ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01507181
Conditions: Suicidal Ideation
Keywords: suicidal ideation major depression treatment resistant ketamine glutamate
Sponsor: James Murrough
Start date: 2012-01-01; Completion date: 2014-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effects of Intravenous (IV) ketamine both in an outpatient population and with subjects on the inpatient unit with suicidal ideation (SI).

Detailed description:
Depression is a debilitating disorder that affects 12-20% of population and is among the top five leading causes of burden of disease worldwide (Kruijshaar ME 2005). Suicide associated with depression and other psychiatric disorders is a pervasive public health problem and results in almost one million deaths per year. Unfortunately, current treatments for severe depression have limited efficacy for suicidality, specifically due to the slow time course of change in suicidal thoughts. Recently ketamine, a glutamate-modulating agent, was shown to have antidepressant and anti-suicidal effect in outpatient depressed patients. The proposed study will test the ability of a single sub-anesthetic intravenous (IV) dose of the glutamate NMDA receptor antagonist, ketamine, to provide rapid decrease in suicidal ideation (SI) in patients hospitalized with SI. In this randomized parallel-arm placebo controlled trial, ketamine is compared to midazolam, which is expected to mimic some of the acute subjective effects of ketamine but not have any sustained antidepressant effects.

Specific Aim 1: To determine feasibility and tolerability of a single low-dose IV infusion of ketamine in patients with prominent SI and elevated risk for suicide.

Hypothesis 1: Ketamine administration will be feasible and well tolerated in patients admitted to a psychiatric hospital with SI.

Specific Aim 2: To test the efficacy of a single IV dose of ketamine, compared to an anesthetic control condition (midazolam), to rapidly reduce SI in a controlled hospital setting.

Hypothesis 2: Ketamine will be associated with significant and rapid reductions in SI and depressive symptoms within 24 hours.

This study will test the rapid anti-suicidal effect of a single IV dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine in suicidality compared with the clinical response to a single IV dose of the short-acting benzodiazepine midazolam. Midazolam is able to induce transient neuropsychiatric effects mimicking ketamine and therefore is expected to protect the integrity of the blind. Participants will continue to receive standard treatment for their psychiatric condition throughout the trial. This unique "proof-of-concept" study in suicidal patients will be conducted over three-year period.

Arms: arm 1: single dose IV ketamine, .5mg/kg arm 2: single dose IV midazolam, .45mg/kg
Interventions: intervention 1: Ketamine intervention 2: Midazolam
Intervention descriptions: intervention 1: single dose IV ketamine, .5mg/kg infused over 40 minutes intervention 2: single dose IV midazolam, .45mg/kg infused over 40 minutes

Protocol documents:
Clinical trial NCT01514240
Conditions: Crohn's Disease
Keywords: mild to moderate active Crohn's disease affecting ileum ileocecal region ascending colon score of 180-400 on the CDAI
Sponsor: AstraZeneca
Start date: 2012-02-01; Completion date: 2014-09-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of ≤ 150.

Detailed description:
A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn's Disease (CD) in Japan

Arms: arm 1: D9421-C 9 mg once daily arm 2: Mesalazine 1 g three times a day
Interventions: intervention 1: D9421-C capsule 3 mg intervention 2: Mesalazine tablets
Intervention descriptions: intervention 1: Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks. intervention 2: Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.

Protocol documents:
Clinical trial NCT01525238
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2012-07-01; Completion date: 2014-09-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

Detailed description:
Primary purpose: The primary purpose is to assess the pharmacokinetics of a single dose of Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with T2DM

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Dapagliflozin
Intervention descriptions: intervention 1: Tablet, Oral, 2.5 mg, Single-dose intervention 2: Tablet, Oral, 5 mg, Single-dose intervention 3: Tablet, Oral, 10 mg, Single-dose

Protocol documents:
Clinical trial NCT01568944
Conditions: Chronic Periodontitis
Keywords: periodontal disease dendritic cells antibiotics
Sponsor: Augusta University
Start date: 2012-03-01; Completion date: 2014-09-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.

Detailed description:
To address this hypothesis, a clinical study in humans with moderate to severe chronic periodontitis has been designed. This is an interventional study involving scaling and root planing and two arms: 1. treatment with PO amoxocillin/metronidazole plus chlorhexidine oral rinse; 2. no antibiotics or oral rinse. It is expected that the antibiotics plus chlorhexidine will prevent the dendritic cell response to infection (bacteremia) elicited by scaling and root planing.

Arms: arm 1: Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg arm 2: Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Interventions: intervention 1: Oral Antibiotic and Oral Rinse intervention 2: Standard Treatment
Intervention descriptions: intervention 1: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID intervention 2: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers

Protocol documents:
Clinical trial NCT01585155
Conditions: Pediatric Ulcerative Colitis
Keywords: Infliximab REMICADE TA-650
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-02-01; Completion date: 2014-09-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also evaluated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TA-650
Intervention descriptions: intervention 1: TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.

Protocol documents:
Clinical trial NCT01598545
Conditions: Postoperative Pain
Sponsor: Emory University
Start date: 2013-02-01; Completion date: 2014-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.

Detailed description:

Arms: arm 1: Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
Interventions: intervention 1: Hydromorphone
Intervention descriptions: intervention 1: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.

Protocol documents:
Clinical trial NCT01603459
Conditions: Spasticity of the Upper and Lower Limb Due to Cerebral Causes
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2012-05-01; Completion date: 2014-09-01
Enrollment: 155 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

Detailed description:
A dose-titration approach will be used over three injection cycles, with a flexible observation period after injections of 12-16 weeks and a total duration of up to 48 weeks. Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be treated.

Arms: arm 1: IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
Interventions: intervention 1: IncobotulinumtoxinA
Intervention descriptions: intervention 1: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.

For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.

Protocol documents:
Clinical trial NCT01614067
Conditions: Diminished Ovarian Reserve Infertility In Vitro Fertilization
Keywords: DOR Infertility IVF ART GnRHa GnRH Antagonist Protocol Ganirelix
Sponsor: University of California, San Francisco
Start date: 2012-05-01; Completion date: 2014-09-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In couples with infertility secondary to Diminished Ovarian Reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.

Detailed description:
Over the past two decades, the success rate of assisted reproductive technology (ART) has dramatically increased. This increase is attributed to improvements in embryo culture, laboratory conditions, and optimization of ovarian stimulation protocols. Over the past years, there has been more interest in altering the ovarian stimulation protocol to improve outcomes. For example, recently our group found that a modification of ovulation trigger toward a more physiologic process improves oocyte quality and pregnancy outcomes. Others have suggested minimal stimulation improves in vitro fertilization (IVF) outcomes. The investigators propose to further investigate modifying the ovarian stimulation for women who have "decreased" ovarian reserve. The investigators propose that a delayed start to ovarian stimulation will improve oocyte maturation and quality and pregnancy outcomes. No published studies to date have evaluated if a delayed start to ovarian stimulation improves pregnancy outcomes. However, the investigators hypothesize that the use an antagonist for a delayed start of stimulation will work by one of two mechanisms:

I. The partial suppression of FSH will allow for further recruitment of early antral follicles.

II. The partial suppression of FSH will allow for further FSH responsiveness in existing follicles to synchronize the primary cohort, thereby increasing the total number of follicles.

Arms: arm 1: Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH. arm 2: Ovarian stimulation with standard antagonist protocols (no delay).
Interventions: intervention 1: Ganirelix acetate
Intervention descriptions: intervention 1: Subjects will receive 7 days of pre-treatment with the GnRH antagonist

Protocol documents:
Clinical trial NCT01628913
Conditions: Pancreatic Neuroendocrine Tumors (pNET)
Keywords: Pancreatic Neuroendocrine tumors PNET BEZ235 Everolimus
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-01; Completion date: 2014-09-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).

Detailed description:
Patients with advanced (unresectable or metastatic), low to intermediate grade (histologically confirmed well and moderately differentiated) pancreatic neuroendocrine tumor (pNET) were randomized to either BEZ235 or everolimus. The study was planned to include 140 patients, with 70 patients in the BEZ235 treatment group and 70 patients in the everolimus treatment group. An interim analysis was conducted on 62 randomized patients. The study was terminated as the BEZ235 treatment did not demonstrate a progression free survival advantage to everolimus treatment.

Arms: arm 1: Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily) arm 2: Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
Interventions: intervention 1: BEZ235 intervention 2: Everolimus
Intervention descriptions: intervention 1: BEZ235 400 mg bid p.o. (by mouth, twice daily) intervention 2: Everolimus 10 mg qd p.o. (by mouth, daily)

Protocol documents:
Clinical trial NCT01640925
Conditions: Cross Infection Pneumonia, Ventilator-associated Catheter-related Infections Infection Due to Indwelling Urinary Catheter Surgical Wound Infection
Keywords: nosocomial infection hospital acquired infection chlorhexidine pneumonia, ventilator-associated catheter-related infections urinary tract infections, catheter-related surgical site infection
Sponsor: Joshua Swan
Start date: 2012-07-01; Completion date: 2014-09-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).

Detailed description:
Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU.

Hypothesis: Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.

Arms: arm 1: Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that. arm 2: Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Interventions: intervention 1: Chlorhexidine gluconate intervention 2: Standard bathing
Intervention descriptions: intervention 1: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours intervention 2: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.

Protocol documents:
Clinical trial NCT01644643
Conditions: Complicated Urinary Tract Infection Complicated Intra-abdominal Infection
Keywords: Ceftazidime, avibactam, metronidazone, Anti-Infectives
Sponsor: Pfizer
Start date: 2013-01-01; Completion date: 2014-09-01
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

Detailed description:
An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant Gram Negative Pathogens

Arms: arm 1: IV treatment arm 2: IV treatment
Interventions: intervention 1: Ceftazidime - Avibactam ( CAZ-AVI) intervention 2: Best Available Therapy intervention 3: Metronidazole
Intervention descriptions: intervention 1: Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes intervention 2: Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation intervention 3: Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion

Protocol documents:
Clinical trial NCT01654107
Conditions: Tobacco Use Disorder
Keywords: tobacco smoking cessation nicotine dependence
Sponsor: Rutgers, The State University of New Jersey
Start date: 2012-07-01; Completion date: 2014-09-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. The investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence).

Detailed description:
In this Stage I Behavioral \& Integrative Treatment Development (R34) project, we propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial.

Arms: arm 1: Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge arm 2: Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge
Interventions: intervention 1: Persistence Targeted Smoking Cessation intervention 2: Clearing The Air intervention 3: Nicotine lozenge
Intervention descriptions: intervention 1: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation") intervention 2: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air intervention 3: 12-weeks 4mg nicotine lozenge

Protocol documents: