ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00401193
Conditions: Menorrhagia Heavy Menstrual Bleeding
Keywords: Menorrhagia Heavy Menstrual Bleeding
Sponsor: Ferring Pharmaceuticals
Start date: 2006-11-01; Completion date: 2008-05-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tranexamic acid tablets intervention 2: Tranexamic acid tablets intervention 3: Placebo tablets
Intervention descriptions: intervention 1: 3900 mg/Day intervention 2: 1950 mg/Day intervention 3: None

Protocol documents:
Clinical trial NCT00412737
Conditions: Influenza
Sponsor: Hoffmann-La Roche
Start date: 2007-01-01; Completion date: 2008-05-01
Enrollment: 477 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Oseltamivir intervention 2: Placebo
Intervention descriptions: intervention 1: Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks. intervention 2: Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.

Protocol documents:
Clinical trial NCT00417274
Conditions: Prostatic Cancer
Keywords: Cancer of Prostate Prostate Cancer Cancer of the Prostate Neoplasms, Prostate Neoplasms, Prostatic Prostate Neoplasms Prostatic Cancer Androgen-Independent Prostate Cancer
Sponsor: Cleveland BioLabs
Start date: 2006-12-01; Completion date: 2008-05-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer.

Detailed description:
Despite a modest improvement in survival with available chemotherapy treatments, androgen-independent metastatic prostate cancer remains essentially incurable.

Several changes in gene function that characterize malignancy have been identified. For example the p53 gene in normal tissue lessens the risk of cancer through growth arrest or cell suicidal programs. Thus the silenced p53 gene present in cancer tissue contributes to the growth of the cancer. In addition when the p53 gene is silenced, a cell survival pathway, controlled by the NF-kB gene, is activated leading increased cell survival.

Quinacrine can activate p53 and inhibit NF-kB, thus reestablishing cell suicidal programs and decreasing cell survival in cancer tissue. Moreover, quinacrine is effective against several prostate tumor cell lines in vitro, and has anti-tumor effects against prostate cancer xenografts in mice.

Arms: arm 1: Uncontrolled treatment arm
Interventions: intervention 1: Quinacrine
Intervention descriptions: intervention 1: 100 mg daily

Protocol documents:
Clinical trial NCT00422084
Conditions: Malaria
Keywords: malaria antimalarial artemisinin based combination therapy (ACT) P. falciparum pyronaridine artesunate (Pyramax)
Sponsor: Medicines for Malaria Venture
Start date: 2007-01-01; Completion date: 2008-05-01
Enrollment: 1272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.

Detailed description:
This is a multi-centre, comparative, randomised, (double-blind, double-dummy), parallel-group, non-inferiority study comparing the efficacy and safety of the fixed combination of PA with that of AL in the treatment of acute, uncomplicated P. falciparum malaria. The study population will include 1269 patients, comprising male and female children (≥20 kg body weight) and adults recruited from study sites in Africa and South East Asia.

Patients will be randomised to receive either oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Days 0, 1, and 2) or AL twice a day plus PA-placebo (once a day) for 3 consecutive days (Days 0, 1, and 2) in a 2:1 ratio. The dose range of PA covered by this regimen is 7.2:2.4 mg/kg to 13.8:4.6 mg/kg, respectively, which has been shown to be effective and safe in Phase I and II studies. Posology will be based on body weight ranges for both the PA and AL regimens.

Patients will be confined to the study facility for ≥4 days (Days 0, 1, 2, and 3) and remain near the study site for ≥7 days, or once fever and parasite clearance has been confirmed for ≥24 hours - whichever occurs later.

The primary efficacy end point for the study is the proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. Scheduled follow-up visits will continue until completion of the study at Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.

Arms: arm 1: Pyronaridine artesunate (PA) arm 2: Arthemether lumefantrine (AL)
Interventions: intervention 1: Pyronaridine artesunate intervention 2: Coartem® (artemether lumefantrine)
Intervention descriptions: intervention 1: Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2) intervention 2: AL (20:120mg tablets) twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)

Protocol documents:
Clinical trial NCT00432666
Conditions: Post-stroke Upper Limb Spasticity
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2006-06-01; Completion date: 2008-05-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.

Detailed description:

Arms: arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection arm 2: None
Interventions: intervention 1: IncobotulinumtoxinA (Xeomin) intervention 2: Placebo
Intervention descriptions: intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection intervention 2: Placebo

Protocol documents:
Clinical trial NCT00434356
Conditions: Metastatic Breast Cancer
Keywords: Avastin MBC Breast Cancer Sutent
Sponsor: Genentech, Inc.
Start date: 2007-03-01; Completion date: 2008-05-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab intervention 2: sunitinib intervention 3: paclitaxel
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Oral repeating dose intervention 3: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00434590
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation Mycophenolic Acid Immunosuppression Cyclosporine
Sponsor: Novartis Pharmaceuticals
Start date: 2007-03-01; Completion date: 2008-05-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate kidney graft function in maintenance renal transplant patients.

Detailed description:

Arms: arm 1: The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME arm 2: Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
Interventions: intervention 1: Enteric coated mycophenolate sodium (Myfortic®)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00441896
Conditions: Infantile Spasms
Keywords: infantile spasms anticonvulsant pediatric epilepsy West Syndrome epileptic spasms
Sponsor: Marinus Pharmaceuticals
Start date: 2007-01-01; Completion date: 2008-05-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of participants, who will receive ascending doses of placebo and ascending doses of ganaxolone. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts.

Detailed description:
Male or female, 4 to 24 months of age (inclusive) with a diagnosis of IS with a 24 hour video EEG (vEEG) recording confirming the diagnosis and previously treated with 3 or fewer antiepileptic drugs (AEDs) are eligible for the study. The subject is able to continue treatment with concomitant AEDs (no more than 2; adrenocorticotropic hormone \[ACTH\], corticosteroids, felbamate, and vigabatrin are not allowed concomitantly). A ketogenic diet is permitted if it can be maintained for the duration of the study.

There will be a total of three weekly 24-hr video EEGs (baseline, end of weeks 1 and 2 of treatment). Dosing titration begins the day after each video EEG during the inpatient stay. All subjects will be receiving ganaxolone the day after the second video EEG.

A Data Monitoring Board (DMB) will determine whether successive cohorts of subjects can be dosed at an increased dose level; up to a maximum of 6 cohorts.

Arms: arm 1: ganaxolone arm 2: placebo
Interventions: intervention 1: Ganaxolone intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00453349
Conditions: Pelvic Inflammatory Disease
Keywords: Uncomplicated pelvic inflammatory disease
Sponsor: Bayer
Start date: 2007-01-01; Completion date: 2008-05-01
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)

Detailed description:

Arms: arm 1: Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days arm 2: Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
Interventions: intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Levofloxacin & Metronidazole
Intervention descriptions: intervention 1: Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days intervention 2: Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days

Protocol documents:
Clinical trial NCT00461786
Conditions: Ovarian Cancer Peritoneal Cancer
Sponsor: Eli Lilly and Company
Start date: 2004-09-01; Completion date: 2008-05-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pemetrexed
Intervention descriptions: intervention 1: 900 mg/m2, intravenous (IV), every 21 days, until disease progression

Protocol documents:
Clinical trial NCT00464308
Conditions: Gastro-oesophageal Reflux
Keywords: Gastroesophageal Reflux Heartburn Proton pump inhibitor GORD
Sponsor: Janssen-Cilag Pty Ltd
Start date: 2006-11-01; Completion date: 2008-05-01
Enrollment: 1392 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare, the number of patients with heartburn and regurgitation symptom resolution after treatment with either rabeprazole 20 mg, esomeprazole 20 mg or esomeprazole 40 mg.

Detailed description:
The study is designed to be conducted in a realistic General Practice (GP) setting, enrolling typical Gastro-oesophageal Reflux Disease (GORD) patients that present for treatment, and for whom a Proton Pump Inhibitor (PPI) would normally be prescribed. The study will be conducted over a 4-week period on the basis that current GP standard practice is to treat the GORD patient for a period of 4-weeks prior to reassessment and further follow-up if required. This study is conducted in patients with GORD - associated heartburn (with or without regurgitation) at multiple GP centers, treatment is assigned based on chance (randomized), similar to the toss of a coin and neither doctor or patient knows which treatment they will receive (double-blinded). Following screening to determine eligibility, patients will be randomized to receive oral treatment with either, 20 mg rabeprazole, 20 mg esomeprazole or 40 mg esomeprazole once daily for 4 weeks. This 4-week study encompasses 2 protocol-mandated visits (baseline on day 0 and final visit on day 28). It is hypothesized that rabeprazole 20 mg will be no less effective than (non-inferior) esomeprazole 40 mg for the degree of GORD symptom resolution. Patients will take one tablet (rabeprazole 20 mg or placebo) and one capsule (esomeprazole 20 mg, esomeprazole 40 mg or placebo) each day for 28 days. The study medication will be taken once daily in the morning before breakfast, except the first dose, which will be taken during Visit 1.

Arms: arm 1: Esomeprazole 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily arm 2: Esomeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily arm 3: Rabeprazole 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily
Interventions: intervention 1: Esomeprazole intervention 2: Rabeprazole intervention 3: Esomeprazole
Intervention descriptions: intervention 1: 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily intervention 2: 20mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily intervention 3: 40mg once daily for 28days - 1 placebo tab/cap \& 1 active tab/cap daily

Protocol documents:
Clinical trial NCT00465738
Conditions: Upper Limb Spasticity
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2007-02-01; Completion date: 2008-05-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).

Detailed description:
IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins. Injected into a muscle, incobotulinumtoxinA causes a reversible local weakening of the muscle for several months, and may improve an impaired muscle function by lessening the muscle tightness within few days. IncobotulinumtoxinA is widely used for various severe neurological conditions. There is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxinA is diluted before injection.

Arms: arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 5.0 mL resulted in a dose of 20 units per 1.0 mL. arm 2: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 mL sterile of NaCl 0.9% solution without preservatives. Dilution with 2.0 mL resulted in a dose of 50 units per 1.0 mL.
Interventions: intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")
Intervention descriptions: intervention 1: active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins; powder for solution for injection; Mode of administration: intramuscular injection; The content of the vial was dissolved in 2.0 or 5.0 mL of sterile sodium chloride \[NaCl\] 0.9% solution without preservatives. Dilution with 2.0 or 5.0 mL resulted in a dose of 50 or 20 units per 1.0 mL.

Protocol documents:
Clinical trial NCT00492232
Conditions: Chronic Insomnia
Keywords: Chronic Insomnia Sleep Initiation and Maintenance Disorder Drug Therapy
Sponsor: Takeda
Start date: 2007-04-01; Completion date: 2008-05-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.

Detailed description:
Approximately 60 to 70 million adults in the United States alone are affected by insomnia. Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and irritability. Recent epidemiologic research focusing on the quality of life has identified significant insomnia-related morbidities that relate to work productivity, health care utilization, and risk of depression. Insomnia is associated with diminished work output, absenteeism, and greater rates of accidents.

Zolpidem is the most commonly prescribed hypnotic in the United States for patients suffering from insomnia.

The purpose of this study is to assess whether ramelteon therapy can facilitate the discontinuation of benzodiazepine therapy in long term users. Subject participation in this study is anticipated to be about 17 weeks.

Subjects were screened and enrolled in a 4-week placebo run-in period, may have been randomized to a 10-week double-blind treatment period, and may have completed with a 2-week open-label treatment period. In the double-blind treatment period, subjects were randomized to one of two treatments: either ramelteon 8 mg tablets taken orally once-daily with concomitant current zolpidem therapy or to placebo-matching tablets once daily with concomitant current zolpidem therapy. Subjects incrementally reduced zolpidem therapy by dose, frequency, or both for up to 10 weeks. Only those subjects who completed the double-blind treatment period and had achieved a 50% reduction in zolpidem therapy during the double-blind treatment period participated in the open-label treatment period in which 8 mg ramelteon was administered. Zolpidem consumed during the open-label treatment period was recorded.

Arms: arm 1: Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks. arm 2: Zolpidem therapy will be reduced by dose, frequency, or both for up to 10 weeks.
Interventions: intervention 1: Ramelteon and zolpidem intervention 2: Placebo and zolpidem
Intervention descriptions: intervention 1: Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks. intervention 2: Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.

Protocol documents:
Clinical trial NCT00499863
Conditions: ADHD
Sponsor: Noven Therapeutics
Start date: 2007-07-01; Completion date: 2008-05-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of efficacy of MTS compared to placebo

Detailed description:
To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.

Arms: arm 1: dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear arm 2: Daily application of matching MTS Placebo Patch
Interventions: intervention 1: methylphenidate transdermal system intervention 2: Placebo
Intervention descriptions: intervention 1: dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear intervention 2: Placebo patch

Protocol documents: