cyrilzakka/clinical-trials huggingface dataset:
Monitor-Guided Analgesia During General Anesthesia - Part I

This prospective randomized clinical trial evaluates the effects of a monitor-guided opioid analgesia during general anesthesia. To date no standard-monitoring device exists to specifically reflect the analgesic component of general anesthesia. Quality and safety of general anesthesia are of major clinical importance and should be improved by limiting the opioid analgesic's dosage to the minimum amount needed. The study compares the effects of monitoring nociception during general anesthesia with different innovative techniques in comparison to routine clinical practice.

This prospective randomized clinical study aims to investigate the effects of a monitor-guided opioid analgesia during general anesthesia by different monitoring systems in comparison to routine clinical practice. Many surgical procedures require general anesthesia. The main components of general anesthesia are hypnosis and analgesia, and anesthesiologists usually combine a hypnotic drug with an opioid analgesic.

Until today, however, there is no standard-monitoring of nociception to specifically reflect the analgesic component of general anesthesia. In clinical practice the opioid dosage is chosen by clinical judgment of the attending anesthesiologist based upon changes of heart rate, blood pressure, pupil size, lacrimation and sweating of the patient.

On the one hand, underdosage of opioids can cause nociception leading to an increased sympathetic tone, increase of plasma levels of stress hormones, nociceptive movements as well as increase postoperative pain. On the other hand, overdosage of opioids can lead to drug side effects such as nausea and vomiting, hemodynamic instability, an increase in recovery times, immunosuppression and an increase in postoperative pain by opioid-induced-hyperalgesia. Quality and safety of general anesthesia are of major clinical importance and can be improved by limiting the administration of opioid analgesics to the optimal individual dose needed. In the last years, different analgesia monitoring devices have been developed for monitoring nociception. The present study evaluates the effects of the administration of opioids during general anesthesia guided by three different monitoring systems in comparison to routine clinical practice. After institutional approval by the Ethics committee of the Medical Board of the City of Hamburg, Germany and obtaining patients' written informed consent the investigators randomize elective patients with major abdominal surgery for open radical prostatectomy into one of four treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Radical open abdominal prostatectomy scheduled in the operation theater where the study is conducted
* \> 18 years

Exclusion Criteria:

* Chronic pain therapy, e.g. out-of-hospital opioid therapy
* Beta blocker and digitalis therapy
* Eye disease with affection of pupil reactivity
* Pacemaker therapy
* Higher degrees of cardiac arrhythmias, e.g. atrial fibrillation
* Pre-operative medication with steroids
Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps

The use of acetic acid in the characterization of polyps, produces a homogeneous white staining in sessile serrated adenomas, but not in tubular or tubulo-villous adenomas, a simple approach to predict polyp histopathology.

To determine the diagnostic accuracy of the use of acetic acid on tubular and serrated adenomas, during colonoscopy, a prospective diagnostic accuracy study was designed, taking as gold standard the pathological anatomy of the resected polyps.

Polyps found during a colonoscopy with suspicion of sessile serrated adenomas or tubular/tubulo villous will be included.

In our experience tubular or tubulovillous adenomas with acetic acid have the same behavior as normal colonic mucosa. When sprayed with acetic acid they stain white, as well as the surrounding mucosa, but with a subsequent rapid loss of the effect. In contrast, serrated adenomas maintain an "aceto-whitening" reaction even though the surrounding normal mucosa loses staining.

The objectives are to determine the sensitivity and specificity, positive and negative probability coefficients of the positive or negative aceto-whitening reaction on serrated adenomas and tubular-tubulo-villous adenomas.

To determine the diagnostic accuracy of the use of acetic acid on tubular, tubulo-villous and serrated adenomas a prospective diagnostic accuracy study was designed considering the gold standard as the pathological anatomy of resected polyps.

As independent variables the presence or absence of aceto-whitening reaction after staining and the diagnostic impression of the endoscopist without acetic acid are considered. The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa.

In case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly.

Place: German Hospital, endoscopy unit.

Data analysis: the data collected in double-entry tables will be captured to obtain the same sensitivity, specificity and positive or negative probability coefficients.

Sample size: 100 polyps.

Estimated duration: 1 month

Eligibility Criteria:
Inclusion Criteria:

* Patients with colonic polyps\> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videoolonoscopy.

Exclusion Criteria:

* Known acetic acid allergy
* Known or documented history of adenomatous or serrated polyposis
* Patients with inflammatory bowel disease
Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve.

The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag.

By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Hydrocephalus
* Newborn through age 20
* External Ventriculostomy with an Extra-Ventricular Drainage system installed

Exclusion Criteria:

* Not diagnosed with Hydrocephalus
* Older than age 20
* No External Ventriculostomy with an Extra-Ventricular Drainage system installed
A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes

This study aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued Luspatercept or epoetin alfa treatment and discontinued the COMMANDS trial (NCT03682536) utilizing existing data from patient medical records.


Eligibility Criteria:
Inclusion Criteria:

* Participant was enrolled in and discontinued the COMMANDS trial.
* Participant was treated with either luspatercept or epoetin alfa and discontinued treatment while enrolled in the COMMANDS trial.
* Participant Patient provides informed consent (only where applicable or required by local regulations).

Exclusion Criteria:

• There are no exclusion criteria for this study.
Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study): Retrospective and Prospective Follow-up Study

The investigator aimed to evaluate the long-term (up to 10 years) follow-up of the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions), which was shown the superiority of IVUS-guided stent implantation at 1 year in terms of major adverse cardiac events.

The investigator will follow-up (up to 10 years) the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions).

Eligibility Criteria:
Inclusion Criteria:

* 1. The patients who enrolled in the XPL-IVUS study.
* 2. Provision of informed consent

Exclusion Criteria:

* 1. This observational study does not have any specific exclusion criteria.
Treating Post-Lyme Disease Syndrome With Acetogenins

To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).

To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS). After failure of antibiotic therapy to relive persistent symptoms of Lyme Disease, the use of Acetogenins to elevate Post-Lyme Disease Syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. A positive Western Blot for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.
2. Must be able to swallow and mixed powder drink.

   -

Exclusion Criteria:

1. Non Positive Western Blot test.
2. Positive Western Blot test where the indivual has not been treated with antibiotics.

   -
Study Evaluating Effexor XR for Major Depression.

Study Evaluating Effexor XR for Major Depression.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with major depression based on DSM-IV-TR
* Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of "depressed mood" at the baseline.

Exclusion Criteria:

* Patients with schizophrenia or any other psychotic disorder
* Patients with history or presence of bipolar disorder
Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical

The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.

This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision.

The primary result measurement will be blood drain output from the knee at 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Primary total knee replacmeent
* Osteoarthritis
* Unilateral

Exclusion Criteria:

* Revision surgery
* Donated preoperative autologous blood
* On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
* Preoperative hepatic or renal dysfunction
* Diagnosis of inflammatory disease
* Diagnosis of inflammatory arthritis
* Pregnant
* Breastfeeding
* Preoperative hemoglobin \<10g/dL
* International Normalized Ratio\>1.4
* Abnormal Partial Thromboplastin Time
* Preoperative platelet count of \<150,000mm\^3
* Creatinine \> 1.4
Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes

The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients with type 2 diabetes are now thought to be attributable to elevated intestinal production and reduced clearance. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with type 2 diabetes. In this regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic dyslipidemia. However, the investigators understanding of the physiological changes that occur with n-3 PUFA supplementation is suboptimal, thereby limiting the investigators appreciation of its impact on CVD risk associated with type 2 diabetes. The effects of n-3 PUFAs on the intestinal production of TRLs and the expression of genes regulating intestinal lipid absorption and chylomicron synthesis have not yet been examined in humans. The general objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will:

* reduce TRL apoB-48 production rate and increase fractional catabolic rate of these lipoproteins,
* decrease the expression of genes that regulate intestinal lipid absorption and synthesis as well as synthesis of apoB-48-containing lipoproteins,
* decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 55 years,
* plasma TG levels above the 50th percentile for age,
* non-smoker,
* BMI between 25.0 and 40.0 kg/m2,
* stable body weight for at least 6 months prior to the study baseline,
* HbA1c between 6.5 and 8.5%,
* baseline fasting plasma glucose \< 15.0 mmol/L
* patients with de novo type 2 diabetes not taking oral hypoglycemic agents -- - or patients having received stable doses of metformin for at least 3 months before randomization.

Exclusion Criteria:

* extreme dyslipidemias such as familial hypercholesterolemia,
* patients with secondary form of diabetes or acute metabolic diabetic complications,
* patients having received or being treated with insulin or a thiazolidinedione within the past 6 months,
* subjects having CVD (CHD, cerebrovascular disease or peripheral arterial disease)
* subjects taking medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents,
* significant alcohol intake
A Single Patient IND for PD-0325901

The purpose of this study is to provide access for a single patient to PD-0325901 who was previously enrolled in a phase I clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Prior treatment with PD-0325901 with ongoing response

Exclusion Criteria:

* none
A Mobile Intervention on Values in Chronic Pain Patients.

The study aims to test a mobile intervention on values and goals in chronic pain patients. The cognitive behavioral intervention is a 10-day course in which participants complete a brief intervention each day (about 10-20 minutes a day). The content of the intervention includes the definition of values; development of individualized values and personal value-oriented goals; and implementation of personal goals in every day life. To assess the effectiveness of the intervention, we use a multiple baseline single case design. Baseline measurements will be assessed daily between 10 and 17 days (the exact number will be randomized). Daily measurements will continue during the intervention. After the intervention, another post measurement will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Chronic, non-tumor related back pain (pain for at least 6 months)
* Ownership of a smartphone
* Numeric Rating Scale for pain result of ≥ 4

Exclusion Criteria:

* High cognitive impairment (e.g., intellectual disability)
* Currently in psychotherapeutic treatment
* Initiation of pain-focused treatment during the study
Women's-Specific Footwear With Prosthetic Feet

The purpose of this study is to address footwear challenges unique to women prosthesis users. Comparing the effectiveness of different footwear and prosthesis combinations will help guide clinical decision making regarding the prescription of prosthetic devices, while keeping what the patient wants in mind.

It is expected that these results will be used to generate new knowledge for the development of versatile prosthetic devices that accommodate a user's unique lifestyle while helping the patient to make good progress in rehabilitation.

Investigators will characterize perceived limitations in footwear among women prosthesis users. Investigators think that women prosthesis users will be restricted in footwear choices and clothing choices due to the use of a prosthetic device.

Specifically, investigators expect perceived limitations in footwear will be greater for shoes with higher heels than shoes without heels.

The project involves development, distribution, and analysis of a questionnaire designed to address footwear use among women lower limb prosthesis users. Responses from sixty women with a lower extremity amputation will be targeted. VA participants will be identified by the MVAHCS. These potential participants will receive the IRB-approved survey via mail. Eligible participants include women with unilateral or bilateral lower extremity amputations.

The questionnaire will target the types of footwear worn by prosthesis users and the types of footwear desired to be worn. It will also capture the various types of prosthetic feet worn in each footwear category, amputation type, time spent walking in a prosthetic device, and general satisfaction with the prosthesis function during daily living when worn with shoes.

