cyrilzakka/clinical-trials huggingface dataset:
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis

This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary biliary cholangitis
* Treated with Ursodeoxycholic Acid in West China Hospital for at least 6 month and suboptimal response to Ursodeoxycholic Acid

Exclusion Criteria:

* Autoimmune hepatitis
* Primary sclerosing cholangitis
A Study to Assess the Effect of a Probiotic on Upper Respiratory Tract Infections in Healthy Children

This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.


Eligibility Criteria:
Inclusion Criteria:

1. Have a parent/guardian able to give written informed consent.
2. If ≥7 years, be able to give written informed assent.
3. Healthy children aged 2 - 8 years old.
4. In general good health, as determined by the investigator.
5. Attending a registered childcare provider or school.
6. Willing to consume the study product daily for the duration of the study.

Exclusion Criteria:

1. Has URTI symptoms at the time of randomisation.
2. Are \<2 or ≥9 years old.
3. Diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma - generally only formally diagnosed after child is 6 years), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis or congenital cardiac defects.
4. Has a family household member that smokes cigarettes in the home.
5. Has taken antibiotics within the previous 2 weeks prior to randomisation.
6. Has taken probiotic supplements within the previous 2 weeks prior to randomisation
7. Daily intake of immune stimulating products, including but not limited to echinacea, vitamin C and zinc in the 2 weeks before randomisation (multivitamins allowed).
8. Has any significant health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
9. Taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
10. Has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed).
11. Has a gastrointestinal or chronic infective disease (i.e., coeliac disease, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.), or with a history of such diseases.
12. Planned extensive travel (for \>1 month) during the study duration.
13. Parent/guardian who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
14. Participants may not be receiving treatment involving experimental drugs. If the Participant has been in a recent experimental trial/study, these must have been completed not less than 60 days prior to this study.
15. Any Participant who is the child of an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy

The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic medication.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and provide informed consent to participate in this study and complete follow-up visits.
* Planned Photorefractive keratectomy (PRK) at the WRAMC Center for Refractive Surgery.
* Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
* Access to transportation to meet follow-up requirements.

Exclusion Criteria:

* Any reason to be excluded for PRK.
* Female subjects who are pregnant, breast feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. \[Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not\].
* Patients with known allergy, sensitivity or inappropriate responsiveness to Gabapentin or any of the medications used in the post-operative course.
* Patients with known depressed renal function.
* Any physical or mental impairment that would preclude participation in any of the examinations.
Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity

This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with upper limb spasticity following a stroke
* Eligible to receive botulinum toxin Type A
* No previous botulinum toxin Type A therapy

Exclusion Criteria:

* None
Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart attack. Although the investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children \< 2 years old with coronary artery abnormalities from KD.


Eligibility Criteria:
Inclusion Criteria:

1. Infant or child aged 1 month to 17 years, who meets clinical criteria for KD according to American Heart Association guidelines (Table 2): Fever (T≥38oC or 100.4oC) ≥ 3 days and ≥ 2 clinical criteria with left anterior descending (LAD)/right coronary artery (RCA) Z score ≥ 3.0 or an aneurysm (≥ 1.5 x the adjacent segment) of one of the coronary artery segments
2. Patient presents within the first 20 days after fever onset
3. Parent or legal guardian able and willing to provide informed consent; adolescent or child assent as appropriate
4. Post-menarchal females: Negative pregnancy test at screening and willing to use two forms of contraception during the study
5. Males engaging in sexual activity that could lead to pregnancy willing to use a condom.

Exclusion Criteria:

1. Use of an IL-1 antagonist within the 3 months prior to enrollment
2. History of chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder
3. History of hypersensitivity to anakinra
4. History of tuberculosis (TB) or TB exposure
Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Each patient must sign a study-specific informed consent form
* Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI
* Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin
* Karnofsky Performance Status score of at least 60%
* Primary tumor at least 4 cm in diameter

Exclusion Criteria:

Laboratory Values of:

* Serum creatinine \> 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min
* Serum total bilirubin \> 1.5 times the upper limit of normal
* ALT (formerly SGPT) \> 1.5 times the upper limit of normal
* Alkaline phosphatase \> 1.5 times the upper limit of normal
* Absolute neutrophil count (ANC) \< 1500/L
* Platelet count \< 100,000/L
* 3+ or greater proteinuria on urinalysis

and

* Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx
* Distant metastases
* Prior history of cancer at any site treated with radiotherapy and/or chemotherapy
* History of SCCHN diagnosed within 5 years of current diagnosis
Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic head and neck (H\&N) malignant lesions

Standard treatment for H\&N lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility Criteria:
Inclusion Criteria:

* symptomatic H\&N malignant lesions (primary solid tumors or metastases from solid tumor)
* age\>18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region
A Study Comparing CoQ10 Levels While Taking 3 Different Statins

The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.

Statins are known effectively treat high cholesterol and heart disease. However, statins may lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be responsible for side effects such as myalgia.

Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins do, while still lowering cholesterol.

In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking 3 different FDA-approved statins, in equipotent doses.

Eligibility Criteria:
Inclusion Criteria:

* LDL-C levels of 100-200mg/dl; triglycerides \</=200mg/dl at screening visit
* Willing to discontinue use of all lipid-altering doses fo medication or supplements for the duration of the study

Exclusion Criteria:

* LDL-C \<100mg/dl or \>200mg/dl, Triglycerides \>200mg/dl
* History of diabetes mellitus or documented fasting blood glucose \>125mg/dl or HbA1c \>6.4%
* History of coronary artery disease
* history of chronic renal or hepatic disease
* known sensitivity of intolerance to a statin
* persistent elevated liver enzymes or CPK (\>3 x upper normal limit)
* currently taking CoQ10 supplements and unable discontinue for duration of study
Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris

To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) authorization
* Stable PV for at least 6 months prior to screening
* Chronic pruritus of the PV plaques to be present for at least 6 weeks prior to screening
* Mild to moderate PV at screening and baseline
* Has a target plaque at baseline on the trunk and/or limbs
* Subject's plaques are amenable to treatment with a topical ointment medication
* Willing and able to comply with the study instructions and attend all scheduled study visits.
* Willing to avoid prolonged exposure of the designated treatment plaques to ultraviolet radiation
* Females of childbearing potential must have a negative pregnancy test at baseline before randomization and must agree to use highly effective contraception during the study
* Men who are sexually active and can father children must agree to use highly effective forms of contraception during the study

Exclusion Criteria:

* Underlying conditions other than psoriasis that, in the opinion of the investigator, currently cause or influence pruritus of the overall skin
* Positive hepatitis serology
* Thyroid abnormalities that may impact itching
* Subjects with spontaneously improving or rapidly deteriorating PV and/or pruritus
* Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
* Active psoriasis or itch affecting the palmar/plantar regions
* Subjects with a clinical diagnosis of bacterial infection of the skin
* Any major medical illness or symptoms of a clinically significant illness that may influence the study outcome
* Any acute chronic medical or psychiatric condition or laboratory abnormality that would make them unsuitable for participation in this study
* Known hypersensitivity to the study treatment excipients and /or polyethylene glycol, that contraindicates participation
* Currently enrolled in an investigational drug or device study or has used an investigational drug or an investigational device treatment within 30 days of randomization/baseline (Note: Subjects who are enrolled in a long-term follow-up study and are not actively receiving an investigational drug or investigational device treatment may be eligible for participation in this study)
* Female who is pregnant or lactating, or is planning to become pregnant during the study
* Subjects participating in any previous SNA-120 (and/or CT327) clinical studies
The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.

Summary:

Preoperative administration of indocyanine green (ICG) improves the detection of liver tumors in patients undergoing minimally invasive liver resection guided by conventional intraoperative ultrasound. The primary objectives of this study are to evaluate the efficacy of ICG fluorescence uptake in combination with intraoperative ultrasonography and preoperative magnetic resonance imaging for detecting liver tumors. Additionally, a machine-learning algorithm will be developed to enhance liver tumor detection using ICG through photographic analysis. Secondary objectives include investigating the distribution of ICG in liver tissue and its correlation with hepatic fibrosis and steatosis, as well as describing patterns of ICG uptake and their relationship with liver tumors. The study also aims to analyze various clinical outcomes such as the 30-day comprehensive complication index, operation time, conversion to open surgery rate, length of hospital stay, liver tumor recurrence, readmission rate, complications, and 90-day mortality. This research seeks to advance tumor detection methods and improve patient outcomes in minimally invasive liver resection procedures.


Eligibility Criteria:
Inclusion Criteria

* Patients with liver tumors with an indication for minimally invasive surgery, evaluated by the hospital's multidisciplinary liver tumor board (MDTB).
* Contrast enhanced MRI within 6 weeks prior to liver surgery
* ≥18 years old
* Absence of exclusion criteria and able to provide consent for data collection and analysis

Exclusion Criteria

* Emergency surgery
* Patients in which ICG is contraindicated: previous history of iodine hypersensitivity, patients with renal failure (GFR \<60 mL/min/1.73 m2), uremia, clinical hyperthyroidism, autonomic thyroid adenomas, or focal and diffuse autonomic abnormalities of the thyroid gland.
* Previous liver surgery.
Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of consciousness. The main questions it aims to answer are:

* Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population?
* What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity?

Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.


Eligibility Criteria:
Inclusion Criteria:

* Currently ICU hospitalized.
* Suppression of consciousness related to a neurological injury by medical chart review.
* Glasgow Coma Scale of less than 13 at enrollment by medical chart review.
* Diagnosis of Acute brain injury by TBI, hypoxic-ischemic insult, cardiac arrest, or stroke by medical chart review.
* 2 to 90 days from acute brain injury to enrollment time by medical chart review.
* Have a surface EEG performed after the current ICU admission
* Clinically stable to undergo MRI scan, This stability is defined by care team concept, which should be stated in the medical records.

Exclusion Criteria:

* Previous medical history of Epilepsy by medical chart review.
* Previous medical history of neurological sequels that lead to dependence on care for basic daily activities, by Barthel index score less than 80.
* Known allergy/Hypersensitivity or medical contraindications (like porphyria or cardiac arrhythmias) to the treatment protocol options, leaving no potential combination of drugs for the intervention without concerns for adverse events related to known preexistent conditions.
* Considered with Brain death by the care team in the medical record, at any time.
* Speaking fluently or at their prior reported baseline mental status by medical chart review before the intervention starts.
* Contraindications for MRI scan.
* Prisoner human subjects by medical chart review.
* Confirmed currently pregnant by medical history or by positive blood or urine pregnancy test done in the present hospital admission.
* Treating physician determines the patient is no candidate to receive 2 of the 5 protocol-specified ASM.
Circadian Timing, Information Processing and Energy Balance Study

This study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic risk factors.

The goal of this study is to determine how sleep and circadian rhythm alignment contribute to neurobehavioral and behavioral mechanisms of cardiometabolic risk. The investigators propose that circadian misalignment, which is more common among individuals with late sleep timing, leads to increased consumption of energy dense/prepared foods and to decreased insulin sensitivity. Short sleep duration and neurobehavioral measures (i.e. delay discounting) may moderate these associations, thus exacerbating cardiometabolic risk factors. There is evidence for a direct biological link between circadian misalignment and insulin resistance, and for a relationship that is mediated through changes in eating behaviors. Insulin resistance and increased caloric intake over time lead to increased BMI and body fat.

In this study, the investigators will conduct cross-sectional and longitudinal analyses to determine biological and behavioral mechanisms that link circadian alignment and sleep duration to changes in cardiometabolic risk over 1 year. This study will identify individual differences that predict risk for cardiometabolic disorders and suggest potential for sleep, circadian and neurobehavioral interventions to reduce cardiometabolic risk.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrate habitual sleep onset time between 10:00 pm-3:00 am on actigraphy;
* able to read and write in English;
* BMI 25-39.9 (overweight, class one obesity, or class two obesity)

Exclusion Criteria:

* High risk or presence of sleep disorders (obstructive sleep apnea (OSA), restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight OSA screening;
* Diagnosed with diabetes or HbA1c\>7 at screening or taking medications known to affect glucose;
* History of cognitive or neurological disorders;
* Presence of major psychiatric disorders, current alcohol or substance abuse as determined by screening questionnaires or self-report;
* Unstable or serious medical illness;
* Overnight shift work or travel over 2 time zones in the past 2 months;
* Use of hypnotic, stimulant or medications know to affect melatonin concentrations such as beta blockers, daily NSAIDs;
* Current smoking;
* Daily caffeine intake \>300 mg;
* Pregnant or lactating;
* Currently on a restrictive of special diet.
Neurophysiological Study of tDCS Effects in Healthy Volunteers

Transcranial direct current stimulation is a tool to modulate cortical excitability.

Anodal transcranial direct currenti stimulation over visual cortex is able to decrease the thermo-nociceptive sensibility and thermonociceptive potentials, whilst cathodal transcranial direct current stimulation has the opposite effect, it decreases VEP amplitude and habituation. This neuromodulation technique is probably a tool in the prevention in episodic and chronic migraine.

The aim of the study is to study short and long term effect of tDCS over pain treshold, contact heat evoked potentials, blink reflex and visual evoked potentials in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* age below 18 or above 65 years
* personal history of recurrent headache or other neurological diseases especially seizures,
* familial history of recurrent headache
* child migraine equivalents (motion sickness, cyclic vomiting or recurrent abdominal pain, somnambulism etc.. . .)
* chronic pain syndromes
* analgesics intake at the time of recording
* contra-indications to tDCS neurostimulation (metal prosthetics in the head or internal stimulation like a pacemaker).
MRI Morphology of Femoral Notch in ACL Injury

This study aims to investigate the association between femoral notch morphology, as assessed by MRI, and the risk of ACL injury


Eligibility Criteria:
Inclusion Criteria:

* patient aged 18-50 years.
* diagnosed with an ACL injury and confirmed by MRI and age-matched controls.

Exclusion Criteria:

* age \<18 yo and \>50 years
* patients with previous knee surgeries
* congenital knee deformities
* systemic conditions affecting bone health