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within category "Pain & Pain Management"
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Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)
The study investigators are interested in learning more about how drugs, that are given to
children by their health care provider, act in the bodies of children and young adults in
hopes to find the most safe and effective dose for children. The primary objective of this
study is to evaluate the PK of understudied drugs currently being administered to children
per SOC as prescribed by their treating provider.
Maria Stanley
All
0 Years to 20 Years old
NA
This study is also accepting healthy volunteers
NCT04278404
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Inclusion Criteria:
1. Participant is < 21 years of age
2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is
willing to provide informed consent/HIPAA:
3. (a) Participant is receiving one or more of the study drugs of interest at the time of
enrollment or (b) Participant is NOT receiving one or more of the study drugs of
interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:
1. Participant has a known pregnancy
Below exclusion criteria apply only to:
Participants receiving one or more of the study drugs of interest at the time of
enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for
details on enrollment cohort specifications and additional eligibility criteria)
2. Has had intermittent dialysis within previous 24 hours
3. Has had a kidney transplant within previous 30 days
4. Has had a liver transplant within previous 1 year
5. Has had a stem cell transplant within previous 1 year
6. Has had therapeutic hypothermia within previous 24 hours
7. Has had plasmapheresis within the previous 24 hours
8. Has a Ventricular Assist Device
9. Has any condition which would make the participant, in the opinion of the
investigator, unsuitable for the study
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome, Other
EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain
Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM
Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful Diabetic Peripheral
Neuropathy (PDPN) in a platform setting to test multiple assets under a single protocol.
Nalini Sehgal
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05476276
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Inclusion Criteria:
1. Able to provide informed consent. Legally Authorized Representatives (LARs) will not
be permitted.
2. 18 years of age and older
3. Diagnosis of diabetes mellitus
4. Meets the Toronto Criteria for probable clinical sensorimotor polyneuropathy, with
PDPN symptoms present for at least six months. This is defined as a combination of
symptoms and signs with any two or more of the following (must be present bilaterally
in the distal lower extremities): neuropathic symptoms, decreased distal sensation, or
unequivocally decreased (or absent) ankle reflexes. Specifically:
a. The presence of any neuropathic symptoms on either the "Douleur Neuropathique en 4
Questions" (DN4) or the EPPIC-Net Neuropathy Exam will suffice to demonstrate
"neuropathic symptoms." b. Decreased distal sensation is satisfied by any of the
following: i. "Yes" is checked at least once under Question 3 of the DN4 which queries
hypoesthesia to touch and pinprick.
ii. At least one score of "reduced" or "absent" on the right AND at least one score of
"reduced" or "absent" on the left in any of the following items from the EPPIC-Net
Neuropathy Exam:
• Pin sensation in segments 1 or 2 (i.e. the toes and feet)
• Vibration at the great toe
• Joint position at the great toe
• Light touch/touch pressure at the great toe
• Temperature at the great toe
• Monofilament at the great toe c. Decreased or absent ankle reflexes is satisfied
by a score of "reduced" or "absent" on the right AND left in the "Ankle reflex"
item in the EPPIC-Net Neuropathy Exam.
5. A score of at least 4 on the "Douleur Neuropathique en 4 Questions" (DN4).
6. Pain reporting during a pre-defined 7-day screening period meets study criteria (to be
established using a centrally-administered screening algorithm) which may account for
mean pain intensity reported, variability in reported values, and adherence in
reporting.
7. Patient reported daily 11-point NRS (for average and worst pain over the last 24
hours) is completed on at least 5 out of the 7 days in the baseline period.
8. Participants must be willing and able to comply with scheduled visits, the treatment
schedule, laboratory testing, and other requirements of the study (e.g., completion of
app-based daily reporting).
9. Females may be included if they meet at least one of the following criteria (note that
individual ISAs may specify more stringent measures to prevent pregnancy):
a. Are not of childbearing potential, defined as one or more of the following: i.
Post-menopausal for at least 1 year ii. Surgically sterile (bilateral tubal ligation,
bilateral oophorectomy, or hysterectomy) iii. XY genotype iv. Turner syndrome v.
Uterine agenesis. b. Are completely abstinent from sexual activity capable of
resulting in pregnancy (as part of their preferred and usual lifestyle). This will
include females whose sole sexual partner is a male who has undergone surgical
sterilization or vasectomy.
c. Women of childbearing potential will agree to practice an effective form of two
types of birth control, which are defined as those, alone or in combination, that
result in a low failure rate (i.e., less than 1% per year) when used consistently and
correctly. This must be done before, throughout, and for 30 days after the last dose
of study drug. Acceptable methods are: i. Hormonal methods such as the vaginal ring,
or oral, implantable, injectable, or transdermal contraceptives for a minimum of 1
full cycle (based on the participant's usual menstrual cycle period) before study drug
administration.
ii. Intrauterine device. iii. Barrier method of contraception: condoms with or without
a spermicidal agent, diaphragm or cervical cap with spermicide
10. Specific requirements of male participants (regarding contraception) will be defined
in the ISAs based on the potential toxicity profile of the asset.
Exclusion Criteria:
3.1.1. Neuropathy Confound Exclusion Criteria
1. Peripheral neuropathy caused by a condition other than diabetes (e.g. HIV,
cancer/chemotherapy-induced, other medication-induced, alcohol-induced, hereditary,
autoimmune neuropathies, uncontrolled or untreated hypothyroidism). Note that
participants will not be tested for HIV, this will be established by patient report or
review of the medical record.
2. Other significant pain conditions involving the same area as the neuropathy (e.g.
physical deformity of the feet, plantar fasciitis, lumbosacral radiculopathy with
distal lower extremity pain, fibromyalgia involving the lower limbs, Morton's
neuroma).
3. Other pain conditions not involving the same area as the neuropathy which (in the
opinion of the investigator) interfere with the participant's ability to rate the
neuropathy pain.
4. Any amputation of the lower limb which interferes with the participant's ability to
rate the neuropathy pain. If there is any amputation please contact the MM.
5. The presence of any current foot ulcer.
6. Significant peripheral vascular disease defined as symptoms consistent with
intermittent claudication.
3.1.2. Medication/Treatment Exclusion Criteria
7. Use of other investigational drugs within 3 months before screening and throughout the
study.
8. Known or suspected hypersensitivity to all of the assets (active component and
excipients) currently being tested in the Platform Protocol.
9. Undergone neurolytic or neurosurgical therapy or used an implanted neurostimulating
device for neuropathic pain in the distal lower limbs within 3 months of screening.
10. Use of the high dose capsaicin patch (8%) in the 6 months before screening and
throughout the study (for the treatment of PDPN). Use of the capsaicin patch in a
manner that is not expected to interfere with the measurement of PDPN severity is
allowed.
11. Participants who receive and are unwilling to discontinue episodic or periodic
treatments for pain in the distal legs and/or feet (e.g., injections of local
anesthetics) will be excluded. Non-pharmacological pain treatment (e.g.
relaxation/hypnosis, physical or occupational therapy, any exercise-based therapy, any
talk-based therapy, acupuncture, TENS) for the treatment of conditions other than PDPN
is allowed. If the treatment is for PDPN it is allowed if it has been stable for at
least 4 weeks prior to screening and is expected to remain stable throughout the
study.
12. Active use of opioids or marijuana for any reason at screening and unwilling or unable
to discontinue use.
3.1.3. Medical Exclusion Criteria
13. Clinically significant ECG or laboratory abnormalities at the Screening Visit that
would put the participant at undue risk or affect the ability of the participant to
participate in the trial (in the opinion of the investigator). Screening ECG and lab
results may be repeated without requiring a rescreen, as long as the participant is
still within the screening window.
14. Participants whose glycemic control has been unstable within 3 months before screening
(e.g. ketoacidosis requiring hospitalization, any recent episode of hypoglycemia
requiring assistance through medical intervention).
15. Proliferative retinopathy or maculopathy requiring acute treatment.
16. Requiring dialysis.
17. Myocardial infarction or stroke in the past 6 months.
18. Known diagnosis of moderate to severe hepatic impairment (equivalent to Child-Pugh
class B or C) OR aspartate aminotransferase or alanine aminotransferase ≥ 3 times the
upper limit of normal.
19. A clinically significant illness or operative procedure within 4 weeks of screening.
20. Clinically significant surgery planned during the study period. If a surgery is
planned, please contact the MM.
21. History of or currently active malignancy or other medical condition that would put
the participant at undue risk or affect the ability of the participant to participate
in the trial (in the opinion of the investigator).
22. Pregnant or nursing (lactating) women. 3.1.4. Psychosocial and Substance Use Disorders
Exclusion Criteria
23. A clinically significant psychiatric disease that would put the participant at undue
risk or affect the ability of the participant to participate in the trial (in the
opinion of the investigator).
24. Alcohol use disorder or other substance use disorders (other than nicotine or
caffeine) in accordance with DSM-5 criteria within 12 months of screening.
25. Positive urine drug tests defined as follows:
1. Two positive urine drug tests for prescription opioids or marijuana, prior to the
initiation of investigational product (IP); or
2. One positive urine drug test for any illegal drugs (other than marijuana) prior
to the initiation of IP.
26. Vulnerable persons defined as either of the following:
1. Individuals whose willingness to volunteer in a clinical study may be unduly
influenced by the expectation, whether justified or not, of benefits associated
with participation or of a retaliatory response from senior members of a
hierarchy in case of refusal to participate.
2. Individuals whose judgment has been impaired by their physical, mental, or
socio-economical condition and those incapable of giving informed consent.
Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia
will provide similar postoperative pain control, hospital length of stay, and postoperative
outcomes compared to surgeon-initiated wound infiltration with local anesthetic in
participants undergoing laparotomy for gynecologic indications.
Sumer Wallace, M.D.
Female
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT06213454
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Inclusion Criteria:
• Ability to understand and the willingness to sign a written informed consent document
• Patients undergoing exploratory laparotomy via midline vertical skin incision for
gynecologic indications at UW Hospital and Clinics
• Patients must be >18 years old
• English speaking (able to provide consent and complete questionnaires)
• Patients must have the ability to understand visual and verbal pain scales
• Patients must be eligible for TAP block placement. This will be confirmed during
preoperative visit with the primary surgeon. Patient's are not eligible if they have
allergies to the anesthetic medications or have had prior abdominal reconstructive
surgery that would alter their abdominal wall anatomy in a way where the block would
not be expected to be effective.
Exclusion Criteria:
• Known allergy to local anesthetics.
• Known history of chronic pain disorders and/or chronic opioid use defined as greater
than 10mg of PO morphine or equivalent used daily for at least 30 days prior to
enrollment.
• Patient has a history of opioid dependence requiring rehabilitation or the use of
opioid antagonists.
• Patients with a planned exploration with biopsies (no organs removed) will be excluded
from the study.
• Individuals who are pregnant, lactating or planning on becoming pregnant during the
study.
• Significant liver disease that would inhibit prescription of opioids.
• Significant kidney disease that would inhibit administration of gabapentin.
• Not suitable for study participation due to other reasons at the discretion of the
investigators.
Cervix, Corpus Uteri, Ovary, Other Female Genital, Uterus, Analgesia, Surgery
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