Eligibility Criteria:
Inclusion Criteria:

* Woman Veteran
* Age 18-80
* Lower Limb Amputation (transtibial, through the knee, transfemoral)
* Eligible to receive care through the VA Health Care System
* Ambulatory and currently using a prosthesis

Exclusion Criteria:

* Syme's Amputation
* Hip Disarticulation
Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation

Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during inspiration, is measured. The ventilator triggers (synchronizes patient effort) and applies proportional assistance based on measured electrical activity of the diaphragm (Edi). This electrical activity is measured through a feeding tube that also has a multiple-array esophageal electrode in it. This mode of ventilation has been proven to be equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath control offered by NAVA may not only trigger faster and synchronize better, but provide the support deemed appropriate by the central nervous center on demand. Traditionally in the intensive care unit (ICU), pressure support is applied to subject breathing spontaneously. Pressure is set to achieve a given tidal volume. The influence of changing lung compliance not only from the lung disease itself, but the interactions of the respiratory muscles can drastically change minute ventilation and contribute to hyper- or hypoventilation. These changes are typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or oxygen saturation (SpO2) monitoring; all of which are potentially preventable if we allowed the central nervous system to control the ventilator. NAVA may allow us to couple the central nervous system (neuro-coupling) with the ventilator to provide real-time proportional assistance, reduce work of breathing and apply physiologic breathing patterns.


Eligibility Criteria:
Inclusion Criteria:

* All intubated and mechanically ventilated patients in our intensive care units (ICUs) will be screened for the following inclusion criteria:

  1. Age: 1 month to 18 years.
  2. Mechanically ventilated for longer than 6 hours
  3. Either:

     1. Eligible for a spontaneous breathing mode of ventilation (not receiving chemical paralytics and has an appropriate spontaneous respiratory drive/rate given the size and condition of the patient) as determined by the team.

        or
     2. Currently in the pressure support ventilation (PSV) or neurally adjusted ventilatory assist (NAVA) mode of ventilation

Exclusion Criteria:

1. Patients in which a nasal gastric or oral gastric tube is contraindicated. Examples are but not limited to: s/p esophagus, tracheal surgery, bleeding disorders, facial trauma.
2. Uncuffed endotracheal tube (ETT)
3. Cervical-spine injury that prohibits rolling the patient for electrical impedance tomography (EIT) band placement.
4. Difficult airway
5. Congenital cyanotic heart defects
6. Positive end expiratory pressure (PEEP) \> 15 cmH2O
7. Fractional inspired oxygen concentration (FIO2) \> 0.8
8. Peak inspiratory pressure (PIP) \> 30 cmH2O
9. Patients who are receiving chemical paralysis
10. History of prematurity (birth at post-conceptual age \<37 weeks)
Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease

This is an observational study, hence there is no study hypothesis


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of von Willebrand Disease who have been prescribed Wilate
Diffusion MRI (Magnetic Resonance Imaging) Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness

Diffusion-weighted sequences have been routinely performed for years to study the pelvis. They have been so far mainly qualitatively interpreted, that is to say as the absence or presence of an hypersignal at a high b value. The quantitative analysis involves placing the region of interest (ROI) on the apparent diffusion coefficient (ADC) map. The manual placement is very operator dependent, and does not reflect the entirety of the studied mass.

In all fields of Magnetic Resonance Imaging, a multiparametric approach integrating diffusion analysis is flourishing. However, the quantitative analysis of the diffusion is still little studied for tumor heterogeneity analysis, including in the gynecological sphere.

The investigators will therefore retrospectively evaluate the apparent diffusion coefficient (ADC) histograms, extracted from the diffusion ponderation sequences, of the magnetic imaging resonance analysis of adnexal masses and confront the results with the anatomo-pathology results, for patients having undergone surgery, and/or with the clinical and imagery follow-up results.

The investigators goal will be to improve the performance of conventional MRI in the analysis of adnexal masses.

The expected benefits of this study are:

* a correlation with the histology analysis or the clinical monitoring
* an improved prediction of the malignancy of the tumor
* an improved magnetic resonance imaging performance for adnexal masses, with better surgical therapeutic management
* an improved negative predictive value, thereby ultimately limiting unnecessary surgical explorations.


Eligibility Criteria:
Inclusion Criteria:

- Women aged over 18 years old, having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.

Exclusion Criteria:

* Examinations without diffusion sequences
* Examinations with incomplete diffusion sequences
* Absence of anato-pathologic result, or absence of gynecological clinical/imaging follow-up.