ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02389374
Conditions: Malaria
Sponsor: Menzies School of Health Research
Start date: 2014-08-01; Completion date: 2015-03-01
Enrollment: 181 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study assessing safety and efficacy of current national guidelines for the treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among the enrolled patients.

Detailed description:
The national guidelines for the treatment of uncomplicated malaria in Bangladesh currently recommend a standard dose of artemether-lumefantrine followed by a single dose of primaquine for P. falciparum malaria and a three day course of chloroquine followed by 14 days of primaquine for vivax malaria.Currently the national treatment guidelines do not include any testing for G6PD deficiency before treatment with primaquine. In order to guarantee safe and efficacious treatment for all patients diagnosed with uncomplicated malaria in Bangladesh, it is essential to monitor the effectiveness and safety of the recommended treatment guidelines. This trial therefore evaluates the local efficacy and safety of the current first line treatment and assesses the G6PD status of the enrolled patients.

Patients with uncomplicated malaria attending the health care center, who meet the study inclusion criteria will be enrolled, treated on site and followed up for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. The study will provide efficacy data for both artemether-lumefantrine and chloroquine and will generate data on G6PD status in the region, which will provide vital information for policy makers in regards to the wider roll out of primaquine for the radical cure of vivax malaria.

Arms: arm 1: P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines arm 2: P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines arm 3: mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Interventions: intervention 1: chloroquine intervention 2: Artemether-lumefantrine combination intervention 3: Primaquine intervention 4: Primaquine
Intervention descriptions: intervention 1: standard dose intervention 2: standard dose intervention 3: single dose intervention 4: 14 days

Protocol documents:
Clinical trial NCT02993302
Conditions: Graves Disease
Keywords: vitamin D graves' disease dendritic cells
Sponsor: Dr Cipto Mangunkusumo General Hospital
Start date: 2014-07-01; Completion date: 2015-03-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro 1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral 1α-D3 on DC maturation in GD patients.

Detailed description:
Patients with Graves' disease were divided into two groups: groups receiving oral 1α-D3 in addition to propylthiouracil (PTU) and groups receiving placebos in addition to PTU. Comparison of DC maturation were performed before and after the oral 1α-D3. DC maturation was assessed based on the expression of DC markers (HLA-DR, CD80, CD40, CD83, CD14 and CD206) and the ratio of cytokines interleukin-12/IL-10.

Arms: arm 1: patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis arm 2: patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis
Interventions: intervention 1: 1α-D3 intervention 2: Placebos
Intervention descriptions: intervention 1: patients were given PTU and 1α-D3 intervention 2: patients were given PTU and placebos

Protocol documents:
Clinical trial NCT01272219
Conditions: Metabolism and Nutrition Disorder Obesity
Sponsor: Novo Nordisk A/S
Start date: 2011-06-01; Completion date: 2015-03-02
Enrollment: 3731 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: liraglutide intervention 2: placebo intervention 3: liraglutide intervention 4: placebo
Intervention descriptions: intervention 1: Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68). intervention 2: Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68). intervention 3: Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks. intervention 4: Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.

Protocol documents:
Clinical trial NCT01465386
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Promyelocytic Leukemia (M3) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Secondary Acute Myeloid Leukemia
Sponsor: Fred Hutchinson Cancer Center
Start date: 2011-11-01; Completion date: 2015-03-02
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well bortezomib works in treating patients with high-risk acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To determine if bortezomib when given as maintenance therapy for six months post-remission can improve the progression-free survival (PFS) rate by 50% (or 4.5 months) in first remission patients with high-risk AML.

SECONDARY OBJECTIVES:

I. To determine the overall survival (OS) after maintenance therapy with bortezomib in first remission AML patients.

II. To assess the safety and tolerability of subcutaneous (SC) administration of bortezomib given as maintenance therapy to first remission AML patients.

OUTLINE:

Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, and then annually for 3 years.

