ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01023958
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2009-11-19; Completion date: 2011-09-19
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.

Detailed description:

Arms: arm 1: open label
Interventions: intervention 1: BI 6727, IV infusion
Intervention descriptions: intervention 1: phase II

Protocol documents:
Clinical trial NCT00502840
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2007-07-23; Completion date: 2011-09-20
Enrollment: 193 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 \>2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 1g iv on days 1 and 15

Protocol documents:
Clinical trial NCT01340768
Conditions: Type 2 Diabetes Mellitus
Keywords: Glucose metabolism disorders Metabolic diseases Peptidase inhibitors
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-06-22; Completion date: 2011-09-21
Enrollment: 870 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.

Detailed description:
This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Arms: arm 1: Sitagliptin 100mg taken orally once daily with or without metformin arm 2: Usual sulfonylurea therapy with or without metformin
Interventions: intervention 1: Sitagliptin intervention 2: Sulfonylurea intervention 3: Metformin
Intervention descriptions: intervention 1: One 100 mg tablet taken orally once daily intervention 2: Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide. intervention 3: Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.

Protocol documents:
Clinical trial NCT00686725
Conditions: Glioblastoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-06-24; Completion date: 2011-09-28
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.

Detailed description:

Arms: arm 1: Standard therapy regimen:

Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m\^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m\^2/day, and may be increased to 200 mg/m\^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.

Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks. arm 2: Early postsurgery temozolomide chemotherapy plus standard regimen:

Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m\^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).

Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
Interventions: intervention 1: Temozolomide intervention 2: Radiotherapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00732615
Conditions: Hypoparathyroidism
Keywords: Hypoparathyroidism
Sponsor: Shire
Start date: 2008-12-18; Completion date: 2011-09-28
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.

Detailed description:
Patients with a history of hypoparathyroidism will be randomized to receive placebo or study drug for 24 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically, calcium levels in the blood and urine). In addition, the patients' intake of Vitamin D and calcium will be measured.

Arms: arm 1: Sterile water for injection arm 2: Initial dose of 50mcg, to be titrated up to 75mcg and then 100mcg dependent upon response
Interventions: intervention 1: Placebo intervention 2: NPSP558
Intervention descriptions: intervention 1: Placebo for subcutaneous injection intervention 2: Parathyroid hormone 50, 75, or 100 mcg injectable subcutaneously daily

Protocol documents:
Clinical trial NCT01415349
Conditions: Healthy
Sponsor: Shire
Start date: 2011-08-11; Completion date: 2011-09-28
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.

Detailed description:

Arms: arm 1: None arm 2: SSP-002358 + omeprazole
Interventions: intervention 1: SSP-002358 intervention 2: SSP-002358 + omeprazole
Intervention descriptions: intervention 1: 1 mg, oral, once intervention 2: SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once

Protocol documents:
Clinical trial NCT00868166
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis TRO19622 Trophos
Sponsor: Hoffmann-La Roche
Start date: 2009-04-30; Completion date: 2011-09-30
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month survival rate.

Detailed description:
A stand alone treatment with TRO19622 is not acceptable for ethical reasons. Riluzole is an approved and widely used ALS treatment in the European community, in Japan and in the USA.

Therefore, in this study, TRO19622 will be assessed as add-on to riluzole in patients suffering from ALS.

At the start of the study, patients will be randomized to one of two groups : TRO19622 (330 mg QD or placebo (once a day).

Each treatment will be administered for 18 months under double-blind conditions. The product under evaluation will be administered to patients receiving the standard of care for ALS, including riluzole.

Riluzole dosage (50 mg bid) must be stable and well tolerated for at least one month prior to inclusion into the study.

After the double-blind period, open-label administration of TRO19622 will be allowed for safety and survival assessments and until efficacy results are available.

A separate open-label protocol will be written 6 months after the randomization of the last patient into the study.

Arms: arm 1: 2 Capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid arm 2: 2 Capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid
Interventions: intervention 1: Olesoxime intervention 2: Placebo Comparator intervention 3: Riluzole
Intervention descriptions: intervention 1: 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid intervention 2: 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid intervention 3: Riluzole given as add-on therapy 50mg bid

Protocol documents:
Clinical trial NCT00965757
Conditions: Rheumatoid Arthritis
Sponsor: Eisai Co., Ltd.
Start date: 2009-07-31; Completion date: 2011-09-30
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: T-614 intervention 2: Placebo
Intervention descriptions: intervention 1: T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks. intervention 2: Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.

Protocol documents:
Clinical trial NCT01016262
Conditions: Proctitis, Ulcerative
Keywords: Ulcerative proctitis Proctocolitis Inflammatory Bowel Disease Gastrointestinal Diseases Colonic Diseases Mesalamine 5-ASA
Sponsor: Forest Laboratories
Start date: 2009-11-30; Completion date: 2011-09-30
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).

Detailed description:
The present study consists of screening period (2 weeks before randomization), DB phase (6 weeks), OL phase (8 weeks) and follow-up visits at Week 3, Week 6 and Week 14. Participants who are eligible will be randomized to receive 1g MAX-002, 1g Canasa® and placebo suppository once daily in the DB phase. Participants who complete or discontinue the study at Week 6 will either receive 1g MAX-002 suppositories on a voluntary basis, standard care treatment as per investigator's discretion or no treatment during the next 8 weeks of the OL phase. Total duration of treatment will be of 14 weeks. Efficacy will primarily be evaluated by percentage of participants who show response as per Mayo DAI Score at Week 6. Participants' safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MAX-002 intervention 2: Placebo intervention 3: Canasa®
Intervention descriptions: intervention 1: MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the open-label (OL) phase. intervention 2: Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase. intervention 3: Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.

Protocol documents:
Clinical trial NCT01066000
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2009-10-31; Completion date: 2011-09-30
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly

Protocol documents:
Clinical trial NCT01170221
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Keywords: ABSSSI Tedizolid Phosphate TR-701 Acute Bacterial Skin and Skin Structure Infections
Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2010-08-15; Completion date: 2011-09-30
Enrollment: 667 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults.

Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment

Detailed description:
The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.

Arms: arm 1: TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo arm 2: Linezolid 600 mg tablets oral twice a day for 10 days
Interventions: intervention 1: TR-701 FA intervention 2: Linezolid
Intervention descriptions: intervention 1: Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo. intervention 2: Oral Linezolid 600 mg twice daily for 10 days

Protocol documents:
Clinical trial NCT00372528
Conditions: Epilepsy
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-03-01; Completion date: 2011-10-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.

Detailed description:

Arms: arm 1: open label treatment
Interventions: intervention 1: pregabalin (LYRICA)
Intervention descriptions: intervention 1: 150 mg up to a maximum of 600 mg per day bid or tid as required

Protocol documents:
Clinical trial NCT00501046
Conditions: Chronic Kidney Disease
Keywords: Kidney Diseases
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2007-07-01; Completion date: 2011-10-01
Enrollment: 1015 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1\) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function and quality of life.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: AST-120
Intervention descriptions: intervention 1: 9g /day (3 times a day) intervention 2: 9g /day (3 times a day)

Protocol documents:
Clinical trial NCT00524368
Conditions: Human Immunodeficiency Virus - Type 1
Keywords: Human immunodeficiency virus - type 1 HIV-1 Infection TMC-114 Darunavir Ritonavir
Sponsor: Tibotec Pharmaceuticals, Ireland
Start date: 2007-10-01; Completion date: 2011-10-01
Enrollment: 590 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).

Detailed description:
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention) study in which 590 patients will be randomly assigned to receive either DRV/rtv 800/100 mg daily or DRV/rtv 600/100 mg twice daily along with the selected OBR. An OBR will consist of at least 2 nucleoside reverse transcriptase inhibitors (NRTIs) selected by the investigator. The study will include a 4 week screening period, 48-weeks of treatment period and 4-weeks of follow-up. The study will also consists of extension phase after Week 48: in regions where DRV is not yet commercially available or reimbursed by the health care system, patients who complete the 48 weeks of treatment with DRV/rtv and who continue to benefit from this treatment, will have the opportunity to continue DRV treatment as a 600 mg twice daily dosage until DRV is reimbursed and available via the public and/or private health care system or until its development is discontinued. Safety evaluation will consists of adverse events (including specific toxicities), clinical laboratory tests, vital signs, electrocardiogram, physical and skin examination.

Arms: arm 1: Two 400 mg darunavir (DRV) ie, TMC114 tablets + one 100 mg ritonavir (rtv) capsule once daily. arm 2: One 600 mg TMC114 tablet + one 100 mg capsule of rtv twice daily.
Interventions: intervention 1: Darunavir (DRV) intervention 2: Ritonavir (rtv)
Intervention descriptions: intervention 1: DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily. intervention 2: DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.

Protocol documents:
Clinical trial NCT00532155
Conditions: Carcinoma Non Small Cell Lung
Keywords: lung cancer angiogenesis inhibitor chemotherapy
Sponsor: Sanofi
Start date: 2007-09-01; Completion date: 2011-10-01
Enrollment: 913 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

Detailed description:
The study included:

* A screening visit of up to 21 days prior to randomization
* Randomization at baseline (Treatment was initiated with 3 days of randomization)
* A treatment period with 3-week treatment cycles until the participant met the following discontinuation criteria: had progressive disease, had unacceptable toxicity, or refused further study treatment
* A post study treatment follow-up period (a visit was scheduled every 8 weeks until death or end of study)

Arms: arm 1: Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal. arm 2: Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
Interventions: intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) intervention 2: Placebo intervention 3: Docetaxel (Taxotere®) intervention 4: Dexamethasone (pre- and post-medication for docetaxel)
Intervention descriptions: intervention 1: 6 mg/kg Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks. intervention 2: Matching placebo to Aflibercept administered intravenously (IV) over 1 hour once on Day 1, every 3 weeks. intervention 3: 75 mg/m² docetaxel in 250 mL dextrose 5% or NaCl 0.9% administered intravenously (IV) over 1 hour, on Day 1 every 3 weeks. intervention 4: As a pre- and post-medication for docetaxel, 8 mg dexamethasone was administered orally, the evening before Day 1, on Day 1 (early morning, 1 hour before docetaxel treatment, and evening) and on Day 2 (morning and evening).

Protocol documents: