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Experimental: Ticagrelor
ticagrelor 60 mg bid monotherapy
Drug: Ticagrelor monotherapy
Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
Other Name: Brilinta
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
California Retina Consultants
Bakersfield, California, United States, 93309
Contact: Luis Lopez   661-325-4393   luis.lopez@californiaretina.com  Â
Principal Investigator: Dante Pieramici, MD Â Â Â Â Â Â
Retinal Consultants Medical Group
Modesto, California, United States, 95356
Contact: Diana Heredia   916-339-2693   herediad@retinalmd.com  Â
Principal Investigator: Margaret Chang, MD Â Â Â Â Â Â
Florida Retina Institute
Jacksonville, Florida, United States, 32216
Contact: Karen Yesensky   904-997-9202 ext 22402   kareny@floridaretinainstitute.com  Â
Principal Investigator: Benjamin Thomas, MD Â Â Â Â Â Â
Florida Retina Institute
Orlando, Florida, United States, 32806
Contact: Martha Haddox   407-849-9621   marthah@floridaretinainstitute.com  Â
Principal Investigator: Matthew Cunningham, MD Â Â Â Â Â Â
Retina Group of Florida
Sarasota, Florida, United States, 34233
Contact: Courtney Smith   941-924-0303   CSmith@retinasarasota.com  Â
Principal Investigator: Jesse McCann, MD Â Â Â Â Â Â
Retina Consultants of Minnesota St. Louis Park
Saint Louis Park, Minnesota, United States, 55416
Contact: Mallorie Schieck   952-259-6264   mschieck@retinamn.com  Â
Principal Investigator: Abdhish Bhavsar, MD Â Â Â Â Â Â
Mississippi Retina Associates
Jackson, Mississippi, United States, 39202
Contact: Anne Britt   601-948-0761   abritt@msretina.com  Â
Principal Investigator: Michael Borne, MD Â Â Â Â Â Â
Long Island Vitreoretinal Consultants
Westbury, New York, United States, 11590
Contact: Kristen D’Amore   516-466-0390   kdamore@vrcny.com  Â
Principal Investigator: Philip Ferrone, MD Â Â Â Â Â Â
North Carolina Retina Associates
Wake Forest, North Carolina, United States, 27587
Contact: Amanda Smith   919-435-9382   asmith@ncretina.com  Â
Principal Investigator: John Thordsen, MD Â Â Â Â Â Â
Charleston Neuroscience Institute
Ladson, South Carolina, United States, 29456
Contact: Carlos Ortiz   843-763-4466   c.ortiz@retinacharleston.com  Â
Principal Investigator: Virgil Alfaro, MD Â Â Â Â Â Â
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
Contact: Shan Woody   803-931-0077   swoody@palmettoretina.com  Â
Principal Investigator: Stephen Hypes, MD Â Â Â Â Â Â
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203
Contact: Lisa Walden   615-345-8912   lwalden@tnretina.com  Â
Principal Investigator: Carl Awh, MD Â Â Â Â Â Â
Austin Retina Associates
Austin, Texas, United States, 78705
Contact: Jenae Goode   512-451-0103   jgoode@austinretina.com  Â
Principal Investigator: Robert Wong, MD Â Â Â Â Â Â
Retina Consultants of Texas
Beaumont, Texas, United States, 77707
Contact: Jessica Hamiton   800-833-5921   jessica.hamilton@retinaconsultantstexas.com  Â
Principal Investigator: Will Pearce, MD Â Â Â Â Â Â
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
Contact: Allison Stroh   800-833-5921   allison.stroh@retinaconsultantstexas.com  Â
Principal Investigator: David Brown, MD Â Â Â Â Â Â
Retina Consultants of Texas
Katy, Texas, United States, 77494
Contact: Kourtney Storey   800-833-5921   Kourtney.Storey@retinaconsultantstexas.com  Â
Principal Investigator: Effie Rahman, MD Â Â Â Â Â Â
Retina Consultants of Texas
San Antonio, Texas, United States, 78240
Contact: Lydia Adams   800-833-5921   lydia.adams@retinaconsultantstexas.com  Â
Principal Investigator: Sarah Holy, MD Â Â Â Â Â Â
Retina Consultants of Texas
The Woodlands, Texas, United States, 77384
Contact: Cassie Cone   800-833-5921   ccone@retinaconsultantsofamerica.com  Â
Principal Investigator: Charles Wykoff, MD Â Â Â Â Â Â
Retina Associates of Utah
Salt Lake City, Utah, United States, 84107
Contact: Caity Kwun   801-312-2070   ckwun@retinautah.com  Â
Principal Investigator: Robert Kwun, MD Â Â Â Â Â Â
Retina Center NW, PLLC
Silverdale, Washington, United States, 98383
Contact: Anna Nelson   360-307-0300   anna@retinacenternw.com  Â
Principal Investigator: David Spinak, MD Â Â Â Â Â Â
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Experimental: DiaBetter Together Intervention
Young Adult participants with type 1 diabetes (ages 17-25) who are approaching transfer from pediatric to adult care will be randomized to either the DiaBetter Together Intervention group or the Usual Care group. After randomization to the intervention group, young adults will be assigned a Peer Mentor. Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult. In both conditions, participation in this study will not impact participants’ ability to contact the pediatric TCH diabetes care team or any other medical services to receive medical care.
Behavioral: DiaBetter Together
Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult, including (a) teaching and modeling strengths-based skills for goal-setting, problem-solving, and stress management; (b) guiding participants in obtaining support from their social support network (e.g., family, friends); (c) developing a plan for accountability around diabetes management and follow-up in adult care; (d) sharing his/her transition experiences and strategies for successfully navigating the adult healthcare system; (e) discussing how to prioritize diabetes self-care; and (f) assisting them in accessing diabetes-related resources (e.g., local diabetes groups, apps, social media). Contact will be in-person, by phone, email, text message, and/or video, approximately weekly for first 3 mos, approximately biweekly for next 3 mos, and approximately monthly for last 6 mos (while COVID-19 safety recommendations are in place, in-person meetings will not occur).
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Older adults with type 2 diabetes experience an accelerated rate of sarcopenia, which is the deterioration in muscle mass, strength and physical performance. Periods of disuse caused by illness or hospitalization cause rapid loss of muscle mass and strength, which negatively impact physical function upon re-ambulation. The impact of type 2 diabetes on acute muscle atrophy and recovery from disuse is a critical issue that has not been investigated.
The overall objectives of this study are to employ highly innovative methods in muscle biopsy specimens in order to decipher the temporal sequence by which mitochondrial dysfunction and lipotoxicity in older adults with pre-diabetes and type 2 diabetes impact atrophy and recovery of muscle mass, strength and physical function following bed rest. Older adults with and without pre-diabetes/type 2 diabetes will complete 10 days of strict bed rest followed by 4 weeks of ambulatory recovery. During bed rest muscle biopsies will be collected to determine mitochondrial function and lipid profile. During the recovery period the recovery of muscle mass, strength and physical function will be determined.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
The purpose of this research study is to test if CGMs are tolerable to youth with pre-diabetes (PD) and their caregivers. We are also evaluating if CGMs add benefit to standard treatment in youth with prediabetes. The CGM in question, Abbott Freestyle Libre 2 is approved by the Food and Drug Administration (FDA) to treat patients aged 4 and up with diabetes. We want to determine if this CGM may benefit people who have PD. People who enter the study will either receive standard medical care for prediabetes or receive standard medical care for prediabetes plus use a CGM for 2 weeks each month to receive real-time biofeedback on their glucose levels during the day.
There will be 3 visits over a 6-month period, baseline, 3-month, and 6-month visits. At each visit fasting labs will be obtained including: complete metabolic panel, lipid panel, pro-insulin, c-peptide, insulin. Anthropomorphics including body mass index, waist circumference, and hip circumference will be monitored.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. PRRT itself is approved by the U.S. Food and Drug Administration (FDA) for people with PanNETs however the combination with cytoreduction is considered experimental.
Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
PRRT is a form of targeted treatment (think of a “lock and key”) done by the use of a small molecule (Lutathera) Lutathera acts as a “key” to “lock” onto certain areas your tumor cells called receptors when injected into a vein and travels through the bloodstream. Lutetium-177 is the radionuclide in Lutathera which is a chemical that delivers strong radiation directly into your tumor cells and works by causing death of the cancerous tissues.
PRRT can only be done on patients who have tumors that have the somatostatin receptors. Before being given PRRT, your treating doctor will run imaging tests to make sure your tumors have these targeted receptors. Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
Participants will be randomized (like the flip of a coin) to one of two arms. Arm 1 is the control arm, which will undergo standard of care cytoreductive surgery (for the tumor). Arm 2 will undergo four cycles of PRRT before cytoreductive surgery.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05890950
Recruitment Status : **RECRUITING NOW**
First Posted : June 6, 2023
Last Update Posted : June 6, 2023
Sponsor:
Information provided by (Responsible Party):
Kallyope Inc.
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Brief Summary:
This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM).
Obesity Type 2 Diabetes Mellitus in Obese
Drug: K-757 and K-833 Drug: Matching placebo to K-757 and K-833
Phase 1
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Study Type :
Interventional  (Clinical Trial)
Estimated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A 28-Day Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes Mellitus
Actual Study Start Date :
March 13, 2023
Estimated Primary Completion Date :
June 2023
Estimated Study Completion Date :
June 2023
Resource links provided by the National Library of Medicine
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Experimental: K-757 and K-833 combination
Drug: K-757 and K-833
Both administered orally
Placebo Comparator: Placebo
Drug: Matching placebo to K-757 and K-833
Both administered orally
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Primary Outcome Measures :
Proportion of participants who experienced 1 or more treatment-emergent AEs [ Time Frame: Up to Day 42 +/- 2days ]
After treatment with the combination of K-757 and K-833
Proportion of participants who discontinued study medication due to an AE [ Time Frame: Up to Day 42 +/- 2days ]
After treatment with the combination of K-757 and K-833
Secondary Outcome Measures :
Area under the concentration-time curve [AUC] of plasma K-757 [ Time Frame: Days 14 and 28 ]
when co-administered with K-833
AUC of plasma K-833 [ Time Frame: Days 14 and 28 ]
when co-administered with K-757
Maximum concentration [Cmax] of plasma K-757 [ Time Frame: Days 14 and 28 ]
when co-administered with K-833
Cmax of plasma K-833 [ Time Frame: Days 14 and 28 ]
when co-administered with K-757
Time of maximum concentration [Tmax] of plasma K-757 [ Time Frame: Days 14 and 28 ]
when co-administered with K-833
Tmax of plasma K-833 [ Time Frame: Days 14 and 28 ]
when co-administered with K-757
Clearance [Cl] of plasma K-757 [ Time Frame: Days 14 and 28 ]
when co-administered with K-833
Cl of plasma K-833 [ Time Frame: Days 14 and 28 ]
when co-administered with K-757
Volume of distribution at steady-state [Vdss] of plasma K-757 [ Time Frame: Days 14 and 28 ]
when co-administered with K-833
Vdss of plasma K-833 [ Time Frame: Days 14 and 28 ]
when co-administered with K-757
Half-life [t1/2] of plasma K-757 [ Time Frame: Days 14 and 28 ]
when co-administered with K-833
t1/2 of plasma K-833 [ Time Frame: Days 14 and 28 ]
when co-administered with K-757
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years to 70 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Inclusion Criteria:
Understand the trial procedures and agree to participate by providing written informed consent.
Be willing and able to comply with all trial procedures and restrictions, including following study diet requirements.
Be between 18 to 70 years of age, inclusive, at the Screening Visit.
Has T2DM in accordance with American Diabetes Association (ADA) guidelines at Screening.
Is on stable metformin monotherapy (total daily dose of 500 to 2,000 mg/day) for at least 3 months and tolerating metformin well in the opinion of the investigator. Note: Both the immediate release (IR) and extended release (XR) formulations of metformin are acceptable.
HbA1c of 7.0% to 10.5% at Screening.
Have a Body Mass Index (BMI) ≥25.0 and <38.0 (kg/m2) at the Screening Visit.
Be weight stable (<5% variation) over the last 3 months, by subject report.
Be a nonsmoker who has not used tobacco or nicotine-containing products (e.g. nicotine patch, e-cigarettes, vapes) for at least 3 months before administration of the initial dose of trial drug and agrees to abstain from smoking tobacco or the use of nicotine-containing products while on study.
Be judged to be in generally good health by the Investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug.
Meet the following requirements:
Is a male who agrees to all of the following:
To use an appropriate method of contraception, including a condom with or without spermicidal cream or jelly, from the first dose of study drug until 14 days after the last dose of study drug. A male subject who had a vasectomy procedure must follow the same restrictions as a non-vasectomized man.
If partner is pregnant, to use a condom.
To not donate sperm from the first dose of study drug until 14 days after the last dose of study drug.
OR
Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
Postmenopausal (aged >45 years and with a minimum of 12 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone (FSH) level in the menopausal range as established for the laboratory performing the test.
Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject’s recall of their medical history.
OR
Is a female of reproductive potential and:
Exclusion Criteria:
Has participated in another interventional investigational study within 30 days of the Screening Visit. The window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the Screening Visit of the current study. If the subject received an investigational medication in the prior study, at least 5 half-lives (or longer if required by local regulations) must have passed between the last dose of the investigational product and the Screening Visit.
Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the Sponsor or study site.
Has a history of multiple significant and/or any severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
Has a known hypersensitivity or contraindication to any component of K-757 or K-833, including excipients.
Has a positive alcohol or drug screen at Screening or admission.
Has a positive pregnancy test.
Is a lactating/nursing female.
Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody, at the Screening Visit. Note: Subjects with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative.
Does not meet study site COVID-19 admission/study participation restrictions.
Has a fever (>38oC).*
Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit.*
Is unable to refrain from the use of prohibited prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication through completion of study participation.
As detailed in Section 10.1, allowable concomitant medications may include HMG-CoA reductase inhibitors (statins), ≤2 permissible anti-hypertensive agents, postmenopausal hormone replacement therapy, and/or proton pump inhibitors (PPIs).
Has been on any GLP-1 receptor agonist, any dipeptidyl peptidase IV (DPP-4) inhibitor, or any approved or investigational medications known to cause weight loss in the prior 3 months.
Has a history of type 1 diabetes mellitus (T1DM) or a history of diabetic ketoacidosis or subject assessed by the investigator as possibly having T1DM.
Has a history of other specific types of other specific types of diabetes (e.g. genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post organ transplant diabetes).
Has been treated with insulin or any other AHAs other than metformin within 4 weeks of screening or within 12 weeks of screening if the AHA was a thiazolidinedione (e.g., rosiglitazone, pioglitazone).
At Screening or Day -1 has a site fasting fingerstick glucose of >270 mg/dL.*
Has evidence or history of diabetic complications or significant end organ damage, eg, proliferative retinopathy and/or macular edema, eGFR (MDRD) ≤60 mL/min, diabetic neuropathy.
One or more self-reported episodes of hypoglycemia (fingerstick glucose <60 mg/dL with symptoms consistent with hypoglycemia or <50 mg/dL irrespective of symptoms) within the last 3 months.
Is using or anticipates the need for using concomitant medications which are inhibitors of P-gp or BCRP or any prohibited medications from screening until the post study visit.
Has excessive consumption of alcohol within 6 months prior to screening (>14 drinks/week for men and >7 drinks/week for women, where l drink= 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or use any of soft drugs(such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine) within 6 months prior to Screening.
Is unwilling or unable to refrain from consuming alcohol from 7 days prior to the first dose of study medication through the completion of study participation.
Has a substance abuse disorder.
Had a previous major psychotic disorder.
Has a corrected QT interval to Fridericia’s formula (QTcF) >450 milliseconds (msec) for males and >470 msec for females at screening or admission.
Has a mean value for triplicate semi-recumbent systolic blood pressure >160 millimeters of mercury (mmHg) and/or diastolic blood pressure (BP) >95 mmHg measured after at least 10 minutes at rest at the Screening Visit. Note: If a subject’s BP is exclusionary on the first triplicate assessment at the Screening visit, they may have 1 repeat triplicate BP assessment at that visit, after another rest of at least 10 minutes, to qualify for the study.
If a subject’s BP is exclusionary at screening but the investigator feels that BP is likely to be below the exclusionary thresholds at admission (Day -2), this criterion can be re-assessed at admission. Adjustment of doses of anti-hypertensives already being taken at screening is permissible, but initiation of new agents is not permissible. For subjects whose BP is exclusionary at Screening and at the first triplicate assessment on Day -2, triplicate assessments can be repeated up to twice on Day -2, as needed.
Has alanine aminotransferase or aspartate aminotransferase (ALT or AST) of >1.0X upper limit of normal (ULN) or total bilirubin >1.2X ULN (isolated bilirubin >1.2X ULN is acceptable if bilirubin is fractionated, and direct bilirubin is within the laboratory normal range) at Screening or admission. (Note: Subjects who do not meet this criterion at Screening or at admission may not be rescreened/retested).
Has serum amylase or lipase >1.2X the ULN at the Screening Visit.
Has a recent history (within past 3 years) or current diagnosis of any of the following GI (gastro-intestinal) related diseases: intestinal obstruction, GI perforation, GI motility disorders, adhesions, Clostridium difficile colitis or have had recent unexplained GI bleeding within 3 months prior to screening.
Has any history of pancreatitis (acute or chronic), gastroparesis, ischemic colitis, inflammatory bowel disease (IBD), celiac disease, irritable bowel syndrome (IBS), or colitis.
Has any past surgical history of gastric banding or bariatric surgery or bowel resection.
Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurologic disorder, neoplastic, or genitourinary abnormalities or diseases.
Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
note – *Subject may be included if they are able to return to the site within 7 days of initial screening and the exclusion criterion is no longer met.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05890950
Layout table for location contacts
Contact: Annemarie Vance
annemarie@kallyope.com
Layout table for location information
QPS, LLC
Newark, Delaware, United States, 19711
Kallyope Inc.
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Layout table for additonal information
Responsible Party:
Kallyope Inc.
ClinicalTrials.gov Identifier:
NCT05890950 Â Â
Other Study ID Numbers:
K-757 P005
First Posted:
June 6, 2023 Â Â Key Record Dates
Last Update Posted:
June 6, 2023
Last Verified:
May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kallyope Inc.:
ObesityType 2 Diabetes Mellitus
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes MellitusDiabetes Mellitus, Type 2OverweightGlucose Metabolism DisordersMetabolic Diseases
Endocrine System DiseasesOvernutritionNutrition DisordersBody Weight
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
People living in rural areas are diagnosed and die from cancer at higher rate than people living in cities. Physical activity has been shown to decrease the risk and occurrence of a variety of cancers, including bladder, breast, colon, endometrial, gastric, kidney, and prostate cancers. Being inactive can cause over 10% of breast and colon cancer cases.
Compared to people living in cities, people living in rural areas tend to be less physically active. They’re also more likely to be overweight/obese or have diabetes. Adults who are overweight, obese, or diabetic often have changes in the way their bodies deal with insulin, glucose metabolism, and inflammation. Physical activity is thought to reduce the risk of cancer by improving these issues over time.
Primary care providers and their staff can identify a patient’s need for more physical activity, but may not have the time or resources to give advice or assistance. We have set up a telephone-based physical activity coaching program, called the MoveLine, to give inactive patients advice and assistance in becoming more physically active.
The purpose of this study is to determine if referring inactive patients to the MoveLine will help them to be more physically active over time. Approximately 880 people will take part in this research in rural areas of Pennsylvania.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Brief Summary:
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.
Condition or disease
Intervention/treatment
Phase
Secondary Hyperparathyroidism End-stage Kidney Disease (ESKD)
Drug: PLS240 Drug: Placebo Drug: Open-Label Extension PLS240
Phase 3
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Brief Summary:
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.
Condition or disease
Intervention/treatment
Phase
Secondary Hyperparathyroidism End Stage Kidney Disease
Drug: PLS240 Drug: Placebo Drug: Open-Label Extension PLS240
Phase 3
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
DrugTrialsForMoney.com is an online resource for patients looking to volunteer for paid clinical trials and other medical studies for money.
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