectious, or inflammatory diseases .
Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy

This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Health care system affiliation
* Referred to carotid endarterectomy
* Symptomatic patients:

  * Carotid stenosis between 70 and 99% (NASCET criteria)
  * TIA or minor stroke attack (RANKIN ≤ 3)
* Asymptomatic patients:

  * Carotid stenosis between 70 and 99% (NASCET criteria)
  * No symptoms
* Patient who has been informed of the study and has given his/her informed consent

Exclusion Criteria:

* Contra indication to MRI
* Renal failure (clearance \< 30ml/mn)
* Patient with active inflammatory disease
* History of cancer
* Pregnancy or lactation
* Patient with carotid disease treated by fibrinolysis
* Patient under guardianship, or unable to understand the purpose of the study
The Clinical Manifestations of the Severe Acute Respiratory Syndrome, Coronavirus 2( SARS-Cov-2 ); Not Only Pulmonary

A prospective observational study to identify different extrapulmonary clinical manifestations of SARS-CoV-2 and its correlations with the disease severity grades.

The current research in this area was retrospective trials; this study is a prospective one. Investigators will perform the extensive recording of extrapulmonary manifestations in adult patients of SARS-CoV-2 and their correlations with the disease severity grades.

Type of the study: a prospective observational study

Study Setting:

Data will be collected from outpatients and inpatients files and a questionnaire.

Sample Size Calculation:

Depending on the average monthly (40-50 cases) and type of the study :

-Investigators will use Steven K. Thompson equation 13 to calculate the size from the next formula

Population size =(752) Sample size = (414) Level of confidence: ( 95%) Error proportion: (0.05) Probability :(20 %) Study power: (80 %)

Eligibility Criteria:
Inclusion Criteria:

* Patients have been confirmed diagnosed with Covid-19 disease by PCR
* Patients aged 18 years and above

Exclusion Criteria:

* Patients aged below 18 years old.
Optimizing In-hospital Use of Evidence-based Therapies for Patients With Cardio-Renal-Metabolic Disease

This study will be a prospective randomized implementation trial for patients hospitalized with heart failure, chronic kidney disease, and/or type 2 diabetes mellitus within Duke University Medical Center. The primary hypothesis is that a virtual quality improvement-based consult intervention will improve the rate of in-hospital evidence-based cardio-renal-metabolic medication use, particularly SGLT2 inhibitor therapy. Approximately 200 patients meeting eligibility criteria will be included in the study. Patients will be assigned into study groups, as defined by randomization of their treating clinician team to receiving the virtual consult versus not.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized adults age ≥ 18 years with ≥1 of the following diagnoses, as defined by the medical record:

1. HF (any ejection fraction)
2. CKD with estimated GFR ≥ 20 mL/min/1.73m2 \*
3. T2DM (by clinical history or hemoglobin A1c)

Exclusion Criteria:

1. End-stage stage renal disease on dialysis or eGFR \<20 mL/kg/1.73m2.
2. Pre-menopausal woman who are either breast-feeding or pregnant
3. History of heart transplant or actively listed for heart transplant
4. Implanted left ventricular assist device or implant anticipated within 3 months.
5. Enrolled in or planning to enroll in hospice care.
6. Active cancer (except localized prostate, breast, or non-melanoma skin cancers)
Ambulation With Labor Epidural in Obese Women

The purpose of this study is to determine if ambulation with a labor epidural in place is associated with decreased rate of cesarean delivery in obese patients.

Obese women are known to have increased risk of cesarean delivery and prolonged labors. Low concentration epidural analgesia can achieve pain relief and allow for ambulation. Prior investigations have not shown a benefit in cesarean delivery between those who ambulate with an epidural and those who do not. These studies were conducted in women with normal weights. It is unknown if ambulation with a labor epidural is beneficial in decreasing cesarean delivery among obese women.

Obese women at term with a singleton pregnancy will be enrolled in this pilot study. Patients will receive their epidural analgesia when they desire per standard protocol at our institution. Following epidural placement, a Modified Bromage Score and straight leg test will be performed. If the patient passes the straight leg test and has a modified Bromage score \> 6, they will be allowed to ambulate. They will be encouraged to ambulate for 20 minutes per hour with another adult alongside them. Obstetric care will be standard of care.

On postpartum day one, the patient will be administered a Labor Agentry Scale. Chart review will then be conducted to review maternal and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

Subjects capable of giving consent Singleton pregnancy Nulliparous (defined as no previous pregnancy beyond 20 weeks 0 days) Gestational age greater than or equal to 37 weeks BMI \> = 35 at time of delivery admission Adult companion available Anticipated vaginal delivery

Exclusion Criteria:

Physical disability precluding ambulation Magnesium Administration Contraindications to neuraxial analgesia Cerclage in current pregnancy Active labor DPE Category III fetal heart tracing Fetal Demise In Utero
Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.

Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.

The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.

Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.

The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.


Eligibility Criteria:
Inclusion Criteria:

* Birth Term strictly less than 33SA
* Gestational age some (assessed on early ultrasound dating)
* Congenital malformation of Absence
* Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (\> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic)
* Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN
* Maximum interval between imaging tests 2 hours
* No parental opposition to the participation of children in the study

Exclusion Criteria:

* Term higher or equal to 33 weeks
* Congenital malformation
* Parental Opposition (or legal representatives) to participate in the study
The German Patient Blood Management Network

* This epidemiological trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort
* Primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program.
* Secondary endpoints are the length of stay on the intensive care unit, total hospital stay and the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and cell saver systems during hospital stay.
* The primary aim is to prove non-inferiority of the intervention (PBM) group when compared with the control group stratified by center.

Background: The transfusion of allogeneic red blood cell units might be associated with increased morbidity and mortality due to infectious, immunological, pulmonary and thromboembolic complications. However, transfusion practice currently varies significantly between hospitals and even between physicians and Patient Blood Management programs have not been implemented nationwide in Germany yet. Patient Blood Management (PBM) concepts aim to identify and optimize patients at risk of allogeneic blood transfusions, to promote blood-sparing techniques and restrictive transfusion practices. A rational use of red blood cell concentrates and safe clinical transfusion practice is mandatory. The purpose of the German PBM network is to evaluate the safety of a standardized, evidence-based Patient Blood management concept.

Study Design and Methods: This epidemiological study is a follow-up of a study that is already being carried out in four German university hospitals. This new prospective, multi-centre trial comprises approximately 20 different hospitals of varying size and levels of patient care. A patient-centred, evidence-based Patient Blood Management program will be enrolled in each of these hospitals reforming the care of adult patients undergoing any type of surgery. This PBM program includes the following three main pillars: 1) preoperative optimization of hemoglobin levels in high-risk patients with anaemia, 2) standardization of transfusion practice and transfusion triggers according to evidence-based guidelines and 3) alternatives to transfusion of allogeneic RBC concentrates and blood-sparing techniques (like routine use of cell saver systems, point-of-care diagnostics, optimized coagulation management, restrictive blood sampling).

Eligibility Criteria:
Inclusion Criteria:

* all surgeries with a general or local anaesthetic
* minimum hospital stay of 24 h
* ≥ 18 years

Exclusion Criteria:

* \< 18 years
* ophthalmologic or dermatologic or outpatient surgery
* all non-surgical anesthetic procedures
Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease

Recently, researchers have paid attention to the development of new products such as supplements food and nutraceuticals for identify and develop integrative therapies to be used in cardiovascular disease. As suggested by literature, some nutritional components (creatine, ribose) can enhance the fundamental energy levels for the functioning of the heart muscle and can enhance the body's antioxidant capacity through the reduction in free radicals activity, one of the main pathogenic mechanisms of these diseases. In this context, the investigators have developed a research with the principal purpose to establish whether a supplement of creatine and ribose can improve the total work capacity during exercise in a population of patients with known ischemic heart disease.

The investigators will enroll patients with previous acute coronary syndrome treated for at least 30 days by hospital discharge. The treatment regimen of all patients will be optimized in accordance with European Society of Cardiology guidelines. Standardized pharmacological treatment during cardiac rehabilitation period will include administration of angiotensin converting enzyme inhibition (ACE), beta-blockers and antiplatelet blockers. Furthermore, in order to keep patients free from angina symptoms, in some cases calcium channel blockers and/or nitrates will be used. The investigators will randomize participants into two groups, one receiving treatment Creatine, D-Ribose, B1 Vitamin, and B6 vitamin, and one receiving placebo in a double blind study design, for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients presented acute coronary syndrome treated with at least 30 days by hospital discharge

Exclusion Criteria:

* oncological diseases
* stable atrial fibrillation
* stent in the common core
* patients who are not able to perform physical activities
* patients with documented sustained ventricular arrhythmias
* pregnant women
Dual Site Left Ventricular (LV) Pacing

The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing:

1. Improves the way the heart's left ventricle functions
2. Decreases the number of hospital and clinic visits for heart failure related symptoms
3. Slows the rate patients experience certain heart failure symptoms
4. Reduces uncoordinated heart contractions


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy
* On heart failure medical regimen (beta blockers and ACE-I or ARB's) for at least one month before randomization
* A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a QRS duration \> 120 ms
* Left ventricular ejection fraction (LVEF) \< 35% or equal
* Willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
* Have a life expectancy of more than 180 days, per physician discretion
* Age 40 or above, ensuring of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Have had previous cardiac resynchronization therapy or a previous coronary venous lead
* Unable to perform a Six-Minute Hall Walk (6MHW) Test
* Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without CHB or planned AVJ ablation prior to randomization
* Have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no AVJ Ablation will be exited.)
* Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
* Have a mechanical tricuspid prosthesis
* Has severe aortic or mitral stenosis
* Enrolled in any concurrent study that may confound the results of this study
* Patients who are or suspect they may be pregnant or plan to become pregnant
Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus

This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.

This is a nation-wide, multicentre, randomised, controlled, and adaptive phase IV clinical trial that aims to assess the effectiveness and cost-effective of pre-emptive pharmacogenetic testing strategies, including those impacted by genetic variants associated with adverse drug reactions (ADRs) or limited efficacy. The clinical trials will evaluate the effective and cost-effective of pre-emptive genotyping by defining a drug-gene-endpoint triad. Study subjects will be pre-emptively genotyped and, if found to have an actionable gene variant, randomly allocated to either a test group where guideline-based treatment modifications will be initiated or a control group that will be managed according to healthcare provider standard of care (SoC). Subsequently, subjects will be prospectively followed at prespecified timepoints. Detailed information on drug-gene-endpoint triads, allocation schemes, and follow-up visits will be provided in each of the subprotocols. A Data Monitoring Committee (DMC), composed of physician experts, will be appointed for each nested trial to review the data on an ongoing basis, ensuring the safety of participants and scientific validity of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
2. Subject or their legally authorized representative has voluntarily signed the informed consent document.
3. Participant is on the waiting list for a kidney transplant.
4. Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.
5. Subjects must be naïve to any genotyping test of the following genes: CYP3A5.

Exclusion Criteria:

1. Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients.
2. History of renal, heart, and/or liver transplant.
3. History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.
4. Any condition or situation precluding or interfering the compliance with the protocol.
5. Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.