cyrilzakka/clinical-trials huggingface dataset:
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation

OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation.

II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.

PROTOCOL OUTLINE:

Patients begin a mycophenolate mofetil (MMF)-containing regimen within the first 5 days after transplantation. Patients have blood drawn on postoperative days 7, 21, 42, 70, 98, 126, and 154. Urine is collected on postoperative days 7, 21, and 42. Patients with T-tube bile externalization also have bile collected on postoperative day 7.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Orthotopic liver or kidney transplant recipients who started on a mycophenolate mofetil-containing immunosuppressive regimen within 5 days after transplant

Kidney transplant recipients will serve as study controls

--Prior/Concurrent Therapy--

* No concurrent bile acid sequestrants
* No mycophenolate mofetil as part of rescue therapy regimen
* No concurrent albumin replacement therapy

--Patient Characteristics--

Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL

Other:

* Not pregnant
* No mental incompetency
* No prisoners or parolees HIV negative
* No active infection defined as: Temperature above 101 F with WBC greater than 12,000/mm3 and left shift OR Two or more positive cultures of a single isolated organism from blood, urine, or sputum
A Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer

This is a prospective, multicenter, open-label, non-randomized study evaluating the ability of \[89\]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology.

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated with Desferroxamine and radiolabeled with \[89\]Zr. \[89Zr\]-Df-IAB2M targets the extracellular domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic prostate cancer lesions.

This is a phase 2, prospective, multi-center, open-label, non-randomized study evaluating the ability of \[89\]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology in patients with biopsy-proven prostate cancer thought to be candidates for radical prostatectomy and pelvic lymph node dissection who are at high-risk for pelvic lymph node metastasis. These patients may have identified lymphadenopathy on conventional imaging but are considered eligible if still judged to be candidates for radical prostatectomy and lymph node dissection.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of prostate adenocarcinoma.
2. Patients considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients may or may not have identified nodal metastasis on conventional imaging but would still be candidates for radical prostatectomy and pelvic lymph node dissection.
3. Patients, who are at high-risk for pelvic lymph node metastasis as defined by a lymph node involvement risk of greater than or equal to 20% using the Briganti nomogram.
4. Age ≥ 18 years.
5. Ability to understand and willingness to sign IRB approved consent form
6. For men of child-producing potential, the use of effective contraceptive methods during the study.

Exclusion Criteria:

1. Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, \[89\]Zr-Df-IAB2M PET/CT and the surgical resection or biopsy procedures used for the study evaluation.
2. Unwillingness or inability to comply with procedures required in this protocol.
3. Other cancers that might potentially interfere with the reading and interpretation of \[89\]Zr-Df-IAB2M PET/CT scans.
4. Patients who are currently receiving any other investigational agent.
5. Patients who have had or are currently receiving androgen deprivation therapy
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance

This is a 12-month, single center, three-arm parallel design, double-blind, randomized clinical trial, to compare the effects of supplemental dietary fiber and metformin (MET) alone and in combination over 12 months on glucose metabolism (insulin resistance \[IR\]), inflammation and BMI in adolescents with obesity and IR, and to assess the relationship between therapeutic intervention(s) and changes in gut microbiome composition and function.

Since MET and FIBER have been shown to reduce weight and increase insulin sensitivity through distinct but overlapping mechanisms of action, our central hypothesis is that the combination of FIBER + MET will have a synergistic effect and be more effective than FIBER or MET alone in improving metabolic function (IR) and reducing BMI and inflammation in adolescents with obesity, IR and family history (FM) of T2DM.

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Eligibility Criteria:
Inclusion Criteria:

1. Age 12-18 years
2. BMI percentile \> 95% for age/sex;
3. Total weight fluctuation over past 6 months \< 10%;
4. HOMA-IR \> 3.16;
5. FH of T2DM (first or second-degree relative).

Exclusion Criteria:

1. Current use of insulin or diagnosis of T2DM;
2. Systolic or diastolic blood pressure (BP) \> 99th percentile for age and sex;
3. Acute infectious or inflammatory condition over the preceding 1 month; hospitalization \> 48 hrs;
4. History of chronic disease such as inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders;
5. Active malignancy;
6. Concomitant use of medication/investigational drug known to affect body weight in the past year;
7. Antibiotic use in past 60 days; probiotic and/or prebiotic supplements use in the past 30 days; use of lipid-lowering and anti-inflammatory medication.
Understanding Performance: Enhancing Recovery as Surgeons

Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors can maximize recovery and performance.

Participants will be asked to wear a biometric sensor for six months. The biometric sensor, namely, 'The Whoop strap' collects heart rate and heart rate variability data.

Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, exercise and mindfulness, and surgical performance as well as video and audio recordings during a simulated surgical task.

Surveys will be individually numbered and a master list of subject number and video, audio, and sensor ID will be kept in a separate location. This practice will enable us to better understand survey feedback by reviewing relevant videos, images, and sensor recordings. Images and data associated with a subject will be labeled with the subject number only.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will include trainee and attending surgeons

Exclusion Criteria:

* Exclusion criteria will be anyone who is not full-time clinically active as a surgical trainee or attending
A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-393(2) in healthy volunteers under fed conditions

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged 19 ≤ \~ \< 55-year-old.
2. Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 ≤ \~ \< 30.5 kg/m2.
3. Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.

Exclusion Criteria:

1. Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
2. Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
3. Those who are pregnant or breastfeeding.
4. Those who are deemed inappropriate to participate in clinical trial by investigators.
Prospective Observation for Serial Changes of Acute Intracranial Artery Dissection Using High Resolution MRI

Intracranial artery disease has been more detected with development of HR-MR. HR-MR can depict vascular wall directly and give us more information beyond the pre-existing imaging modalities such as digital subtraction angiography, magnetic resonance angiography, computed tomography angiography. Hence, HR-MR is considered to become promising imaging modality for intracranial artery disease and many studies have been published recently. However, there was not enough to differentiate various intracranial artery disease such as atherosclerosis, dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. In real clinical arena, intracranial artery disease is too difficult to diagnose and distinguish among the disease. Of the disease, usefulness of HR-MR has been consistently published in the detection and diagnosis of intracranial artery dissection recently. HR-MR seems to be the most important and reliable imaging method in intracranial artery dissection as of now. Therefore, intracranial artery dissection is necessary to study using HR-MR. Intracranial artery dissection is dynamic vascular pathology. The geometric change is the most common among intracranial artery disease. However, there was no report about the geometric change in HR-MR. The investigators acquired retrospective data about the natural course of intracranial artery dissection in HR-MR and are preparing for publishing an article. However, the data is not prospective and not intraindividual comparison. Therefore, reliability is not enough to convince the natural course. If the investigators got prospective and intraindividual data, definite natural course of intracranial artery dissection could be acquired and would be helpful to diagnose the dissection and differentiate from other vascular pathologies. The prospective longitudinal information from this study could guide us as the important map on the confusing HR-MR findings. The protocols for imaging are as follows: initial (optional), 1 month, 3 month, 6 month (optional), 12 month.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* acute intracranial artery dissection

Exclusion Criteria:

* angioplasty, or stenting,
* contraindication for MR imaging,
* Hypersensitivity to gadolinium based contrast media,
* Pregnant or lactating women,
* Renal condition : eGFR \< 60, 6) Patients unable and/or unwilling to comply with treatment or study instructions
Phacoemulsification Under Topical Anesthesia and Its Complications

The purpose of this study is to determine if topical anesthesia is safe for phacoemulsification in eyes with comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* patients with cataract with a visual acuity less than 0.8

Exclusion Criteria:

* none
Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. It involves the injection of local anesthetics into the interfascial plane, deep to erector spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.


Eligibility Criteria:
Inclusion Criteria:

- Any lumbar spinae surgery on 2 or more lumbar levels

Exclusion Criteria:

* Contraindication to NSAID
* Allergy to any local anesthetics
Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy

Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World Health Organization and the National Hansen's Disease Program consider clofazamine to be standard therapy for treatment of multibacillary leprosy. In recent years, the availability of the drug has become limited and is currently available only under a research protocol and is considered "investigational." Use of Clofazamine in patients presenting with lepromatous leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other therapies. This drug will be used prospectively for patients who require treatment of leprosy as deemed appropriate by a Kaiser Permanente Southern California physician.

Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.

Eligibility Criteria:
Inclusion Criteria:

* Known or suspected leprosy confirmed by skin biopsy and/or slit skin smears.
* Multibacillary leprosy (lepromatous leprosy or borderline-lepromatous).
* Paucibacillary leprosy (borderline, borderline tuberculoid, or indeterminate) if there is involvement of the cranial nerves or active acute neuritis.
* Known or suspected ENL(erythema nodosum leprosum) (a specific immune reaction with painful skin nodules and fever)
* Known or suspected dapsone-resistant leprosy or relapsed leprosy.
* Intolerance of other antileprosy antibiotic (where clofazamine is substituted as apart of multidrug regimen)

Exclusion Criteria:

* Uncomplicated paucibacillary leprosy which would otherwise be treated with dapsone and rifampin only.
* Known prior intolerance of Clofazamine
* Any minor (even with parental consent)
* Any fertile woman who is pregnant a specific immune reaction with painful skin rash and fever)
Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors

The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of \[14C\]FTD or \[14C\]TPI.

This is a Phase 1, open-label study evaluating the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of \[14C\]FTD or \[14C\]TPI. The study will be conducted in 2 parts: mass balance part and TAS-102 extension part. After completion of the mass balance part, patients will receive continued treatment with TAS-102 during the study extension part.

Eligibility Criteria:
Inclusion Criteria:

1. Has advanced solid tumors (excluding previously treated breast cancer) for which no standard therapy exists
2. ECOG performance status of 0 or 1
3. Is able to take medications orally
4. Has adequate organ function (bone marrow, kidney and liver)
5. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
2. Certain serious illnesses or medical condition(s)
3. Has had either partial or total gastrectomy
4. Has a medical condition that jeopardizes or impairs ability to collect representative excreta
5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
6. Known sensitivity to TAS-102 or its components
7. Is a pregnant or lactating female
8. Refuses to use an adequate means of contraception (including male patients)
9. Is an occupationally exposed worker as defined by relevant ionizing radiation regulations
10. Has been exposed to 14C in the last 12 months
Acuvue Oaysis Contact Lens Wearers Being Refit Into P7 Contact Lenses

Determine the likelihood of successfully refitting a satisfied AOA CL wearers into P7A CLs

PRECISION7m for Astigmatism is a 1-week, silicone hydrogel (serafilcon A), daily wear, contact lens (CL) with extended wear approval made of a novel material that incorporates the Activ-Flo System. The Activ-Flo System has a moisturizing agent within the CL matrix, which allows for continual release of the moisturizing agents while also providing up to 16 hours of comfortable wear and precise vision for the life of the CL. While initial P7A data are promising, the literature currently lacks a targeted study aimed at determining how patients perform in P7A after transitioning out of other commonly prescribed silicone hydrogel CLs. This transition could be particularly important for patients who have astigmatism given that they tend to struggle with CLs more than spherical CL wearers.1 Thus, the purpose of this study is to determine the success rate of refitting current, satisfied ACUVUE OASYS for Astigmatism CL wearers into P7A. Understanding how a P7A CL wearer reacts to transitioning into P7A from AOA will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting successful AOA patients into the newer P7A technology, which could help grow the P7A CL market by not limiting P7A refits to problem-solving events.

Eligibility Criteria:
Inclusion Criteria:

1. Adults, 18- to 40-year-old, AOA CL wearers with best-corrected 20/20 visual acuity or better.
2. Participants will be required to have worn AOA CLs for at least 3 months in the past year and currently wearing these CLs.
3. All participants will be required to have a CLDEQ-8 score \<12 while wearing their habitual CLs (AOA CLs) and to indicate that they are satisfied with AOA CLs (Yes/No).
4. Participants will be required to be able to wear P7A CLs (astigmatism ≥0.75D OD/OS).
5. Astigmatism ranging from 0.75 D to 2.50 D in each eye
6. Participants will be required to wear the study CLs for ≥13 hours with no overnight wear
7. Participants will be willing to wear the CL every day of the week, except during the washout period
8. Participants will be required to provide a glasses prescription that is less than 3 years old

   -

Exclusion Criteria:

* 1. Have presbyopia and/or need a reading add as determined during their initial manifest refraction 2. Have worn P7A in the past 3. Are past rigid CL wearers 4. Have a history of being diagnosed with dry eye or ocular allergies 5. Have known systemic health conditions that are thought to alter tear film physiology 6. Have a history of viral eye disease 7. Have a history of ocular surgery 8. Have a history of severe ocular trauma 9. Have a history of corneal dystrophies or degenerations 10. Have active ocular infection or inflammation 11. Are currently using isotretinoin-derivatives or ocular medications 12. Are pregnant or breast feeding
Weaning with Tracheostomy - an Observational Study on Patient-centered Outcomes

Background: It is largely undocumented how long it takes to wean from invasive mechanical ventilation (IMV) with tracheostomy and to what extend these patients suffer from dyspnea or discomfort and how often sputum retention occurs requiring burdensome endotracheal suctioning. In patients undergoing invasive mechanical ventilation via endotracheal tube, dyspnea is prevalent and associated with poorer quality of life and more symptoms of post-traumatic stress disorder (PTSD)

Objectives: The present study aims to assess the duration of the weaning period, and the prevalence and severity of dyspnea and discomfort in patients with tracheostomy-facilitated weaning.

Study design: Prospective observational multicenter cohort study. Study population: Tracheostomized critically ill patients weaning from IMV.

Main study parameters/endpoints:

Prevalence and severity of dyspnea and discomfort during weaning, duration of weaning with tracheostomy, frequency of endotracheal suctioning, time with tracheostomy, clinical outcomes, and mortality rates. Long term outcomes are the prevalence quality of life, PTSD, anxiety and fear.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Scheduled to start weaning from iMV, as per clinical decision

Exclusion Criteria:

* Deafness or Blindness
* Inability to speak or comprehend Dutch and English language
* Neuromuscular Disease
* Chronic positive pressure respiratory support at home (excluding night-time CPAP for sleep apnea)
* Support by Ventricular Assist Device or Extracorporeal life support (ECMO or ECCO2R) during tracheostomy-facilitated weaning phase.
* Tracheostomy primarily indicated for chronic upper airway obstruction or to secure airway patency due to persistent stupor/coma or swallowing disorder