ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00972283
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-09-01; Completion date: 2010-10-28
Enrollment: 1006 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe, and the United States of America (USA).

The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone.

Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582.

The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine intervention 3: insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted. intervention 2: Injected subcutanoeusly (under the skin) according to approved label. Dose was individually adjusted. intervention 3: Injected subcutaneously (under the skin) at each main meal. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT00171314
Conditions: Breast Cancer
Keywords: breast cancer letrozole zoledronic acid adjuvant postmenopausal
Sponsor: Novartis Pharmaceuticals
Start date: 2004-03-01; Completion date: 2010-11-01
Enrollment: 527 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

Detailed description:

Arms: arm 1: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1 arm 2: Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score \<= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1
Interventions: intervention 1: Zoledronic acid intervention 2: Letrozole
Intervention descriptions: intervention 1: Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months. intervention 2: Letrozole tablets 2.5 mg/day/taken orally for 5 years.

Protocol documents:
Clinical trial NCT00339183
Conditions: Metastatic Colorectal Cancer
Keywords: Oncology Cancer Metastatic Colorectal Cancer EGFr Panitumumab Clinical Trial Amgen
Sponsor: Amgen
Start date: 2006-06-30; Completion date: 2010-11-01
Enrollment: 1186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.

Detailed description:

Arms: arm 1: Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks. arm 2: Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.
Interventions: intervention 1: Panitumumab intervention 2: FOLFIRI
Intervention descriptions: intervention 1: Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy. intervention 2: FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 racemate (or 200 mg/m\^2 I-leucovorin), 5-FU bolus 400 mg/m\^2, 5-FU infusion 2400 mg/m\^2.

Protocol documents:
Clinical trial NCT00471146
Conditions: Carcinoma, Pancreatic Ductal
Keywords: Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.
Sponsor: Pfizer
Start date: 2007-07-01; Completion date: 2010-11-01
Enrollment: 630 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

Detailed description:
This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AG-013736 intervention 2: Gemcitabine intervention 3: Gemcitabine intervention 4: placebo
Intervention descriptions: intervention 1: oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression. intervention 2: intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression. intervention 3: intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression. intervention 4: placebo

Protocol documents:
Clinical trial NCT00571649
Conditions: Venous Thromboembolism
Keywords: Acute medical illnesses with increased risk for VTE. Deep vein thrombosis (DVT) Pulmonary embolism (PE), Venous Thromboembolic disease (VTE), Medical illness
Sponsor: Bayer
Start date: 2007-12-01; Completion date: 2010-11-01
Enrollment: 8101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

Detailed description:
The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Arms: arm 1: Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days arm 2: Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin intervention 3: Rivaroxaban placebo intervention 4: Enoxaparin placebo
Intervention descriptions: intervention 1: Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days intervention 2: Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days intervention 3: Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days intervention 4: Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Protocol documents:
Clinical trial NCT00623103
Conditions: Parkinson's Disease Dementia
Keywords: Parkinson's disease dementia cholinesterase inhibitor rivastigmine
Sponsor: Novartis
Start date: 2008-01-01; Completion date: 2010-11-01
Enrollment: 583 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

Detailed description:

Arms: arm 1: Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally). The 12 mg/day dose or the highest dose tolerated was maintained until week 76. arm 2: Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\^2 patch or the highest well tolerated dose was maintained until week 76.
Interventions: intervention 1: Rivastigmine capsule intervention 2: Rivastigmine transdermal patch
Intervention descriptions: intervention 1: Rivastigmine capsules orally twice a day. Target dose 12 mg/day. intervention 2: Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period.

Protocol documents:
Clinical trial NCT00707031
Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia, GLP-1, metformin
Sponsor: Sanofi
Start date: 2008-06-01; Completion date: 2010-11-01
Enrollment: 639 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide in comparison to exenatide (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life \[PAGI-QOL\]).

Detailed description:
Patients who complete the 24-week main open-label treatment would undergo a variable open-label extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 24) for the last randomized patient.

Arms: arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 1-step initiation regimen of exenatide: 5 mcg twice daily (BID) for 4 weeks, followed by 10 mcg BID up to the end of treatment.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Pen auto-injector intervention 3: Exenatide intervention 4: Prefilled pen injector intervention 5: Metformin
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: None intervention 3: Self administered by subcutaneous injections twice daily within the hour preceding breakfast and within the hour preceding dinner. intervention 4: None intervention 5: Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Protocol documents:
Clinical trial NCT00811941
Conditions: Alcohol Dependence
Keywords: Pharmacologic Actions Alcohol-Related Disorders Alcoholism Mental Disorders Central Nervous System Agents
Sponsor: H. Lundbeck A/S
Start date: 2009-03-01; Completion date: 2010-11-01
Enrollment: 665 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.

Detailed description:
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the long-term safety and tolerability as well as to evaluate the efficacy of as needed use of 18.06 mg nalmefene in patients with alcohol dependence.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Nalmefene
Intervention descriptions: intervention 1: as-needed use, tablets, orally, 52 weeks intervention 2: 18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Protocol documents:
Clinical trial NCT01067105
Conditions: Perennial Allergic Rhinitis
Keywords: Perennial allergic rhinitis allergic rhinitis ciclesonide
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2010-02-01; Completion date: 2010-11-01
Enrollment: 824 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.

Detailed description:
This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: ciclesonide HFA 160 μg once daily
Interventions: intervention 1: ciclesonide HFA 160 μg
Intervention descriptions: intervention 1: ciclesonide HFA 160 μg once daily

Protocol documents:
Clinical trial NCT00052429
Conditions: Head and Neck Cancer
Keywords: stage II lymphoepithelioma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2002-09-01; Completion date: 2010-11-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.

Detailed description:
OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.

Phase I

* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II.

Phase II

* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Arms: arm 1: Phase I

* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Interventions: intervention 1: cisplatin intervention 2: fluorouracil intervention 3: adjuvant therapy intervention 4: radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00118378
Conditions: HIV Infections Fatigue
Keywords: HIV AIDS Modafinil Depression
Sponsor: New York State Psychiatric Institute
Start date: 2004-12-01; Completion date: 2010-11-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.

Detailed description:
Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be caused by ARVs or by the virus itself. This study will determine if modafinil can reduce fatigue in HIV/AIDS patients.

This study will last 12 weeks. Participants will be randomly assigned to receive either modafinil or placebo daily for 4 weeks. Participants who show an improvement in symptoms will receive modafinil for an additional 8 weeks. Participants who do not respond to modafinil will have the opportunity to receive other drug treatments. All participants will have weekly study visits for the first 4 weeks of the study and biweekly visits for the remainder of the study. At each visit, participants will complete various tasks to determine cognitive function and self-report scales will be used to determine symptoms of depression and fatigue.

Arms: arm 1: Participants will take modafinil for 4 weeks. arm 2: Participants will take placebo for 4 weeks.
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg per day, increasing to 200 mg per day as clinically indicated intervention 2: 50 mg per day, increasing to 200 mg per day as clinically indicated

Protocol documents:
Clinical trial NCT00124748
Conditions: Leukemia, Myeloid, Chronic Phase
Keywords: CML Philadelphia positive Bcr-abl imatinib mesylate Chronic myeloid leukemia (CML) in chronic phase
Sponsor: Novartis Pharmaceuticals
Start date: 2005-06-01; Completion date: 2010-11-01
Enrollment: 476 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.

Detailed description:

Arms: arm 1: Oral dose of 400mg Imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol. arm 2: Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
Interventions: intervention 1: Imatinib mesylate
Intervention descriptions: intervention 1: Imatinib is packaged in bottles as 100mg and 400mg tablets

Protocol documents:
Clinical trial NCT00125034
Conditions: Neoplasm Metastasis Colorectal Cancer
Keywords: FOLFOX-4 Cetuximab First-line mCRC EGFR positive metastatic CRC
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-07-01; Completion date: 2010-11-01
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cetuximab intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops intervention 2: Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops

Protocol documents: