Clinical trials: Safety and Effectiveness
Malaria
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally…
- Trial name
- NCT03521973
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Gabon
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle…
- Trial name
- NCT01905683
- Testing
- IncobotulinumtoxinA (16-20 Units per kg body weight)
- Where
- 43 sites in Austria, Czechia and 10 more
- Volunteers
- 370 people
- Sponsor
- Merz Pharmaceuticals GmbH
Labor Pain
Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients
Labour is a very painful experience and epidural analgesia is considered the gold standard for pain relief in labour. Epidural scarcity, cost and shortage of skilled personnel to administer it is a limitation to it's usage in…
- Trial name
- OCTAPPENALA (NCT05565274)
- Volunteers
- 166 people
- Sponsor
- Federal Medical Centre, Yenagoa
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
Cranioplasty, Craniofacial Abnormalities
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and…
- Conditions
- Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
- Trial name
- NCT05362370
- Testing
- Stryker's PEEK Customized Implant
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 99 people
- Sponsor
- Stryker Craniomaxillofacial
Hemophilia B
Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B
The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B.
- Trial name
- PUPs B-LONG (NCT02234310)
- Testing
- rFIXFc
- Where
- 27 sites in United States, Australia and 9 more
- Volunteers
- 33 people
- Sponsor
- Bioverativ, a Sanofi company
Respiratory Syncytial Virus Infection
A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV
To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.
- Trial name
- NCT06206720
- Testing
- Deuremidevir Hydrobromide for Suspension
- Where
- 22 sites in China
- Volunteers
- 60 people
- Sponsor
- Vigonvita Life Sciences
Acute Sinusitis
Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
This is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients
- Trial name
- CASIS (NCT04664803)
- Testing
- Cefecin Tab., Omnicef Cap.
- Volunteers
- 284 people
- Sponsor
- Korea United Pharm. Inc.
Nasal Congestion and Inflammations, Rhinitis
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation upper airway, characterized by nasal…
- Trial name
- NCT01393561
- Testing
- Group 1, Group 2
- Volunteers
- 167 people
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
Pleural Effusion, Pleurisy
Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy
This is a prospective study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections in patients undergoing medical thoracoscopy.
- Conditions
- Pleural Effusion, Pleurisy, Empyema
- Trial name
- APT (NCT02446782)
- Testing
- Cefazolin, saline
- Where
- India
- Volunteers
- 100 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Attention-Deficit/Hyperactivity Disorder (ADHD)
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with…
- Trial name
- NCT02633527
- Testing
- 100mg SPN-812, 200mg SPN-812, 300mg SPN-812
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Congenital Adrenal Hyperplasia
Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1
Children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency tend to have elevated circulating levels of androgens, which can accelerate skeletal maturation and adversely impact adult height.
- Trial name
- NCT02574910
- Testing
- Abiraterone acetate
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- University of Texas Southwestern Medical Center
Refractory Partial Seizures
To Evaluate The Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
- Trial name
- NCT00699582
- Testing
- E2007 (perampanel)
- Where
- 92 sites in United States, Austria and 12 more
- Volunteers
- 389 people
- Sponsor
- Eisai Inc.
Synovial Sarcoma, Cancer
A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.
- Conditions
- Synovial Sarcoma, Cancer, Soft Tissue Sarcoma, Sarcoma
- Trial name
- NCT03520959
- Testing
- LV305, G305
- Where
- 29 sites in United States, Canada
- Volunteers
- 1 people
- Sponsor
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Alpha-Mannosidosis
Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis
The main objectives of the study are to evaluate safety and efficacy of repeated treatment with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6 years
- Trial name
- rhLaman-08 (NCT02998879)
- Testing
- Velmanase Alfa (e.g. Lamazym)
- Where
- 6 sites in Austria, Denmark and 3 more
- Volunteers
- 5 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Prader-Willi Syndrome
Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period
This is a multi-center, multi-period study with an open-label period followed by a double-blind, placebo-controlled, randomized withdrawal period evaluating the safety and efficacy of DCCR treatment.
- Trial name
- NCT03714373
- Testing
- DCCR
- Where
- 28 sites in United States, United Kingdom
- Volunteers
- 115 people
- Sponsor
- Soleno Therapeutics, Inc.
Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD)
Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB08 injection compared to Norditropin NordiFlex in pediatric patients with growth hormone deficiency (PGHD).
- Conditions
- Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD), Growth Hormone
- Trial name
- NCT07126288
- Testing
- GB08, Norditropin NordiFlex
- Where
- 16 sites in China
- Volunteers
- 268 people
- Sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.
Lymphangioma, Lymphatic Malformations
Bleomycin as an Effective and Curative Adjunct Therapy for Lymphangioma
Lymphatic malformations (LM), or lymphangiomas, are common vascular anomalies in children, most often occurring in the head and neck, less commonly in the axilla, abdomen, thorax, groin, and extremities.
- Trial name
- NCT06943703
- Testing
- Sclerotherapy with intralesional bleomycin injection
- Where
- Vietnam
- Volunteers
- 809 people
- Sponsor
- National Children's Hospital, Vietnam
Hemophilia A
BAX 855 PK-guided Dosing
1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%) 2.
- Trial name
- PROPEL (NCT02585960)
- Testing
- PEGylated Recombinant Factor VIII
- Where
- 83 sites in United States, Australia and 20 more
- Volunteers
- 135 people
- Sponsor
- Baxalta now part of Shire
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