cyrilzakka/clinical-trials huggingface dataset:
The Effects of ESP Block and Mid-Transverse Process to Pleura Block on Postoperative Opioid Consumption and Quality of Recovery

Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) have recently been described for the treatment of pain after lumbar spinal surgery. Although these blocks have been shown to be effective in the treatment of pain after lumbar spinal surgery when compared with postoperative pain, they have not been compared in terms of the quality of recovery and opioid consumption after lumbar spinal surgery.

The aim of this clinical trial is to compare the effects of Erector Spinae Area (ESP) Block and Mid-Transverse Process to Pleura Block(MTP) on quality of recovery and opioid consumption in patients scheduled for lumbar spinal surgery. The effects of the 2 blocks on postoperative pain will also be compared and recorded.


Eligibility Criteria:
Inclusion Criteria:

* Elective Lumbar Spinal surgery performed
* ASA I-III
* 18-75 years old

Exclusion Criteria:

1. Refusal at enrollment
2. Request for withdrawal from the study
3. Inability to give informed consent
4. Emergency surgery
5. Bleeding diathesis
6. Presence of contraindications to the LA agents used in this study
7. Use of chronic opioids
8. Psychiatric disorders
9. Presence of infection at the injection site
Metabolism Evaluation Through Resting Indirect Calorimetry in Bladder Cancer (METRICS)

This study is being done to learn more about energy needs and muscle function during treatment for bladder cancer. These insights can help improve future patient care. The study team found in a previous study that resting energy can be different than what estimates show. Patients with bladder cancer are known to suffer a decline in physical resilience over time. Monitoring patients to understand these changes better could help design future treatments with these vulnerabilities in mind.

The investigators' long-term goal is to improve cachexia treatment for patients with cancer. The project is significant because identifying cachexia earlier in its onset allows for earlier and more successful treatment. Major barriers to early detection and treatment are: 1) clear specific lab tests to confirm the diagnosis and 2) identifying when resting energy expenditure (REE) increases. It is the investigators' expectation that at the completion of these descriptive studies, key factors will be identified to guide earlier detection and treatment of cachexia. Platinum-based chemotherapy and surgery are a dual-phase treatment regimen to treat bladder cancer that has a high risk of worsening cachexia compared to other cancer types not requiring such an intensive treatment regimen. Inhibition of Growth differentiation factor 15 (GDF-15) is a promising preventive strategy against cachexia in patients with bladder cancer. Understanding GDF-15 and REE changes over the course of treatment could inform proactive rather than reactive strategies to support the health of these patients and translate to patients with other types of cancer. The objective of this application is to assess changes in GDF-15 and REE levels during the treatment course for advanced bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed cancer diagnosis
* Scheduled for platinum-based chemotherapy followed by radical cystectomy
* Adequate renal and cardiac function for platinum-based chemotherapy

Exclusion Criteria:

* Prior chemotherapy or radiotherapy for bladder cancer
* Severe cardiac, renal, hepatic, respiratory or metabolic diseases
* Pregnant or breastfeeding
* Uncontrolled conditions that could affect study outcomes
Critical Care Optimized Pediatric and Neonatal Quantitative Neuromonitoring

The detection and appropriate treatment of seizures significantly impact the neurological prognosis of patients in intensive care. Indeed, altered brain function including seizures is described in critically ill children, regardless of the reason for admission. Most seizures are subclinical and therefore impossible to diagnose without neuromonitoring tools. Despite being concidered ad Gold Standard, continuous EEG (cEEG) with video recording shows difficulty of implementation and interpretation at all hours of the day and night explaining that less than 10% of centers in France use cEEG routinely. Most departments prefer simplified techniques, including amplitude traces (aEEG) which can be used continuously at the bedside. However, the positive predictive value of aEEG in the detection of seizures does not exceed 78% and 64% in newborns and children respectively making necessary an optimization of the information provided by these techniques.

This project is a pragmatic diagnostic study that aims at developing and evaluating a neuromonitoring interface adapted to the needs of pediatric and neonatal intensive care units and meeting the requirements of neurophysiologists in terms of EEG trace quality.

This research will take place in three phases :

1. Parameterization of the interface, which will display an 8-channel aEEG trace associated with reading aids (CDSA and automated seizure detection) available to the clinician.
2. Teams' training regarding the placement of additional electrodes and the use of reading aid tools.
3. Patient's inclusion. The obtained traces will be accessible at any time for direct interpretation and can be read on demand by a neurophysiologist during office hours.

Post-hoc review of the entire EEG trace by an expert in pediatric EEG, blinded to the interpretation made at the bedside (gold standard).

Research hypothesis is that continuous neuromonitoring combining optimized quantitative EEG techniques and targeted advice from a neurophysiologist would allow the detection of a majority of seizure events requiring treatment and background trace abnormalities associated with critical encephalopathy.

Eligibility Criteria:
Inclusion Criteria :

* Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring. The same patient may be included multiple times.
* Written non-opposition from legal representatives.
* Patients affiliated with or beneficiaries of a social security or similar scheme (CMU).

Exclusion Criteria :

* Parents who do not understand French.
* Inability to set up monitoring equipment (neurosurgery preventing access to electrode placement sites).
* Corrected age \< 37 weeks of gestation (GA) for preterm infants.
Exploring Neurophysiological Markers of Brain Health

The combination of transcranial magnetic stimulation (TMS) and electroencephalography (EEG) has been suggested as a promising brain imaging tool for identifying biomarkers of brain health.

In this pilot study, study investigators will explore the neurophysiological metrics of brain health with a non-invasive brain imaging technique, alongside behavioral and fMRI metrics collected through another study (NCT04869111).

The Direct Electro-Physiological Imaging medical device (Delphi-MD), developed by QuantalX Neuroscience, combines both TMS and EEG technologies. This is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in participants, and the EEG device records brain electrophysiological response to the stimulation.

Recruitment for this pilot study will be restricted to participants in the imaging cohort of a separate study, The BrainHealth Project (NCT04869111). As that cohort is already completing behavioral and fMRI metrics, this exploratory study would allow study investigators to examine relevant associations between those metrics with the neurophysiological metrics from the Delphi device.

Study participants will complete two in-person sessions with the Delphi-MD device that align with their pre-scheduled imaging appointments.

Eligibility Criteria:
Inclusion Criteria:

* Must be an active brain imaging participant in The BrainHealth Project (NCT04869111)
* Minimum age of 22
* Fluent in English
* Able to read \& hear information over a computer
* Must pass an MRI safety screener to assess the presence of contraindicators for MRI compatibility (i.e., non-removable metal within/on the body, claustrophobia, pregnancy, non-correctable vision problems, head trauma, and CNS disease)or other standard requirements as determined by the Imaging Center.
* Must pass a modified TMS Adult Safety Screen
* Meet all criteria for study as determined by the study physician

Exclusion Criteria:

* A diagnosis of a neurodegenerative disease
* A history of stroke, concussion, or brain injury that currently hinders them from functioning at their prior level
* A diagnosis of autism spectrum disorder that currently hinders them from functioning independently.
* Metallic brain implants or fragments (like a shunt, pacemaker, clips, coils, bullet fragments, cochlear implants)
* Magnetically activated implants or electronically implanted devices
* Medication pumps
* Personal or family history of epilepsy, seizure(s), seizure disorder.
* History of, or risk factors for syncope (fainting)
* Report significant cognitive challenges
* Report untreated health issues (like substance abuse, hypertension, hypo- or hyper-thyroidism)
* Have claustrophobia
Neuromodulation Parameter Efficacy

The objective of this study is to determine the efficacy of neuromodulation using various stimulation paradigms in the treatment of several disorders including chronic pain.

Different stimulation parameters will be tried in a blinded fashion to compare efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for, and have been consented for, implantation of a neuromodulation device.

Exclusion Criteria:

* Non-English speaking
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis

This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This study will test the hypothesis that the wet weight of sputum expectorated is greater following the use of Aerosure than following the use of a sham Aerosure device.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CF (established by genotype or sweat sodium \>70mmol/l or sweat chloride of \>60 mmol/l
* Admitted to King's College Hospital within 48 hours of an acute infective pulmonary exacerbation characterised by an increase in respiratory symptoms requiring intravenous antibiotics

Exclusion Criteria:

* Acute respiratory failure
* Haemodynamic instability (including severe right heart failure with hypotension)
* Current severe haemoptysis
* Ineffective cough
* Rib fractures
* Pregnancy
* Current or recent pneumothorax
* Epilepsy
* Current pulmonary embolism
* Oesophageal varices
* Recent thoracic upper gastro-intestinal tract or facial surgery
* Active tuberculosis
* Recent brain, eye, ear, ENT surgery
* Myocardial infarction
* Ascending aortic aneurysm
* Acute diarrhoea
* Pulmonary embolism
* Angina
* Severe hypertension (systolic \>200 mm Hg, diastolic \>120 mm Hg)
* Confusion/dementia
* Inability to give consent
Preconception and Pregnancy Obesity Treatment and Prevention Among Women With a History of Depression

The purpose of the Preconception and Pregnancy Obesity Treatment and Prevention Among Women with A History of Depression preliminary study is to provide a lifestyle intervention for women with a history of depression who are trying to conceive or are pregnant in order to prevent excessive pre-pregnancy weights, avoid excessive gestational weight gain, and to improve other markers of metabolic health. The treatment program consists of 10 private sessions with a trained clinician at no cost to participants.

The investigators are evaluating a new lifestyle intervention to help women with a history of depression who are pregnant or trying to conceive to learn to exercise, eat well, and live a healthy lifestyle. They are interested in examining if this therapy-based program can positively impact eating and exercising habits and see if the treatment is enjoyable. All participants will receive this intervention.

Eligibility Criteria:
Inclusion Criteria:

* History of depression
* Pregnant in first trimester or planning to become pregnant within next year
* Ability to give informed consent
* Age \> or = 18 and \< 45 years
* Overweight or obese (Body mass index \> 25 kg/m\^2)

Exclusion Criteria:

* Unwilling/unable to comply with study procedures
* Endorsed item on the Physical Activity Readiness Questionnaire (PAR-Q)
* Diagnosis of anorexia nervosa or bulimia nervosa in the past month
* Diagnosis of substance dependence in the past month
* Active suicidality (Montgomery Asberg Depression Rating Scale (MADRS) item 10 score \> 4)
* Exercising regularly (i.e., 5 days per week for 30 min)
* Neurologic disorder or history of head trauma
* Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries, contraindications to exercise for pregnant women)
IFM 99-02 Thalidomide in Myeloma

Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma


Eligibility Criteria:
Inclusion Criteria:

* de novo myeloma
* according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
* patients from 18 to 65 years old
* beta2microglobulin \< 3 mg/l or del13 absent
* signed informed consent
* eligible for transplantation

Exclusion Criteria:

* peripheral neurological toxicities
* uncontrolled or severe cardiovascular disease
* other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
* patient who received biphosphonate during the last 60 days
* renal failure definited as creatinine \> 150 µmol/l
* patient with obvious vascular cerebral medical history
* liver dysfunction definited as bilirubin \> 35 µmol/l or ASAT, ALAT, PAL \> 4N
* respiratory dysfunction
* HIV +
* Patient who refused to use an acceptable barrier method for contraception
Study of KRN951 in Patients With Solid Tumors

The purpose of this study is to assess the safety and tolerability of KRN951 administered to patients with solid tumors. In the single dose period, patients in each cohort will receive one oral dose of KRN951 in the first day, followed by a 6-day rest period during which no treatment is received. After that, patients in each cohort will receive one oral dose of KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no treatment is received. Treatment will be continued in the absence of disease progression or unacceptable adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Solid tumors to be unresponsive to, or untreatable by standard therapies
* ≥ three-month life expectancy
* Eastern Cooperative Oncology Group Performance Status score of 0, 1 or 2

Exclusion Criteria:

* Hematologic abnormality
* Myocardial infarction or clinically symptomatic left ventricular failure
* Active hypertension or controllable hypertension more than 3 antihypertensive medications
* Symptomatic CNS metastasis
* Unhealed wounds
* Active infections
* Hepatic or renal functional disorder
* Any of the HBs antigen, HCV antibody and HIV antibody positivity
* Prior use of any chemotherapy, radiotherapy, immunotherapy or surgery within four weeks previous to first dose of study drug
* Pregnant or lactating women
* Women of childbearing potential and fertile men, unless willing to use adequate contraceptive protection
Graves' Orbitopathy and Hypercholesterolemia

The investigators have recently observed retrospectively that the occurrence of Graves' Orbitopathy in patients with Graves' disease is less frequent in patients with normal cholesterol levels, in line with another recent observation suggesting that statins play a protective role in Graves' patients from developing Graves' Orbitopathy. The present study is designed in order to investigate the possible association between Graves' Orbitopathy and high cholesterol level as well as the relation between Graves' Orbitopathy degree and high cholesterol level


Eligibility Criteria:
Inclusion Criteria:

1. Graves' disease with Graves' Orbitopathy
2. Graves' disease without Graves' Orbitopathy

Exclusion Criteria:

1. Previous treatment with radioiodine
2. Previous treatment with thyroidectomy
Heavy Metal Exposure in Predicting Peripheral Neuropathy in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy

This research trial studies heavy metal exposure in predicting peripheral neuropathy in patients with stage I-III breast cancer undergoing chemotherapy. Studying samples of blood and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may help doctors find out whether side effects from chemotherapy are related to heavy metal exposure.

PRIMARY OBJECTIVES:

I. To describe the correlation, if any, of specific heavy metals with high grade symptoms of peripheral neuropathy, defined as grade \>= 3 peripheral neuropathy, (utilizing the Common Terminology Criterial for Adverse Events \[CTCAE\] version \[v.\] 4.0) in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy.

SECONDARY OBJECTIVES:

I. To characterize the range of specific heavy metals in a cohort of breast cancer patients undergoing (neo)adjuvant chemotherapy treatment.

II. To evaluate the reproducibility of sera and urine testing of heavy metal levels by inductively coupled plasma mass spectrometry (ICP-MS) testing in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy.

OUTLINE:

Patients undergo serum and urine sample collection for heavy metal analysis by ICP-MS at baseline and at the completion of treatment. Patients also complete neurotoxicity assessment questionnaire at baseline and at the completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed invasive mammary carcinoma; any histologic sub-type allowed
* Patients must be diagnosed with stage I, II or III breast cancer
* Patients must be undergoing treatment with an adjuvant or neoadjuvant cytotoxic chemotherapy that includes a taxane, specifically paclitaxel, nab-paclitaxel (Abraxane), or docetaxel
* Patients may have received prior endocrine and/or radiation therapy
* Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have been previously treated with cytotoxic chemotherapy
* Patients with pre-existing peripheral neuropathy
With Love: Using Promotoras for a Hispanic Community Palliative Care Promotora Palliative Care

Despite being strongly recommended, the integration of palliative care in oncology has not been widely adopted. Very few people have access to comprehensive palliative care. Access is even lower in rural and Hispanic communities. Even in communities with access, uptake is often low due to a lack of education on the part of both patients and providers regarding palliative care. This study aims to use an innovative approach to provide quality palliative care to oncology Hispanic patients by using community health workers also known as promotoras.

Palliative care has been highly recommended to be an integral part of oncology yet very few people have access to comprehensive palliative care. Access is even lower in rural, low socio-economic and Hispanic communities. Palliative care has been shown to decrease healthcare costs. This study will use an innovative approach to provide quality palliative care to gynecology-oncology Hispanic patients by using community health workers also known as promotoras. The promotora model has been shown to be successful in several behavioral modification programs. The investigators aim to use promotoras to deliver a comprehensive and culturally sensitive educational intervention that covers self-care in the presence of cancer, advance directives, pain management, and care taker awareness. The goal of the intervention will be to decrease number of emergency department visits and hospital admissions of patients with advanced cancer, and increase the rate of completion of advanced directives, as well as improve overall quality of life (as measured by standardized scales) when comparing the intervention group vs. the control (usual care) group. The investigators will additionally assess the cost effectiveness of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Must be a Texas Tech University Health Sciences Center El Paso (TTUHSC El Paso) or University Medical Center (UMC) El Paso patient
* Must be Hispanic
* Must have a cancer diagnosis

Exclusion Criteria:

* Under 17 years of age
* Not Hispanic
* Is not a patient of UMC or TTUHSC El Paso
Exploring the Use of Pulse Tissue Doppler in Predicting Extubation Success in Mechanically Ventilated Patients

Determining the appropriate extubation timing for mechanically ventilated patients is a critical issue in the Intensive Care Unit (ICU). Early or delayed extubation may prolong mechanical ventilation and ICU stay, leading to an increased mortality rate. Currently, extubation timing relies solely on the Spontaneous Breathing Trial (SBT), but its reliability is relatively low, with a extubation failure rate ranging from 10% to 40%. Therefore, accurately predicting potential post-extubation issues and early identification of reasons for SBT trial failure are crucial for improving patient outcomes. Commonly used parameters for assessing readiness for extubation do not fully reflect organ dysfunction, and the investigators plan to utilize comprehensive techniques, including bedside lung and diaphragm ultrasound parameters, to enhance the accuracy of predicting extubation outcomes in patients who pass the SBT trial.

All patients included in the study underwent a spontaneous breathing trial (SBT) using pressure support ventilation (PSV) strategy. This strategy employed pressure support(PS)≤9 cmH2O and positive end-expiratory pressure (PEEP)≤5 cmH2O. The duration of the trial was 30 minutes, and the FiO2 level was set at the same level (≤0.5) used during mechanical ventilation. After successful completion of the spontaneous breathing trial (SBT), ultrasound images were promptly acquired, and the Rapid Shallow Breathing Index (RSBI) was calculated based on the values displayed by the ventilator . Simultaneously, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score was computed and recorded. The decision to extubate, made by the attending physician (unaware of the ultrasound examination parameters), was based on clinical judgment. The primary endpoint event was extubation failure, defined as successful completion of SBT but an inability to sustain spontaneous breathing for more than 48 hours without noninvasive or invasive ventilation support.

Eligibility Criteria:
Inclusion Criteria:

* Patients were enrolled if participants had been intubated and mechanically ventilated for more than 24 hours and were ready for participants first SBT according to ICU weaning criteria.

Exclusion Criteria:

* paralytic drugs taken within 24 hours prior to the trial;
* diagnosis of diaphragmatic paralysis or paradoxical movement of the hemidiaphragm detected by ultrasound or poor imaging quality;
* Pregnancy;
* Ascites;
* age\<18years;
* Post-thoracotomy;
* Existence of pneumothorax;
* presence of large pleural effusion, subcutaneous emphysema, flail chest or right-sided rib fractures;
* presence of neuromuscular diseases.