ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00812461
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: 2011-04-01
Enrollment: 678 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of 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 efficacy and safety of as needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 24 weeks in adult 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, 6 months intervention 2: 18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Protocol documents:
Clinical trial NCT01044459
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2009-11-01; Completion date: 2011-04-01
Enrollment: 605 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.

Detailed description:

Arms: arm 1: aclidinium bromide, inhaled, 52 weeks of treatment arm 2: aclidinium bromide, inhaled, 52 weeks of treatment
Interventions: intervention 1: Aclidinium Bromide 200 µg intervention 2: Aclidinium Bromide 400 µg
Intervention descriptions: intervention 1: aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment intervention 2: aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Protocol documents:
Clinical trial NCT01179191
Conditions: Chronic Disease Pain
Keywords: chronic pain Embeda opioid moderate pain severe pain conversion converting switching morphine aberrant behavior Pain (DT) + Chronic Disease (DT)
Sponsor: Pfizer
Start date: 2010-08-01; Completion date: 2011-04-01
Enrollment: 684 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.

Detailed description:
The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.

Arms: arm 1: None
Interventions: intervention 1: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Intervention descriptions: intervention 1: Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.

Protocol documents:
Clinical trial NCT01438424
Conditions: Hepatitis B Virus HBV
Sponsor: Bristol-Myers Squibb
Start date: 2001-01-01; Completion date: 2011-04-01
Enrollment: 1053 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Entecavir intervention 2: Lamivudine
Intervention descriptions: intervention 1: Tablets, Oral, 1.0 mg, once daily intervention 2: Oral, 100 mg, daily

Protocol documents:
Clinical trial NCT00049543
Conditions: Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Squamous Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2002-09-01; Completion date: 2011-04-01
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase III trial studies how well gefitinib works in treating patients with stage IB, II, or IIIA non-small cell lung cancer that was completely removed by surgery. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if gefitinib may be an effective treatment in preventing tumors from returning after they have been removed by surgery.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess, in comparison with placebo, the impact of adjuvant therapy with two years of daily oral ZD1839 (IRESSA) (gefitinib) on the overall survival of patients with completely resected (T1N1-2, T2N0-2, T3N0-2) non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To compare the disease-free survival in the placebo arm to the ZD1839 (IRESSA) arm.

II. To confirm the prognostic significance of epidermal growth factor receptor (EGFR) expression, phosphorylation and mutations when present in the primary tumor.

III. To assess the ability of EGFR expression, phosphorylation and mutations in the primary tumor to predict the relative impact of ZD1839 (IRESSA) on survival.

IV. To establish a comprehensive tumour bank linked to a clinical database for the further study of molecular markers in resected NSCLC.

V. To further evaluate toxicity related to ZD1839 (IRESSA).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive gefitinib orally (PO) once daily (QD) for 2 years in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 6 months, every 6 months for 3 years, and then annually thereafter.

Arms: arm 1: Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: gefitinib intervention 2: placebo intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00051636
Conditions: Paget's Disease of Bone
Keywords: Bisphosphonate SAP SAP excess non-inferiority therapeutic response extended observation period
Sponsor: Novartis Pharmaceuticals
Start date: 2001-01-01; Completion date: 2011-04-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.

Detailed description:

Arms: arm 1: Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. arm 2: Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Interventions: intervention 1: Zoledronic Acid intervention 2: Risedronate intervention 3: Placebo to Risedronate intervention 4: Placebo to Zoledronic Acid intervention 5: Calcium and Vitamin D
Intervention descriptions: intervention 1: Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion. intervention 2: Oral risedronate 30 mg capsules. intervention 3: Oral placebo of risedronate capsules. intervention 4: 5 mL of sterile water one dose intravenous infusion. intervention 5: Calcium and vitamin D supplements were supplied.

Protocol documents:
Clinical trial NCT00093782
Conditions: Metastatic Gastrointestinal Carcinoid Tumor Pulmonary Carcinoid Tumor Recurrent Gastrointestinal Carcinoid Tumor Recurrent Islet Cell Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2003-12-01; Completion date: 2011-04-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description:
OBJECTIVES:

I. To assess the objective tumor response rate (i.e. partial or complete responses as defined by the RECIST criteria) in patients with progressive metastatic neuroendocrine tumours given CCI-779.

II. To assess the stable disease rate and duration, time to progression, median survival time, 1-year survival rate and toxicity in patients with metastatic neuroendocrine carcinomas given CCI-779. As of 19 July 2010, overall survival follow-up is to be discontinued for the four remaining patients on long term follow-up. At that point in time, these patients had been off-treatment for 3 to 5 years. Time to progression and median survival times will be based on the currently available data.

III. To measure baseline levels of various elements up- and downstream of the mammalian target of rapamycin (mTOR). Where post-treatment biopsies are available, they will be analyzed for suppression of elements in the mTOR pathway as well as for any effect on cell cycle progression, apoptosis or anti-angiogenic effects.

OUTLINE: This is an open-label, multicenter study.

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR.

Patients are followed up for survival.

Arms: arm 1: Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
Interventions: intervention 1: temsirolimus intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00098722
Conditions: HIV Infections
Sponsor: ViiV Healthcare
Start date: 2004-12-01; Completion date: 2011-04-01
Enrollment: 474 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \[OBT (3-6 drugs based on treatment history and resistance testing)\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Maraviroc (UK-427,857) intervention 2: optimized background therapy intervention 3: Maraviroc (UK-427,857) intervention 4: optimized background therapy intervention 5: optimized background therapy
Intervention descriptions: intervention 1: maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. intervention 2: \[OBT (3-6 drugs based on treatment history and resistance testing)\] intervention 3: maraviroc (UK-427,857) 150 mg taken twice daily intervention 4: \[OBT (3-6 drugs based on treatment history and resistance testing)\] intervention 5: \[OBT (3-6 drugs based on treatment history and resistance testing)\]

Protocol documents:
Clinical trial NCT00103740
Conditions: Paget's Disease of Bone
Keywords: Zoledronic acid, risedronate, Paget's disease of bone
Sponsor: Novartis Pharmaceuticals
Start date: 2002-04-01; Completion date: 2011-04-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.

Detailed description:

Arms: arm 1: Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. arm 2: Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Interventions: intervention 1: zoledronic acid intervention 2: placebo to zoledronic acid intervention 3: Risedronate intervention 4: Placebo to risedronate intervention 5: Calcium and vitamin D supplements
Intervention descriptions: intervention 1: 5 mg zoledronic acid in 5 mL of sterile water for infusion intervention 2: 5 mL of sterile water for infusion intervention 3: 30mg oral tablets overencapsulated to match the placebo capsules intervention 4: oral capsules intervention 5: Calcium and vitamin D supplements were supplied

Protocol documents:
Clinical trial NCT00141518
Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Health economics,Quality of life
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2006-03-01; Completion date: 2011-04-01
Enrollment: 77 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study.

Detailed description:

Arms: arm 1: Duodopa-naïve participants titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually. arm 2: Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually. arm 3: Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually.
Interventions: intervention 1: Levodopa-carbidopa intestinal gel (LCIG) intervention 2: CADD-Legacy® 1400 ambulatory infusion pump intervention 3: percutaneous endoscopic gastrostomy tube (PEG tube) intervention 4: jejunal extension tube (J-tube)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00264004
Conditions: Tumors
Keywords: Advanced Solid Tumours phase II Hypertension RECENTIN
Sponsor: AstraZeneca
Start date: 2005-11-01; Completion date: 2011-04-01
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.

Detailed description:

Arms: arm 1: 30 mg AZD2171 arm 2: 45 mg AZD2171
Interventions: intervention 1: AZD2171
Intervention descriptions: intervention 1: 30 mg \& 45 mg oral tablet

Protocol documents:
Clinical trial NCT00325403
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension
Sponsor: United Therapeutics
Start date: 2006-10-01; Completion date: 2011-04-01
Enrollment: 349 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12.

Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Detailed description:

Arms: arm 1: Subjects receive UT-15C (oral treprostinil) twice daily. arm 2: Subjects receive placebo (sugar pill) twice daily.
Interventions: intervention 1: Oral treprostinil (UT-15C) Sustained Release Tablets intervention 2: Placebo
Intervention descriptions: intervention 1: Sustained release oral tablet, twice daily intervention 2: Placebo oral tablet twice daily

Protocol documents:
Clinical trial NCT00333138
Conditions: Multiple Sclerosis
Keywords: FTY720 MS Multiple Sclerosis RRMS
Sponsor: Novartis
Start date: 2003-05-01; Completion date: 2011-04-01
Enrollment: 281 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Detailed description:

Arms: arm 1: Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. arm 2: Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. arm 3: Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
Interventions: intervention 1: FTY720 intervention 2: Placebo
Intervention descriptions: intervention 1: FTY720 capsule was taken orally once a day intervention 2: Placebo 1.25 mg capsule was given once daily

Protocol documents: