ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02121067
Conditions: Contraception Malposition of Intrauterine Contraceptive Device
Keywords: postpartum contraception intrauterine device intrauterine system mirena uterine involution
Sponsor: University of North Carolina, Chapel Hill
Start date: 2014-09-01; Completion date: 2016-06-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.

Detailed description:

Arms: arm 1: Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
Interventions: intervention 1: Levonorgestrel Intrauterine System (LNG-IUS)
Intervention descriptions: intervention 1: The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled

Protocol documents:
Clinical trial NCT02122146
Conditions: Neoplasms
Keywords: ADC PF-06664178 solid tumors tumors neoplasm metastasis NSCLC non small cell lung cancer OVCA ovarian cancer Phase 1 breast cancer
Sponsor: Pfizer
Start date: 2014-08-01; Completion date: 2016-06-01
Enrollment: 31 participants; Allocation: ; Intervention model: 

Brief summary:
To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Detailed description:

Arms: arm 1: Experimental
Interventions: intervention 1: PF-06664178 intervention 2: PF-06664178
Intervention descriptions: intervention 1: Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined. intervention 2: Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.

Protocol documents:
Clinical trial NCT02128828
Conditions: AIDS Dementia Complex HIV-1-Associated Cognitive Motor Complex Human Immunodeficiency Virus
Keywords: AIDS Dementia Complex HIV-1-Associated Cognitive Motor Complex Human Immunodeficiency Virus
Sponsor: University of Hawaii
Start date: 2014-04-01; Completion date: 2016-06-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals with cognitive impairment. The investigators will study the effect of cenicriviroc on cognition in 24 subjects over a 24 week period.

Detailed description:
HIV-associated neurocognitive disease (HAND), particularly in its milder form, is estimated to occur in greater than 30% of HIV infected individuals in the era of potent antiretroviral therapy. As even mild disease leads to functional consequences with decreased ability to live independently, HAND is of substantial public health concern. HIV-induced immune activation/inflammation of monocytes (MO) may be primarily responsible for the development of HAND.

Cenicriviroc is a combined CCR5 and CCR2 chemokine co-receptor antagonist. The investigators hypothesize that dual CCR5 and CCR2 blockade with the use of CVC will lead to measurable reductions in MO activation and lead to cognitive improvement by decreasing HIV infection of MO and by interrupting the trafficking of such MO into the central nervous system.

The investigators propose a single arm, 24-week trial of CVC in 24 subjects with HIV-1 infection suppressed on ART (plasma HIV RNA \< 50 copies/ml) for 1 year or more with mild to moderate cognitive impairment.

Arms: arm 1: cenicriviroc 50 mg tablets, number of tablets adjusted for other antiretroviral medications or other drugs, given once daily
Interventions: intervention 1: cenicriviroc
Intervention descriptions: intervention 1: cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc

Protocol documents:
Clinical trial NCT02135107
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease
Sponsor: Eisai Co., Ltd.
Start date: 2013-09-01; Completion date: 2016-06-01
Enrollment: 517 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of rabeprazole 10mg once and twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.

Detailed description:
This is randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks. The 8-week Treatment Period (unblinded) was followed by a 52-week Maintenance Period (blinded). Participants with cure (modified Los Angeles Classification Grade N or Grade M) at the final endoscopy of the Treatment Period were entered into the Maintenance Period. Participants without cure were discontinued from the study. The participants in the Treatment Period were randomized to take Arm C or Arm D at a ratio of 1:1. The non-recurrence rate as endoscopically confirmed at 52 weeks shall be the primary end point, and this shall be examined through a randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of rabeprazole 10mg twice daily over a period of 52 weeks.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Rabeprazole intervention 2: Rabeprazole intervention 3: Rabeprazole intervention 4: Rabeprazole
Intervention descriptions: intervention 1: Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). intervention 2: Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded). intervention 3: Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind). intervention 4: Rabeprazole 10 or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).

Protocol documents:
Clinical trial NCT02140593
Conditions: Gastrointestinal Cancer
Sponsor: Herlev Hospital
Start date: 2014-09-01; Completion date: 2016-06-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade.

The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.

Detailed description:

Arms: arm 1: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo). arm 2: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Interventions: intervention 1: Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo). intervention 2: Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02156076
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Bristol-Myers Squibb
Start date: 2014-07-25; Completion date: 2016-06-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD, respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will reduce AF burden as compared to baseline relative to placebo.

Detailed description:
Primary Purpose: Protocol designed to assess, by the use of long term non-invasive beat-to-beat monitoring with the SEEQ Mobile Cardiac Telemetry (MCT) system, the effect of BMS-919373 on the percent change from baseline relative to placebo of atrial fibrillation burden in subjects with paroxysmal atrial fibrillation.

