cyrilzakka/clinical-trials huggingface dataset:
Gadolinium-Based-Contrast-Agents (GBCA) Enhancement During MR Urography

Rationale: Dotarem provides superior enhancement characteristics compared to other GBCA in fMRU

Specific Aims: Compare enhancement characteristics of Dotarem to other GBCAs in the kidneys used in fMRU

Primary Objectives: Review functional analysis curves and data of fMRU studies and determine enhancement characteristics in the kidneys of the three GBCAs (Dotarem, Gadovist, Magnevist)

A retrospective review will be performed of all functional MRI urography (fMRU) cases at two institutions (Children's Hospital of Philadelphia and Vanderbilt Children's Hospital). Over 1000 studies have been performed between the institutions and the normal studies will be selected based on radiology reports and reviewed to confirm they are normal. The fMRU is performed with Gadolinium based contrast agents (GBCAs), initially was performed with Magnevist, then switched to Gadavist, and most recently converted to Dotarem. The fMRU software for analysis of the functional data provides enhancement curves of the aorta and kidneys. fMRU enhancement curves are generated by drawing regions of interest in the aorta and renal parenchyma and calculating the average signal intensity over time. A comparison of the enhancement curves will be performed of the three GBCAs in the normal pediatric population. The enhancement curves will provide peak enhancement values within the aorta and kidneys (Time to peak = TTP) and allow comparison between the GBCAs. The enhancement intensity versus time will be evaluated for each GBCAs, providing an evaluation of how long renal parenchymal enhancement is maintained. Additional functional data will be reviewed such as calyceal transit time (CTT) and renal transit time (RTT).

Eligibility Criteria:
Inclusion Criteria:

* Pediatric population which obtained MRI/fMRU study

Exclusion Criteria:

* Bilateral abnormal kidneys
Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)

The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT.


Eligibility Criteria:
Inclusion Criteria:

1. Are willing to voluntarily participate and sign the study consent
2. Know/suspect they have SCT and are willing to get tested to confirm/learn about their SCT status
3. Be willing and able to participate in the 2- year study plan.
4. Adults ages 18-65

Exclusion Criteria:

1. Unwilling to sign consent
2. Known end-stage renal disease or dialysis
3. Known SCD (including sickle cell-beta thalassemia)
4. People who do not have SCT
Stem Cell Transplant w/Laronidase for Hurler

The investigators hypothesize that weekly infusions of Laronidase ERT for 10-12 weeks prior to transplant and 8 weeks following transplant will result in a reduction of glycosaminoglycans (GAG) burden that is associated with decreased complications following transplant.

Subjects will receive laronidase once a week intravenously for 10-12 weeks prior to transplant and for approximately 8 weeks after transplant. Laronidase will be given by intravenous infusion (IV) through a catheter and from there to your child's body's cells and organs to break down the glycosaminoglycans (GAG) buildup.

Prior to starting ERT, subjects will have a complete physical examination, which includes a complete assessment of your child's airway and lungs. In addition to standard treatment evaluations and tests, which are done prior to hematopoietic stem cell transplant (HSCT), subjects will have the following tests: an additional teaspoon of blood for a baseline test for serum antibodies against laronidase, before and after the fourth dose of laronidase, the investigators will collect 2 teaspoons of blood for an alpha-L-iduronidase enzyme level; to watch for side effects to laronidase and the development of antibodies to laronidase, approximately 2 teaspoons of blood will be collected every 3 weeks while the subject is receiving laronidase ERT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of mucopolysaccharidosis type IH (MPS I, Hurler syndrome) who are candidates for first hematopoietic stem cell transplant (HSCT) according to a University of Minnesota myeloablative HSCT protocol.

Exclusion Criteria:

* Not being considered for University of Minnesota myeloablative HSCT protocol.
* Previous administration of laronidase enzyme
* Second or subsequent HSCT.
Longitudinal Outcomes of DBS in PD

Vanderbilt University Medical Center is one of the largest-volume DBS centers in the country. From 2007 through October 2017, 265 Parkinson's disease (PD) patients underwent deep brain stimulation (DBS), 168 of those implanted in subthalamic nucleus (STN) and 97 in globus pallidus interna (GPi). Pre-operatively, each patient is extensively evaluated with a battery of validated motor, cognitive, and mood instruments. This information is stored in RedCAP, a secure online database platform. In an attempt to capture longitudinal outcomes in this population of interest, we will recruit all PD patients two years or more status post DBS who are receiving regular care at Vanderbilt University Medical Center. Study participants will undergo a condensed evaluation of motor function (Unified Parkinson's Disease Rating Scale Part III), cognitive performance (Mini-Mental Status Examination), mood (Beck Depression Inventory), and quality of life (Parkinson's Disease Questionnaire-39). These results will be compared to baseline measures performed pre-operatively, allowing for assessment of interval change. STN and GPi DBS patients will be analyzed separately.

Patients will be recruited from review of movement disorders neurologists' outpatient census. All patients with PD two or more years status post DBS will be contacted via phone and/or mailed letter. Any interested patient will be mailed or e-mailed (via RedCAP) a copy of the study informed consent form. Willing patients will present to the Vanderbilt Movement Disorders Clinic for an opportunity to inquire further about the study and sign the informed consent form in person.

Participants will have a single study visit, ideally coordinated with their regularly scheduled neurology follow-up. During the study visit, the following evaluations will be performed by a trained research assistant:

Video-recorded UPDRS III BDI MMSE PDQ-39 In addition, current PD medications and number of falls in the past 6 months will be recorded. Assessments will occur in the on-medication, on-DBS state.

The video-recorded UPDRS III will be reviewed and score at a subsequent date by a blinded rater (movement discord trained neurologist).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Parkinson's disease
* status post deep brain stimulation (DBS) implantation in the subthalamic nucleus (STN) or globus pallidus interna (GPi) at Vanderbilt University Medical Center

Exclusion Criteria:

- unable to complete study assessments
FLX475 in Combination With Ipilimumab in Advanced Melanoma

This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent.

The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.


Eligibility Criteria:
Inclusion Criteria:

* Stage IV or unresectable Stage III advanced melanoma
* Prior treatment with at least 2 months of anti-PD-(L)1 agent
* Measurable disease at baseline
* Tumor available for biopsy

Exclusion Criteria:

* History of allergy or severe hypersensitivity to biologic agents
* History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy
* Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists
Correlation Between Cervical Spine Muscle Disorders and the Occurrence of Symptoms of Temporomandibular Joint Dysfunction

This study evaluated the correlation between the occurrence of disorders of selected muscles of the cervical spine and the occurrence of symptoms of TMJ dysfunction

The examination includes personal questionnaire, physical examination and an algometer measurement on the upper fibers of the trapezius, levator scapula, sternocleidomastoid and rectus capitis posterior major to define pressure sensitivity of neck muscles and define is there a correlation between the occurrence of disorders of selected muscles of the cervical spine and the occurrence of symptoms of TMJ dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* age 19-25 years
* relatively good health
* consent to participate in the research experiment

Exclusion Criteria:

* people with skin problems in the head and neck area that that made the examination impossible
* previous head and neck surgeries and traffic injuries
* coagulation disorders or taking medications that reduce blood coagulability
* venous thrombosis in the neck area
* sensory disorders
* dislocation of the jaw in the past
* taking painkillers 12 hours before starting the study
* being under orthodontic or physiotherapeutic treatment focused on TMJ dysfunctions
GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Visceral fat dysfunction is an important factor in the onset of PCOS. GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. The purpose of this study was to compare whether the combined treatment of GLP-1 receptor agonists and calorie restrict diet reduced more visceral fat of overweight/obese patients with PCOS at the same weight loss (7%) compared with calorie restrict diet alone.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18- 45;
* Meet 2003 Rotterdam criteria;
* overweight/obesity,BMI≥24kg/m2.

Exclusion Criteria:

* any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)；
* treatment with any other drugs that may interfere with the trial, including traditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazone within the last 3 months；
* chronic kidney disease or severe liver dysfunction；
* malignant tumors；
* mental illness;
* pregnancy or lactation；
* inflammatory bowel disease;
* recent participation in other weight-loss research projects within the last 3 months.
A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms

This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed.

The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.

The design will be an open-label trial of eight weeks duration with 20 children with Autism co-morbid for ADHD. The subjects will receive 7 days of 10 mg of Daytrana. The children will be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is complete. After each week of treatment, response will be reassessed and the dose will be increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which case, the dose will be reduced to the previous dose or the patch wear time may be revised.

Eligibility Criteria:
Inclusion Criteria:

* Between 6 and 11 years
* Autism Spectrum Disorder
* Attention Deficit Hyperactivity Disorder
* Stimulant medication-free at study entry
* No clinically significant abnormalities that preclude safe participation
* Sufficient developmental level (\~3 yrs)
* Able to keep appointments
* Able to communicate effectively
* Teacher cooperation

Exclusion Criteria:

* Received an investigational medication in the previous 30 days
* Current medication treatment is effective and well-tolerated
* Medical conditions that affect patient safety
* MAOIs within one month
* Hypertension
* Bipolar disorder or psychosis
* Anticonvulsants
* Psychotropic medication or health food supplement
* Tourette Disorder
* Seizure disorder
* Neurological condition
* Structural heart disease
A Pilot Dosing and Timing Study to Optimize Imaging When Utilizing Endoscopic Fluorescence Imaging System During Laparoscopic Biliary and Hepatic Operations

Operations on the liver, bile ducts, and gallbladders are some of the most commonly performed abdominal operations in the United States. Cholecystectomy, removal of the gallbladder, is the most common of these with more than 750,000 performed annually. Injury to the common bile duct (CBD) during these procedures occur infrequently (approximately 0.1% to 0.5%), but it is an important source of patient morbidity. Serious injuries often require at least one surgical repair, and these repairs have variable long-term outcomes. Techniques to allow the visualization of the bile ducts may prevent such an injury, by providing vital information about the presence of gallstones in the CBD and show a surgical road map of the ducts. Near-infrared (NIR) cholangiography has the advantage over standard cholangiography of not exposing patients and healthcare providers to radiation. This technique also allows the superimposition of the cholangiogram onto the normal image.

This study is being conducted to optimize an imaging technique called PINPOINT. Images will be obtained during clinically necessary operations. The images will be evaluated to determine the best method for locating and outlining the anatomy. The information learned will guide the future use of PINPOINT in laparoscopic procedures.


Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, subjects must fulfill all of the following criteria:

1. Subjects who are healthy men or women 18 years of age or older.
2. Subjects who are scheduled for laparoscopic biliary or hepatic operations.
3. Subjects who sign an approved informed consent form for the study.
4. Subjects who are willing to comply with the protocol.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

1. Subjects with a known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
2. Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
3. Subjects who are pregnant or lactating females.
4. Subjects, who are actively participating in another investigational clinical study and who, in the Investigator's or Sponsor's opinion, should not be enrolled in this study.
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients

The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Patients with Essential Hypertension
* Other inclusion applied

Exclusion Criteria:

* Orthostatic hypotension with symptom
* Other exclusion applied
Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide

Historically, the best results of allogeneic SCT have been obtained when the stem cell donor is a human leukocyte antigen (HLA)-matched sibling, however, this is only available for approximately 30 percent of patients in need for SCT. Alternative donor sources include matched unrelated donor utilizing the donor registry, cord blood transplant and mismatched donor transplant. A human leukocyte antigen (HLA)-haploidentical donor is one who shares, by common inheritance, exactly one HLA haplotype with the recipient, and includes the biologic parents, biologic children and full or half siblings. There is strong body of evidence supporting the use of haplo-SCT in patient who lack a matched sibling or unrelated donor with high rates of successful engraftment, effective Graft Versus Host Disease (GVHD) control and favorable outcomes comparative to those seen using other allograft sources, including HLA-matched sibling SCT. Furthermore, it provides a cost-efficient donor option in a timely manner especially for patients who need to proceed quickly to transplant due to concern of disease relapse/progression.

An open label, single-arm, single-center study to evaluate the safety, efficacy and feasibility of haplo-SCT as an alternative donor source for patients who lack a matched sibling/unrelated donor options. The choice of the chemotherapy treatment for transplantation will be up to the investigator. Post-transplant cyclophosphamide will serve as the backbone of the immunosuppression treatment to prevent GVHD.

GVHD Prevention Treatment:

Cyclophosphamide will be administered IV on Day 3 and Day 5 post transplant.

Tacrolimus will be administered IV until patient can take it by mouth starting on day of transplant and continue approximately 100 days post-transplant.

Mycophenolate mofetil will be administered IV until patient can take it by mouth starting on Day 1 post transplant until 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Ages 16 years old and up
* Performance Status 70 percent or above
* Patients should have the following diseases:
* Acute myelogenous leukemia (AML)
* Acute lymphocytic leukemia or lymphoblastic lymphoma (ALL)
* Transfusion dependent myelodysplastic syndrome (MDS)
* Non-Hodgkin's Lymphoma (NHL)
* Chronic lymphocytic leukemia (CLL)
* Pulmonary function as measured by forced expiratory volume at one second (FEV1) and/or corrected diffusing capacity of lung for carbon monoxide (DLCO) at 60 percent of predicted or above
* Left ventricular ejection fraction at 45 percent or above
* If the donor-specific HLA antibodies (DSA) are positive, the patient must undergo a desensitization protocol resulting in undetectable DSA prior to day of transplant

Exclusion Criteria:

* Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except for hydroxyurea)
* Uncontrolled bacterial, fungal or viral infections at time of study enrollment
* Positive for HIV, human T-cell leukemia virus (HTLV-1) and/or Hepatitis C
* Subjects with signs/symptoms of active central nervous system (CNS) disease
Neurofeedback Rehabilitation with FES and VR for PD

recoveriX PRO system is a Brain-Computer Interface (BCI) device that combines Motor Imagination (MI), with Functional Electrical Stimulation (FES) and Virtual Reality (VR) as feedback devices. The user wears an electroencephalography (EEG) cap that registers the neural activity during the mental practice. This system allows the user to control the feedback devices (FES +VR) with the MI.

The goal of this clinical trial is to know the safety and clinical effectiveness of recoveriX-based treatment for improving motor functions in Parkinson's Disease patients. Researchers will compare the functional results obtained by recoveriX system, to the standard treatment based in FES + VR + MI without monitoring the EEG activity.

The questions to answer are:

1. Will Parkinson's patients who undergo recoveriX therapy significantly improve their motor functions?
2. Is the functional improvement achieved with the BCI treatment superior to the standard MI+FES+VR treatment?
3. Is the recoveriX-based therapy as safe as the standard treatment?

Participants will have to perform a complete assessment to evaluate their functionality before and after the intervention (motor skills, walking ability, fatigue, impact of the disease in daily living activities).

Patients in the BCI group will receive 6 sessions per week during 4 weeks of BCI training with FES and VR feedback (24 sessions in total).

Patients in the control group receive 6 sessions of FES + VR therapy per week for 4 weeks (24 sessions in total). Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD
* HY stage between 1 to 3
* MOCA \>22
* Age between 40 - 80 years old
* Ability to walk independently
* Stable medication usage
* Stable neurological condition
* Able to sign the informed consent.
* Able to follow the study protocol.

Exclusion Criteria:

* Other neurological diseases
* Severe depression
* Uncontrolled diabetes
* Concomitant severe neurologic, cardiopulmonary, or orthopedic disorders
* Debilitating conditions or vision impairment that would impede full participation in the study.
* Unpredictable motor fluctuations
* Pregnant
* Active or passive implanted medical devices such as pacemakers which do not allow the use of FES.
* Implanted metallic fragments in the upper and lower extremities which can limit the use of FES.
* Under the influence of anesthesia or similar medication.
* With fractures or lesions in the upper and lower extremities.
* Inadequate control of a BCI system.
Photobiomodulation and Root Resorption

Objectives: The aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. Materials and Methods: 30 patients, who were admitted to the ............. University Faculty of Dentistry Orthodontics Department for treatment, with an indication of upper right 1st premolar tooth extraction was included. Before the individuals' orthodontic treatment, 0.022 slot MBT brackets and tubes were placed on the maxillary 1st premolar and molar. A 150g buccal tipping force was applied to the 1st premolar. Individuals were then randomly divided into 3 groups. For the first group; laser application was performed with a 810 nm GaAlAs laser device at 0,3,7,14,21 and 28 days to 8 J/cm2. Second group; an LED application according to the manufacturer's instructions with a 850 nm wavelength and 20 mW/cm2 output power for 10 minutes per day during the experiment. Third group; a placebo therapy was completed whereby a laser device that did not make active pulses was used. At the end of four weeks, the amount of root surface resorption was compared using micro-CT imaging after the extraction of the teeth.


Eligibility Criteria:
Inclusion Criteria:

* No history of orthodontic treatment
* No systemic disease or craniofacial anomaly
* No dental trauma and tooth with root resorption
* Having good oral hygiene
* No periodontal disease (no more than 3mm pocket)
* No restored or endodontically untreated upper right 1st premolar teeth
* Having the maxillary right 1st premolar tooth extraction indication of orthodontic treatment

Exclusion Criteria:

* Problems in patient compliance
* Inadequate oral hygiene
* Development of any medical problem making orthodontic treatment contraindicated during the study period