cyrilzakka/clinical-trials huggingface dataset:
Prophylactic IABP in High-risk Patients Undergoing CABG

Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.


Eligibility Criteria:
Key inclusion criteria:

Hemodynamically stable high-risk patients before CABG, defined by the following criteria:

* Age \>18 years
* Isolated CABG planned
* Informed consent in trial participation given
* Any left ventricular functional impairment (regional wall motion abnormality or global LVEF\<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography
* Elevated cardiac biomarkers (CK-MB \> 6% of total-CK, Troponin I \> 3-fold of specific test reference) or myocardial infarction (NSTEMI or STEMI) within the last 4 days.

Key exclusion criteria:

* Contraindications for IABP
* Cardiogenic shock
* Shock of any other cause
* Critical preoperative state according to EuroSCORE II-criteria
* Cardiac surgical procedure other than CABG planned
* Severe comorbidity with life expectancy \< 6 months
* Incapability of giving informed consent
Dumping Syndrome and Quality of Life After Vagus Nerve-preserving Distal Gastrectomy

There is no consensus on what type of function-preserving gastrectomy can provide the best patient quality of life (QOL). This study aims to evaluate the incidence of dumping syndrome after vagus nerve-preserving distal gastrectomy (VPNDG).

The study is designed as a prospective observational phase II study with a follow-up period of 12 months. Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach who are planned to undergo laparoscopic VPNDG with Roux-en Y gastrojejunostomy will be enrolled. Primary endpoint is incidence of dumping syndrome defined by Sigstad score 7 after a 3-month interval. Other outcomes include operative data, early complication, and patient QOL using the European Organization for Research and Treatment of Cancer C-30 and STO22 modules.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach planned to undergo laparoscopic vagus nerve-preserving distal gastrectomy

Exclusion Criteria:

* Sacrificed vagus nerve
* Anastomosis other than Roux-en Y gastrojejunostomy or uncut Roux-en Y gastrojejunostomy
* conversion to an open procedure
* combined resection of other organs
A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research

Minimal risk research study:

1. Comparing polyester nasal swabs and foam nasal swabs to detect SARS-CoV-2 virus;
2. Quantifying the development and trajectory of the disease through clinic visits and blood values.

This work will serve both the Everett Clinic and broader UnitedHealth Group patient populations as well as advance the public health emergency response to the community spread of SARS-CoV-2 virus, especially as the number of cases and deaths continues to rise in many geographies. A recent study conducted at The Everett Clinic showed that foam nasal swabs were able to detect SARS-CoV-2 virus at comparable levels to nasopharyngeal (NP) swabs. We now look to build off this work by comparing polyester foam swabs, which are more readily available and mass producible, to foam nasal swabs, in their sensitivity for detecting SARS-CoV-2 virus. We also plan to assess the viability of dry swabbing, where the swab is stored without saline or viral transport media (VTM) at room temperature for four days, to calculate the degradation of the viral sample.

Finally, we will collect up to 50 mL/visit of blood longitudinally from patients who have previously tested positive for SARS-CoV-2 at visit one, two, and four weeks following their initial COVID-10 diagnosis.The medical professional drawing the blood will determine if the patient is at an increased risk from a blood draw due to underlying conditions such as anemia. In these cases, the amount of blood drawn will be left to the discretion of the medical professional but shall not surpass 10 mL per visit.These longitudinal blood samples will help us gain a better understanding of the trajectory of COVID-19 (in terms of both clinical symptomology and viral load) and antibody development. At each visit, nasal swabs and blood samples will be collected, and the blood samples will be stored in a repository for future research.

Eligibility Criteria:
Inclusion Criteria:

* Existing patient of the Everett Clinic (i.e., has previously sought care)
* Tested positive for SARS-CoV-2 virus (confirmed by RT-PCR) prior to time of enrollment

Exclusion Criteria:

* Not able to demonstrate understanding of the study
* Not able to safely travel to the clinic without endangering themselves or risking exposing others to SARS-CoV-2
* Medical history evidencing any of the following

  * Active nosebleed in the past 24 hours
  * Nasal surgery in the past two weeks
  * Chemotherapy treatment with low platelet and low white blood cell counts
  * Acute facial trauma
* Advanced COVID-19 state that would preclude safe and feasible sample collection
Evaluation of Articaine 4% Versus Mepivacaine 2% for Surgery of Molars Thirds: Clinical Trial.

