ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02131233
Conditions: HIV Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-05-23; Completion date: 2016-12-19
Enrollment: 802 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) \<40 copies/mL at Week 48.

Detailed description:

Arms: arm 1: Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks arm 2: Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
Interventions: intervention 1: Reformulated Raltegravir intervention 2: Raltegravir intervention 3: TRUVADA™ intervention 4: Placebo to Reformulated Raltegravir intervention 5: Placebo to Raltegravir
Intervention descriptions: intervention 1: Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily intervention 2: Raltegravir 400 mg tablet orally twice daily intervention 3: Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label) intervention 4: Placebo to reformulated raltegravir 2 tablets orally once daily intervention 5: Placebo to raltegravir 1 tablet orally twice daily

Protocol documents:
Clinical trial NCT01931670
Conditions: Endometriosis
Keywords: Non-Menstrual Pelvic Pain (NMPP) Dysmenorrhea (DYS) Elagolix Endometriosis Associated Pain Gonadotropin-Releasing Hormone Antagonist
Sponsor: AbbVie
Start date: 2013-09-09; Completion date: 2016-12-19
Enrollment: 815 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.

Detailed description:
The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

Arms: arm 1: Placebo twice daily (BID) for the 6-month Treatment Period arm 2: Elagolix 150 mg once daily (QD) for the 6-month Treatment Period arm 3: Elagolix 200 mg BID for the 6-month Treatment Period
Interventions: intervention 1: placebo intervention 2: Elagolix
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02017444
Conditions: Idiopathic Intracranial Hypertension
Keywords: Pseudotumor Cerebri Benign Intracranial Hypertension Headaches Tinnitus Papilledema Blindness Optic Disk Intracranial Hypertension Clinical Trial, Phase 2 11beta-Hydroxysteroid Dehydrogenase Type 1 Obesity
Sponsor: University of Birmingham
Start date: 2014-04-25; Completion date: 2016-12-19
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assessing the safety and effectiveness of a 11-βhydroxysteroid dehydrogenase type 1 inhibitor (AZD4017), in a placebo controlled trial, in acute idiopathic intracranial hypertension (IIH) IIH is a condition of young, overweight women with characteristic raised intracranial pressure (pressure around the brain) leading to papilloedema (swelling of the nerve supplying the eye), visual loss and headaches. Medical literature (Cochrane review) demonstrates there is little evidence for the treatments used for IIH. Weight control appears the most effective method of improving symptoms but weight loss is difficult to maintain. 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) is an enzyme which regulates local steroid levels and our previous research suggests it may influence the production of brain fluid(cerebrospinal fluid or CSF). 11β-HSD1 levels fall with weight loss and this is associated with with decreased intracranial pressure.

Our primary outcome is to determine whether AZD4017, an inhibitor of 11β-HSD1, will reduce the pressure in the brain and as a consequence improve IIH. Patients are eligible to enter the study if they are between 18-55 years old with acute (\<6 months) IIH, signs of active disease (papilloedema and raised CSF pressure (\>25 cmH20)), no other major illnesses and have no plans for pregnancy during the study period.

This is an MRC funded single centre, phase II, double-blinded, randomised control drug trial. It will be conducted at the University Hospital Birmingham and the University of Birmingham will act as Sponsor. Eligible participants will be randomly assigned to AZD4017 or a placebo ('dummy' with no active drug) for 3 months with a follow up a month later. Investigations during the study will include bloods, urine samples, pregnancy tests, lumbar punctures, DXA scans and small fat/skin biopsies. Participants will benefit from increased monitoring and a potential improvement in their condition.

We hypothesise that specific inhibition of 11β-HSD1 will decrease intracranial pressure and consequently treat patients with IIH, thus opening a new and entirely novel therapeutic avenue.

Detailed description:

Arms: arm 1: Matched placebo tablet B.D for 12 weeks arm 2: AZD4017 400mg tablet B.D. for 12 weeks
Interventions: intervention 1: AZD4017 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Matched placebo (matched to AZD4017 arm)

Protocol documents:
Clinical trial NCT02210195
Conditions: Cannabis Dependence Alcohol Dependence Cannabis Use Disorder Alcohol Use Disorder
Keywords: Cannabis Treatment Alcohol Treatment Alcohol-Related Disorders Cannabis-Related Disorders Substance-Related Disorders Emend NK1 receptor antagonist Alcohol Cannabis aprepitant
Sponsor: The Scripps Research Institute
Start date: 2014-09-04; Completion date: 2016-12-19
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The primary hypothesis is that subjects treated with aprepitant will have significantly less alcohol and marijuana use than subjects treated with placebo.

Detailed description:
Consistent with the scope and methods of the parent grant, this was a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants received weekly protocol-specific counseling. Research assessments occurred weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.

Arms: arm 1: 125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. arm 2: Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
Interventions: intervention 1: aprepitant intervention 2: Placebo intervention 3: Manual-guided behavioral counseling
Intervention descriptions: intervention 1: 125 mg daily for 8 weeks. intervention 2: Placebo daily for 8 weeks. intervention 3: Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.

Protocol documents:
Clinical trial NCT02392286
Conditions: Crohn's Disease Inflammatory Bowel Disease
Keywords: Corticosteroid
Sponsor: Yale University
Start date: 2015-03-01; Completion date: 2016-12-19
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.

Detailed description:
* Determine if weight-based corticosteroid (1mg/kg daily) induces remission at a greater rate than fixed corticosteroid dosage.
* Determine if weight-based corticosteroid is associated with greater rate of adverse events than fixed corticosteroid dosage.

Arms: arm 1: Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily. arm 2: Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Interventions: intervention 1: Corticosteroid
Intervention descriptions: intervention 1: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.

Protocol documents:
Clinical trial NCT00867113
Conditions: Gastrointestinal Stromal Tumor (GIST)
Keywords: Imatinib Protein Kinase Inhibitors Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Adjuvant PERSIST PERSIS-5
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-22; Completion date: 2016-12-20
Enrollment: 91 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The purpose of this trial is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST.

Detailed description:
This is a Phase II, non-randomized, open-label, multi-center study conducted in the USA. The primary endpoint is to evaluate the use of long term adjuvant imatinib mesylate in patients at significant risk for recurrence following complete resection of primary GIST. A total of 85 adult patients, 18 years of age and older will be enrolled.Participants will take 400 mg of imatinib mesylate daily by mouth for a total of 5 years. At the conclusion of the treatment period, patients will be followed for 2 years for survival, status of response and antineoplastic treatments and quality of life.

Arms: arm 1: All subjects received in tablet form imatinib (STI571) 400 mg once daily.
Interventions: intervention 1: imatinib mesylate
Intervention descriptions: intervention 1: imatinib mesylate was supplied in 100 and 400 mg tablets

Protocol documents:
Clinical trial NCT01174563
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-05-23; Completion date: 2016-12-20
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

Protocol documents:
Clinical trial NCT01210495
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Sponsor: Pfizer
Start date: 2010-12-06; Completion date: 2016-12-20
Enrollment: 224 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.

Detailed description:

Arms: arm 1: Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration arm 2: Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study
Interventions: intervention 1: Axitinib (AG-013736) intervention 2: Best Supportive Care intervention 3: Placebo intervention 4: Best Supportive Care
Intervention descriptions: intervention 1: Axitinib \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID intervention 2: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life. intervention 3: Placebo \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID intervention 4: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

Protocol documents:
Clinical trial NCT01294579
Conditions: Lymphoma, Non-Hodgkin
Keywords: Non-Hodgkin's Lymphoma Ofatumumab Relapsed Rituximab Bendamustine
Sponsor: Novartis Pharmaceuticals
Start date: 2011-05-17; Completion date: 2016-12-20
Enrollment: 49 participants; Allocation: ; Intervention model: 

Brief summary:
The purpose of this phase II open label study was is to evaluate the safety and efficacy of ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent B-NHL who had relapsed after Rituximab treatment. A maximum of 53 subjects at least 18 years old with Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, or follicular lymphoma; Grades 1, 2 and 3a, would have been enrolled (34 in Stage 1 and 19 in Stage 2). Subjects should have had Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following completion of therapy or subjects should have relapsed or have had disease progression following response to prior rituximab-based therapy a Eastern Cooperative Oncology Group (ECOG) Performance status of 0 1 or 2. During the induction phase, ofatumumab 1000 mg IV on day 1 of each cycle (cycles 1-6) were followed by Bendamustine 90 mg/m2 IV on days 1, 2 of each cycle (cycles 1-6).During the maintenance phase, subjects with a PR or CR after the induction phase received ofatumumab 1000 mg IV every 2 months for 2 years.

Detailed description:

Arms: arm 1: 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years.

Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
Interventions: intervention 1: Ofatumumab intervention 2: Bendamustine
Intervention descriptions: intervention 1: 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase

1000 mg IV every 2 months for 2 years intervention 2: 90 mg/m2 on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)

Protocol documents:
Clinical trial NCT01374906
Conditions: Cushing's Disease
Keywords: SOM230 Cushing's Disease Mean Urinary Free Cortisol Pasireotide Pasireotide LAR Pasireotide long-acting release secondary hypercortisolism secondary hypercorticism Itsenko-Cushing disease increased secretion of adrenocorticotropic hormone (ACTH) hyperpituitarism
Sponsor: Novartis Pharmaceuticals
Start date: 2011-11-04; Completion date: 2016-12-21
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

Detailed description:

Arms: arm 1: Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms. arm 2: Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms.
Interventions: intervention 1: pasireotide LAR intervention 2: SOM230 LAR 30 mg intervention 3: SOM230 LAR 10 mg
Intervention descriptions: intervention 1: Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \>1.5xULN unless titration was precluded by safety reasons). intervention 2: starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose. intervention 3: starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.

Protocol documents:
Clinical trial NCT02140411
Conditions: Retinal Vein Occlusion Age Related Macular Degeneration
Sponsor: Novartis Pharmaceuticals
Start date: 2015-04-25; Completion date: 2016-12-21
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration.

Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.

Detailed description:

Arms: arm 1: Ranibizumab treatment
Interventions: intervention 1: Ranibizumab Intravitreal injections
Intervention descriptions: intervention 1: Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.

Protocol documents:
Clinical trial NCT01576484
Conditions: Hypercholesterolemia Heterozygous Familial Hypercholesterolemia
Sponsor: Regeneron Pharmaceuticals
Start date: 2012-02-28; Completion date: 2016-12-22
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).

Detailed description:

Arms: arm 1: Participants who received placebo in parent study (NCT01576484), has received a subcutaneous injection of placebo matched to alirocumab every 2 weeks for 4 years in this study. arm 2: Participants who received alirocumab in parent study (NCT01576484), has received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.
Interventions: intervention 1: Alirocumab intervention 2: Placebo Matched to Alirocumab
Intervention descriptions: intervention 1: Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody intervention 2: Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody

Protocol documents:
Clinical trial NCT00951015
Conditions: Infection, Human Immunodeficiency Virus
Keywords: GSK1349572 emtricitabine tenofovir efavirenz abacavir antiretroviral therapy naive dose selection HIV-1 Infection integrase inhibitor HIV infection once daily lamivudine
Sponsor: ViiV Healthcare
Start date: 2009-07-30; Completion date: 2016-12-22
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

Detailed description:
This Phase IIb study in HIV-infected antiretroviral naive adult subjects will include a dose-ranging evaluation of GSK1349572 10mg, 25mg and 50mg once daily blinded doses and a control arm of open label efavirenz 600mg once daily. Background ART for all study subjects will be chosen by the investigators and will be either Truvada or Epzicom/Kivexa. Data from the three doses of GSK1349572 will be compared on the basis of antiviral activity, safety/tolerability and pharmacokinetics over 16-24 weeks.

Several planned interim analyses will evaluate data in real time; any doses considered inferior will be dropped and subjects on those doses of GSK1349572 will have the option to switch to either the highest dose still under investigation or the selected dose. Subjects will be able to remain in the study, unless they reach a stopping criterion, for at least 96 weeks.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Arms: arm 1: subjects will receive GSK1349572 10mg once daily blinded to dose arm 2: subjects will receive GSK1349572 25mg once daily blinded to dose arm 3: subjects will receive GSK1349572 50mg once daily blinded to dose arm 4: efavirenz will serve as the internal control arm
Interventions: intervention 1: GSK1349572 intervention 2: efavirenz
Intervention descriptions: intervention 1: investigational HIV-1 integrase inhibitor intervention 2: approved therapy for HIV-1 infection, used as an internal study control

Protocol documents: