cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Neurofeedback for the Treatment of Chronic Pain

This study evaluates the effectiveness of neurofeedback (teaching participants to gain control over their own brainwaves) in chronic pain. The study is made up of four pilot studies. Participants who take part will undergo the cold pressor test, submerging their hand in cold water in order to simulate chronic pain. Brain activity will be measured using electroencephalography (EEG).

Chronic pain is a persisting pain which often exists in the absence of detectable tissue damage. It is also associated with feelings of depression, anxiety, and despair. Current treatments for chronic pain usually involves drug treatments, which often has unwanted side effects.

This study aims to assess the effectiveness of neurofeedback, which refers to teaching participants to gain control over their own brainwaves, as an intervention to treat chronic pain. It is believed that by teaching participants to gain control over a brain signal associated with pain resilience, the participant can reduce some of the negative effects associated with chronic pain.

Participants who take part in this study will have their brain activity recorded using electroencephalography (EEG), and have pain elicited using the cold pressor test (CPT), which involves the participant submerging their wrist in cold water to elicit a chronic pain-like sensation. This is a safe, regularly used method, and the participant is free to remove their hand early if the pain becomes too great.

Some participants who take part will undergo neurofeedback training, which will involve them viewing a signal associated with pain resilience, and learning to increase it over multiple sessions.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study
* Must be aged 40 or older

Exclusion Criteria:

* Current or planned hospitalisation during the period of study.
* Non-English speaking participants
* Participants already involved in clinical trials, if it is not possible to schedule around this
* Unable, in the opinion of the research investigator, to comply or adhere to the requirements of the study.
* Patients with chronic pain in both upper limbs
* History of brain injury, stroke or neurosurgical procedures
* An implanted neurostimulator (e.g., deep brain stimulator)
* Damaged skin tissue on the head, or a skin condition such as severe eczema, or any skin allergies
* Failure of cognitive test (Montreal Cognitive Assessment) will exclude participants from taking part in studies that use neurofeedback procedures
* Some but not all of the study will be unavailable to participants currently undergoing psychotherapy (such as cognitive behavioural therapy).
The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

This is a pilot study to evaluate a restraint device for lumbar punctures. Designed to help improve the restraint techniques for lumbar puncture, the restraint device will be compared to the current standard of manual physical restraint in neonatal and pediatric patients (age 1 day to 90 days of life). The investigators will study 30 subjects, with 20 randomized for the experimental device and 10 randomized for the "control" group, which is current standard of care. The investigators' primary outcomes will include time of procedure, red blood cells in the cerebrospinal fluid as well as physician satisfaction. Subjects will be eligible if they are 1-90 days of life, and their treating physician believes lumbar puncture is indicated. There is no follow-up once the lumbar puncture has been completed and the data has been obtained.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 to 90 days of life
* Indication for lumbar puncture procedure as determined by the treating physician
* Informed Consent from the subject's legal guardian indicating their acceptance of a lumbar puncture for the work-up of sepsis
* Informed consent to enrolled in said protocol

Exclusion Criteria:

* No indication for lumbar puncture procedure as determined by treating physician
Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0

The study evaluated the safety, tolerability and acceptability of a lifestyle modification program with nutritional supplementation designed to restore balance to healthy bowel function in generally healthy subjects

To investigate the safety, tolerance and acceptability of a lifestyle modification and targeted nutraceuticals for balanced bowel function in generally healthy volunteers. To evaluate safety and tolerability, blood samples were drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. Quality of life questionnaires, medical symptom questionnaire were evaluated at baseline, week 1, week 2 and week 4. Vitals signs, weight and body composition were monitored at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 and ≤ 69 years old
* Generally healthy and meeting entrance criteria
* Score ≥ 8 points on the Purify Readiness Scale (Appendix B)
* Willingness to make required lifestyle changes during study participation
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Change in prescription medications, over-the-counter medications, medical foods, and nutritional supplements within 30 days prior to Day 1 and for the duration of the study.
* Use of medications classified as narcotics 15 days prior to Day 1 and for the duration of the study.
* Use of prescription medications and/or over-the-counter medications for acute and semi-acute medical conditions 15 days prior to Day 1 and for the duration of the study. Use of acetaminophen is permitted on an as-needed basis.
* Use of an investigational drug or participation in an investigational study within 30 days prior to Day 1 and for the duration of the study.
* Use of oral or injectable corticosteroids within 30 days prior to Day 1 and for the duration of the study.
* Use of anticoagulant medications (heparin compounds, platelet inhibitors or warfarin) within 30 days prior to Day 1 and for the duration of the study. Use of aspirin 81 mg or 325 mg once daily is permitted.
* Use of neuro-active prescription medications specifically major and atypical antipsychotic medications within 30 days prior to Day 1 and for the duration of the study.
* Use of prescription medications, over-the-counter medications, medical foods, and nutritional supplements for the treatment of hyperlipidemia within 30 days prior to Day 1 and for the duration of the study.
* Use of prescription medications, over-the-counter medications, medical foods, and nutritional supplements for the treatment of hyperglycemia within 30 days prior to Day 1 and for the duration of the study.
Evaluation of an App Based on Artificial Intelligence for Pain Assessment in Pediatric Department

Accurate assessment of pain in Pediatric Department is challenging. However, recent publications highlight that children do not receive optimal pain management, particularly in Emergency Departments.

An Artificial Intelligence-based tool could help physicians to optimize analgesia use.

Acute pain is the reason that the majority of patients present to the Emergency Department. Multiple studies conducted over many years have demonstrated that pain is poorly managed in the Emergency Department. This phenomenon has been referred to in the Medical Literature as "Oligoanalgesia.". Morever, untreated pain can have short and long term effects in Pediatric population, including sensitisation to pain episodes in later life and can affects the Neurodevelopment of the child.

The generally accepted standard for pain assessment is self-reported; however, in preverbal children who cannot communicate their pain, age-appropriate behavioural or observational pain assessment tools are recommended. Because children are not always able to voice their feelings, they completely depend on their caregiving team for the interpretation and management of their pain and discomfort. Thus, accurately validated scales to assess pain levels are crucial. In France, the EVENDOL is the most used widely scale. The EVENDOL scale (from the French Evaluation Enfant Douleur) is used to evaluate pain in children in any situation covering a wider age group than other pain scales (birth up to seven years). Despite a large number of scales with a variety of Psychometric properties having been published in the last decades, to date, there is no criterion standard when considering the assessment of pain. As a result, children continue to be suffered pain without adequate pain management. International guidelines incorporate the need for prompt recognition of pain.

Artificial Intelligence (AI) in Medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. AI in this field can be used to support clinician decision making, allow curiosity-driven care, remove the need to complete mundane tasks, improve communication, and facilitate collaboration. Evaluation of the face is central to all observational pain assessment tools, as the face is highly accessible and facial expressions are considered the most encodable feature of pain Therefore.the investigators aim to develop, validate and asses a system based on Digital Face Recognitation for pain assessment in the Children's Department.

Eligibility Criteria:
Inclusion Criteria:

* Child under 18
* Informed and written consent of a parent or guardian (only 1 accompanying person allowed).

Exclusion Criteria:

* Language barrier.
* Refusal to participate by parents/children
* Sign of collapsus, or in serious clinical condition (stage I or II) requiring absolute emergency care,
* Delayed mental or staturo-ponderal development
* Facial injury or wound, presence of a bandage on the face, pre-existing facial deformity
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent has been obtained.
* Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information \[US sites\] and written Data Protection consent \[EU sites\]).
* Patient must be an outpatient at the time of Visit 1 (Screening).
* Patient meets the DSM-5 criteria for MDD based on SCID-5, with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
* Diagnosis of MDD confirmed through a formal adjudication process.
* Patient demonstrates ability to follow study instructions and likely to complete all required visits.
* Patient must have an inadequate response, as measured by the modified ATRQ, to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
* Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and patients must agree to continue taking the same ADT dosing regimen through completion of Visit 6/ET. Patients who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
* Male and female patients must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
* Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria:

* Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
* Patient has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.
North American Acute Coronary Syndrome (ACS) Reflective III Pilot

The North American ACS Reflective III Pilot is an observational, Quality Enhancement Research Initiative (QuERI), knowledge translation program designed to give feedback to physicians on their post-ACS lipid-lowering management in an effort to support their decision-making and choice of therapies and thereby better achieve evidence-based, guideline-recommended management of post-ACS patients. The ACS Reflective III Pilot follows the completed ACS Registries I, II, and III, ACS Reflective I, and the ongoing ACS Reflective II programs.

The main objectives are:

1. To identify and describe post-ACS patients who do not achieve guideline-recommended LDL-C "target" (\<1.8 mmol/L in Canada, \>50% LDL-C lowering on high-intensity statin in the U.S.);
2. To identify opportunities where PCSK9 inhibitor therapy may be of potential benefit in the management of post-ACS patients to achieve guideline-recommended LDL-C goal by 1 year follow-up; and,
3. To determine reasons why physicians are not prescribing guideline-recommended LDL-C lowering therapies and/or patients are not achieving guideline-recommended LDL-C goals.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age;
2. ACS 1-12 months prior to enrolment defined by symptoms of myocardial ischemia with an unstable pattern, occurring at rest or with minimal exertion, within 72 hours of an unscheduled hospital admission due to presumed or proven obstructive coronary disease and at least one of the following:

   1. Elevated cardiac biomarkers (e.g., troponin) = myocardial infarction (MI); or,
   2. Resting ECG changes consistent with ischemia, plus additional evidence of obstructive coronary disease from regional wall motion or perfusion abnormality, 70% or greater epicardial coronary stenosis by angiography, or need for coronary revascularization procedure = unstable angina (UA); and,
3. LDL-C ≥1.81 mmol/L (70 mg/dL) despite maximally tolerated statin ± ezetimibe therapy (including patients who are intolerant of ≥2 statins).

Exclusion Criteria:

1. Participating in a research study where the lipid-modifying therapy is unknown, randomly assigned (i.e., choice not determined by the physician), or not approved for clinical use; or
2. Follow-up or life expectancy \<1 year.
A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent.
* No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram and routine laboratory evaluations.
* Low-density lipoprotein cholesterol (LDL-C) level of 70-190 mg/dL (inclusive).
* Body mass index (BMI) ≥18 and ≤ 28 kg/m\^2 , body weight \>= 50 kg for male or \>= 45 kg for female.

Exclusion Criteria:

* Triglyceride concentration \>400 mg/dL (4.5 mmol/L).
* History of hypersensitivity reactions to any substance of the investigation drug or other monoclonal antibodies.
* Drug or alcohol abuse within 6 months prior to dosing.
* Blood pressure \>140 mmHg (systolic) or \> 90 mmHg (diastolic)
Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

The purpose of this study is to investigate post-operative and post-radiation upper esophageal sphincter opening measures in oral cancer patients, compare measures to age- and gender-matched healthy adults, and determine relationships with patient swallowing outcomes and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Oral cancer that includes tongue or floor of mouth clinical stage T1 or higher
* May have disease that extends to base of tongue or other site as long as floor of mouth or tongue are involved
* Adults at least 18 years of age

Exclusion Criteria:

* Oral cancer of the lip, cheek, palate or other site not impacting tongue or floor of mouth musculature
* History of floor of mouth, tongue base, pharyngeal or laryngeal surgical resection
* History of radiation treatment to the head and neck
* History of dysphagia prior to onset of oral cancer symptoms
* Allergy to lidocaine, barium, adhesive tape or apple flavoring
* Woman of childbearing years who are pregnant
The Effect of Relaxation Techniques on Earthquake Survivors

The aim of this study is to investigate the effect of relaxation and breathing exercises on individuals experiencing post-earthquake stress-related symptoms.

Earthquakes negatively affect survivors both physically and psychologically. Early psychological symptoms after disasters are considered normal responses to an abnormal event. Therefore, it is not unexpected to feel very intense negative emotions after such traumas. However, the chronicity of these negative emotions puts the lives of individuals at risk. Mental problems such as stress, depression, posttraumatic stress disorder and anxiety are seen at high levels among earthquake survivors. In this study, it was aimed to investigate the effect of relaxation and breathing exercises applied to earthquake survivors who experienced post-earthquake stress-related symptoms.

There are two gropus: relaxing exercise group and control group. Relaxing and breathing exercise protocol is only for relaxing exercise group. A protocol consisting of 40 minutes of progressive muscle relaxation exercise and breathing exercises, 3 times a week for 4 weeks, was planned. Control group participants were asked to continue their daily lives. Evaluations were made before and 4 weeks after the intervention and stress-related symptoms were measured.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a Beck anxiety inventory score greater than 8 and anxiety experience for more than 1 month
* Individuals who experienced the earthquake of February 6, 2023 Kahramanmaraş / Türkiye and agreed to participate in the study
* Individuals without cognitive impairment
* Individuals who can understand and apply verbal commands in Turkish

Exclusion Criteria:

* Any history of psychiatric medication support for the last 6 months
* Any history of psychological problems before the earthquake
Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial

To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension

In order to derive a reliable correlation between statin use and the reduction of portal hypertension, it is necessary to proceed with a clinical study with a high level of evidence, such as a randomized controlled clinical trial study. In addition, previous small randomized controlled trials had a limitation in that patients with various causes of liver cirrhosis were included. In this study, only patients diagnosed with chronic hepatitis B and compensated cirrhosis who are taking antiviral treatment will be included in the study, and in patients whose viral activity are suppressed by taking antiviral treatment, it was investigated whether statin administration had a significant effect in additionally improving portal pressure. We want to prove it through a randomized controlled clinical trial study.

Eligibility Criteria:
Inclusion Criteria:

1. Adults between 19 and 69 years of age
2. If HBsAg positivity has been observed for more than 6 months or a clinical history of chronic hepatitis B is confirmed
3. When liver cirrhosis is diagnosed histologically, radiologically, or clinically (if one or more of A-D is applicable) A. When stage F4 fibrosis is confirmed by liver biopsy B. When splenomegaly is observed with morphological changes (surface nodularity and hypertrophy of the caudate lobe) appropriate for liver cirrhosis.

   C. If the platelet count is less than 100,000/mm3 in two consecutive tests D. When esophageal varices or gastric varices are confirmed by upper gastrointestinal endoscopy
4. If the serum HBV DNA is well controlled to 2000 International Unit (IU)/mL or less while taking antiviral treatment
5. When the splenic elasticity measured by two-dimensional shear wave elastography is greater than 25 kilopascal(kPa)
6. When informed consent is possible

Exclusion Criteria:

1. Hepatitis C or HIV co-infected person
2. Those who continuously drink more than the standard (alcohol intake exceeding 20g per day)
3. In case of decreased liver function with Child Pugh score of 7 or higher
4. History of decompensated cirrhosis: history of ascites, spontaneous bacterial peritonitis, hepatic coma, varicose bleeding, hepatic nephrotic syndrome
5. If there is a history of cancer (except for cases where there is no recurrence for 5 years after treatment due to early solid organ tumors (early gastric cancer, thyroid cancer))
6. If there is a serious comorbidity whose life expectancy is estimated to be less than 3 years
7. In case of chronic kidney disease estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
8. If portal vein thrombosis is diagnosed
9. Previous intrahepatic portal vein shunt intervention or liver transplantation
10. A history of statin administration within the last 2 years
11. In case of side effects from previous statin administration (drug-related hepatotoxicity, muscle toxicity, allergic reaction, etc.)
A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning (USF)

Increased computational power has made it possible to implement complex image recognition tasks and machine learning to be implemented in every day usage. The computer vision and machine learning based solution used in this project (Nelli) is an automatic seizure detection and reporting method that has a CE mark for this specific use.

The present study will provide data to expand the utility and detection capability of NELLI and enhance the accuracy and clinical utility of automated computer vision and machine learning based seizure detection.

This is a prospective, blind comparison to the clinical gold standard for seizure characterization. This study is intended to compare the Nelli Software's ability to identify seizure events to vEEG review in adults with suspected nighttime seizures. Simultaneously, Nelli will continuously record audio and video while video-electroencephalography (vEEG) is recorded per typical standard of care. Events with positive motor manifestations will be independently identified, following standard clinical practice, by three epileptologists using clinical vEEG data. Nelli Software will review the audio and video data and independently identify events with positive motor manifestations. The outcomes of event identification will be compared between Epileptologists and the Nelli Software. For each category of event captured the positive percent agreement will be calculated using the exact binomial method. The primary endpoint of this study is to demonstrate that Nelli is able to identify seizures that have a positive motor component with a sensitivity of \> 70%.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing video-EEG monitoring for clinical purposes who are suspected of having seizures.

Exclusion Criteria:

-