The extraction of third molars, a frequent treatment in clinical dental practice, can lead patients to painful symptoms during and after surgery. The dental surgeon must correctly indicate the need for extraction and also provide patients who need this treatment greater comfort and control of pain in the trans and postoperative period. Thus, it is necessary to use an effective local anesthetic favoring the factors inherent to the postoperative and achieving good treatment results.

This study will compare the use of Articaine at 4% to that of Mepivacaine at 2% for lower third molar surgeries semi-included and / or included. I will select 16 patients who require surgical treatment for extraction of third molars, aged between 16 and 40 years at the São Paulo State University. These will participate simultaneously in the two groups: Group 1 mepivacaine (MEP) and Group 2 articaine (ART), and the division will be performed by randomization, so that each patient will have each side (right or left) allocated in different groups. The primary evaluation variable will be to compare the pain index in the immediate postoperative period, using Visual Analog Scale (VAS), and will also analyze Hemodynamic Parameters, such as Patient and Operator satisfaction. The results will be submitted to qualitative and quantitative statistical analysis. The descriptive data will be compared using the statistical analysis of variance (ANOVA) and Tukey test with a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Classification -(ASA I) patients;
* Patients with need for extraction of lower third molars included and / or semi-included;
* Teeth in opposing hemiarch with the same classifications as Pell and Gregory and Winter;
* Age between 16 and 40 years;
* Patients who agree to voluntarily participate in the survey.

Exclusion Criteria:

* History of allergic reactions (hypersensitivity) to anesthetics;
* Patients presenting with local or systemic alterations that contraindicate the procedure;
* Current use of drugs that may interfere with the action of anesthetics;
* Need for sedatives or anxiolytic drugs during extraction;
* Pregnancy or breastfeeding;
* Third erupted lower third molars.
Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy

The aim of this study is to compare the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.

Fluid therapy is one of the main tools used in anesthesiology to maintain adequate hemodynamic stability. Goal-directed fluid therapy (GDFT) based on cardiac output and/or dynamic parameters of fluid responsiveness (e.g. pulse pressure variation) has been shown to decrease post-operative complications. The main inconvenience of protocol based therapy is its technical complexity which requires considerable time, attention, and vigilance. GDFT assisted by a closed-loop system, when compared to manual GDFT, is associated with a longer preload independent state and could increase clinician adherence to protocol. To this day no study has compared closed-loop assisted GDFT to standard of care.

Goal:

This study compares the results of the study entitled "Crystalloids or Colloids for Goal directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) to a standard of care group (started retrospectively before the first included patient of the above study) where fluid therapy is based only on static variables (e.g. arterial pressure, heart rate, central venous pressure (CVP), and urine output.) These groups consisted of the same population undergoing the same types of surgery.

Hypothesis:

A protocolized approach using computer-assisted GDFT when compared to standard of care is associated with less fluid administration and less blood transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring general anesthesia.

Exclusion Criteria:

* Patients under 18 years of age
* Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring
* Patients with arrhythmia and/or atrial fibrillation
* Patients who are allergic to HES (hydroxyethyl starch)
* Patients with renal insufficiency (serum creatinine of \>2 mg/ml) or hepatic dysfunction (liver enzymes \>1.5)
* Patients who has coagulation disorders (values higher than 1.5x normal values)
* Patients without the capacity to give written informed consent or refusal of consent
* Pregnancy at time of enrollment.
Hypnosis for Pain and Itch Following Burn Injuries

The purpose of this study is to determine whether hypnosis will decrease the intensity of either pain or itch in patients who have sustained a burn injury. Primary hypothesis: Hypnosis will provide more effective relief from post-burn itch and pain than a control intervention at 1-month, 3-months, 6-months and 1-year post-burn injury.

Secondary hypothesis 1: Subjects treated with hypnosis will report better sleep quality and fewer symptoms of Post Traumatic Stress Disorder (PTSD).

Secondary Hypothesis 2: Subjects treated with hypnosis will require less escalation of the gabapentin doses and have lower average pain scores than those in the control group.

Exploratory Hypothesis: Subjects who will randomize to the hypnosis treatment group early after injury will report lower rates of neuropathic pain and itch than subjects who will be enrolled in the study and receive hypnosis later in the healing process.

This is a randomized, controlled study comparing two groups of subjects, those in the control (standard care) group and those in the experimental group (hypnosis).

Control subjects will receive treatment as usual, which consists of a standardized protocol for treating post-burn itch. This protocol is based on past research and combines medications in a stepped approach that establishes therapeutic decisions based on clearly defined criteria.

Subjects randomized to the experimental group will undergo four sessions of live hypnosis completed over a two month period. They will be provided with a Compact Disk (CD) of each session and instructed to listen to it daily. Post-hypnotic suggestions will address uncomfortable sensations, with additional suggestions for improved sleep and well-being. Subjects may be inpatient or outpatients.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Ability to provide informed consent for study participation
* ability to read and understand English
* Undergoing pharmacologic therapy for burn related itch according to the standard itch protocol
* Scoring of 4 out of 10 on the Numerical Rating Scale for average itch or pain

Exclusion Criteria:

* Age less than 18 or greater than 65
* Inability to provide informed consent
* Inability to read or understand English
* Delirium
* History of mania, paranoia, dissociation and current suicidal ideation
Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors

Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other factors (genetic, psychological) could have a major and independent role in the development of the post operative pain.The main objective of this study is to identify genetic and psychological profile (cognitive and emotional) of patients who develop chronic pain after lung surgery.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing lung resection surgery.
* 18 years and older (without superior limit);
* Affiliated to french "securité sociale"

Exclusion Criteria:

* Emergency procedure
* litigation or search for compensation;
* Previous intervention in the same region;
* Peripheral neurological pathology (polyneuropathy) or central (brain damage, multiple sclerosis ...) that may interfere with the evaluation of the post-operative pain
* Participation in another biomedical research protocol if there is an incompatibility with the present protocol.
* mental disability
* vulnerable person within the meaning of French law,
* poor understanding of French.
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER

This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU838 in adult patients with PMS. The study will consist of the following periods:

Screening Period: Approximately 28 days Main Treatment Period: Up to 120 weeks (approximately 2 years) Open Label Extension Period: Up to approximately 8 years

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age 18 to 65 years (inclusive).
* EDSS score at screening between 3.0 to 6.5 (both inclusive)
* No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed according to 2017 revised McDonald Criteria 1 and the 2013 revised classification of disease courses 2 as either

  1. SPMS inpatients showing evidence of Gd+MRI lesions (active SPMS) or without Gd+MRI lesions (non-active SPMS) in the last 12 months, OR
  2. PPMS
* Willingness and ability to comply with the protocol.
* Written informed consent given by the patient before the beginning of any study-related procedure.
* Documented evidence of disability progression not temporarily related to a relapse in the last 24 months before randomization, adjudicated by a central independent reviewer

Exclusion Criteria:

* Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis.
* Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e.,presence of anti-NMO \[aquaporin-4\] antibodies or anti-MOG antibodies).
* Previous or current use of MS treatments lifelong, or within a pre-specified time period.
* Use of any investigational product within 8 weeks or 5 the respective PK half- life before the date of informed consent, whichever is longer, and throughout the study.For some investigational products, prolonged biological effects beyond 8 weeks should be considered.
* Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) within14 days before randomization. In case of known SARS-CoV-2 infection, patients should be randomized no earlier than 14 days after 2 consecutive negative tests confirming virus negative status.The screening period can be extended for these patients to accommodate the required virus negativity.
* Positive IFN-gamma release assay (IGRA) for Mycobacterium tuberculosis at SV1.
* Positive hepatitis B virus (HBV) surface antigen, hepatitis B core antibody, positive hepatitis C virus (HCV) antibody, and/or HIV-antigen-antibody test at SV1.
National Acalabrutinib Observational Study

The efficacy and safety of acalabrutinib in the treatment of patients with chronic lymphocytic leukemia (CLL) have been well established through 3 phase III clinical trials (ELEVATE TN, ASCEND, ELEVATE R/R) that led to European Medicines Agency approval in November 2020. The aim of this French longitudinal, non-interventional/observational, multicenter study is to describe the efficacy and safety of acalabrutinib treatment for CLL patients in real life.

The primary objective is then to estimate the time to discontinuation of acalabrutinib therapy and the reasons for discontinuation, overall and by treatment line.

The secondary objectives are to describe the baseline clinical and demographic characteristics of patients with CLL treated with acalabrutinib, to assess the efficacy of acalabrutinib through progression-free survival, overall survival, time to next treatment or death, describe acalabrutinib treatment patterns in CLL patients and reasons, identify key determinants of acalabrutinib discontinuation in CLL patients, estimate healthcare resource utilization. The overall response rate will be estimated as an exploratory objective.

Patients included in this study will be CLL patients treated with acalabrutinib at the discretion of their physician between January 1, 2021 and December 31, 2022, who have been informed of the study and do not object to electronic processing of their data for research purposes (or do not object during their lifetime in the event of the patient's death prior to study initiation).

Secondary data will be extracted from the hospital's patient records once a year. The protocol calls for the recruitment of 350 patients at 70 centres with a 3-year follow-up. Interim analyses will be performed annually until the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥ 18 years old,
* CLL patients initiated with acalabrutinib at their physician's discretion between January 1st 2021 and December 31st 2022,
* Patients alive at study initiation and who have been informed verbally and/or in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control (certified by physician); or patient who died before study initiation and who did not object to data collection for research purpose(s) during his or her lifetime.

Exclusion Criteria:

* Patients participating in a clinical trial with an investigational drug within 30 days prior to acalabrutinib initiation,
* Patients who initiated acalabrutinib treatment before January 1st 2021.
What Are the Determinant Factors of Ceasing Anti-seizure Medication in Infants With Neonatal Seizures?

The investigators aimed to determine the factors for ceasing anti-seizure medication in infants who experienced seizures during the neonatal period. This retrospective, single-center, descriptive study was conducted in Balıkesir between December 2020 and February 2023, and 157 neonates were recruited.

This retrospective, single-center, descriptive study was conducted at the Department of Paediatric Neurology between December 2020 and February 2023, and 157 neonates were recruited to determine the factors related to ceasing ASM treatment in infants at a follow-up 2 years. According to the International League Against Epilepsy (ILAE) classification of neonatal seizures and their etiology, patients who were diagnosed with such seizures and received anti-seizure medication within the first 28 days of life were followed until their ASM was ceased after they were discharged from the neonatal intensive care unit. Infants are defined as children aged younger than 12 months. During this stage of neuronal development, the central nervous system is more susceptible to the harmful effects of external factors. Consequently, the investigators have planned to evaluate the study's initial 12-month follow-up results for our group. Afterwards, the infants were divided into two groups: the first group consisted of infants who continued to receive ASM treatment after 12 months of age (referred to as "infants still on ASM after 12 months", n=69); the second group consisted of infants who had stopped ASM treatment before 12 months of age (referred to as "infants who had ceased ASM before 12 months", n=88).

Eligibility Criteria:
Inclusion Criteria:

* Neonates with seizures diagnosed clinically or with conventional electroencephalography (cEEG) confirmation were enrolled.

Exclusion Criteria:

* with abnormal paroxysmal events that weren't determined to be seizures by cEEG, amplitude integrated EEG (aEEG) and video records,
* stopped medications due to their parents' decisions,
* with missing hospital records,
* delivered from pregnancies by assisted reproductive techniques were not enrolled.
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast

The purpose of this study is to investigate whether the addition of whey protein to a breakfast high in carbohydrate content will influence acute metabolic and appetite responses, as well as responses to a subsequent lunch meal.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 years old (male)
* Recreationally active (\>30 minutes of structured exercise, 5 times/week)

Exclusion Criteria:

* Metabolic disease (e.g. Type 2 diabetes, thyroid disorders)
* Taking any prescribed medication
* Regular breakfast skipper
* Food allergies or intolerances
* Eating disorders
* Smoker