cyrilzakka/clinical-trials huggingface dataset:
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)

The objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate kidney uptake in chronic kidney failure patients.

Chronic kidney failure patients will be ask to perform two positron emission tomography scan during the same day. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine the difference between the two tracers and will ultimately be compared with precedent results of healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 40
* Kidney failure if GFR betweem 30 and 60 mL/min/1.73m2
* Stable medication for at least 4 weeks

Exclusion Criteria:

1. Receive cytotoxic therapy for primary or secondary kidney disease within 6 months prior to enrollment
2. Organ Transplant History
3. Class IV congestive heart failure (New York Heart Association)
4. Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment
5. Coronary revascularization (percutaneous coronary intervention or arterial bypass) or valve repair/replacement within 12 weeks of enrollment or is scheduled to undergo one of these procedures within 4 weeks of enrollment
6. Any condition outside the realm of renal and cardiovascular disease, such as, but not limited to, malignancy, with a life expectancy of less than 2 years in the clinical judgment of the investigator
7. Active malignancy requiring treatment at Visit 1 (except successfully treated basal or squamous cell carcinoma).
8. Hepatic impairment (aspartate transaminase or alanine transaminase \>3x upper limit of normal; or total bilirubin \>2x upper limit of normal at time of enrollment
9. Pregnancy or lactation
10. Adherence to a ketogenic diet, consumption of ketogenic products or supplements or intermittent fasting or other diet or supplements that may significantly increase ketones in the past two months.
11. Daily alcohol consumption \>2 servings per day
12. Participation in other interventional research projects concurrently or participation in other PET research projects in the last year, which exceeds the recommended limits
13. Inability to lie still in supine position;
14. Medical fluid restriction limiting fluid intake for the procedure
A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials

This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry is to determine the long-term safety of anti-HCV regimens in the pediatric population. Secondary objectives of this Registry are to determine whether subsequent detection of HCV RNA in participants who relapse following sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection, and to characterize resistance mutations and the persistence of resistance mutations in pediatric participants who did not achieve SVR. Once enrolled, participants will be followed for up to 5 years.


Eligibility Criteria:
Key Inclusion Criteria:

* Have previously participated in a Gilead-sponsored chronic hepatitis C study as an adolescent or pediatric participant and received at least one Gilead HCV direct acting antiviral
* Parent or legal guardian able to provide written informed consent OR individual is able to provide written informed consent prior to any study procedures and willing to comply with study requirements as determined by institutional review board (IRB)/independent ethics committee(IEC)/local requirements and Investigator's discretion.
* Individual is able to provide written assent, if they have the ability to read and write, as determined by IRB/IEC/local requirements and Investigator's discretion

Key Exclusion Criteria:

* Individual is currently receiving or plans to initiate a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry.
* History of clinically-significant illness or any other major medical disorder that may interfere with the individual's follow-up, assessments or compliance with the protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
BladdEr Full OR Empty for Pelvic Radiation Therapy

The present study evaluates empty and full bladder protocols for radiation therapy of genitourinary (GU), gynecological (Gyn), and gastrointestinal (GI) malignancies of the pelvis.

Pelvic radiation therapy plays a key role in the treatment of common genitourinary (GU), gynecological (Gyn), and gastrointestinal (GI) malignancies of the pelvis. Prior to starting a course of radiation therapy, patients undergo a CT simulation that allows for computer-based optimization of radiation dose delivery to target while simultaneously minimizing dose to surrounding normal tissues, such as the bladder and rectum. Commonly, physicians instruct patients undergoing pelvic radiation therapy to present with a reproducibly full bladder for the simulation and for each subsequent treatment session with the hope that increased distance between normal tissues (anterior bladder wall and bowel) and treatment target will limit toxicity. However, treating with a full bladder can result in wide variations in bladder volume. Often patients are unable to reproduce the bladder distention achieved at simulation, especially as typical urinary symptoms related to radiation develop during treatment. As the initial CT simulation is used to calculate dose distribution, bladder volume changes can affect radiation dose distribution to the bladder itself as well as adjacent pelvic organs. Given the challenges and uncertainties of treating with a full bladder, there has been increasing interest in bladder empty protocols. Retrospective, non-randomized, single-institution studies demonstrate that bladder empty protocols reduced absolute variation in bladder volume during treatment, had minimal impact on treatment related toxicity, and had non-inferior biochemical progression free survival, GI toxicities, and GU toxicities. However, prospective data is very limited. The present study plans to fill this knowledge gap by randomizing study participants to empty and full bladder protocols for simulation and radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Persons, aged at least 18 years
* Deemed eligible to undergo curative intent radiation therapy for primary GU, GI, or Gyn malignancy of the pelvis.
* For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
* For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

* Pregnancy
* Tumor invading the bladder, as judged by the enrolling physician based on available clinical information
* Contraindications to radiotherapy, including Crohn's disease and active connective tissue disorders such as scleroderma or uncontrolled lupus
* Prior radiation therapy to an area requiring treatment in the present study
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.


Eligibility Criteria:
Major Inclusion Criteria:

1. Subject meets one of the following:

   1. Completed Study 14-002 or 14-003 (Group A)
   2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
2. Body mass index from 18 to \<45 kg/m2
3. Consent to use a medically acceptable method of contraception
4. Willing and able to provide written informed consent

Major Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating
2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or OSA that is associated with excessive sleepiness
3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
4. Presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy or safety assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
5. History of bariatric surgery within the past year or a history of roux-en-y procedure
6. Presence or history of significant cardiovascular disease
7. Use of any over the counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
8. Received an investigational drug other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
9. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Serial Changes of Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1) Levels in Patients With Acute Respiratory Distress Syndrome

The purpose of this study is to determine the impact of the serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) on etiology and prognosis of acute respiratory distress syndrome (ARDS)

The triggering receptor expressed on myeloid cells-1 (TREM-1), a member of the immunoglobulin superfamily, is upregulated on phagocytic cells in the presence of bacteria or fungi infection and weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form (sTREM-1) in body fluids. The level and serial change of a serum sTREM-1 from cirtical ill patients has been shown to be a good diagnostic and prognostic indicator of ventilation associated pneumonia (VAP) and severe sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill clinical diagnosis of ARDS
* Require mechanical ventilation support

Exclusion Criteria:

* Pregnant
* Immunocompromised
Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS

The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis.

The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis (MS). The study is designed to research how well this technique can help people with MS improve their memory and their ability to function better in everyday life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis
* Ability to read and speak English fluently
* Difficulties with learning and memory skills

Exclusion Criteria:

* Prior diagnosis of stroke or other neurological injury/disease
* Flare up of symptoms within a month of study participation
* History of significant psychiatric illness (e.g., bipolar disorder, schizophrenia, psychosis) or current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II
* Current significant alcohol or substance abuse
* Taking exclusionary medication (study team will review medications)

For Optional MRI:

* Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
* Dental implants
* Left-handed
Predicting the Effect of Laser Peripheral Iridotomy

This study will compare the angle parameters of patients with PACS before and after LPI. The investigators will analyze the results of patients with different angle closure mechanisms before and after LPI, and participants hope to find the structural parameters for predicting the effect of LPI.

Primary angle-closure glaucoma is the leading cause of blindness worldwide. It is associated with increased intraocular pressure, which causes optic nerve damage and field defects if untreated. The aqueous humor leaves the anterior chamber through the trabecular meshwork and flows into the aqueous vein and the superior scleral vein through the collector channels and Schlemm's canal. If the trabecular meshwork is not blocked, a wide angle allows enough aqueous humor to drain out. The iris corneal translocation may lead to angle-closure glaucoma.

Laser peripheral iridectomy is recognized as the best surgical method to relieve pupil block. Previous studies have shown increased anterior chamber depth (ACD), area (ACA), and volume (ACV), and increased Angle open distance (AOD) after LPI surgery.

However, postoperative outcomes of LPI were not the same for patients with different angle closure mechanisms.

Postoperative outcomes for LPI were best for patients with pupillary block type, but were moderate for patients with plateau iris group and mixed group.

The purpose of this study, conducted in Chinese subjects, aims to use UBM to evaluate changes in the anterior segment parameters of LPI, and to propose methods to predict postoperative outcomes of LPI.

