cyrilzakka/clinical-trials huggingface dataset:
Trial of Alvimopan in Major Spine Surgery

The Investigator has chosen to study the reconstructive spinal surgery patient population because it is believed that the use of alvimopan in these patients at the University of Virginia will give the scientific community significant insight into the broader applicability of this drug into other surgical populations, the impact of this drug on the perception of pain (as opposed to simply the consumption of opioids), and its impact on total hospital charges, resource utilization, and functional outcomes.

Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects. Such side effects may include urinary retention, altered mental status, depressed respiratory drive, and constipation, and may lead to reduced nutritional intake in the postoperative period. Importantly, post-operative nutrition may impact the incidence of complications following spine surgery.1 Alvimopan is a peripheral-acting opiate antagonist designed to decrease the gastrointestinal complications of perioperative systemic opioid administration.

Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects including constipation. Alvimopan is a drug approved by the Food and Drug Administration (FDA) and is used to help the bowel recover more quickly in patients who are having bowel surgery, so that they can eat solid foods and have regular bowel movements. Alvimopan is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the constipation effects of opioid (narcotic) medications that are used to treat pain after surgery.

The purpose of this study is to determine if the use of alvimopan in major spine surgery reduces the time to first bowel movement. By assessing the use of alvimopan in reconstructive spinal surgery patients, researchers hope to give the scientific community insight into the broader use of this drug in other surgical populations, as well as gathering information on the impact of hospital charges and overall post-operative patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Major spine surgery scheduled as part of clinical care
* 18-80 years

Exclusion Criteria:

* More than three doses of any opioid within one week of surgery
* Pregnancy
* Prisoners
* Unable to provide consent
* Emergency surgery
* Chronic kidney disease stage 5 (GFR \< 15 ml/min)
* Severe hepatic impairment
* Recent myocardial infarction (within the last 3 months)
Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)

The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.

Summary:

The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.

Eligibility Criteria:
Inclusion Criteria:

* Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry.

Indications:

The Barostim System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

Contraindications:

* Bilateral carotid bifurcations located above the level of the mandible
* Baroreflex failure or autonomic neuropathy
* Uncontrolled, symptomatic cardiac bradyarrhythmias
* Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50%
* Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
* Known allergy to silicone or titanium
Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, and various prosthetic implants. The conservative treatment options, however, are limited to NSAIDs and bracing or steroid injections.

Advances in topical therapies have the potential to deliver focused treatment to the CMC joint. Novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that has theoretical impact on inflammation reduction in human subjects treated with the topical foam.

This pilot study seeks to investigate potential benefit in the use of Theraworx Foam in patients diagnosed with thumb CMC OA. Patients presenting to the upper extremity orthopedic surgery clinic for thumb/hand/wrist pain will be diagnosed by a Board Certified Hand Surgeon as per standard protocols. Patients who are recommended to follow a conservative treatment modality and are interested in participating in this study will be randomized into treatment or control groups. Both groups will undergo symptom assessment, strength testing, and range of motion testing prior to starting the standard conservative treatment of bracing. The treatment group will use the TheraWorx topical foam and the compression wrap nightly for 2 weeks for at least 6 hours per night. Control group will use a compression wrap for the same time period. Both groups will return at 1 and 2 weeks for repeat strength and range of motion testing and symptom assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Thumb CMC arthritis
2. greater than or equal to age 18
3. Interested in non-operative treatment of thumb arthritis

Exclusion Criteria:

1. Recent corticosteroid injection into the thumb joint
2. Non-English speaking
3. skin lesions or rashes on the thumb
4. current use of topical anti-inflammatory medications
5. concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
6. known allergy to magnesium
Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)

Vaccines against the coronavirus type 2 causing severe acute respiratory syndrome Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have been created in a short period of time due to the rapid spread of the virus. These vaccines use different and sometimes innovative technologies, such as the use of ribonucleic acid (RNA), or a non-replicating viral vector. Efficacy ranging from 70-90% in the first weeks after the second injection of these vaccines has been reported, with side effects whose causality remains to be determined.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Eligibility Criteria:
Inclusion Criteria:

* Participant must live in the Principality of Monaco
* Deliver a written consent to participate to the study
* And/Or Have been infected with SARS-CoV-2
* And/Or Have been, or are about to be, vaccinated against SARS-CoV-2

Exclusion Criteria:

- None of the above
An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer

This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Histologically proven epithelial ovarian cancer
* ECOG 0-1
* Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months
* With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication
* Prior treatment with 1 or more chemotherapy regimen

Exclusion Criteria:

* Platinum resistant disease: PFI \< 6 months (progression within six months after first-line platinum-based chemotherapy)
* Unwilling or unable to have a central venous catheter
* Patients with hepatic impairment (Patients with elevated bilirubin)
* Patients with renal impairment (Patients with serum creatinine \>1.5 mg/dL)
* Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3)
* Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex)
* AIDS-related Kaposi's sarcoma
* Lactation or pregnancy
Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects

To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated IRB/IEC-approved informed consent form before any study-specific screening procedures are performed.
* Men or women aged 18 to 50 years, inclusive, at screening.
* Women of nonchildbearing potential, defined as being surgically sterile or postmenopausal for \> 1 year, may be included. For women below 50 years of age, at least two years of retrospective amenorrhea and FSH\>38 and estrogen \<20 are required.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening: BMI = weight (kg)/(height \[m\])2

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.
* Hypersensitivity to citalopram or any of the inactive ingredients in citalopram.
Study on Treatment of Varicose Veins by Endovenous Laser (1940 Nm Vs 1470 Nm)

The goal of this clinical trial is to compare efficacy of two wavelength for EndoVenous Laser Ablation (EVLA) in treatment of varicose veins of the lower limbs.

The main questions it aims to answers are :

1. Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ?
2. Is the increase of wavelength reduce complication or pain ? Participants are patients with varicose veins of lower limbs and candidate for endovenous laser ablation.

After laser ablation patients will be followed during 5 years for clinical evaluation, recording potential treatment complications and quality of life evaluation.

Researchers will compare strategy 1(EVLA with an endovenous laser at 1940 nm) vs strategy 2 (EVLA with an endovenous laser at 1470 nm) in varicose veins treatment to see if efficacy of treatment is not reduce, and to see if complications of EVLA treatment can be reduced.


Eligibility Criteria:
Inclusion Criteria:

* Primary insufficiency of the great saphenous vein (GSV) and/or small saphenous vein (SSV)
* Patient candidate for endothermic treatment of the lower limbs
* CEAP: C2 - C6
* Patient with a target vein diameter (GSV and/or SSV) \>= 3 mm throughout the target vein segment
* Patient affiliated or beneficiary of a social security scheme
* Patient having signed the informed consent

Exclusion Criteria:

* Patient with a current serious pathology and/or a life expectancy of less than 5 years
* Patient who has had a deep or superficial vein thrombosis in the previous 6 months
* Obliterating arteriopathy of the lower limb concerned, with an IPS \< 0.8 or \> 1.3
* Patient with post-thrombotic obstructive syndrome at the popliteal and/or femoral and/or iliac stage on the ipsilateral lower limb
* Patient with primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb
* Suspicion of non-post-thrombotic iliac compression on echo-doppler
* Contraindication to the planned treatment technique
* Patient whose geographical distance is not compatible with the follow-up of the study
* Pregnant or breastfeeding women
* Patient linguistically or psychologically unable to understand the information given, to give informed consent or to answer the study questionnaires.
* Protected patients: Adults under guardianship, or other legal protection; Hospitalized without consent.
Neural Correlates of Cognition and Mood

The overall objective of this study is to determine the neural correlates of cognition and mood. This study represents the first preliminary study to begin investigating cognitive and emotional states in patients who have undergone implantation of invasive electrodes for the purpose of seizure localization. In the post-implantation paradigm where patients remain under close supervision with intracranial instrumentation for recording, this study aims to create the platform and preliminary data to inform a larger study for calibrated examination of neural correlates of cognition and mood. As such, this study has the following specific aims:

Aim 1: Establish a portable platform for the assessment of cognitive, behavioral, and emotional tasks with time synchronization to ECoG/SEEG recording platform Aim 2: Quantify the variance in clinical assessments of mood and cognitive function in patients undergoing phase II epilepsy monitoring Aim 3: Assess the relationship between validated surveys/tasks and electrophysiology

Study interventions are limited entirely to validated surveys completed on a computer or tablet PC, as outlined above. Patients may elect to have electrodes to be implanted that are not used in standard-of-care at this institution, but are FDA-approved for the same indications. Patients who consent and complete enrollment will be asked to complete cognitive and behavioral tasks on a portable computer or tablet PC while the invasive electrodes remain implanted. Tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer.

The primary outcome for this study includes percentage of completed cognitive or behavioral tasks as a measure of the feasibility of the administration of these tasks. As this is a feasibility study, we are interested in the practical aspects of data acquisition.

Secondary outcomes include the cognitive and behavioral tasks themselves and their relationship with electrophysiology.

Eligibility Criteria:
Inclusion Criteria:

* Patient is able to consent for themselves and the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation.

Exclusion Criteria:

* None
Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device

This study will be conducted without blind method. The portable seat device devised to maintain lumbar lordosis will be made within 1 year after the loss of ambulation in the participants with Duchenne muscular dystrophy with prospective design.

In the control group, the presence of scoliosis will be calculated 5 years after the loss of ambulation in participants with Duchenne muscular dystrophy through analysis of retrospective medical records who had not been applied the portable seat device.

In the retrospective data of Seoul National University Children's Hospital, the incidence of 5-year scoliosis in the control group in the past using steroids alone was 70% in patients with confirmed Duchenne muscular dystrophy. When applying the portable seat device (experimental group), the incidence of scoliosis is expected to decrease to 50% (ie, 35% because of 50% of 70%) compared with using steroid alone.

In this study, investigators will enroll 70 control subjects who did not use the portable seat device through retrospective data. The number of subjects required to show the difference between the significance level of 5% and the power of 80% was 19, and 28 participants with DMD are required considering 30% dropout rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of Duchenne muscular dystrophy diagnosed by genetic study were included.

  1. Within 1 year after loss of ambulation (Vignos scale 7 points or more)
  2. Condition without scoliosis
  3. Conditions that do not have physical (eg, cerebral palsy) and mental (eg, moderate or higher intellectual disability) comorbid conditions that will affect the use of postural seat device.

Exclusion Criteria:

1. Patients who do not agree to participate in this study
2. Patients not taking steroids
3. Patient with scoliosis
Myofascial Release and Muscle Activity

The aim of the study is to assess the impact of SMR intervention in the hamstring muscles on the activity of the biceps and gluteus muscles.

The study will cover 40 men, players of amateur football leagues, aged 18 - 40. The test will include the measurement of sEMG of the biceps and gluteal muscles during the exercise, followed by myofascial self-release (SMR). Muscle sEMG was re-measured immediately after roller therapy.

Eligibility Criteria:
Inclusion Criteria:

* signing informed consent to participate in the study
* age in the range of 18-40 years

Exclusion Criteria:

* people who had orthopedic injuries to the lower limbs and the lumbar-pelvic-iliac complex in the last year
* people who reported pain in the lower limbs and the lumbar-pelvic-iliac complex on the day of the examination
* people who underwent myofascial therapy in the last 6 weeks
* people with non-specific neuromuscular disorders
Exogenous Ketones for Acutely Decompensated HEart Failure

This study will evaluate whether supplementation of exogenous ketones in patients with severe left ventricular dysfunction and acutely decompensated heart failure requiring inotropic therapy would improve the patient's hemodynamics and symptoms.

The study will include patients with acutely decompensated chronic heart failure requiring inotropic therapy for the syndrome of low cardiac output. While being on the inotropic therapy, the patients will be randomized to oral supplementation of exogenous ketones vs. placebo, which will be repeatedly administered over 9 hours. The patients will undergo continuous invasive hemodynamic monitoring by pulmonary artery catheter, repeated laboratory assessment, and repeated assessment of the severity of symptoms for 24 hours.

Exogenous ketones will be administered orally using monoester 3-OHB concentrate without added salts (25g 3-OHB in 65ml H.V.M.N Ketone Ester, H.V.M.N, USA or equivalent). The drink will be administered over 10 mins every 3 hours, 3 times in a row (hour 0, 3, 6).

All patients with K\<3.7 mmol/l will receive a continuous infusion of 7.5% potassium until reach target K levels of 4.0-4.9 mmol /l. Glycemia will be controlled as needed by insulin and dextrose to maintain glucose concentration of 4 - 12 mmol/l

All patients will receive standard treatment of acute heart failure, including intravenous diuretics and inotropic therapy. The recommended inotropic therapy will include milrinone 0.5 ug/kg/min, levosimendan 0.1 ug/kg/min up to 25mg without initial bolus, or dobutamine 0.5 ug/kg/min in patients without chronic therapy with beta-blockers.

The severity of symptoms will be self-reported by the patient using 1-10 visual analog scale.

Workflow:

* Hemodynamic assessment, assessment of ketones concentration: 1-3h before randomization, 0-9h hourly, 16-24h (next morning)
* Biochemical assessment (renal function, liver enzymes, BNP, hs-TnT) 0h, 9h, 16-24h
* Assessment of symptoms and Scv02: 0h, 1h, 3h, 9h, 16-24h

Statistical methods:

Each study arm will include 12 patients. The study size was estimated to have power of (1 - beta) of 0.8 and alpha of 5% for between-group comparison of changes in cardiac index and stroke volume index by ANOVA and for comparison of the changes in cardiac index and stroke volume index by paired t-tests.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure due ischemic or nonischemic cardiomyopathy
* Acute decompensation of heart failure with the need of inotropes
* Achievement of relative stabilization on inotropes (INTERMACS class \>2)
* Left ventricular ejection fraction \<= 35%
* Age \>18 years

Exclusion Criteria:

* Deteriorating cardiogenic shock with likely need of mechanical circulatory support in the subsequent 48 hours
* Chronic kidney disease grade 4 or 5
* Diabetic ketoacidosis (3-OHB \>2mmol/l at baseline)
* Hemodynamic severe arrhythmias
* Acute heart failure due to transient triggers (acute coronary syndrome, atrial fibrillation, infection etc..)
* Contraindications to invasive hemodynamic monitoring
Early Mobilisation in the Surgical Robot Assisted Spinal Surgery

In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of degenerative diseases or spinal fracture
* single level instrumentation sugery
* sign informed consent

Exclusion Criteria:

* multilevel instrumentaion surgery
* diagnosis of severe osteoperosis (BMD \< 60mg/cm3) by QCT
* coagulant function abnormality
* severe internal disease
* not suitable for inclusion
Evaluation of the Predictive Role of Choline PET/CT on the Survival of Patients Affected by Prostate Cancer.

the increase in the serum PSA (prostate specific antigen) value following radical treatment commonly involves subsequent treatment which, in the absence of morphological evidence of disease recovery, is conducted empirically through local radiotherapy or systemic hormonal therapy. The use of PET with choline is therefore of extreme clinical interest as it allows to identify the site of disease recurrence, thus being able to direct towards a specific therapeutic treatment. The diagnostic accuracy of choline PET in identifying the location of the disease has been widely demonstrated in the literature and is comparable to those of conventional diagnostic methods previously described for the restaging of patients with prostatic disease. The real advantage of this method is the possibility of obtaining the same information as conventional methods by carrying out a single exam.


Eligibility Criteria:
Inclusion Criteria:

* adult patients suffering from prostate cancer who have undergone choline PET/TC

Exclusion Criteria:

* patients \< 18 years