ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00066937
Conditions: Temporomandibular Joint Disorders
Sponsor: Johns Hopkins University
Start date: 2002-11-01; Completion date: 2008-07-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD.

Detailed description:
This is a randomized, controlled trial evaluating pharmacological (nortriptyline vs. active placebo - benztropine) and psychological (cognitive-behavioral therapy vs. disease education) treatments for pain and disability due to temporomandibular joint disorder (TMD). Patients 18 to 65 years old meeting RDC criteria for TMD and other eligibility criteria complete a 3-week baseline monitoring phase prior to randomization. Active treatment consists of weekly visits for 8 week, then maintenance treatment for 6 months. Outcome measures include pain, physical and psychosocial function and are assessed at post-treatment, 3-months, and 6-months

Arms: arm 1: Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT. arm 2: Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT. arm 3: Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management. arm 4: Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.
Interventions: intervention 1: Nortriptyline Oral Capsule intervention 2: Benztropine Oral Product intervention 3: CBT intervention 4: Disease MGT
Intervention descriptions: intervention 1: Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile. intervention 2: Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. intervention 3: Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking. intervention 4: Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.

Protocol documents:
Clinical trial NCT00073008
Conditions: Lung Cancer, Non-Small Cell
Keywords: EGFR ErbB1 ErbB2 metastatic lapatinib Her-2/neu protein kinase inhibitor BAC GW572016 Advanced NSCLC
Sponsor: GlaxoSmithKline
Start date: 2003-11-01; Completion date: 2008-07-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to evaluate and compare the efficacy of two dose schedules of an oral investigational drug for the treatment of advanced or metastatic non-small cell lung cancer.

Detailed description:

Arms: arm 1: Randomized, open-label, parallel group, 2-stage study to evaluate and compare 2 dose schedules (1500 mg once daily and 500 mg twice daily) of oral lapatinib.
Interventions: intervention 1: GW572016 (lapatinib)
Intervention descriptions: intervention 1: tyrosine kinase inhibitor

Protocol documents:
Clinical trial NCT00088595
Conditions: Carcinoid Tumors
Keywords: SOM230 Sandostatin Carcinoid syndrome
Sponsor: Novartis Pharmaceuticals
Start date: 2004-01-01; Completion date: 2008-07-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Study evaluating SOM230 in patients with metastatic carcinoid tumors

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Pasireotide (SOM230)
Intervention descriptions: intervention 1: Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred.

Protocol documents:
Clinical trial NCT00104416
Conditions: Epilepsy, Tonic-Clonic
Keywords: antiepileptic drugs seizures primary generalized tonic-clonic seizures Epilepsy lamotrigine anticonvulsants LAMICTAL
Sponsor: GlaxoSmithKline
Start date: 2004-12-01; Completion date: 2008-07-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: lamotrigine (LAMICTAL) extended-release intervention 2: Placebo
Intervention descriptions: intervention 1: Primary experimental dosage form intervention 2: Placebo control

Protocol documents:
Clinical trial NCT00105079
Conditions: HIV Infections
Sponsor: Hoffmann-La Roche
Start date: 2005-04-01; Completion date: 2008-07-01
Enrollment: 337 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. arm 2: lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Interventions: intervention 1: saquinavir [Invirase] intervention 2: Lopinavir/ritonavir intervention 3: Emtricitabine/tenofovir disoproxil fumarate intervention 4: Ritonavir
Intervention descriptions: intervention 1: 1000 milligram (mg) Oral (po) twice daily (bid) intervention 2: Lopinavir/ritonavir 400/100 mg po bid intervention 3: Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd intervention 4: 100 mg po bid

Protocol documents:
Clinical trial NCT00113087
Conditions: Heart Defects, Congenital Heart Failure, Congestive
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Start date: 2003-08-01; Completion date: 2008-07-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental and functional status, ventricular geometry, function, and atrioventricular (AV) valve regurgitation. In addition, the study will determine the relationship between genetic polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I therapy and compare the incidence of adverse events in subjects treated with ACE-I with those in subjects treated with placebo.

Detailed description:
BACKGROUND:

Growth impairment is common in infants and children with congenital heart disease, most often in the presence of congestive heart failure and/or cyanosis. Growth failure is noted in many infants with a single ventricle who manifest both cyanosis and heart failure that commonly persist after palliative surgery. Whether this impairment is related to persistent or progressive abnormalities in cardiac structure and function is not known. ACE-Is are widely used in the treatment of infants with severe congestive heart failure to improve cardiac function and somatic growth. The ability of an ACE-I to improve somatic growth in infants with a single ventricle has not been previously studied.

