cyrilzakka/clinical-trials huggingface dataset:
Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

Procedural sedation involves the administration of sedative medications that allow patients to tolerate painful procedures. Procedural sedation has been formally recommended by experts from the French Society of Emergency Medicine (SFMU) since 2010 and procedural sedation using propofol in emergency departments has been recommended by the American College of Emergency Physicians in 2018.

Propofol monotherapy is now widely used in emergency medicine (EM) in France as part of procedural sedation for performing painful procedures, however propofol has no analgesic properties per se .

Pupilometry makes it possible to study the depth of analgesia by evaluating the body's nociceptive response via the ANS by studying the pupil diameter.

This technique would allow the evaluation of the analgesia level in patients sedated by PROPOFOL during the realization of painful procedures. Variations in pupil diameter during painful procedures under procedural sedation in an emergency department will be assesed in this study. Secondly, patients satisfaction following the procedure will also be evaluated by the use of the French version of the "ISAS-F", the Iowa Satisfaction with Anesthesia Scale.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* patient admitted at vital emergency room,
* patient with an orthopedic trauma,
* patient under procedural sedation with PROPOFOL.

Exclusion Criteria:

* Patient's refusal of pupilometry measurement.
* Pre-existing pupil abnormalities.
* history of pathologies with dysautonomic impairment (advanced diabetes, systemic amyloidosis, multiple sclerosis, uncontrolled hypertension, ...).
* Recent administration of Metoclopramide, Droperidol, Clonidine, Dexmedetomidine
* Nitrous oxide prior to procedural sedation
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure

The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.

Aim To compare clinical outcome with a strategy of conduction system pacing and atrioventricular nodal ablation (CSP+AVNA), versus atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) and heart failure (HF), to guide future management of these patients.

Hypotheses

1. CSP+AVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization.
2. CSP+AVNA is non-inferior to AF ablation in patients with persistent AF for reducing mortality and heart failure hospitalization.

Design Investigator-initiated, prospective randomized, controlled, open-label, multicentre study conducted in \~ 30 centres from 14 countries in Europe with expertise in CSP and AF ablation.

Sample size 220 patients

Study duration 4 years

Eligibility Criteria:
Inclusion Criteria:

(i) Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure.

(ii) At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP \> 1000 pg/ml or BNP \> 250 pg/ml measured at any timepoint during this interval.

(iii) Previous or current rate or rhythm control drug therapy. (iv) Age \> 60 years

Exclusion Criteria:

(i) NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy.

(ii) Life expectancy \< 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable.

(vi) Participation in another controlled trial. (vii) Inability to sign and informed consent form.
Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease (BOREAL)

The purpose of this study is to evaluate the ability of the Bora Care remote monitoring solution to detect early acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).

Worldwide, COPD has been increasing for 20 years with nearly 300 million patients, i.e. 4 to 10% of the adult population (7.5% in France). According to the WHO, it is now the fourth leading cause of death in the world.

Acute exacerbations of COPD (worsening of symptoms requiring an increase in treatment) represent frequent events in the course of the disease and the consequences are significant for the patient in terms of vital prognosis, deterioration of respiratory function, impact on quality life and for the health system in terms of cost. Missed diagnosis and delayed treatment are associated with impaired outcomes. The prevention and early treatment of acute exacerbations of COPD therefore have a major role in the management of COPD patients and could be facilitated by telemonitoring tools.

The purpose of the present study is to validate the interest of remote monitoring of various parameters (cardio-respiratory, environmental, symptom questionnaires) to predict and detect early the occurrence of acute exacerbations of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Patient with COPD defined according to the SPLF recommendations, whose level of lung function in a stable state is known (measurement less than 12 months old)
* Patient with at least one of the following criteria :

  * Hospitalized for a COPD exacerbation at the time of enrolment in the study, and having had at least one other exacerbation in the last 12 months
  * Followed-up and part of the active file of the site, having had at least 2 exacerbations during the last 12 months, including one with hospitalization
  * COPD patient with at least 2 exacerbations in the last 12 months, including one with hospitalization
* Patient having given written informed consent to participate in the study
* Patient affiliated to the French social security system

Exclusion Criteria

* Vulnerable patient (minor, protected adult, prisoner)
* Patient unable to use the BoraBand tool and without access to a caregiver
* Presence of a comorbidity considered unstable or very severe by the investigator
* Patient already participating in another interventional research study
Collaborative Care for Opioid Dependence And Pain Pilot Study

This pilot study evaluates a collaborative care program to assist with opioid tapering in patients with chronic pain. Patients will be randomized to receive the intervention or usual care.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain for at least 6 months
* Receiving daily opioid treatment

Exclusion Criteria:

* Not speaking English
* Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder
* Known life expectancy of less than 6 months
Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy

The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.


Eligibility Criteria:
Inclusion Criteria:

* unruptured tubal EP
* gestational mass of less than or equal to 3.5 cm in ultrasonography report

Exclusion Criteria:

* hemodynamic instability
* contraindications related to the use of MTX
* hepatic
* renal and active pulmonary diseases
* peptic ulcer
* immune deficiency status
* alcohol abuse
* blood dyscreasia
Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms

The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.

Thirty participants will be recruited. Volunteers will be randomly assigned to the control group or experimental group. Before the training period, symptoms, balance and neuromuscular performance will be assessed. Participants in the experimental group will perform strength training twice a week (50 min each) for eight weeks. Then, four weeks of detraining will be completed.

Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria
* at least 18 years old

Exclusion Criteria:

* severe comorbidity or any other type of condition that negatively influences participation in the training program
* cognitive disorders
* heart problems
* surgeries or fractures in the last 6 months
* regular practice of physical exercises in the least 3 months before program.
Post-Breast Procedure Pain Syndrome Study

The purpose of this study is to better understand and characterize the pain that some patients experience after undergoing various breast surgeries, including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic breast augmentation, and breast reduction.

Post-operative breast pain is one of the most common adverse effects after breast surgery procedures. According to previous studies, anywhere from 20-60% of breast surgery patients report mastalgia as an adverse outcome of surgery (1, 2). Although the exact mechanism has not been well defined, the pain is generally neuropathic in nature and described as a burning sensation, electric and shock like, with a stabbing quality (2,3). The large majority of post-operative mastalgia is therefore believed to be secondary to nerve damage, particularly injury to the intercostobrachial nerve, and less commonly the long thoracic, medial and lateral pectoral, and/or the thoracodorsal nerves. Other reported causes of post-operative breast pain include scarring pain, lymphedema, radiation plexopathy, and hematomas (1-5).

Increasing rates of breast surgeries, whether elective, diagnostic, prophylactic, or therapeutic, warrant a more detailed examination of this pain-syndrome, particularly as previous research in the area is rather limited and narrow. A better understanding of the potential mechanisms causing pain, as well as more accurate and current incidence rates, and comparisons of adverse outcomes among the various options available to patients can help guide physicians towards improved clinical practices and patients towards more informed decision-making. Therefore, we designed this prospective cohort study to better understand the underlying mechanisms which may cause post-operative pain after various types of breast surgeries including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic augmentation, and breast reduction, as well as to compare and contrast incidence, quality, and distribution of the post-operative pain caused by these various surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo one or more of the breast surgical procedures being studied for this project
* Willingness and ability to sign an informed consent document
* No allergies to anesthetic or analgesic medications
* Female,
* 18-80 years of age
* ASA class I-III adult

Exclusion Criteria:

* Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
* Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, or history of chronic pain syndrome or neuropathy.
* Subjects with a history of alcohol or drug abuse within the past 3 months
* Subjects with a history of pain medication abuse
* Any other conditions or use of any medication which may interfere with the conduct of the study
A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone

This study is a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the United States and Canada.


Eligibility Criteria:
Inclusion Criteria:

* Are girls with Turner syndrome who are being or will be treated with Nutropin, Nutropin AQ, or Protropin
* Are willing to keep follow-up appointments throughout study participation
* Are girls with Turner syndrome who have submitted Form 4 upon discontinuation and may also submit Form 9

Exclusion Criteria:

* Have Noonan syndrome
* Subjects treated within the last 6 months with a non-Genentech GH preparation
* Have closed epiphyses prior to NCGS enrollment
* Have active neoplasia
Interactive Voice-Based Administration of the PHQ-9

This study investigates a new delivery method for the Patient Health Questionnaire - 9 (PHQ-9), a clinically accepted tool for diagnosing major depressive disorder. The new tool records auditory responses to the assesment and the study will examine if the instrument is effective at capturing participant depression levels. If proven effective, future studies may investigate if the new format can be used to improve at home clinical care.

This study is an investigation of a new delivery system of the Patient Health Questionnaire - 9 (PHQ-9), a clinically accepted tool for diagnosing major depressive disorder. The purpose of the study is to examine if the new delivery system of the PHQ-9 is effective at capturing participant depression levels. The new version uses a Mirror device, which is similar to a smart television with a mirror interface. The device records auditory responses to the PHQ-9 through Amazon Alexa. We will be comparing the responses from the Mirror device to those given on the clinically established paper format. If proven effective at capturing depression levels of patients, future studies may investigate if the new format can be used to improve at home clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Newly admitted patients to the Oklahoma State University Behavioral Medicine Clinic

Exclusion Criteria:

* Vulnerable populations, such as children (i.e., minors or individuals under the legal age of consent) and individuals who are incarcerated (i.e., prisoners), will be excluded.
* Individuals who are not their own guardian (i.e., those suffering from severe disabilities) will also be excluded.
The Efficacy of Light-to-moderate Resistance Training in Sedentary Pregnant Women

Maintaining a physically active lifestyle is associated with many health benefits, including lower risk of cardiovascular disease, diabetes, hypertension, some type of cancer, and depression . Pregnant, healthy women are recommended to do 30 minutes or more of light to moderate exercise a day, although most women in the Western world do not follow current recommendations and decrease their exercise level.

Benefits of exercise during pregnancy are several, including a protective effect against the development of gestational diabetes mellitus, reduced pregnancy related low back pain, and risk of caesarean delivery. On the contrary, a recent review concludes that sedentary behaviors are associated with higher levels of C Reactive Protein and LDL Cholesterol, a larger newborn abdominal circumference, and macrosomia.

Previous studies show that exercise during pregnancy is associated with improvements in psychological well-being among previously sedentary women.

Only a few RCT's have studied resistance exercise during pregnancy. These studies have found reduced fatigue and reduced need of insulin among women with gestational diabetes mellitus who did resistance exercise, with no adverse effects on fetus or the pregnant woman.

The aim of this study is to evaluate the efficacy of regular light -to-moderate resistance exercise among sedentary pregnant woman, with regard to fatigue, health related quality of life, pain location and intensity, body weight gain, blood pressure, and childbirth outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Single pregnancy and ≥18 of age
* Ability to understand verbal and written Swedish
* Inclusion during gestational week 20+0-20+6.

Exclusion Criteria:

* Follows the recommendation regarding contraindications according to the American Collage of Obstetricians and Gynecologists 2002
* Severe pain from the pelvic or the back
* Regular exercise \>150 minutes per week the last six months
Database of Patients Undergoing Cardiac Computed Tomographic Angiography at William Beaumont Hospital (CT DATABASE)

The purpose of the study is to establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all William Beaumont Hospital (WBH) patients undergoing Cardiac Computed Tomographic Angiography (CCTA) testing for clinical or scientific reasons.

The principal goal of his project is to enable the study investigators to organize WBH research activity in the field of CCTA by concentrating data from all the patients who allow use of their data in one organized, audited and securely stored database. It will allow the ability to collect retrospective and prospective data from a number of different clinical systems and securely maintain patient medical record numbers for the reference on future projects as well as identification of patients with multiple studies and multiple follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* all retrospective patients who under went a CTA and were granted a waiver of consent
* all prospective patients CTA patients who gave informed consent.

Exclusion Criteria:

* Non CTA patients
* Patients who refused participation.
3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study

The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse.

This is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q \[pelvic organ prolapse quantification\] grade) and/or full-thickness rectal prolapse.

Intervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed.

The specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse
* age 18-70 y.o.

Exclusion Criteria:

* severe concomitants chronic diseases (American Society of Anesthesiologists class III - IV),
* ongoing oncological diseases,
* ongoing hematological diseases,
* ongoing inflammatory diseases of the colon and pelvic organs,
* pregnancy
Incidence, Characterisation and Outcome-relevance of Perioperative SGLT2 Inhibitor Associated Ketoacidosis

The goal of this observational study is to generate data on the incidence and outcome-relevance of sodium-glucose cotransporter 2 (SGLT2) inhibitor associated ketoacidosis in adult patients with regular intake of any SGLT2 inhibitor within the last three months that are undergoing in-patient surgery. Further, it will describe strategies in current clinical practice to prevent and manage SGLT2 inhibitor associated ketoacidosis. The specific aims of this study are:

1. To assess the incidence of SGLT2 inhibitor associated ketoacidosis in surgical patients
2. To characterise fasting times in patients with SGLT2 inhibitor associated ketoacidosis
3. To describe the management of SGLT2 inhibitor associated ketoacidosis in current clinical practice
4. To assess the outcome impact of SGLT2 inhibitor associated ketoacidosis


Eligibility Criteria:
Inclusion Criteria:

* Prescription and regular intakte of any SGLT2 inhibitor within the last three months (regardless if SGLT2 inhibitor was discontinued preoperatively or not)
* Surgical procedure
* At least one overnight stay in the hospital following surgery
* Age \>= 18 years

Exclusion Criteria:

* Unwilling and/or unable to consent
* Outpatient surgery
Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME

CardioSignal technology (mechanocardiography) could enable home follow-up after admission for acute heart failure, thus improving guidline-directed medical therapies for heart failure dose escalation while reducing the logistical constraints and stress associated with frequent hospital visits. The intended purpose is to detect signs of HF in adults (aged 18 years or older and \< 85 years)

CardioSignal is a smartphone-based innovation using the smartphone's built-in motion sensors (accelerometer and gyroscope) for measuring heart mechanical motion (seismocardiography and gyrocardiography) when placing the phone on the chest for one minute. Innovation also includes cloud-based data analysis for heart motion signals. CardioSignal is a class IIa medical device (software as a medical device) for detecting atrial fibrillation (Afib) and measuring heart rate and soon detecting heart failure. CardioSignal provides accurate and actionable insights of heart health without the need for additional hardware for everyone and everywhere using their smartphone.

Relevant disease areas include atrial fibrillation, heart failure, and related conditions such as stroke and transient ischemic attack (TIA). The innovation supports long-term monitoring and prevention efforts for high-risk populations, including patients with hypertension, diabetes, sleep apnea, cancer, and those with a history of cardiovascular disease as well as patients discharged after a surgical operation.

The primary user groups are patients at home and healthcare providers at point-of-care. CardioSignal empowers patients to self-monitor heart health easily and affordably, enabling proactive care and improved outcomes across diverse populations, including elderly patients, chronic disease sufferers, and those awaiting specialist care or surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted at emergency room for acute heart failure.
* Patients discharged from emergency room after an episode of acute heart failure.
* Either LVEF\>40% or ≤40%, either known or assessed during the index hospitalization (however at least 1/3 of patients are required from each category).
* BNP \> 200 pg/ml OR NT-ProBNP \> 800 pg/ml
* Patients with connected smartphone.

Exclusion Criteria:

* Patients \<18 years and \>85 years.
* Pregnant women. lactating woman.
* Previous history of allergic asthma at an early age.
* Patients with a history of pulmonary embolism.
* Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax. (patient with a pacemaker).
* Known allergies for: bisoprolol, ramipril, Entresto, spironolactone, empagliflozine, dapagliflozine.
* The participant's inability to adhere to study procedures or give informed consent.