Clinical Trial Participation
Healthy volunteers as well as patients play a vital role in clinical trials as they help in developing new treatments, understanding, and preventing severe diseases. There are various stages where one can participate.
Phase I trial
It is the first trial in which a potential drug is tested on humans to establish its safety and the maximum dosage that can be administered without adverse effects. Typically the drug at this phase is tested on healthy volunteers and in some rare cases on patients of a particular condition.
Phase II and III trial
In these phases participants include patients of the condition the drug is being tested for. Patients and volunteers at these stages take clinical trials on a voluntary basis only. To participate you must meet inclusion criteria sign consent forms after a through explanation and understanding of the trial. You can also exit the trial freely if so wish.
You can get paid for participating in a clinical trial. However not all trials pay so you have to find out the payments are mostly based on your viability as a candidate, the treatment period and severity of the trial.
Clinical Trial Centers
FRED HUTCH: Hutchinson Cancer Research Center: Wong Trisha E MD
COSMOS: Hutchinson cancer center is conducting a five-year, large scale randomized test on the effects of cocoa extract in reducing the risk of cancer
Immunology Study: This clinical study research is focused on developing an immunotherapy based cancer treatment.
Prostate cancer lifestyle study: The PALs study will be on prostate cancer patients whose life styles are on active surveillance of their cancer. The goal is to try and establish if weight loss through exercise and dieting improves the health of men with low-grade prostate cancer.
The study (VRX496) is a new promise for HIV genetic therapy to help CD4+ T cells withstand destructive nature of HIV infections. The therapy infects cells with genetic material to incorrectly come up with HIV-related proteins and when treated with VRX496 they produced defective HIV copies.
In the trial, 5 HIV positive patients with failing ART got single infusions of VRX496 treated CD4+ T cells. It was observed patients CD4+ count rose temporarily and in one participant CD4+ count dropped 100-fold. Overall the study was found safe and researchers proposed multiple infusion gene therapy treated viral load could be more effective.
The latest report on VRX496 indicates that the 19 participants taking ART and on VRX496 was safe. When ART was interrupted the viral load fell moderately and then rose. Temporary fever and chills were observed after treatment.
T cells disappeared for the most part within weeks but in some participants were still present although in small amounts up to 5 years. The reason for the disappearance is not yet known. Making 3 infusions did not make cells last any longer. Conditioning agents are speculated to be a remedy to help the body retain modified T cells.
Johns Hopkins Center
Johns Hopkins is one of the biggest clinical trials center. Hundreds of trials are offered at the center each year. You can assess the current trials being conducted and how you can enroll and be part of it. Some of the trials are based on these diverse areas and in different trial units:
Peripheral Artery Disease (PAD) is a great mortality and morbidity cause especially in older patients. Pain in legs while walking and a sense of relief with rest-Claudication is a symptom of PAD. CLEVER- Claudication Exercise Versus Endoluminal Revascularization is a randomized clinical trial to determine optimal treatment for PAD treatment due to aortoiliac disease. The study compares benefits of endovascular revascularization, supervised exercise, and optimal medical attention.
Eligible persons must be 40 years and above suffering from Claudication as a result of aortoiliac peripheral arterial illness.
FDA Approved cholesterol pill
The study involves testing the body’s response after a 3-wk cholesterol lowering course. The participants are exposed to non-invasive MRI in an attempt to improve treatment and evaluation of blood vessel problems. There are three clinic visits in four weeks. A cholesterol tablet will be taken daily, with blood samples and MRI taken of the leg and arm throughout the testing period.
Eligible persons must; have diabetes, be between 40 and 90 years of age, not be on any cholesterol medication, and not be currently smoking. Compensation will be provided and other exclusions may apply.
If you experience severe or moderate burning, throbbing pain in the feet and piercing as a type I or II diabetes patient between 18 and 65 years, you qualify for the study. It is designed to evaluate efficacy of an investigational drug for diabetic peripheral neuropathy.
IDeaLS- Improving Diabetes through Lifestyle and Surgery Study
The study aims at comparing weight loss effects on diabetes through gastric banding, bypass surgery and lifestyle changes through diet and exercise. This study is for Obese (BMI 30-40) type II diabetes patients and must have EHP- Employee Health Plan insurance to participate in the 45 subjects’ randomized study.
The study involves screening visits to determine weight loss effects on diabetes. Participants are randomly exposed to roux-en-Y gastric bypass, medical weight loss, or adjustable gastric banding interventions. Medical weight loss and surgery will be covered by the EPH insurance and individuals compensated $100-300.
Caregiver memory solution
The study is enrolling people suffering from memory loss and their caregivers. The aim is to find out if elderly people with memory problems can remain home longer by providing assistance to caregivers about appropriate care. It is also aimed at improving quality of life despite the memory issues.
Low income elderly people with memory problems living in Baltimore are welcome. Trained team of professionals will give 18 months long care coordination services from their homes.
Gastroparesis Registry 2 (GpR2)
People with gastroparesis suffer from nausea, vomiting, stomach pain, discomfort and weight loss due to the stomach’s muscles inability to push the food effectively- the cause is not yet known. People with a history of prior stomach surgery, diabetes or viral infections are at a higher risk of developing gastroparesis. This study aims at understanding gastroparesis to make better diagnosis and treatment.
Eligibility: 18 years and above, must show symptoms of gastroparesis. The studies will be conducted in 9 medical centers and will involve about 1000 subject. No costs will be charged and no medication will be administered.
DIGEST- Diabetes and Idiopathic Gastroparesis Efficacy, Safety and Tolerability Study. This study is to establish how gastroparesis patients react to investigative drug velusetrag and how well it can treat gastroparesis symptoms in order to determine how safe it is and tolerability levels.
Patients with idiopathic diabetes or gastroparesis diabetes symptoms between 18-75 years are viable. It is a chance to compare velusetrag and placeb in idiophatic and diabetic gastroparesis treatment.
Influenza Vaccine study at the Bayview Division of Geriatrics are conducting research on protection of Influenza vaccine in older patients- 75 years and above. Participation involves a series of question on phone or in person about your health history over the years. Measurement of vital signs grip strength, urine sample, walking sped and urine specimen. You then receive a free influenza vaccine.
Three to four weeks later you make you make the second visit to review your general health, measure vitals and they take a blood sample. Apart from the free flu shot, participants get up to $40 to cover expenses related to the study.
This is a sleep and sensory study to examine the association sensory and sleep abilities in arthritis. Participants must:
- Be above 50 years of age
- Have knee osteoarthritis
- Experience knee pain
- Have trouble sleeping or be good sleeper
The study will involve sensory testing and two at home sleep studies. All fees like parking are catered for and an additional compensation of $100.
The study aims at comparing brain function and structure in children with autism and children without. Children between the ages of 8-12 are viable for this MRI research study. There are no medical risks or direct medical benefit from this study. The study involves two days of paper and pen tasks, computer games and a brain MRI scan.
Participants will get $50 daily; free IQ tests and reports, as well as a picture of the brain.
Multidisciplinary Association for Psychedelic Studies (MAPS)
This is a non-profit that focuses on treatment for PTSD- Post-traumatic stress disorder by investigating the benefits of Marijuana and psychedelics. They are recruiting phase 3 to test MDMA- better known in social circles as ecstasy.
MAPS founder explained that there are so many people suffering from PTSD and the existing psychotherapies. MAPS will be enrolling participants in North Hollywood, New Orleans, Louisiana; Colorado; Fort Collins, California; Boulder, Colorado; and Mount Pleasant, South Carolina.
The non-profit aims to get 100 to 150 participants with severe PTSD; they will undergo 15 sessions in a 12-week long treatment period. During this treatment plan, some participant will receive placebo while others will receive MDMA-assisted therapy. Researchers will then analyze the results and determine how to move into the second part of phase 3 trial.
Rogel Cancer Center
In a finding Rogel Cancer researchers realized that protein NLRP6 made gastrointestinal symptoms worse in GVHD – graft vs. host disease. In a study using mice subjects, knocking down NLRP6 protein had better survival rate and less severe GVHD
In a global tour to Serbia, Australia and Guatemala, Roger cancer center under Fulbright Global Scholar award aims at establishing and teaching Americans how to minimize cancer risks by studying feeding habits across the globe.
Xinhua Hospital, Shanghai, China
The study aims at using STIC technology in fetal congenital heart disease diagnosis and provides a basis for prenatal counseling. Eligible participants should be; between 18 to 35 years, female with singleton pregnancy having fetal echocardiography, not using drugs or harmful substances during the early duration of pregnancy, willing to finish pregnancy check at the hospital and finally deliver or have an abortion there, on willing informed consent.
Exclusion criteria include:
Pregnant women above 35 years
Women with mental illnesses
Multiple or twin pregnancy
Fetus with other complications other than congenital heart issues
Duke University, North Carolina, United States
The trial focuses on evaluating DCSTT-diabetes coping skills training for breast cancer survivors to help them adhere to self-management for diabetes. The protocol integrates 3 components to improve self-management and reduce symptoms; health lifestyle, adherence training and coping skills training.
Type 2 diabetes and breast cancer are a worldwide menace and the numbers are expected to keep growing. Cancer reoccurrence rates are higher in breast cancer survivors with type 2 diabetes; they are a risk of developing other complications and premature death as well. Maintain a glycemic control is important to control symptoms and reduce health problems. Physical activity, dietary modification and medication are among the vital diabetes self-managements strategies. Most patients have a problem maintain the strategies and achieving the glycemic control. This randomized is an interventional trial with parallel assignment.
Cedars-Sinai Los Angeles, California
This is a phase 1b study involving single and multiple doses of Obinutuzumab given as IV infusion in adults with ESRD. Participants will enroll in two cohorts; cohort 1 and 2 where they will receive pretreatments to reduce risks of infusion-related reactions.
In cohort 1, the participants will receive single dose Obinutuzumab on day one following aggregated data up to 4 weeks after administration. Cohort 2 will then proceed with Obinutuzumab administered on days 1 and 15.
Transplantation; participants from cohort 1 or 2 who qualify for kidney transplant and have a viable kidney will receive additional Obinutuzumab infusions during transplant and 24th week after transplantation.
All tolerability and safety assessments are conducted at week 24 during desensitization period and the 28th week after transplantation. All participants are monitored for at least 1 year after the last Obinutuzumab infusion.
Medical University of South Carolina, Charleston
The study will establish whether social skills paired with brain stimulation can help male teenagers learn how make and keep friends. Brain stimulation has proven effective in some people. The study is a 14-week long program where participating boys will interact in small groups and be taught social skills. During the study duration, participants will receive both non-active (placebo) and active brain stimulation. MRI scans will be taken before and after to see if the brain stimulation and training made a difference in brain activity.
Outcomes will be primarily measures through social responsiveness scale (SRS) and test for adolescent social skills knowledge (TASSK). Participants must be 14-17 years of age, have autism spectrum disorder, and it should be on voluntary basis.
Intellectual disability with a full scale IQ of less than 70
Not viable for MRI such as those with metallic implants in the head
Seizures within the past 12 months
Yale University, New Haven, Connecticut
The study explores screening for diseases causing problems in fighting infections. Currently, there is method to screen infants for immunodeficiency at birth. However, babies born with few T-Cells type of immune system may be found by studying TRECS.
Will collect samples from babies with various immunodeficiency conditions to find out which disorders can be identified by screening dry blood spots for TREC- T-cell receptor excision circles.
Try to develop alternative screening tests based on materials collected from dried blood spots. Children with low number of T-Cells and have primary immunodeficiency are eligible for this study prior to getting a bone marrow transplant.
Participating children give up to 5ml of blood usually collected when the child is undergoing other tests. The liquid blood is used to determine the number of T cells and the rest is used for making dried blood spots. The dried blood is used in developing screening tests for primary immunodeficiency. Data reports include the child’s diagnosis, age medication and are kept coded by diagnosis and a code number label and not the participant’s name.
OHSU, Portland, Oregon
The core aim is to test an intervention promote and disseminate adoption of positive behavior in parents of obese Hispanic kids using per mentors. The trial evaluates feasibility and efficacy of this method by reducing adiposity as indicated by BMI- Body Mass Index. There are two approaches:
Placebo comparator: parent mentor has some education. The mentor will provide coaching based on guidelines around physical activity and diet.
Active comparator: the mentor has positive deviance. The mentors provide coaching based on findings from the positive deviance study.
Participants should be Hispanic, 2 to five years, attending Head Start facility, and no medical disorders that inhibit growth and development.
Beth Israel Deaconess Medical Center Boston, Massachusetts
This experimental study aims at evaluating MBS therapy in treating chronic pain. Brief pain questionnaire will be administered to assess the pain level. Participant’s inclusion criteria;
18 years and above
Consistent pain; a minimum of 3 days per week and dated at least 3 months before enrollment
Chronic pain without clear cause after evaluation by specialists
Diagnosed source of pain like malignant diseases , neurological disorders among other causes
People under 18
Severe depression or attempted suicide
Patients with diagnosis of significant psychiatric disorders like bi-polar and schizophrenia. Mild cases of depression, anxiety, and stress are not considered exclusions.
Vanderbilt University Medical Center Nashville, Tennessee
The study’s purpose is to evaluate the relationship between cholinergic receptor system and cognitive impairment in aging adults living with chronic HIV. The researchers aim to investigate if presence of HIV in the brain affects the neural system that form cognition by using anti-cholinergic drugs and compare the results to from normal, uninterrupted cognitive aging.
The two cohorts will be exposed to the study differently:
HIV positive participants: They will be given each of the 4 treatments high dose mecamylamine 20mg, high dose scopolamine 5 mcg/kg, and a low dose combination of mecamylamine and scopolamine (10mg and 2.5mcg/kg)
HIV negative participants: They will be given each of the 4 treatments high dose mecamylamine 20mg, high dose scopolamine 5 mcg/kg, and a low dose combination of mecamylamine and scopolamine (10mg and 2.5mcg/kg) or placebo
Primary outcome measures will measure cognitive outcome looking for impairment of cholinergic neurotransmitter system
Secondary outcome measures will explore the HIV-Status interaction and age which are likely to lead to impaired cognitive performance in HIV positive.
There are so many clinical trial centers constantly conducting various studies of multiple medical areas. Finding the right trial to join in an attempt to get closer to a cure for whatever disease is essential. You do not necessarily have to be sick to participate in a clinical trial. Most clinical trials need healthy volunteers to compare effects of possible treatments. You can do it for moral obligation or financial gain, and in some cases you can achieve both.
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