Arms: arm 1: Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days arm 2: BMS-919373 3 mg tablets orally once daily for approximately 28 days arm 3: BMS-919373 5 mg tablets orally once daily for approximately 28 days arm 4: BMS-919373 12 mg tablets orally once daily for approximately 28 days
Interventions: intervention 1: BMS-919373 intervention 2: Placebo (Matching with BMS-919373)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02168439
Conditions: Laceration Anxiety
Keywords: Dexmedetomidine Midazolam
Sponsor: University of Pittsburgh
Start date: 2014-06-01; Completion date: 2016-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.

Detailed description:

Arms: arm 1: Intranasal Dexmedetomidine 2 micrograms/kilogram once arm 2: Intranasal Midazolam 0.4 milligram/kilogram
Interventions: intervention 1: Dexmedetomidine intervention 2: Midazolam
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02182492
Conditions: Chronic Rhinosinusitis Endoscopic Sinus Surgery
Sponsor: Zheng Liu
Start date: 2014-01-01; Completion date: 2016-06-01
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Endoscopic sinus surgery (ESS) is widely considered to be the gold standard in the surgical management of chronic rhinosinusitis (CRS) that has failed maximal medical therapy. Nevertheless, the postoperation medical therapy was considered as a crucial procedure for the success of ESS. Both glucocorticoids and macrolide antibiotics have been recommended for the treatment of CRS, but their effect as postoperation medical therapies of ESS need more clinical data to clarify.

The purpose of this prospective, randomized,study is to determine the effect of glucocorticoids and macrolide antibiotics for the postoperation medical therapy of ESS in different subtypes of CRS.

Detailed description:
Chronic rhinosinusitis (CRS) is a multifactorial inflammatory disorder that causes various symptoms including nasal obstruction, rhinorrhea, olfactory dysfunction, facial pain, and headache . Endoscopic sinus surgery (ESS) is usually recommended for patients who do not response well to conservative treatments. Although surgery is effective to alleviate symptoms and improve the quality of life of CRS patients, a followed long-term postoperative medical treatment is indispensable. Current European and American guidelines recommend glucocorticoids and antibiotics as the primary pharmacotherapeutic approaches for CRS before and after ESS. However, there are a number of CRS patients not responding well to glucocorticoid treatment and conflicting results exist regarding the efficacy of long-term, low-dose macrolide treatment. One potential reason is that CRS is a heterogeneous group of disorders unified by similar clinical presentations and its phenotypes and/or endotypes may be important factors determining the efficacy of treatments.

Arms: arm 1: Fluticasone propionate nasal spray arm 2: Clarithromycin tablet
Interventions: intervention 1: Clarithromycin intervention 2: Glucocorticoid
Intervention descriptions: intervention 1: Clarithromycin 250 mg tablet once daily for 3 months intervention 2: Fluticasone propionate nasal spray 200 μg/d for 3 months

Protocol documents:
Clinical trial NCT02199743
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: schizophrenia schizoaffective cognition lurasidone Latuda
Sponsor: University of Texas Southwestern Medical Center
Start date: 2013-02-01; Completion date: 2016-06-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
24 individuals with schizophrenia or schizoaffective disorders, who are currently considered stable, will be recruited, screened for entry criteria into a blinded study with a 4-week randomization to either lurasidone, haloperidol, or perphenazine to examine glutamate-related outcomes with lurasidone as compared to haloperidol and perphenazine.

Detailed description:
At study start all volunteers will be discontinued from their current antipsychotic drug (APD) and switched to haloperidol 4mg for 5 days. At the end of this discontinuation period, all baseline symptom ratings and cognition testing will be done, as well as the baseline imaging procedures. At the end of the baseline procedures, volunteers will be blindly randomized, either to lurasidone at 40mg (N=12), or to haloperidol at 4mg/d or perphenazine at 16mg/d (N=12). Doses will increase to 80mg/d lurasidone, 8 mg/d haloperidol, or 32 mg/d of perphenazine at the beginning of week two. Dose should be stable for the last 3 weeks of treatment unless side effects are prominent, then the dose can be decreased to 40 lurasidone/4 haloperidol/16 perphenazine mg/d for optimal clinical management. The randomization strategy will be designed and implemented by the research pharmacist in four blocks of six volunteers; drug will be dispensed by the research pharmacy according to the randomization schedule. The randomization will be followed by a four week treatment period at optimal dose levels. On the last two days of the 4 week stable dosing period, the specified glutamate outcome measures will be completed (neuroimaging and cognitive testing) along with all the symptom outcome measures, testing for drug plasma levels, and usual blood safety measures. Patients will be seen weekly for clinical evaluation; suicidality will be monitored weekly. All medications other than study drugs will be discontinued, as much as possible, for the 24-48 hr assessment period. After the evaluation phase, patients will be cross-titrated back to their original treatment medication and dosing.

This design will generate outcomes from 12 patients on lurasidone vs. 12 patients on haloperidol/ perphenazine.

Arms: arm 1: Lurasidone 40mg po qhs with food x 1 week; Lurasidone 80mg po qhs with food x 3 weeks arm 2: Haloperidol 4mg po qhs with food x 1 week; Haloperidol 8mg po qhs with food x 3 weeks. arm 3: Perphenazine 16mg po qhs with food x 1 week; Perphenazine 32mg po qhs with food x 3 weeks.
Interventions: intervention 1: Lurasidone intervention 2: Haloperidol intervention 3: Perphenazine
Intervention descriptions: intervention 1: Compare to haloperidol and perphenazine intervention 2: Compare to lurasidone intervention 3: Compare to lurasidone

Protocol documents:
Clinical trial NCT02214420
Conditions: Hepatitis C
Sponsor: SC Liver Research Consortium, LLC
Start date: 2014-10-01; Completion date: 2016-06-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prior trials have shown that many G1 CHC patients are ineligible or intolerant to pegylated (PEG)-based regimens due to prior severe side effects, worsening of cytopenias, exacerbation of underlying psychiatric disorders, or autoimmune disorders. These patients will not be candidates for treatment with the approvals of SMV and SOF in early 2014 due to the combination with PEG-regimens. Results of the COSMOS study suggest that these patients are likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy, and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed in order to confirm this hypothesis.

Detailed description:

Arms: arm 1: IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) arm 2: IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day
Interventions: intervention 1: Simeprevir intervention 2: Sofosbuvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02218463
Conditions: Prepubertal Labial Adhesions
Keywords: Vulvar disease, adhesions, topical therapy Labial adhesions prepubertal girls Labial agglutination Labial fusion
Sponsor: Children's Mercy Hospital Kansas City
Start date: 2014-09-01; Completion date: 2016-06-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
First-line treatment for labial adhesions in prepubertal girls has been topical estrogen. This study aims to evaluate an alternative and less costly option of treatment with potentially less side effects.

Primary Hypothesis:

There will be a difference in complete resolution of labial adhesions with topical estrogen with lateral traction as compared to an emollient with lateral traction.

Detailed description:
The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in combination with vulvar irritation. For many years, first-line treatment for labial adhesions in prepubertal girls has been topical estrogen. With the use of topical estrogen, 50% of labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of treatment. However, because topical estrogen is systemically absorbed, its use is associated with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical estrogen. In addition, topical estrogen is costly. Therefore, there continues to be controversy over the optimal treatment of labial adhesions in prepubertal girls.

Generally, for medical treatment of labial adhesions, topical estrogen is applied to the adhesion whist applying gentle lateral traction to promote separation of the labia. It is, therefore, plausible that the lateral traction applied to the adhesion site is what ultimately results in the separation of the labial fusion, while the use of estrogen improves healing after mechanical separation.

This is a single site, prospective, randomized, double-blinded study evaluating the comparative effectiveness of topical estrogen with lateral traction versus topical emollient with lateral traction for the treatment of labial adhesions in prepubertal girls.

Arms: arm 1: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily arm 2: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
Interventions: intervention 1: Estradiol cream 0.01% intervention 2: Cetaphil
Intervention descriptions: intervention 1: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily intervention 2: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily

Protocol documents:
Clinical trial NCT02224274
Conditions: Cardiac Arrest Postresuscitation Syndrome Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)
Keywords: Antiplatelet Therapy Cardiac Arrest Therapeutic hypothermia Myocardial infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)
Sponsor: University Medical Centre Ljubljana
Start date: 2014-08-01; Completion date: 2016-06-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after cardiac arrest as in normothermic patients. The reasons for this are probably slower gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism we expect its effect to be good even in patients with therapeutic hypothermia after cardiac arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous coronary intervention will be randomised into two groups. One will be treated with ASA and clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before and 2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will be measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the groups will be analysed.

Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia and percutaneous coronary intervention (PCI).

Detailed description:

Arms: arm 1: These patients will be treated with clopidogrel 600 mg loading and than 75 mg/24 h. arm 2: These patients will be treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Interventions: intervention 1: Clopidogrel intervention 2: Ticagrelor
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: