cyrilzakka/clinical-trials huggingface dataset:
Effect of Ketamine on BIS Values

Aim of this trial is to define if Concentration at the effector site (Ce) of Ketamine, calculated with DOMINO model infusion pump are correlated with Bispectral Index BIS values during general anaesthesia for breast surgery.

Correlation between Concentration at the effector site (Ce) of Ketamine and Bispectral Index (BIS) values during general anaesthesia for breast surgery has not been defined yet.

We want to analyze this correlation during general anaesthesia conducted using Propofol, ketamine and remifentanil. All of these drugs will be delivered with Targeted-ControlledInfusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil and Domino for Ketamine).

Eligibility Criteria:
Inclusion Criteria:

* Undergo gneral anaesthsia with Targted Controlld Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model)

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Benzodiazepiones absuntion
* Obesity
Observational Study of Patients with Advanced Melanoma (skin Cancer) to Assess If IOpener®-melanoma Test Can Predict Response to Immunotherapy.

The goal of this observational study is to assess whether the IOpener® melanoma test can assist treating physicians in deciding which therapy is most suitable for patients with skin cancer (advanced cutaneous melanoma). For this purpose it is evaluated how well the IOpener-melanoma test can predict the result of cancer treatment in the treatment groups (standard of care anti-PD1 mono-therapy and standard of care anti-PD1 + anti-CTLA-4 therapy).

Participants will be asked to provide blood sample for analysis using IOpener®-melanoma test. Patients will receive regular medical care, the test results will not be used to make any treatment decisions. The patients will visit the clinic for treatment administration and clinical evaluation as part of their regular medical care.


Eligibility Criteria:
Inclusion Criteria:

* First line treatment for unresectable stage III or IV cutaneous melanoma (according to AJCC version 8) with anti-PD1 monotherapy (nivolumab or pembrolizumab) or anti-PD1 + anti-CTL4A combination therapy (nivolumab and ipilimumab).
* Anticipated life expectancy exceeding 3 months.
* Aged 18 years or older and able to provide written informed consent.

Patients who have completed adjuvant treatment with anti-PD1 immunotherapy at least 6 months ago can be included.

Exclusion Criteria:

* Prior treatment for irresectable stage III or stage IV melanoma with BRAF/MEK inhibitors.
* Presence of progressive/symptomatic brain metastases at baseline.
* WHO performance score ≥ 2.
* Adjuvant treatment with anti-PD1 immunotherapy received within the last 6 months.
* Patients undergoing experimental treatments or therapies.
* Presence of any medical or other condition that in the opinion of the investigator(s) would preclude the participation in a clinical study.
* Unwillingness or inability to comply with study and follow-up procedures.
Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

Incomplete resection of endometriosis lesions often results in recurrence of symptoms and the need for repeated surgery, with considerable associated morbidity. The aim of this pilot project is to determine the feasibility of fluorescence imaging to improve the treatment of endometriosis in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Females aged ≥ 18 years
2. Scheduled for surgery for the treatment of endometriosis
3. WHO performance score of 0-2
4. Written informed consent

   For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
5. A negative serum pregnancy test prior to receiving the tracer
6. Willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter.

Exclusion Criteria:

1. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
2. Pregnancy
3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
4. Significant renal, cardiac, or pulmonary disease (ASA III-IV)
Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation

NeoTapAdvancedSupport (NeoTapAS) is a free-of-charge mobile application that showed good accuracy in HR estimation. This study aims to evaluate the impact of NeoTapAS on timing of HR communication and of resuscitation interventions in a high fidelity simulation scenario.

Assessing the HR by auscultation can be limited due to imprecise auscultation and/or errors in mental computation, leading to inappropriate or delayed resuscitation. Previous studies evaluated a free-of-charge mobile application (NeoTapAdvancedSupport, NeoTapAS) to help HR assessment in a simulated scenario of neonatal resuscitation. NeoTapAS showed good accuracy in estimating HR and could be a useful tool in resource-constrained settings.

Another potential advantage of using NeoTapAS may be the anticipation of HR communication during resuscitation, because it avoids mental computation and possible errors due to the stressful situation. In addition, prompt HR assessment may lead to anticipating resuscitation interventions. However, these hypotheses remain to be demonstrated.

The aim of this study is to evaluate the promptness in HR communication using NeoTapAS compared with mental computation in a high-fidelity simulated newborn resuscitation scenario. In addition, the impact of NeoTapAS on timing of resuscitation procedures will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric residents from third to fifth year of residency of the University of Piemonte Orientale who were trained on neonatal resuscitation

Exclusion Criteria:

* Lack of EC approval
* Lack of consent to record the scenario and to use the data
The Effect of Dexamethasone Administration Route in PENG Block for Pediatric Hip Surgery

This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain, inflammatory response, and neuromonitoring parameters in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate pain scale at multiple time intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time to first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric hip surgery.

Pediatric hip surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes. The pericapsular nerve group (PENG) block is a regional anesthesia technique that offers targeted analgesia for hip procedures while preserving motor function, making it particularly suitable for pediatric patients.

Dexamethasone is commonly used as an adjuvant in regional anesthesia to prolong analgesia and mitigate inflammation. However, the optimal administration route of dexamethasone in the context of PENG block for pediatric hip surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses.

This prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the PENG block. All patients will receive standardized general anesthesia and PENG block using a local anesthetic at a fixed concentration.

The primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels. The study will also monitor neuromonitoring parameters during surgery to ensure patient safety and evaluate the influence of dexamethasone on neurological outcomes.

Safety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.

Eligibility Criteria:
Inclusion Criteria:

* children scheduled for hip surgery
* body weight \> 5kg

Exclusion Criteria:

* infection at the site of the regional block,
* coagulation disorders,
* immunodeficiency,
* American Society of Anesthesiologists (ASA) physical status of IV or higher,
* history of regular steroid medication.
The Effect of Nursing Care Program on Women With Endometriosis

This study was carried out to determine the effect of the endometriosis nursing care program (ENCP) given to women with endometriosis in line with the Health Promotion Model, on the quality of life and healthy lifestyle behaviors of women.

This experimental study, which was conducted in a single-blind, with control group, prospective, randomized type in the first test-post-test order, was carried out in the endometriosis polyclinic of Istanbul Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital.

In the preliminary evaluation, 46 women with Endometriosis Health Profile Questionnaire-5 (EHP-5) scores of 22 and above (50 and above in the 100 system) constituted the sample of the study, including 23 intervention and 23 control groups. While the Nursing Care Program for Women with Endometriosis (NCPE) was applied to the intervention group, only routine care was applied to the control group. Introductory Information Form, EHP-5, Healthy Lifestyle Behaviors Scale II (HLBSII), and Satisfaction Questionnaire for NCPE were used as data collection forms in the study.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with endometriosis,
* Being in the reproductive period,
* No communication barrier,
* Not having been diagnosed with a psychiatric illness,

Exclusion Criteria:

* Getting pregnant during the study,
* It was determined as wanting to leave the study,
Frozen Embryo Donation Study

The purpose of this study is to improve patient understanding of and interest in donating frozen embryos resulting from in vitro fertilization (IVF) to others undergoing infertility treatment.

The first phase of this study involves the mailing of a survey to current Boston IVF patients who have embryos frozen in storage. A survey will be sent to these individuals to assess their knowledge and understanding of frozen embryos and if they would be interested in embryo donation.

The second phase of research will randomize these patients into two groups: control and intervention. The control groups will receive their standard of treatment regarding frozen embryos, which consists of receiving a yearly storage bill. The intervention group will receive a letter from their physician of record and a follow up phone call from a research assistant offering the opportunity to schedule a consult with a licensed social worker at Boston IVF. The consult is meant to serve as a chance to discuss the difficult decision around embryo disposition. The consult for these patient will be free of charge, covered with funds from our grant. Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered. These enhanced services will also be free of charge to subjects.

The third phase of the study includes the mailing of a letter to a random sample of patients with embryos frozen in storage at Boston IVF. This letter will be an invitation to contact Boston IVF to schedule a consult with a licensed social worker to discuss embryo disposition options. The consult for these patient will be free of charge, covered with funds from our grant.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Boston IVF with embryos frozen in storage
A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)

As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine management of patients with von Willebrand disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and non-experimental. During the observation period, the routine medical care of the patient will be documented.

It is expected that there will be no difference in the safety and tolerability of Humate-P® ivr compared to Humate-P®


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of any age;
* Patients who are suffering with von Willebrand disease previously treated with Humate-P®;
* Patients who are able to communicate well with the Investigator and his/her representatives;
* Patients who are able and agreeing to comply with all study requirements;
* Patients who have provided written signed and dated informed consent prior to any study procedures being performed.

Exclusion Criteria:

* Patients who have received any investigational drug ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
Benefits of Assistive Listening Device for Speech Intelligibility

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.


Eligibility Criteria:
Inclusion Criteria:

* adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
* experienced hearing aid users
* symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
* good written and spoken English language skills
* healthy outer ear as confirmed by otoscopy

Exclusion Criteria:

* contradictions to medical device noted upon otoscopy
* known hypersensitivity or allergy to materials of investigational device or comparator
* inability to produce reliable test results
* known psychological problems
* self reported symptoms of dizziness or vertigo
The Role of Systemic Immuno-inflammatory Factors in Resectable Pancreatic Adenocarcinoma

Pancreatic cancer is a highly aggressive malignancy, its prognosis remaining poor despite the current advances in treatment. Systemic inflammatory reaction has been recently recognized as an important factor in the progression of cancer. The immune-inflammatory response has been measured through different scores or ratios, that combine the values of circulating immune cells, like neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), systemic immune-inflammation index (SII), prognostic nutritional index (PNI). The utility of these scores in different types of cancer has been more and more discussed. In pancreatic cancer, there has been no definite conclusion regarding the role of systemic immune-inflammatory factors; since controversies still exist, a deeper exploration of this subject, through more studies is welcomed. Our study intends to analyze the utility of systemic immune-inflammatory markers in resectable pancreatic cancer.

Our study is an observational cohort study, with retrospective data collection; it is a single-center study, that takes place in a hospital with experience in hepato-bilio-pancreatic surgery. The investigators intended to evaluate the role of the circulating immune cells (neutrophils, lymphocytes, monocytes) and different immune-inflammatory scores (NLR, LMR, PLR, SII, PNI) in predicting the overall survival of patients diagnosed with pancreatic ductal adenocarcinoma, that undergo curative surgical treatment. The investigators intended to assess the prognosis power of these factors in both preoperative and postoperative settings, as well as their dynamic after surgery. Through this study, the investigators hope to identify easy-to determine and easy-to-use markers that can be incorporated in clinical practice and that can effectively predict survival in pancreatic cancer patients. Nonetheless, the investigators want to explore the dynamic of the immune-inflammatory markers after curative surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pancreatic ductal adenocarcinoma
* Curative surgical procedure

Exclusion Criteria:

* Other histopathological types of pancreatic malignancies
* Palliative surgical interventions
* Incomplete/ insufficient data
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections

The presence of S aureus in the nasal passages of diabetic patients may be a risk factor for diabetic foot lesion infections. Our aim is to compare the genetic profiles of S aureus strains found in the noses and on the foot lesions of diabetic patients. The investigators are also studying the virulence of these strains, the prevalance of S aureus at either site, and whether or not the quantity of S aureus found in the nose affects the risk for infection in foot lesions. The investigators also use this study to test the sensitivity and specificity of the GeneXpert system.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetic patients
* Patients consulting or hospitalized in the Diabetology departments of one of the participating centers
* Grade 2-4 ulcer on the foot or ankle (both primo and recurrent events are acceptable)

Exclusion Criteria:

* Patient refuses to participate
* Pregnant, parturient or breastfeeding women
* Patient does not have diabetic foot or arteritic
* Diabetic ulcer is located elsewhere than the foot or ankle
* The ulcer is non-swabbable
* Patient does not have social-security coverage
* Patient is under any type of guardianship
Impact of Multi-Component Interventions on High-Risk COPD Smokers

Study Participants: In our study, we focus on smokers who self-report a "current smoking" status or smoking cessation less than 6 months. This trial is a sub-trial of "Impact of Multi-Component Interventions on a High-Risk COPD population" (Protocol ID: CAMS\&PUMC-IEC-2024-040). All smokers in this trial are either from the high-risk COPD population (defined by COPD-SQ score≥16) .

Intervention: For study participants in the intervention arm, we will ask them to finish an online COPD-SQ questionnaire with notification of his or her COPD high risk. For those whose score of COPD-SQ ≥ 16, we will provide a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For smokers in the intervention arm, we provide a digital health intervention program, NicQuit, to whom could familiarly use intelligent mobile phones, and health education for all smokers. We also provide community-based spirometry pulmonary function test (PFT) and education to smokers. If smokers whose post-bronchodilator FEV1/FVC\<0.7, they will be spirometry-defined COPD patients and will be encouraged to seek treatment and medication to the superior hospitals. Additionally, we provide (1) another digital health intervention programs to smokers with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12.

Comparison: Those who are assigned in the control arm, we will ask them to finish the same COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Outcomes: The primary outcomes are self-reported average number of cigarettes consumed per day, smoking dependence index, and CO measurement.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35 and above;
* High-risk COPD population defined by the score of COPD-SQ ≥ 16;
* Self-report currently smoking or smoking cessation less than 6 month;
* Local residents who stay within a township in the previous 3 months and plan to stay within the same township for the next 12 months.

Exclusion Criteria:

* Those who suffer from severe cognitive disorder or total loss of ability of daily living.
Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED)

This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Prior histologic confirmation of non-small cell lung cancer (NSCLC).
* Optional: NSCLC histologic confirmation of metastasis of NSCLC.
* Presence of unidimensionally measurable disease in the brain.
* No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
* Age: \>18 years.
* Subjects must not have systemic disease that in the opinion of the investigator is in immediate need of chemotherapy
* Karnofsky Performance status \>=70%.
* Absolute neutrophil count (ANC) \>1,500/mm\^3, platelets \>100,000/mm\^3, hemoglobin \>8 g/dL.
* Serum creatinine and bilirubin \<1.5 times upper normal limit of testing laboratory.
* Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) \<3 times upper limit of testing laboratory.
* Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable.
* Prior neurosurgery \>2 weeks from initiating treatment with temozolomide.
* Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with temozolomide.
* Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception.
* Written informed consent.

Exclusion Criteria:

* Chemotherapy or biologic therapy within four weeks prior to initiating therapy with temozolomide.
* Prior radiation therapy for brain \<4 weeks from initiating therapy with temozolomide.
* Surgery within two weeks prior to temozolomide administration.
* Recursive Partitioning Analysis (RPA) class III
* Patients with a single brain metastasis amenable to radiosurgery of resection
* Known Human Immunodeficiency Virus (HIV) disease.
* Acute infection requiring intravenous antibiotics.
* Any reason making compliance to the protocol improbable.