ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01472939
Conditions: Gastroesophageal Reflux Disease
Sponsor: Shire
Start date: 2012-02-27; Completion date: 2013-05-14
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent symptoms while on PPI therapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SSP-002358 (0.1 mg) + PPI intervention 2: SSP-002358 (0.5 mg) + PPI intervention 3: SSP-002358 (2.0 mg) + PPI intervention 4: Placebo + PPI
Intervention descriptions: intervention 1: 0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI intervention 2: 0.5 mg tablet t.i.d. taken in addition to a PPI intervention 3: 2.0 mg tablet t.i.d. taken in addition to a PPI intervention 4: Placebo t.i.d. taken in addition to a PPI

Protocol documents:
Clinical trial NCT01081132
Conditions: Attention-Deficit/Hyperactivity Disorder
Sponsor: Shire
Start date: 2011-09-19; Completion date: 2013-05-16
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the ADHD-RS-IV

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Extended-release Guanfacine Hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on weight. intervention 2: Matching placebo will be provided as 1,2,3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on weight.

Protocol documents:
Clinical trial NCT00712322
Conditions: Neurogenic Detrusor Overactivity
Keywords: Pediatric, Children, Urodynamics, Oral Suspension, Overactive bladder, Dose-finding, Neurogenic Detrusor Overactivity, Meningomyelocele, Spinal cord injury
Sponsor: Warner Chilcott
Start date: 2008-10-07; Completion date: 2013-05-23
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.

Detailed description:

Arms: arm 1: Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 milligrams/kilogram/day (mg/kg/day) dispensed per twice a day (BID) dosing, for 14 days. arm 2: Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. arm 3: Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.
Interventions: intervention 1: Darifenacin
Intervention descriptions: intervention 1: Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.

Protocol documents:
Clinical trial NCT01602562
Conditions: Herpes Simplex
Keywords: Herpes simplex infection valaciclovir herpes simplex virus hematopoietic stem cell transplantation
Sponsor: GlaxoSmithKline
Start date: 2012-05-07; Completion date: 2013-05-24
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety of valaciclovir (VACV) in the adult and pediatric HSCT patients.

Detailed description:
This clinical study is a multicenter open-label study on the adult and pediatric hematopoietic stem cell transplantation (HSCT) patients. The primary objective is to confirm the preventive efficacy for herpes simplex virus (HSV) infection of 256U87 (VACV: valaciclovir) due to the treatment before or immediately after hematopoietic stem cell transplantation. The secondary objective is to confirm the safety of VACV in the case of its use for such a purpose.

This clinical study consists of the following two periods: the screening period lasting 7 days at the longest and the administration period from 7 days before HSCT to 35 days after HSCT (43 days in total). During the administration period, adult patients are orally given a VACV tablet twice daily, while pediatric patients are orally given VACV granules twice daily at a dose of 25 mg/kg b.w. (maximum dose per treatment: 500 mg). Pediatric patients weighing 40 kg or over may be orally given a VACV tablet twice daily.

Arms: arm 1: Adult patients (16-65 years): A VACV tablet (containing 500mg of valaciclovir) is orally given twice daily. Pediatric patients (1-16 years): VACV granules are orally given at a dose of 25 mg/kg b.w. twice daily. The maximum dose per treatment is limited to 500 mg. Pediatric patients weighing 40 kg or over may be orally given a VACV tablet (containing 500 mg of valaciclovir) twice daily.
Interventions: intervention 1: VACV tablets (Adults or pediatrics) or granules (pediatrics)
Intervention descriptions: intervention 1: A white to slightly yellowish white film coated tablet contains 556 mg of valaciclovir hydrochloride (500 mg of valaciclovir)). VACV granules have no or slightly specific odor.

Protocol documents:
Clinical trial NCT00503425
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2005-06-30; Completion date: 2013-05-26
Enrollment: 215 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the safety and efficacy of MabThera in participants with active rheumatoid arthritis who have had an inadequate response to prior treatment with DMARDs and/or anti-TNF alpha agent. Participants will be treated with MabThera 1000 milligrams (mg) intravenously (IV) on days 1 and 15. Participants were followed every 8 weeks to complete 24 weeks of follow-up. After completion of the Week 24 visit, the participants were followed every 3 months for up to 18 months for an overall study duration of 24 months (104 weeks). After week 36, eligible participants who achieve moderate or good response according to the European League Against Rheumatism (EULAR) response criteria will receive re-treatment with MabThera. Participants will receive concomitant treatment with DMARDs, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics throughout the study period. The anticipated time on study treatment is 2 years, and the target sample size is 200 participants.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 1000 mg IV on days 1 and 15

Protocol documents:
Clinical trial NCT00943761
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-10-23; Completion date: 2013-05-29
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).

Detailed description:

Arms: arm 1: Participants received vaniprevir 300 mg twice daily (b.i.d.) in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily. arm 2: Participants received vaniprevir 600 mg b.i.d. in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.
Interventions: intervention 1: Vaniprevir 600 mg b.i.d. intervention 2: Vaniprevir 300 mg b.i.d. intervention 3: Pegylated interferon intervention 4: Ribavirin
Intervention descriptions: intervention 1: Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks intervention 2: Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks intervention 3: Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks intervention 4: Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (\<75 kg or ≥75 kg, respectively), for 48 weeks

Protocol documents:
Clinical trial NCT01702298
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-12-07; Completion date: 2013-05-29
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the safety and tolerability of sitagliptin 100 mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus with inadequate glycemic control on metformin.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants will continue pre-study dose of metformin \>=1000 mg per day.
Interventions: intervention 1: Sitagliptin 100 mg/simvastatin 40 mg FDC intervention 2: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks intervention 2: Participants will continue pre-study dose of metformin tablet(s) \>=1000 per day

Protocol documents:
Clinical trial NCT01824446
Conditions: Healthy
Sponsor: Shire
Start date: 2013-05-01; Completion date: 2013-05-29
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Radiolabeled SPD602 (FBS0701, SSP-004184)
Intervention descriptions: intervention 1: A single oral dose of 3g of radio-labelled SSP-004184 on Day 1

Protocol documents:
Clinical trial NCT00456846
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer, ABI-007, Abraxane
Sponsor: Celgene
Start date: 2008-02-01; Completion date: 2013-05-31
Enrollment: 123 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m\^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.

Detailed description:
This is an open-label, phase II study to determine the toxicity and antitumor activity of ABI-007 100 mg/m2 administered weekly for 3 weeks followed by a rest week (4-week cycle) as first line therapy to patients with metastatic breast cancer in the following 2 cohorts: Patients who have received a taxane as part of their adjuvant therapy, and patients who did not receive a taxane as part of their adjuvant therapy. Patients will be assessed for antitumor response every 8 weeks.

The last subject received study treatment 11DEC2012. The study was terminated on 31 May 2013 via a notification letter to all investigators on 14 May 2013.

Arms: arm 1: 100 mg/m\^2 ABI-007 was administered by intravenous (IV) infusion over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
Interventions: intervention 1: ABI-007
Intervention descriptions: intervention 1: 100 mg/m\^2 ABI-007 weekly for 3 weeks followed by 1 week rest

Protocol documents:
Clinical trial NCT01102140
Conditions: Cardiomyopathy Heart Failure
Keywords: Cardiomyopathy Heart Failure
Sponsor: Jennifer Cowger , MD, MS
Start date: 2010-07-01; Completion date: 2013-05-31
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This blinded, controlled study will examine the impact of pomegranate polyphenol extract (POMx, from Pom Wonderful, LLC), 1000mg on cardiomyopathy in subjects with chronic renal insufficiency.

Detailed description:
Heart failure (HF) is a disease of great prevalence in the U.S. with an associated high morbidity and mortality. In individuals with concomitant chronic renal insufficiency (CRI), outcomes are even worse due to pharmaceutical under treatment and higher baseline levels of oxidative stress. Reactive oxygen species (ROS) are generated during mechanoenergetic uncoupling and can cause myocardial protein, lipid, and DNA damage, leading to the development of HF. One means of preventing the progression of HF may be through ROS reduction or an improvement in systemic or local oxidative stress handling. In this randomized, single blind placebo-controlled pilot study, we hypothesize that 12 weeks of treatment with oral pomegranate extract (POMx) will lead to a reduction in oxidative stress (as assessed by measuring thiobarbituric acid-reactive substances, F8-isoprostanes, and glutathione) in subjects (n=30) with cardiomyopathy (LVEF ≤40%) and CRI (GFR \<60 ml/hr). Secondary aims include assessing the impact of POMx on myocardial remodeling and endothelial dysfunction by measuring serum collagen levels and asymmetric dimethylarginine, respectively. Findings from this study will serve as pilot data for a larger randomized trial of longer term POMx therapy in subjects with cardiomyopathy.

Arms: arm 1: 15 subjects will received 1000 mg of oral POMx for 12 weeks. arm 2: 15 subjects will receive a matching sugar pill for 12 weeks.
Interventions: intervention 1: POMx, pomegranate polyphenol extract intervention 2: Sugar Pill
Intervention descriptions: intervention 1: 1000 mg orally once daily. intervention 2: Matching sugar pill

Protocol documents:
Clinical trial NCT01376804
Conditions: Kidney Transplantation, Cytomegalovirus Infections
Sponsor: Hoffmann-La Roche
Start date: 2011-07-31; Completion date: 2013-05-31
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.

Detailed description:

Arms: arm 1: Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm \[7 \* Body Surface Area \* Creatinine Clearance\].
Interventions: intervention 1: valganciclovir [Valcyte]
Intervention descriptions: intervention 1: Oral, daily for up to 200 days.

Protocol documents:
Clinical trial NCT00123487
Conditions: Myeloid Leukemia, Chronic, Accelerated Phase Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Keywords: Accelerated Phase Chronic Myeloid Leukemia Lymphoid Blast Phase Chronic Myeloid Leukemia Myeloid Blast Phase Chronic Myeloid Leukemia Philadelphia Positive Acute Lymphoblastic Leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2005-06-01; Completion date: 2013-06-01
Enrollment: 638 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

Detailed description:

Arms: arm 1: 70 mg dasatinib twice a day (BID) arm 2: 140 mg dasatinib once a day (QD)
Interventions: intervention 1: dasatinib intervention 2: dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 70 mg BID, indefinitely, survival study intervention 2: Tablets, Oral, 140 mg QD, indefinitely, survival study

Protocol documents:
Clinical trial NCT00402168
Conditions: Renal Transplant
Sponsor: Bristol-Myers Squibb
Start date: 2007-01-01; Completion date: 2013-06-01
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Belatacept intervention 2: Cyclosporine A intervention 3: Tacrolimus
Intervention descriptions: intervention 1: IV, IV Infusion, 5 mg/kg once every 28 days for one year intervention 2: Tablets, Oral, Trough of 100-250 ng/mL, 2\* daily for one year intervention 3: Tablets, Oral, Trough of 5-10 ng/mL, 2\* daily for one year

Protocol documents:
Clinical trial NCT00425555
Conditions: Cutaneous T-Cell Lymphoma
Keywords: Cutaneous T-Cell Lymphoma, adults Mycosis Fungoides Sézary Syndrome CTCL
Sponsor: Novartis Pharmaceuticals
Start date: 2007-01-01; Completion date: 2013-06-01
Enrollment: 139 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.

Detailed description:

Arms: arm 1: Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). arm 2: Participants received Panobinostat 20 milligrams per day (mg/day) capsule orally, once a day (OD) on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5).
Interventions: intervention 1: Panobinostat
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00528112
Conditions: Contraception
Keywords: Contraception Intrauterine IUD IUS
Sponsor: Bayer
Start date: 2007-08-01; Completion date: 2013-06-01
Enrollment: 2885 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

Detailed description:
Drop out-rate will be covered in Participant flow section.

Arms: arm 1: Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro arm 2: Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Interventions: intervention 1: LCS12 intervention 2: LCS16
Intervention descriptions: intervention 1: Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h intervention 2: Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h

Protocol documents:
Clinical trial NCT00968708
Conditions: Diabetes Mellitus, Type 2 Acute Coronary Syndrome
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus cardiovascular outcomes heart attack stroke dipeptidyl-peptidase IV inhibitors metabolic disorders metabolic diseases glucose metabolism disorders
Sponsor: Takeda
Start date: 2009-09-01; Completion date: 2013-06-01
Enrollment: 5380 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

Detailed description:
Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by Takeda for use in patients with type 2 diabetes mellitus.

Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus patients who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome.

This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in adults with type 2 diabetes mellitus and acute coronary syndrome.

Arms: arm 1: Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines. arm 2: Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and \<60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR \<30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Interventions: intervention 1: Alogliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Alogliptin tablets intervention 2: Alogliptin placebo matching tablets

Protocol documents:
Clinical trial NCT01030783
Conditions: Advanced Renal Cell Carcinoma
Sponsor: AVEO Pharmaceuticals, Inc.
Start date: 2009-12-01; Completion date: 2013-06-01
Enrollment: 517 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.

Detailed description:
This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.

Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib and stratified by geographic region (North America/Western Europe, Central/Eastern Europe, or rest of the world); number of prior treatments (0 or 1); and number of metastatic sites/organs involved (1 or ≥ 2).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tivozanib (AV-951) intervention 2: Sorafenib
Intervention descriptions: intervention 1: Tivozanib: 1.5 mg orally once daily. Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. intervention 2: Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.

Protocol documents: