ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01565850
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment-Naive
Sponsor: Gilead Sciences
Start date: 2012-04-01; Completion date: 2014-02-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.

Detailed description:

Arms: arm 1: D/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo arm 2: DRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo
Interventions: intervention 1: D/C/F/TAF intervention 2: DRV intervention 3: COBI intervention 4: FTC/TDF intervention 5: D/C/F/TAF Placebo intervention 6: DRV Placebo intervention 7: COBI Placebo intervention 8: FTC/TDF Placebo
Intervention descriptions: intervention 1: DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily intervention 2: DRV 800 mg (2 × 400 mg tablets) administered orally once daily intervention 3: COBI 150 mg tablet administered orally once daily intervention 4: FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily intervention 5: D/C/F/TAF placebo tablet administered orally once daily intervention 6: DRV placebo tablet administered orally once daily intervention 7: COBI placebo tablet administered orally once daily intervention 8: FTC/TDF placebo tablet administered orally once daily

Protocol documents:
Clinical trial NCT01577758
Conditions: Advanced Gastrointestinal Malignancies
Keywords: Phase 1, Advanced gastrointestinal malignancies, MLN0264, Guanylyl Cyclase C(GCC), Antibody Drug Conjugate(ADC)
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2012-06-01; Completion date: 2014-02-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.

Detailed description:

Arms: arm 1: MLN0264 starting dose 0.3 mg/kg escalated until Maximum Tolerated Dose (MTD) was determined, 30-minute infusion, on Day 1 of each 21-Day treatment cycle.
Interventions: intervention 1: MLN0264
Intervention descriptions: intervention 1: MLN0264 30-minute infusion on Day 1 of each treatment cycle

Protocol documents:
Clinical trial NCT01587989
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2012-02-01; Completion date: 2014-02-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: methotrexate intervention 2: methotrexate intervention 3: placebo intervention 4: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 15-25 mg orally weekly, Weeks 1-12 intervention 2: 15-25 mg orally weekly, Weeks 13-24 intervention 3: methotrexate placebo orally weekly, Weeks 13-24 intervention 4: 8 mg/kg iv every 4 weeks, 24 weeks

Protocol documents:
Clinical trial NCT01590888
Conditions: Huntington Disease
Sponsor: Prana Biotechnology Limited
Start date: 2012-04-01; Completion date: 2014-02-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Huntington disease (HD) is an inherited neurodegenerative disease which affects over 30,000 people in both the United States and Australia. HD is characterized by brain cell death that usually begins between the ages of 30 to 50, and results in motor, cognitive and behavioral signs and symptoms. While there are medications to help relieve some of the disease symptoms, there is no known treatment to address the cognitive impairment associated with HD.

Normally occurring metals in the brain play a significant role in diseases such as Alzheimer disease and HD. PBT2 is a drug designed to interrupt interactions between these biological metals and target proteins in the brain, to prevent deterioration of brain cells. PBT2, has shown in animal models, and as well as in a small group of patients with Alzheimer's disease, it may improve cognition. There is some indication in animal models of HD, that the drug may improve motor function and control and reduce the amount of brain cell degeneration.

PBT2-203 will evaluate how safe and well tolerated PBT2 is at a dose of 100 mg or 250 mg a day administered as oral daily capsules compared to a placebo over a six month treatment period. The trial will also measure whether there is an effect on cognitive abilities as well as other HD symptoms including motor and overall functioning of individuals with HD.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: PBT2 intervention 2: PBT2 intervention 3: Placebo
Intervention descriptions: intervention 1: 250mg capsules administered orally once per day for 26 weeks intervention 2: 100mg capsules administered orally once per day for 26 weeks intervention 3: Matching capsules administered orally once per day for 26 weeks

Protocol documents:
Clinical trial NCT01597557
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation Electrical Cardioversion Magnesium Sulfate
Sponsor: State University of New York at Buffalo
Start date: 2012-04-01; Completion date: 2014-02-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed study is designed to evaluate the effect of an intravenous infusion of magnesium sulfate in facilitating successful cardioversion of atrial fibrillation and in decreasing the energy threshold (in J) required for successful cardioversion of atrial fibrillation into sinus rhythm.

Detailed description:
Patients with atrial fibrillation may suffer from disabling symptoms such as palpitations, shortness of breath or worsening heart failure. In such patients, it may be beneficial to convert their rhythm to sinus rhythm. Cardioversion can be achieved either pharmacologically or electrically. Pharmacological cardioversion is less successful acutely than electrical cardioversion and may be associated with complications such as prolongation of the QT interval and torsades de pointes (polymorphic ventricular tachycardia). Thus, cardioversion is most often accomplished electrically, using biphasic synchronized shocks of 75-200 Joules. Biphasic electrical cardioversion in atrial fibrillation has shown to be successful (i.e., converting to sinus rhythm) about 88% of the time, on average. The success rate appears to largely depend upon the duration of the arrhythmia and the presence and severity of structural heart disease.

In this study, we will evaluate the effect of intravenous magnesium sulfate on the success rate of electrical cardioversion, and also assess its effect in decreasing the energy levels needed for successful cardioversion. If the study is successful, we will have shown that a simple and inexpensive intervention can increase the success rate of electrical cardioversion, increasing the proportion of patients who can be restored to sinus rhythm. In addition, success with lower energy levels may improve the safety of cardioversion, as high energy levels are more likely to be associated with side effects

Arms: arm 1: Patients in this arm are give magnesium sulfate 2 grams intravenous drip before the cardioversion procedure arm 2: Patients in this arm receive normal saline drip intravenously before the cardioversion procedure
Interventions: intervention 1: Magnesium Sulfate intervention 2: Placebo
Intervention descriptions: intervention 1: 2 grams intravenous drip over 30 minutes intervention 2: Normal Saline 50 ml intravenous drip over 30 minutes

Protocol documents:
Clinical trial NCT01598506
Conditions: Labor Pain
Sponsor: Emory University
Start date: 2013-09-01; Completion date: 2014-02-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the dose of hydromorphone which will relieve the pain of women in labor 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 4 out of 10 thirty minutes after intrathecal injection in 50% of women. Secondary objectives include determining this dose at five and ten minutes after injection. Thirty women admitted to labor and delivery for planned vaginal delivery desiring epidural placement 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 and the epidural is placed, visual analogue pain scores will be assessed 60 minutes following injection. 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, fetal heart rate, and any side effects will also be assessed.

Detailed description:

Arms: arm 1: Laboring patients 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 NCT01600014
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2012-05-01; Completion date: 2014-02-01
Enrollment: 463 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.

Detailed description:

Arms: arm 1: Topical field treatment once daily for 3 consecutive days on the face or scalp arm 2: Topical field treatment once daily for 3 consecutive days on the face or scalp
Interventions: intervention 1: Ingenol mebutate gel, 0.015% intervention 2: Vehicle gel
Intervention descriptions: intervention 1: Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015% intervention 2: Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%

Protocol documents:
Clinical trial NCT01631474
Conditions: Acne Vulgaris
Keywords: acne anti-androgen clascoterone cassiopea
Sponsor: Intrepid Therapeutics, Inc.
Start date: 2012-06-01; Completion date: 2014-02-01
Enrollment: 363 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.

Detailed description:

Arms: arm 1: low dose of CB-03-01, 0.1% applied twice a day arm 2: medium dose of CB-03-01, 0.5% applied twice a day arm 3: high dose of CB-03-01, 1% applied once a day arm 4: high dose of CB-03-01, 1% applied twice a day arm 5: vehicle cream, applied once or twice a day
Interventions: intervention 1: CB-03-01 intervention 2: Vehicle intervention 3: CB-03-01
Intervention descriptions: intervention 1: Topical cream, applied once a day intervention 2: Topical cream, applied once or twice a day intervention 3: Topical cream, applied twice a day

Protocol documents:
Clinical trial NCT01641120
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Intramuscular Injections Relapsing Remitting
Sponsor: Trinity Health Of New England
Start date: 2012-05-01; Completion date: 2014-02-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.

Detailed description:

Arms: arm 1: Subjects used a 30 gauge needle for intramuscular injection of Avonex. arm 2: Subjects used a 25 gauge needle for intramuscular injection of Avonex.
Interventions: intervention 1: Avonex
Intervention descriptions: intervention 1: Intramuscular injection administered using 25 gauge or 30 gauge needle

Protocol documents:
Clinical trial NCT01673984
Conditions: Prostate Cancer
Sponsor: Ipsen
Start date: 2012-08-01; Completion date: 2014-02-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.

Detailed description:

Arms: arm 1: None arm 2: One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Interventions: intervention 1: Decapeptyl® SR 22.5mg intervention 2: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
Intervention descriptions: intervention 1: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days). intervention 2: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall

Protocol documents:
Clinical trial NCT01683058
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-01-01; Completion date: 2014-02-01
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.

Detailed description:

Arms: arm 1: Aripiprazole IM Depot 400 mg or 300 mg once monthly (every 28 days) for 24 weeks
Interventions: intervention 1: Aripiprazole IM Depot
Intervention descriptions: intervention 1: Aripiprazole IM Depot 400 mg or 300 mg

Protocol documents:
Clinical trial NCT01689441
Conditions: Severe Sepsis or Septic Shock
Sponsor: Brigham and Women's Hospital
Start date: 2013-02-01; Completion date: 2014-02-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.

Detailed description:

Arms: arm 1: Calcitriol 2mcg IV x 1 arm 2: Normal saline 2cc IV x 1
Interventions: intervention 1: Calcitriol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01707381
Conditions: Ocular Hypertension Open Angle Glaucoma
Sponsor: Bausch & Lomb Incorporated
Start date: 2012-11-01; Completion date: 2014-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Detailed description:

Arms: arm 1: Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. arm 2: BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
Interventions: intervention 1: BOL-303259-X intervention 2: Timolol maleate
Intervention descriptions: intervention 1: Topical ophthalmic solution intervention 2: Topical ophthalmic solution

Protocol documents:
Clinical trial NCT01709903
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-01; Completion date: 2014-02-01
Enrollment: 744 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD

Detailed description:
To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.

The study population will consist of approximate 736 male and female adults (age 40 years and greater) with a clinical diagnosis of stable COPD \[GOLD (2010)\] and a smoking history of at least 10 pack years. It is anticipated that approximately 981 patients will need to be screened in order to randomize 736 patients into 2 treatment arms of the study with an equal randomization ratio, meaning QVA149 (368 patients), fluticasone/salmeterol (368 patients). Treatment randomization will be stratified by current/ex-smoker status and prior ICS use. It is intended that 552 patients will complete the study at Week 26 without major protocol deviations. Dropouts will not be replaced.

This will be a multi-national study, including China, and at least two other countries.

Standardization FEV1 AUC0-12h will be performed in a subgroup of around 100 patients (50 patients per treatment arm) in pre-selected centers.

Arms: arm 1: QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg arm 2: Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
Interventions: intervention 1: QVA149 intervention 2: Fluticasone/salmeterol intervention 3: Placebo to QVA149 intervention 4: Placebo to fluticasone/salmeterol
Intervention descriptions: intervention 1: QVA149 110/50 µg capsules q.d. for inhalation, delivered via Novartis single dose dry powder inhaler (SDDPI). intervention 2: Active fluticasone/salmeterol (500/50µg) b.i.d via a dry power inhaler Accuhaler® device. intervention 3: Placebo to QVA149 with SDDPI intervention 4: Placebo to fluticasone/salmeterol with Accuhaler

Protocol documents:
Clinical trial NCT01712516
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QVA149
Sponsor: Novartis Pharmaceuticals
Start date: 2012-12-01; Completion date: 2014-02-01
Enrollment: 1001 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

Detailed description:

Arms: arm 1: 27.5/12.5 ug twice daily (b.i.d.) Single Dose Dry Powder Inhaler (SDDPI arm 2: 27.5 ug b.i.d. arm 3: 12.5 ug b.i.d. arm 4: b.i.d.
Interventions: intervention 1: QVA149 intervention 2: QAB149 intervention 3: NVA237 intervention 4: Placebo
Intervention descriptions: intervention 1: QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI intervention 2: QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI. intervention 3: NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI. intervention 4: Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

Protocol documents:
Clinical trial NCT01713283
Conditions: Hepatitis C Virus
Sponsor: Gilead Sciences
Start date: 2012-10-01; Completion date: 2014-02-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Treatment-naive and treatment-experienced participants will receive SOF+RBV for 12 weeks. arm 2: Treatment-naive and treatment-experienced participants will receive SOF+RBV for 24 weeks.
Interventions: intervention 1: SOF intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents: