Clinical trials: Menopausal Hormone Therapy
Lysosomal Acid Lipase Deficiency
Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) in Participants With Lysosomal Acid Lipase Deficiency
This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid…
- Trial name
- ARISE (NCT01757184)
- Testing
- Sebelipase Alfa
- Where
- 40 sites in United States, Argentina and 13 more
- Volunteers
- 66 people
- Sponsor
- Alexion Pharmaceuticals, 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.
Menopausal and Female Climacteric States
Treatment Of Hot Flashes/Flushes In Postmenopausal Women (WARM Study)
The purpose of this study is to determine whether GSK232802 is safe and effective in reducing the frequency and severity of hot flashes associated with menopause.
- Trial name
- NCT00604825
- Testing
- GSK232802, PREMARIN
- Where
- 87 sites in United States, Argentina and 7 more
- Volunteers
- 356 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease
Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT)
Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis.
- Trial name
- EPOCH-RRT (NCT02488317)
- Testing
- Decision Aid
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- Arbor Research Collaborative for Health
Smoking Cessation
Smoking Cessation After Hospitalization for a Cardiopulmonary Illness
Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of…
- Trial name
- STOPP (NCT01791803)
- Testing
- hypnotherapy, Nicotine
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- North Shore Medical Center
Smoking, Smoking Cessation
A Novel Treatment to Boost Quit Attempts and Cessation Among Unmotivated Smokers
A sample of smokers who have no current plans to quit will be recruited for this study and randomized to one of two intervention conditions: 1. Practice Quit Attempt (PQA) aided by brief advice and self-help materials, or 2.
- Trial name
- NCT00706979
- Testing
- Practice Quit Attempt plus nicotine lozenge, Practice Quit Attempt only
- Volunteers
- 849 people
- Sponsor
- Medical University of South Carolina
Menopausal Symptoms
European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)
The objective of the active surveillance study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral continuous combined HRT products.
- Trial name
- NCT00214903
- Where
- Germany
- Volunteers
- 30,597 people
- Sponsor
- Center for Epidemiology and Health Research, Germany
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
Bladder Cancer, Cervical Cancer
Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking
RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more effective than counseling and the…
- Conditions
- Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer
- Trial name
- NCT00365508
- Testing
- nicotine lozenge, nicotine patch
- Where
- 10 sites in United States
- Volunteers
- 642 people
- Sponsor
- Fox Chase Cancer Center
Smoking Cessation
Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate…
- Trial name
- NCT01544153
- Testing
- WEB, Social Network, Nicotine Replacement Therapy (NRT)
- Where
- United States
- Volunteers
- 5,292 people
- Sponsor
- Truth Initiative
Pompe Disease
Safety and Efficacy of Clenbuterol in Individuals With Late-onset Pompe Disease and Receiving Enzyme Replacement Therapy
Funding Source- FDA OOPD The purpose of this study is to investigate the safety and efficacy of clenbuterol on motor function in individuals with late-onset Pompe disease (LOPD) who are treated with enzyme replacement therapy…
- Trial name
- NCT01942590
- Testing
- Clenbuterol
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Dwight Koeberl, M.D., Ph.D.
Common Variable Immunodeficiency, X-linked Agammaglobulinemia
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
- Conditions
- Common Variable Immunodeficiency, X-linked Agammaglobulinemia, Autosomal Recessive Agammaglobulinemia
- Trial name
- NCT00542997
- Testing
- Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)
- Where
- 19 sites in France, Germany and 7 more
- Volunteers
- 51 people
- Sponsor
- CSL Behring
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
Sly Syndrome, MPS VII
A Study of UX003 Recombinant Human Beta-Glucuronidase (rhGUS) Enzyme Replacement Therapy in Subjects With Mucopolysaccharidosis Type 7, Sly Syndrome (MPS 7)
The primary objective of the study is to evaluate the long-term safety of UX003 in subjects with MPS 7.
- Conditions
- Sly Syndrome, MPS VII, Mucopolysaccharidosis, Mucopolysaccharidosis VII
- Trial name
- NCT02432144
- Testing
- UX003
- Where
- 7 sites in United States, Brazil and 2 more
- Volunteers
- 12 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Acute Kidney Injury in Pediatric Patients
Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children
The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury…
- Trial name
- NCT02561247
- Testing
- Prismaflex HF20 CRRT Filter, Prismaflex® System 7.10 and 7.20
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Vantive Health LLC
Cholesterol Ester Storage Disease(CESD), Lysosomal Acid Lipase Deficiency
Safety, Tolerability and Pharmacokinetics of SBC-102 (Sebelipase Alfa) in Adult Participants With Lysosomal Acid Lipase Deficiency
This was the first clinical study of SBC-102 (sebelipase alfa) for the treatment of Lysosomal Acid Lipase (LAL) Deficiency. It was an open-label dose escalation study in adult participants with liver dysfunction due to LAL…
- Conditions
- Cholesterol Ester Storage Disease(CESD), Lysosomal Acid Lipase Deficiency, LAL-Deficiency
- Trial name
- NCT01307098
- Testing
- Sebelipase alfa 0.35 mg/kg, Sebelipase alfa 1 mg/kg, Sebelipase alfa 3 mg/kg
- Where
- 7 sites in United States, Czechia and 2 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Congenital Adrenal Hyperplasia
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
This study is a parallel arm, randomised, open-label study, including dose titration and admissions for four overnight stays for 24-hour endocrine profiles.
- Trial name
- NCT02716818
- Testing
- Chronocort®, standard glucocorticoid therapy
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Neurocrine UK Limited
Renal Failure, End Stage Renal Disease
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Trial name
- NCT02644941
- Testing
- Human Acellular Vessel (HAV), ePTFE graft
- Where
- 38 sites in United States, Germany and 4 more
- Volunteers
- 355 people
- Sponsor
- Humacyte, Inc.
Immunologic Deficiency Syndromes
Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases
Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries.
- Trial name
- NCT00811174
- Testing
- Octagam 10%
- Where
- Austria
- Volunteers
- 5 people
- Sponsor
- Octapharma