ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00971841
Conditions: Esophageal Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2008-03-01; Completion date: 2012-04-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous Phase 2 study (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). To evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.

Detailed description:

Arms: arm 1: One hour intravenous infusion on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consists of 49 days. Day 1 dose same level as last dose of original Study CA139-540 (100mg/m2, 80 mg/m2, or 60 mg/m2). Treatment to continue until disease progression or unacceptable toxicity apparent.
Interventions: intervention 1: Paclitaxel
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00984334
Conditions: Chronic Pain Opioid Induced Constipation
Keywords: pain opioid constipation Subjects taking opioids for chronic non-cancer pain, who experience symptoms of opioid induced constipation
Sponsor: S.L.A. Pharma AG
Start date: 2009-10-01; Completion date: 2012-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose. If naloxone is given by mouth it would relieve the effects of constipation but as it goes into the blood stream very quickly, it would also reverse the effects of the opioid and therefore stop the pain relief. The aim of this study is to examine a slow release formulation of naloxone to see if is can reduce constipation without reducing the pain relieving effects of the opioid.

Detailed description:
Naloxone has been used for many years as an IV or IM injection for the reversal of opioid effects (following opioid overdose) and has been evaluated as an oral formulation to manage opioid-induced constipation. Immediate release oral naloxone preparations have however led to reversal of opioid effects and withdrawal. This has initiated the development of prolonged (slow release) naloxone preparations which prevent the systemic levels of naloxone reaching levels where the central opioid effects may be reversed. Naloxone has a high first pass metabolism (98%) and short half life (\~1hr).

The objectives of this trial are to identify the optimum dosage regime of Naloxone SR capsules based on tolerability level, to improve spontaneous bowel movement frequency, and relieve GI symptoms, in patients suffering with opioid induced constipation.

Arms: arm 1: Placebo capsules once daily for three weeks then twice daily for three weeks. arm 2: Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks. arm 3: Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks. arm 4: Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks. arm 5: Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Interventions: intervention 1: Naloxone SR 5 mg capsules intervention 2: Placebo intervention 3: Naloxone SR 10 mg capsules intervention 4: Naloxone SR 20mg capsules intervention 5: Naloxone SR 2.5 mg capsules
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00986362
Conditions: Vitrectomy
Keywords: Safety in pediatrics
Sponsor: ThromboGenics
Start date: 2010-02-01; Completion date: 2012-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ocriplasmin intervention 2: Placebo
Intervention descriptions: intervention 1: 175µg ocriplasmin intravitreal injection intervention 2: Placebo intravitreal injection

Protocol documents:
Clinical trial NCT00988325
Conditions: Influenza
Sponsor: Hoffmann-La Roche
Start date: 2011-01-01; Completion date: 2012-04-01
Enrollment: 65 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir \[Tamiflu\] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.

Detailed description:

Arms: arm 1: infants 3 to \<12 months arm 2: infants 1 to \<3 months of age arm 3: infants 0 to 30 days (post natal) of age
Interventions: intervention 1: Tamiflu
Intervention descriptions: intervention 1: oral repeating dose

Protocol documents:
Clinical trial NCT00996606
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-10-01; Completion date: 2012-04-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to their current DMARD therapy.

Detailed description:

Arms: arm 1: Participants with active RA will receive tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions will be given from Baseline to Week 44, and participants will be assessed through Week 48.
Interventions: intervention 1: DMARDs intervention 2: Tocilizumab
Intervention descriptions: intervention 1: Participants may continue on a stable dose of their current DMARD therapy as prescribed. The choice of DMARD is at the discretion of the treating physician and is not specified by the protocol. intervention 2: Tocilizumab will be given as 8 mg/kg via IV infusion every 4 weeks for a total of 12 infusions. The maximum allowed dose is 800 mg.

Protocol documents:
Clinical trial NCT00999167
Conditions: Cirrhosis Hepatic Encephalopathy
Keywords: Cirrhosis Episodic Hepatic Encephalopathy HE HPN-100 GT4P glycerol phenylbutyrate
Sponsor: Amgen
Start date: 2009-12-01; Completion date: 2012-04-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).

Detailed description:
Part A: Open-label, dose-escalation lead-in to assess HPN-100 safety and PK Approximately 10 subjects with HE and cirrhosis classified as Child Pugh B or C will undergo a one-step dose escalation over 4 weeks. Subjects will initially receive 6 mL HPN-100 BID for 1 week. On Day 7 and following satisfactory safety assessment of the subject, the dose will be escalated to 9 mL BID for an additional 3 weeks.

In addition to a safety assessment, subjects will undergo 12-hour PK assessments on Days 7 and 28, with sampling at the following time points (relative to the first dose): 0 (pre-first daily dose of HPN-100), 2, 4, 8 (approximately 2 hours before the second daily dose of HPN 100), and 12 hours post-first dose (approximately 2 hours after the second daily dose of HPN-100). Additional PK samples will be collected on Days 8, 15, and 21 (at pre-first dose and 4 hours post-first dose).

The DSMB will review all safety information, including laboratory values, to determine if Part B may be initiated.

Subjects enrolled in Part A may be eligible for Part B as long as they meet the eligibility criteria.

Part B: Randomized, double-blind assessment of HPN-100 in HE subjects Subjects who meet all entry criteria and are judged to be compliant with their prescribed SOC will be eligible for randomization to receive either HPN-100 or matching placebo for 16 weeks. Efficacy will be assessed by the proportion of subjects experiencing episodes of HE, as well as by other outcome measures, including daily home assessments.

Study acquired from Horizon in 2024.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: HPN-100 intervention 2: Placebo
Intervention descriptions: intervention 1: Part B: 6 mL BID for 16 weeks. intervention 2: Part B: same as experimental arm

Protocol documents:
Clinical trial NCT01000337
Conditions: Liver Dysfunction
Keywords: Liver Apoptosis
Sponsor: University of Athens
Start date: 2009-10-01; Completion date: 2012-04-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anesthesia may affect the function of vital organs. Liver is one of them. The investigator's hypothesis is that intravenous or inhalation anesthesia does not impair liver function as assessed by more elegant tests like markers indicating liver apoptosis. In the present randomized prospective trial female patients scheduled for mastectomy or thyroidectomy will receive inhalation or total intravenous anesthesia and markers for liver dysfunction will be determined.

Detailed description:
Female patients undergoing mastectomy or thyroidectomy under sevoflurane or propofol anesthesia will be recruited for the study. The type of anesthesia will be determined in a random way using a computer generated table.

All patients will be preoxygenated for 3 minutes before induction of anesthesia. Patients assigned to the sevoflurane group will receive an inhalation induction with sevoflurane via a primed anesthetic circle system and anesthesia will be maintained with sevoflurane. In the propofol group patients anaesthesia will be induced and maintained with propofol.

Blood samples for liver apoptotic markers will be collected before induction of anesthesia, after skin closure as well as 24 and 48 hours postoperatively.

Blood samples will be centrifuged, stored at -80 degrees Celsius and analyzed for M30 and M60 values with radioimmunoassay technique. Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) levels will also be determined.

Arms: arm 1: Volatile anesthetic arm 2: Intravenous anesthetic
Interventions: intervention 1: Sevoflurane intervention 2: Propofol
Intervention descriptions: intervention 1: Sevoflurane concentration for induction of anesthesia 7-8%, for maintenance of anesthesia 2%. intervention 2: Propofol to induce anesthesia 2.5 mg/kg, for maintenance of anesthesia 6 mg/kg/h

Protocol documents:
Clinical trial NCT01012336
Conditions: Chemotherapy-Induced Nausea and Vomiting Ovarian Cancer
Keywords: efficacy and safety of Aprepitant/Ramosetron/Dexamethasone in ovary cancer patients with taxol and carboplatin
Sponsor: Samsung Medical Center
Start date: 2010-05-01; Completion date: 2012-04-01
Enrollment: 89 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aprepitant/Ramosetron/Dexamethasone
Intervention descriptions: intervention 1: Aprepitant: The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3.

