cyrilzakka/clinical-trials huggingface dataset:
Anesthesia Depth During Opioid Free Anesthesia

Opioid-free anesthesia is feasible and effective but still not common practice. Anesthesia depth monitoring is not investigated for use in anesthesia combining low dose infusions of several drugs with different sedative patterns on EEG. This is an observational study comparing opioid-free anesthesia with regular anesthesia in regards to DSA, SEF and PSI from the Sedline monitor.

Patients who undergo general anaesthesia are more or less extensively monitored, with the sole purpose of surveilling depth of anesthesia and nociception. Parameters such as heart rate, blood pressure, pupillary size and sweating has historically been used as predictive markers for this surveillance. However, these clinical parameters have low predictive capacity and there is a tendency to overdue perioperative sedation and misinterpret sympathetically derived reactions as pain. This could lead to higher incidence of postoperative delirium and opioid induced hyperalgesia. On the contrary, an overestimated trust in the mentioned parameters might lead to increased risk of intra-operative awareness.

The usefulness of processed encephalography (pEEG) during anesthesia has since long been promoted for anesthesia providers. Since then, several commercial devices has been developed and deployed for clinical use. Although mixed results are presented in clinical studies there is now a significant empirical experience for its use in routine anesthesia with volatile anesthetics and propofol. Density spectral array (DSA) is the latest contribution in the field of encephalographic monitoring. It is a two-dimensional graph plotting the power of each frequency-interval on a time-scale.

More and more data on the effectiveness and safety of opioid free anaesthesia (OFA) have been released, especially as a direct result of the ongoing opioid-epidemic affecting a large number of people worldwide. The algorithms for the commercial devices, using DSA, has to this date not been validated for multimodal anesthetic regimens using ketamine and dexmedetomidine.

The purpose of this observational study is to compare DSA pattern and data for pEEG between OFA and total intravenous anaesthesia or general anaesthesia with volatile anesthetics for patients undergoing laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic surgery
* Adult patients
* Ability to accomodate verbal and written information in swedish
* Voluntary

Exclusion Criteria:

* Pregnancy
* Intolerance to NSAID
Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab

Aim of this study is to determine wether the macromolecular spectral characteristic of ulcerative colitis patients - measured by Physiological Intermolecular Modification Spectroscopy (PIMS) - is a predictive factor for response to Simponi treatment

It is widely appreciated that almost all proteins and other biological macromolecular in vivo exist, at least transiently, as components of structural and functional complexes. This transient interaction in simple component solutions have been studied using well established daylight light scattering (LS) method which reflects molecular oscillation (7-12). Protein association, protein unfolding, protein aggregation and cellular crowding are known to affect the normal function of cellular system (13-19). In many cases, the resulting small changes in normal protein-protein intra- and intermolecular interactions are thought to lead to a variety of human diseases (20, 21). Based on these and the acquired knowledge on LS, the cutting edge technology, PIMS has been developed. PIMS is a label free technology that is able to study protein-protein and protein-solvent interactions in multi-component solutions. It provides individual real time dynamic fingerprint of total physiological macromolecular assemblies in a tissue in presence and absence of exogenous molecules (drug or drug candidate, peptide or protein).

This technology is based on dynamic molecular resonance of proteins and macromolecules. Cellular extracts in physiological conditions are frozen at -37°C. Macromolecular spectra are registered as the temperature within the sample raises from -37 to 37°C. This provides, within the organ of interest, dynamic fingerprint of an individual entire macromolecular assemblies. The present technology can therefore rapidly and specifically determine the response of a tissue or cell when an exogenous molecule is administrated. It reflects patient molecular capacity to respond to the drugs effect and allows to identifying different subpopulations within a group in response to a specific treatment. It highlights the responders from non-responders to a given treatment.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe active ulcerative colitis
* qualified for initiating Golimumab therapy, i.e.inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine or intolerance of medical contraindications to such therapies
* must be able and willing to provide written informed consent
* must have a negative tuberculosis screening or if inactive (latent) tuberculosis diagnosed anti-tuberculosis therapy to be started before initiation of Golimumab therapy in accordance with local recommendations

Exclusion Criteria:

* cancer
* type one diabetes
* current infection and/or inflammation other than related to ulcerative colitis
* autoimmune diseases
* any contraindications stated by Golimumab product label
Clinical Electrophysiology Assessment for Low Back Pain

Non specific chronic low back pain (LBP) is a debilitating disorder characterized by tremendous personal and socioeconomic impact, with long-term sick leave, low quality of life, and very high financial costs. Evidence suggests that patients with non specific LBP presented with altered muscle activity pattern when compare with healthy people. It has been reviewed that exercise therapy was effective for modulation of muscle dysfunction in chronic low back pain. However, there is a lack of objective assessment of the pain relief in low back pain rehabilitation. Clinical application of surface electromyography (EMG) may provide a quantitative and objective tool to evaluate the rehabilitation outcome in patients with non specific chronic low back pain before and after treatment.

Objectives: To verify the usefulness of surface electromyography (EMG) in low back pain (LBP) rehabilitation assessment.

Setting: Out-patient physiotherapy musculoskeletal rehabilitation

Participants: One hundred adults with non specific chronic low back pain (LBP) will be recruited.

Methodology: A prospective correlation study between clinical examination and electrophysiology assessment. This project will perform carefully with a definitive chronic low back pain (LBP). Firstly, we will compare the surface EMG features from patients with LBP to normal data. In addition, the changes in electrophysiology assessment will be compared with clinical assessment by Numeric Pain Rating Scale (NPRS). This allows us to verify the potential clinical application of surface EMG features in physiotherapy progress assessment.

Eligibility Criteria:
Inclusion Criteria:

* One hundred persons with non specific low back pain will be recruited consecutively from the Specialist Outpatient Department (SOPD) of Physiotherapy Department of Queen Elizabeth Hospital. Subjects will be included in the study if they presented with symptom duration of greater than three months with no radiological abnormality detected.

Exclusion Criteria:

* All subjects should be able to provide informed consent and demonstrate sufficient ability to tolerate the experiment procedure to avoid aggravation of symptoms during the experiment procedures. Subjects will be excluded if they have any major orthopedic, neurological, circulatory or respiratory conditions, a history or family history of epilepsy, recent or current pregnancies, and previous surgery to the abdomen or back. The back pain history in the previous year will be documented for those eligible subjects.
Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention

Stress is a common problem with significant consequences for health. It can be a trigger for somatic diseases as well as psychological disorders and leads through missed working days and healthcare cost to a high economic loss. It is for health and economic reasons essential to develop and evaluate effective interventions that can inoculate against stress and build inner strength.

A cognitive-behavioural training for groups that is well evaluated and has shown to be effective is the Stress-Inoculation-Training by Meichenbaum. As the public utilization of methods of the complementary and alternative medicine is increasing a rigorous evaluation is needed. Integrative Kinesiology is a popular method that has been said to be effective against stress and its symptoms.

The investigators propose a randomized controlled evaluation and comparison of the interventions to each other and to a waiting-list control group. Hypothesis: Healthy volunteers attending a two dayseminar will show significantly reduced psychobiological reactivity, decreased stress perception and less anxiety to a standardized psychosocial stress test compared to the waiting list group. A total of 64 healthy volunteers will be randomly assigned to one of the three groups. The efficacy of the interventions will be measured through the Trier Social Stress Test (TSST) to measure the psychobiological stress reactivity.


Eligibility Criteria:
Inclusion Criteria:

* Ready to participate in randomly one of the three groups
* mentally and physically healthy
* Sufficient German-speaking abilities to participate in the training

Exclusion Criteria:

* previous experience with Integrative Kinesiology or cognitive-behavioural therapy
* previous experience with the Trier Social Stress Test
* daily alcohol consumption: \> two alcoholic drinks
* daily tobacco consumption: \> 5 cigarettes per day
* any kind of drug abuse
* pregnancy, after the second trimenon
* intake ofe hormonal compounds (birth control pill and hormon replacement therapy)
Study of the Effects of the Consumption of Different Products Cocoa Derivatives at the Risk of Crystallization of Uric Acid in Urine of Volunteers.

The present study aims to assess the effectiveness of theobromine, -product present in high proportion in the cacao-, to prevent the development of uric acid kidney stones.

Renal lithiasis is a pathology that affects a high percentage of the population, and although it has been known for a long time, advances carried out in the treatment are limited to the surgical aspects, while the causes responsible for the formation of kidney calculus are not corrected, which leads to a high recurrence.

The "healing" of renal lithiasis inevitably goes through the elimination of the alterations related to the genesis of kidney calculus. It the case of uric acid lithiasis the most important are having urinary pH less than 5.5 and an elevated uricosuria, which can be corrected relatively easy by undergoing changes in dietary habits, and with pharmacological treatment with citrate -which produces and increase in pH- or with inhibitors of the xantino-oxidase as allopurinol. However, among the prophylactic treatments available for ural acid lithiasis, so far it does not exist one for urinary acid crystallization inhibition.

Recently, the effects of theobromine as an inhibitor of the crystallization of uric acid have been described, but only in vitro. The present study aims to assess the effectiveness of theobromine, -product present in high proportion in the cacao-, to prevent the development of uric acid kidney stones.

The study is a unicentric, low intervention, non-randomized, prospective study to assess the effects of the consumption of different cocoa derivate products, in the risk of crystallization of uric acid in the urine. Participants in the study are healthy volunteers and will it will be carried out with 20 individuals who will be recruited in the Research Laboratory in Renal Lithiasis of the Baleares Isles University.

Patients will take a urine test previously to undergo 4 dietary interventions, with their subsequent urine measurements. Patients will choose one diet to follow for 1 day, and will be provided with the corresponding cocoa derivate for the diet (soluble cocoa, black chocolate, chocolate with milk). The day after the diet they will take a fast-picking of urine accumulated during the night of which they followed the controlled diet (12 h nocturne sample), then follow a 6 day washout period, and select another diet to follow and repeat until they have gone through the 4 diets and measurements.

Eligibility Criteria:
Inclusion Criteria:

* Compliance in participating and collaborating in the study

Exclusion Criteria:

* Cocoa / chocolate allergy or theobromine
* Pregnancy, nursing period (women)
* pharmacological treatment
* chronic diseases (diabetes, kidney failure, heart failure, hyperuricemia, ...)
Allograft Dysfunction in Heart Transplant

The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes.

Adult heart-transplant patients, excluding those with a GFR less than 30 mL/min/1.73m2, contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be enrolled over 60 months. Patients will be recruited from UCSD. The investigators will specifically enroll all eligible heart-transplant patients.

Brief protocol:

Cardiac MRI is performed. Cine images in standard views are obtained. T1 and T2 mapping sequences are performed on short axis images pre- and post-gadolinium contrast. For stress imaging, intravenous regadenoson is given as a 0.4 mg bolus followed by a 5 mL saline flush. After 30 seconds, short-axis images are acquired for 30 consecutive heartbeats with administration of gadolinium. Rest imaging is performed 30 minutes after stress imaging. Lastly, late gadolinium enhancement images are obtained in standard views. Images are analyzed offline by a blinded independent reader. Patients will be followed for at least 1 year after enrollment for MACE.

Peripheral blood and endomyocardial biopsies will also be collected, timing as per usual clinical care as well as for-cause, for single cell RNAseq analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old.
* At least three months status post heart transplantation.

Exclusion Criteria:

* Biopsy proven acute rejection episode in the past 3 months.
* Patients with symptoms or signs of acute myocardial ischemia or recent acute coronary syndrome in the past 3 months.
* Uncontrolled obstructive ventilatory disease including asthma and COPD.
* History of generalized tonic-clonic seizures.
* Second or third degree AV nodal block.
* Sinus node dysfunction.
* Contraindications to MRI including cardiovascular implantable electronic devices.
* Renal dysfunction with an estimated GFR less than 30 mL/min/1.73m2.
* Prior adverse reaction to either regadenoson or gadolinium contrast. Prior adverse reaction to adenosine or dipyridamole will be assessed on a case-by-case basis.
* Systolic blood pressure greater than 180 or less than 85 mmHg.
* Diastolic blood pressure greater than 120 or less than 40 mmHg.
* Resting heart rate greater than 120 or less than 45 beats per minute. - Severe claustrophobia.
Comparing of Different Visual Aids Like Video,info-graphics and Pamphlets in Enhancing Community Awareness and Promoting Behavioral Change Towards the Prevention of Hypertension in Basilica of the Most Holy Trinity Onitsha Anambra State,Nigeria

The goal of this observational study is to assess different level of enhanced awareness and behavioral change of adults over the age of 35 who will be educated using video,infographic and pamphlet for the interval of one month


Eligibility Criteria:
Inclusion Criteria:

* Adults age over 35 years old
* Who does not know his/her blood pressure status within the last 6 months (The person who does not know he or she has a hypertension or not.)
* Who agree to participate

Exclusion Criteria:

* Who cannot come to the church 4 weeks later after the intervention.
* Known hypertensive patients
Cleveland African American Prostate Cancer Project

The purpose of this research is to test intervention strategies that encourage and support Black or African American men who are 40 and older to complete prostate cancer screening, and specifically to complete a prostate-specific antigen (PSA) test.

This intervention is designed to evaluate the effectiveness of three different approaches to increasing PSA screening in African American men, starting at age 40. The approaches are 1) education and passive navigation, 2) education and active navigation, and 3) education and active navigation with community based outreach. Completion of a PSA blood test is the primary outcome of this study, which will be evaluated four months following the recruitment phase at each shop. At the 4 month follow-up, participants will be asked about PSA completion; participants who completed PSA screening will be asked to provide outcomes from their PSA screening (ie. PSA results and provider recommended next steps), as well as their feelings regarding their screening experience, trust in the screening process, and knowledge about prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* ≥40 years old
* Self-identify as Black or African American
* Have a prostate gland (includes biological males, transwomen)
* PSA-naïve or has not received a PSA test in the past 12 months
* Has not had a previous prostate cancer diagnosis
* English speaking
* Ability to consent to study

Exclusion Criteria:

* Individuals who have had a prostatectomy
Influence of Anthropometric Data, Shoulder Complex Muscle Strength, and Abdominal-lumbar Endurance in Closed Kinetic Chain Upper Extremity Stability Test

A previous study of the Closed Kinetic Chain Upper Extremity Stability Test (EPOLTEST) in a population aged 18 to 25 years isolated 3 main factors influencing the CKCUEST score: upper extremity span, weight, and sex of the individual. A predictive equation for the CKCUEST score was thus established and to date has a capacity to determine the real score of approximately 51%.

The results of this first study show that a certain number of variables have not been studied.

The purpose of this study, EPOLTEST 2, is to take into account the variables already studied on a larger population (18-50 years old) and to add an assessment of shoulder muscle strength and abdominolumbar endurance.


Eligibility Criteria:
Inclusion Criteria:

* Aged to 18 to 50 years
* Capacity to consent
* Who has signed the consent

Exclusion Criteria:

* Fracture history or upper limb luxation \< 1 year
* Pain or discomfort that prevents the test from being performed
* History of abdominal surgery or hernia \< 1 year
* Pregnant or nursing
* Refuse to participate
* Guardianship or protection of vulnerable adult
Intraarticular Dextrose Prolotherapy for Symptomatic Knee Osteoarthritis

The purpose of this research is to learn more about treating Symptomatic Knee Osteoarthritis (OA) with an ultrasound-guided hypertonic dextrose injection. Researchers would like to determine best practice for injection frequency and effectiveness of the dextrose injection for symptomatic knee OA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of knee OA by clinical criteria (American College of Rheumatology).
* Identification of knee osteoarthritis by a radiologist on an existing knee radiograph obtained within 3 years of enrollment.
* Moderate to severe knee pain for at least 3 months, defined as a score of ≥ 4 (on a 0-10 point numeric rating scale) in response to the question "What is the average level of your left/right knee pain in the past 3 months?".

Exclusion Criteria:

* Pregnancy.
* Diabetes.
* Anticoagulation therapy.
* History of total knee replacement.
* Prior knee prolotherapy or other regenerative product.
* Any knee injection within 3 months.
* Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.
* Daily use of opioid medication.
* Allergy or intolerance to study medication, corn allergy.
* Body mass index (BMI) greater than 40 kg/m\^2.
* Comorbidity severe enough to prevent participation in the study protocol.
Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease

The trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods.

Small-incision open cholecystectomy (minilaparotomy) for gallbladder disease has been proven superior to conventional open cholecystectomy. However, it was rapidly overshadowed by laparoscopic cholecystectomy when the latter method was introduced. Today, some 25% of all gallbladder surgery is done with the conventional open cholecystectomy, often on elderly and frail patients. Previous trials comparing minilaparotomy and laparoscopic cholecystectomy have been hampered by surgeons´ different expertise with the two methods. These studies indicate that operation time is shorter and that health care cost is lower for minilaparotomy compared to laparoscopic cholecystectomy, but hard data are scarce. The objective of the present trial is to randomize eligible patients to two groups of surgeons, well trained in either minilaparotomy cholecystectomy or laparoscopic cholecystectomy. Surgeons in the minilaparotomy group will consider extension of the incision when necessary, and surgeons in the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open cholecystectomy if this is indicated. The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.

Comparison: Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease.

Eligibility Criteria:
Inclusion Criteria:

1. Cholecystectomy is considered the best available treatment.
2. The patient understands trial information and is capable of making a decision after having received information.
3. The patient wants to undergo cholecystectomy and accepts participation in the trial.

Exclusion Criteria:

1. Age below 18 years.
2. The patient is unable to understand trial information.
3. Competence for both trial groups are lacking when a patient is randomized.
4. The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy).
5. The indication of cholecystectomy is proven or suspected cancer of the gallbladder.