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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.

424 Study Matches

Mechanisms and effects of pallidal deep brain stimulation on levodopa resistant motor signs in Parkinson's disease; Udall Project 2, Aim 2

We hope to identify patterns in the brain that may be related to symptoms of PD, such as problems with walking. We are also testing different stimulation settings to see if they might be more effective than the settings that are currently used for treatment. This research may aid in our understanding of PD and how to treat it more effectively with DBS.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016988
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Inclusion Criteria:

• receiving DBS therapy in for treatment of Parkinson's Disease (PD)
• implanted with Medtronic Percept DBS system
• at least 3 months since initial activation of the DBS
Exclusion Criteria:

• musculoskeletal disorders that significantly affect the ability to perform the motor tasks
• dementia or cognitive impairment
• other significant neurological disorders
• post-operative complications or adverse effects of the DBS stimulation
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson Disease
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Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to treat medically intractable symptoms.

Principal Investigator: Colum MacKinnon
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1608M93561
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Inclusion Criteria:

• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
Exclusion Criteria:

• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Conditions: Brain & Nervous System
Keywords: Clinics and Surgery Center (CSC), DBS, Deep Brain Stimulator, Parkinson's Disease, PD
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Kinematic signatures of postural instability and gait in Parkinson Disease

The purpose of this research is to better understand balance and walking in patients with Parkinson’s Disease. This research study uses small wearable devices that attach to clothing and can measure the body’s location while performing walking and balance tests.

Principal Investigator: Robert McGovern, MD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00005877
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Inclusion Criteria:

• People diagnosed with Parkinson's disease, with or without implanted Deep Brain Stimulator (DBS). May be at any age of disease progression.
• Healthy adults of similar age to participants who have Parkinson's Disease and are enrolled in the study.
Exclusion Criteria:
People who have dementia of sufficient severity to impair their ability to make health-care decisions for themselvess
Conditions: Brain & Nervous System
Keywords: Parkinson's, Parkinson's Disease, Deep Brain Stimulator, DBS
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Causal Modeling of Ecological Momentary Assessment and Wearable Data in Youth

Researchers want to find out more about how physical, cognitive, and emotional factors affect eating.

Principal Investigator: Amy Gross
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021073
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Inclusion Criteria:

• 13-17 years old
• BMI at or above the 95th percentile
• own a smartphone
• willing to wear a FitBit or Garmin that we provide, download the FitBit or Garmin app on your smartphone and allow transfer of data to study staff
Exclusion Criteria:

• medication changes in the last 28 days for medications that are likely to affect appetite, mood, and attention
Conditions: Brain & Nervous System, Children's Health
Keywords: adolescents, Eating behaviors
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Colorectal Cancer Metastatic dMMR/MSI-H Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab/Atezolizumab Combination Versus Single Agent Atezolizumab in the First-Line Treatment of Patients With Deficient DNA Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer

We are studying how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating people with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC045
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Inclusion Criteria:

• diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer except for one cycle of FOLFOX or capecitabine and oxaliplatin (CAPOX), with or without bevacizumab
• tumor determined to be mismatch-repair deficient (dMMR)
• able to walk & do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional criteria apply (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• treatment with oxaliplatin chemotherapy within 6 months prior to randomization
• history of significant liver, heart, lung, or autoimmune disease etc. (study staff will review)
Conditions: Cancer
Keywords: Colon Cancer, Metastatic Colorectal Adenocarcinoma, Rectal Cancer, Stage IV Colorectal Cancer
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A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients

We are looking at the addition of nivolumab to chemotherapy compared to usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body. Immunotherapy, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells. Giving nivolumab with chemotherapy may help doctors find out if the treatment is better or the same as the usual approach.

Principal Investigator: Edward Greeno, M.D.
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC037
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Inclusion Criteria:

• inoperable, recurrent, or metastatic anal cancer
• restricted from strenuous activity but can walk and are able to carry out work of a light or sedentary nature
• requirements for lab results at a defined level (study staff will review)
• history of significant heart disease
Exclusion Criteria:

• women who are pregnant or breastfeeding
• previous use of systemic chemotherapy or other investigational drugs
• prior immunotherapy
• active autoimmune disease or history of autoimmune disease
• other primary cancer within the last 3 years
• intermittent peripheral neuropathy
• additional exclusion criteria that study study will review
Conditions: Cancer
Keywords: Anal Cancer
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The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib

We are studying how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Principal Investigator: Kiran Lassi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC030
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Inclusion Criteria:

• diagnosis of HER2-positive breast cancer
• received neoadjuvant (before surgery) chemotherapy
• had surgery that removed all disease in the breast and lymph nodes
• restricted from strenuous activity but can walk and do work of a light or sedentary nature, e.g., light house work, office work
• additional criteria apply (study staff will review)
Exclusion Criteria:

• women who are pregnant or breastfeeding
• history of prior invasive breast cancer within past 3 years
• peripheral neuropathy that is more than intermittent & mild
• see link to clinicaltrials.gov for additional exclusion criteria
Conditions: Cancer
Keywords: Breast Cancer, HER2 Positive Breast Cancer
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The Women Kidney Program

The purpose of this study is to capture clinical information on how kidney disease affects the health of women, focusing on menstrual and reproductive health, the transition to menopause (the time when your menstrual periods stop permanently), and menopause itself. We also wish to learn more about how women’s health affects their kidney disease, bone and heart health.

Principal Investigator: Angie Lobo Romero
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020957
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Inclusion Criteria:

• female as biological sex
• diagnosis of a kidney disease or after kidney transplant
• at least 18 years old
Exclusion Criteria:

• unable to speak English
Conditions: Kidney, Prostate & Urinary, Women's Health
Keywords: Clinics and Surgery Center (CSC), Kidney disease, kidney transplant
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Personalized Nutrition Therapy Using Continuous Glucose Monitoring to Improve Outcomes in Type 2 Diabetes Mellitus

The purpose of this research study is to learn more about how food affects blood sugar levels, and whether a continuous glucose monitor (CGM) can help to individualize nutrition education for people with diabetes. Participation in the study would require 3-4 clinic visits over a period of 14 weeks. Participants will also be asked to: meet with a registered dietitian every 2 weeks (virtually), keep food logs, wear a CGM and an activity monitor, answer survey questions, and provide blood samples to measure markers of diabetes control (like hemoglobin A1c).

Principal Investigator: Anne Bantle
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019848
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Inclusion Criteria:

• at least 18 years of age
• diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c of 7.0 - 9.5%
• Stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period
Exclusion Criteria:

• Type 1 diabetes mellitus
• treatment with insulin, sulfonylurea, or meglitinide
• use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid)
• BMI < 25 kg/m2
• weight change > 5 pounds in the 3 months prior to study enrollment
• estimated glomerular filtration rate <60 ml/minute/1.73 m2
• pregnant or breastfeeding
• anemia
• presence of any disease that would make adherence to the protocol difficult
Conditions: Diabetes & Endocrine
Keywords: Diabetes, T2D, Type 2 Diabetes
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Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma

To determine the prognostic factors for visual outcome for newly diagnosed NF1-OPGs. Hypothesis: Patients (<18 years of age) with tumors involving the optic tracts and/or radiations will demonstrate worse visual outcomes compared to those without optic tract involvement.

Principal Investigator: Christopher Moertel, MD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: 1606M89501
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Inclusion Criteria:

• less than 18 years old
• EITHER the clinical diagnosis of NF1 OR have a constitutional NF1 mutation
• newly diagnosed Optic Pathway Glioma (OPG) (confirmed by MRI within 1 month of enrollment)
• additional inclusion and exclusion criteria (study staff will review)
Exclusion Criteria:

• OPGs involving only the optic radiations
• prior therapy for an OPG (e.g. surgery [including biopsy], radiotherapy, chemotherapy, etc.)
• prior therapy for another (non-OPG) tumor
• history of hydrocephalus requiring surgical intervention
Conditions: Cancer, Cancer
Keywords: OPG, Optic Pathway Glioma
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COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000295
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Inclusion Criteria:

• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
Exclusion Criteria:

• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
Conditions: Cancer
Keywords: Germ Cell Tumor, Malignant Germ Cell Tumor
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Stability 2: ACL Reconstruction +/- Lateral Tenodesis with Patellar vs Quad Tendon (Protocol # PRO19020231) (STABILITY 2)

The purpose of this multicenter study is to compare outcomes between patients who will undergo different types of ACL reconstruction. All patients will have a tendon from their own knee used to reconstruct the ACL. Prior to knee surgery, researchers will randomize (i.e. a coin toss) to determine if ACL reconstruction will be done with patellar or quadriceps tendon and if the lateral extra-articular tenodesis will or will not be added to the ACL surgery. We will follow-up with participants as they undergo treatment and recovery after surgery for 2 years.

Principal Investigator: Jeffrey Macalena
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000971
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Inclusion Criteria:

• age 14-25
• ACL deficient knee
• at least two of the following: participate in a competitive pivoting sport; have a pivot shift of grade 2 or greater; have generalized ligamentous laxity
Exclusion Criteria:

• previous ACL repair on either knee
• partial ACL tear
• multiple ligament injury (two or more ligaments requiring surgery)
• pregnancy
Conditions: Bone, Joint & Muscle
Keywords: Clinics and Surgery Center (CSC), ACL, Anterior cruciate ligament reconstruction, joint instability
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An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose PR001A in Infants with Type 2 Gaucher Disease

PR001A is designed to deliver a normal GBA1 gene copy into the body to increase the activity of GCase, which is low in Type 2 Gaucher Disease (GD2) patients. The new GBA1 gene will remain a child’s body cells for many years and possibly for the rest of their life. A participant will need one surgery during which the study drug will be given and will stay in the hospital for at least 48 hours following the surgery.

Principal Investigator: Chester Whitley, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00008823
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Inclusion Criteria:

• 0 to 24 months of age
• clinical diagnosis on Gaucher disease, Type 2 (GD2)
• Bi-allelic GBA1 mutation
• child has a reliable caregiver (i.e., parent/legal guardian) who is willing and able to participate in the study as a source of information on the patient's health status and cognitive and functional abilities
Exclusion Criteria:

• diagnosis of a significant CNS disease other than GD2
• able to walk independently
• any other significant medical diagnosis (study staff will review)
• significant laboratory test result abnormalities
• unable to tolerate diagnostic imaging (MRI, CT scan) or unable to tolerate contrast agent
• unable to have sedation or anesthesia
Conditions: Rare Diseases
Keywords: Gaucher disease, Type 2 (GD2)
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PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE)

More than 65% of people with lower extremity peripheral artery disease (PAD) are overweight or obese. Overweight or obese people with PAD have greater functional impairment and faster functional decline than normal weight people with PAD. Walking exercise is first line therapy to improve walking performance in PAD. However, our NHLBI-funded observational longitudinal study of functional decline in PAD showed that overweight and obese PAD participants who combined weight loss with walking exercise had significantly less functional decline than those who walked for exercise but did not lose weight. Therefore, we hypothesize that among people with PAD who are overweight or obese, a weight loss intervention combined with exercise will improve walking ability more than exercise alone. However, the effects of intentional weight loss in overweight or obese people with PAD are unknown and may not be beneficial if weight loss exacerbates PAD-related sarcopenia. Behavior change that achieves sustained weight loss is particularly challenging in older obese people with chronic disease. Therefore, among people with PAD and BMI>28 kg/m2, we will conduct a randomized clinical trial to test the hypothesis that a weight loss intervention combined with walking exercise achieves greater improvement in functional performance than exercise alone at 12-month follow-up.

Principal Investigator: Diane Treat-Jacobson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00000513
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Inclusion Criteria:

• at least 18 years old
• diagnosis of Peripheral Artery Disease (PAD) with leg symptoms
• BMI 25kg/m2 or more
Exclusion Criteria:

• above or below knee amputation, critical limb ischemia, or wheelchair confinement
• walking is limited by a condition other than PAD
• heart attack or stroke in the past 3 months
• medical or mental health disease that will interfere with study participations (study staff will review)
• currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
• unwilling/unable to use a smart phone and unwilling to attend weekly study sessions
• unable to speak English
Conditions: Heart & Vascular
Keywords: cocoa, intercede, pad, peripheral arterial disease, peripheral artery disease, prove
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A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated with Lonapegsomatropin (SkyPASS) (SkyPASS)

The purpose of this study is to evaluate the long-term safety and effectiveness of Skytrofa treatment in children growth hormone deficiency. Patient care will follow the normal treatment practices at the clinic. No additional visits will be performed beyond the usual clinical practice.

Principal Investigator: Brad Miller, MD, PhD
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00002030
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Inclusion Criteria:

• 1 to 18 years old
• on treatment with SKYTROFA (lonapegsomatropin)
Exclusion Criteria:

• participating in any interventional clinical study for short stature
Conditions: Diabetes & Endocrine, Rare Diseases, Rare Diseases, Rare Diseases
Keywords: growth hormone and growth hormone deficiency

Projecting Outcomes in Respiratory Technology Dependent Children After Serious Illness (Project ORCAS)

We are hoping to understand more about how being in the ICU impacts children who use breathing support at home and their families. As part of this research study, families will be asked to complete the following during the four study periods: - Complete questionnaires - Airway oscillometry will be used to test your child’s breathing - Complete short daily surveys

Principal Investigator: Julia Heneghan
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021472
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Inclusion Criteria:

• Current pediatric ICU admission of at least 24 hours
• Presence of CRTN (any use of supplemental respiratory support, from nasal cannula to around-the-clock mechanical ventilation via a tracheostomy, when the child is at his or her clinical baseline)
• age at least 4 weeks (and at least 40 weeks corrected gestational age) and <17 years at the time of enrollment;
• Presence of at least one parent or legal guardian in the home who would be able to provide information about the child’s daily activities outside the hospital via web- and texting-based interfaces
Exclusion Criteria:

• Child is enrolled in an interventional study related to provision of pediatric critical care services
• Family does not speak English to an extent to be able to adequately participate in consent discussions or study protocols
Conditions: Children's Health, Respiratory System
Keywords: critical care, outcomes
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Monoclonal Gammopathy and Amyloidosis Registry and Biobank (MGARB)

The purpose of this study is to establish a registry and biobank to study monoclonal gammopathy and amyloidosis. We aim to understand better the changes these diseases cause, the symptoms they present, and the clinical progression to be able to better prevent them and treat them in the future.

Principal Investigator: Sabine Karam
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00018498
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Inclusion Criteria:

• diagnosis of monoclonal gammopathy or amyloidosis
Exclusion Criteria:

• unable to speak English
Conditions: Rare Diseases
Keywords: Clinics and Surgery Center (CSC), amyloidosis, monoclonal gammopathy
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A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species (OASIS)

This study will look at an investigational study drug, called olorofim, to determine how safe the study drug is, how well it is tolerated and whether it is effective compared to AmBisome® (a standard of care treatment) to treat invasive fungal disease (IFD). We expect that you will be in this research study for up to 18 weeks or just over 4 months.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019092
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Inclusion Criteria:

• over 18 years old
• weigh more than 40 kg (88 pounds)
• Invasive Aspergillosis (IA) at any site
• require therapy with an antifungal agent other than a mold-active azole
Exclusion Criteria:

• women who are pregnant or breastfeeding
• known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
• people with chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis
• human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy
• certain heart and liver conditions (study staff will review)
Conditions: Infectious Diseases, Respiratory System
Keywords: Aspergillosis, IA, Invasive Aspergillosis (IA), Lung Infection
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Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia

The purpose of this study is to compare the effectiveness of megestrol alone, or combined with metformin, on the growth of Endometrial Intraepithelial Neoplasia (EIN). Participants will receive medication directed against EIN prior to the planned procedure (hysterectomy or progestin IUD placement). Women will receive either megestrol acetate pills by mouth twice a day for 3 to 5 weeks, or megestrol acetate and metformin pills twice a day by mouth for 3 to 5 weeks.

Principal Investigator: Britt Erickson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001945
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Inclusion Criteria:

• endometrial intraepithelial neoplasia (EIN) on an endometrial biopsy or dilation and curettage specimen
• willing to have surgery (hysterectomy) or non-surgical treatment with a progestin IUD
• if diabetic, blood glucose must be appropriately controlled as evidenced by a hemoglobin A1c of < 8.0 in the last three months prior to enrollment
• women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:

• Current hormonal contraceptives or post-menopausal hormone replacement therapy, and uses of progestins (including progestin containing intrauterine device (there are exceptions, study staff will review)
• current use of metformin therapy. If previously used, it must be discontinued at least a year ago
• women who are pregnant or breast feeding
• history of pulmonary embolism, thrombotic stroke, arterial thrombosis or deep vein thrombosis
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Endometrial Carcinoma, endometrial intraepithelial neoplasia (EIN)
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ALX-HPP-501: An Observational,Longitudinal Prospective, Long-term Registry of Patients with Hypophosphatasia

This is a long-term registry is designed to collect data on hypophosphatasia (HPP) to better understand the condition and learn more about the disease, how patients feel about living with HPP and effect of HPP on the patients wellbeing and health. The study will look at participant’s medical records and health questionnaires about the health status of patients. This study collects observational data from clinical care and does not involve any treatment for HPP or administration of medication for HPP.

Principal Investigator: Kyriakie Sarafoglou
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00004936
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Inclusion Criteria:

• confirmed diagnosis of HPP.
• documented alkaline phosphatase (ALP) activity below the lower limit of normal for age and sex, or a documented ALPL gene mutation.
• able to read and speak English
Exclusion Criteria:

• currently participating in an Alexion-sponsored clinical trial
Conditions: Rare Diseases
Keywords: HPP, Hypophosphatasia
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Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies

The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.

Principal Investigator: Elliot Arsoniadis
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00017257
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Inclusion Criteria:

• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
Conditions: Cancer, Prevention & Wellness
Keywords: Clinics and Surgery Center (CSC), Anal Cancer
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Principal Investigator: Colleen Correll
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: 1506M74443
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Inclusion Criteria:

• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
Conditions: Arthritis & Rheumatic Diseases, Cancer
Keywords: juvenile idiopathic arthritis (JIA), pediatric rheumatic disease
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A longitudinal study of imaging biomarkers in amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS)

The purpose of the study is to test new biomarkers of amyotrophic lateral sclerosis (ALS) and primary lateral sclerosis (PLS) using MRI scans at 3 tesla (3T). Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments.

Principal Investigator: David Walk
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: 1306M35941
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Inclusion Criteria:

• 21 to 75 years old
• diagnosis of possible, laboratory-supported probable, probable, or definite ALS or PLS
Exclusion Criteria:

• other neurodegenerative diseases (Parkinson disease, Alzheimer's disease, etc).
• inability to undergo MRI scanning
• needs assistance to walk or climb stairs
Conditions: Brain & Nervous System, Rare Diseases
Keywords: ALS, Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis
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Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM sleep Behavior Disorder

This research is being completed to examine the cells, brain imaging, and speech in individuals with REM Sleep Behavior Disorder who are taking serotonergic medications such as Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine and Sertraline. The purpose of examining these is to try and see if we can predict signs of Dementia with Lewy bodies (a progressive form of dementia with an increase in decline of thinking, reasoning, and other functions). This may benefit others by enabling us to diagnose Dementia with Lewy Bodies sooner rather than later.

Principal Investigator: Michael Howell
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00019626
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Inclusion Criteria:

• 18 to 75 years old
• diagnosis of polysomnogram-confirmed RBD (e.g. narcolepsy) with history of dream enactment or clear dream enactment visualized on video from polysomnogram
• dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication
• for Healthy Volunteers: on serotonergic medication for at least 6 months without history of dream enactment
• the following serotonergic medications are included for both groups: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline
Exclusion Criteria:

• Parkinsons disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimers disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy)
• untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing
• unable to have a MRI scan
• women who are pregnant
• for Healthy Volunteers: same exclusion criteria as those with 5-HT RBD group, plus history of dream enactment, or increased REM motor tone
Conditions: Rare Diseases, Brain & Nervous System
Keywords: dream enactment, Serotonergic REM sleep behavior
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Can spectral power and coherence reflect the integrity of the efferent cerebellar cortical pathway in cerebellar mutism syndrome?

This study will be measuring brain activity using EEG and assessing motor skills and speech in children following cancerous brain tumor resection. No direct cancer treatments or objectives are being targeted.

Principal Investigator: Sharyl Samagia-Grivette
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00019602
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Inclusion Criteria:

• Cerebellar Mutism Syndrome (CMS) & Comparison (without CMS) Groups: ages 10 years 0 months to 25 years 11 months of age & fluent in English (parents/guardian do not need to be fluent in English)
• For those with Cerebellar Mutism Syndrome (CMS): history of resection of posterior fossa tumor at least 2 years before starting the study and at least 3 months post chemotherapy and radiation treatment
Exclusion Criteria:

• Comparison group without CMS: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder
• any genetic condition
• any neurologic condition including history of stroke, seizure disorder, or brain injury
• history of brain tumor or other cancer diagnosis
• CMS Group: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder prior to brain tumor diagnosis
• any genetic condition prior to brain tumor diagnosis
• any neurologic condition including history of stroke, seizure disorder, or brain injury disorder prior to brain tumor diagnosis
Conditions: Brain & Nervous System, Cancer, Children's Health
Keywords: brain tumor, cerebellar mutism syndrome (CMS)
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A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

We are looking at how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body and may stop the growth of tumor cells that need estrogen to grow. We will compare the effectiveness of the two different treatments.

Principal Investigator: Rahel Ghebre, Dr
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC048
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Inclusion Criteria:

• newly diagnosed, stage II-IV low-grade serous ovarian cancer fallopian tube or primary peritoneal cancers
• surgery for maximal cytoreduction completed within 8 weeks of randomization
• bilateral salpingo-oophorectomy completed
• able to take oral medications
Exclusion Criteria:

• prior neoadjuvant chemotherapy, endocrine therapy or radiotherapy for the treatment of this disease
• severe cardiac disease
Conditions: Cancer
Keywords: Fallopian Tube cancer, Ovarian cancer, Peritoneal cancer, Serous carcinoma
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Collaborative Solutions for Breaking Up Sedentary Time in Black Older Adults with Type 2 Diabetes: The Interrupt T2D Study

Black Americans are 60% more likely to be diagnosed with Type 2 Diabetes (T2D) and 2 times more likely to die from T2D than non-Hispanic White Americans. Recent research has shown that sedentary behavior (such as sitting or lying down) have a significant negative impact on health. We are doing a small study with older people who identify as Black or African American and have T2D to look at ways to reduce sedentary behavior. The study will last about 1-2 months for each participant.

Principal Investigator: Mary Whipple
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021174
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Inclusion Criteria:

• self-identify as Black or African American.
• 55 years and older
• speak and read English.
• self-reported diagnosis of type 2 diabetes (T2D)
Exclusion Criteria:

• evidence of cognitive impairment that could impact ability to consent and/or participation
• physical impairment or disability that interferes with ability to engage in physical activity such as severe osteoarthritis, lower extremity amputation (other than toe(s) or partial foot), regular use of a walker or wheelchair, etc.
• unstable medical or mental health condition (study staff will review)
Conditions: Diabetes & Endocrine, Heart & Vascular, Prevention & Wellness
Keywords: behavior change, community engaged research, diabetes, physical activity, sedentary behavior, T2D
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Multimodal profiling of response to pediatric Comprehensive Behavioral Intervention for Tics

This study identifies the bio-behavioral predictors and correlation of responses to Comprehensive Behavioral Intervention to Tics (CBIT) in young people with tic disorder.

Principal Investigator: Sonya Wang
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020174
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Inclusion Criteria:

• age 10-17 years at time of enrollment
• current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
• at least moderate tic severity
• full scale IQ greater than 70
• English fluency to ensure comprehension of study measures and instructions
Exclusion Criteria:

• inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG
• actively suicidal
• previous diagnosis of psychosis, cognitive disability, or structural brain disease
• history of seizure disorder
• active substance abuse or dependence
• presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met
• concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
• psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
• four or more previous sessions of CBIT
Conditions: Brain & Nervous System, Children's Health, Mental Health & Addiction
Keywords: cbit, mental health, motor tic, tic, tourette syndrome, vocal tic
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The TrialNet Natural History Study of the Development of Type 1 Diabetes

TrialNet is an international research group dedicated to the study, prevention, and early treatment of Type 1 diabetes. Type 1 diabetes is now understood as a disease that develops over time in stages. Stage 1 starts with the appearance of having two or more autoantibodies. This is followed by Stage 2, which is the development of abnormal blood glucose levels. Stage 3 is the clinical diagnosis of Type 1 diabetes. This study will help us learn more about how Type 1 diabetes occurs through the screening of diabetes-related autoantibodies and monitoring individuals who have tested positive for these autoantibodies.

Principal Investigator: Antoinette Moran
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: SITE00000016
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Inclusion Criteria:

• 2.5 to 45 years old and have an immediate family member with type 1 diabetes (child, parent, or sibling)
• 2.5 to 20 years old who have an extended family member with type 1 diabetes (cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Exclusion Criteria:

• already have diabetes
• history of being treated with insulin or oral diabetes medications
• using systemic immunosuppressive agents (topical and inhaled agents are acceptable)
• have any known serious diseases
Conditions: Diabetes & Endocrine
Keywords: T1DM, Type 1 Diabetes

Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

Principal Investigator: Greg Helmer
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00013236
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Inclusion Criteria:

• at least 18 years old
• Ejection Fraction: between 20% and 40% measured by transthoracic echocardiography (TTE)
• diagnosis and treatment for heart failure should be established at least 90 days before entering the study & should be on stable, optimal medical therapy for at least 30 days
Exclusion Criteria:

• myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• any planned cardiac surgery or interventions within the next 180 days
• women who are pregnant, planning to become pregnant, or are breast feeding
• additional cardiac and medical diagnosis will exclude participation (study staff will review)
Conditions: Heart & Vascular
Keywords: Clinics and Surgery Center (CSC), Dilated Cardiomyopathy, Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)