Eligibility:


Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study:  
Both
Accepts Healthy Volunteers:  
No


Inclusion Criteria:

  • Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS).
  • Naive to treatment with any anti-TNF therapy.
  • An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment.
  • Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period.
  • Use of highly effective contraception as defined by the protocol.


Exclusion Criteria:

  • A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps.
  • Prior or planned surgery for UC.
  • Past or present ileostomy or colostomy.
  • Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol.
  • Chronic hepatitis B or C infection, HIV or tuberculosis (active or latent).

Possible Research Patients

Autism Spectrum

Eligibility:


Ages Eligible for Study: 18 to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Ulcerative Colitis (UC) confirmed on endoscopy.
  • Moderately to severely active UC (Mayo score 6-12).
  • Currently receiving treatment with aminosalisylate, prednisone, or budesonide.


Exclusion Criteria:

  • Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis.
  • Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk.
  • History of uveitis macular edema.
  • Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during Screening.

Ulcerative Colitis

Eligibility:


Ages Eligible for Study: 18 Years to 75 ​
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:


1) Female or male from 12 years of age or older.
2) Non-childbearing or consent to use birth control.
3) Have persistent Asthma as defined by the National Asthma Education and Prevention Program.
4) Be a current non-smoker.
5) Be able to discontinue current asthma medication.
6) Be able to use MDI and dry powder inhaler devices….
More information regarding this study available upon request.

 

Exclusion Criteria:

Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control method or patients who suffer from COPD as defined by the GOLD Report 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as defined in GINA Report, 2016.


Inability to carry out pulmonary lung function testing, to comply with study procedures or with study drug intake.
Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of >10 pack-years or having stopped smoking one year or less prior to screening visit.


History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.


An asthma exacerbation requiring oral corticosteroids within 3 months or hospitalization within 6 months prior to screening.


Patients who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement.


Patients with known intolerance/hypersensitivity or contra-indication to treatment with ß2-adrenergic receptor agonists, inhaled corticosteroids or propellant gases/excipients.
Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-IgE, anti-IL5 or other monoclonal or polycolonal antibodies within 12 weeks prior to screening.


Use of potent cytochrome P450 3A4 inhibitors and inducers within 4 weeks prior to screening.


History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.


Patients who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.

Eligibility:


Ages Eligible for Study: 18 Years or older.
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No


Inclusion Criteria:

  • Male or female subjects 18 years or older, able to provide written informed consent, and able to understand and willing to comply with the requirements of the study.
  • Histological evidence of definite NASH based on NASH CLinical Research Network (CRN) criteria, as confirmed by the central histopathologist, on a liver biopsy obtained no more than 6 months prior to Day 1.
  • NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2).
  • Fibrosis stage 1 (limited to 20% of subjects), stage 2, or stage 3 using the NASH CRN Histologic Scoring System.
  •   Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug.
  • If on vitamin E or pioglitazone, subjects must have been on a stable dose for at least 3 months prior to the biopsy (whether historical or qualifying biopsy).


Exclusion Criteria:

  • Current or history of significant alcohol consumption, defined as more than 20 g/day for females and more than 30 g/day in males on average, or inability to reliably quantify alcohol consumption based on investigator's judgement.
  • Use of the following drugs (which may have potential hepatotoxic effects) within 6 months prior to Day 1: amiodarone, methotrexate, tamoxifen, valproic acid, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, or systemic glucocorticoids for more than 4 weeks at doses greater than replacement doses.
  • Uncontrolled diabetes (HbA1c ≥9%) within 60 days prior to Day 1.
  • Presence of cirrhosis on liver biopsy (fibrosis stage 4 based on the central histopathologist reading).
  • Hepatitis and fibrosis more likely related to etiologies other than NASH such as:


a - alcoholic steatohepatitis
b - autoimmune hepatitis
c - hepatitis B virus (HBV) infection
d - hepatitis C virus (HCV) infection
e - primary biliary cirrhosis
f - primary sclerosing cholangitis
g - Wilson's disease
h - alpha-1-antitrypsin deficiency
i - hemochromatosis or iron overload
j - drug-induced liver disease
k - other biliary liver disease

  • ALT or AST >5 times upper limit of normal (ULN) or total bilirubin >1.5 times ULN during screening (unless subject has elevated total bilirubin due to Gilbert's as documented in the medical records).
  • Current use of the following medications that are considered significant inhibitors of OATP1B1 and OATP1B3 transporters: atazanavir, cyclosporine, eltrombopag, gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications.
  • Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy.
  • Inability to safely obtain a liver biopsy.
  • Known human immunodeficiency virus (HIV) infection.
  • Weight loss ≥ 10% within 6 months of Day 1.
  • Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement.
  • History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
  • Significant systemic or major illness other than liver disease that in the opinion of the investigator would preclude the subject from participating in and completing the study, including but not limited to acute coronary syndrome or stroke within 6 months of screening or major surgery within 3 months of screening.​

Eligibility:


Ages Eligible for Study: 50 to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No


Inclusion Criteria:


- Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including:Mini Mental State Examination score equal to or greater than 24; Clinical Dementia Rating (CDR) global score of 0.5 with CDR Memory Box score of 0.5 or greater
- Impaired episodic memory confirmed by a list learning task.
- Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography (PET) or cerebrospinal fluid assessment or both
- Study partner able to support the participant for duration of the study.

Eligibility:


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
    -The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
    -The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
    -Either out patients or residents of an assisted-living facility or a skilled nursing home
    -Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >=4 (moderately ill) at screening and baseline
    -Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
    -Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

  • Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).
    -Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease).

Below are various paid medical research studies that are currently being conducted. If you or a loved one suffers from one of the conditions below, you/they might qualify to be part of one of our clinical studies here in Miami.


Please call for information, to enter into our database or to be considered for future clinical studies.​​

Crohn's Disease

Asthma

Alzheimer's Disease

           ADHD

Eligibility:


Ages Eligible for Study: 18 to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon.
  • Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years.
  • Use of effective contraception as defined by the protocol.


Exclusion Criteria:

  • A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminant colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.
  • Planned surgery for CD.
  • Ileostomy or colostomy.
  • Has received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efilizumab, as stated in the protocol).
  • Chronic hepatitis B or C infection, HIV, active or latent tuberculosis (patients with prior history of BCG vaccination must pass protocol-defined screening criteria)

Alzheimers With Agitation

Eligibility:


Ages Eligible for Study: 18 Years or older.
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No


Inclusion Criteria:


1.Subject meets the DSM-5 criteria for ASD for an autism diagnosis and is confirmed using ADOS-2 criteria
2.A full scale IQ score 70 on the WASI® -II


General Exclusion Criteria:


1.Pregnancy or breastfeeding, or intention to become pregnant during the study
2.Neurologic and Psychiatric Exclusion Criteria
3.Previous initiation of new or major change in psychosocial intervention (including investigational) within 6 weeks prior to screening.
4.Minor changes in ongoing treatment (e.g., missed therapy sessions because of holiday or vacation, planned break in therapy due to school holidays, or changes in college or school programs) are not considered significant.
5.Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy Endpoints.
6.Substance use disorders (including alcohol or substance abuse or dependence disorder) during the last 12 months, as defined by the DSM-5 criteria.
7.Significant risk for suicidal behavior, in the opinion of the investigator
8.Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months.
9.Clinical diagnosis of peripheral neuropathy.


Ulcerative Colitis

Non-Alcoholic Steatohepatitis (NASH) Fibrosis

Eligibility:


Ages Eligible for Study:   6 Years to 11 Years   (Child) and 12 to 17
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Criteria

Inclusion Criteria:

- Healthy male or female patients, 6-11 years of age, inclusive.
- Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM V), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
-Attention Deficit/Hyperactivity Disorder Rating Scale-V, Home Version: Child, Investigator Administered and Scored (ADHD-RS-V) score of at least 28.
-CGI-S score of at least 4 at screening.
Weight of at least 20 kg.
-Free of medication for the treatment of ADHD for at least one week prior to randomization and agreement to remain so throughout the study.
-Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, vital signs, and electrocardiogram.
-Written informed consent obtained from the subject's parent or legal representative and informed assent from the subject, if applicable.
- Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the acceptable birth control methods beginning 30 days prior to the first dose.


Exclusion Criteria:

- Current diagnosis of major psychological disorders. Subjects with Major Depressive Disorder are allowed in the study if the subject is free of episodes both currently and for the last six months.
- Current diagnosis of major neurological disorders. Subjects with seizures or a history of seizure disorder within the immediate family (siblings, parents), or a history of seizure-like events are excluded from the study.
- Current diagnosis of significant systemic disease.
- Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within the six months before Screening or at Screening.
- BMI greater than 95th percentile for the appropriate age and gender.
- History of an allergic reaction to viloxazine or related drugs.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
- Subjects who received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing of SM.
- Any reason, which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Positive drug screen at the Screening Visit. A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening; the subject will be required to discontinue the stimulant for the study, beginning at least one week prior to the Baseline Visit.
-Pregnancy or refusal to practice abstinence or acceptable birth control during the study (for female subjects of childbearing potential).

Participants in our medical studies are compensated: $100 to $4,000.
Please contact us for more information:


IMIC Inc.
18320 Franjo Rd
Palmetto Bay, FL 33157
(786)600-7005, (786)310-7377, 
Fax 1305-252-2199
info@aktamedika.com
www.aktamedika.com

www.imicinc.com