Arms: arm 1: Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: bortezomib
Intervention descriptions: intervention 1: Given SC

Protocol documents:
Clinical trial NCT00413218
Conditions: Candidiasis, Invasive Candidemia Mycoses
Keywords: Invasive Candida infections BAL8557 ASP9766 Isavuconazole Candidemia Candidemia and other invasive candida infections Phase III study
Sponsor: Astellas Pharma Inc
Start date: 2007-03-08; Completion date: 2015-03-03
Enrollment: 450 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Detailed description:
Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral isavuconazole. Patients are randomized to isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.

Arms: arm 1: Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily. arm 2: Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
Interventions: intervention 1: Isavuconazole intervention 2: Caspofungin intervention 3: Voriconazole
Intervention descriptions: intervention 1: Administered by intravenous infusion. intervention 2: Administered by intravenous infusion. intervention 3: Administered by intravenous infusion.

Protocol documents:
Clinical trial NCT01943799
Conditions: Chronic HBV Infection
Keywords: Hepatitis B (HBV) Oral antiviral (OAV) GS-4774
Sponsor: Gilead Sciences
Start date: 2013-09-13; Completion date: 2015-03-03
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.

Detailed description:

Arms: arm 1: Participants will continue their prebaseline OAV regimen alone from baseline to Week 48. arm 2: Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20. arm 3: Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20. arm 4: Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
Interventions: intervention 1: GS-4774 intervention 2: OAV Regimen
Intervention descriptions: intervention 1: Administered as a subcutaneous injection every 4 weeks for a total of 6 doses intervention 2: Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)

Protocol documents:
Clinical trial NCT00934544
Conditions: Myelofibrosis
Keywords: Myelofibrosis Post-Polycythemia Vera Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2015-03-04
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).

Detailed description:
This study included a randomized treatment phase, followed by an extension phase. The treatment phase lasted from Study Day 1 (day of randomization) to the occurrence of a protocol-specified progressive disease event or study conclusion, whichever came first. The extension phase (including crossover of control group patients) lasted from the progressive disease event until the earliest of the following events: a) the patient was no longer receiving clinical benefit, b) the patient chose to withdraw from the study, or c) the study ended. All patients received ruxolitinib in the extension phase of the study. Maximum individual patient duration was 5 years.

Arms: arm 1: 5 mg tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule arm 2: Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Patients randomized to BAT were eligible to cross over to receive open-label ruxolitinib after a qualifying progression event, if they met the safety criteria. After the primary analysis in January 2011, patients randomized to receive BAT were allowed to cross over to receive ruxolitinib and move to the extension phase of the study without a qualifying progression event.
Interventions: intervention 1: Ruxolitinib intervention 2: Best Available Therapy (BAT)
Intervention descriptions: intervention 1: 5 mg tablets packaged as 60-count in high-density polyethylene bottles intervention 2: Prescribing and usage per respective package inserts

Protocol documents:
Clinical trial NCT00979134
Conditions: Cancer Advanced Solid Malignancies
Keywords: Cancer Tumour Advanced Solid Malignancies FGFR Squamous NSCLC Gastric adenocarcinoma
Sponsor: AstraZeneca
Start date: 2009-10-21; Completion date: 2015-03-05
Enrollment: 95 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

Detailed description:

Arms: arm 1: Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) arm 2: Dose expansion phase, at the RD defined in Part A arm 3: Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A
Interventions: intervention 1: AZD4547 intervention 2: AZD4547 intervention 3: AZD4547
Intervention descriptions: intervention 1: Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily intervention 2: Patients start at a dose of 80 mg twice daily, with no washout intervention 3: Single dose is followed by washout 5-10 days before multiple dose

Protocol documents:
Clinical trial NCT02152605
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: SGRQ vilanterol long-acting beta2-agonist long-acting muscarinic antagonist COPD umeclidinium
Sponsor: GlaxoSmithKline
Start date: 2014-09-01; Completion date: 2015-03-05
Enrollment: 498 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a 12-week, multicenter, randomized, double blind, parallel group, placebo-controlled study.

The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25 microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory Questionnaire (SGRQ) scores and symptoms as reflected by rescue medication use observed in the 6 month placebo controlled study (DB2113373). Lung function will be assessed as it provides an objective measure to support the subjective patient reported outcomes of SGRQ and rescue medication use. The study is intended to provide additional evidence to support the use of UMEC/VI for the maintenance treatment of COPD Approximately 496 subjects will be randomized from approximately 62 centers in order to ensure 422 subjects complete 12 weeks of treatment. Eligible subjects will be randomized to UMEC/VI 62.5/25mcg or placebo in a 1:1 ratio. All treatments will be administered once-daily in the morning via a Dry Powder Inhaler (DPI).

There will be a total of 5 clinic visits. The total duration of study participation will be approximately 15 weeks. All subjects will be provided with albuterol/salbutamol to use as needed for the relief of COPD symptoms throughout the run-in and double-blind treatment periods.

Detailed description:

Arms: arm 1: The subjects will receive UMEC/VI 62.5/25 mcg, administered as one inhalation once-daily in the morning via a dry powder inhaler (DPI) arm 2: The subjects will receive placebo, administered as one inhalation once-daily in the morning via a DPI
Interventions: intervention 1: UMEC/VI intervention 2: Placebo
Intervention descriptions: intervention 1: Dry white powder delivered via DPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg intervention 2: Dry white powder delivered via DPI (2 strips with 30 blisters each, both containing lactose with magnesium stearate), administered as one inhalation of placebo

Protocol documents:
Clinical trial NCT02189837
Conditions: Primary Hyperlipidemia and Mixed Dyslipidemia
Keywords: Raised cholesterol Cholesterol Elevated Cholesterol Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases
Sponsor: Amgen
Start date: 2014-07-08; Completion date: 2015-03-05
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks. arm 2: Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks. arm 3: Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks. arm 4: Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
Interventions: intervention 1: Evolocumab intervention 2: Atorvastatin intervention 3: Placebo to Evolocumab intervention 4: Placebo to Atorvastatin
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by mouth intervention 3: Administered by subcutaneous injection intervention 4: Administered by mouth

Protocol documents:
Clinical trial NCT01353911
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-06-27; Completion date: 2015-03-10
Enrollment: 368 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.

Detailed description:
Amendment 4 unblinded treatment after an interim analysis for all subsequently enrolled TN participants (the Second Cohort) who were receiving grazoprevir 400 or 800 mg daily, and they were down-dosed to 100 mg daily between Treatment Week (TW) 3 and TW12 for the remainder of the 12-week treatment course.

Amendment 5 allowed treatment-naïve participants with chronic hepatitis C and compensated cirrhosis to be enrolled and receive open-label grazoprevir 100 mg in combination with Peg-IFN and RBV, without a corresponding control arm.

Arms: arm 1: TN non-cirrhotic (NC) participants receive Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. arm 2: TN NC participants receive Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. arm 3: TN NC participants receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. arm 4: TN NC participants receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. arm 5: TN NC participants start a 4 week lead-in with Peg-IFN + RBV, then receive Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy. arm 6: As the result of an interim analysis, TN NC participants assigned to the 400 mg grazoprevir group were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV and will remain in the study. arm 7: As the result of an interim analysis, TN NC participants assigned to the 800 mg grazoprevir group were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV and will remain in the study. arm 8: TN cirrhotic participants receive open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
Interventions: intervention 1: Grazoprevir intervention 2: Boceprevir intervention 3: Placebo for Grazoprevir intervention 4: Placebo for Boceprevir intervention 5: Peg-interferon alfa-2b intervention 6: Ribavirin
Intervention descriptions: intervention 1: Orally once daily in AM. Blinded or open-label depending on treatment arm. intervention 2: Four 200 mg capsules orally three times daily. intervention 3: Orally once daily in AM. intervention 4: Four capsules orally three times daily. intervention 5: 1.5 μg/kg/week subcutaneous injection. intervention 6: 300 mg to 700 mg orally twice daily.

Protocol documents: