cyrilzakka/clinical-trials huggingface dataset:
Detection of EEG-Based Biomarkers of Chronic Low Back Pain

Chronic low back pain (CLBP) is a pervasive disorder affecting up to one-fifth of adults globally and is the single greatest cause of disability worldwide. Despite the high prevalence and detrimental impact of CLBP, its treatments and mechanisms remain largely unclear. Biomarkers that predict symptom progression in CLBP support precision-based treatments and ultimately aid in reducing suffering. Longitudinal brain-based resting-state neuroimaging of patients with CLBP has revealed neural networks that predict pain chronification and its symptom progression. Although early findings suggest that measurements of brain networks can lead to the development of prognostic biomarkers, the predictive ability of these models is strongest for short-term follow-up. Measurements of different neural systems may provide additional benefits with better predictive power.

Emotional and cognitive dysfunction is common in CLBP, occurring at the behavioral and cerebral level, presenting a unique opportunity to detect prognostic brain-based biomarkers. Likewise, improvements in electroencephalogram (EEG) neuroimaging strategies have led to increased spatial resolution, enabling researchers to overcome the limitations of classically used neuroimaging modalities (e.g., magnetic resonance imaging \[MRI\] and functional MRI), such as high cost and limited accessibility. Using longitudinal EEG, this patient-oriented research project will provide a comprehensive neural picture of emotional, cognitive, and resting-state networks in patients with CLBP, which will aid in predicting symptom progression in CLBP. Through this award, the investigators will use modern EEG source analysis strategies to track biomarkers at baseline and 1- and 2-month follow-ups and their covariance with markers for pain and emotional and cognitive dysfunction. A 5-month follow up will also be used to only assess patient reported outcomes. In Aim 1, the investigators will identify and characterize differences in resting-state, emotional, and cognitive networks between patients with CLPB and age/sex-matched controls. In Aim 2, the investigators will identify within-subject changes across time and their relationship with clinical symptoms. In Aim 3, as an exploratory aim, the investigators will apply machine- and deep-learning strategies to detect a comprehensive signature of CLBP using EEG features from resting-state, emotional, and cognitive networks.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of Chronic Low Back Pain

Exclusion Criteria:

* Current diagnosis of cancer
* Severe psychiatric conditions
* Pending personal litigation relating to an injury or receiving workers' compensation benefits
* Being a non-English speaker.
Radiation Exposure Using Laser Guided Fluoroscopy in Various Orthopaedic Procedures

Introduction: The orthopaedic surgeon is frequently exposed to ionizing radiation, especially during intraoperative fluoroscopy. It is expected that using a laser guided fluoroscopy technique, which should improve accuracy of radiography, should also reduce the amount of time of exposure to radiation. Finally, the literature appears controversial in this matter with no clear conclusions that could be drawn from such.

Hypothesis: The test hypothesis is that the use of the laser-aiming device for fluoroscopy in several orthopaedic procedures will reduce the exposure of the patient and the surgeon to the damaging effects of radiation. The null hypothesis then states that there will be no difference in exposure to radiation between the group using the laser device and the group not using the apparatus.

Methods: A prospective randomized controlled trial will be performed in which patients undergoing fluoroscopy will be randomly allocated to two groups. One group will undergo imaging with use of the device throughout the procedure and the other group will undergo radiation without the laser guided device. Number and time of exposure will be recorded for each procedure. It is of the utmost importance that the complexity of the procedures remains relatively similar. It is believed that a good measure of complexity is the surgical time. Therefore, any procedures that are statistically similar from a set mean (p \> 0.05) would be included into the study. It is also important that one or two surgeons with similar expertise and years of experience perform the surgeries to avoid confounding factors. It is expected that throughout the duration of the study (8 weeks) 50-100 cases would be reported which would produce statistically significant results. The results will be analyzed by calculating confidence intervals and differences between means of continuous data and significance levels by the Student's t test. Statistical significance will be set to P \< 0.05.

Risks and Benefits: This study involves minimal risk. The use of the laser guide will not increase or introduce any risks other than the associated inherent surgical risks. The risks usually associated with this type of studies concern breach of confidentiality. To reduce this risk, research numbers will be assigned to subjects' data collected during the procedure, whose personal information will be found in another password-protected database.

This study will help the investigators to investigate a technique that may help reduce the amount of time that a patient is exposed to radiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with fractures requiring surgery with fluoroscopic assistance

Exclusion Criteria:

* Patients with fractures treated without surgery
Prognostic Factors for Difficult Intubation

Difficult intubation is the situation that anesthesiologists don't want to face. Sometimes, difficult intubation affects the patient's oxygen saturation and harms for life. Many studies try to identify the predictors of difficult airway in pediatric patients. In this study, the investigator team want to identify the predictors of difficult intubation in pediatric patient by using additional parameters which are including hyomental distance, sternomental distance, neck circumference, ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance, Ratio of height to hyomental distance.

After approval from the instution's Ethics Committee, a prospective cohort study was conducted in pediatric patients aged between 1-8 years, ASA physical status I-II who were scheduled for general anesthesia in elective surgery. One day prior surgery, Children and their parents were invited to be participated in the study by using verbal invitation and flyer. After giving consent, Addition physical examinations which are the measurements of hyomental distance, sternomental distance and neck circumference were done by two independent investigators. The ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance and ratio of height to hyomental distance. At the day of surgery, standard general anesthesia (balance technique) was done. The child was intubated using aged appropriated laryngoscope by general anesthesiologist. Cormack-Lehane grading was used to identify the difficult intubation. (grade III and IV). Data will be analyzed by R Program. The statistically significance was set as P\<0.05. Multivariate Logistic Regression analysis will be used to identify the predictors of difficult intubation.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged between 1-8 years
* Schedule for elective surgery
* Having balance Anesthesia technique for surgery

Exclusion Criteria:

* Having aspiration risks
* Having history of difficult airway
* Abnormality of cervical spine /head and neck area
* Parental refusion
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

This 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks).

Patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. A responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in this study were as follows:

* Group A: ≥ 60 kg; maximum 15 mg/day
* Group B: 40-59 kg; maximum 9 mg/day
* Group C: 20-39 kg; maximum 6 mg/day
* Group D: \< 20 kg; maximum 3 mg/day

Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients.
2. Age of 6-12.
3. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
4. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study

Exclusion Criteria:

1. Have enrolled in Study MEM-MD-57A
2. Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being.
3. Participation in any other clinical investigation using an experimental drug within 30 days of screening.
4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS.
5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of schizophrenia
* Clinical stability for 16 weeks (4 months) prior to randomization
* Antipsychotic treatment stability for the past 12 weeks prior to randomization
* With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics)

Exclusion Criteria:

* Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
* Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
* Patient has a body mass index (BMI) of \<17 or \>40 kg/m2, respectively)
* Diagnosis of mental retardation or severe organic brain syndromes
* In the investigator's judgment, a significant risk of suicide or violent behavior
Cognitive Ability Training in Seniors

This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation \[tDCS\]) during working memory training in seniors with subjective memory impairments.The placebo-controlled double blinded study includes 50 elderly probands which were randomized into verum or sham tDCS.


Eligibility Criteria:
Inclusion Criteria:

* native german speaker
* between 60-70 years old
* subjective memory impairment

Exclusion Criteria:

* psychiatric, neurological diseases
* uncorrected hearing or vision deficits
* actual psychopharmaco intake
* metal parts in the head
* medical electronical implants
Metastatic Left Colon and Rectal Cancer Treatment With Anti_EGFR Targeted Therapy

Colorectal cancer ranks the second lethal cancer and third prevalent malignant tumour worldwide, Despite of different odern modalities for diagnosis,large number of cases diagnosed at metastatic advanced stage .

New treatment approach has been discovered habe been discovered making a huge revolution in metastatic colorectal cancer represented by targeted therapy including anti_EGFR ,anti_angiogenic and kinase inhibitors .

Retrospective study aims to evaluate the effect of EGFR expression in metastatic colorectal cancer and the outcome of treatment with anti_EGFR targeted therapy between left colon and rectal cancer

Eligibility Criteria:
Inclusion Criteria:

1. age above 18
2. Both sex
3. Performance status zero to one according to ECOG scale system
4. Histo-pathologial diagnosis adenocarcinoma of left colon or rectum.
5. Patients diagnosed with left colon and rectal cancer.
6. Patients eligible to receive chemotherapy (with renal and liver chemistry, and normal CBC.
7. Patients diagnosed with metastatic stage.
8. K-RAS wild type.

Exclusion Criteria:

1. Second malignancy
2. Histo-pathological types other than adenocarcinoma.
3. Right colon cancer patients.
4. Patients refused receiving anti_EGFR targeted therapy.
5. Patients with any abnormalities preventing to receive chemotherapy.
6. Early stages of colorectal cancer.
7. K-RAS mutant type.
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure

The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) over 20 weeks of treatment.

Omecamtiv mecarbil (AMG 423, CK-1827452) is a novel small molecule that increases cardiac contractility by selectively and directly activating the enzymatic domain of cardiac myosin heavy chain, the force-generating motor protein of the cardiac sarcomere. This is a randomized, placebo-controlled, multicenter, phase 2 study, consisting of a dose escalation phase to select 1 of 3 omecamtiv mecarbil oral formulations in 2 dose escalation cohorts, followed by an expansion phase to evaluate 20 weeks of administration of the selected omecamtiv mecarbil formulation at 2 target dose levels, compared with placebo.

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 4 weeks prior to screening
* Treated with stable, optimal pharmacological therapy for ≥ 4 weeks
* History of left ventricular ejection fraction (LVEF) ≤ 40%
* Elevated N-terminal prohormone B-type natriuretic peptide (NT-proBNP)

Exclusion criteria:

* Severe uncorrected valvular heart disease
* Hospitalization within 30 days prior to enrollment
* Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
* Acute myocardial infarction, unstable angina or persistent angina at rest within 30 days prior to randomization
* Systolic blood pressure \> 160 mmHg or \< 90 mmHg or diastolic blood pressure \> 90 mmHg
* Total bilirubin ≥ 2 x upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x ULN
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2
Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients

Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in both healthy volunteers and Parkinson's disease patients and to determine if there is a difference in the way that the body deals with Cogane (pharmacokinetics) between these two groups.

It is expected that the study will prove that Cogane™ is safe and well tolerated and will provide us with a pharmacokinetic profile for both subject groups.


Eligibility Criteria:
Key Inclusion Criteria (Healthy Volunteers):

* Male \& Female healthy volunteers aged between 40 and 80 years at the time of informed consent
* Females of non-childbearing potential
* General Good Health

Key Exclusion Criteria (Healthy Volunteers):

* No clinically significant and relevant medical history
* Smoked within the 3 months prior to screening
* Use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration

Key Inclusion Criteria (Parkinson's disease patients):

* Male \& Female Parkinson's disease patients aged between 40 and 80 years at the time of informed consent
* Must have a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria
* Subjects who are taking Parkinson's disease treatments should be on a stable regimen for at least 4 weeks prior to screening

Key Exclusion Criteria (Parkinson's disease patients):

* Diagnosis of dementia
* Parkinson's disease of a known genetic cause
* History of surgical intervention for Parkinson's disease
Visceral Fat, Metabolic Rate, and CHD Risk in Young Adults

To measure visceral (intraabdominal) fat by computerized tomography (CT) scan and to measure resting metabolic rate by indirect calorimetry in 400 CARDIA subjects, ages 28-40 years (100 of each race/gender group) from the Oakland, California and Birmingham, Alabama centers.

BACKGROUND:

The prevalence of obesity increased markedly in the United States from the 1960's to the 1980's, and varied by race and gender with particularly high rates of obesity among Black women. Reasons for the ethnic differences in the prevalence of obesity were not understood. This cross-sectional study was performed in conjunction with the 10-year follow-up examination for the Coronary Artery Risk Development in Young Adults (CARDIA) study, an NHLBI-funded longitudinal study of development of risk factors for coronary heart disease (CHD) in young black and white adults.

This study represented a unique opportunity to investigate factors that may influence the development of obesity, to better understand the relationship between obesity and cardiovascular risk factors, and to increase understanding of racial differences in adiposity.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

DESIGN NARRATIVE:

The cross-sectional study tested the hypothesis that visceral adipose tissue, the component of fat considered to be most strongly related to coronary heart disease (CHD) risk factors, differed in Black and white subjects. Specifically, the investigators proposed that Black subjects had less visceral adipose tissue for a given level of total body fat than white subjects. Further, the relationship between visceral adipose tissue and risk factors for CHD was similar in all subjects. This would explain the different relationship between obesity and CHD risk factors seen in Black vs white subjects. A second specific aim was to determine whether Black women had a lower resting energy expenditure than Black men or whites. This could explain the higher prevalence of obesity in Black women than in Black men or whites of either gender. CT scans were recorded on tape and shipped to the University of Colorado Health Sciences Center where visceral adipose tissue was quantified. Dietary intake and physical activity were measured as important covariates in the relationship between metabolic rate and adiposity, and thyroid function was measured as a determinant of resting energy expenditure. The CARDIA study provided funding for cardiovascular risk factor measurements, including blood pressure, lipids, insulin, glucose, smoking, and anthropometric measurements including dual energy absorptiometry (DEXA) measurements of total and regional body fat.

The study was renewed in 1999 through March 2004 to perform a five-year follow-up of the cohort.

Eligibility Criteria:
Beneficial Exposome Study

The purpose of this study is to explore the positive, holistic health outcomes resulting from regular exposure to naturally occurring compounds predicted to have health benefits. The researchers hope to learn how the human body is influenced by regular exposure to these compounds.

Considerable research has been conducted on the effects of environmental exposure on human diseases. This is also known as "exposome" research. However, there is limited research on the impact of beneficial exposomes found in the natural environment. The researchers would like to identify and measure the benefits of these naturally occurring compounds on holistic human health.

Through blood specimens, the researchers will observe biomarkers such as cortisol levels and inflammatory markers. Data will be collected from wearable sensors to observe the effects of beneficial exposomes on areas such as cardiovascular health and sleep quality. There will be surveys to understand well-being, stress, and mood. Through such observations, this study aims to understand the positive impacts of intentional exposure to selected compounds found in nature.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Read, speak, and understand English
* Live in the US territory

Exclusion Criteria:

* Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol
* Is pregnant
* Is breastfeeding
* Has epilepsy
* Has allergies to Cupressaceae family of plants, common plants include redwoods, junipers, cypress, cedar, fir, and sequoia
Auricular Vagus Nerve Stimulation (aVNS) in Chronic Spinal Cord Injuries (SCI)

The purpose of this research is to test if Auricular Vagal Nerve Stimulation (aVNS) is safe in persons with spinal cord injury (SCI).


Eligibility Criteria:
Inclusion Criteria:

1. Males and females
2. Chronic (equal or greater to 1 year) motor-complete and incomplete SCI Abbreviated Injury Scale (AIS) of A or B at the C5-T10 levels

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Prisoner
3. Failure to satisfy inclusion criteria
4. Previous bariatric surgery
5. Active implantable devices (such as pacemakers)
6. Skin irritation or damage at the site (ear)