cyrilzakka/clinical-trials huggingface dataset:
Combination of an Investigational Cannabinoid and Methadone for HIV-associated Neuropathy

The purpose of this study is to evaluate the effectiveness of methadone alone and in combination with SAB378 for the treatment of painful HIV-associated neuropathy.

Distal sensory polyneuropathy is the most common neurological complication of HIV disease and its treatment. To date no standard effective therapy has been identified.

In this study, scientists will evaluate the effectiveness of treating HIV-associated neuropathy with methadone alone and in combination with a novel cannabinoid SAB378. A cannabinoid is a molecule found only in the Cannabis plant. Cannabis and some cannabinoids are effective analgesics or pain relievers. The rationale for combination therapy is twofold: (1) medications with unique mechanisms of action may affect different aspects of neuropathic pain and (2) combination therapy may act synergistically-meaning the combined effect may be greater than the effect of each drug alone.

Approximately 84 participants will be enrolled in this double-blind, placebo-controlled, crossover study. Participants will be randomly assigned to three treatment groups-those receiving methadone and SAB378 placebo (an inactive substance), those receiving methadone and active SAB378, or those receiving methadone placebo and SAB378 placebo. All participants will be exposed to each of the 3 treatment groups during the study.

This trial is part of the Neurologic AIDS Research Consortium, an effective collaborative clinical study group dedicated to the study of HIV-associated neurological disease.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* HIV-associated neuropathy diagnosed by a neurologist
* Presence of at least a moderate pain score on the basis of completion of a baseline pain diary
* Stable antiretroviral regimen for at least 8 weeks prior to study entry.
* Hemoglobin ≥ 8.0 g/dL for males and ≥ 7.5 g/dL for females

Exclusion Criteria:

* Active AIDS-defining opportunistic infection within 45 days prior to study entry
* Renal insufficiency
* Chronic liver disease
* B12 deficiency
* Family history of hereditary neuropathy
* Discontinuation of dideoxynucleoside NRTI within 16 weeks prior to entry
* On neuroregenerative therapy
* Treatment with neurotoxic drugs within 120 days prior to entry
* Respiratory compromise
* Hypotension
* Active substance abuse or dependence
* History of alcohol-related complications within 6 months prior to screening
* Women of childbearing potential
Quality Assurance of Electronic Data Capturing (EDC) in Pain Treatment

There are actually no standardized quality assurance procedures included in pain treatment processes.

In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested in pain therapy centres using the validated questionnaire "Activity Index". The acceptance of electronic data capturing is tested in patients and therapy teams (doctors and nurses).

Regarding the demand for a duly documented efficacy of the therapy applied, a standardized procedure is imperative to show the medical and economic advantages of a given therapy. To obtain valid results, it is necessary to use a standardized process, monitored with a validated questionnaire.

In this multi-center study the Activity Index Questionnaire will be tested regarding its outcome quality regarding usability and patient acceptance. Each center collects data of 10 patients with injection pain therapy. Each patient is interviewed twice and after the 2nd interview each patient will fill out a feasibility questionnaire. During the whole study, the use and consumption of oral analgetic drugs are monitored in a diary. The statistical Analysis is done descriptive. Before entering the study, each patient has to give informed consent to participate. National Registration Guidelines for post market surveillance will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Willingness for therapeutic pain injection in lumbar spine

Exclusion Criteria:

* Cognitive impairment, technical Problems in interviewing patients
The Effect of Reflexology and Pelvic Floor Muscle Exercises (Kegel) on Urinary Incontinence in MS Patients

The research was carried out as experiment, control group, pretest-posttest model and single-blind. The population of the study consisted of MS patients who applied to OMU (Ondokuz Mayıs University) Neurology Service and Neurology Outpatient Clinic between March 2020 and February 2022. Fifteen patients who met the inclusion criteria were included in the study. Patients were divided into reflexology, pelvic floor muscle exercise and control groups. The control group was not intervened, only data collection tools were applied.

The research was carried out as experiment, control group, pretest-posttest model and single-blind. The population of the study consisted of MS patients who applied to OMU (Ondokuz Mayıs University) Neurology Service and Neurology Outpatient Clinic between March 2020 and February 2022. Fifteen patients who met the inclusion criteria were included in the study. Patients were divided into reflexology, pelvic floor muscle exercise and control groups. The control group was not intervened, only data collection tools were applied.

reflexology intervention The reflexology application was carried out in a separate and quiet room, on a stretcher/bed where the patient could lie down, by adjusting the temperature so that they would not feel cold/sweaty. First, the feet were cleaned with a warm, damp cotton towel. Odorless, room temperature baby oil was used to provide lubricity during the reflexology application. The reflexology protocol was started with the right foot. First of all, rotation, vibration, etc. are applied to the ankle and ankle areas. relaxation techniques were applied for 2 minutes. Afterwards, reflexology massage was applied to the spinal cord, brain, pituitary areas, kidney, ureter and bladder areas with appropriate techniques. The session was concluded with solar plexus compression and relaxation maneuvers. The same protocol was applied in the left foot. Immediately after each reflexology session, the patient was allowed to drink 1 glass (200 ml) of water to accelerate the excretion of toxic products. Reflexology session was completed in 40 minutes for both feet. Foot reflexology was applied to the reflexology group twice a week (40 minutes for both feet) for a total of 4 weeks.

Pelvic floor muscle exercise (Kegel) application In the Kegel exercise group, the patients were taught the Kegel exercise at the first interview, and it was provided to be done under the guidance of the researcher. Afterward, they were asked to apply at least three times a day for four weeks, and a reminder SMS was sent to the patients daily.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MS at least 6 months ago,
* Having an EDSS of \<5,

Exclusion Criteria:

* To have wound on foots, varicose veins, etc. history of fractures causing loss of function, nail fungus,
* pregnancy,
* presence of acute infection
* To using any diuretic or incontinence medication,
* To have a curettage or pregnancy history in the last 6 months
The Recurrence Mechanism of Venous Tinnitus After Boney Wall Reconstruction Based on Multimodal Imaging and Multiphysics Coupling

Venous tinnitus (VT) is seriously affecting the quality of life of five million patients in China. Bony wall reconstruction is the main treatment method, but the postoperative recurrence rate exceeds 30%, and the specific mechanism is unclear. Based on our previous work, a scientific hypothesis was put forward: the key to the recurrence of V T is pathologic remodeling of the peri-sinus bony wall mediated by the venous sinus morphology, blood flow, and pressure after surgical reconstruction. As a continuation of the National Natural Science Foundation of China-Youth Project, this project intends to combine multimodal imaging technology, multiphysics coupled numerical model and machine learning method to analyze analyze the data after bone wall reconstruction in multiple dimensions: ① To explore the influence of peri-sinus bony wall morphology, venous sinus morphology, intra-sinus blood flow, intra-sinus pressure, and cerebral perfusion on the recurrence of VT using ultra-high resolution CT, vessel wall MR, 4D Flow MR and ASL MR imaging technology; ② To explore the influence of blood flow impact, sinus wall pressure and peri-sinus bone wall deformation on the recurrence of VT using multiphysics coupling numerical model with vessel, blood flow, bone and acoustic fields; ③ To determine the risk factors and their weights of VT recurrence using machine learning methods, and to establish a personalized surgical planning and prognostic evaluation models; Thus, to verify the hemodynamic and biomechanical mechanisms of VPT recurrence to achieve personalized and effectively treatment. This project may prevent and warn the recurrence of VPT after bony wall reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* patients with venous tinnitus, a rhythmic noise that follows the heart beating without external stimuli and can disappear or significantly reduce after compression of the affected side of the neck
* the normal otoscopy
* venous tinnitus patients with confirmed sigmoid sinus wall dehiscence with or without sigmoid sinuses enlargement, diverticula and transverse sinuses stenosis using dual-phase enhanced CT examination
* preoperative DSA examination
* bone wall reconstruction

Exclusion Criteria:

* contraindications for CT and MR Examination
* tumor and arterial abnormalities
Real-life Effectiveness of Vortioxetine in Depression

Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences.

Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice.

The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life.

This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.


Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥18 years
* The patient is an outpatient, treated in a GP or psychiatric outpatient practice
* The patient has a diagnosis of major depressive episode according to local diagnostic criteria
* The patient has been prescribed vortioxetine according to the local Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* The patient is unable to read and understand the information sheet and informed consent form or the Patient Reported Outcomes (PRO)
* The patient is concurrently participating in a clinical trial
* The patient has a diagnosis of schizophrenia or other psychotic disorder according to local diagnostic criteria
* The patient has a diagnosis of bipolar disorder according to local diagnostic criteria
* The patient has a substance use disorders other than tobacco use disorder
* The patient has dementia or other neurodegenerative disease significantly impacting cognitive functioning
* The patient has a mood disorder due to a general medical condition or substances
* The patient is pregnant, ≤6 months post-partum or breastfeeding
* The patient is at significant risk of suicide in the investigator's opinion or the patient has attempted suicide within the last six months
* The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.

Eligibility Criteria:
Inclusion Criteria:

* Not pregnant
* Weight over 50kg presenting for open myomectomy
* No history of allergy to any study medication
* No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
* No history of drug or alcohol use or abuse disorder or pre-existing liver disease.
Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor

This study aims to compare the effectiveness of spinal anesthesia adjuvant and quadratus lumborum block on the opioid requirement and perioperative pain on patients undergoing laparoscopic kidney transplant donor.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years undergoing laparoscopic donor nephrectomy
* Patients with BMI ≤ 35 kg/m2
* Patients with American Society of Anesthesiology (ASA) physical status 1-2
* Patients who are willing to participate in this study

Exclusion Criteria:

* Cardiovascular disease (uncontrolled stage 2 hypertension, heart failure, arrhytmia)
* Recent onset cerebrovascular diseasae of \< 3 months
* Infection on spinal site
* Coagulopathy
* Elevated intracranial pressure
* Severe renal or liver dysfunction
* Valvular heart disease or atrioventricular block
Probing Neural Circuitry for the Control of Movement

The investigators are interested in examining 1) the basic organization of spinal and cortical circuitry for the control of movement and 2) the influence of injury of these circuits. To investigate the neuronal circuitry, the investigators use various types of mechanical or electrical stimulation of the limbs, transcranial magnetic stimulation of the cortex and galvanic vestibular stimulation in both uninjured human subjects and subjects with a neurological injury (such as spinal cord injury, or Parkinsons's disease).


Eligibility Criteria:
Inclusion Criteria:

* control subjects: no neurological movement disorder
* patients: neurological movement disorder

Exclusion Criteria:

patients and control subjects:

* presence of any central psychiatric disorder that precludes subject from giving informed and voluntary consent
* presence of any cardiovascular conditions or limitations that restrict the ability to walk on a treadmill continuously for more than 20 minutes
* for the electrical stimulation examination, subjects with metal implants are also excluded
* for the TMS and GVS examination, subjects with the following conditions are excluded: metal implants in the head, cardiac pacemakers, history of migraine headaches, history of major head injury, history of stroke, history of seizures, previous brain neurosurgery, unstable medical conditions, major psychiatric disorders, pregnancy -
Using NIATx Strategies to Implement Integrated Services in Routine Care

This is an implementation research study designed to evaluate a defined strategy, NIATx, for its effectiveness in installing and sustaining evidence-based integrated services for persons with co-occurring substance use and mental health disorders. This study is a cluster randomized wait-list control group design, in which a cohort of 25 addiction treatment agencies receives the active NIATx approach during an index 12 month period. The second (wait-list) cohort of 25 addiction treatment agencies activates NIATx strategies during a second index 12 month period. The primary "subjects" of the research are the treatment agencies themselves. The study specific aims are:

1. Relative to wait-list, to determine if NIATx strategies improve implementation outcomes (integrated service fidelity and receipt of more integrated services)
2. Relative to wait-list, to determine if NIATx strategies improve patient care outcomes (psychiatric, alcohol and drug problem severity)
3. Across entire sample, to evaluate variation in the extent of and fidelity to NIATx strategies

NIATx implementation strategies consist of learning sessions, individualized coaching and peer to peer sharing.


Eligibility Criteria:
Inclusion Criteria:

* Organizations who are licensed addiction treatment providers in the state of Washington were identified and provided the opportunity to participate in the study.

Eligibility criteria include:

* outpatient and/or intensive outpatient services
* tax-exempt, government status or at least 50% publicly funded (e.g., block grants, Medicare, Medicaid)
* no prior participation in NIATx research studies (this last criterion excludes 39 agencies who were involved in the NIDA funded NIATx 200)

Exclusion Criteria:

* Public mental health and private addiction treatment agencies are also excluded because only addiction treatment providers in Washington are required to use the state clinical information system, and therefore cannot provide the necessary standardized data
Effect of Omega 3 Fatty Acids on Vascular Function

The mechanisms through which omega-3 fatty acids reduce adverse cardiac events remain uncertain. The aim of the study was to investigate the effect of omega-3 fatty acid supplementation on endothelial vasomotor function, endogenous fibrinolysis, and platelet and monocyte activation in patients with coronary heart disease.

Twenty patients with a previous myocardial infarction were recruited into a randomised, double-blind, placebo-controlled, crossover trial of omega-3 fatty acid supplementation (2g/day for 6-weeks). Peripheral blood was taken for analysis of platelet and monocyte activation, and forearm blood flow was assessed in a subset of 12 patients during intrabrachial infusions of acetylcholine, substance P and sodium nitroprusside. Stimulated plasma tissue plasminogen activator (t-PA) concentrations were measured during substance P infusion.

Eligibility Criteria:
Inclusion Criteria:

• Myocardial infarction at least 3 months previously.

Exclusion Criteria:

* Dietary fish allergy or intolerance
* Women of child bearing potential
* Malignant arrhythmias
* Renal or hepatic failure
* Severe or significant co-morbidity
* Previous history of blood dyscrasia
* Unable to tolerate the supine position
* Lack of informed consent
* Blood donation within last 3 months
Comparison of Nutritional Products for People With Type 2 Diabetes

Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.

Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Type 2 diabetes
* 18 to 75 years of age
* Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
* If female is of childbearing potential, is practicing birth control
* BMI greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
* Medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit

Exclusion Criteria:

* Uses exogenous insulin for glucose control
* Type 1 diabetes
* History of diabetic ketoacidosis
* Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
* Active malignancy
* Significant cardiovascular event less than 12 weeks prior to study entry
* End stage organ failure or is status post organ transplant
* Has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
* Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
* Taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
* Fainted or experienced other adverse reactions in response to blood collection prior to this study
* Has clotting or bleeding disorders
* Allergic or intolerant to any ingredient found in the study products
* Participant in a concomitant trial that conflicts with this study
Retrospective Study on Epidemiology of Colorectal Lesions

Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.

Colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on colorectal lesions.

Eligibility Criteria:
Inclusion Criteria:

* Colonoscopies performed in Lyell McEwin Hospital between 2010-2016

Exclusion Criteria:

* Sigmoidoscopies