ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01692782
Conditions: Adult Attention Deficit Hyperactivity Disorder
Keywords: ADHD Attention deficit hyperactivity disorder
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2012-12-01; Completion date: 2013-12-01
Enrollment: 341 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD).

Detailed description:
This is a Phase 2, randomized, double-blind, parallel-group, multicenter, outpatient study evaluating the efficacy and safety of SEP 225289 in adults with ADHD using 2 oral dosages (4 or 8 mg SEP 225289 once daily \[QD\]) versus placebo over a 4 week treatment period.

Arms: arm 1: SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses arm 2: SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses arm 3: 4 capsules of placebo
Interventions: intervention 1: SEP-225289 intervention 2: SEP-225289 intervention 3: Placebo
Intervention descriptions: intervention 1: SEP-225289 4mg once daily intervention 2: SEP-225289 8mg once daily intervention 3: Placebo once daily

Protocol documents:
Clinical trial NCT01698320
Conditions: Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2012-10-01; Completion date: 2013-12-01
Enrollment: 364 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax® device performance through the life of the device during the study.

Detailed description:

Arms: arm 1: During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise. arm 2: During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.

The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.
Interventions: intervention 1: Placebo MDPI intervention 2: Albuterol MDPI
Intervention descriptions: intervention 1: Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention. intervention 2: Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.

Protocol documents:
Clinical trial NCT01702363
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD), GSK573719, Pharmacogenetics
Sponsor: GlaxoSmithKline
Start date: 2012-08-01; Completion date: 2013-12-01
Enrollment: 131 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety and tolerability of GSK573719 Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.

Detailed description:
Chronic Obstructive Pulmonary Disease (COPD) treatment guidelines recommend an incremental approach to pharmacological treatment as the disease state worsens, involving the use of combinations of drug classes with different or complementary mechanisms of action \[Celli, 2004, GOLD 2009\]. As disease progresses from mild to moderate, regular treatment with one or more long-acting bronchodilators is recommended. Inhaled bronchodilators, including beta2 agonists and anticholinergics are included with inhaled corticosteroids (ICS) therapy and are mainstays of therapy in patients diagnosed with COPD. Since GSK573719 Inhalation Powder is expected to be used for chronic management of COPD as long-acting muscarinic antagonist (LAMA), this study is intended to evaluate the safety and tolerability of long-term administration of GSK573719 Inhalation Powder 125 mcg in Japanese patients with COPD at doses possibly used to be in Japan.

In this study, patient safety will also be monitored by evaluating pulmonary function and clinical symptoms.

Arms: arm 1: 125mcg
Interventions: intervention 1: GSK573719
Intervention descriptions: intervention 1: GSK573719 inhalation powder inhaled orally once daily for 52 weeks.

Protocol documents:
Clinical trial NCT01707043
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis taclonex crossover
Sponsor: Wake Forest University
Start date: 2012-10-01; Completion date: 2013-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open label, investigator-blinded, cross over, prospective, single center study of subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension will each be applied topically once daily.

The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque psoriasis.

Detailed description:
* Following satisfaction of entry criteria, all subjects at the Baseline/Screening visit will be randomized 1:1 to receive either Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment or Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension to use once daily for three days to affected areas of the body, excluding face and intertriginous areas. Subjects will be aware of which product they are using. Investigators will remain blinded.
* Subjects will be randomized to use either the ointment or the scalp suspension for the first three day treatment period, then cross over to use the other product for second three day treatment period.
* Each medication will be used within its FDA-approved label for the treatment of plaque psoriasis in subjects aged 18 and older. Subjects may not treat areas of the face, axilla or groin in this study.
* At the Day 3 and Day 6 visits the subjects will complete a questionnaire about their psoriasis treatment preferences.
* Pregnancy tests will be done on females of childbearing potential at Baseline/Screening.
* Adverse events will be monitored at each visit.

Arms: arm 1: All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas, then switch to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days arm 2: All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days, then switch to Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas,
Interventions: intervention 1: Taclonex
Intervention descriptions: intervention 1: Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).

Protocol documents:
Clinical trial NCT01709695
Conditions: ADHD Attention Deficit Hyperactivity Disorder
Keywords: Intuniv Attention Deficit Hyperactivity Disorder fMRI
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2011-03-01; Completion date: 2013-12-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study proposes to evaluate the effects of guanfacine extended release on brain activation during fMRI in children and adolescents with ADHD between the ages 8-15 and ADHD subjects randomized to placebo treatment.

This study also proposes to collect DNA on study participants, to examine the genetic underpinning of the observed fMRI activation profiles at baseline and in response to treatment. The purpose is to examine polymorphisms of the adrenergic 2A gene (and other related targets) for genetic biomarkers in association with the fMRI findings of this study.

Detailed description:
This study proposes to evaluate the effects of guanfacine on brain activation during fMRI in 12 children and adolescents ages 8 - 15 with ADHD treated with once-daily INTUNIV(TM) (guanfacine; GXR) extended release tablets and 12 ADHD subjects randomized to placebo treatment. Children will be comprehensively assessed using a variety of clinical and neuropsychological measures. They will be scanned at baseline while performing both the go/no-go task (a well validated task for measuring inhibitory control (Durston et al., 2002, 2003)) and the Stay Alert task - a new task designed to measure the arousal component of attention, which was used successfully in a recent fMRI study of guanfacine in healthy adults (Clerkin et al., 2009). They will then be treated with GXR or placebo for 6 - 8 weeks in accordance with titration and dosing strategies used in recent Phase III dose optimization trials (e.g., up to 4 mg/day), and re-scanned while performing the same two tasks. The fMRI scans will be conducted using a dedicated research 3.0 T Siemens scanner.

Arms: arm 1: Flexible dose titration of guanfacine extended release (Intuniv; active medication). The medication is titrated in doses from 1 - 4 mg once daily arm 2: Flexible dose titration of placebo
Interventions: intervention 1: Guanfacine Hydrochloride XR intervention 2: Placebo
Intervention descriptions: intervention 1: Weekly adjustments based on parent ratings of symptoms, side effects, and health status per vital signs up to 4mg maximum dose intervention 2: Weekly adjustments based on parent ratings of symptoms, side effects, and health status per vital signs up to 4mg maximum dose

Protocol documents:
Clinical trial NCT01711853
Conditions: Renal Insufficiency, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2012-10-01; Completion date: 2013-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.

Detailed description:

Arms: arm 1: patient to receive a capsule containing 75 mg of dabigatran etexilate
Interventions: intervention 1: Dabigatran Etexilate
Intervention descriptions: intervention 1: Dabigatran Etexilate 75mg twice daily

Protocol documents:
Clinical trial NCT01733121
Conditions: Tardive Dyskinesia
Sponsor: Neurocrine Biosciences
Start date: 2012-12-01; Completion date: 2013-12-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Detailed description:
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-titration study to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to subject's optimal dose in the range of 25 to 75 mg) compared to placebo, administered once daily (q.d.) for a total of 6 weeks of treatment. Approximately 90 medically stable male and female subjects with one of the following clinical diagnoses will be enrolled: schizophrenia or schizoaffective disorder with neuroleptic-induced TD; mood disorder with neuroleptic-induced TD; or gastrointestinal disorder with metoclopramide-induced TD.

For subjects randomized to active treatment, the starting dose will be 25 mg NBI 98854, which may be escalated in increments of 25 mg every 2 weeks to a maximum of 75 mg to achieve an optimal dose of NBI-98854 for each subject

Arms: arm 1: Dose titration to determine a subject's optimal dose in the range of 25 to 75 mg NBI-98854. Dose titration is performed in increments of 25 mg. NBI-98854 administered as one (1) 25 mg capsule, two (2) 25 mg capsules, or one (1) 25 mg capsule and one (1) 50 mg capsule by mouth, taken every morning between 7:00am - 10:00am for 6 weeks. arm 2: Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
Interventions: intervention 1: NBI-98854 intervention 2: NBI-98854 intervention 3: Placebo
Intervention descriptions: intervention 1: 25 mg capsule intervention 2: 50 mg capsule intervention 3: None

Protocol documents:
Clinical trial NCT01733329
Conditions: Postpartum Hemorrhage
Keywords: Buccal Misoprostol Uterine Atony Postpartum Hemorrhage
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Start date: 2008-02-01; Completion date: 2013-12-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage.

Design: randomized, double-blinded, placebo-controlled trial.

Detailed description:
Patients and methods: 120 pregnant women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.

Arms: arm 1: women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony. arm 2: women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
Interventions: intervention 1: Misoprostol intervention 2: Folic Acid
Intervention descriptions: intervention 1: At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist. intervention 2: At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.

Protocol documents:
Clinical trial NCT01734525
Conditions: Candidemia
Keywords: candidemia intensive care unit 1,3 beta-D-glucan
Sponsor: Universidade Federal do Rio de Janeiro
Start date: 2012-11-01; Completion date: 2013-12-01
Enrollment: 85 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.

Therefore, the objectives of this study are:

1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
2. To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.

Detailed description:
Entry criteria are: In the ICU for \>2 days AND systemic antibiotics \>2 days OR central venous catheter for \>days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.

Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.

If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (\>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for \>14 days.

Arms: arm 1: Patients at risk will receive therapy with anidulafungin
Interventions: intervention 1: Anidulafungin
Intervention descriptions: intervention 1: Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards

Protocol documents:
Clinical trial NCT01735617
Conditions: Endocrine Disease Adrenal Insufficiency Congenital Adrenal Hyperplasia
Keywords: congenital adrenal hyperplasia glucocorticoids cortisol adrenal
Sponsor: Neurocrine UK Limited
Start date: 2012-12-01; Completion date: 2013-12-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone cortisol, which is released in the body following a regular daily pattern. The objective of the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream once Chronocort® is taken and what affects it has on other hormones in the body. Since Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is hoped that patients with CAH will be treated more effectively to manage their disease.

Detailed description:
This study is a Phase 2 pilot study to characterize and examine the pharmacokinetics and efficacy profile of Chronocort® in adults with congenital adrenal hyperplasia (CAH). It is designed as a two-part, single cohort, open label, multiple dose Phase 2 pilot study to: (Part A) characterize and examine the pharmacokinetics (PK) and disease bio-marker behavior following short-term dosing with Chronocort®; and to (Part B) examine the disease control after six months dose titration with Chronocort® in adults with CAH.

Arms: arm 1: Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response
Interventions: intervention 1: Hydrocortisone Modified Release Capsules
Intervention descriptions: intervention 1: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Protocol documents:
Clinical trial NCT01736397
Conditions: Iron Deficiency Iron Deficiency Anemia
Keywords: CKD Chronic Kidney Disease Phosphorus Iron Deficiency Iron Deficiency Anemia Elevated Phosphorus
Sponsor: Keryx Biopharmaceuticals
Start date: 2012-11-01; Completion date: 2013-12-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.

Detailed description:
This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.

Arms: arm 1: Ferric citrate will be taken with or within one hour of meals or snacks. The starting dose of ferric citrate is 3 tablets/day and titrated by the subject's serum phosphorus results at each treatment visit. arm 2: Placebo will be taken with or within one hour of meals or snacks. The starting dose of placebo is 3 tablets per day and titrated by the subject's serum phosphorus results at each treatment visit.
Interventions: intervention 1: Ferric Citrate intervention 2: Placebo
Intervention descriptions: intervention 1: Dose depends on serum phosphorus levels collected at each study visit. intervention 2: None

Protocol documents:
Clinical trial NCT01739361
Conditions: Severe Sepsis
Sponsor: Vanderbilt University
Start date: 2013-04-01; Completion date: 2013-12-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cell-free hemoglobin can be measured in the plasma of patients with sickle cell anemia, hemodialysis, after red blood cell transfusion, and in patients with sepsis. Cell-free hemoglobin in these patient population has been associated with poor outcomes, including an association with an increased risk of death. Acetaminophen may have a protective effect in these patient populations by inhibiting hemoprotein-mediated lipid peroxidation. The purpose of the present trial is to study the effect of acetaminophen on lipid peroxidation in adults with severe sepsis and detectable cell-free hemoglobin.

The primary hypothesis is that systemic markers of oxidative stress and lipid peroxidation, as measured by F2-isoprostanes, will be significantly lower in patients with severe sepsis and detectable cell-free hemoglobin who receive acetaminophen compared to placebo. The secondary hypothesis is that patients with severe sepsis and detectable cell-free hemoglobin treated with acetaminophen will have better clinical outcomes, including decreased incidence of acute kidney injury and lower rates of hospital mortality, compared to those who receive placebo.

Detailed description:

Arms: arm 1: Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours. arm 2: Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.
Interventions: intervention 1: Acetaminophen intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: