cyrilzakka/clinical-trials huggingface dataset:
How do Sleeping Pills Affect Pain in the Brain?

If you are age 20-55 years old and have trouble falling or staying asleep, then please contact a UCSD research team to find out how a study drug affects these symptoms and how your brain works. This is a one-week experimental pain research study using a study drug compared to placebo. Your participation will include questionnaires, a physical exam and functional Magnetic Resonance Imaging (fMRI) brain imaging techniques. We will test pain perception by applying brief mild to moderate heat pain to the forearm, and also have you perform simple computer tasks while we image and record brain activity using fMRI.

It is well known that chronic pain syndromes are associated with alterations in sleep continuity and sleep architecture. Similarly, recent evidence indicates that sleep deprivation interferes with normal pain perception producing hyperalgesic changes, and with the regular analgesic effects of certain pain drugs (reviewed in Kundermann B et al., 2004). However, the role of the nonbenzodiazepine hypnotic agents in pain perception is not well understood. Lunesta (eszopiclone), unlike other nonbenzodiazepine sleep medications, is approved for long-term use (no significant addictive effects of the drug are observed following the treatment of up to 6mo). Its antinociceptive properties have not been examined and, if found, could potentiate the use of this drug for pain control, especially in patients with comorbid chronic pain and insomnia.

The objective of this proposal is to use Functional Magnetic Resonance Imaging (fMRI) with an experimental pain paradigm in a group of chronic insomnia patients. The study will consist of three sessions, the first of which will include questionnaires, and a mental and physical health evaluation including an EKG and blood draw. Following the initial screening session subjects will be randomly assigned to either the study drug or placebo groups, and complete 2 additional identical study sessions using fMRI. The first fMRI session will be before taking the drug/placebo, and the second session will be after taking the study drug/placebo nightly for 1 week. During these fMRI sessions, subjects will undergo psychophysical testing of their sensitivity to warmth and heat and will rate various temperatures for pain intensity and pain unpleasantness. Subjects will also complete additional tasks including motor inhibition and face matching during scanning.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-55
* Primary Insomnia

Exclusion Criteria:

* Certain medical conditions/medications
* MRI related
HN-BIO: A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

The purpose of this study is to explore biomarker development in patients with newly diagnosed Head and neck squamous cell carcinoma (HNSCC) receiving curative therapy.

After being informed about the study and potential risks, all patients giving written informed consent will be assigned to Cohort A or Cohort B.

Cohort A will recruit up to 40 patients planned to receive curative radiotherapy for HNSCC. Patients will undergo a baseline fMRI (Functional Magnetic Resonance Imaging) scan and within 72 hours a biopsy of the primary tumor will be performed in out-patient clinic. In week 2 of radiotherapy a further biopsy of the primary site will be performed with a paired fMRI performed within 72 hours prior to biopsy assess evolving changes in imaging and tumor microenvironment biomarkers during radiotherapy. A further optional biopsy and paired MRI scan in week 4 will be considered for patients who are tolerating therapy without toxicities. 16-24 hours prior to each biopsy the volunteer will take oral pimonidazole.

Cohort B will recruit up to 20 patients planned to receive curative surgery for HNSCC. Each patient will undergo a baseline fMRI scan performed within one week prior to surgery. At time of initial consent they will receive a prescription for oral pimonidazole hydrochloride which they will be asked to take the 16-24 hours before planned surgery. Following surgery whole tumor samples will be processed to permit spatial reconstruction of pimonidazole staining hypoxia to correlate with fMRI imaging.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Histologically proven Head and Neck Squamous Cell carcinoma
* Primary or nodal disease \> 3cm for biomarker imaging
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Planned for curative surgery or (chemo)radiotherapy
* Willingness to undergo repeat MRI imaging
* Able to receive and understand verbal and written information regarding study and able to give written informed consent
* Adequate renal function: Calculated creatinine clearance \>/= 30ml/min
* Be able to lie comfortably on back for 1 hour

Exclusion Criteria:

* As judged by investigator evidence of systemic disease that makes unsuitable for study
* Contra-indication for serial MRI scans
* Previous solid tumor treated within last 5 years
* Pregnancy
* History of gadolinium contrast allergy
* Non-reversible clotting abnormality
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions

To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in terms of cosmesis (appearance) of the repaired wound when these devices are used for closure of surgical and traumatic wounds .

To demonstrate safety of BondEase™.