Eligibility Criteria:
Inclusion Criteria:

1. Patient was diagnosed of primary angle closure angle suspect;
2. received ultrasound Biomicroscopy before and after laser peripheral iridotomy;
3. Voluntary participation in this study;
4. Have enough language comprehension ability;
5. Patient or his legal representative has sign the informed consent.

Exclusion Criteria:

1. severe health problems resulting in a life expectancy of less than 1 year;
2. previous intraocular surgery or penetrating eye injury;
3. media opacity preventing laser peripheral iridotomy;
4. Researchers think not suitable to participate in this clinical trial subjects;
5. Refused to sign the informed consent.;
6. There are important viscera function failure or other serious disease, including clinical related coronary artery disease, cardiovascular disease or myocardial infarction into the group of the first six months; serious neurological or psychiatric illness; serious infections; coagulant function abnormality; general active infectious diseases; malignant tumor; serious immune diseases.
Virtual Human Delivered Nutrition Module for Colorectal Cancer Prevention

This study uses the opinions of adults between the ages of 45 and 73 years old to develop and test an interactive nutrition module for use in an existing colorectal cancer screening intervention using virtual human technology. The main questions answered include:

* What content do adults want to receive from a web-based interaction about colorectal cancer screening and nutritional risks for colorectal cancer?
* Does a brief interaction with a virtual human delivering tailored cancer prevention information impact cancer prevention intentions and attitudes among a national sample of geographically rural U.S. adults?

This study will contribute to knowledge of what messages and graphics promote understanding of cancer risk and promote screening with the potential to promote behaviors that reduce cancer risk.

The study occurred in two phases. Phase one was a qualitative aim that collected feedback from participants in iterative cycles of focus groups and individual think-aloud interviews. Phase one feedback was analyzed and applied to develop a tailored, web-based prototype that addressed participant desires for an intervention to address colorectal cancer prevention and nutrition risk education. The prototype was a brief conversation delivered by an interactive Virtual Health Assistant (virtual character with audio and visual elements that mimic a conversation with a human).

Eligibility Criteria:
Inclusion Criteria:

* Eligible adults will be between 45 -73 years old,
* Proficient in English and
* Geographically residing in rural areas (based on zip code)
* Identify as Black or White racial identity

Exclusion:

* Completed a colonoscopy in the past 10 years
* Completed a sigmoidoscopy in the past 5 years
* Completed a home stool test in the past 12 months
Concussion Symptom Treatment and Education Program (C-STEP) in Post-Concussion Syndrome

This prospective randomized intervention study aims to determine if the Concussion Symptom Treatment Program (C-STEP), a cognitive behavioral therapy, improves outcomes for children with post-concussion syndrome.

This prospective randomized intervention study aims to determine if C-STEP improves outcomes for children with post-concussion syndrome. Forty children with post-concussion syndrome referred to the Nationwide Children's Hospital (NCH) Complex Concussion Clinic will be randomized to receive either usual care in the NCH Complex Concussion Clinic (comparison) or usual care in the NCH Complex Concussion Clinic plus four weekly sessions of C-STEP (treatment).

C-STEP has been developed for patients with post-concussion syndrome. The CBT intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training (adapted from McNally et al., 2018). Psychoeducation involves providing patients and families with information about typical concussion symptoms and recovery, the role of non-injury/psychological factors in post-concussion syndrome, and information about the mind-body connection. Activity management involves setting specific goals to achieve a return to normal daily activities such as school attendance, schoolwork completion, household activities, and participating in social/leisure activities. The sleep hygiene component involves providing individualized recommendations to promote healthy sleep habits such as eliminating naps, keeping a consistent sleep schedule, turning off electronics at bedtime, or other needed modifications. Finally, relaxation training involves teaching specific evidence-based strategies for relaxation and coping with stress such as diaphragmatic breathing and progressive muscle relaxation.

Eligibility Criteria:
Inclusion Criteria:

* Children age 10-17 years or adults age 18 years (total age range 10-18) at the time of the enrollment visit
* Diagnosed concussion occurring between 1 month and 12 months prior to the enrollment visit
* Endorsing at least 2 symptoms on the SCAT-5 symptom checklist
* Intent to participate in the full CCC treatment program (including exercise visits once per week)

Exclusion Criteria:

* Adults unable to consent, Prisoners, Females currently known to be pregnant, Non-English speaking patient
* Anticipated inability to complete surveys or other study procedures (due to cognitive or other disability)
* Anticipated inability to complete a brain MRI (due to claustrophobia, implanted hardware or other contraindications)
* Pre-injury severe mental illness (defined as inpatient psychiatric hospitalization, suicide attempt, history of psychotic symptoms, or bipolar disorder)
The Effect of Music Periodicity on Interictal Epileptiform Discharges

The purpose of this study is to determine if having children listen to the music of Wolfgang Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike discharges on his/her Electroencephalography (EEG). These spike discharges often occur during a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike discharges after listening to Mozart's music, this information may lead to new understanding and possible treatments for epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Female or male with BCECTS clinical history, and at least one seizure, as defined by the International League Against Epilepsy.
* EEG consistent with features of BCECTS: centrotemporal (rolandic) interictal spike discharges (ISDs) with otherwise normal background interictal EEG
* Screening neurological examination normal (by PI or other pediatric neurologist in the Division of Pediatric Neurology at MUSC)
* Age 5-12 years, inclusive
* On less than or equal to 2 anti-epileptic drugs (AED) \[Range 0-2 AEDs\]

Exclusion Criteria:

* Currently taking Clonazepam or other Benzodiazepines
* Inability to complete 12 hour admission and comply with study protocol
* Prohibited Therapy or Activities During Study Period: Use of computer or video games. Viewing of video tapes will be prohibited due to potential effect of music in videos on underlying process of study.
* Due to the confounding factor of probably suppression of IEDs after a clinical seizure, any subject experiencing a seizure of any duration 24 hours prior to beginning the study will be excluded from the study.
* For any subject experiencing a seizure during the study, data analysis will cease from that point onward.
Efficacy of Manual Therapy for the Treatment of Migraine.

Introduction According to the World Health Organization (WHO) at least 47% of adults have suffered from headache in the last year. The headache is not only painful but also disabling, it can be accompanied by social and personal problems, with a decrease in the quality of life and with economic losses. Migraine affects a large number of people and, if the predisposing factors are not controlled, it can become chronic. Once the chronification point of migraine has arrived, it seriously affects the quality of life of people, both in the workplace, social and leisure.

objective Perform the application of a manual therapy treatment based on protocols that include techniques already proven to improve different areas of impact in patients with migraine. To evaluate various aspects, we will include the intensity of pain, the frequency of episodes, anxiety and depression, quality of life, etc ... and the limitations or disability that it produces.

Material and methods This is a prospective, single-blind, randomized study with patients diagnosed with migraine. The sample will be distributed in 4 groups: a) experimental group that will receive combined treatment of soft tissues with techniques evidenced independently; b) Group that will receive independent structural techniques; c) the group that will receive the set of protocols a and b; d) and the placebo control group.

Evaluation An initial assessment will be carried out, another at the end of the treatment and another follow-up one month after the end of the treatment. In addition, the evaluation will include the following instruments: the HDI scale (Headache Disability Inventory), the MIDAS scale (Migraine Disability Assessment Scale), the SF-36 Questionnaire, the EVA Scale (Visual-Analogue Scale), the HIT-6 Questionnaire, the BDI Questionnaire (Beck Inventory Depression), the STAI Questionnaire (The State-Trait Anxiety Inventory), the change perceived after the treatment and medication intake.


Eligibility Criteria:
Inclusion Criteria:

* Have at least 4 migrainous crises per month, following the criteria established by the IHS
* history of episodes of more than a year of evolution
* use of stable medication during the four weeks prior to the start of the study
* between 18 and 60 years old

Exclusion Criteria:

* currently being in physiotherapy preventive treatment
* being in the process of pharmacological adaptation
* have artery-vertebral involvement problems (bone degeneration, metabolic or musculoskeletal problems that involve vertebral artery risk)
* suffer from dizziness
* suffering dizziness or unbalanced tension.