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195 Clinical Trials near Fairfield, CT
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerCediranib + Olaparib vs Bevacizumab for Recurrent Glioblastoma
Fairfield, Connecticut
This trial compares two treatments for patients with glioblastoma that has returned. One treatment uses pills that block enzymes needed for tumor growth. The other treatment uses an IV drug that helps the immune system fight cancer and prevents tumors from growing. The goal is to see which treatment works better at stopping the cancer from progressing.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Hypertension, Myocardial Infarction, HIV, Others
Must Not Be Taking:PARP Inhibitors, VEGF Pathway
70 Participants Needed
Chemotherapy + Veliparib for Pancreatic Cancer
Fairfield, Connecticut
This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to FOLFIRI in treating patients with pancreatic cancer that has come back after a period of improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Brain Metastases, Seizures, Heart Failure, Others
Must Not Be Taking:Irinotecan, PARP Inhibitors
123 Participants Needed
Elotuzumab + Triple Therapy for Multiple Myeloma
Fairfield, Connecticut
This partially randomized phase I/II trial studies the side effects and best dose of elotuzumab and to see how well it works when given together with lenalidomide, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to block cancer growth.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Non-secretory MM, Amyloidosis, POEMS, Others
Must Not Be Taking:Zidovudine, Stavudine
142 Participants Needed
Chemotherapy for Breast Cancer
Bridgeport, Connecticut
This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Heart Failure, Hypertension, Others
454 Participants Needed
ABBV-916 for Early Alzheimer's Disease
Fairfield, Connecticut
This trial is testing a new drug called ABBV-916 to see if it can help people aged 50-90 who are in the early stages of Alzheimer's disease. Participants will receive the drug regularly over several months. The study aims to find out if the drug is safe and effective by monitoring changes in symptoms and side effects.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:50 - 90
Key Eligibility Criteria
Disqualifiers:Vasogenic Edema, Microhemorrhages, Others
Must Not Be Taking:Anticoagulants
106 Participants Needed
Stem Cell Therapy for Neurological Disorders
Westport, Connecticut
This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Medically Unstable, Others
500 Participants Needed
PCT+2HOPE for Opioid Use Disorder
Bridgeport, Connecticut
Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use \[i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used\], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Unstable Medical, Psychiatric Illness, Others
Must Be Taking:MOUD
532 Participants Needed
Neck Stretch for Shoulder Issues
Fairfield, Connecticut
This study will examine the effects of a single session of a quick stretch technique delivered to the neck on neck and shoulder motion as well as shoulder strength in collegiate overhead athletes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Not Listed
20 Participants Needed
DiviTum-TKa Assay for Breast Cancer
Fairfield, Connecticut
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize (improve) these levels in patients with estrogen receptor (ER) or progesterone receptor (PR) positive, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and are receiving CDK 4/6 inhibitors. CDK4/6 inhibitors in combination with endocrine therapy (ET) is first line treatment for metastatic hormone positive (ER/PR positive) breast cancer (mBC). Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division). DiviTum-thymidine kinase activity (TKa) is a Food and Drug Administration approved assay which showed that a TKa is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. Using the DiviTum-TKa may improve medication compliance and remove potential drug-drug interactions in patients with ER/PR positive HER2-negative MBC.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-metastatic Disease, Prior CDK4/6 Use, Others
Must Be Taking:CDK4/6 Inhibitors
50 Participants Needed
Surgical Ablation for Rapid Heartbeat
Bridgeport, Connecticut
This trial is testing a new procedure that treats fast heartbeats without damaging the heart's natural pacemaker. It is aimed at patients with Inappropriate Sinus Tachycardia (IST) who do not respond to or cannot tolerate medications. The procedure works by carefully modifying parts of the heart to correct the abnormal rhythm.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:ICDs/Pacemakers, Channelopathies, Congenital Heart Disease, Others
142 Participants Needed
Culturally Tailored Recovery Programs for Substance Abuse
Hartford, Connecticut
The main goal of this current study is to develop and optimize methods for increasing access to, uptake of, and engagement in MAT (Medication Assisted Treatment) among communities of color.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Informed Consent
525 Participants Needed
CLAAS Device for Atrial Fibrillation
Bridgeport, Connecticut
This trial is testing a new heart device called the CLAAS® to see if it works as well as other similar devices. It is aimed at patients with a specific type of irregular heartbeat that can lead to strokes. The device helps by blocking off a small part of the heart to stop blood clots from forming.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Infection, Stroke, Heart Failure, Others
Must Not Be Taking:Antiplatelets, Anticoagulants
1600 Participants Needed
Monitoring Methods for Pancreatic Cyst
Fairfield, Connecticut
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50 - 75
Key Eligibility Criteria
Disqualifiers:Acute Pancreatitis, Chronic Pancreatitis, Pancreatic Malignancy, Others
4606 Participants Needed
Stem Cells + Light Therapy for Alzheimer's Disease and Autism
Westport, Connecticut
The purpose of the study is to evaluate the use of autologous Bone Marrow Derived Stem Cells (BMSC) as a means to improve cognitive impairment as occurs in Alzheimer's Disease and other dementias and to improve behavior and socialization issues which occur in adult Autism Spectrum Disorder. The use of Near Infrared Light, in conjunction with the use of BMSC, will also be assessed.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Unstable Health, Pregnancy, Others
100 Participants Needed
Marker-Directed Monitoring for Breast Cancer
Fairfield, Connecticut
This trial studies if using blood tests to decide when to do scans is as effective as the standard way for monitoring patients with a specific type of breast cancer that has spread. The blood tests act like an early warning system for cancer activity.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cirrhosis, Untreated B12 Deficiency, Thalassemia, Others
Must Be Taking:Endocrine Therapy
739 Participants Needed
Stem Cell Therapy for Retinal and Optic Nerve Disorders
Westport, Connecticut
This trial will use stem cells from patients' own bone marrow to treat severe vision loss caused by retinal or optic nerve damage. The stem cells will be injected into the eye to help repair the damaged tissues. SCOTS is the largest ophthalmology stem cell study registered at the National Institutes of Health, using autologous bone marrow-derived stem cells for retinal and optic nerve diseases.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Inadequate Exam, No Follow-up, No Consent, Others
500 Participants Needed
Genetic Testing for Early-Stage Lung Cancer
Fairfield, Connecticut
This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Neoadjuvant Therapy, Metastatic Cancer, Pregnancy, Others
Must Not Be Taking:EGFR Inhibitors, ALK Inhibitors, PD-1/PD-L1 Inhibitors, CTLA-4 Inhibitors
8300 Participants Needed
Sitz Baths for Pelvic Organ Prolapse
Bridgeport, Connecticut
The purpose of this study is to evaluate the utility of postoperative sitz baths in patient pain perception and recovery following surgical repair of prolapse. The SORE Study is a prospective, randomized controlled trial that aims to compare postoperative pain intensity one week after native tissue repair of pelvic organ prolapse for patients undergoing a sitz bath regimen versus usual care. Findings from this study may contribute to more robust, multimodal postoperative pain management plans if proven efficacious or, alternatively, reduce plastic medical waste and simplify postoperative pain plans if found to be ineffective.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Mesh Repair, Genital Infections, Pregnancy, Others
Must Not Be Taking:Opioids
112 Participants Needed
Play-Based Training for Adverse Childhood Experiences
Fairfield, Connecticut
This research project was developed in an effort to support teachers of young children exposed to adversity and to assist them with enhancing children's development through play. The project utilizes an occupational therapist-led teacher training program manual and an accompanying fidelity checklist. This training is provided via virtual group sessions (Telehealth) and consists of five 45-minute-long sessions addressing ways to promote children's play and playfulness in the classroom and techniques to reduce teacher/caregiver burnout. The training was facilitated via Zoom with eleven teachers employed by an agency serving children exposed to adversity. The fidelity raters scored the fidelity checklist while reviewing video recordings of the training sessions. Participants responded to a Background Questionnaire via Qualtrics and were interviewed before and after the training. The interview data was used to analyze the impact of the training.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Not Teachers, No Internet Access
12 Participants Needed
Cervical Exercises for Shoulder Motion and Strength
Fairfield, Connecticut
The goal of this clinical trial is to investigate the impact of performing cervical exercises during a simulated game on shoulder range of motion and strength in collegiate baseball picthers. The main questions it aims to answer are:
Can performing cervical retraction/extension exercises help to maintain shoulder internal rotation range of motion in the throwing shoulder after a pitching session? Can performing cervical retraction/extension exercises help to maintain shoulder external rotation strength in the throwing shoulder after a pitching session?
Researchers will compare the effects of cervical retraction/extension exercises to no exercise to see if shoulder range of motion or strength is impacted.
Participants will perform end-range cervical retraction and cervical retraction with extension, holding the end-range of motion for 3 seconds and performing 10 repetitions of each exercise between each inning of a simulated 5-inning game.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Sex:Male
Key Eligibility Criteria
Disqualifiers:Recent Surgery, Rehabilitation, Pain, Others
6 Participants Needed
Why Other Patients Applied
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
Predictive Analytics + Clinical Decision Support for HIV Prevention
Bridgeport, Connecticut
Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the U.S. initiative to end the HIV epidemic, but healthcare providers lack tools to support PrEP discussions and prescribing for patients likely to benefit. This research will evaluate whether integrating automated tools into electronic health records to help providers efficiently and equitably identify potential candidates for PrEP, discuss PrEP, and prescribe PrEP can improve PrEP initiation and persistence in safety-net community health centers. It will achieve this by conducting a stepped-wedge trial of a decision support tool with an embedded HIV prediction model to identify patients likely to benefit from PrEP. The intervention will be delivered to healthcare providers in 16 community health centers within the national OCHIN network.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:HIV/STI Care, Correctional, Mobile, School-based
16 Participants Needed
Mirror Therapy Device for Stroke
Bridgeport, Connecticut
This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Not Cleared For Rehab, Others
10 Participants Needed
GP0116 for Facial Wrinkles and Folds
Westport, Connecticut
This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22+
Key Eligibility Criteria
Disqualifiers:Allergies, Facial Surgery, Others
186 Participants Needed
RF Ablation for Atrial Fibrillation
Bridgeport, Connecticut
The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Previous Cardiac Surgery, Renal Dysfunction, Others
Must Be Taking:Class I/III AAD
53 Participants Needed
TAVR for Aortic Stenosis
Bridgeport, Connecticut
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Age < 65, LVEF ≤ 20%, Others
650 Participants Needed
Contingency Management for HIV Prevention
Bridgeport, Connecticut
The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and support services (CoMPASS) to promote HIV prevention among individuals with opioid use disorder who have injected drugs in their lifetime. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Kidney Disease, Others
Must Not Be Taking:PrEP
526 Participants Needed
NovoSorb BTM for Severe Burns
Bridgeport, Connecticut
This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Hypersensitivity To Polyurethane, Multiple Traumas, Advanced Malignancy, Others
150 Participants Needed
Endocrine Therapy Interruption for Breast Cancer During Pregnancy
Fairfield, Connecticut
The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 42
Sex:Female
Key Eligibility Criteria
Disqualifiers:Post-menopausal, Metastatic Cancer, Noncompliance, Others
Must Be Taking:Endocrine Therapy
518 Participants Needed
Ellansé S for Nasolabial Folds
Westport, Connecticut
The study will be a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial to evaluate the safety and effectiveness of ELLANSÉ®-S for the treatment of NLFs. Subjects will be randomized to receive treatment (ELLANSÉ®-S) in one NLF and control (Radiesse®) in the contralateral NLF. A total of 126 subjects will be treated. The control and test articles will be supplied in sterile ready-to-use, pre-filled syringes. Initial treatment and any 4-week touch-up will be done consistent with initial randomization. Any retreatment(s) in either NLF will be with ELLANSÉ®-S.
Subjects who meet Inclusion/Exclusion criteria will receive an initial treatment, an optional touch up at the 4-week visit, and may be eligible to receive retreatment at either 12 or 18 months after treatment (determined by when the fold has returned to baseline score, or the fold has lost at least 1 point on the Wrinkle Severity Rating Scale (WSRS) from optimal improvement). Retreatment to one side is allowed if only one side qualifies, but the other side may not be retreated at a later visit. If retreatment occurs, the subject may also be eligible to receive an optional touch up at the 4-week follow up visit. If a touch up occurs after the initial or retreatment injection, the subject will return for an additional safety visit 2 weeks after each injection. A week 4 safety visit will occur after retreatment touch-up. Primary effectiveness will be assessed at 6 months. All subjects will be followed for a minimum of 24 months after the initial treatment phase. After each injection, subjects will be contacted by telephone call/email after 72 hours and will return for a safety visit 2 weeks after treatment. At the week 4 visit, subjects will be assessed for a touch up. If a touch up is indicated as determined by the investigator, the investigator will use the same material as that used for initial treatment for the respective side. In addition, subjects will be seen at 6 weeks 3, 6, 9, 12, 18, and 24 months (from the end of the initial treatment phase). Subjects receiving a retreatment (at 12 or 18 months after treatment) will return for additional safety visits at 2 weeks and 3 and 6 months after this retreatment (the 6 month coincides with regularly scheduled visit). Subjects will have the option of a retreatment touch up injection at 4 weeks after retreatment, and if they do will have another call at 72hrs and a week 2 safety visit.
The validated Wrinkle Severity Rating Scale will be used for assessment of the primary effectiveness endpoint (1). Assessment of the secondary effectiveness endpoints will include use of WSRS, the Global Aesthetic Improvement Scale (GAIS), VAS pain assessment, the validated FACE-Q Appraisal of Nasolabial Folds Questionnaire, the FACE-Q Satisfaction with Treatment Outcome Scale and the FACE-Q Age Appraisal VAS.
The study will last approximately 30 months. All subjects will be recruited within approximately 6 months after the recruitment of the first subject and followed for a minimum of 24 months after the initial treatment visit. Subjects receiving a retreatment (at 12 or 18 months) will receive a telephone call/email 72 hours after retreatment and they will return for an additional safety visit 2 weeks after retreatment. Subjects may receive a retreatment touch up at 4 weeks after retreatment, and if touched up, will have safety visits at 2 and 4 weeks. All retreated subjects will also be asked to attend month 3 and month 6 safety visits. The 6-month safety visit will correspond with the next study visit (e.g., 18 month or 24-month visit depending on when they are reinjected)
126 male and female subjects will be enrolled. This enrollment number accounts for a 20% attrition rate, to ensure an adequate safety population for long-term follow-up, and a Per Protocol Set (PPS) of at least 101 NLFs per treatment arm. At least 20% of treated subjects will have Fitzpatrick Skin Types IV, V, and VI. Of these, at least, 10% will be Type IV, 5% Type V and 5% Type VI. The investigative sites will be encouraged to enroll both male and female subjects. In addition, up to 2 non-randomized, non-split-face run-in subjects will be treated with ELLANSÉ®-S by each investigator to allow the investigator to become familiar with injection characteristics. This run-in cohort will be required to meet all study inclusion/exclusion criteria and will be followed in the same manner as the non-run-in cohort. Up to seven US sites will participate.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Autoimmune, Others
Must Not Be Taking:Steroids, Chemotherapy, Immunosuppressants, Others
126 Participants Needed
Letrozole for Hormone Receptor-Positive Breast Cancer
Bridgeport, Connecticut
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
3966 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
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Frequently Asked Questions
How much do clinical trials in Fairfield, CT pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in Fairfield, CT work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in Fairfield, CT 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Fairfield, CT is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Fairfield, CT several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in Fairfield, CT?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in Fairfield, CT?
Most recently, we added PCT+2HOPE for Opioid Use Disorder, Sitz Baths for Pelvic Organ Prolapse and ELAPR002f Gel for Acne Scars to the Power online platform.
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