This study has been approved by the Institutional Review Boards/Research Ethics Boards of all participating clinical centers:

Hospital for Sick Children, Toronto, Canada

Children's Hospital Boston, Boston, MA

Columbia College of Physicians and Surgeons, New York, NY

Children's Hospital of Philadelphia, Philadelphia, PA

Duke University Medical Center, Durham, NC

Brody School of Medicine at East Carolina University, Greenville, NC

Wake Forest Baptist Medical Center, Winston Salem, NC

Medical University of South Carolina, Charleston, SC

Primary Children's Medical Center, Salt Lake City, UT

Children's Hospital of Wisconsin, Milwaukee, WI

Cincinnati Children's Hospital Medical Center, Cincinnati, OH

DESIGN NARRATIVE:

This is a prospective, randomized, double-blind, placebo-controlled trial of ACE-I in infants with a single ventricle. After stratification by ventricular anatomy, neonates will be randomly assigned to receive enalapril or placebo and then followed for 14 months.

Arms: arm 1: Enalapril (angiotensin converting enzyme inhibitor) arm 2: Placebo (Ora-Plus and Ora-Sweet)
Interventions: intervention 1: Enalapril intervention 2: Placebo
Intervention descriptions: intervention 1: Enalapril to target dose of .4mg/kg/day divided to twice per day (BID) intervention 2: Participants will receive placebo

Protocol documents:
Clinical trial NCT00118404
Conditions: Depression
Keywords: Cognitive therapy Antidepressants Psychotherapy
Sponsor: University of Texas Southwestern Medical Center
Start date: 2000-03-01; Completion date: 2008-07-01
Enrollment: 523 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.

Detailed description:
Cognitive therapy (CT) is a short-term talking therapy that focuses on changing negative thinking patterns and helping patients develop coping skills to deal with their experiences. Evidence suggests that CT is effective in treating a number of psychiatric conditions, including anxiety and anger. This study will determine the effectiveness of cognitive therapy versus antidepressant medication or placebo in preventing relapse of depression in people with recurrent depression.

This study lasted approximately 36 months and comprised three phases. For the first 12 weeks, all participants received between 16 and 20 CT sessions. Participants were then randomly assigned to receive additional CT sessions, antidepressants, or placebo for an additional 8 months. Upon completing treatment, participants entered follow-up study visits once every 4 months for the next 24 months. Clinician-rated scales and questionnaires were used to assess depressive symptoms of participants at study start and at the end of each study phase.

Arms: arm 1: Participants received acute phase and continuation phase cognitive therapy arm 2: Participants received acute phase cognitive therapy and continuation phase pill placebo arm 3: Participants received acute phase cognitive therapy and continuation phase fluoxetine
Interventions: intervention 1: Continuation phase cognitive therapy intervention 2: Continuation phase fluoxetine intervention 3: Continuation phase pill placebo intervention 4: Acute phase cognitive therapy
Intervention descriptions: intervention 1: Continuation phase cognitive therapy included 10 sessions over 8 months. intervention 2: The dosage of fluoxetine was increased to 40 mg over 8 months. intervention 3: The dosage of pill placebo was increased to 40 mg over 8 months. intervention 4: For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Protocol documents:
Clinical trial NCT00125164
Conditions: Growth Disorders Insulin-Like Growth Factor-1 Deficiency
Keywords: Primary IGF-1 Deficiency
Sponsor: Ipsen
Start date: 2004-03-01; Completion date: 2008-07-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to determine whether twice daily weight based dosing with recombinant human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of prepubertal children with short stature associated with low IGF-1 levels but who produce sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or to active treatment.

Detailed description:
Prepubertal growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, primary IGFD is defined as short stature (height standard deviation score\[SDS\]\<-2 below the mean for age and gender), low serum IGF-1 (IGF-1 SDS \<-2 below the mean for age and gender), and levels of growth hormone (GH) that are normal (≥7ng/mL) after a GH stimulation test. Primary IGFD is believed to result from a lower than normal ability to produce IGF-1 when exposed to normal levels of GH, i.e., a type of GH insensitivity or GH resistance.

This trial is one year, randomized, open label, observation-controlled, parallel-dose comparison efficacy and safety study conducted in approximately 40 centers across the United States.

Arms: arm 1: Observational Group arm 2: Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm. arm 3: Injection of rhIGF-1 80 μg/kg BID arm 4: Injection of rhIGF-1 120 μg/kg BID
Interventions: intervention 1: rhIGF-1 (mecasermin, Tercica, Inc.)
Intervention descriptions: intervention 1: Twice Daily Injection

Protocol documents:
Clinical trial NCT00125788
Conditions: Sickle Cell Anemia Thalassemia
Keywords: sickle cell disease sickle cell anemia L-glutamine Sickle Cell Anemia (homozygous) Sickle ß0-Thalassemia
Sponsor: Emmaus Medical, Inc.
Start date: 2004-03-01; Completion date: 2008-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to evaluate the effects of L-glutamine as a therapy for sickle cell anemia and sickle ß0-thalassemia. as evaluated by the number of occurrences of sickle cell crises.

Detailed description:
The primary purpose of this study is to evaluate the effectiveness of oral L-glutamine in the therapy of sickle cell anemia and sickle ß0-thalassemia.

The secondary purpose is to assess the effect of L-glutamine frequency of hospitalizations for sickle cell pain, frequency of emergency room visits for sickle cell pain; energy and appetite levels; narcotics usage.

Methodology:

By site, patients will be randomized to L-glutamine or placebo in a 1:1 ratio after a 4-week screening period. Patients will undergo 48 weeks of treatment with dosing BID orally, with dose calculated according to patient weight. Patient visits will occur every 4 weeks. After 48 weeks of treatment, dose will be tapered to zero within 3 weeks. A final evaluation visit will occur 2 weeks after last dose.

Arms: arm 1: L-glutamine arm 2: maltodextrin
Interventions: intervention 1: L-glutamine intervention 2: Placebo
Intervention descriptions: intervention 1: Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams. intervention 2: Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams.

Protocol documents:
Clinical trial NCT00154284
Conditions: Organ Transplantation, Renal Transplantation
Keywords: Renal transplantation, everolimus, immunosuppressants, basiliximab, cyclosporine microemulsion discontinuation, cyclosporine microemulsion minimization
Sponsor: Novartis
Start date: 2005-07-01; Completion date: 2008-07-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Detailed description:
This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

Arms: arm 1: Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. arm 2: Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
Interventions: intervention 1: Everolimus (Certican) intervention 2: Cyclosporine (Neoral) intervention 3: Steroid intervention 4: Basiliximab (Simulect)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice. intervention 4: None

Protocol documents:
Clinical trial NCT00162136
Conditions: Solid Malignancies
Sponsor: R-Pharm
Start date: 2005-09-01; Completion date: 2008-07-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ixabepilone
Intervention descriptions: intervention 1: Intravenous (IV) Infusion; 10, 20, 30, 35, 40 \& 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles

Protocol documents:
Clinical trial NCT00181766
Conditions: ADHD NOS
Keywords: ADHD NOS Adults Strattera (atomoxetine) Open-Label
Sponsor: Massachusetts General Hospital
Start date: 2003-12-01; Completion date: 2008-07-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the treatment of adults with attention deficit hyperactivity disorder not otherwise specified. The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day, whichever is less) in adults with ADHD NOS will be safe and well tolerated.

Detailed description:
Strattera (atomoxetine) is a non-stimulant specific norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for the treatment of child, adolescent and adult patients with ADHD. It is possible Strattera could be a viable alternative treatment for ADHD individuals. The purpose of this study is to assess the effectiveness, safety and tolerability of Strattera in adults with ADHD NOS. If this initial study shows promise, we will follow-up with a randomized clinical trial.

The study includes:

1. use of a six-week design to document the response rate,
2. weekly assessments to document the impact of Strattera NOS on functional capacities,
3. careful assessment of safety and tolerability.

Primary outcomes measure symptom reduction.

Arms: arm 1: None
Interventions: intervention 1: Strattera (atomoxetine)
Intervention descriptions: intervention 1: Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).

Protocol documents:
Clinical trial NCT00189202
Conditions: End Stage Renal Disease Kidney Transplantation
Sponsor: University of Michigan
Start date: 2004-08-01; Completion date: 2008-07-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes.

This study will evaluate:

1. Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,
2. Decreased rates of metabolic complications such as post-transplant diabetes,
3. The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.

Detailed description:
This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and only 3 doses of steroids.

Arms: arm 1: Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Interventions: intervention 1: Sirolimus
Intervention descriptions: intervention 1: Thymoglobulin induction, sirolimus and no maintenance corticosteroid

Protocol documents: