cyrilzakka/clinical-trials huggingface dataset:
Nutrition Education in Spine Surgery

The goal of this interventional study is to learn if having 15 minutes of surgery related nutrition education changes the food choices participants make during the time right before and after a spine surgery in participants who have a surgery with Dr. John Edwards. The main questions it aims to answer are:

* Does nutrition education at a participant's preoperative appointment help them choose healthier foods and drinks that help their recovery from surgery?
* Does choosing to drink some extra nutrients before and after surgery help participants feel better and make it easier to have other foods and liquids after surgery? Researchers will compare participants getting extra education with those in a control group who have normal instructions from the clinic to see if extra education makes a difference in people's food choices. Researchers will also look at how well participants do with the extra nutrition they get before and after surgery, and if choosing to include it changes with the extra education.

Participants will:

* Complete 2 surveys (PROMIS global and food frequency) at both their preoperative and postoperative appointments
* Complete one survey 2 days after their surgery asking about how well they did with liquids and solid foods in the 24 hours after surgery
* Choose whether or not they decide to have a drink with extra nutrients before and after surgery, and let the researchers know what they chose.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Patient of Dr. John Edwards undergoing spine surgery
* Patient is willing and able to complete all study requirements, including any education and follow up appointments

Exclusion Criteria:

* Under 18 years of age or pregnant
* Known allergies or intolerances to any supplement ingredients
* Patients deemed medically unstable by Dr. Edwards
* Patients with uncontrolled diabetes, as identified as Hemoglobin A1C\>7.5
* Patients unwilling or unable to complete all study requirements including any education and follow up appointments
Sentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-Dye

The sentinel lymph node (SLN) procedure is a standard staging technique in several types of cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an optimal dye and technique for identification of the nodes. In this study the investigators used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.

Patients planned for a laparoscopic resection of a colorectal carcinoma without distant metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten minutes after injection the investigators searched for fluorescent nodes with the NIR laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H\&E and additional immunohistochemistry.


Eligibility Criteria:
Inclusion Criteria:

* Oral and written Informed Consent (IC)
* Age 18 years and older
* Patients histological or radiological suspicion of colon cancer
* Surgical resection of the tumor
* Regular Pre-operative work-up

Exclusion Criteria:

* Gross lymph node involvement
* Distant metastases
* Advanced disease with invasion of adjacent structures
* Prior colorectal surgery
* Metastatic or T4 disease discovered during intraoperative staging
* Contraindications to laparoscopy
* Rectal cancer
* Allergy to iodine
* Patients at higher risk for anaphylactic reactions
A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face

The purpose of this study is to investigate the efficacy and safety of NT 201 injections in the treatment of enlarged pores and excessive sebum production in the face.

Eligible subjects will be randomized to one of the two treatment groups: NT 201 group and placebo in order to receive one session of injections with either NT 201 or placebo in the upper face (forehead and cheek area) on Day 1 and followed for about 90 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Cheek pore size assessed as "large" by the investigator
* Oily skin on the forehead

Exclusion Criteria:

* Treatment with Botulinum toxin (BoNT) of any serotype in the face within the last 12 months
* Facial cosmetic procedure (e.g., chemical peel, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows) within the last 12 months
* Treatment with any dermal filler in the face within the last 12 months
* Any previous insertion of permanent material in the face, including permanent dermal fillers (e.g., silicone, polymethyl methacrylate)
* Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype
Extended ECG Monitoring in HCM Patients

The purpose of this study is to determine, among a large cohort of 300 consecutive patients with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the iRhythm Technologies, Inc. Zio XT device results in identifying a greater burden of nonsustained ventricular tachyarrhythmia (nsVT) compared to current ACCF/AHA guideline recommended 48-hour monitoring.

Optimal duration to monitor patients for identifying nsVT remains unclear. The investigators aim to determine the prevalence and burden of nsVT with longer term monitoring with the iRhythm Zio XT device over a 2-week period vs. 48 hours; and whether, this greater burden of nsVT compared to conventional shorter monitoring potentially identifies a subset of HCM patients who may be at higher risk of sudden cardiac death.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 to 65 years of age at time of informed consent and must not be a member of a vulnerable population.
* Subject has been diagnosed with hypertrophic cardiomyopathy, as defined by a maximal LV wall thickness of ≥15 mm anywhere in LV wall, in absence of another cause that could be responsible for the LV hypertrophy.
* Subject eligible to receive the Zio XT device per the current approved indications for use.

Exclusion Criteria:

* Subject with pacemaker
* Known skin allergies or reaction to adhesives
* The investigator deems a condition that could limit a subject's ability or unwillingness to participate in the study, comply with study required monitoring and/or follow-up visits.
Does Dry Needling Affect Treatment Outcomes of Interlaminar Epidural Steroid Injection in Cervical Disc Herniation?

Chronic neck pain is among the most frequently seen chronic painful conditions. As an important cause of disability, chronic neck pain is a musculoskeletal disorder that negatively affects quality of life. Cervical disc herniation is one of the leading causes of chronic neck pain and conservative methods such as exercise and pain medications are used first in the treatment. In patients unresponsive to conservative treatment, epidural steroid injection is successfully and frequently used treatment option. Epidural steroid injection in the cervical region can be applied with two approaches: interlaminar or transforaminal.

Myofascial trigger point characterized by intramuscular taut band and hypersensitive spots is a condition in which central and peripheral sensitization play a role in the pathophysiology. There are underlying myofascial trigger points in many etiologies that cause chronic neck pain. Trigger points can increase the severity of pain and in some cases they can be the main factor in the etiology of pain. Therefore, the presence of myofascial trigger points should be investigated, even if another cause is detected in chronic neck pain. Dry needling is an easily applicable and effective treatment option in myofascial trigger point.

Although it is well known that myofascial trigger points frequently accompany cervical disc herniation, their effect on treatment outcomes has not been investigated. In this study, we aimed to investigate the effect of dry needling for trigger points on the treatment results of interlaminar epidural steroid injection in patients diagnosed with cervical disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65
* Chronic neck pain due to cervical disc herniation for at least 3 months and being unresponsive to conservative treatment
* Presence of at least one active myofascial trigger point on physical examination of cervical paraspinal muscles, scapulothoracic muscles and extremity muscles.

Exclusion Criteria:

* Previous surgical/interventional procedure for the cervical region
* Previous application of dry needling/acupuncture to any part of the body
* Presence of other musculoskeletal disorders (such as lateral epicondylitis, tendinitis, entrapment neuropathy) that may cause diagnostic confusion in terms of pain pattern and localization
* Signs of trauma, fracture, malignancy, or active infection
* Rheumatological (RA, AS, etc.), endocrinological (such as osteoporosis, Paget's disease) or another systemic disease that may change the anatomical or physiological structure of the relevant regions
* Presence of coagulopathy
* History of whiplash injury, cervical spinal stenosis, cervical spondylosis
* Have a diagnosis of fibromyalgia
* Being pregnant and breastfeeding
* Presence of mental deterioration or psychiatric/neurological disease that can affect flow of the study.
Evolution of Coronavirus Disease 2019 (COVID-19) Patients in Extremadura

At the end of January 2020, the international community was informed of the presence of a new viral disease that started in Wuhan (China) and spread rapidly throughout the world. The identified virus belonged to the coronavirus family (SARS-CoV-2) and the disease was named COVID-19. Today there are more than 2 million people diagnosed in Spain and more than 40 thousand in Extremadura. The partial knowledge about the development, evolution of the affected citizenship and their prognosis both early and late makes it necessary to analyze in depth their global and particular characteristics.

We will carry out a multicenter, observational, descriptive, cross-sectional and longitudinal study of patients diagnosed with SARS-CoV-2 virus infection in the Community of Extremadura to determine the effectiveness of drug treatments and the clinical and evolutionary characteristics of these patients and the different factors that may influence its evolution.

Epidemiological, socio-sanitary, clinical, analytical and radiological data will be collected retrospectively and prospectively from all patients diagnosed with COVID-19 without hospital admission in our community from the start of the pandemic and for one year from the start of the study.

These data will be obtained mainly from the clinical history and collected in the data collection notebooks and electronic base designed for the study for subsequent analysis. The data collection period will be one year, estimating a sample of 5,000 patients.

In addition, patients included in the study prospectively will be asked for consent to collect a blood sample for freezing and storage in the Biobank of Extremadura and subsequent use to determine biomarkers and genetics.

The present study will be carried out in accordance with the observational National Post-Authorization Study (EPA) for medicines for human use proposed by Valdecilla Health Research Institute (IDIVAL), the main objective of which is to determine the effectiveness of the pharmacological treatments currently used in COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age and sex, including minors and pregnant women.
* Patients diagnosed with SARS-Cov2 infection according to the clinical and microbiological criteria established by the Health Authorities and clinical practice (these can be modified based on the Technical document "Clinical management of COVID-19" of the Ministry of Health) who require or not hospitalization and who receive or not specific pharmacologic treatment for the SARS-Cov2 infection.

Exclusion Criteria:

* Patients who do not give their informed consent to participate in the study.
Predicting the Outcome of Total Knee Arthroplasty and Spinal Surgeon

The purpose of this observational study is to investigate the preoperative and operative factor of pain and functional outcome at one years following total knee arthroplasty and spinal surgeon.


Eligibility Criteria:
Inclusion Criteria:

1. The patients have been waiting for surgery for treatment of osteoarthritis or disc degeneration disease.
2. Must be between 18 and 65 years of age, of either sex.
3. Must demonstrate willingness to participate in the study by signing the written informed consent.

Exclusion Criteria:

1. Patients with Mandatory spondylitis, infections, neoplasms, inflammation, deformities, or previous surgery of spine or knee.
2. The patient is participating in an interventional clinical trial or has in an interventional clinical trial within 30 days prior to enrollment.
MILESTONE - MobILe and tEchnological SoluTions for OccupatioNal drivErs

Professional drivers in freight transport often experience difficult, exhausting and stressful working conditions due to various reasons: irregular sleep patterns, uncertainty in traffic, frequently changing schedules, busy schedules, a lot of time away from home, etc. These working conditions can lead to significant health problems with a significant impact on road safety. According to the International Road Transport Union, Europe is currently facing the most acute driver shortage in decades; which threatens the continued growth of the road transport sector, and its ability to provide solutions to expected volume growth. Technology will play an important role in making road transport safer and more efficient. MILESTONE\&#39;s overall objective is to develop and test technological interventions which are expected to reduce the difficult working conditions, stress, negative health effects of professional drivers.

The overall objective of MILESTONE is to develop and test technological interventions to reduce the difficult working conditions, stress, negative health effects of professional drivers.

1. Understanding the impact of personal state and contextual stress on driving behavior and road safety, and aims to analyze the relationship between physiological and mental state (e.g., sleep quality, fatigue, sleepiness, stress, thermal comfort), general health status, work-related factors, external stressors, and driving parameters linked to road safety.
2. Developing an intervention to keep drivers within their \&#34;stress tolerance zone\&#34; (STZ) (personal zone within which stress is acceptable)
3. Analyzing the impact of the MILESTONE interventions for different categories of drivers (long-haul, short-haul and local delivery), compared to an active and passive control group

Eligibility Criteria:
Inclusion Criteria:

* Working as long-haul, short-haul, or local delivery driver (in a transport company or self-employed)
* Having a smartphone
* Dutch-speaking

Exclusion Criteria:

* No excessive alcohol use
* No drugs use
* Not having an infectious disease
* Not being pregnant
Efficacy of Computer-Based Cognitive Game Training for Healthy Elderly

