cyrilzakka/clinical-trials huggingface dataset:
Role of 18F-FDG PET/CT in the Evaluation of Cavernous Sinus Syndrome: a Pilot Study

Cavernous sinus syndrome (CSS) can be caused by a wide range of inflammatory, malignant, benign, vascular and miscellaneous disorders. Even after modern advances, reaching the final etiological diagnosis remains a challenge in CSS. This study is planned to determine the role and incremental value of 18F-FDG PET/CT in characterising different cavernous sinus pathologies based on their metabolic activity and detecting extracranial involvement.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with age greater than or equal to 18 years,
2. with newly diagnosed CSS,
3. lesion seen on MRI in the CS, and
4. willing to give written informed consent.

Exclusion Criteria:

1. Pregnant and lactating patients
2. Patients already being treated (including steroids)
A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children

The purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children. This study also evaluates the effect of rIL-2 on the immune system of these patients.

IL-2 is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. HIV-infected patients do not produce enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in these patients. First, it is necessary to determine the safety and effectiveness of this drug in HIV-infected children.

According to study records, IL-2 has not been tested in HIV-infected children. Experience with IL-2 in pediatric populations is extremely limited. Pahwa et al. gave 30,000 units/kg daily IV to a child with severe combined immunodeficiency. This dose was well tolerated and the patient improved clinically as well as immunologically. Part A is necessary to determine the maximum tolerated dose of IL-2 in infected children. Part B will determine the efficacy of the maximum tolerated dose in infected children.

Part A: Children will receive rIL-2 intravenously for 5 days every 8 weeks for 3 cycles. The study will enroll 4 patients in each of 3 dose levels. Dose escalation may occur if all 4 patients in a dose level tolerate therapy without evidence of Grade 3 (or higher) toxicity. If 1 of 4 subjects in any dose level experiences at least Grade 3 toxicity, 2 additional patients will be enrolled in that dose level. If 1 of these 2 additional patients experiences at least Grade 3 toxicity, dose escalation will not proceed. NOTE: Once Part A is completed and the maximum tolerated dose is established, children who participated in Part A and received less than the maximum tolerated dose will be offered additional therapy consisting of 3 cycles of rIL-2 at the maximum tolerated dose.

Part B: Children will receive rIL-2 intravenously at the maximum tolerated dose established in part A. Treatment will be given for 5 days every 8 weeks for 3 cycles. \[AS PER AMENDMENT 6/4/98: Children will receive rIL-2 intravenously at the lowest dose for 5 days every 8 weeks for 6 cycles. Patients who received this dose in part A will also be offered this regimen.\]

Eligibility Criteria:
Inclusion Criteria

Children may be eligible for this study if they:

* Are HIV-positive.
* Have decreased immune system functioning (CD4 count 500-1000 for 3- to 5-year-olds or CD4 count 200-500 for 6- to 12-year-olds).
* Have symptomatic HIV infection.
* Have a viral level less than 400 copies/ml.
* Are between the ages of 3 and 12 (consent of parent or guardian required).

Exclusion Criteria

Children will not be eligible for this study if they:

* Have an active opportunistic infection.
* Are pregnant.
Music Therapy: An Adjunct To Gastroschisis Infants' Care

The investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their infant at risk for chronic gastrointestinal discomfort.

Babies will be enrolled during the perinatal period, with therapy to begin after surgical repair of the gastroschisis defect and when the neonatologist deems the baby stable enough for music therapy intervention. Enrolled subjects may receive up to 3 music therapy sessions/week and these sessions may continue until discharge. There is no follow up after discharge.

Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:

1. Pre music therapy behavior state will be assessed using CRIES scale and recorded.
2. Five minutes of baseline vital signs will be recorded.
3. Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be maintained at 65-75dB. Session will stop if infant shows any signs of distress/agitation. Vital signs will be collected every 1-4 minutes during music session.
4. After session behavior state using CRIES scale will be recorded.
5. Family/caregiver will be given a questionnaire to fill out.
6. 30 min of quiet will start.
7. At the end of quiet time, behavior state and vital signs will be recorded for the last time.

Prior to starting the music therapy session, family/caregivers, if present, will be informed of study session progression. They will be reminded of appropriate behavioral protocol to maintain therapeutic environment during session - i.e. minimal taking \& touching, cell phones off etc. A "Do Not Disturb - Music Therapy Session in Progress" will be posted outside pts room on the door.

Behavioral state data and vitals signs collected during sessions will be entered into a database. Also recorded, will be general information about the baby and its mother, such as, gestational age, apgar scores, mothers age and race, number of days post surgical repair etc.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Gastroschisis
2. Patient is stable enough to receive music therapy as determined by Neonatologist
3. Patient has passed their newborn hearing screen

Exclusion Criteria:

1. Neonatologist feels patient/family would not be an acceptable research candidate.
The Desensitizing Treatment Effects of the Laser and Ozone on Dentin Hypersensitivity: In-vivo Comparison

The goal of this split mouth clinical trial is to compare clinical efficacy of diode laser and gas ozone in the treatment of dentine hypersensitivity (DHS) of non-carious-cervical lesion. The main questions it aims to answer are:

* gas ozone affects dentine hypersensitivity?
* diode laser affects dentine hypersensitivity? Participants, affected of DHS , were treated with gas ozone and diode laser.The pain severity was quantified according to the Visual Analogue Scale (VAS) before and after the treatmens.


Eligibility Criteria:
Inclusion Criteria:

* Stimulated dentine hypersensitivity greater than 6 on visual analogue scale (VAS)
* DHS affected two teeth, not contiguous, of different mouth semiarch.

Exclusion Criteria:

* Periodontal surgery in the last 3 month
* Use of desensitizing paste in the last 3 month
* Pregnant or breastfeeding state
* Teeth with caries, reconstructions, pulpits congenital anomalies, fracture, and occlusal interferences.
Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery

Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort. It was a controlled randomized single-center prospective study in order to explore the efficacy of this new mode of mechanical ventilation after corrective open-heart surgery for congenital heart disease.

1. To evaluate the effect of the patient-ventilator interaction in children underwent open-heart surgery when ventilated with NAVA, compared with conventional mechanical ventilation.
2. To verify the benefits of NAVA in improving the gas exchange and hemodynamics after biventricle repair for CHD.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent cardiac surgery with biventricle repaired
* patients need mechanical ventilation more than 24hrs after cardiac surgery

Exclusion Criteria:

* age \>18 years
* inappositely of catheter insertion
* hemodynamic instability
* coagulation disorders or bleeding
* inclusion in other research protocol
Natreon Healthy Skin Study - PrimaVie Supplement

This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1 of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo (control) to take twice daily for 14 weeks.

Subjects will be assessed based on they type of Fitzpatrick skin type they have, will be return for a total of 6 study visits over 14 weeks where the following research activities will take place through the course of the study: medical/dietary history, medications will be recorded, supplement randomization based on one of the three arms will occur at study visit 1, and distribution of the study product will occur at all study visits, supplement tolerabiltity assessment, investigator and subject appearance assessment, photography of the face (left, right and front) will be taken, non-invasive assessments including Trans-epidermal Water Loss, hydration, elasticity, laser speckle perfusion, a skin biopsy of left inner upper arm (only at study visits 2 and 6), adverse event review, and supplement count/compliance review.

Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to discontinue any dietary or nutritional supplements, other than a general multivitamin, starting two weeks before onset of study and also during the study.
* Subjects must be willing to maintain their present diet with no major changes throughout the study.
* Subjects must be willing to take the dietary supplements as required by the study protocol twice daily.
* Female subjects must be between the ages of 30 to 65 years of age
* Subjects must provide written informed consent and are willing to comply with all study procedures.

Exclusion Criteria:

* Any dermatological disorder that may interfere with the accurate evaluation of the subject's skin.
* Subjects who are pregnant, breast feeding, or planning a pregnancy.
* Clinically significant unstable medical disorders.
* History of, diabetes, heart or kidney disease
* History of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
* Any skin disease in the area of the upper inner arm where the biopsies will be obtained.
* Currently taking the following medications:

  * Steroids
  * Beta-blockers
  * Immunosuppressant's
  * Hydochlorothiazide,
  * Statins
  * Aspirin
  * ACE Inhibitors
  * Muscle relaxants
  * Stimulants
* Prisoners
* Males
Dynesys Spinal System Post Market 522 Study

The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.

Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.

Eligibility Criteria:
Inclusion Criteria:

1. Skeletally mature between the ages of 20-80
2. Candidate for posterior lateral fusion between T1-S1 with autograft
3. Degenerative spondylolisthesis with evidence of neurologic impairment or failed previous fusion (pseudoarthrosis)
4. Symptoms of leg and/or back pain
5. Non-responsive to conservative/non-surgical treatment for at least three (3) months
6. Must be willing and able to comply with study requirements; including complete necessary study paperwork and return for required follow-up visits

Exclusion Criteria:

1. Active systemic or local infection
2. Obesity
3. Use of interbody device
4. Pregnancy
5. Mental illness
6. Incarceration
7. Alcohol or drug abuse
8. Severe osteoporosis or osteopenia
9. Use in the cervical spine
10. Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
11. Soft tissue deficit not allowing sound closure
12. Any medical or physical condition that would preclude the potential benefit of spinal implant surgery
13. Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device
14. Active malignancy or other significant medical comorbidities
15. Any medical or mental condition which would put the patient at high risk due to the severity of surgery
16. Inadequate pedicles of the thoracic, lumbar and sacral vertebrae
17. Patient unwilling or unable to follow postoperative instructions
Effects of Lower Body Positive Pressure in People With Knee Osteoarthritis

The goal of this clinical trial is to compare effects of retro walking exercise versus forward walking using lower body positive pressure on knee pain, physical function, and quadriceps muscle strength in people with mild to moderate knee OA. The secondary aim is to compare effects of retro walking exercise versus forward walking using lower body positive pressure on mobility function, balance, and self-reported health outcomes in people with mild to moderate knee OA. The main questions it aims to answer are:

* Does retro walking exercise improve knee pain, physical function and Quadriceps muscle strength compared to forward walking exercise using lower body positive pressure in people with mild to moderate knee osteoarthritis?
* Does retro walking exercise improve Mobility function, balance, and self-reported health outcomes compared to forward walking exercise using lower body positive pressure in people with mild to moderate knee osteoarthritis?

Participants will walk (retro versus forward) on a lower body positive pressure treadmill.

If there is a comparison group: Researchers will compare \[retro walking compares to forward walking\] to see if \[improve in knee pain, physical function, and quadriceps muscles strength\]


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate knee osteoarthritis
* Edge bigger or equal 40 years
* Knee pain reported by participants in the past 30 days
* One or both knees osteoarthritis graded with Kellgren \& Lawrence grade 1 - 3

Exclusion Criteria:

* If they didn't meet the inclusion criteria
* History of hip, knee or ankle injury or surgery within the last year
* Kellgren \& Lawrence grade \> 3 of severe knee OA
* Diagnosed with rheumatoid arthritis
* History of knee injection with any medicine that reduce pain within the last year
* History of other medical condition that would disturb normal walking function
* Receive physical therapy in the last three months
* Pregnant
* Other conditions that are Contra indication to lower body positive pressure.
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone

The purpose of this study is to assess the efficacy and safety of sublingual naloxone in the treatment of chronic itch in patients under arsenic exposure.

This study aims to determine the efficacy and safety of sublingual naloxone in the treatment of chronic, refractory itch in patients under long-term arsenic exposure. In this study, 120 subjects with a moderate-to-severe symptom of itching (numeric rating scale, NRS≥3) will be recruited and randomly treated with either sublingual naloxone (60 subjects) or placebo (60 subjects). The severity of itching will be evaluated in the wash out phase, baseline, and one week after the treatment through reporting of subjective symptomatology (itch NRS) via the interview. Quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) and Dermatology Life Quality Index (DLQI) will serve as the secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or over and without diseases except arsenic-related pruritus
2. Ability to study protocol and to give informed consent by himself/herself voluntarily
3. The number of male or female subjects is required more than 1/3 of the total number of subjects
4. Numeric Rating Sscale≥3 at the baseline
5. Subjects taking hormone-containing medications must be on a stable dose for 6 months prior to study start to avoid any confounding influence on sensory and pain perception

Exclusion Criteria:

1. Use of oral anti-inflammatory medications for 2 weeks prior to the study start.
2. Use of oral anti-histamines for 2 weeks prior to the study start.
3. Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.
4. Use of oral neuromodulatory agents for 2 months prior to study start.
5. Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).
6. Use of nicotine-containing products for the past 6 months prior to study start.
7. History of basic itchy dermatological diseases before such as eczema wich may influence the judgement of drug efficacy.
8. Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy.
9. Known history of central or peripheral nervous system dysfunction.
10. History of acute hepatitis, chronic liver disease or end stage liver disease.
11. History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
12. History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls.
13. Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start.
14. Use of illicit drugs within the past 6 months prior to study start.
15. Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents.
16. Patients considered by researchers that are not suitable to the study.
Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by DCT. They will receive four consecutive WCT application in one month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin (\[HbO2\]), deoxy-hemoglobin (\[Hb\]) and the derived change in blood volume (\[tHb\]) in/surround the cupping sites during treatment. The investigators hope to interpret the curative effect of DCT from the perspective of modern hemodynamics.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had non-specific low back pains at least 12 weeks now.
* Healthy people who are interested in dry cupping therapy

Exclusion Criteria:

* Patients who have had non-specific low back pains at least 12 weeks now.
* Healthy people who are interested in dry cupping therapy

Exclusion Criteria:

* Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
* Patients who are inappropriate to the wet cupping treatment.

  * AIDS, Active Hepatitis, Tuberculosis, Syphilis
  * Patients who regularly take anticoagulants, antiplatelet drugs
  * Anemia, thrombocytopenia
  * Hemorrhagic disease like hemophilia
  * Diabetes
  * Severe cardiovascular disease
  * Kidney diseases (renal failure, chronic renal disease)
* Patients who have experiences of wet cupping treatment during last 3 months.
* Patients who have had treatment for low back pain during last 2 weeks.
* Patients who are in pregnancy or have plan to conception.
* Patients who have vertebra surgery or have plan of surgery.
* Patients who are inappropriate to join this trial judged by the radiologists or specialists.
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform

The purpose of this study is to compare three different ways to deploy a clinician-decision support platform called NOCTEM COAST among behavioral health care providers who encounter patients with insomnia.

Insomnia and other sleep disorders are highly prevalent among military service members and compromise readiness, health, and performance; increase the risk of injury; and are associated with astronomical healthcare costs. The first-line treatment recommended for insomnia is cognitive-behavioral treatment for insomnia (CBTI). However, the large number of service members who are in need of this treatment outnumber the clinicians who are experts in behavioral sleep medicine and who currently provide this intervention in a cost-efficient manner and in a way that is acceptable and accessible to patients and clinicians. To address this challenge and scale the delivery and access to evidence-based behavioral sleep interventions, NOCTEM™ has developed a digital health platform called COAST (Clinician Operated Assistive Sleep Technology). However, the most effective way to implement the use of digital sleep health technology, and its comparative impact on patient outcomes, remain to be determined. Therefore, this trial will compare three different ways to deploy the NOCTEM™ platform among behavioral health care providers who encounter patients with insomnia. Specifically, the study will evaluate and compare without external or internal support (NOCTEM), with external support (i.e., facilitation) offered by the NOCTEM team (NOCTEM+EF), and with external support and internal support from local champions (NOCTEM+EF/IF). The trial will also compare the overall magnitude of improvements in insomnia among patients who use the NOCTEM app with their provider.

Eligibility Criteria:
Inclusion Criteria:

For clinicians:

* Completion of the first half of the workshop or similar Behavioral Sleep Medicine workshop in the past 6 months
* Completion of the second half of the workshop, including a training session to learn about the use of the NOCTEM platform
* See patients who present with insomnia
* Use cognitive-behavioral techniques as part of their practice

For patients:

* Are service members, veterans, or adult dependents who receive behavioral health care at one of the participating sites
* Present with complaints of insomnia
* Own a smart phone or smart device
* Deemed suitable by their clinician to receive the sleep intervention via the NOCTEM platform
* Confirm their willingness to use the NOCTEM app for sleep care with their provider

Exclusion Criteria:

For clinicians:

* Do not provide direct behavioral health care to service members
* Do not complete the two-part workshop and the 2-week proficiency training

For patients (recommended):

* Suspected, diagnosed, or inadequately untreated sleep apnea (less than 4 hours of continuous positive airway pressure \[CPAP\] use per night)
* Psychotic symptoms
* A history of bipolar disorders
* Women who are pregnant or breastfeeding and parents of children younger than 3 months of age