ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00049673
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
Sponsor: NCIC Clinical Trials Group
Start date: 2002-10-15; Completion date: 2013-09-19
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.

Detailed description:
OBJECTIVES:

* Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation.
* Compare progression-free survival of patients treated with these regimens.
* Compare quality of life of patients treated with these regimens.
* Compare toxic effects of these regimens in these patients.
* Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens.

OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo observation.

For both arms, patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for up to 4 years, and then annually thereafter.

After the treatment/observation period, patients are followed annually..

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.

Arms: arm 1: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. arm 2: Patients undergo observation.
Interventions: intervention 1: prednisone intervention 2: thalidomide
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT01718509
Conditions: Binge Eating Disorder
Sponsor: Shire
Start date: 2012-11-26; Completion date: 2013-09-20
Enrollment: 390 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

Detailed description:
Not Required

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Placebo
Intervention descriptions: intervention 1: 50 or 70 mg administered orally, once-daily for up to 12 weeks intervention 2: Administered once-daily, orally, for up to 12 weeks

Protocol documents:
Clinical trial NCT01905540
Conditions: Healthy
Sponsor: Shire
Start date: 2013-08-05; Completion date: 2013-09-20
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.

Detailed description:

Arms: arm 1: 40 mg/kg (oral capsule form) given once on Day 1 arm 2: 21.8 mg/kg (oral capsule form) given once on Day 1 arm 3: 40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1 arm 4: 21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1
Interventions: intervention 1: SSP-004184AQ intervention 2: SSP-004184SS
Intervention descriptions: intervention 1: Magnesium salt intervention 2: Disodium salt

Protocol documents:
Clinical trial NCT01777334
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2013-01-23; Completion date: 2013-09-24
Enrollment: 905 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.

Detailed description:
This is a Phase IIIb multicenter, randomized, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI Inhalation Powder (62.5/25 mcg) when administered once-daily via a novel dry powder inhaler (DPI) compared with tiotropium (18 mcg) administered once-daily via the HandiHaler over a treatment period of 24 weeks in subjects with COPD. Eligible subjects will be randomized 1:1 to UMEC/VI Inhalation Powder (62.5/25 mcg), or tiotropium (18 mcg) for 24 weeks.

There will be a total of 10 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7- to 10-day run-in period followed by a 24-week treatment period. Clinic visits will be at Screening, Randomization (Day 1), Day 2 and after 4, 8, 12, 16, 20 and 24 weeks, and 1 day after the Week 24 visit (Visit 1 to Visit 10, respectively). Additionally a safety Follow-Up assessment will be conducted either by phone call or clinic visit where required approximately 7 days after the end of the study treatment (Visit 10 or Early Withdrawal, if applicable). The total duration of subject participation, including the Follow-Up will be approximately 26 weeks.

Arms: arm 1: Long-acting muscarinic antagonist (LAMA)/Long-acting Beta agonist (LABA) arm 2: Long-acting muscarinic antagonist (LAMA)
Interventions: intervention 1: Umeclidinium/Vilanterol 62.5/25 mcg intervention 2: Tiotropium 18 mcg
Intervention descriptions: intervention 1: Inhalation Powder intervention 2: Inhalation Powder

Protocol documents:
Clinical trial NCT01905553
Conditions: Healthy
Sponsor: Shire
Start date: 2013-08-27; Completion date: 2013-09-24
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to administration under fasted conditions.

Detailed description:

Arms: arm 1: 21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions arm 2: 21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions
Interventions: intervention 1: SSP-004184SS
Intervention descriptions: intervention 1: Disodium salt

Protocol documents:
Clinical trial NCT01718483
Conditions: Binge Eating Disorder
Sponsor: Shire
Start date: 2012-11-26; Completion date: 2013-09-25
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Placebo
Intervention descriptions: intervention 1: 50 or 70 mg administered orally, once-daily for up to 12 weeks intervention 2: Administered once-daily, orally, for up to 12 weeks

Protocol documents:
Clinical trial NCT01324232
Conditions: Central Neuropathic Pain Multiple Sclerosis
Sponsor: Avanir Pharmaceuticals
Start date: 2011-09-08; Completion date: 2013-09-26
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.

Detailed description:
The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 (dextromethorphan \[DM\]/quinidine \[Q\]) capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM and 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of participants with multiple sclerosis (MS) over a 12-week period. The MS participant population enrolled includes participants with relapsing-remitting multiple sclerosis (RRMS) and participants with secondary progressive multiple sclerosis (SPMS).

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: AVP-923-45 intervention 2: AVP-923-30 intervention 3: AVP-923-20 intervention 4: Placebo
Intervention descriptions: intervention 1: AVP-923-45 (dextromethorphan 45 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment. intervention 2: AVP-923-30 (dextromethorphan 30 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment. intervention 3: AVP-923-20 (dextromethorphan 20 mg/quinidine 10 mg) capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment. intervention 4: Matching placebo capsules administered once daily for first 7 days followed by twice daily for 11 weeks of the study to complete 12 weeks of treatment.

Protocol documents:
Clinical trial NCT01749137
Conditions: Overweight
Keywords: Overweight
Sponsor: Rhythm Pharmaceuticals, Inc.
Start date: 2013-01-14; Completion date: 2013-09-28
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of RM-493 on mean percent body weight loss, and other weight loss parameters as well as Pharmacokinetic (PK) profile, and ambulatory blood pressure in obese participants. The study is designed to evaluate the efficacy and tolerability of a single dose of RM-493. The study drug (RM-493 and placebo) will be administered subcutaneously in a blinded fashion.

Detailed description:

Arms: arm 1: Participants received 1 milligram (mg) setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days. arm 2: Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
Interventions: intervention 1: Setmelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: Daily subcutaneous infusion intervention 2: Daily subcutaneous infusion

Protocol documents:
Clinical trial NCT02435381
Conditions: Alcohol Dependence Alcohol Abuse Substance Abuse
Sponsor: Baylor College of Medicine
Start date: 2013-02-01; Completion date: 2013-09-30
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effects of treatment with carisbamate compared to treatment with placebo, on alcohol-induced stimulant and subjective effects in non-treatment seeking alcohol-dependent human volunteers.

Detailed description:
This within-subjects placebo-controlled experimental protocol will assess the effects of carisbamate (600mg qd) on the positive subjective effects of alcohol in non-treatment-seeking alcohol-dependent volunteers. Participants will receive study drug (carisbamate or placebo) from days 2- 4. On day 4, study drug will be followed by alcohol (0.8g/kg; 16% by volume) and a placebo beverage (1% by volume as a mask), both separated by 2 hours. Physiologic, subjective effects and BAL will be obtained after the alcohol challenges. Participants will be discharged on day 4 and asked to return a week later to repeat the study under the alternate study drug condition (active carisbamate vs. placebo).

Arms: arm 1: Participants will receive placebo from days 2- 4. arm 2: Participants will receive carisbamate 600mg qd from days 2- 4.
Interventions: intervention 1: Carisbamate intervention 2: Placebo
Intervention descriptions: intervention 1: 600mg Orally on days 2-4 intervention 2: Placebo treatment only

Protocol documents:
Clinical trial NCT00312208
Conditions: Breast Cancer
Sponsor: Sanofi
Start date: 2001-11-01; Completion date: 2013-10-01
Enrollment: 3299 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective :

* To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes.

Secondary objectives :

* To compare toxicity and quality of life between the 2 above-mentioned arms.
* To evaluate pathologic and molecular markers for predicting efficacy.

Detailed description:

Arms: arm 1: Doxorubicin in combination with cyclophosphamide followed by docetaxel (AC -\> T) arm 2: Docetaxel in combination with doxorubicin and cyclophosphamide (TAC)
Interventions: intervention 1: docetaxel, doxorubicin, cyclophosphamide intervention 2: Docetaxel,doxorubicin, cyclophosphamide
Intervention descriptions: intervention 1: TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel. intervention 2: AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.

Protocol documents:
Clinical trial NCT00700427
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Adult long term maintenance of response Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2008-06-01; Completion date: 2013-10-01
Enrollment: 2017 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).

Detailed description:

Arms: arm 1: Atomoxetine 40-100 milligrams per day (mg/day) orally, once daily or twice daily for 24 weeks, followed by atomoxetine 80-100 mg/day orally, once daily or twice daily for 25 weeks. arm 2: Atomoxetine 40-100 mg/day orally, once daily or twice daily for 24 weeks, followed by placebo orally, once daily for 25 weeks.
Interventions: intervention 1: atomoxetine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Oral 40-100 mg/day intervention 2: Oral delivery of matching placebo

Protocol documents:
Clinical trial NCT01024972
Conditions: Subarachnoid Hemorrhage Cerebral Vasospasm
Sponsor: University of Massachusetts, Worcester
Start date: 2009-10-01; Completion date: 2013-10-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a known complication after SAH and significantly increases disability and death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have shown that the muscles in the artery wall play a role in cVSP.

Dantrolene has been FDA approved and extensively used in clinical practice as a muscle relaxant for more than 30 years. It has been shown to provide some benefit in animal studies of cVSP, as well as in a small number of humans. However, the first human studies have only been observational and over a short period of time.

This study will evaluate the safety and tolerability of intravenous dantrolene given every 6 hours over seven days to patients with or at risk for cVSP after SAH. The goal is to determine if future efficacy studies should be done to determine if treatment with Dantrolene may improve the outcome of patients with cVSP after SAH.

Detailed description:
Once eligibility criteria are met, patients will be randomized to either dantrolene-IV or placebo (equiosmolar, volume-equivalent sterile water with 5% mannitol as dantrolene-IV also contains 5% mannitol). Study subjects will be visited daily by a study nurse to determine side effects, tolerability, record hemodynamic measures and laboratory values. Patients will have daily serum Na, osmolality, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALK) measured. In addition, daily bedside transcranial doppler will be performed by a blinded examiner. Patients will undergo cerebral angiograms per clinical routine. Angiographic measurements of arterial narrowing will be performed by a blinded radiologist. Specific stop criteria are pre-defined.

Arms: arm 1: Dantrolene 1.25mg/kg IV every 6 hours x 7 days arm 2: Equiosmolar volume (5% Mannitol)
Interventions: intervention 1: Dantrolene intervention 2: Placebo
Intervention descriptions: intervention 1: Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days intervention 2: equiosmolar volume (5% mannitol) every 6 hours x 7 days

Protocol documents:
Clinical trial NCT01035229
Conditions: Carcinoma
Keywords: Hepatocellular carcinoma randomized trial medical treatment RAD001 placebo Advanced Hepatocellular Carcinoma (HCC)
Sponsor: Novartis Pharmaceuticals
Start date: 2010-04-01; Completion date: 2013-10-01
Enrollment: 546 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

Detailed description:

Arms: arm 1: Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the investigational drug. In addition to taking Everolimus, all patients also received BSC as per normal local practice. arm 2: Placebo Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placeb Everolimus, all patients also received BSC as per normal local practice.
Interventions: intervention 1: Everolimus intervention 2: Everolimus Placebo intervention 3: Best Supportive Care (BSC)
Intervention descriptions: intervention 1: Everolimus (labeled as RAD001) was formulated as tablets of 2.5 mg strength and blisterpacked in units of 10 tablets. intervention 2: Everolimus Placebo matched to the everolimus 2.5 mg tablet strength was blister-packed in units of 10 tablets. Matching placebo tablets were formulated to be indistinguishable from the everolimus tablets. Everolimus placebo was taken as a daily oral dose of 7.5 mg and was defined as the control drug. intervention 3: BSC was defined as drug or non-drug therapies, nutritional support, physical therapy or anything that the Investigator believed to be in the patient's best interest, but excluding other antineoplastic treatments. BSC administered to the patient throughout the study was to be reported on the Concomitant Medication/Significant Non-Drug Therapy electronic case report from (eCRF). Permitted BSC treatments during the study included, but were not limited to, the following: Pain medication to allow the patient to be as comfortable as possible, Bisphosphonates for bone metastases, Localized radiotherapy, for the treatment of pre-existing, painful bone metastases, Nutritional support or appetite stimulants (i.e. megestrol) as recommended by the Investigator, Oxygen therapy and blood products or transfusions

Protocol documents:
Clinical trial NCT01193608
Conditions: Alzheimer's Disease
Keywords: Randomized Safety Study Adaptive Double Blind
Sponsor: Pfizer
Start date: 2010-09-01; Completion date: 2013-10-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: AAB-003 (PF-05236812) intervention 2: AAB-003 (PF-05236812) intervention 3: AAB-003 (PF-05236812) intervention 4: AAB-003 (PF-05236812) intervention 5: AAB-003 (PF-05236812) intervention 6: Placebo
Intervention descriptions: intervention 1: 0.5 mg/kg AAB-003, IV intervention 2: 1 mg/kg AAB-003, IV intervention 3: 2 mg/kg AAB-003, IV intervention 4: 4 mg/kg AAB-003, IV intervention 5: 8 mg/kg AAB-003, IV intervention 6: Placebo, IV

Protocol documents:
Clinical trial NCT01204710
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Sponsor: Eli Lilly and Company
Start date: 2010-10-01; Completion date: 2013-10-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.

Detailed description:

Arms: arm 1: 1 cycle = 3 weeks (21 days) arm 2: 1 cycle = 3 weeks (21 days)

Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.
Interventions: intervention 1: Olaratumab intervention 2: Mitoxantrone intervention 3: Prednisone
Intervention descriptions: intervention 1: 15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8 intervention 2: Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1

Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²) intervention 3: 5 mg orally (PO) twice daily (BID) on each day

Protocol documents: