cyrilzakka/clinical-trials huggingface dataset:
Using Eye Mask and Earplugs on Prevention of Delirium

This research is planned as a randomized controlled experimental study to examine the effect of using eye mask and earplugs in preventing delirium with evidence-based nonpharmacological nursing interventions in intensive care units.

In the prevention of delirium, the necessity of using a multicomponent, nonpharmacological interventions is emphasized and focused on nursing interventions. In this regard, it is believed that the use of eye mask and ear plugs, which have recently started to take place in the guides, as well as known evidence-based nursing interventions, will provide nurses with power to improve delirium-related outcomes.

The research is expected to consist of intervention and control groups older than 18, volunteering to participate in the research, which the expected length of stay in the ICU more than 24 hours at Başkent University Ankara Hospital. Data will be collected through Patient Information Form, APACHE II, Glasgow Coma Scale, Richmond Sedation Agitation Scale, Nursing-Delirium Screening Scale, Richard-Campbell Sleep Scale and Daily Monitoring Form. In preparation step of the research, nurses will be trained, guidelines are required for nurses, necessary interventions will be planned. At the application stage , after determining the experimental and control groups, eye mask and ear plugs will be given before going to sleep in addition to the patients in the experimental group, before going to sleep, and followed for three days. Also, it will be examined through a semi-structured interview technique for the examination of patients in the experimental group.It is believed that the early diagnosis of delirium, nonpharmacological interventions to be implemented will affect the diagnosis-treatment costs positively by reducing morbidity and mortality rates.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* The expected duration of stay in the intensive care unit is more than 24 hours.
* In the first 24 hours of hospitalization,
* On mechanical ventilation, conscious patients
* Patients who volunteered to participate in the study
* Not using sleeping pills\* \* Prescription drugs (benzodiazepines, nonbenzodiazepines), quetiapine, antihistamines, antidepressants used for their sedative effects

Exclusion Criteria:

* illness
* Suspected or approved drug or alcohol poisoning
* Contraindication to the use of earplugs or eye masks (eg facial trauma or other safety concerns)
* Patients using hearing aids
* Severe neurological deficits defined as coma (Richmond Agitation Sedation Score \<-4 or -5 (deeply sedated and coma) due to cranial trauma, malignancy, anoxic brain injury, or cerebral edema)
* Having a known cognitive disorder (such as dementia, Alzheimer's, psychosis.)
* Patients with a Glasgow coma scale (GCS) of 8 and below
Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture

This study aims to evaluate the safety and efficacy of a three-dimensional navigation intracardiac guidance kit to perform atrial septal puncture in patients requiring catheter ablation, which will be compared with procedures using traditional kit for atrial septal puncture.

Atrial septal puncture has become a key technique in cardiac interventional procedures. Traditional septal punctures are routinely perfomed under two-dimensioanl guidance, whic are likely to be not acurate sometimes.

This study is aimed to study the safety and efficacy of a novel designed three-dimensional navigation Intracardiac guidance kit for atrial septal puncture in patients with atrial fibrillation requiring catheter ablation and to explore the possibility of transseptal without fluoroscopy using the three-dimensional positioning intracardiac guidance.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with atrial fibrillation.
2. Requiring catheter ablation therapy.
3. Voluntarily sign the informed consent.

Exclusion Criteria:

1. Previous atrial septal puncture.
2. Blood clots in the left atrium or left atrial appendage
3. Left atrial mucinous tumor.
4. Atrial septal defect, including previous surgical correction or interventional occlusion.
5. Acute or severe systemic infection.
6. Cardiac function (NYHA classification) Ⅲ-Ⅳ.
7. Contraindications to anticoagulation.
8. Left ventricular ejection fraction \<35%.
9. Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
10. Patients with malignancy with expected survival of less than 1 year.
11. Myocardial infarction or any cardiac intervention or open procedure within the last 3 months
12. Stroke and other cerebrovascular disease or thromboembolic disease within the last 3 months.
13. Participated in clinical trials of other drugs or devices in the past 3 months.
14. Any other condition that the investigator deems inappropriate for participation in this trial.
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room

Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children. The purpose of this study is to determine the efficacy and safety of sodium nitroprusside in children who will be having surgery, and who require blood pressure lowering in order to decrease the amount of blood loss during their surgery.

The trial is a multicenter randomized, double-blind, parallel group, dose-ranging, effect-controlled study examining the effects of sodium nitroprusside in pediatric subjects requiring relative hypotension during a surgical or medical procedure. The goal is to establish the starting and maximum infusion rates that afford optimum blood pressure control in children and a safe dosing regimen in children. The objective is to describe the relationship between the infusion rate of nitroprusside and changes in blood pressure.

The specific aims of this trial are:

1. To define the onset and offset of blood pressure lowering effects of nitroprusside to obtain adequate instructions for dose titration in the pediatric population.
2. To construct a dose-response model that defines the relationship between nitroprusside infusion rate and changes in blood pressure in pediatric subjects.
3. To assess the safety of nitroprusside administration in pediatric subjects requiring controlled reduction of blood pressure.

Eligibility Criteria:
Inclusion Criteria:

Study subjects must meet all of the following criteria:

* Subject is less than 17 years of age
* Neonates must be full-term gestation and have a body weight of at least 2.5 kg
* Subject requires pharmacologically-induced hypotension for acute blood pressure management for surgery or other invasive procedure, e.g., cerebral artery embolization
* Duration of the subject's controlled hypotension is expected to be ≥ 2 hours
* Subject requires general anesthesia with endotracheal intubation
* Subject requires placement of intra-arterial line during the surgical or medical procedure
* The subject's parent or legal guardian gives permission (informed consent) and subject gives assent when appropriate.

Exclusion Criteria:

Subjects will be excluded if any of the following criteria exist:

* Subject has a known allergy to SNP
* Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes
* Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or procedures
* Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
* Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
* Subject is moribund (death likely to occur within 48 hours)
* Subject has a positive result for the urine or serum human chorionic gonadotropin (HCG) test administered at screening.
Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain

Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended.
* Hair that covers the scalp and is at least 1/4 inch in length

Exclusion Criteria:

* Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
* Pre-existing alopecia
* Previous brain radiotherapy
* scalp metastases or scalp wounds
* use of hair dyes
TPN-Induced Hyperglycemia: Impact on Clinical Outcome in Intensive Care Unit (ICU) and Non-ICU Patients

A growing body of evidence suggests hyperglycemia is associated with adverse outcomes in patients with and without diabetes. Observational studies document an association between hyperglycemia and poor clinical outcomes in cardiothoracic surgery, elective surgery, myocardial infarction, stroke. Randomized studies indicate glycemic control is associated with improved outcomes in diabetic patients with critically illness. Hyperglycemia is a recognized and common complication of patients receiving total parenteral nutrition (TPN). Few studies in the literature have looked into the impact of TPN-associated inhospital complications and mortality. Accordingly, this study aims to evaluate the impact of hyperglycemia on clinical outcome (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay, and mortality) in patients receiving TPN. We will perform a retrospective chart review of all patients treated with TPN from 1/01/06 to 12/31/06 at Grady Memorial Hospital. We hypothesize that patients receiving TPN who develop hyperglycemia experience higher morbidity (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay) and mortality compared to TPN patients with euglycemia. The results of this study will help us to formulate a prospective randomized clinical trial on the management of TPN-associated hyperglycemia in hospitalized patients.

This study aims to evaluate the impact of hyperglycemia on clinical outcome (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay, in hospital mortality) in patients receiving total parenteral nutrition. We will perform a retrospective chart review of all patients admitted to the hospital receiving TPN from 1/01/06 to 12/31/06 at Grady Memorial Hospital. The results of this study will help us to formulate a prospective randomized clinical trial on the management of TPN-associated hyperglycemia in hospitalized patients.

Hypotheses:

We hypothesize that patients receiving TPN who develop hyperglycemia experience higher morbidity (infections, systemic sepsis, cardiac complications, acute renal failure, length of stay) and mortality compared to TPN patients with euglycemia.

Specific Aim:

To determine the impact of hyperglycemia on clinical outcome (infection, systemic sepsis, cardiac complications, acute renal failure, length of stay, mortality) in patients receiving total parenteral nutrition.

Eligibility Criteria:
Inclusion Criteria: Perform a retrospective chart analysis of all patients receiving TPN at Grady Memorial Hospital during the period of 1/01/06 to 12/31/06.

Exclusion criteria: None except for charts without adequate data sufficient for chart review.
Acupuncture for Dizziness and Vertigo in Emergency Department

This study was conducted at China Medical University Hospital, Taiwan, between January 2019 and December 2023, with 345 patients diagnosed with dizziness and vertigo (ICD-10 codes R42 and H81). Patients received acupuncture in addition to standard Western medical care. The Visual Analogue Scale (VAS) was used to assess symptom severity before and after the acupuncture intervention. Secondary analyses explored the influence of ICD-10 classification, gender, and seasonality on treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

Patients who were diagnosed as ICD number R42 and H81

Exclusion Criteria:

Patients who were not suitable to accept acupuncture or refused to accept acupuncture
Transcranial Doppler During Liver Transplantation

This is a prospective study that would investigate the transcranial doppler (TCD) changes during the living donor liver transplantation and the association between the TCD changes and the post-transplant neurological complications.

Objectives:

Participants \& Setting:

Intervention \& Measurements:

Sample size:

Eligibility Criteria:
Inclusion Criteria:

* all patients scheduled for living donor liver transplantation for whatever the indication at Gastrointestinal surgery center (GISC)

Exclusion Criteria:

* Patients with coexisting neuropsychiatric or cerebrovascular disorders or those who have a history of head trauma or brain surgery
Postpartum Anemia and Postpartum Depression

Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting women after childbirth. Both disorders have a significant impact on women's health and functional status. Despite common symptoms and characteristics, a link between these entities has not been adequately studied. The objective of this study is to determine whether postpartum anemia is an independent risk factor for the development of postpartum depression. This prospective cohort study will include all women delivered by elective term cesarean delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for assessment of PPD, functional status and lactation will be administered before discharge and at 3 \& 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for correlation with depressive symptoms, functional status and lactation success.


Eligibility Criteria:
Inclusion Criteria:

* Women after term elective cesarean section

Exclusion Criteria:

* age \< 16 years, preterm (\< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy
Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

The aim of this study is to analyze the differential expression of the miR transcriptome in the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each biopsy and the miRNA profiles will be characterized using a dedicated miR array.


Eligibility Criteria:
Inclusion Criteria:

* patient older than 40th, suffering of a C-SCC
* letter of consent signed by the patient
* to be registered to social security

Exclusion Criteria:

* Pregnant women or breastfeeding.
* Small C-SCC (size \< 6mm)
* Allergy to Xylocaine
* All vulnerable (minor, adult guardianship...)
VENOUS: A Translational Study of Enterococcal Bacteremia

The purpose of this study is to assemble a multicenter prospective cohort of patients with enterococcal bloodstream infections (BSIs) to provide data on outcomes of patients with enterococcal BSIs for sample size calculations for future trials, as well as to characterize enterococcal isolates causing BSIs in order to comprehensively dissect the molecular epidemiology of infecting organisms for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient
* ≥1 positive blood culture with Enterococcus spp. (VRE or VSE) during hospitalization
* bacterial isolate(s) is/are available for further characterization
* Repeat blood culture(s) within 7 days from the first positive culture

Exclusion Criteria:

* Cultures obtained from patients not admitted to the hospital
* Isolate(s) not available for further studies.
Sarcopenia in Patients With Gastrointestinal Stromal Tumours

The treatment of advanced gastrointestinal stromal tumours (GIST) has shifted since the arrival of targeted therapies. Imatinib is an active multikinase inhibitor that mainly targets C-kit tyrosine-kinase receptors and the platelet-derived growth factor receptor. Imatinib use has been validated for adjuvant and palliative therapy settings. Imatinib is generally well-tolerated and known to improve performance status but up to 16% grades 3-4 toxicities, leading to at least 40% withdrawals, have been reported.

Recently, in oncology, sarcopenia was shown to be a predictor of severe toxicity patients included in phase 1 trials, suggesting that it should be considered an inclusion criterion for such studies. Sarcopenic patients had low performance status, shorter survival, more chemotherapy toxicities and post-operative infections, and longer post-operative hospitalization times. In addition, exposure to tyrosine-kinase inhibitors (e.g. sorafenib or sunitinib) has been associated with dose-limiting toxicity (DLT) in patients with renal cell or hepatocellular carcinomas.

Computed tomography (CT) scans acquired during routine care have been validated as an accurate and robust imaging technique to evaluate sarcopenia in cancer patients.

Aims of the study were:

* to assess the influence of imatinib on sarcopenia patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST)
* to compare imatinib-induced toxicities between patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) with pre-treatment sarcopenia and patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) without pre-treatment sarcopenia

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST)
* Patients treated with imatinib prescribed at a fixed dose of 400 mg/day from 1 January 2005 to 31 December 2013
* Aged \> 18 years

Exclusion Criteria:

* Patients who did not have CT imaging within the 30 days preceding treatment onset
Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.

The primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in France in two cohorts defined by their treatment initiation period.


Eligibility Criteria:
Inclusion Criteria:

* Any subjects from the participating sites (dead or alive) who have received at least one dose of cabozantinib within the ATU program or between 10/12/2016 and 16/02/2018 and for whom the medical file is available

Exclusion Criteria:

* Patients alive at study initiation who have not received information notice
* who have opposed to data collection.
The Incremental Risk of Intraoperative Fentanyl on PONV

The aim of this quality control study is to describe the presence and intensity of postoperative nausea and vomiting (PONV) and its correlation with intraoperative fentanyl dosing. Additionally, the investigators will examine pain scores.

The primary aims of this quality control study are:

1. to determine whether there is an independent association between the intraoperative administration of fentanyl (both as a continuous and categorical variable) and PONV within 24 postoperative hours
2. determine whether or not the intraoperative fentanyl amount can be used to successfully restratify patients for PONV beyond the simplified Apfel score for PONV

All required data is collected in regular daily practice. The following variables will be assessed by univariable models:

Preoperative variables (e.g. patient characteristics) Surgical/Anesthesia variables (e.g. type/length of surgery, antiemetics) Outcome variables (PONV, worst pain as delineated in the outcomes section), Intraoperative fentanyl measured 1) as a continuous variable and 2) by predefined limits of 0 to 0.2mg, \>0.2-0.5mg, \>0.5 to 0.8mg, and \>8mg.

Finally for the multivariable model, the investigators will adjust for confounders, specifically for sex (m/f), history (Hx) of PONV (y/n), Hx of motion sickness (y/n), current smoker (y/n), age (years), expected duration of surgery (min; \>60 min), postoperative opioids (y/n), the use of preemptive PONV Therapy (0,1,2 medications), propofol vs. inhalative agents (y/n), and surgery type (3 kinds) from the patient's electronic record. In the event that insufficient event rates are observed, we will collapse the variables into the simplified Apfel score to assess the independent value of fentanyl in predicting PONV.

In addition to a logistic model as delineated above, we will conduct the following:

1. receiver operating characteristic (ROC) curves of the logistic model without fentanyl, with fentanyl (continuous), and with fentanyl (categorical).
2. additionally, ROCs of a simplified model using the Apfel score, the Apfel score with fentanyl (continous), and the Apfel score with fentanyl (categorical) will be made. Comparison of area under the receiver operating characteristics(AUROCs) by DeLong
3. net reclassification improvement (NRI) of both the logistic model with and without fentanyl as well as the Apfel score with and without fentanyl

To assess pain and administered fentanyl, we will examine pain scores by the numeric rating scale (NRS).

Eligibility Criteria:
Inclusion Criteria:

* In-patients with an expected simplified Apfel score of 2 or higher,
* Aged \>= 18 years, and
* Undergoing general anesthesia (with or without neuraxial or regional anesthesia.)
* in abdominal, gynecological or otorhinolaryngological surgery

Exclusion Criteria:

* Outpatients
* Patients with chronic pain, defined as recurring pain requiring intermittent hospitalization or regular intake of pain medication.
* Non-opioid naïve patients, defined as a history of abuse or having taken opioids within the last 30 days
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after a bunionectomy.


Eligibility Criteria:
Key Inclusion Criteria:

* Before Surgery:

  * Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)
* After Surgery:

  * Participant is lucid and able to follow commands
  * All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

* Before Surgery:

  * Prior history of bunionectomy or other foot surgery on the index foot
  * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  * Any prior surgery within 1 month before the first study drug
* After Surgery:

  * Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined inclusion/exclusion criteria may apply