ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00576823
Conditions: Hydronephrosis Neurogenic Bladder
Keywords: child bladder neuropathic alpha blockers
Sponsor: Sanofi
Start date: 2007-12-01; Completion date: 2009-10-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure \[LPP\] of neuropathic etiology.

Secondary objectives were:

* To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents,
* To investigate the number of Urinary Tract Infection (UTI) episodes,
* To investigate the pharmacokinetics of Alfuzosin (population kinetics).

Detailed description:
The study consisted of 2 phases:

* a 12-week efficacy phase then,
* a 40-week safety extension phase.

All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets.

Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. The treatment was the same as in the 12-week efficacy phase.

All patients had a one-week follow-up period after the last dose intake.

Arms: arm 1: Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age. arm 2: Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow tablets or preferred to take the solution or had a body weight \< 30 kg. arm 3: Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30 kg.
Interventions: intervention 1: Alfuzosin
Intervention descriptions: intervention 1: Dose: 0.2 mg/kg/day

Route: oral

Protocol documents:
Clinical trial NCT00581100
Conditions: Nail Psoriasis Plaque Psoriasis
Keywords: Nail Psoriasis Plaque Psoriasis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-09-01; Completion date: 2009-10-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.

Detailed description:
This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.

Arms: arm 1: etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24 arm 2: etanercept 50 mg SC once weekly for the complete 24 week treatment period
Interventions: intervention 1: etanercept
Intervention descriptions: intervention 1: Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.

Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.

Protocol documents:
Clinical trial NCT00586573
Conditions: ADHD
Keywords: ADHD Namenda
Sponsor: Massachusetts General Hospital
Start date: 2007-03-01; Completion date: 2009-10-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to assess the efficacy and tolerability of a 12-week trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine hydrochloride will be associated with improving ADHD symptoms and associated deficits in executive functions. We also expect that memantine will be well-tolerated with predictable adverse events.

Detailed description:
Memantine (Namenda) is a low-affinity N-methyl-D-aspartate (NMDA) receptor antagonist believed to work by blocking prolonged low-level activation of the NMDA receptor and resultant neuronal damage caused by abnormal glutamatergic activity, yet also allowing normal physiological activity of the NMDA channel. Memantine (Namenda) was approved by the U.S. Food and Drug Administration in 2003 for the treatment of moderate to severe Alzheimer's disease. Memantine improves or delays the decline in cognition (attention, language, visuo-spatial ability), as well as functional and behavioral symptoms in adults with moderate Alzheimer's disease.

Although the efficacy and safety of memantine has not been tested in people with ADHD, the spectrum of disorders possibly amenable to NMDA receptor antagonist treatment may include ADHD and associated executive function deficits (EFDs). To this end, we are proposing an open-label pilot study of memantine in adult subjects with ADHD and ADHD Not Otherwise Specified (NOS).

This will be a 12-week, open-label pilot study to assess the efficacy and tolerability of memantine hydrochloride (Namenda) administered to 20 adults 18-55 years of age with ADHD and ADHD NOS. All subjects that enter the study will undergo standard screening and diagnostic procedures. After obtaining written informed consent from the subject, the diagnosis of ADHD will be established through clinical evaluation by an expert clinician. Only consenting subjects satisfying inclusion and exclusion criteria will be included in the study.

Arms: arm 1: None
Interventions: intervention 1: memantine hydrochloride
Intervention descriptions: intervention 1: tablet, 5-20 mg, twice daily, by mouth, 12 weeks

Protocol documents:
Clinical trial NCT00586716
Conditions: End Stage Renal Disease
Sponsor: Loma Linda University
Start date: 2004-11-01; Completion date: 2009-10-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Detailed description:
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Arms: arm 1: Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list arm 2: Intravenous immune globulin for patients who have living donors with positive crossmatch results.
Interventions: intervention 1: intravenous immune globulin
Intervention descriptions: intervention 1: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Protocol documents:
Clinical trial NCT00595413
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis Atacicept Adalimumab Humira®
Sponsor: EMD Serono
Start date: 2007-09-01; Completion date: 2009-10-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo matched to atacicept intervention 2: Atacicept: with loading dose intervention 3: Atacicept intervention 4: Adalimumab
Intervention descriptions: intervention 1: Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks. intervention 2: Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks. intervention 3: Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks. intervention 4: Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.

Protocol documents:
Clinical trial NCT00600756
Conditions: Schizophrenic Disorders
Keywords: schizophrenia SWNK
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2009-10-01
Enrollment: 798 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Quetiapine XR intervention 2: Risperidone
Intervention descriptions: intervention 1: Oral, once daily, tablets of 400 mg to 800 mg intervention 2: Oral, once daily, tablets of 2 mg to 6 mg

Protocol documents:
Clinical trial NCT00601367
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2008-01-01; Completion date: 2009-10-01
Enrollment: 480 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

Detailed description:

Arms: arm 1: Initial dosage:

Patients were to take one 50 mg flibanserin tablet in the evening.

Subsequent dosage titrations:

Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.

Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.

Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.
Interventions: intervention 1: flibanserin flexible dose
Intervention descriptions: intervention 1: Initial dosage:

Patients were to take one 50 mg flibanserin tablet in the evening.

Subsequent dosage titrations:

Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.

Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.

Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.

Protocol documents:
Clinical trial NCT00607789
Conditions: Binge Eating Depression
Sponsor: University of Cincinnati
Start date: 2006-10-01; Completion date: 2009-10-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to test the safety of duloxetine and see what effects (good and bad) it has on the subject's binge eating disorder and comorbid depressive disorder (depression occurring with binge eating disorder) compared to placebo (inactive pill).

Detailed description:
This is a 12-week, double blind, randomized, placebo-controlled, parallel-group, flexible-dose study of duloxetine 60-120 mg/day in patients with BED and comorbid depressive disorders. Patients will be randomly assigned to either duloxetine 30 mg capsules or matching placebo at the baseline visit. The initial dose of study medication will be one 30 mg duloxetine capsule/day or placebo with a planned increase to 60 mg/day (2 X 30 mg) or matching placebo at the end of week 1. Further dose increases of 30 mg up to 120 mg/day will be allowed after the end of week two based on the investigators' assessment of efficacy and tolerability. Dosing will be either once per day or twice a day depending on tolerability. Patient visits will occur at screening and baseline and at the end of weeks 1, 2, 4, 6, 8, 10, and 12. Study drug will be tapered by 30 mg every 3 days at the end of the study.

Arms: arm 1: Start with 30 mg duloxetine hydrochloride capsule/day to be increased up to 120 mg per day. arm 2: Sugar pill with matching dosage as Duloxetine
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg/day - 120 mg/day intervention 2: identical to study drug

Protocol documents:
Clinical trial NCT00611026
Conditions: Overactive Bladder
Keywords: Treatment of overactive bladder
Sponsor: Pfizer
Start date: 2008-02-01; Completion date: 2009-10-01
Enrollment: 2417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tolterodine ER intervention 2: Placebo intervention 3: Fesoterodine
Intervention descriptions: intervention 1: The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks. intervention 2: Placebo treatment will be once daily(QD) for 12 weeks. intervention 3: The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

Protocol documents:
Clinical trial NCT00615199
Conditions: Crohn's Disease
Sponsor: Pfizer
Start date: 2008-01-01; Completion date: 2009-10-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo
Intervention descriptions: intervention 1: administration via oral route twice daily intervention 2: administration via oral route twice daily intervention 3: administration via oral route twice daily intervention 4: administration via oral route twice daily

Protocol documents:
Clinical trial NCT00618774
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2008-01-01; Completion date: 2009-10-01
Enrollment: 259 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

Detailed description:

Interventions: intervention 1: telmisartan40/amlodipine5 intervention 2: telmisartan80/amlodipine5
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00621192
Conditions: Necrotizing Enterocolitis Intra-abdominal Infection
Keywords: meropenem infants intra-abdominal infection pharmacokinetics safety
Sponsor: The Emmes Company, LLC
Start date: 2008-06-01; Completion date: 2009-10-01
Enrollment: 200 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these young babies.

Detailed description:
This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics (PK-PD) of meropenem in infants \<91 days of age with suspected and complicated intra-abdominal infections.

The specific aims of this trial are:

1. To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections.
2. To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections.
3. To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.

Arms: arm 1: These

Participants were subdivided into the following four groups based on Gestational Age (GA) and Postnatal Age (PNA):

Group 1: GA at birth below 32 weeks - PNA \<2 weeks; Group 2: GA at birth below 32 weeks - PNA ≥2 weeks and \<91 days; Group 3: GA at birth 32 weeks or older - PNA \<2 weeks; Group 4: GA at birth 32 weeks or older - PNA ≥2 weeks and \<91 days.
Interventions: intervention 1: meropenem
Intervention descriptions: intervention 1: Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant.

20 mg/kg every 12 hours in infants \<32 weeks GA and PNA \< 2 weeks 20 mg/kg every 8 hours in infants \<32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA \< 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks

Protocol documents:
Clinical trial NCT00621855
Conditions: Coronary Disease
Sponsor: Boehringer Ingelheim
Start date: 2008-03-01; Completion date: 2009-10-01
Enrollment: 1878 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.

Detailed description:

Arms: arm 1: twice daily dosing, arm 2: twice daily dosing, patients with moderate renal impairment allocated 50mg bid arm 3: twice daily dosing, patients with moderate renal impairment allocated 75mg bid arm 4: twice daily dosing, patients with moderate renal impairment allocated 110mg bid arm 5: matched placebo
Interventions: intervention 1: placebo intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate intervention 4: dabigatran etexilate intervention 5: dabigatran etexilate
Intervention descriptions: intervention 1: matched placebo intervention 2: capsules, twice daily, 26 weeks treatment intervention 3: capsules, twice daily, 26 weeks treatment intervention 4: capsules, twice daily, 26 weeks treatment intervention 5: capsules, twice daily, 26 weeks treatment

Protocol documents:
Clinical trial NCT00625443
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: Idiopathic Thrombocytopenic Purpura ITP Chronic Idiopathic Thrombocytopenic Purpura
Sponsor: Eisai Inc.
Start date: 2007-05-01; Completion date: 2009-10-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).

Detailed description:
Participants eligible to enroll into this rollover protocol will begin study treatment within 2-5 days of their Day 28 study termination visit in Protocol 501-CL-003 (NCT00441090). Participants who met the primary efficacy response criterion in Protocol 501-CL-003 will continue receiving the same study treatment to which they were assigned in the previous protocol in a double-blinded manner, these being one of the following 5 treatments:

* avatrombopag 2.5 mg daily
* avatrombopag 5 mg daily
* avatrombopag 10 mg daily
* avatrombopag 20 mg daily
* placebo

Participants who did not meet the primary efficacy response criterion in Protocol 501-CL-003 who otherwise meet the eligibility criteria for this rollover protocol will be offered open label avatrombopag 10 mg daily.

This is a parallel group, rollover study.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Blinded (placebo) intervention 2: Open Label (Avatrombopag tablets) intervention 3: Blinded (Avatrombopoag tablets)
Intervention descriptions: intervention 1: Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months intervention 2: Dose 10 mg

Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months intervention 3: Dose: 2.5, 5, 10, or 20 mg

Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months

Protocol documents: