ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00132808
Conditions: Osteopenia
Keywords: Postmenopausal osteoporosis osteopenia zoledronic acid Osteopenia (osteoporosis prevention)
Sponsor: Novartis Pharmaceuticals
Start date: 2004-07-01; Completion date: 2008-02-01
Enrollment: 581 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.

Detailed description:

Arms: arm 1: Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 arm 2: Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12 arm 3: Placebo given at randomization and Month 12
Interventions: intervention 1: Zoledronic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: Zoledronic acid 5 mg intravenous intervention 2: Physiologic 0.9% normal saline

Protocol documents:
Clinical trial NCT00142116
Conditions: Waldenstrom's Macroglobulinemia Lymphoplasmacytic Lymphoma
Keywords: thalidomide rituximab Waldenstrom's
Sponsor: Steven P. Treon, MD, PhD
Start date: 2003-05-01; Completion date: 2008-02-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the percentage of people who can attain remission and the length of time such responses to therapy are sustained, as well as the side effects that might result from rituximab and thalidomide in people with lymphoplasmacytic lymphoma.

Detailed description:
* Patients will receive thalidomide(200mg) orally once daily for two weeks. If after two weeks of thalidomide, the patient is doing well the dose of thalidomide will increase (400mg) and they will remain on it for up to 50 additional weeks. The length of time a patient is on thalidomide will depend upon how they are responding to therapy.
* During the second week of the study patients will also begin receiving rituximab intravenously once weekly for 4 weeks, which may then be repeated 8 weeks later depending upon the response.
* A determination of how the patient is responding will be made based on testing conducted at 12 weeks. This testing includes blood tests and possibly a bone marrow biopsy. If it is determined that the disease is not progressing, patients will begin a second phase of treatment which includes 4 additional weekly infusions of rituximab and the continuation of oral thalidomide.
* If it is determined at the 12-week evaluation, or at any time thereafter, that the disease has progressed (by studying serum immunoglobulin M (IgM) levels, bone marrow involvement, tumor cells, and/or development of new signs and symptoms) then the patient will be removed from the study.
* Periodic examinations and tests will be done to determine how the patient is doing, what response and side effects (if any) the patient may be having from the study drugs. If patient is responding to therapy then they will remain on this study and followed for a period of two years.
* Bone marrow biopsies and aspirations will be obtained at 3-6 month intervals extending for 2 years following the last treatment.

Arms: arm 1: Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks

Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.
Interventions: intervention 1: Thalidomide intervention 2: Rituximab
Intervention descriptions: intervention 1: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks. intervention 2: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.

Protocol documents:
Clinical trial NCT00143507
Conditions: Coronary Disease Ventricular Dysfunction, Left
Sponsor: Institut de Recherches Internationales Servier
Start date: 2004-12-01; Completion date: 2008-02-01
Enrollment: 10917 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ivabradine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00151814
Conditions: Hypertension
Keywords: Olmesartan PK in children
Sponsor: Daiichi Sankyo
Start date: 2005-09-01; Completion date: 2008-02-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years

Detailed description:

Arms: arm 1: Children less than 6 years old received 0.3 mg/kg. Children 6 years old or older received 40 mg, if they weighed 35 kg or more; 20 mg if they weighed less than 35 kg.
Interventions: intervention 1: Olmesartan medoxomil
Intervention descriptions: intervention 1: Children less than 6 years old: oral suspension or tablets equal to 0.3 mg/kg; 20 mg or 40 mg tablets for older children depending on weight.

Protocol documents:
Clinical trial NCT00156533
Conditions: Insomnia Primary Insomnia Psychophysiologic Insomnia
Keywords: Insomnia Sleep zolpidem Ambien Hypnotics
Sponsor: University of Rochester
Start date: 2005-03-01; Completion date: 2008-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We want to assess whether "how and when" one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.

Detailed description:
To date, the aggressive treatment (Tx) of chronic insomnia has been evaluated in terms of whether maintenance therapy is possible. While what constitutes maintenance therapy is a matter of debate, there are two studies which show that benzodiazepine receptor agonists (BZRAs) 1) are effective when used intermittently for up to 3 months and 2) may be used on a nightly basis for up to 6 months with no loss of efficacy.

The significance of the present research is two fold. First, it will allow us to compare the two primary strategies used for long term treat of insomnia (nightly dosing vs intermittent dosing). Second, it will allow an evaluation of the possibility that extended treatment, given careful withdrawal from medication, may yield long term clinical gains.

Re: Objective 1: It is widely assumed that intermittent dosing confers increased efficacy. That is, less frequent medication use will extend the duration of time for which the medication is maximally potent. An empirical assessment of this proposition is required. If incorrect, physicians and patients should be encouraged to adopt a more aggressive approach to treatment. If correct, physicians and patients should be encouraged to adopt the intermittent dosing approach to treatment.

Re: Objective 2: It is widely assumed that treatment with sedatives (sleep promoting medications) constitutes only palliative care. An empirical assessment of this proposition is required. If correct, physicians and patients should be encouraged to adopt a more aggressive approach to long term treatment. If incorrect, physicians and patients should be encouraged to adopt an approach to treatment that is not currently a standard of practice: extended treatment with a clear plan to taper medication that is designed to maintain the clinical gains that occurred with medication use.

We propose to evaluate the above issues in a pilot study of 40 subjects with Primary Insomnia where subjects are randomized to one of 4 conditions:

1. QHS dosing with placebo
2. QHS dosing with 10mg of zolpidem
3. Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
4. Monitor only condition.

Arms: arm 1: QHS dosing with placebo (i.e. nightly dose) arm 2: QHS dosing with 10mg of zolpidem (i.e. nightly dose) arm 3: Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed arm 4: Monitor only condition (no placebo, no drug).
Interventions: intervention 1: Zolpidem intervention 2: Sugar Pill
Intervention descriptions: intervention 1: 10 mg of Zolpidem intervention 2: None

Protocol documents:
Clinical trial NCT00183339
Conditions: Autistic Disorder
Keywords: Autism
Sponsor: University of North Carolina, Chapel Hill
Start date: 2005-07-01; Completion date: 2008-02-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism.

Detailed description:
Autism, a brain disorder that affects a small percentage of Americans, often results in a lifetime of impaired thinking, feeling, and social functioning. The disorder generally becomes apparent in children by the age of 3. Autism typically affects a person's ability to communicate, form relationships with others, and respond appropriately to the external world. Some people with autism can function at a relatively high level, with speech and intelligence intact. Others have serious cognitive impairments and language delays, and some never speak. This study will assess the safety and effectiveness of treating autistic children with fluoxetine to enhance developmental processes in core areas impacted by autism.

Each participant was randomly assigned to treatment with double-blinded placebo or fluoxetine for 12 months. After initial screening and randomization, participants were assessed every two weeks for approximately the first 3 months, or until the dose of medication is stabilized. After this initial period, they were assessed on a monthly basis. Dosing was flexible as determined by the adverse and beneficial responses to treatment although there was a suggested titration schedule.

Arms: arm 1: Placebo, liquid solution flexible dose 0.5 to 5ml every morning (AM) arm 2: Fluoxetine, 20mg/5ml solution, flexible dose 0.5 to 5ml every AM
Interventions: intervention 1: Fluoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule. intervention 2: Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.

Protocol documents:
Clinical trial NCT00186498
Conditions: Depressive Disorder, Major
Sponsor: Stanford University
Start date: 2004-02-01; Completion date: 2008-02-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether taking the medication memantine reduces impairment of memory and attention associated with electroconvulsive therapy.

Detailed description:
The primary objective of this study is to determine whether the novel NMDA antagonist memantine, FDA approved for use in moderate to severe alzheimers dementia, may reduce the neurocognitive deficits associated with right unilateral ECT treatments in patients receiving ECT for a severe and relatively refractory Major Depressive episode.

Our hypothesis is that the use of an NMDA antagonist would reduce intracellular calcium levels, and glutamatergic stimulation during ECT. This reduction in excitatory stimulation during ECT would reduce hippocampal and prefrontal neuronal endangerment and dysfunction, thereby reducing cognitive impairment associated with right unilateral ECT treatments. We also hypothesize that ACTH and cortisol levels will correlate with neurocognitive impairment in placebo treated subjects, but not in the memantine treated individuals.

Arms: arm 1: Patients received a placebo capsule starting the day before ECT begins and while receiving ECT arm 2: Patients receive memantine starting the day before ECT begins and while receiving ECT
Interventions: intervention 1: memantine intervention 2: Placebo Oral Capsule
Intervention descriptions: intervention 1: Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT intervention 2: Patients received a placebo capsule starting the day before ECT begins and while receiving ECT

Protocol documents:
Clinical trial NCT00191945
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2005-05-01; Completion date: 2008-02-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1). The double blinded period will last 12 weeks and the treatment open phase will last up to 1 year, and atomoxetine treatment will be administered.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Detailed description:

Arms: arm 1: atomoxetine: 0.5 mg/kg/day every day (QD),by mouth (PO) for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year arm 2: placebo every day (QD), by mouth (PO) for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year (open-label extension)
Interventions: intervention 1: Atomoxetine Hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00194116
Conditions: Bipolar Disorder
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2004-09-01; Completion date: 2008-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Divalproex Sodium ER intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. intervention 2: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.

Protocol documents:
Clinical trial NCT00200967
Conditions: Asthma
Sponsor: Milton S. Hershey Medical Center
Start date: 2004-12-01; Completion date: 2008-02-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.

Detailed description:
BACKGROUND:

The purpose of this study is to compare the effects of a long-acting beta agonist in patients with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the beta-2 adrenergic receptor.

DESIGN NARRATIVE:

Participants were homozygous for arginine or glycine at the 16th amino-acid position of the β-2 adrenergic receptor (B16 Arg/Arg or B16 Gly/Gly). Individuals were matched against their opposite genotype by forced expiratory volume in one second (FEV1) and race. Matched participants entered an 8-week run-in period. This is a 62-week crossover design where subjects receive the following therapies:

* Beclomethasone HFA (240 µg twice a day (BID)) + as-needed (PRN) albuterol: 8-week run-in
* Beclomethasone HFA (240 µg BID) + salmeterol (50 µg BID) + PRN ipratropium bromide + PRN albuterol: 18-week treatment period
* Beclomethasone HFA (240 µg BID) + PRN albuterol: 8-week run-out
* Beclomethasone HFA (240 µg BID) + placebo salmeterol + PRN ipratropium bromide + PRN albuterol: 18-week treatment period
* Beclomethasone HFA (240 µg BID) + PRN albuterol: 10-week run-out

The order of treatments received during the two treatment periods is randomized.

Arms: arm 1: B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone hydroflouroalkane (HFA), followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA arm 2: B16 Gly/Gly genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
Interventions: intervention 1: salmeterol intervention 2: beclomethasone HFA
Intervention descriptions: intervention 1: 50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina) intervention 2: 240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)

Protocol documents:
Clinical trial NCT00223977
Conditions: Iron Deficiency Anemia
Keywords: Anemia.
Sponsor: Watson Pharmaceuticals
Start date: 2003-12-01; Completion date: 2008-02-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Detailed description:

Arms: arm 1: 125 mg sodium ferric gluconate weekly x 8 weeks arm 2: 250 mg sodium ferric gluconate complex weekly x 4 weeks arm 3: 325 mg ferrous sulfate three times daily x 8 weeks
Interventions: intervention 1: Sodium Ferric Gluconate Complex intervention 2: Sodium Ferric Gluconate Complex intervention 3: Oral Iron
Intervention descriptions: intervention 1: 125 mg weekly x 8 weeks intervention 2: 250 mg weekly x 4 intervention 3: 325 mg ferrous sulfate orally three times daily x 8 weeks

Protocol documents:
Clinical trial NCT00237666
Conditions: Bipolar II Disorder Major Depressive Episode
Keywords: Bipolar II Disorder Major Depressive Episode
Sponsor: The Medical Research Network
Start date: 2005-02-01; Completion date: 2008-02-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.

Detailed description:
Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipolar II patients is often complicated and there is no clinical unanimity on what approaches to follow. Administration of proven antidepressants would seem most appropriate and are most often used, but their use often involves a number of difficulties. Among these are:

* antidepressant efficacy is established for unipolar patients and extrapolation to Bipolar II patients is done without empirical support
* Bipolar II patients can have switches into hypomanic behavior in response to antidepressant treatment given as monotherapy
* even when mood stabilizers are concomitantly given, switches to hypomanic states still occur when antidepressants are added
* antidepressants can cause cycle acceleration or induce rapid cycling when given to Bipolar II patients
* non-response and loss of response are common reactions to antidepressants in Bipolar II patients

This study will also assess the tolerability of Geodon in the treatment of patients diagnosed with Bipolar II disorder who currently meet criteria for a Major Depressive Episode by examining the incidence of adverse events and the withdrawal rate due to adverse events.

This will be an open-label study. Subjects will be treated for 8 weeks with Geodon, starting at a dose of 20 mg twice per day. The maximum dose will be 60 mg twice per day. Subjects will have a physical exam, electrocardiogram (ECG), standard laboratory tests and a urine drug screen at the screen visit.

Efficacy evaluations will include 17-item Hamilton Depression Scale, Hamilton Anxiety Scale (HAM-D), Montgomery-Asberg Depression Rating Scale, and the Young Mania Rating Scale. Social outcome will be measured with a quality-of-life scale (the Q-LES-Q). Overall efficacy will be rated using the Clinical Global Severity and Improvement Scales.

Arms: arm 1: Ziprasidone monotherapy, 20-60 mg BID.
Interventions: intervention 1: Ziprasidone
Intervention descriptions: intervention 1: Ziprasidone 20-60 mg BID, taken orally.

Protocol documents: