ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00287287
Conditions: Thyroid Neoplasms
Keywords: Lenalidomide Clinical Trials phase II Carcinomas, thyroid Radioiodine-Unresponsive Papillary Follicular
Sponsor: Kenneth Ain
Start date: 2006-02-01; Completion date: 2010-07-06
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to assess the anti-tumor activity of REVLIMID® (lenalidomide), administered as a single agent, in patients with distantly metastatic thyroid carcinomas which are unresponsive to systemic radioiodine, in terms of tumor response and response duration.

Detailed description:
Thalidomide has found new uses as a tumor anti-angiogenesis agent that is capable of diminishing the proliferation of angiogenesis-dependent solid malignancies. Distantly metastatic, unresectable medullary thyroid carcinomas, as well as de-differentiated papillary and follicular thyroid carcinomas, which no longer concentrate radioiodine, have no known effective systemic therapies. We have verified, in the context of a completed phase 2 clinical trial, that thalidomide has significant activity in thyroid carcinomas that are no longer radioiodine avid and are rapidly progressive. This activity has only limited durability of around 7 months and is associated with significant toxicities of sedation, constipation and neuropathy.

REVLIMID® (lenalidomide) is an analog of thalidomide with the chemical name, alpha-(3-aminophthalimido) glutarimide. REVLIMID® is noted to be more potent than thalidomide in inhibiting the production of TNF-alpha. It has more than doubled the inhibition of microvessel growth at the same concentration as thalidomide in a rat aorta angiogenesis model as well as greatly enhanced activity as an IMiD. Most importantly, it lacks much of the toxicity of thalidomide, particularly in regards to somnolence, neuropathy, or biochemical effects. In fact, patients with multiple myeloma, known to be resistant to thalidomide, were still seen to exhibit clinical responses to REVLIMID®. This makes REVLIMID® an appropriate agent to investigate in a phase 2 trial in thyroid carcinoma.

Arms: arm 1: Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 Study Title: REVLIMID (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and 
Follicular Thyroid Carcinoma 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
09-21-2008 
NCT Number: 
NCT00287287 
IRB Number 
05-701-F3R 
Coversheet created: 
05-28-2020
Clinical trial NCT00983385
Conditions: Chronic Pain Low Back Pain
Keywords: low back pain pain assessment tapentadol centrally acting analgesic
Sponsor: Grünenthal GmbH
Start date: 2009-09-30; Completion date: 2010-07-06
Enrollment: 208 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

Detailed description:

Arms: arm 1: Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol immediate release (IR) tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.
Interventions: intervention 1: Tapentadol PR intervention 2: Observation period intervention 3: Tapentadol PR
Intervention descriptions: intervention 1: Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusted with 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed a dose of 500 mg of Tapentadol per day. intervention 2: Eligibility assessment period to characterize the baseline over a one week period (week -1). Participants continued their previous treatment prior to allocation to tapentadol, if eligible. intervention 3: Maintenance Period: In this period participants continued Tapentadol Prolonged Release (PR) on the dose established in the Titration and Optimal Dose Period. Tapentadol IR participants were not permitted to exceed a total daily tapentadol dose of 500 mg.

Protocol documents:
Clinical trial NCT00976560
Conditions: Depressive Disorder, Major
Keywords: Lack of interest and energy Psychomotor retardation Cytokines Major Depressive disorder
Sponsor: GlaxoSmithKline
Start date: 2009-09-25; Completion date: 2010-07-07
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of GW856553 or placebo for six weeks. Safety, tolerability, pharmacokinetics and pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed.

The primary endpoint is the change from baseline associated with GW856553 versus placebo at Week 6 in the Bech (6-item HAMD-17) score. Interim analyses of the primary endpoint will be performed throughout the study to potentially adapt the study design by changing the randomization ratio and/ or reducing the total number of subjects to be randomized into the study. Exploratory analyses will be performed by associating changes in cytokine levels and selected clinical symptoms; PK/PD modelling will also be used to identify the most sensitive clinical and biological markers.

Detailed description:

Arms: arm 1: GW856553 7.5 mg BID arm 2: Matching Placebo BID
Interventions: intervention 1: GW856553 intervention 2: Placebo
Intervention descriptions: intervention 1: Wet Granulated, film coated white, 9mm round, biconvex, plain faced tablets, containing 7.5 mg of GW856553 intervention 2: Film coated white, 9mm round, biconvex, plain faced tablets obtained by direct compression.

Protocol documents:
Clinical trial NCT01038297
Conditions: Scar Prevention
Keywords: Scarring
Sponsor: Pfizer
Start date: 2009-12-01; Completion date: 2010-07-07
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: EXC 001 intervention 2: Placebo
Intervention descriptions: intervention 1: Intradermal injections of EXC 001 and placebo given on various schedules. intervention 2: Intradermal injections of EXC 001 and placebo given on various schedules.

Protocol documents:
Clinical trial NCT00764660
Conditions: Alcoholism
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-02-13; Completion date: 2010-07-08
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol dependence.

Detailed description:

Arms: arm 1: Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks. arm 2: Participants received matching placebo tablets by mouth twice daily for 12 weeks.
Interventions: intervention 1: SCH 900435 intervention 2: Placebo
Intervention descriptions: intervention 1: tablets intervention 2: tablets

Protocol documents:
Clinical trial NCT00877487
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Sponsor: Shire
Start date: 2009-04-30; Completion date: 2010-07-08
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the maintenance of efficacy, as measured by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and are maintained on their screening dose of commercial SPD489.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks. intervention 2: 1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.

Protocol documents:
Clinical trial NCT00673790
Conditions: Hypertension
Keywords: nebivolol BYSTOLIC ™ hydrochlorothiazide lisinopril Prinivil (TM) Zestril (TM) losartan Cozaar (TM) Impaired Fasting Glucose Impaired Glucose Tolerance hypertension
Sponsor: Forest Laboratories
Start date: 2008-05-15; Completion date: 2010-07-09
Enrollment: 537 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and placebo in hypertensive patients.

Detailed description:
This study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide).

All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin receptor blocker. All medications are approved and marketed for the treatment of hypertension.This study is being conducted in about 500 patients at approximately 80 research centers in the United States.

The study consists of approximately 9 study visits over a period of 5 months. During these visits, patients will undergo routine health exams and some special laboratory tests such as an oral glucose tolerance test.

Arms: arm 1: Nebivolol with concomitant losartan or lisinopril arm 2: HCTZ with concomitant losartan or lisinopril arm 3: Placebo with concomitant losartan or lisinopril
Interventions: intervention 1: Nebivolol with concomitant losartan or lisinopril intervention 2: HCTZ with concomitant losartan or lisinopril intervention 3: Placebo with concomitant losartan or lisinopril
Intervention descriptions: intervention 1: Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration. intervention 2: Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration. intervention 3: Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Protocol documents:
Clinical trial NCT00644423
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD Cognition Fish Oil Omega-3 Fatty Acid
Sponsor: Durham VA Medical Center
Start date: 2008-09-22; Completion date: 2010-07-15
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An increasing literature shows that omega-3 fatty acids provide numerous health benefits, including a variety of psychiatric symptoms and disorders including stress, anxiety, cognitive impairment, mood disorders (major depression and bipolar disorder) and schizophrenia. Omega-3 fatty acids may additionally represent a promising treatment strategy in patients with PTSD. Moreover, given its beneficial cardiovascular effects, adjunctive omega-3 fatty acids may also benefit the general health status of these veterans, who frequently present with a variety of comorbid medical disorders.

Detailed description:
See brief summary

Arms: arm 1: Omega-3 Fatty Acid arm 2: Placebo
Interventions: intervention 1: Omega-3 Fatty Acid intervention 2: Placebo
Intervention descriptions: intervention 1: One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid) intervention 2: Matching Placebo

Protocol documents:
Clinical trial NCT00826280
Conditions: Coronary Artery Disease (CAD)
Keywords: pharmacologic stress ischemia coronary artery disease (CAD)
Sponsor: Astellas Pharma Inc
Start date: 2009-03-24; Completion date: 2010-07-15
Enrollment: 347 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Observe whether the administration of caffeine prior to regadenoson will affect the interpretation of test results in subjects with coronary artery disease (CAD) undergoing SPECT MPI

Detailed description:
All subjects will undergo rest and stress scans. Those subjects who qualify by demonstrating at least 1 reversible defect, will undergo a third scan. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent. Prior to the third scan, the subject will be administered blinded capsules of placebo or caffeine.

Arms: arm 1: Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection arm 2: One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection arm 3: Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Interventions: intervention 1: regadenoson intervention 2: overencapsulated caffeine intervention 3: technetium intervention 4: placebo
Intervention descriptions: intervention 1: IV intervention 2: oral intervention 3: IV intervention 4: oral

Protocol documents:
Clinical trial NCT01059851
Conditions: Insomnia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-05-24; Completion date: 2010-07-15
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function are similar to those observed in healthy participants; and will evaluate the safety and tolerability of suvorexant both in participants with impaired renal function and in healthy participants.

Detailed description:
Study Design:

This study plans to enroll 16 participants in Part I (8 participants with severe renal impairment and a control group of 8 healthy participants) and 32 participants in Part II (8 participants with moderate renal impairment and a control group of 8 healthy participants; and 8 participants with mild renal impairment and a control group of 8 healthy participants).

Part II will be conducted only if the primary hypothesis is not met in Part I and there is a significant difference in the PK of suvorexant between healthy participants and severe renal impairment participants.

Arms: arm 1: Participants with severe renal impairment will receive a

single dose of 20 mg open-label suvorexant during Part I of the

study. arm 2: Healthy participants matched to participants with severe renal impairment will receive a single dose of 20 mg open-label suvorexant during Part I of the study. arm 3: Participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study. arm 4: Healthy participants matched to participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study. arm 5: Participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study. arm 6: Healthy participants matched to participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.
Interventions: intervention 1: Suvorexant
Intervention descriptions: intervention 1: single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with \~240 mL of water after an 8 hour fast

Protocol documents:
Clinical trial NCT01018030
Conditions: Sinusitis, Acute
Keywords: uncomplicated acute rhinosinusitis fluticasone furoate sinusitis
Sponsor: GlaxoSmithKline
Start date: 2010-01-06; Completion date: 2010-07-16
Enrollment: 741 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).

Detailed description:
\- Rationale - Acute rhinosinusitis (ARS) is a condition caused by inflammation of the nose and the paranasal sinuses that generally lasts up to 4 weeks. Despite ARS being a self-limiting condition, untreated or inadequately treated sinus infection can lead to the development of complications. Uncomplicated ARS is a subset of ARS and is distinguished from the common cold by the persistence or the worsening of sinus inflammation after the usual period for recovery of viral infection of the nasal cavity (i.e., 10 days). Clinically the difference is based on the following criteria: symptoms are present at least 10 days but less than 4 weeks beyond the onset of upper respiratory symptoms OR symptoms worsen after 5 days from their onset.

In the primary care settings, ARS is often treated empirically with antibiotics although they are shown to provide limited benefit in the uncomplicated ARS population. Alternatively, the use of an intranasal corticosteroid (INS) to control symptoms of uncomplicated ARS is plausible based on clinically proven ability to reduce inflammation and mucosal swelling.

This study is a phase II study.

* Objective - The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with uncomplicated ARS.
* Study Design - This is a randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study. The study includes a 2-week post-treatment follow-up period.

Approximately 720 subjects will be randomized to one of three treatment groups for a period of 14 days: FFNS 110 mcg QD, FFNS 110 mcg BID, and placebo nasal spray.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: FFNS 110 mcg QD intervention 2: FFNS 110 mcg BID intervention 3: Placebo Nasal Spray
Intervention descriptions: intervention 1: Active Nasal Spray (AM) and Placebo Nasal Spray (PM) intervention 2: Active Nasal Spray (AM) and Active Nasal Spray (PM) intervention 3: Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)

Protocol documents:
Clinical trial NCT01096680
Conditions: Sleep Deprivation
Sponsor: Shire
Start date: 2010-04-05; Completion date: 2010-07-18
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: SPD489 20 mg intervention 2: SPD489 50 mg intervention 3: SPD489 70 mg intervention 4: Armodafinil intervention 5: Placebo
Intervention descriptions: intervention 1: Single oral dose of 20 mg intervention 2: Single oral dose of 50 mg intervention 3: Single oral dose of 70 mg intervention 4: Single oral dose of 250 mg intervention 5: Single oral dose

Protocol documents:
Clinical trial NCT00773461
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2008-10-31; Completion date: 2010-07-22
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Placebo
Intervention descriptions: intervention 1: 8mg/kg iv every 4 weeks for 24 weeks intervention 2: iv every 4 weeks for 24 weeks

Protocol documents:
Clinical trial NCT00502853
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2007-10-25; Completion date: 2010-07-23
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will measure the effect of MabThera in combination with methotrexate on the progression of synovitis, the extent of bone marrow edema, and the number of erosions in the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of 10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate
Intervention descriptions: intervention 1: 1000mg iv on days 1 and 15 intervention 2: 10-25mg/week

Protocol documents: