cyrilzakka/clinical-trials huggingface dataset:
A Novel Way to Estimate Epidural Depth in Morbidly Obese Parturient

The purpose of this study is to determine the correlation between actual epidural needle depth (ND) and the use of ultrasound with an epidural depth equation (EQ-US) to estimate epidural depth (Est-D) in morbidly obese parturients. It is well documented that in women with a BMI greater than 40 kg/m2 successful epidural placement is more difficult. To the best of our knowledge the use of an epidural depth equation, which was developed in an earlier study using height and weight, with ultrasound visualization will improve identification of the epidural space.

The investigators plan to enroll women who are morbidly obese (BMI \> 40 kg/m2) and request epidural analgesia for labor. After written informed consent, 160 patients will have the use of the epidural depth equation with ultrasound (EQ-US) to estimate epidural depth (Est-D). US visualization of the epidural space will be completed by the principle investigator who has had extensive training in epidural US visualization. The EQ-US depth will be recorded. After US use, another provider who is listed as an investigator will place the epidural catheter without prior knowledge of the estimated epidural depth with the use of the equation and US. The actual needle depth to the epidural space (ND) will be recorded.

Data collected from the patient's medical record will include demographic data (age, height, weight) gravidity, parity, and cervical dilation. Measured variables will include the estimated epidural depth (Est-D) as measured by the epidural depth equation with the use of ultrasound (EQ-US), and actual epidural needle depth (ND). The investigators believe that the use of ultrasound with the epidural depth equation (EQ-US) to estimate epidural depth (Est-D) in morbidly obese parturients will have a high correlation with actual epidural needle depth (ND).

Eligibility Criteria:
Inclusion Criteria:

All women of childbearing age (including children aged 14 years and above) with a BMI \> 40kg/m2 who request epidural analgesia at Magee-Womens Hospital will be eligible to participate in the study. Men will not be included since they can not become pregnant. All patients will be recruited at Magee-Womens Hospital.

Exclusion Criteria:

Patients with severe preeclampsia will be excluded from the study, as these patients may have significant edema which could alter ultrasound and/or epidural needle depth measurement. Patients with a history of back surgery, significant scoliosis, and/or lumbar pathology (i.e. Ankylosing Spondylitis) will be excluded from the study because these conditions could complicate ultrasound visualization and/or epidural needle placement.
Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue

Adhera® Fatigue Digital Program (or AFDP) is a digital health program based on behavioral and emotional change techniques that provides personalized physical and emotional self-management support for patients with long COVID-related fatigue.

The digital health solution is designed to be used for 3 months, and includes a mobile application and a smartwatch. This is a clinical study, with 30 participants in the experimental intervention group and 30 in the control group, that will be carried out at the Jordi Gol Primary Care Research Institute (IDIAPJGol) - Institut Català de la Salut and Distrito sanitario Aljarafe-Sevilla Norte (DASN) - Servicio Andaluz de Salud, in Spain. The investigators will focus on evaluating the feasibility of the program in supporting fatigue and also physical and emotional self-management and, consequently, in improving the patients' well-being and quality of life.

The COVIDAI study will collect data on symptomatology and emotional well-being in a population of patients with fatigue related to a diagnosis of long COVID for 3 months using or not using the Adhera® Fatigue Digital Program (30 participants in the experimental intervention group and 30 in the control group). The aim of the study is to evaluate the feasibility of the program in supporting physical and emotional self-management in long COVID patients with fatigue and, consequently, in improving the patients' quality of life.

Personalized digital health solutions for both physiological and psychological long COVID-related symptoms would allow an optimization of the cost-effectiveness model for the management of long COVID patients. Similarly, the early detection of complications associated to long COVID on patients from vulnerable groups would improve the care timeline and the patient's prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over 18 years of age.
* With long COVID, according to the World Health Organization (WHO) consensus definition
* Having a history of fatigue symptoms
* Obtain a score between 4 and 10 on the question "By how much do you rate your fatigue level from 0 to 10 in the last 7 days?", where 0 is no fatigue and 10 is the worst fatigue imaginable
* Have an Android or iOS smartphone compatible with the intervention program.
* Agree to participate in the study and sign the informed consent form
* Willingness and availability to comply with all study guidelines and procedures

Exclusion Criteria:

* Hospital admission during the period of study participation.
* Participation in another study with pharmacological treatment
* Patients who are not technologically literate or unable to use the mobile application.
* Known severe psychiatric illness or presence of relevant cognitive impairment, at the discretion of the recruiting physician
* With mobility restrictions that limit the patient's ability to perform mild physical activity
* Being pregnant
* Patients who do not understand or speak Catalan or Spanish.
NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients

The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support.

HFNO (high-flow nasal oxygenation and NIV (non invasive ventilation) are to be randomly compared in the ARDS postextubation period.

Eligibility Criteria:
Inclusion Criteria:

ARDS

Exclusion Criteria:

Severe ICU-aquired weakness Severe COPD
Role of Hypothermia in Endovascular Stroke Thrombectomy

Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach.

In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear.

The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years or more;
2. acute ischemic stroke within 24 hours from onset to randomization;
3. NIHSS ≥6 points before randomization;
4. Internal carotid artery, or the middle cerebral artery M1 or M2 occlusion confirmed by CTA/MRA/DSA;
5. Baseline ASPECTS score ≥ 3 and ≤8, or cerebral infarction core volume \< 100ml;
6. The patient decides to undergo endovascular therapy;
7. The patient or patient's representative signs a written informed consent form.

Exclusion Criteria:

1. CT or MR evidence of hemorrhage;
2. Currently pregnant or lactating (women patients);
3. Allergy to radiographic contrast agents, or nitinol devices;
4. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
5. Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
6. Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
7. Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
8. Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
9. Intracranial aneurysm, arteriovenous malformation;
10. Any terminal illness with life expectancy less than 6 months;
11. Participating in other clinical trials.
Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation

The research purpose is to investigate the feasibility of using a motor-cable-driven system for wrist and forearm recovery of hemiplegic subjects suffered from stroke, where assistive force would be generated from cables connected to pulleys and electrical motors. The system may use EMG signal to control the movements.


Eligibility Criteria:
Inclusion Criteria:

* Sub-acute and chronic stroke patients (ischemic or hemorrhagic).
* Sufficient cognition to follow simple instructions as well as understand the content and purpose of the study.

Exclusion criteria:

1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication.
2. Any additional medical or psychological condition affecting their ability to comply with the study protocol.
Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass

Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm.

Excess BMI loss 5 years after surgery was investigated

Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm).

Excess BMI loss 5 years after surgery was investigated

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
* Age older than 18 years

Exclusion Criteria:

* Patients undergoing other bariatric techniques than RYGB
* Patients undergoing RYGB with different BPL or AL lengths than that reported for this study
* Any other surgical procedure added to the bariatric surgery
* Impossibility to comply with pre-established clinical follow-up.
Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use

Rationale: MagTrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. However, MagTrace® is known to interfere with MRI during follow-up imaging when using 2 mL. No data is available for patients who received 1 mL of MagTrace®, as is described in our current protocol. A contrast enhanced mammography (CEM) could be an alternative for MRI if it still shows artefacts.

Objective: The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a sentinel node biopsy.

Study design: Prospective trial in an outpatient clinic setting.

Study population: Patients who were included in the previous MagTrace study will be asked to participate in this subsequent trial.

Study procedure: Participants will undergo MRI and CEM as standard 1-year follow-up. Since the MagTrace study started in August 2021 and finished in February 2022, this trial will start August 2022 to February 2023.

Main study parameters/endpoints: To evaluate the use of MRI and CEM, the following primary endpoints will be assessed: Visibility and size of artefacts undergoing MRI and CEM and its consequences of the quality for image assessment.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since MagTrace® will be implemented as standard localisation technique for breast conserving surgery and sentinel lymph node biopsy in Zuyderland MC, the information obtained from this trial is essential for the follow-up planning of all breast cancer patients. Therefore, the burden for the patients (undergoing extra imaging) will be in proportion to the added value of this trial.


Eligibility Criteria:
Inclusion Criteria:

* Female patients of 18 years and older.
* Previously underwent sentinel lymph node biopsy using MagTrace®.
* Undergoing standard follow-up for previous breast cancer

Exclusion Criteria:

* Unable to comprehend the extend and implications of the study and sign for informed consent.
* Standard MRI exclusion criteria:

  * Implantable (electrical) devices (e.g., pacemaker, cochlear implants, neurostimulator);
  * Any other metal implants;
  * Claustrophobia;
  * MR-incompatible prosthetic heart valves.
* Standard CEM exclusion criteria:

  * Breast implants.
A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048

This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or females with either normal renal function or mild or moderate renal impairment will receive RO5024048 orally for 5 days. Target sample size is \<50.


Eligibility Criteria:
Inclusion Criteria:

* male or female adults, 18-75 years of age
* normal, or mildly or moderately impaired renal function (creatinine clearance \>/= 30 mL/min)
* BMI 18-40 kg/m2
* stable renal function
* agree to abstain from alcohol consumption during study drug adminsitration and limit consumption up to the end of the study
* agree to abstain from coffein consumption throughout study

Exclusion Criteria:

* positive urine or blood test for drugs of abuse not under a physician's prescription
* positive for HIV or HCV, or HBV with clinical symptoms or history of hepatitis
* uncontrolled hypertension
* renal transplant, dialysis patient, nephritic syndrome
* clinically significant cardiovascular, central nervous system, gastrointestinal or liver disease or disorder
Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery

Hydrocortisone has been shown to improve the early outcome of high risk patients after cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory action. In this prospective interventional study this hypothesis is to be proven.

Methods: Prospective interventional randomized double blind placebo controlled study.

Intervention: Hydrocortisone in stress doses vs. placebo

Patients: 92 high risk patients after cardiac surgery

Measurements: Cytokines, Toll-like receptors, NF kappa B, outcome data, health care related quality of life, PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min

Exclusion Criteria:

* Pregnancy
* Severe liver insufficiency
* Severe renal insufficiency
* Insulin dependent diabetes mellitus
* Steroid therapy
* Psychiatric disease
Contraceptive Choice Center

The Contraceptive Choice Center will use an innovative-model of contraceptive care which was developed as a part of the Contraceptive CHOICE Project (CHOICE). This delivery model will deliver high-quality family planning services for women and reduce unintended pregnancies and births. This intervention will result in improved health for women, improved health care, and reduced costs to Medicaid.

The Center will provide care to women ages 14-45 years of age.

The Center will provide high-quality contraceptive care using the innovative model of the Contraceptive CHOICE Project. Specifically, the model will provide the following components: 1) Structured, evidence-based contraceptive counseling; 2) education of providers about long-acting reversible contraceptive (LARC) methods and evidence-based guidelines for contraceptive provision; 3) removal of patient barriers to family planning services; and 4) post-visit contraceptive support. The model addresses the barriers to contraceptive uptake.

Eligibility Criteria:
Inclusion Criteria:

* Childbearing-age seeking family planning services
* Negative pregnancy test
* Willing and able to undergo informed consent

Exclusion Criteria:

* Current participation in a research study that would interfere with the conduct of this study
* Currently pregnant
Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study

Worldwide 200 million adults annually undergo major noncardiac surgery and 5 million of these patients will suffer a major vascular complication. Despite the magnitude of this problem our capacity to predict these events is limited. Although perioperative myocardial infarction (MI) is the most common major perioperative cardiac complication, little is known about its pathophysiology. Coronary computed tomography angiography (CTA) is a potential non-invasive method for the detection of coronary artery disease and cardiac risk stratification in the non-operative setting; however, the value of this test to enhance risk prediction among patients scheduled for noncardiac surgery is unknown. This study is an international prospective cohort study to determine among patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery: 1) if preoperative coronary CTA has additional predictive value for the occurrence of major perioperative cardiac events and 2) the underlying coronary anatomy associated with perioperative MIs.


Eligibility Criteria:
Inclusion Criteria:

* age \>=45 years
* undergoing non cardiac surgery requiring an overnight stay and general or regional anaesthetic
* at least one of:

  1. Coronary Artery Disease (CAD)
  2. Peripheral Vascular Disease (PVD)
  3. History of Stroke
  4. History of Congestive Heart Failure (CHF)
  5. Combination of at least 3 of:
* age \>= 70 years
* history of treatment for hypertension
* history of treatment for dyslipidemia
* smoking in last 2 years
* diabetic and currently taking insulin or oral diabetic drugs
* history of Transient Ischemic Attack (TIA)

Exclusion Criteria:

* contraindications to CTA
Videos for Advance Care Planning in Young Adults

This study is a randomized trial of adolescent and young adults with advanced cancer and their caregivers to assess preferences for care in advanced cancer. This research study is examining the similarities and differences between patient's and caregiver's goals of cancer care.

The names of the study interventions involved in this study may include:

* Questionnaires
* Video
* Phone Interview

The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits.

- Patients and their caregivers will be randomized into the same group; either ACP video decision aid intervention or usual care.

* Patients' and caregivers' knowledge, preferences (goals of care, CPR, ventilation), and decisional conflict be assessed before and after the ACP video decision aid intervention or usual care.
* Participants will be in this research study for up to 3 months with only 2 study visits.
* It is expected that about 100 people (50 patients and 50 caregivers) will take part in this research study.

Eligibility Criteria:
All patients will be recruited from the outpatient clinics of Dana-Farber Cancer Institute (both pediatric and adult clinics),the inpatient settings of Boston Children's Hospital and Brigham and Women's Hospital, the inpatient or outpatient clinics of Massachusetts General Hospital, or virtually. Eligible study participants will give written consent to the primary investigator or study staff member before initiation of study procedures if recruited in-person. If participants are enrolled and complete study procedures virtually, they will provide verbal consent before initiating study procedures.

If in-person visits cannot be conducted, eligible participants will be still be mailed a pre-notice letter that offers the chance for participants to opt-out or opt-in via email or phone call. After one week, we will call participants we have not heard from and ask if they would consider participating.

Patient Eligibility criteria will include patients who are:

i) Diagnosed with advanced cancer (i.e., initial first-line therapy is unsuccessful, marked by progression or relapsed disease) ii) Aged between 18-39, which is the legal age for completing an ACP document (e.g., POLST/MOLST); iii) Speak English; and iv) Have a caregiver or identified surrogate decision maker who is able to participate.

v) Treated at Dana-Farber Cancer Institute or Massachusetts General Hospital

Exclusion criteria will include:

i) A diagnosis of low-grade glioma given the fact that progressive or relapsed low grade may not be clinically characterized as advanced disease and associated poor prognosis.

ii) Visually impaired (note, hearing impaired is not an exclusion as the video is closed captioned); iii) Psychological state not appropriate for ACP discussions as determined by the primary oncologist; and, iv) Unable to participate in ACP discussions due to mental incapacity as determined by the Short Portable Mental Status Questionnaire
Effects of Saline Eustress in Plant Food (ESEPF)

The aim of the project is to study if supplementation with eustress plant food like lettuce grown in mild salinity condition affects health in a healthy population.

Salinity can affect the levels of bioactive compounds in leafy vegetables. The aim of the project is to verify the impact, if any, of the changing of bioactive compounds in the physiology of the study population. The participants will be randomly assigned to the control group that will eat 100 gr of untreated (control) lettuce and the intervention group that will consume 100gr of eustress lettuce. Blood samples and urine samples will be collected at time zero (start) after 12 days. Each subject will be subjected to two venous blood samples taken at the beginning of the observation and at the end. The samples obtained will be transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the experimenters at the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, insulin, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, AST, ALT, GGT, ALP, Ferritin, free Iron, transferrin, total proteins, magnesium, calcium, insulin, osteocalcin, calcitonin, parathyroid hormone, c terminal peptide of collagen (CTX), Vitamin D, Phosphate, Potassium.

Eligibility Criteria:
Inclusion Criteria:

* Italian
* age: 18-65 years
* currently injury free
* Body mass index between 18.5 and 28 kg/m2

Exclusion Criteria:

* Use of vitamins and minerals supplements,
* use of medications
* Presence of metabolic or chronic disease
* Pregnancy, breastfeeding condition,
* smokers