ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02442700
Conditions: HIV Dyslipidemia
Keywords: HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir
Sponsor: Ramathibodi Hospital
Start date: 2014-05-01; Completion date: 2015-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in HIV-infected patients who are on antiretroviral therapy especially protease inhibitors including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals. The study was conducted as a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given the other treatment for an additional 12 weeks. Patients were observed for lipid profiles including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL); and the side effects including clinical and laboratory (serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase (CPK)). The follow-up visits were every 4 weeks until the end of the study.

Detailed description:

Arms: arm 1: Treatment visits were seperated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks arm 2: Treatment visits were seperated by a 2-week washout period. Treatment B = adminstration placebo for 12 weeks; Treatment A = adminstration pitavastatin for 12 weeks
Interventions: intervention 1: pitavastatin intervention 2: placebo
Intervention descriptions: intervention 1: Treatment A = administration pitavastatin for 12 weeks intervention 2: Treatment B = administration placebo for 12 weeks

Protocol documents:
Clinical trial NCT02519387
Conditions: Osteoarthritis Rheumatoid Arthritis Lower Back Pain Joint Pain Muscle Pain
Sponsor: Mundipharma Pharmaceuticals Sdn. Bhd.
Start date: 2013-07-01; Completion date: 2015-01-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase IV, open-label and single-arm study of patients with non-malignant pain due to osteoarthritis, rheumatoid arthritis, low back pain and joint/muscle pain, who were not responding to non-opioid analgesics. The primary objective was to assess the efficacy of buprenorphine transdermal patch for pain control among these patients.

Detailed description:
Buprenorphine transdermal (BTDs) is a semi-synthetic opioid analgesic. Earlier studies have shown BTDs to be non-inferior to an oral codeine-paracetamol combination and prolonged-release tramadol, in terms of pain control as well as sleep quality. BTDs is registered for use in Malaysia but the scientific data on efficacy and tolerability among Malaysians was not available. Thus, this study was conducted to evaluate the efficacy and tolerability of BTDs among Malaysian patients.

Patients eligible for entry into the study were adults aged ≥ 40 years who met the inclusion criteria and qualified from baseline screening and liver function test (LFT) assessment. The study excluded patients who met the exclusion criteria and failed prior the LFT assessment. Patients received an initial dose of 5 mg BTDs after qualifying on the baseline screening and LFT test. The dose could be up-titrated to a maximum of BTDs 20mg (2 X 10 mg) to achieve stable pain control.

There were six visits during the three-month study period. At visit 1, patients received 5mg of Sovenor® as initial treatment dose. Visit 2 occurred 7 days after the first visit; visit 2 and visit 3 were dose titration visits. Visit 4 and visit 5, were for assessment purposes. Primary treatment efficacy was measured during each visit with additional assessments of patients' sleep quality and quality of life, while physicians' and patients' treatment satisfaction assessed during the final visit. Safety was measured by monitoring the occurrence of adverse events (AEs).

Arms: arm 1: Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months
Interventions: intervention 1: Buprenorphine Transdermal Patch
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02528097
Conditions: Spontaneous Bacterial Peritonitis
Sponsor: NYU Langone Health
Start date: 2010-09-01; Completion date: 2015-01-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of end-stage liver disease with a mortality of up to 10% primarily due to the development of kidney failure. Current standard practice is to treat this infection with broad spectrum antibiotics and salt-poor albumin administration on day one and three of treatment. In this study the investigators test the hypothesis that the administration of a second dose of albumin at 48 hours only to patients with renal insufficiency is as effective at preventing kidney failure as administering the second dose to all patients at 72 hours. In addition, a kidney function determined approach to albumin dosing may lead to substantial cost and resource saving from decreased albumin use without compromising treatment efficacy.

Detailed description:

Arms: arm 1: albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) arm 2: Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr \> 1.0 or BUN or Cr are above baseline.
Interventions: intervention 1: Standard Care intervention 2: Experimental
Intervention descriptions: intervention 1: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) intervention 2: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline)

Protocol documents:
Clinical trial NCT00911170
Conditions: Cancer Colon Cancer Colorectal Cancer Fever Locally Advanced Metastatic Colorectal Cancer Neutropenia Rectal Cancer
Keywords: adenocarcinoma of the colon or rectum febrile neutropenia Bevacizumab Avastin 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)
Sponsor: Amgen
Start date: 2009-11-03; Completion date: 2015-01-02
Enrollment: 847 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI).

This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.

Detailed description:

Arms: arm 1: Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). arm 2: Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
Interventions: intervention 1: Pegfilgrastim intervention 2: Placebo intervention 3: Bevacizumab intervention 4: Standard Chemotherapy
Intervention descriptions: intervention 1: Administered as a single 6 mg subcutaneous injection using a pre-filled syringe. There will be no dosage adjustments for investigational product. intervention 2: Administered as a single subcutaneous injection using a pre-filled syringe. intervention 3: 5 mg/kg by intravenous (IV) infusion on day 1 of each 14-day cycle. intervention 4: Each participant received one of the following chemotherapy regimens at the discretion of treating physician:

FOLFOX: Oxaliplatin, leucovorin, and 5-fluorouracil; FOLFIRI: Irinotecan, leucovorin and 5-flurouracil.

Protocol documents:
Clinical trial NCT01732770
Conditions: Post Menopausal Osteoporosis
Sponsor: Amgen
Start date: 2012-11-07; Completion date: 2015-01-07
Enrollment: 643 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.

Detailed description:

Arms: arm 1: Participants received denosumab 60 mg subcutaneous injection once every 6 months for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1. arm 2: Participants received zoledronic acid 5 mg by intravenous infusion on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
Interventions: intervention 1: Denosumab intervention 2: Zoledronic Acid intervention 3: Placebo to Denosumab intervention 4: Placebo to Zoledronic Acid
Intervention descriptions: intervention 1: Denosumab 60 mg administered by subcutaneous injection once every 6 months. intervention 2: Zoledronic acid 5 mg administered by intravenous infusion once a year intervention 3: Administered by subcutaneous injection once every 6 months intervention 4: Administered by intravenous infusion once a year

Protocol documents:
Clinical trial NCT01896232
Conditions: Secondary Hyperparathyroidism Chronic Kidney Disease
Keywords: Secondary Hyperparathyroidism, renal, kidney, kidneys, dialysis, hemodialysis, chronic kidney disease, CKD, SHPT
Sponsor: Amgen
Start date: 2013-08-13; Completion date: 2015-01-08
Enrollment: 683 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by \> 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

Detailed description:

Arms: arm 1: Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL. arm 2: Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Interventions: intervention 1: Etelcalcetide intervention 2: Cinacalcet intervention 3: Oral Placebo intervention 4: Intravenous Placebo
Intervention descriptions: intervention 1: Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels. intervention 2: Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels. intervention 3: Administered orally once a day. intervention 4: Administered intravenously (IV) three times per week.

Protocol documents:
Clinical trial NCT02006628
Conditions: Schizophrenia Schizophrenia-related Psychotic Disorder
Keywords: GWP42003 Cannabinoids Schizophrenia CBD Cannabidiol
Sponsor: Jazz Pharmaceuticals
Start date: 2014-02-25; Completion date: 2015-01-08
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the change in symptom severity in participants with schizophrenia or related psychotic disorder when treated with GWP42003 or placebo in conjunction with existing anti-psychotic therapy over a period of six weeks.

Detailed description:
This eight-week (six-week treatment period and two-week follow-up), multi-centre, double-blind, randomized, placebo-controlled, parallel group study aimed to determine the efficacy, safety and tolerability of GWP42003 in participants with schizophrenia or a related psychotic disorder.

Eligible participants entered the study at a Screening and Randomization Visit (Day 1), where eligibility was established. Once all inclusion and exclusion criteria were reviewed, participants were randomized to receive either GWP42003 or placebo in conjunction with their prescribed anti-psychotic medications and began treatment on Day 1 as instructed. Assessments were performed on Days 8, 22, and 43. A safety follow-up visit was conducted on Day 57.

Arms: arm 1: Participants received GWP42003 (100 mg/milliliter \[mL\]), 5 mL twice daily (BID) administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks. arm 2: Participants received placebo (0 mL cannabidiol \[CBD\]), volume matched to the 5 mL BID dose level, administered orally, 5 mL in the morning and 5 mL in the evening for 6 weeks.
Interventions: intervention 1: Placebo intervention 2: GWP42003
Intervention descriptions: intervention 1: Placebo oral solution (0 milligrams \[mg\]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring. intervention 2: GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.

Protocol documents:
Clinical trial NCT02248259
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-10-08; Completion date: 2015-01-08
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.

Detailed description:

Arms: arm 1: Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:

* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. arm 2: Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:

* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. arm 3: Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:

* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). arm 4: Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:

* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
Interventions: intervention 1: BI 409306 intervention 2: Itraconazole
Intervention descriptions: intervention 1: Oral single dose of BI 409306 intervention 2: Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole

Protocol documents:
Clinical trial NCT02103062
Conditions: Colorectal Neoplasms
Keywords: Metastatic Colorectal Cancer nab®Paclitaxel Response Evaluation in Solid Tumors Progression Free Survival Overall Survival Duration of Response RAS
Sponsor: Celgene
Start date: 2014-05-05; Completion date: 2015-01-09
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Abraxane (nab-paclitaxel) in subjects with previously treated metastatic colorectal cancer. Subjects will be placed into two separate cohorts based on their RAS mutation status.

Detailed description:
ABI-007-COLO-001 is a Phase 2, single arm, open label, multicenter study to evaluate the efficacy and safety of Abraxane (nab-paclitaxel) given on days 1, 8 and 15 of a 28 day cycle in subjects with previously treated metastatic colorectal cancer. Subjects will be enrolled into cohorts by RAS mutation status (wildtype or mutated). Stage 1 in a given cohort will enroll 15 subjects in the Intention to Treat population and if more than 8 subjects have Progression Free Survival at the 8 week assessment, then Stage 2 will open in the respective cohort. Stage 2 will enroll an additional 28 subjects for a total of 43 subjects in each cohort. The study will be positive if more than 26 subjects with Progression Free Survival at the 8 week assessment are observed in 43 subjects per cohort. Interim analysis after Stage 1 did not meet protocol defined criteria to proceed to Stage 2. Patients currently enrolled will be followed for Progression Free Survival and until 28 days after last dose, secondary endpoints including overall survival will not be followed

Arms: arm 1: Abraxane (nab®paclitaxel) 125 milligrams per meter squared on days 1, 8 and 15 of a 28 day cycle
Interventions: intervention 1: ABI-007
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01377480
Conditions: Chagas Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-07-06; Completion date: 2015-01-12
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.

Detailed description:

Arms: arm 1: Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days arm 2: Posaconazole placebo (10 mL) oral suspension twice daily for 60 days arm 3: Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days arm 4: Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
Interventions: intervention 1: Posaconazole intervention 2: Placebo for posaconazole intervention 3: Benznidazole
Intervention descriptions: intervention 1: POS 40 mg/mL oral suspension intervention 2: Placebo oral suspension intervention 3: BNZ 100 mg oral tablet

Protocol documents:
Clinical trial NCT01522443
Conditions: Prostate Cancer Castration Resistant Prostate Cancer Pain Prostatic Neoplasms
Keywords: prostate cancer castration resistant prostate cancer bone pain CRPC
Sponsor: Exelixis
Start date: 2012-03-01; Completion date: 2015-01-13
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases.

This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

Detailed description:

Arms: arm 1: Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.

There will be a maximum of 10 infusions for mitoxantrone placebo. arm 2: Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.

There will be a maximum of 10 infusions for mitoxantrone.
Interventions: intervention 1: cabozantinib intervention 2: mitoxantrone intervention 3: prednisone
Intervention descriptions: intervention 1: Tablets taken orally once daily. intervention 2: Given by IV once every 3 weeks. intervention 3: Taken twice a day orally by mouth. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

Protocol documents: