cyrilzakka/clinical-trials huggingface dataset:
COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

The study objective is to clarify whether the application of CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce mortality and prevent organ failures in septic shock patients in intensive care unit (ICU).

Septic shock is a life-threatening clinical condition characterized by cardiovascular failure as a consequence of infection. Septic shock frequently causes multi-organ failure in the ICU. For this reason the extracorporeal therapies for the treatment of renal failure have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is CPFA (coupled plasma-filtration adsorption) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The study objective is to clarify whether the application of CPFA in addition to the current clinical practice is able to reduce mortality and prevent organ failures in septic shock patients in intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the ICU in septic shock
* All patients that develop septic shock while in the ICU

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Cardiopulmonary resuscitation
* Cerebral coma
* Metastatic cancer
* Presence of relative or absolute contraindications to CPFA
* Estimated life expectancy less than 2 weeks
* Already included in the study
* Admission from an other ICU where the patient remained for more than 24 hours
* Absence of informed consent
Aromatherapy and Anxiety Study

While intra-articular injections can alleviate pain in orthopedic patients, this can be an anxiety-provoking experience. Adult patients scheduled to receive an injection at the study location will be randomly assigned to one of three groups. The control group (C) will receive the current standard of nursing care. The first experimental group (A) will receive a guided meditation prior to receiving the injection. The second experimental group (B) will receive an Elequil Aromatab and the same guided meditation prior to receiving the injection.

The objective of the study is to measure the difference in anxiety levels of adult orthopedic patients in need of intra-articular injections who receive a guided meditation only prior to their injection, compared to those who receive a guided meditation and an aromatherapy Elequil Aromatab prior to injection, as well as compared with those who receive the usual standard of care

Eligibility Criteria:
Inclusion Criteria:

* Patient has an in-office appointment at the NYU Langone Ambulatory Care-23rd Street location with either the Ortho A \& B (primarily those patients who may be seeking knee or hip replacement surgery), Hand, or Primary Sport clinics.
* Patient has an order for an intra-articular injection (as determined by clinic MD) and has consented to receiving that treatment.
* Patient is English speaking.

Exclusion Criteria:

* Patient has a cognitive or physical disability that would interfere with their ability to complete the study's pre and post assessments with RN.
* Patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general.
Replication of the GRADE Diabetes Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal than 30: days \[0,0\]
* Diagnosis of Type 2 Diabetes: days \[- All Data, 0\]
* 2+ recorded HbA1c levels: days \[-365,0\]
* Metformin use: days \[-30, 0\]

Exclusion Criteria:

* Type 1 or Secondary DM: days \[-All Data, 0\]
* Previous organ transplant: days \[-All Data, 0\]
* HIV/AIDS: days \[-All Data, 0\]
* History of bariatric surgery: days \[-All Data, 0\]
* Congestive heart failure: days \[-All Data, 0\]
* NYHA \>=3: days \[-All Data, 0\]
* Pancreatitis: days \[-All Data, 0\]
* Medullary thyroid cancer/MEN-2: days \[-All Data, 0\]
* History of MI: days \[-365, 0\]
* Stroke: days \[-365, 0\]
* Coronary Revascularization: days \[-365, 0\]
* PTCA/Stenting/CABG: days \[-365, 0\]
* Trans myocardial revascularization: days \[-365, 0\]
* Carotid bypass: days \[-365, 0\]
* Cerebrovascular revascularization: days \[-365, 0\]
* PVD: days \[-365, 0\]
* CCI \>=10: days \[-365, 0\]
* History of cancer, other than non-melanoma skin cancer: days \[-1,825, 0\]
* Treatment of metformin more than 10 years: days \[-3,650, 0\]
* Treatment with any diabetes drug other than metformin; PCOS; symptomatic hyperglycemia; pregnancy; gestational diabetes: days \[-180, 0\]
* History of hemolytic anemia; history of severe liver disease; current alcoholism; chronic transfusion requirement; ESRD: days \[-180, 0\]
* Oral, IV, or IM cortisone, hydrocortisone, prednisone, methylprednisone, or dexamethasone: days \[-90, 0\]
* Treatment with atypical antipsychotics, language barriers, nursing home, or missing age or gender: days {-180, 0\]
* Hospitalization with length of stay \>3 days: days \[-30, 0\]
The Effect of an Electronic Decision Support System on Preventing Pressure Ulcers and Urinary Infectionsin Home Care

The home care of fully dependent patients is often provided by informal family caregivers. Therefore, caregivers need support systems to make the right decisions during home care to prevent pressure ulcers and urinary infections. This study aims to evaluate the impact of using an electronic decision support system (E-DSS), offered through a mobile-compatible webpage, on preventing the risk of pressure ulcers and urinary infections in fully dependent patients receiving home healthcare services.

The study is planned in two phases. In the first phase, the development of the electronic decision support system to be provided through a mobile-compatible webpage is targeted. In the second phase, a randomized controlled trial will be conducted to assess the usability of the developed decision support system by caregivers.

For the project, patients with a Barthel Index score between 0-20 (if an insufficient number of patients is available, those scoring between 21-61 will also be included) will be selected and divided into intervention and control groups. Caregivers of the intervention group will use the electronic decision support system via a mobile-compatible webpage for eight weeks to receive guidance on preventing pressure ulcers, urinary infection prevention strategies, in-bed mobilization, and nutrition recommendations. Caregivers in the control group will continue with the routine practices of the home healthcare services provided by the Turkish Ministry of Health.

The study outcomes will be evaluated at the beginning and at the ninth week using the Braden Pressure Ulcer Risk Scale, the Ghent Global IAD Classification Tool (GLOBIAD), the ISTAP Skin Tear Classification System, urinalysis (UA), the Urine Color Scale, and the Mini Nutritional Assessment-Short Form (MNA-SF). Additionally, at the end of the study, caregivers in the intervention group will be assessed using the System Usability Scale (SUS-TR), the Mobile Application Usability Scale, the Mobile Application Loyalty Scale, and the Mobile Application Willingness to Use Scale.


Eligibility Criteria:
Inclusion Criteria:

1. Patients receiving home healthcare services.
2. Patients with a total Barthel Index score of 0-20 (fully dependent) and 21-61 (severely dependent).
3. Caregivers who are familiar with using mobile devices and voluntarily agree to participate.

Exclusion Criteria:

1. Patients with a Barthel Index score of 62 or above.
2. Patients with an acute medical condition (e.g., hospitalization due to infection or newly developed severe illness).
3. Caregivers with cognitive or technological limitations preventing
4. Caregivers who are not literate in Turkish and unable to use the application.
5. Terminal-stage patients\* with a life expectancy of a short period.
6. Caregivers with severe cognitive impairment (e.g., advanced-stage dementia) or untreated psychiatric disorders (e.g., schizophrenia).
7. Patients without an informal caregiver providing care at home.
8. Patients with an existing urinary infection based on hospital urinalysis records.
Temporal Trends of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea

Cardiovascular disease (CVD) is caused by atherosclerosis of the artery and is classified into coronary artery disease, cerebrovascular disease, and peripheral arterial disease, depending on the location of the artery and the target organs. However, since CVD share a similar pathophysiology and the probability of incidence of other CVD in CVD patients is very high. It is thought that CVD incidence and mortality can be reduced by predicting the degree of incidence of other CVD in CVD patients. The aim of this study is to investigate the incidence and mortality of other CVD diseases in CVD patients.


Eligibility Criteria:
Inclusion Criteria:

* Koreans who diagnosed with coronary artery disease between 2009 and 2018
* Koreans who diagnosed with peripheral artery disease between 2009 and 2018
* Koreans who diagnosed with cerebrovascular disease between 2009 and 2018
* more than 18 years old

Exclusion Criteria:

* less than 18 years old
Effect of Magnesium Supplementation on Elevated Systolic Blood Pressure

The purpose of this study is to assess whether 480 mg/day magnesium glycinate supplementation for 12 weeks lowers blood pressure.

This clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure in 120 adults aged 30-74 who have a systolic blood pressure of 130-154 mmHg.

Eligibility to participate in the trial will be determined by a 2-stage screening process. Interested participants will complete a pre-screening form online. If eligibility criteria are met, the potential participants will be scheduled for an in-person screening clinic visit. At the visit, eligible participants will be reminded about the study details and potential risks and will be given the opportunity to sign the Informed Consent. Consented participants will be assigned by chance (like a coin toss) to daily magnesium or to placebo. Participants will take 4 study capsules per day (2 capsules in the morning and 2 capsules in the evening) for 12 weeks.

Assessments at the screening visit include seated blood pressure; pulse; weight, height, waist and hip circumference measurements; fasting blood and urine collection; and health and diet questionnaires. Participants will return for a clinic visit at 12 weeks to assess these measures.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of systolic blood pressure 125-159 mmHg
* Measured seated systolic blood pressure 130-159 mmHg at screening visit
* Body mass index less than 40 kg/m2
* Total magnesium intake from supplements of no more than 100 mg/day
* Willing to maintain current diet and supplement use patterns during the 12-week intervention period

Exclusion Criteria:

* Measured seated diastolic blood pressure 100 mmHg or greater at screening visit
* Antacid or laxative use 4 times/week or more within the past 3 months
* History of cardiovascular disease (myocardial infarction, stroke, revascularization \[coronary artery bypass graft or percutaneous transluminal coronary angioplasty\], or angina pectoris)
* History of invasive cancer diagnosed within the last 5 years (non-melanoma skin cancer permitted)
* History of type 1 or 2 diabetes
* History of renal disease
* History of kidney failure
* History of dialysis
* History of pancreatitis
* History of inflammatory bowel disease
* History of hypermagnesemia
* Women who are pregnant, nursing, or intend to become pregnant during the period of treatment
* Plan to relocate out of Boston area within the next year
* Unwillingness and/or inability to swallow 4 pills per day
* Inability to provide written informed consent
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants

prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines

Exclusion Criteria:

* Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections
Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study

FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site.

First primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems

Second primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days and 12 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent about the study
* Elective PCI with following indications:

Stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI

* patient eligible for coronary angiography and both radial and femoral PCI
* requirement of using a vascular closure device (without contraindications)

Exclusion Criteria:

* inability to understand and sign the informed consent term
* pregnancy
* less 18 years of age
* single diagnostic coronary angiography
* active or high bleeding risk (thrombocytopenia \<50,000/µl)
* femoral approach and PCI without using a vascular closure device
* other conditions hampering involvement in the study
Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias

The investigation of biomarkers for immune status and metabolic state, as well as host microbiota composition, in patients with ventricular arrhythmias before and after radiofrequency ablation, can provide new insights for specific and personalized treatment. This can help establish early prediction and prognosis models and provide a basis for clinically effective diagnosis and treatment.

Abnormal immune and metabolic states can lead to the occurrence of various systemic diseases, including the development of cardiovascular diseases through multiple mechanisms. On the other hand, various diseases can also feedback and regulate the immune and metabolic systems. However, currently there is no research on the impact of immune and metabolic states on ventricular arrhythmia. Exploring the biomarker characteristics and risk stratification of patients with ventricular arrhythmias undergoing radiofrequency ablation before and after the procedure can provide new insights for specific and personalized treatment. It can establish early prediction and prognostic models, providing evidence for clinically effective diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ventricular premature beats, ventricular tachycardia, or ventricular fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.

Exclusion Criteria:

* Age \<18 or \>80 years old;
* Patients with autoimmune diseases or immune deficiencies, or those who have used immunosuppressive or immune modulating agents in the past 3 months;
* Platelet count \<100×10\^9/L or functional platelet defects;
* Congenital or acquired coagulation or bleeding disorders;
* Patients with a history of organ transplantation or are preparing to receive organ transplantation;
* Unwilling to sign an informed consent or cooperate with the examination.
Video-Assisted Training in the Intensive Care Process Focuses on the Intensive Care Experiences of Patients Who Will Undergo Open Heart Surgery and Effect on Anxiety Levels

The study will consist of experimental and control groups. Patients in the experimental group will be administered the Patient Introduction Form, Intensive Care Experience Scale and State Anxiety Scales before surgery. Then, video-supported training will be given about the intensive care process, and the State Anxiety Scale and Intensive Care Experience Scales will be re-administered to the patients 24 hours after the surgery. These scales will be administered to the patients in the control group without video-supported training. No intervention other than standard nursing care will be given to patients.

The study will consist of experimental and control groups. Patients in the experimental group will be administered the Patient Introduction Form, Intensive Care Experience Scale and State Anxiety Scales before surgery. Then, video-supported training will be given about the intensive care process, and the State Anxiety Scale and Intensive Care Experience Scales will be re-administered to the patients 24 hours after the surgery. These scales will be administered to the patients in the control group without video-supported training. No intervention other than standard nursing care will be given to patients. The study will have a sample size of 62: 31 experimental and 31 control groups.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-75,
* Those who agree to participate in the research and volunteer,
* No communication problems,
* Cognitive level scales are suitable for application,
* Patients without vision and hearing problems were included in the study.

Exclusion Criteria:

* Leaving work voluntarily,
* Patients whose cognitive level scales were not suitable for application were excluded from the study.
Blood Flow Restriction Exercise-induced Hypoalgesia

The goal of this crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (EIH) between isometric exercise with blood flow restriction (BFR) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. It is presumed that the addition of BFR to isometric exercises induces a greater effect in EIH.

Patients who agree to participate in this research will be randomly assigned to two intervention sequences (AB or BA), where intervention A (experimental) corresponds to isometric exercises with BFR, and intervention B (control) corresponds to isometric exercises alone. For one week, each participant attended two sessions, separated by a 72-hours wash-out period. The primary variables will be the pressure pain threshold (PPT) and conditioned pain modulation (CPM). Secondary variables will be the pain intensity and distribution, kinesiophobia, upper extremity disability, and quality of life. Results will be measured before intervention (T1, pre-intervention), immediate after intervention (T2, post-intervention 1) and 10 minutes after intervention (T3, post-intervention 2).


Eligibility Criteria:
Inclusion Criteria:

* Age between 40-65 years.
* Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging.
* Undergoing arthroscopic rotator cuff repair
* Be able to read and understand Spanish.

Exclusion Criteria:

* Massive irreparable RC tears, concomitant fracture, labral or nerve injury.
* Suspicion of developing/diagnosis a frozen shoulder.
* Revision surgery after RC repair.
* Previous corticosteroid injection (\< 1 year).
* Recent surgery (\< 1 year) in the contralateral shoulder.
* A history of deep venous thrombosis/pulmonary embolism.
* Peripheral vascular disease, thrombophilia or clotting disorders.
* Severe or uncontrolled hypertension, or any comorbid condition that prevents participants from complete the intervention.
Auto-immune Diseases and Quality of Life

Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM) are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for 100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases and require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM on the everyday life of patients are heavy, and notably linked to skin involvement, to diminished functional capacities and psychological problems. The vast majority of these diseases concern middle-aged, professionally-active individuals, for whom the socio-professional repercussions are major and too often neglected. The aim of this study is to analyse the consequences of auto-immune diseases on quality of life. Current quality of life questionnaires are not suitable, and do not reveal the reality of the situation and its different nuances. In this research, the quality of life of patients will be envisaged through their everyday lives. How do these patients construct the social reality of the disease? How do they perceive their health status and their social situation? How do they organize their everyday lives around the disease: work, leisure, relationships with their entourage... ?


Eligibility Criteria:
Inclusion Criteria:

* For all patients:
* Patients aged 18 to 75 years
* Patients able to understand written and spoken French
* Patients who have been given oral and written information about the research

For patients with SLE:

- SLE defined by American College of Rheumatology (ACR) 1997 criteria

For patients with systemic sclerosis:

- SSc according to the Leroy or American Rheumatism Association (ARA) criteria

For patients with IM:

- IM according to the Trojanov criteria

Exclusion Criteria:

* Refusal to take part in the study
* Cognitive/psychological status incompatible with interviews