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Study matches: 5

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

This research is being done to find out the successfulness and clinical effectiveness of using the Intracept® Intraosseous Nerve Ablation System in adult subjects with chronic low back pain.
Swati Shah at sshah@pennstatehealth.psu.edu or 717-531-0003 x281203
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Skeletally mature subjects age 25 – 70 years, inclusive
Chronic lower back pain for at least six (6) months
Failure to respond to at least six (6) months of non-operative conservative management.
Fluent in reading, writing, speaking, and understanding the English language.
Willing and able to follow the requirements of the protocol, including the post-operative management program and follow-up schedule
Exclusion Criteria:
Current or history of symptomatic spinal stenosis
Current or history of osteoporotic or tumor-related vertebral body compression fracture
Current or history of vertebral cancer or spinal metastasis
Current or history of spinal infection
Metabolic bone disease (e.g. osteogenesis imperfecta)
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NCT03246061
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Location
Hershey, PA

A phase 2b, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a Staphylococcus aureus 4-antigen vaccine (SA4Ag) in adults undergoing elective open posterior fusion procedures with multilevel instrumentation. Protocol Number: B3451002

Vaccine to decrease or prevent MRSA infection in spinal surgery patients
Deborah Hoffman at dhoffman1@pennstatehealth.psu.edu or 717 531 0003 x283063
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Elective instrumented fusion of at least 3 levels
•cervical to lumbar
scheduled procedure must be at least 10 days after vaccine
Open posterior procedure
18 to 86 years old
Exclusion Criteria:
spinal fusion within past 6 months
major surgery within the last 3 months or anticipate major surgery
recent vaccination or infection
malignancy
staged spinal surgery
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NCT02388165
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Hershey, PA

SPIRIT 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Endometriosis-Associated Pain

Endometriosis is a common chronic condition that can cause pain in the lower part of the stomach (pelvis) during the menstrual period and at other times and pain during sexual intercourse. The purpose of this study is to test how effective and safe the investigational study drug, relugolix (rel-U-GO-lix), given with or without low-dose estradiol and norethindrone is in treating endometriosis-associated pain. Estradiol is a form of estrogen and norethindrone is form of progesterone. Both estrogen and progesterone are hormones normally made by women’s bodies. These hormones help control the menstrual cycle and menstrual periods and also support bone health. The study wants to know if endometriosis pain affects how women function, how they feel and if the study drug is effective and safe at treating the pain from endometriosis.
Heidi Watts at hwatts@pennstatehealth.psu.edu or 717-531-6272
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Premenopausal female aged 18 to 50 years old
Has a diagnosis of endometriosis verified by surgery in the last 10 years
Has regular menstrual cycles (21 to 35 days long)
Has moderate, severe, or very severe pain during menstrual cycles
Is not expected to undergo gynecological surgery (or other surgical procedures for treatment of endometriosis) during the study
Exclusion Criteria:
Has a history of chronic pelvic pain that is not caused by endometriosis
Has had 4 or more prior laparoscopic, surgical, or other invasive procedure for endometriosis
Has had gynecological surgery or other surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit
Has unexplained vaginal bleeding outside of the patient’s regular menstrual period or pregnancy
Has a gastrointestinal disorder affecting absorption or gastrointestinal motility, history of or currently has osteoporosis or a systemic autoimmune disease
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NCT03204318
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Hershey, PA

A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects with Charcot-Marie-Tooth Disease

A Randomized, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of FLX-787-ODT for Treatment of Muscle Cramps in Adult Subjects with Charcot-Marie-Tooth Disease
Ruth Stewart at rstewart@pennstatehealth.psu.edu or 717-531-0003
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Diagnosis of Charcot Marie Tooth disease
Experience at least 5 muscle cramps per week
Exclusion Criteria:
Major gastrointestinal disorders or oral or esophageal lesions/ulcers
Significant swallowing problems
Inability to tolerate a spicy sensation in the mouth or stomach
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NCT03254199
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Hershey, PA

Adaptation of trunk muscles in patients with chronic back-pain

The objective of this study is to evaluate the function of back muscles in patients with chronic back pain, and to understand how back muscles are affected by posterior lumbar surgery. Patients who are candidates for lumbar fusion will be evaluated before and after the surgical procedure.
Daniel Cortes at researchsubjects@mne.psu.edu or 8148633103
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Candidates for Lumbar Fusion Surgery
Exclusion Criteria:
Allergy to ultrasound gels
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N/A
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Study Locations

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Location
Hershey, PA
State College, PA