The declination on cognitive and motor functions in older adults increases the difficulty to achieve successful aging. Previous studies had reported that contrast to the traditional cognitive training methods, computer cognitive training (CCT) is comparable or has better effect on the cognitive function improvement with elders.On the other hand, some researchers claimed motor-cognitive dual-task training may possess greater effects than single cognitive training on cognitive functions. However, it is still on debate. Therefore, the research aims to investigate cognitive and motor benefits to healthy older adults over 65s trained by our computer-based cognitive game with high and low level of motor engagements.The research questions include: (1) Is CCT beneficial of cognitive functions? (2) Does CCT with high level of motor engagements (i.e. motor-cognitive dual-task training) have greater effects than single cognitive training on cognitive functions? (3) Can the training effect remain?

Quasi-experimental design was adapted in our research.There are four time-series assessments during the experiment: baseline, pretest, posttest, and follow-up. After the baseline assessment, participants were randomized to two groups: gross-motor group (GMG) and fine-motor group (FMG). The intervals between baseline and pretest as well as between pretest and posttest were both 4 weeks, while the interval between posttest and follow-up was 8 weeks.

The investigators developed a computer-based cognitive game and compared the efficacy of cognitive and motor functions between computer-based cognitive game combining two different demands on motor control. Investigators hypothesized: All participants who take part in the computer-based cognitive game training don't have learning effects on pretest and are able to improve cognitive functions including short-term memory, divided attention and inhibitory function after intervention; Gross-motor group make more progress than fine-motor group on cognitive and motor functions after intervention. Furthermore, gross-motor group maintained more training effect over cognitive and motor functions at follow-up than fine-motor group.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 65 years old
2. Montreal Cognitive Assessment (MoCA) score ≥ 18
3. clear eyesight and hearing
4. both upper and lower limbs are functional
5. normal communication

Exclusion Criteria:

1. injury, fracture, and breathing problem
2. surgery during the research
3. severe disease affecting cognitive functions.
Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Diagnosis established for at least 1 year;
* Post-bronchodilator FEV1/FVC \< 0.7
* Post bronchodilator FEV1 \<70% predicted
* Age: 40 years or older
* Smoking cigarettes, at least 10PY
* Patient signed the informed consent form

Exclusion Criteria:

* Bullous Emphysema (ruled out by recent CT)
* Hospitalization due to exacerbation of COPD within the last 3 months
* Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks
* Systemic steroid treatment in the last 4 weeks
* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
* Severe cardiac disease, e.g., CHF grade 3 or higher
* Acute MI within last 3 months
* CABG within last 3 months
* Other severe systemic disease
Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

Drug-drug interaction (DDI) and Cardiodynamic Evaluation Study To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 \[CYP\]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects.

This is an open-label, fixed-sequence DDI and cardiodynamic study in healthy adult subjects.

Twenty-six (26), healthy, adult male and female (non-childbearing potential) subjects will be enrolled.

Screening of subjects will occur within 28 days prior to the first dosing.

To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 \[CYP\]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects.

Visit assessments include Clinical laboratory tests, Safety ECGs and Cardiodynamic ECGs. Subjects will be housed on Day -3 of Period 1, until after the 24-hour blood draw and/or study procedures are completed on Day 12 of Period 2.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female (of non-childbearing potential), 18-55 years of age, inclusive at Screening
* Non-smoker
* Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 at Screening
* Medically healthy with no clinically significant medical history
* Ability to swallow multiple capsules/tablets.
* Ability to understand the study procedures, willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical condition or disease
* History or presence of hypersensitivity to edasalonexent or excipients based upon known allergies to compounds of a similar class such as salicylates, fish oil, eicosapentaenoic acid, or DHA
* History or presence of hypersensitivity to midazolam, deflazacort, or related compounds (e.g., steroids or their formulation including lactose).
* Participation in another clinical study within 30 days prior to the first dosing