Ramosetron: 0.3 mg i.v. a single dose on day 1, administered over 30 seconds, 30 minutes prior to chemotherapy.

Dexamethasone: 20mg diluted in 50ml of 0.9% saline i.v. a single dose on day 1, administered over 30minutes prior to chemotherapy (taxane). Because all patients are premedicated with dexamethasone 20 mg before taxane administration, the dose of dexamethasone can not be reduced to 12 mg.

Protocol documents:
Clinical trial NCT01020305
Conditions: Prostate Cancer Prostatic Neoplasms Castrate-resistant Prostate Cancer (CRPC) Androgen-insensitive Prostate Cancer Hormone-refractory Prostate Cancer Metastatic Disease
Sponsor: Sandy Srinivas
Start date: 2009-10-01; Completion date: 2012-04-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates if temsirolimus causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).

Detailed description:
Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC, there remains unmet medical need. New therapies that extend survival of patients beyond that provided by chemotherapy are needed.

The mechanisms of tumor progression to castration-resistance are unclear, but preclinical studies suggest that functional loss of the tumor suppressor gene PTEN and subsequent up-regulation of Akt, which is upstream of mTOR, may be involved in prostate cancer progression and metastasis. Based on these observations, it is hypothesized that mTOR inhibitor temsirolimus may prolong hormone sensitivity and delay disease progression in castration-resistant prostate cancer patients before antiandrogen withdrawal.

This study will assess efficacy on the basis of serum levels of PSA, an established surrogate endpoint for efficacy in prostate cancer.

Arms: arm 1: Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks

Casodex (bicalutamide) administered 50 mg/day orally (PO)
Interventions: intervention 1: Temsirolimus intervention 2: Casodex (bicalutamide)
Intervention descriptions: intervention 1: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)

IUPAC name: (1R,2R,4S)-4-{(2R)-2-\[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido\[2,1-c\]\[1,4\]oxazacyclohentriacontin-3-yl\]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate intervention 2: Casodex (bicalutamide) 50 mg/day PO

Protocol documents:
Clinical trial NCT01045798
Conditions: Invasive Candidiasis
Keywords: Candidiasis Invasive Candidiasis Fungal Infection Empirical Therapy
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-12-01; Completion date: 2012-04-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot feasibility study that investigates antifungal therapy with caspofungin in patients at high-risk for developing invasive candidiasis in a critical care setting.

Detailed description:
Hypothesis: In high-risk non-neutropenic participants in the ICU, the proportion of participants discontinued from study therapy in order to be empirically treated with antifungal therapy for suspected candidiasis outside of the context of this protocol is less than 20% (i.e., the upper bound of the 95% confidence interval for the observed proportion is less than 20%).

Arms: arm 1: caspofungin acetate arm 2: normal saline
Interventions: intervention 1: Caspofungin acetate intervention 2: Placebo
Intervention descriptions: intervention 1: 70 mg of caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days) intervention 2: Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)

Protocol documents:
Clinical trial NCT01051817
Conditions: Relapsing-remitting Multiple Sclerosis RRMS
Keywords: relapsing-remitting multiple sclerosis RRMS
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2012-04-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: infusion 10 mg/Kg intervention 2: infusion

Protocol documents:
Clinical trial NCT01053819
Conditions: Psoriasis Melanoma Non-melanoma Skin Cancer
Keywords: psoriasis melanoma non-melanoma skin cancer etanercept Enbrel
Sponsor: University of Alabama at Birmingham
Start date: 2007-09-01; Completion date: 2012-04-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In psoriasis patients, thick psoriatic plaques can obscure these lesions, and clinicians rely heavily on visual inspection to recognize suspicious or atypical pigmented lesions. However, successful systemic treatment and subsequent clearing of psoriatic plaques may allow clinicians to better evaluate pigmented lesions, thereby increasing the likelihood of early identification and treatment of suspicious lesions such as nonmelanoma skin cancer and malignant melanoma.

Detailed description:
No further description is desired.

Arms: arm 1: open label treatment(50 mg SQ)per Food and Drug Administration approval for 24 weeks
Interventions: intervention 1: etanercept
Intervention descriptions: intervention 1: Patients will receive six months of treatment with Enbrel 50mg SQ given twice a week for the first three months and 50 mg once a week thereafter.

Protocol documents:
Clinical trial NCT01058005
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: MS
Sponsor: Biogen
Start date: 2010-03-01; Completion date: 2012-04-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer acetate.

Detailed description:
The protocol was amended in 15 March 2011 to discontinue participants' enrollment and efficacy assessments, and to offer the opportunity for participants already enrolled to continue receiving study treatment for their planned participation in the study. The study had been active in several countries for approximately 1 year, and enrollment had been significantly slower than expected. Thus, the decision was made by the Sponsor to terminate the study since current and projected future enrollment rates would not have provided valuable information in a reasonable timeframe. All clinical efficacy and magnetic resonance imaging (MRI) procedures were removed from the protocol, and safety assessments were to be managed through standard of care activities.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: BG00002 (natalizumab) intervention 2: interferon beta-1a intervention 3: glatiramer acetate
Intervention descriptions: intervention 1: 300 mg intravenous injection every 4 weeks intervention 2: 44 mcg subcutaneous injection 3 times per week intervention 3: 20 mg subcutaneous injection once daily

Protocol documents:
Clinical trial NCT01085331
Conditions: Metastatic Colorectal Cancer
Keywords: Mek Inhibitor Metastatic Colorectal Cancer K-Ras Mutation Phase II Second line K-Ras mutated metastatic colorectal cancer
Sponsor: EMD Serono
Start date: 2010-03-01; Completion date: 2012-04-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The research trial is testing the experimental treatment pimasertib (MSC1936369B) in combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal cancer subjects. The study will be run in two parts:

Part 1, or Safety Run-in Part: Will determine the maximum tolerated dose and the recommended Phase 2 dose (RP2D) of pimasertib combined with FOLFIRI as second-line treatment in subjects with metastatic K Ras mutated colorectal cancer.

Part 2 or Phase 2 Randomised Part: Will assess the anti-tumor activity of pimasertib combined with FOLFIRI compared to FOLFIRI with placebo as second-line treatment in metastatic K Ras mutated colorectal cancer subjects.

Phase I which Is an open label dose escalation "3+3" cohort, non-randomized, safety Phase II which is a double blind randomized safety/efficacy

Detailed description:

Arms: arm 1: None arm 2: Planned, not performed arm 3: Planned, not performed
Interventions: intervention 1: Pimasertib intervention 2: Placebo intervention 3: FOLFIRI
Intervention descriptions: intervention 1: Subjects will be administered with pimasertib orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle. intervention 2: Subjects will be administered with placebo orally once daily on days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle. intervention 3: Subjects will be administered with FOLFIRI (laevoleucovorin 200 milligram per square meter \[mg/m\^2\] intravenous \[i.v\] infusion over 90 minutes or leucovorin \[dl-leucovorin\] 400 mg/m\^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m\^2 given as a 90-minute infusion in 500 milliliter \[mL\] dextrose 5%; followed by a bolus 5-fluorouracil \[FU\] 400 mg/m\^2 and a 46-hour infusion 5-FU 2400 mg/m\^2) at conventional doses on days 1 and 15 of the same 28 day cycle.

Protocol documents:
Clinical trial NCT01090063
Conditions: Moderate to Severe Palmar Plantar Psoriasis
Keywords: Palmar Plantar Psoriasis
Sponsor: Tufts Medical Center
Start date: 2010-02-01; Completion date: 2012-04-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the short and long term safety and effectiveness of ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.

Detailed description:

Interventions: intervention 1: Ustekinumab
Intervention descriptions: intervention 1: Dosing will consist of a 45mg subcutaneous injection for patients weighing less than 100 kg and a 90 mg subcutaneous injection for patients whose weight is greater than 100 kg. Dosing will begin on week 0 followed by subsequent dosing on week 4 and week 16.

Protocol documents: