Clinical trials: Hormone Replacement
Primary Immune Deficiency Disease
Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
- Trial name
- NCT00634569
- Testing
- Flebogamma 5% DIF
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Instituto Grifols, S.A.
Acute Kidney Injury
A Net Ultrafiltration Challenge to Predict Preload-dependence (UF CHALLENGE)
Hemodynamic instability episodes are a frequent complication of renal replacement therapies in critically ill patients, and their incidence is associated with worse survival.
- Trial name
- UF CHALLENGE (NCT05214729)
- Testing
- Fast ultrafiltration challenge, Slow ultrafiltration challenge
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Hospices Civils de Lyon
Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT)
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)
The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT).
- Conditions
- Regional Citrate Anticoagulation (RCA), Continuous Renal Replacement Therapy (CRRT), Acute Kidney Injury
- Trial name
- NCT02860130
- Testing
- Prismocitrate 18, No Anticoagulation
- Where
- 12 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Vantive Health LLC
Smoking
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)
The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional…
- Trial name
- NCT01967719
- Testing
- mTHS 2.2, mCC, NNS
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Hemophilia B, Hemophilia A
A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)
To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study.
- Trial name
- NCT03587116
- Testing
- Standard of Care FIX Replacement therapy, Standard of Care FVIII Replacement therapy
- Where
- 75 sites in United States, Australia and 16 more
- Volunteers
- 212 people
- Sponsor
- Pfizer
Smoking
Phase I Study: Stop Smoking Therapy for Ontario Patients (STOP)
20% of Ontarians smoke. There was a decline in smoking prevalence from 1995 but it has remained unchanged since 2002. This rate of smoking cessation has not kept up with the rest of Canada.
- Trial name
- NCT00356993
- Testing
- Nicotine Replacement Therapy, behavioural intervention
- Where
- Canada
- Volunteers
- 6,009 people
- Sponsor
- Centre for Addiction and Mental Health
Glaucoma
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.
- Trial name
- NCT01514734
- Testing
- Brinzolamide/timolol maleate fixed combination
- Where
- Brazil
- Volunteers
- 9 people
- Sponsor
- Alcon Research
Primary Immune Deficiency
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID).
- Trial name
- NCT01199705
- Testing
- Immune Globulin Subcutaneous (Human) (SCIG)
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- CSL Behring
Fabry Disease
Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease
Study to compare the efficacy and safety of migalastat and enzyme replacement therapy (ERT) in male and female participants with Fabry disease who are currently receiving ERT and who have an alpha galactosidase-A (α Gal-A)…
- Trial name
- NCT01218659
- Testing
- migalastat hydrochloride, agalsidase
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 68 people
- Sponsor
- Amicus Therapeutics
Smoking Cessation
Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
Varenicline is considered to be a first-line tobacco cessation treatment. Previous studies have evaluated the impact of the combination of varenicline and nicotine patches (versus varenicline alone) on smoking cessation, though…
- Trial name
- NCT03722966
- Testing
- Varenicline, Oral Nicotine Replacement Therapy (NRT), Medication Reminders
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Cigarette Smoking
Free Samples for Health
The Free Samples for Health (FreSH) study tests whether providing free samples of stop smoking medicine called nicotine replacement therapy at dental visits results in a greater number of people quitting smoking than providing a…
- Trial name
- FreSH (NCT05627596)
- Testing
- Ask-Advise-Refer, Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release, Nicotine lozenge
- Where
- United States
- Volunteers
- 1,239 people
- Sponsor
- Sandra Japuntich
Gaucher Disease
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003.
- Trial name
- NCT01422187
- Testing
- Taliglucerase alfa
- Volunteers
- 19 people
- Sponsor
- Pfizer
Menopause
Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age.
- Trial name
- NCT00185458
- Testing
- LNG IUS
- Where
- 12 sites in Belgium, Finland and 2 more
- Volunteers
- 394 people
- Sponsor
- Bayer
Acute Kidney Injury
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI).
- Trial name
- SCD-PED-01 (NCT02820350)
- Testing
- SCD-F40
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- CytoPherx, Inc
Smoking
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product…
- Trial name
- NCT01967706
- Testing
- mTHS, mCC, NRT
- Where
- Japan
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking Cessation
Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to: 1.
- Trial name
- NCT01287377
- Testing
- Telephone Counseling, Nicotine Patches
- Where
- United States
- Volunteers
- 243 people
- Sponsor
- University of California, San Diego
Smoking Cessation
Telephone Counseling and the Distribution of Nicotine Patches to Smokers
The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to: 1.
- Trial name
- NCT00851357
- Testing
- Nicotine Patch, Telephone Counseling, Self-Help Materials
- Where
- United States
- Volunteers
- 4,200 people
- Sponsor
- University of California, San Diego
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
Acute Kidney Failure
The Effect of Loop Diuretics on Severity and Outcome of Acute Kidney Injury
The primary objective is to safely determine if the investigators can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease.
- Trial name
- NCT01275729
- Testing
- Furosemide
- Where
- 4 sites in United States
- Volunteers
- 96 people
- Sponsor
- University of Chicago
Nicotine Dependence
Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging
The proposed research will provide significant new gender-specific information of scientific and clinical relevance on the function of the mu-opioid system in nicotine dependence and therapeutic effectiveness of nicotine…
- Trial name
- NCT01664741
- Testing
- Nicotine patch - transdermal
- Where
- United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University