cyrilzakka/clinical-trials huggingface dataset:
MR Image Synthesis With Low Gadobutrol Dose and AI

Study 22403 is a Phase 1 / Proof of Concept exploratory investigation to assess the non-inferiority of low dose gadobutrol and SubtleGAD™, a software medical device using an Artificial Intelligence (AI) deep learning-based method to enhance the contrast signal from images acquired with low dose administration of gadobutrol (GAD) contrast. The primary objective is to demonstrate noninferiority of synthesized Central Nervous System (CNS) magnetic resonance (MR) images for 1 or 2 different gadobutrol-enhanced low-dose groups (0.01mmol/kg, and0.025 mmol/kg) compared to gadobutrol-enhanced CNS MR images at a standard dose of 0.1 mmol/kg. This investigation is a prospective, randomized, open label, multi-center study with blinded reads in participants with known or highly suspected CNS pathology. There will be at least 60 participants enrolled (30 per study arm). SubtleGAD will be used as a post-processing tool, prior to blinded read assessment of MR images acquired in either arm of the study.


Eligibility Criteria:
Inclusion Criteria:

1. At the time of signing the informed consent at least 18 years of age and less than or equal to 89 years of age.
2. Have known or highly suspected brain lesions referred for contrast-enhanced MRI of the CNS.
3. Have an estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m\^2.
4. Be fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and being capable and willing to consent to participate.

Exclusion Criteria:

1. Considered clinically unstable or has a concomitant/intercurrent condition that would not allow participation in the study.
2. Diagnoses of multiple sclerosis or other disease process that is expected to change its enhancement pattern in the time period of the follow-up.
3. Brain pathology or abnormalities that are not considered lesions.
4. Any contraindication for MRI procedure or gadobutrol administration.
5. Has severe cardiovascular disease.
6. Is expected or is scheduled to have a change in any treatment or procedure between the two study periods that may alter image comparability.
7. Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 24 hours after the second study MRI.
8. Women currently lactating, pregnant, or planning on becoming pregnant during the study.
9. Women of childbearing potential with a positive urine pregnancy test within 24 hours before either gadobutrol administration.
10. Receipt of any gadolinium-based contrast agent \<72 hours prior to the study MRIs.
11. Participants with acute kidney injury.
A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients

To determine the virologic benefits associated with the addition of hydroxyurea (HU) to combination drug therapy with didanosine (ddI), stavudine (d4T), and efavirenz (DMP) in HIV-infected patients. To assess the safety and tolerance of this regimen, with or without HU.

HU or placebo is added 30-60 days after the initiation of DMP, ddI, and d4T combination therapy. Patients are stratified according to antiretroviral experience (naive or experienced). Patients are followed for 48 weeks to determine safety, efficacy, and effect of treatment on viral, immunologic,and biochemical parameters.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection, as documented by a licensed ELISA that is confirmed either by Western blot, positive HIV culture, positive HIV antigen, positive plasma HIV RNA, or a second antibody test positive by a method other than ELISA.
* CD4 cell count of at least 100 cells/mm3 within 30 days of study entry.
* Over 500 HIV-1 RNA copies/ml as measured by the Roche Amplicor or Ultra Sensitive Assay within 30 days of study entry.
* Treatment-experienced patients must have documented HIV RNA values of less than or equal to 100,000 copies/ml within 30 days of study entry.

Prior Treatment:

Excluded:

Acute therapy for an infection or other medical illness. Acute therapy must have been completed 14 days prior to the time of study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Malignancy requiring systemic therapy.

Patients with the following prior conditions are excluded:

* History of acute or chronic pancreatitis.
* History of generalized peripheral neuropathy.
* Inability to tolerate ddI at 200-400 mg/day or d4T at 60-80 mg/day. For purposes of this study, intolerance will be defined as the same recurrent toxicities requiring dose interruptions and dose reductions or permanent discontinuation of the drugs (other than Grade 3 or 4 anemia).

Prior Medication:

Excluded:

Antiretroviral therapy. If antiretroviral-experienced, no prior NNRTI's or HU and no more than 12 weeks experience with ddI and/or d4T. Protease inhibitor experience is allowed. Experienced patients must be on a stable antiretroviral therapy 30 days prior to study screening and continue this regimen until study entry.

Risk Behavior:

Excluded:

Current ethanol abuse by personal history or a report from a primary physician.
Enhanced Recovery After Spine Surgery Randomized Clinical Trial

The purpose of this study is to compare two different approaches to the care patients receive before, during and after their spinal surgery and to determine if either approach has a significant difference in patient outcomes, opioid use, and recovery following spine surgery. The study will compare the standard-of-care surgical approach taken at the Hospital of the University of Pennsylvania with the Enhanced Recovery After Spine Surgery (ERASS) pathway. ERASS is a program that will provide additional education before your surgery, reduce your opioid consumption, and provide earlier physical therapy than you would normally receive under the standard-of-care approach, among other protocols outlined in this consent. Patients will be randomized to receive either of these approaches and the researchers will collect information to better understand if the ERASS approach provides more patient benefits.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and older (both male and female), who present to the department of neurosurgery at the Hospital of the University of Pennsylvania and who are determined to require elective spine surgery with one of two senior spine neurosurgeons, Drs. Malhotra and Marcotte.

Exclusion Criteria:

* Patients who are pregnant
* Incarceration
* Patients under the age of 18
* Patients unable to participate in the consent procedure
* Patients undergoing emergent surgery
* Patients with liver disease
ET-01 in Subjects With Lateral Canthal Lines, LCL-207

This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Eligibility Criteria:
Inclusion Criteria:

* 25 - 65 years of age
* minimal to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet wrinkles on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating

Exclusion Criteria:

* history of adverse reactions to any prior botulinum toxin treatments
* history of vaccination or non-response to any prior botulinum toxin treatments
* botulinum toxin treatment in the prior 6 months
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach

The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.

This study will randomize institutions in blocks to transition from usual institutional care for infants with NOWS to the ESC care approach at a randomly allocated transition period (from usual care to the ESC care approach).

During the initial birth hospitalization, the clinical site research team will collect data under waiver of consent for infants who meet eligibility criteria.

The site research team will obtain informed consent from the legal guardian(s) to obtain long-term outcomes for eligible infants and caregivers. Clinical site research team members may obtain this consent at any point during the hospital stay for infants who meet the trial's inclusion criteria. This data will allow the protocol study team to short- and long-term outcomes for infants managed with the ESC care approach compared to usual institutional care.

Eligibility Criteria:
Inclusion Criteria:

* 1. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:

  1. Maternal history of prenatal opioid use
  2. Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
  3. Infant toxicology screen positive for opioids during the initial hospital stay

Exclusion Criteria:

* 1. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at \>60 hours of life or treated with opioids for NOWS at the transferring hospital
A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders

This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.

The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.

Eligibility Criteria:
Inclusion Criteria:

* Children of either sex who are treated with NutropinAq® for the treatment of growth failure
* Patients who are willing to comply with follow-up appointments throughout study participation
* Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable

Exclusion Criteria:

* Patients not treated with NutropinAq®
* Patients with closed epiphyses
* Patients with active neoplasia
Restylane Silk for Photoaged Thinned Hands

To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands


Eligibility Criteria:
Inclusion Criteria:

* Female volunteer
* Aged from 40-70 years on the day of screening
* No known medical conditions that may interfere with study participation
* Moderate to very severe Photoaged thinning of the hands based on the 5-point hand grading scale
* Willingness to not use any products on their hands for the duration of the study
* Read, understand, and sign informed consent forms
* Willingness to sign photography release form
* Willing and able to comply with all follow-up requirements
* Willingness to undergo Restylane Silk injections to one hand

Exclusion Criteria:

* Any significant skin disease at treatment area
* Any medical condition which could interfere with the treatment
* Inability or unwillingness to follow the treatment schedule
* Inability or unwillingness to sign the informed consent
* History of poor wound healing
* History of keloid formation
* History of HIV, hepatitis, immuno-compromised
* Pregnant or lactating
* Previous use of deep chemical peels on the treatment area
* Previous injections of Restylane Silk to the hands
* Known hypersensitivity to Restylane Silk or any of its ingredients
* Previous laser or light based treatments to the treatment area 6 months prior to the screening visit
Penn State Hershey Sitting and Health Study

The purpose of this study is to: (a) evaluate if a desk-based elliptical device can help employees to increase their daily physical activity without compromising work productivity; and (b) evaluate the effects of different types of incentives for pedaling the desk-based elliptical device on employees' pedaling quantity over a one-month intervention period. The study will involve placing a compact elliptical device (provided at no cost by the research team) under employees' desk at Penn State Hershey Medical Center/College of Medicine. Data evaluating the effects of the elliptical device on work productivity will be obtained from both employees and the employees' supervisors.


Eligibility Criteria:
Inclusion Criteria:

* Full time employee, employed at least 35 hours per week at Penn State Hershey
* Able to provide documented approval from supervisor to participate
* Age 18-70 years
* Overweight or obese (BMI between 25-55)
* Sit at desk at least 5 hours per day
* Have regular working hours between 6 am and 6 pm on weekdays
* Ability to understand written and spoken English
* Own a smartphone (Android or iPhone) with Internet access
* Willing to download cycling app on smartphone during one month study period

Exclusion Criteria:

* Not present in Penn State Hershey office during study period due to personal circumstances such as travel/extended vacation or leave, relocation, or health-related circumstances
* Advised to only do physical activity recommended by a physician
* Chest pain during physical activity or during prior month
* Currently has a desk-based pedaling device or treadmill workstation already installed at desk
Impact of Probiotic Use on Immune Cell Function in Children

Probiotics are microorganisms that are believed to provide health benefits when consumed. The term probiotic is currently used to name ingested microorganisms associated with beneficial effects to humans and animals. Probiotics are popularized in the lay literature for many different clinical problems. They have been studied in infants and children as a preventive or treatment for a variety of infections. Studies on the medical benefits of probiotics have yet to reveal a cause-effect relationship, and their medical effectiveness has yet to be conclusively proven for most of the studies conducted thus far. The putative benefit of probiotics in the prevention of infection relates to potential benefits to the innate and adaptive immune systems of infants.

The goals of this investigation are to study immune system cell function and microbiome in children who are taking probiotics.

To accomplish this goal, we propose a pilot study for which we will obtain blood and nasopharyngeal and stool samples prior to and post probiotic use in children greater than 12 months-36 months over a 27-38 day period


Eligibility Criteria:
Inclusion Criteria

* Healthy children greater than 12 months-36 months of age
* English speaking parent
* Child has not received a live vaccine such as MMR or Varicella in the past 2 weeks

Exclusion Criteria

* Asthma/allergic rhinitis
* Premature birth (\< 36 weeks gestation)
* Known to be lactose intolerant
* Immunodeficiency or any underlying problem requiring the use of steroids or other immunosuppressive agents
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen in the last 2 weeks
* Currently taking probiotics, have received probiotics in the previous two weeks or are unwilling to refrain from the use of non-study probiotics during the next 30 days
* Any antibiotic treatment in the last 2 weeks
* Conditions which might interfere with dispersion of the probiotic after oral administration such as short gut or anomalies of the digestive tract
* Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Sleep Apnea and Visual Perceptual Skill Learning

The purpose of this study is to determine whether obstructive sleep apnea affects sleep dependent memory and learning. Subjects with apnea will be given a test of perceptual skill learning (the Visual Discrimination Task (VDT)) that has previously been shown to depend on sleep. Subjects will be tested on this task before and after sleep. The difference in performance after sleep compared to before sleep provides a measure of sleep dependent learning. Participants will be tested on one night when they have less apnea because they are using continuous positive airway pressure (CPAP) as prescribed by their physician, which is well known to reduce apnea; and on another night when they are in their native state and have a greater degree of apnea. Memory performance will be compared between the two nights to determine how apnea affects sleep dependent memory.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of sleep apnea
* Use PAP therapy as prescribed by his/her physician for 3-4 weeks prior to enrollment
* Right-handed

Exclusion Criteria:

* Major neurological or psychiatric condition
* Chronic pain condition
* Learning disabilities
* Serious brain or head injury (e.g. seizure, stroke, head trauma)
* Major surgery or general anesthesia in the past year
* Pregnant or nursing
* Problems with eyes or vision (besides corrected-to-normal with glasses or contacts)
* Past diagnosis of infection that can affect the brain (e.g. meningitis, HIV/AIDS)
* Medications that affect sleep (antidepressants, muscle relaxants, sleep aids, beta-blockers, stimulants, or corticosteroids)
* Recreational drug use, including marijuana
* Night-shift work
* Cancer or cancer treatment in the last 2 years
* Smoke more than 10 cigarettes per day
* Consume more than 3 caffeinated foods or beverages per day
Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer

This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy

Primary Objective:

- Evaluate tumor cell free (cf)DNA as a dynamic marker of response to immuno-oncology (IO) therapy

Exploratory Objective:

- Collect data on somatic mutations in cfDNA to gain insight into the biology of IO-responders and -non-responders

Eligibility Criteria:
Inclusion Criteria:

* Renal Cell Carcinoma with clear cell component
* Stage IV
* Receiving IO-containing regimen
* Measurable disease per RECIST 1.1

Exclusion Criteria:

* Active cancer (exclusion criteria only for healthy patient cohort)
Intestinal Microbiota and Treatment of GD

Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in GD patients and healthy controls and analyse the relationship between intestinal microbiota and GD drug therapy.

Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in GD patients and healthy controls before and found that gut microbiota changed between GD patients and healthy controls.But there are few articles on the relationship between intestinal microbiota and drug treatment of GD, so Investigators explored the relationship between intestinal microflora and methimazole treatment for GD.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* GD was clinical diagnosed and accept the standard treatment of methimazole or propylthiouracil and thyroid function returned to normal

Exclusion Criteria:

* Pregnancy
* Lactation
* Cigarette smoking
* Alcohol addiction
* Hypertension
* Diabetes mellitus
* Lipid dysregulation
* BMI \> 27
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
* History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
* History of malignancy or any gastrointestinal tract surgery
Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry

The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.

This is a prospective, single arm, single center study of patients with ruptured or unruptured saccular aneurysms that are embolized using MicroVention second-generation hydrogel coils and undergo balloon remodeling with the MicroVention Scepter Occlusion Balloon Catheter. Data for each patient will be collected 6 ± 3 months post-procedure for the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18-80 years of age.
* Patient has a documented, previously treated or untreated saccular intracranial aneurysm, 4- 20 mm unruptured or ruptured, suitable for treatment with balloon assisted coil embolization.
* Target aneurysm has a neck ≥4mm or the largest diameter to neck ratio of 2 or less.
* Patient has a Hunt and Hess Score of 3 or less.
* Patient has a premorbid mRS of 3 or less.
* Patient or patient's legally authorized representative has provided written informed consent.
* Patient is willing to and can comply with study follow-up requirements.

Exclusion Criteria:

* Inability to obtain informed consent.
* Patient is \<18 or \>80 years of age.
* Target aneurysm is dissecting, fusiform, mycotic, or arteriovenous malformation-related.
* Aneurysm that was treated previously with stent-assisted coiling.
* Implantation of the stent after the balloon-assisted coiling or combined stent and balloon assisted coiling.
* Target aneurysm is deemed unsuitable for balloon-assisted coiling by the treating physician prior to the procedure.
* Target aneurysm will be treated with a total coil length comprised of less than 80% second generation MicroVention Hydrogel Coils.
* Balloon-assisted coiling will be performed using a balloon catheter other than the MicroVention Scepter balloon (Scepter C, Scepter XC, any future Scepter configurations).
* Patients in which the target aneurysm is planned not to be coiled in one procedure (i.e. staged procedure).
* Patients with more than one aneurysm that requires treatment. (However, a second small low risk aneurysm that does not require therapy may be allowed.)
* Patients with a life expectancy of ≤ 9 months.