ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01157429
Conditions: Posttraumatic Stress Disorder PTSD
Keywords: Cognitive Behavior Therapy Children Adolescents Pharmacotherapy
Sponsor: Tulane University School of Medicine
Start date: 2010-06-01; Completion date: 2012-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show whether D-cycloserine in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo to reduce symptoms of posttraumatic stress disorder (PTSD) in 13-18 year-old children.

Detailed description:
While most individuals with PTSD treated with cognitive behavioral therapy (CBT) show improvement, they still have some enduring symptoms and functional impairment. Accordingly, there is a need for treatment advances. D-cycloserine (DCS), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. DCS was found to enhance learning and memory, and also facilitates extinction of fear reactions. However, DCS only produces an extinction effect when paired with behavioral training, not when simply given alone. Thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. The research also includes a three-month follow-up.

Arms: arm 1: Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine. arm 2: Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.
Interventions: intervention 1: D-cycloserine intervention 2: Placebo pill intervention 3: CBT
Intervention descriptions: intervention 1: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol. intervention 2: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol. intervention 3: 12-session CBT protocol, called Youth PTSD Treatment.

Protocol documents:
Clinical trial NCT01162733
Conditions: Infectious Disease
Keywords: Vancomycin Therapeutic Levels Infectious Disease Recommendations
Sponsor: Christiana Care Health Services
Start date: 2010-07-01; Completion date: 2012-06-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.

Detailed description:
Recently, the Infectious Disease Society of America (IDSA) has released new dosing recommendations for intravenous (IV) vancomycin. These new recommendations suggest administering an initial dose of 25-30 mg/kg of vancomycin as opposed to 10-15 mg/kg which is more traditionally done. Currently in the Emergency Department (ED) some practitioners are using the new IDSA dosing recommendations for vancomycin, while other practitioners have not changed their clinical practice. There is currently little data available to suggest that implementing these new vancomycin dosing regimens in the ED will achieve therapeutic vancomycin levels more rapidly than our traditional dosing practice.

Arms: arm 1: Vancomycin 15mg/kg arm 2: Vancomycin 30mg/kg
Interventions: intervention 1: Vancomycin intervention 2: Vancomycin
Intervention descriptions: intervention 1: 15mg/kg intervention 2: 30mg/kg

Protocol documents:
Clinical trial NCT01163747
Conditions: Rheumatoid Arthritis
Sponsor: Genentech, Inc.
Start date: 2010-09-01; Completion date: 2012-06-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.

Detailed description:

Arms: arm 1: Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations. arm 2: Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
Interventions: intervention 1: tocilizumab intervention 2: methotrexate intervention 3: 23-Valent Pneumococcal Polysaccharide Vaccine intervention 4: Tetanus Toxoid Adsorbed Vaccine
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: A stable dose of between 7.5 and 25 mg/week, oral or parenteral. intervention 3: Intramuscular or subcutaneous injection intervention 4: Intramuscular injection

Protocol documents:
Clinical trial NCT01166178
Conditions: Osteoporosis Multiple Sclerosis
Keywords: Multiple Sclerosis Osteoporosis Zoledronic Acid
Sponsor: Novartis
Start date: 2010-10-01; Completion date: 2012-06-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis and to support the optimal use of zoledronic acid for this indication. Primary objective is the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region assessed by T-Score at month 12 relative to screening as measured by Dual X-ray Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.

Detailed description:

Arms: arm 1: Participants received zoledronic acid infusion in addition to calcium and vitamin D arm 2: Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Interventions: intervention 1: Zoledronic Acid intervention 2: Placebo intervention 3: Calcium and Vitamin D combination
Intervention descriptions: intervention 1: Zoledronic acid 5 mg once a year via intravenous infusion intervention 2: Placebo to zoledronic acid once a year via intravenous infusion intervention 3: Calcium 500 mg and Vitamin D 400 IU combined tablet, taken orally twice a day

Protocol documents:
Clinical trial NCT01167829
Conditions: Healthy
Keywords: Experimental Acyline plus 27 oral testosterone pills taken 3x/day
Sponsor: University of Washington
Start date: 2010-07-01; Completion date: 2012-06-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood testosterone levels over a 24-hour period.

Detailed description:
We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days.

The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.

There are overnight stays on Day 1 and Day 9 to allow monitoring of blood testosterone levels over a 24 hour period, from @9 AM to 9 AM the next morning. At those visits, blood is drawn at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24 hours after the morning dose.

Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. We have used acyline in over 125 men without serious side effects. The use of testosterone in this study is experimental and there may be unknown or unanticipated risks.

Arms: arm 1: None
Interventions: intervention 1: Oral Testosterone intervention 2: Acyline
Intervention descriptions: intervention 1: Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills) intervention 2: 300 ug/kg injection on Day 0

Protocol documents:
Clinical trial NCT01179516
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder Depression Drug Therapy
Sponsor: Takeda
Start date: 2010-08-01; Completion date: 2012-06-01
Enrollment: 469 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.

Detailed description:
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.

The study enrolled 469 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 10 mg
* Vortioxetine 15 mg
* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 14 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Arms: arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate release tablets intervention 2: Vortioxetine placebo-matching capsules

Protocol documents:
Clinical trial NCT01193218
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-09-01; Completion date: 2012-06-01
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.

Detailed description:

Arms: arm 1: BI 10773 tablets low dose once a day arm 2: BI 10773 tablets mid-low dose once a day arm 3: BI 10773 tablets mid-high dose once a day arm 4: BI 10773 tablets high dose once a day arm 5: Placebo tablets once a day
Interventions: intervention 1: Placebo (low dose) intervention 2: Placebo (low dose) intervention 3: Placebo (mid dose) intervention 4: Placebo (high dose) intervention 5: BI 10773 intervention 6: Placebo (mid dose) intervention 7: Placebo (high dose) intervention 8: Placebo (high dose) intervention 9: BI 10773 intervention 10: BI 10773 intervention 11: Placebo (mid dose) intervention 12: Placebo (high dose) intervention 13: Placebo (low dose) intervention 14: Placebo (low dose) intervention 15: BI 10773 intervention 16: Placebo (mid dose)
Intervention descriptions: intervention 1: Placebo tablets once a day intervention 2: Placebo tablets once a day intervention 3: Placebo tablets once a day intervention 4: Placebo tablets once a day intervention 5: BI 10773 tablets low dose once a day intervention 6: Placebo tablets once a day intervention 7: Placebo tablets once a day intervention 8: Placebo tablets once a day intervention 9: BI 10773 tablets mid-high dose once a day intervention 10: BI 10773 tablets high dose once a day intervention 11: Placebo tablets once a day intervention 12: Placebo tablets once a day intervention 13: Placebo tablets once a day intervention 14: Placebo tablets once a day intervention 15: BI 10773 tablets mid-low dose once a day intervention 16: Placebo tablets once a day

Protocol documents:
Clinical trial NCT01197612
Conditions: Chronic Sinusitis Polyposis
Sponsor: University of Michigan
Start date: 2010-09-01; Completion date: 2012-06-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.

Detailed description:

Arms: arm 1: each subject serves as their own control with one nostril being treated with pulmicort and one not
Interventions: intervention 1: pulmicort
Intervention descriptions: intervention 1: applied to nasal packing after surgery

Protocol documents:
Clinical trial NCT01222832
Conditions: Paranasal Sinus Disease
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Start date: 2010-07-01; Completion date: 2012-06-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.

Detailed description:
Same as above

Arms: arm 1: Nasopore sponge soaked in Bacitracin, no oral antibiotics arm 2: Nasopore sponge soaked in saline, routine oral antibiotics
Interventions: intervention 1: Bacitracin
Intervention descriptions: intervention 1: Bacitracin soaked nasopore sponge

Protocol documents:
Clinical trial NCT01225341
Conditions: Herpes Labialis
Keywords: HSV-1 Herpes labialis Cold sores Fever blisters
Sponsor: DeNova Research
Start date: 2010-08-01; Completion date: 2012-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis.

Detailed description:

Arms: arm 1: Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. At the 12 month visit, patients will receive injections of saline. arm 2: Patients will be injected every 3 months with saline for a period of 12 months. At the 12 month visit, patients will receive injections of onabotulnimtoxinA.
Interventions: intervention 1: onabotulinumtoxinA intervention 2: Bacteriostatic normal saline
Intervention descriptions: intervention 1: Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle. intervention 2: Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.

Protocol documents:
Clinical trial NCT01227668
Conditions: Irritability Associated With Autistic Disorder
Sponsor: Bristol-Myers Squibb
Start date: 2011-03-01; Completion date: 2012-06-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

Detailed description:
Phase 1: Single blind/ Phase 2: Double blind

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 2-15 mg, once daily, 13-42 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 16 weeks

Protocol documents:
Clinical trial NCT01244503
Conditions: Metabolic Syndrome Nonalcoholic Fatty Liver Disease
Sponsor: Virginia Commonwealth University
Start date: 2011-02-01; Completion date: 2012-06-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting NASH with a high probability.

Detailed description:
The OBT was chosen to assess, along with other parameters, liver health in subjects suspected of NAFLD (non alcoholic fatty liver disease).

Octanoate is absorbed promptly from the intestinal lumen and transported rapidly to the liver through the portal venous system, enters the hepatic mitochondria independently of the carnitine transport system and undergoes hepatic mitochondrial beta-oxidation which produces acetyl coenzyme A (CoA). Finally, acetyl CoA enters the Krebs cycle and is oxidized by carbon dioxide (CO2). This is a non invasive test that can be performed routinely at every visit to assess disease severity. The subject is connected to a breath analyzer via a nasal cannula for approximately 1 hour, that measures baseline breath and changes in delta over baseline due to metabolization of Octanoate.

Arms: arm 1: Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.
Interventions: intervention 1: Sodium Octanoate Breath Test
Intervention descriptions: intervention 1: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed.

Protocol documents:
Clinical trial NCT01263691
Conditions: Bacillus Anthracis (Anthrax) Infection
Keywords: AVA AV7909 Anthrax vaccine
Sponsor: Emergent BioSolutions
Start date: 2010-12-01; Completion date: 2012-06-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.

Detailed description:
AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine, adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant, and one which increases the speed and the degree of the immune response to Protective Antigen (PA), the major vaccine antigen. In the current study, the safety, tolerability, and antibody response to PA will be studied for four different combinations of AVA and CPG 7909, and compared to both AVA and a saline placebo. All formulations of AV7909 have the same or less AVA than the licensed AVA vaccine and all have less CPG 7909 per dose than the formulation used in the first Phase I volunteer study of CPG 7909 combined with AVA.

Arms: arm 1: BioThrax, 0.5 mL AVA per dose arm 2: 0.5 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose arm 3: 0.5 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose arm 4: 0.25 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose arm 5: 0.25 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose arm 6: Saline control
Interventions: intervention 1: BioThrax intervention 2: AV7909 Formulation 1 intervention 3: AV7909 Formulation 2 intervention 4: AV7909 Formulation 3 intervention 5: AV7909 Formulation 4 intervention 6: Control
Intervention descriptions: intervention 1: BioThrax intervention 2: AV7909 Formulation 1 intervention 3: AV7909 Formulation 2 intervention 4: AV7909 Formulation 3 intervention 5: AV7909 Formulation 4 intervention 6: Saline control

Protocol documents:
Clinical trial NCT01277289
Conditions: Crohn's Disease
Keywords: dexamethasone ery-dex Chron's disease CD
Sponsor: Quince Therapeutics S.p.A.
Start date: 2009-06-03; Completion date: 2012-06-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

Assessment of the efficacy of EryDex vs PLACEBO in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids.

Secondary objectives:

1. safety of EryDex
2. emergence of new adverse effects from steroids or disappearance of those possibly pre-existing in the various subgroups of patients;
3. duration of the period of remission;
4. evaluation of the hypophysis-adrenal function;
5. study of plasma concentrations of dexamethasone;
6. effect of therapy on the metabolism of calcium and on indexes of inflammation;
7. assessing the quality of life;
8. rate of surgical resection
9. evaluation of the indirect costs of care.

Detailed description:
This was a multicenter, randomized, double-blind, PLACEBO-controlled, parallel-group study comparing EryDex versus PLACEBO. Patients with steroid-dependent Crohn's disease were enrolled and randomized to undergo 12 infusions of intraerythrocyte dexamethasone (EryDex), or PLACEBO. A balanced (1:1) randomization between the two treatment groups (EryDex / PLACEBO) was employed.

At the time of randomization, study patients were stratified at each study site according to their previous therapy with AZT/6MP/MTX (never treated with AZT/6MP/MTX or intolerant/resistant to the therapy with AZT/6MP/MTX). The treatment was planned to be performed with 12 monthly infusions of EryDex or PLACEBO.

Patients were followed-up after completion of the treatment for 6 months in patients regularly completing the study and 3 months in patients discontinuing from the study prematurely. The evaluation of the primary and secondary objectives was to be done at the 12th month of study (one month after the last study drug infusion), or upon relapse.

Arms: arm 1: Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval arm 2: placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval.
Interventions: intervention 1: Dexamethasone
Intervention descriptions: intervention 1: 500 mg/20 ml encapsulated in erythrocytes, every month for 12 months

Protocol documents: