Experimental Medicine: What You Need to Know about Clinical Trials

Clinical Trial Participation

Healthy volunteers, as well as patients, play a vital role in clinical trials as they help in developing new treatments, and 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 with 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 and sign consent forms after a thorough explanation and understanding of the trial. You can also exit the trial freely if so wish.

Payment

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 the severity of the trial.

Clinical Trial Centers

FRED HUTCH:  Hutchinson Cancer Research Center: Wong Trisha E MD

Fred Hutch is a team of researchers who are working around the clock for various cancer studies. Some of the current studies you can volunteer for include;

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 immunotherapy-based cancer treatment.

Prostate cancer lifestyle study: The PALs study will be on prostate cancer patients whose lifestyles 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.

CATIE

The study (VRX496) is a new promise for HIV genetic therapy to help CD4+ T cells withstand the 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 therapies treated viral load could be more effective.

Recent study

The latest report on VRX496 indicates that the 19 participants taking ART and on VRX496 were 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 for 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.

https://www.catie.ca/

Johns Hopkins Center

Johns Hopkins is one of the biggest clinical trials centers. 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:

Vascular Disease

Peripheral Artery Disease (PAD) is a great mortality and morbidity cause,d especially in older patients. Pain in the legs while walking and a sense of relief with rest-Claudication are symptoms of PAD. CLEVER- Claudication Exercise Versus Endoluminal Revascularization is a randomized clinical trial to determine the optimal treatment for PAD treatment due to aortoiliac disease. The study compares the 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.

Diabetes

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 an 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.

Neuropathic Diabetes

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 the 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.

Memory

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 the quality of life despite memory issues.

Low-income elderly people with memory problems living in Baltimore are welcome. A trained team of professionals will give 18 months long care coordination services from their homes.

Gastroenterology

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 diagnoses and treatments.

Eligibility: 18 years and above, must show symptoms of gastroparesis. The studies will be conducted in 9 medical centers and will involve about 1000 subjects. 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 the investigative drug Velusetrag and how well it can treat gastroparesis symptoms in order to determine how safe it is and its tolerability levels.

Patients with idiopathic diabetes or gastroparesis diabetes symptoms between 18-75 years are viable. It is a chance to compare Velusetrag and placebo in idiopathic and diabetic gastroparesis treatment.

Vaccines

Influenza Vaccine study at the Bayview Division of Geriatrics is conducting research on the protection of Influenza vaccine in older patients- 75 years and above. Participation involves a series of questions on phone or in person about your health history over the years. Measurement of vital signs grip strength, urine sample, walking speed, and urine specimen. You then receive a free influenza vaccine.

Three to four weeks later you make the second visit to review your general health, measure vitals, and give a blood sample. Apart from the free flu shot, participants get up to $40 to cover expenses related to the study.

Arthritis

This is a sleeping and sensory study to examine the association between 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 a good sleeper

The study will involve sensory testing and two at-home sleep studies. All fees like parking are taken care of and a compensation of $100 will be given.

Autism

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 benefits 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)

Severe PTSD

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 participants will receive a placebo while others will receive MDMA-assisted therapy. Researchers will then analyze the results and determine how to move into the second part of the phase 3 trial.

Rogel Cancer Center

Improving Bone Marrow Transplant Patient Outcomes

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 a better survival rate and less severe GVHD

Looking for the link between diet and cancer

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

Fetal Congenital heart disease using STIC

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

Diabetes in breast cancer survivors

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; healthy 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. Maintaining glycemic control is important to control symptoms and reduce health problems. Physical activity, dietary modification, and medication are among the vital diabetes self-management strategies. Most patients have a problem maintaining the strategies and achieving glycemic control. This randomized is an interventional trial with a parallel assignment.

Cedars-Sinai Los Angeles, California

Study of Obinutuzumab in Adults with end-stage renal disease (ESRD) waiting for a transplant

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; cohorts 1 and 2 where they will receive pretreatments to reduce the risks of infusion-related reactions.

In cohort 1, the participants will receive a single dose of 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 a kidney transplant and have a viable kidney will receive additional Obinutuzumab infusions during transplant and the 24th week after transplantation.

All tolerability and safety assessments are conducted at week 24 during the 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

Neurostimulation as a learning enhancement for Autism

The study will establish whether social skills paired with brain stimulation can help male teenagers learn how to 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 measured through the 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 a voluntary basis.

Exclusion;

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

Newborn screening for infants with immunodeficiency

The study explores screening for diseases causing problems in fighting infections. Currently, there is a 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.

This study:

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 a low number of T-Cells and who 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, and age medication and are kept coded by diagnosis and a code number label and not the participant’s name.

OHSU, Portland, Oregon

Parent intervention Childhood obesity

The core aim is to test an intervention that promotes and disseminates the adoption of positive behavior in parents of obese Hispanic kids using mentors. The trial evaluates the 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 a Head Start facility, and have no medical disorders that inhibit growth and development.

Beth Israel Deaconess Medical Center Boston, Massachusetts

MBS- Mild Body Syndrome for chronic pain treatment

This experimental study aims at evaluating MBS therapy in treating chronic pain. A 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

Exclusion criteria:

Diagnosed sources of pain like malignant diseases, and neurological disorders among other causes

People under 18

Severe depression or attempted suicide

Pregnancy

Patients with a diagnosis of significant psychiatric disorders like bipolar and schizophrenia. Mild cases of depression, anxiety, and stress are not considered exclusions.

Vanderbilt University Medical Center Nashville, Tennessee

Premature aging- Mental Ability Challenge Study in Adults With and Without HIV

The study’s purpose is to evaluate the relationship between the cholinergic receptor system and cognitive impairment in aging adults living with chronic HIV. The researchers aim to investigate if the presence of HIV in the brain affects the neural system that forms cognition by using anticholinergic drugs and compare the results to 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 of mecamylamine 20mg, a high dose of 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 of mecamylamine 20mg, a high dose of 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 outcomes by looking for impairment of the 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.

Conclusion

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 the effects of possible treatments. You can do it for a moral obligation or financial gain, and in some cases, you can achieve both.

References

Corson, Timothy W., and Craig M. Crews. “Molecular Understanding and Modern Application of Traditional Medicines: Triumphs and Trials.” Cell, vol. 130, no. 5, 2007, pp. 769–774.

López-Lázaro, Miguel. “Anticancer and Carcinogenic Properties of Curcumin: Considerations for Its Clinical Development as a Cancer Chemopreventive and Chemotherapeutic Agent.” Molecular Nutrition & Food Research, vol. 52, 2008.