This is a two-phase, multi-center, prospective, randomized, parallel-group study, in which a total of 153 subjects (102 in the BondEase™ group and 51 in the CWCD group) with traumatic lacerations and incisions will be enrolled. Overall, eligible subjects will be randomized in a pre-defined 2:1 ratio to BondEase™ skin adhesive or CWCD.

In Part 1 of the study 30 subjects will be randomized in a 2:1 ratio (BondEase™ : CWCD). This part of the study is designed to assess the feasibility and validate use of the device. Pediatric subjects younger than age 18 will not be included in this part of the trial. The results from these 30 subjects will be compiled and submitted to FDA for review and approval prior to proceeding with Part 2. Part 2 of the study will only be initiated after FDA indicates it is acceptable to begin. In Part 2 of the study a total of 123 subjects will be randomized, of which 82 subjects will be randomized to the BondEase™ group and 41 subjects to the CWCD group. This will result in 102 subjects in the BondEase™ group and 51 subjects in the CWCD group across the both parts of the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects at least 1 year of age (for Part 2 only) or at least 18 years of age (for both Part 1 and Part 2).
2. Has a wound requiring surgical repair, where the use of a tissue adhesive is appropriate
3. Is in good general health
4. Subject or the guardian understands and is willing to sign informed consent prior to study entry and agrees to be available for the Day 10, Day 28, and Day 90 (Part 1/pilot phase only) follow-up visits

Exclusion Criteria:

1. Significant or multiple traumas
2. Known peripheral vascular disease
3. Known diabetes mellitus type 1 or type 2
4. Known blood clotting disorder
5. Patient or family history of keloid formation or hypertrophy
6. Known HIV seropositivity or is immunocompromised
7. Been treated with an investigational drug or medical device in the past 30 days
8. A hypersensitivity or contraindication to any of the components of BondEase™
9. Known pre-operative systemic or local infection
10. Any other diseases or conditions which might interfere with the wound healing process
11. The wound to be treated with the test device may not have any of the following characteristics:

    * A "burst" or stellate laceration
    * Heavily contaminated (Contaminated Wound: wounds that are grossly contaminated with foreign material requiring extensive cleansing.
    * Human or animal bite
    * Decubitus etiology
    * Evidence of active infection or gangrene
    * On mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips)
    * On an area which may be regularly exposed to body fluids or with dense natural hair, (e.g., scalp)
    * Under tension or over a joint
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints.

Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).


Eligibility Criteria:
Inclusion Criteria:

* Adult age 21 and older
* Subjects with minimum of 2 year life expectancy
* Subjects have signed the informed consent document
* Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
* Patient must be able and willing to comply with all required follow-up exams.

Exclusion Criteria:

* Currently participating in another trial where the primary endpoint has not been reached yet.
* Known allergy to any of the device components
* Pregnant (females of childbearing potential only)
* Known connective tissue disorders
* Known active infection
* Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR.
* Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
Evaluation of Interferon-gamma Responses to HCMV Infection in HIV Positive Individuals

The study is designed to evaluate interferon responses to CMV in HIV positive individuals and a component will look at interferon responses to CMV in HIV positive individuals over time after commencement of antiretroviral therapy. We will also look at the correlation between CD4 T cell numbers and HLA type with the interferon response.


Eligibility Criteria:
Inclusion Criteria:

1. HIV positive with history of documented HCV infection
2. Over 18 years old
3. HIV positive
4. Antiretroviral naive, starting on antiretroviral therapy
Transcutaneous Posterior Tibial Nerve Stimulation in Patients With Multiple Sclerosis Related Urge Incontinence

Recently, several studies have investigated the safety and efficacy of the Stoller afferent nerve stimulation (SANS) treatment in Multiple Sclerosis (MS) patients. However, because of the differences among the published protocols (percutaneous versus transcutaneous stimulation, stimulation site, total number of sessions), and the absence of data on the duration of the effect, this treatment is not yet currently included in the rehabilitation programs. The present study aims at evaluating the efficacy of a protocol of SANS in the short- and medium-term follow-up.

The efficacy of the proposed stimulation protocol on the physiological parameters of bladder function will be also investigated.

The primary outcome will be the variation of urinary urgency and incontinence. It will be evaluated by self-reported measuring scales, such as the Overactive Bladder Questionnaire (OAB-q) and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) in their Italian forms.

The expected outcome is that the treatment of posterior tibial nerve stimulation will reduce the frequency and the urgency of urination, and urinary incontinence. Moreover, results from the follow-up will allow estimating the duration of the expected outcome.

Eligibility Criteria:
Inclusion Criteria:

* MS diagnosis according to the revised McDonalds criteria. Relapsing-remitting, primary and secondary progressive MS forms are allowed;
* Expanded Disability Status Scale (EDSS) between 2 and 6.5 included;
* MiniMental State Examination ≥ cut off 24/84 by sex/age

Exclusion criteria:

* Any of the following in the month before enrolment: an MS relapse; current corticosteroids therapy because of MS; change in medicines prescribed against fatigue; attending an intensive physical therapy program;
* New or active lesions on a brain or spinal cord MRI scan in the 12 months before the study enrolment;
* Any musculoskeletal disease or any additional neurological disorder
* Urinary infections or surgery in perineal regions
* Skin lesions or carcinoma in situ
* Pregnancy
* Expanded Disability Status Scale (EDSS) ≥ 7;
Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals

The purpose of this study is to determine whether inversions (specific yoga postures in which the heart is higher than the head) and other dynamic and static yoga postures affect heart rate variability, oxygen uptake, blood pressure, blood parameters and other objective measures of health, and a variety of subjective and objective measures of health in female and male individuals in Sweden.

This randomized, controlled trial involving 44 male and females in Sweden will investigate whether yoga inversions and semi-inversions and other dynamic and static yoga postures will affect the following variables: heart rate variability, oxygen uptake, anthropometric variables, common symptoms in general practice, sleepiness, sleep quality and recovery/recuperation after sleep, blood pressure, blood lipids, blood proteins, blood sugar, salivary cortisol, hand grip strength, relaxation and recovery perceived stress, self-rated health, rating of perceived exertion, satisfaction with life, and work-family conflict.

Participants will be divided into an intervention group and a passive control group. The intervention group will participate in six to ten weeks of yoga classes. The classes will be held 1-2 times a week for approximately one hour each and will include yoga poses and breathing techniques. The control group will not participate in any intervention but will conduct their lives as usual.

The variables will be assessed at baseline; at the end of the intervention; and three, six, and twelve months after the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-40 years old

Exclusion Criteria:

* Aged 40 or more years
* Takes medication for high blood pressure or other strong medication
* Recently had an operation
* Diagnosed with eye disease (e.g., glaucoma)
* Diagnosed with depression or burnout syndrome
* Diagnosed with serious back or neck problems
* Participates in intense physical activity more than once a week
* Has digestive problems such as acid reflux
* Serious disorder that affects the ability to do the yoga postures
Dynamic Evaluation of COVID-19 Diagnostic Tests

Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated.

We propose to compare to the Gold-Standard defined above, the combination of an SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.

This is an interventional study comparing gold standard anamnesis, thoracic CT and PCR versus SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.

Patients will be sampled for the tests at Day 1 and then monitored for symptoms and clinical data and additional test at Day 21.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patient with confirmed Gold-Standard SARS-CoV-2 (COVID-19) infection
* Presenting at least one criterion for hospitalization:

  * Respiratory failure and oxygenation
  * Circulatory failure (systolic BP \< 90 mmHg)
  * Neurological failure (confusion, drowsiness, altered consciousness)
  * Polypathological terrain and co-morbidities (chronic respiratory failure, heart failure or cardiovascular pathology, renal failure, diabetes, immunosuppression, obesity, cirrhosis)
* Eligible for different sampling methods
* Beneficiary of a social insurance scheme or entitled person

Exclusion Criteria:

* Gold Standard not in favour of SARS-Cov-2 infection (COVID 19)
* Minor patient
* Refusal to participate
* Patient under guardianship
* Patient under guardianship
* Pregnant or breastfeeding woman
Study the Safety and Efficacy of "Compont Medical Glue" in the Treatment of Esophagogastric Varices

To observe the Safety and Efficacy of Compont Medical Glue in the Treatment of Esophagogastric Varices.

"Compont Medical Glue" is a kind of histoacryl producted by Compont Company. It has been used to treat esophagogastric varices for several years. This study is a prospective multicenter,open study on the safety and efficacy of Compont Medical Glue in the treatment of esophagogastric varices. Weather the patient receiving injection of Compont Medical Glue is according to the degree of esophageal-gastric varices and is decided by the experienced endoscopic physicians. No additional intervention will be given to the patients, no matter whether patients are participated in the study.

Eligibility Criteria:
Inclusion Criteria:

* Esophagogastric varices caused by portal hypertension with or without history of bleeding and no matter whether emergency bleeding.
* Patients may need to receive injection of histoacryl.
* Have signed informed consent.

Exclusion Criteria:

* Allergic to formaldehyde or cyanoacrylate.
* Women who are pregnant or breast-feeding.
* With contraindications of endoscopic exam.
* Computed tomography(CT)/Computed tomography angiography(CTA) shows that patient with severe portosystemic shunt.
* Large amount of blood accumulated in the stomach severely affects the endoscopic vision clarity.
* Other reasons that researcher think the patient is unsuitable for participating in the study.
Causes and Consequences of Primary Ovarian Insufficiency

100 women with primary ovarian insufficiency will be included for extensive diagnostic workup to improve diagnostic precision by extended autoantibody screening and genetic and toxicological testing.


Eligibility Criteria:
Inclusion Criteria:Women 40 years or younger, more than 4 months amenorrhea, more than 2 FSH measurements in menopausal range (drawn at least 2 months apart), ability to provide informed concent -

Exclusion Criteria:History of oophorectomy, chemotherapy or radiation

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Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident

The undernourishment and the prevention of its risk at the elderly person in seniors's resident represent a major issue in public health. The diagnosis of undernourishment and its risk are systematically recommended in these structures where the nutrition of these people is a problem because often inappropriate for their capacities of prehension and consequently for their nutritional needs. One of the solutions to remedy can be found in the " finger-food ".

The study FIFO ("Finger-Food") suggests verifying the hypothesis which the finger-food would allow to increase the nutritional intake of the resident who have disorders of the prehension and\\or requiring a nutritional stimulation and\\or require an help to the preparation of the meal.


Eligibility Criteria:
Inclusion Criteria:

* Residents institutionalized in seniors's resident for 3 months at least
* Residents in disability to feed single-handedly because of cognitive and/or physical disorders
* Having at least use of a hand
* Do not opposing the participation in the study or information and not opposition of the family / close to confidence / legal guardian in case of resident in incapacity to understand (senility, insanity)

Exclusion Criteria:

* Confined to bed
* Specific diets (without residue, allergen, ...)
* Enteral nutrition
* Absence motricity of 2 hands
Needle Guiding Robot for Radiofrequency Ablation: Safety and Efficacy Study on Hepatocellular Carcinoma Patients

The needle guiding robot helps targeting of radiofrequency ablation needles by matching computed tomography images and patients' bodies. Actual insertion of needles will be performed by doctors. This study evaluates the safety and efficacy of needle targeting on patients with hepatocellular carcinoma.

A robotic system has been developed that includes a needle-path planning system and a needle-guiding robot arm with computed tomography (CT) guidance. The robot consists of robot base, 5-axis robot arm with guiding end-effector and path-planner. Optical tracking system with a custom-designed registration jig is used for the spatial registration and validation. Advantages of the robotic system would be accurate targeting with diverse angulation of the robot arm in CT-guided tumor ablation. Furthermore, robotic intervention might potentially decrease procedure time and radiation exposure to patients. The purpose of this clinical trial with patients with hepatocelluar carcinoma is to assess the safety and efficacy of our CT-guided needle-guiding robot.

Eligibility Criteria:
Inclusion Criteria:

* Patients with up to three Hepatocellular carcinomas (HCC) with no single HCC larger than 3 cm
* Candidates for CT-guided radiofrequency ablation of HCC
* Child-Pugh class A or B

Exclusion Criteria:

* Patients with untreatable/unmanageable coagulopathy
* Patients who are allergic to CT contrast media
* Patients with vascular invasion or extrahepatic metastases
ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study

The median effective dose (ED50) and ED95 of intranasal dexmedetomidine as a single bolus have not been described for sedation in children undergoing transthoracic echocardiography (TEE) study. This information is important to compare agents and to determine the most effective sedative dose. The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal dexmedetomidine to investigate age-related differences in participants undergoing transthoracic echocardiography study.

The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal dexmedetomidine in children undergoing transthoracic echocardiography study. In phase 1, 120 participants were randomized in a Dixon-Massey study to describe the minimum local sedative dose. In phase 2, a further 160 participants were randomly allocated to receive sedation with doses in the upper dose-response range to define the ED95

Eligibility Criteria:
Inclusion Criteria:

* Children, aged between one and 24 months. classified as (American Society of Anesthesiologists) ASA physical status I or II, undergoing TEE were enrolled in the study.

Exclusion Criteria:

* Known allergy or hypersensitive reaction to dexmedetomidine
* Organ dysfunction, and significant developmental delays or behavior problems
* Cardiac arrhythmia
* Known. acyanotic congenital heart disease or children after cardiac interventional procedures for follow-up examination.