cyrilzakka/clinical-trials huggingface dataset:
Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon

Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation.

But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient.

RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.

Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients.

At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI.

The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.

Eligibility Criteria:
Inclusion Criteria:

* Diameter stenosis\>=50% by visual estimation intend to undergo drug-coated balloon implantation
* Target vessel diameter\> 2.5mm

Exclusion Criteria:

* Chronic Total Obstructive lesion
* Diagnose patients with acute myocardial infarction \<24 hours
* Can't tolerate or not suitable for RIPC
* Severe hepatic and renal insufficiency
* Expected survival \<1 year
* Severe calcification needing rotational atherectomy
* Intolerable to dual antiplatelet therapy
Video Based Mindfulness Based Stress Reduction

To evaluate the feasibility of a video based mindfulness intervention for stress reduction and to evaluate the cortisol response in persons with PD and their caregivers. The data from this project will be used for a future grant application of a stress reduction intervention in persons with PD.

Participants will be enrolled at the VA Portland and have a baseline assessment. The baseline will assess neurological disorders (including Parkinsonism) and current stress. All participants will attend 10 weeks of mindfulness based stress reduction (MBSR) through video feed on the Portland VA campus. During the week prior to the first class and the week after the last class, participants will complete questionnaires regarding stress, collect saliva samples, and, for the Parkinson's patient, monitor motor symptoms of PD using diaries and inertial sensors. A final visit will assess stress, neurological diseases, and Parkinsonism.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Some Postural instability
* Tremor in upper limb
* Caregiver willing to also participate

Exclusion Criteria:

* No neurological disease
* Cognitive deficits
* Other neurological/psychological disorder
* Completion of a stress reduction program in the last 12 months
Fast & Fed Pharmacokinetic (PK) Study

The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14 hours).


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory, male and female volunteers between 18 to 55 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2, and a total body weight \> 50 kg (110 lbs);
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator and the Sponsor;
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, NuvaRing®, Depo-Provera®, or double-barrier and have a negative pregnancy test at Screening and Day 0 of each dosing period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy

Exclusion Criteria:

* History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products;
* Females who are pregnant or lactating;
* Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);
* History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding);
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies;
* Positive alcohol or drug test;
* Have taken any medications (except acceptable forms of birth control) within 10 days prior to dosing or throughout the study, unless in the opinion of the Investigator and the Sponsor, the medication will not interfere with the study procedures, data integrity, or compromise the safety of the subject;
* Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment;
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum);
* Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the study;
* Alcoholism or drug abuse within 2 years prior to the Screening Visit;
* Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.
Effects of DASH Diet on Corticosteroids Medication Use

To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.

Objective: To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.

Design: A randomized clinical trial was undertaken in 60 patients on corticosteroid therapy for 10 weeks. Patients were randomly assigned to a DASH or control diet. Fasting blood sample were measured to determine blood glucose and lipid profile. Blood pressure and anthropometric measurements were measured based on the standard guidelines.

Eligibility Criteria:
Inclusion Criteria:

* patients who were on corticosteroid therapy

Exclusion Criteria:

* refuse to follow the visits
Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit

In intensive care unit, patients suffered pain and anxiety from mechanical ventilation, presence of endotracheal tube, central venous catheter, postoperative wound, and invasive procedures. Adequate analgesia and sedation can reduce pain and anxiety. However, traditional sedatives carry the risk of unstable hemodynamic status, respiratory depression, increased mechanical ventilation time, incidence of delirium, and length of ICU stay. Dexmedetomidine is a highly selec¬tive α2-adrenergic receptor agonist which causes sedative effects and reduces opioid requirements in the perioperative period. Memis et al had found that dexmedetomidine may prevent inflammatory effects in sepsis patients during sedation. Oxidative stress status is related to the inflammatory response. Moreover, oxidative stress may result in dysfunction of microcirculation. Dysfunction of microcirculation may cause vasoconstriction or microthrombosis, and it will impair tissue perfusion and result in organ dysfunction. The goal of this study is to compare the effects of dexmedetomidine and midazolam on requirement of analgesics, weaning parameter, hemodynamic status, time of extubation, incidence of delirium, and length of ICU stay, oxidative stress status, and microcirculation.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is older than 18 years old and less than 80 years old
* Patient who is admitted to intensive care unit with artery line
* Patient's hemodynamic status is stable under adequate management and absence of signs of shock
* Patient who has understood the inform consent and agree to participate this study

Exclusion Criteria:

* Patient's hemodynamic status is unstable in spite of adequate management or presence of signs of shock
* Patient who has a past history of allergy to study drugs
* Patient who has renal failure or requires renal replacement therapy
* Patient who has liver cirrhosis or liver failure
* Patient who has participated in any other investigational study of other drugs currently
* Female patient who is pregnant or considers breast feeding currently
A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients

This study will confirm the safety and efficacy of avutometinib in combination with defactinib in Japanese patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

This is a multi-center, open label Phase 2 study designed to evaluate safety and tolerability and confirm efficacy by BICR of avutometinib in combination with defactinib in Japanese patients with molecularly profiled recurrent LGSOC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven LGSOC (ovarian, peritoneal)
* Documented mutational status of KRAS by validated diagnostic test of tumor tissue
* Documented disease progression (radiographic or clinical) or recurrence of LGSOC and have received at least one platinum-based chemotherapy agent
* Measurable disease according to RECIST 1.1
* An Eastern Cooperative Group (ECOG) performance status ≤ 1.
* Adequate organ function
* Adequate recovery from toxicities related to prior treatments
* Agreement to use highly effective method of contraceptive, if necessary

Exclusion Criteria:

* Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
* Co-existing high-grade ovarian cancer or another histology
* History of prior malignancy, excluding ovarian cancer, with recurrence \<3 years from the time of enrollment
* Major surgery within 4 weeks
* Symptomatic brain metastases requiring steroids or other interventions
* Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy
* For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor
* Active skin disorder that has required systemic therapy within the past year
* History of rhabdomyolysis
* Concurrent ocular disorders
* Concurrent heart disease or severe obstructive pulmonary disease
* Patients with the inability to swallow oral medications
Evaluation of the Patient Deterioration Warning System

The overall goal of the project is to reduce the number of unexpected patient deteriorations by 50% at Emergency Departments (ED) by investigating if the novel Patient Deterioration Warning Systems (PDWS), can improve clinicians' ability to identify deterioration at an earlier stage.

A third of all acute medical patients with normal vital signs at arrival, experience a deterioration in vital signs during the 24 first hours. This can potentially lead to dire consequences for these patients, as the risk of deterioration is present across all severity levels. The utilization of patient monitoring systems in the dispersed and shared working environments of EDs and acute wards may help to identify some of the reasons for failure to rescue patients. Thus, quantifying the extent to which a patient is being monitored, may be an aid to bridge the current gap between usage of automated and manual monitoring as clinical work will continue to depend on tacit knowledge and intuition.

Several systems and protocols have been established to swiftly deal with identified deterioration. Most systems struggle with issues of clinical adherence and are difficult to assess on-the-fly, and in some cases nurses failed to notice abnormality in 43% of patients experiencing deterioration. Although the trajectories of patients' vital signs have been identified as more important than the initial scoring value, most of the widely used Track and Trigger systems lack a temporal aspect. Furthermore, a limited number of these Track and Trigger systems have been integrated into real time clinical decision support systems, which has not evolved much in the last decades.

The PDWS deals with these challenges by aggregating and summarizing all vital values measured with the ED's patient monitors in the ongoing admission to intuitively present the state and trajectory. The investigators intend to determine if making the PDWS system available to nurses and physicians throughout the entire ED improves their ability to identify patients at risk of deterioration. To make this assessment, the PDWS will be evaluated in a cluster randomized trial (CRT) at two ED facilities in Denmark. The CRT is structured in three 5-week intervention, and three 5-week control periods, separated by a washout period of at least one week. The primary outcome is in-hospital deterioration - defined as transfer to the intensive care unit, heart/respiratory failure or death. The effect the PDWS will be assessed by comparing the proportions of events in each study arm using Pearsons's chi-squared test on these two samples. Furthermore, the technical and economical effects are evaluated using the Technology Acceptance Model, and the Model for Assessment of Telemedicine.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the emergency department

Exclusion Criteria:

* Critically ill patients who die during their admission
* Orthopedic patients with minor injuries
Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk

A post market clinical follow-up study investigating the safety of Biatain Silicone Sacral while used as prevention in hospital admitted patients at risk of developing a pressure injury.

The investigation was a multi-centre, open label, non-comparative, single-arm, prospective study, conducted at three investigational sites in Danish hospitals. 67 hospital-admitted patients were enrolled in the study over a 3-month recruitment period. The target population were patients ≥18 years of age with an expected hospital-stay of more than 24 hours from baseline and a Braden score of 6-18.

At daily visits skin inspections for signs of non-blanchable erythema or sacral pressure injury were performed by partial lift and reapplication of the dressing. After 7 days, or earlier if the patient was discharged, a termination visit was performed. Skin assessment was performed upon removal of the dressing and a termination form completed. Information regarding adverse events and device deficiencies were collected at all visits.

There were no follow-up visits after termination of the study.

Eligibility Criteria:
Inclusion Criteria:

* Hospital-admitted patients at risk of developing a pressure injury with an expected hospital-stay of more than 24 hours from visit 1
* ≥18 years of age and has full legal capacity
* Has given written consent to participate by signing the Informed Consent signature Form
* Has a Braden score of 6-18 at screening (performed within the last 24 hours)
* Intact sacral skin (non-breached skin, without signs of non-blanchable erythema over bony prominence/pre-existing sacral pressure injury over bony prominence)

Exclusion Criteria:

* Suspected or actual spinal injury precluding the patient from being turned
* Sacral erythema, sacral pressure marks, pre-existing sacral pressure injury
* Trauma to sacrum
* Topical treatment with steroid creme in the sacral area (treatment must have been terminated at least 14 days prior to enrollment)
* Pregnancy or breastfeeding
Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain

Taken together, studies of the value of pre-emptive analgesia are inconclusive. This randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to test that a reduction in post-operative morphine consumption can be achieved by a single-dose of etoricoxib before induction of anesthesia.

Patients undergoing transabdominal hysterectomy were randomized to a group taking a single dose (orally) of etoricoxib 120 mg (n = 18), etoricoxib 180 mg (n = 17) or placebo (n = 15) 2 hours before surgery under the same standardized general anesthesia. At the post-anesthetic care unit, intravenous morphine titration was given before starting self-controlled analgesia (PCA) device. Morphine consumption, pain relief score, sedative score, global evaluation score, and side-effects were recorded at 1, 2, 4, 8 and 24 h post-operatively. The primary end points were morphine consumption within 24-hr post-operatively and total pain relief over 8 h (TOPAR8). Patient global satisfaction was also assessed.

Eligibility Criteria:
Inclusion Criteria:

* The ASA I or II patients undergoing elective transabdominal hysterectomy with general anesthesia

Exclusion Criteria:

* Patients with history of opioid addiction or chronic pain
* Allergy to other nonsteroidal anti-inflammatory, or asthma
* Concomitant use of tricyclic antidepressants, opioid analgesics, antihistamines, tranquilizers, hypnotics, sedatives, or systemic corticosteroids
* Those unable to understand the principle of patient-controlled analgesia(PCA) device were excluded from the study
Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine

The objective is to describe and quantify levels of platelet reactivity in three different cohorts of patients taking thienopyridine: patients who report nuisance bleeding, patients who report alarming bleeding, and patients who report no nuisance or alarming bleeding. The investigators hypothesize that patients with nuisance or alarming bleeding events on maintenance thienopyridine therapy will have lower levels of platelet reactivity than patients without nuisance or alarming bleeding on thienopyridine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older from both genders
* Underwent PCI within the last year
* Taking maintenance dose of clopidogrel 75 mg once a day or prasugrel 10 mg once a day for at least five days

Exclusion Criteria:

* Known allergies to aspirin, clopidogrel, or prasugrel.
* Use of a glycoprotein (GP)IIb/IIIa inhibitor within 8 hours of the blood draw.
* Patient known to be pregnant or lactating
* Patient with known history of anemia, thrombocytopenia, bleeding disorder, or currently active bleeding
* On warfarin therapy at the time of blood draw
* Known blood transfusion within the preceding 10 days of the blood draw
* Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS, not to include aspirin) within the previous 5 days
* Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Assisted Fluid Management IDE Study

The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.

The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.

Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.

Eligibility Criteria:
Inclusion Criteria:

* Be ≥ 18 years of age
* Abdominal, pelvic, major peripheral vascular surgery expected to last \>2 hours post anesthesia induction
* Participate or have authorized representative participate in the Informed Consent process and sign/date the IRB approved informed consent form.

Exclusion Criteria:

* Are \< 18 years of age
* Emergent or cardiovascular surgical procedure
* Are pregnant
* Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Clinical Study)
* Refusal of patient or authorized representative to sign consent
The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure

The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure during general anesthesia.

It is well known that cuff pressure of tracheal tube should not be over 30 cmH2O. Therefore, anesthesiologists usually pay attention to maintain adequate cuff pressure, especially just after completion of tracheal intubation. Recently, esophageal stethoscope is widely used for exact monitoring of patient's body temperature. However, inserting of foreign body in esophagus could affect on the cuff pressure.

The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure.

Eligibility Criteria:
Inclusion Criteria:

* Patient receiving general anesthesia for elective surgery

Exclusion Criteria:

* who doesn't agree to enroll
* who has any clinical disease or history of surgery in esophagus
* who has aspiration tendency
High Voltage Pulsed Current and Microcurrent Stimulation Therapy in Treatment of Wounds.

The purpose of this study is to evaluate the effectiveness of high-voltage pulsed current (HVPC) and microcurrent stimulation therapy (MST) in treating chronic wounds and to compare their effects.

Sixty patients with chronic wounds (pressure ulcers) and their ages will be ranged from 45 to 60 years old. They will be recruited from the outpatient clinic at Kasr Al-Aini Hospitals and they will be randomly assigned into two groups of equal numbers, each one will contain thirty patients. High-voltage pulsed current group and microcurrent stimulation therapy groups. The change in wound surface area and wound volume will be measured before the intervention and after six weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients are of both sexes.
* Subject's age will be from 45 to 60 years.
* All patients will enter the study having their informed consent.
* All patients will be assessed by a physician before starting the study procedure.
* All patients suffer from a chronic wound not healed more than or within six weeks.

Exclusion Criteria:

* Patients with acute wounds.
* Patients with burn wound injuries.
* Malignancy in the wound.
* Necrotic tissue in the wound.