ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01412424
Conditions: Acromegaly
Keywords: acromegaly IGF-1 growth hormone Octreolin octreotide somatostatin analog
Sponsor: Chiasma, Inc.
Start date: 2012-03-01; Completion date: 2014-05-01
Enrollment: 155 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety of MYCAPSSA™ treatment in patients with acromegaly.

Detailed description:
The study consisted of 2 periods, a Core Treatment Period of up to 7 months and an optional Extension Treatment Period of up to 6 months, for a total study duration of up to 13 months. The Core Treatment Period consisted of 2 phases, a Dose Escalation Phase of at least 2 months to identify the therapeutic dose for each study participant and a Fixed Dose Phase of 2 to 5 months during which the therapeutic dose was maintained.

Participants were eligible to enter the Fixed Dose Phase of the Core Treatment Period if they were clinically and biochemically controlled. The same criteria were used to allow entry into the voluntary 6-month Extension Treatment Period.

The Core Treatment Period of the study was completed if the participant had at least 2 months of treatment in the Fixed Dose Phase and a total treatment duration of at least 7 months. Participants who elected to continue into the Extension Treatment Period maintained their therapeutic dose during this period. At the end of the study (after the last dose of MYCAPSSA in either the Core Treatment Period or the Extension Treatment Period), there was a 2-week follow-up period for safety assessments.

Arms: arm 1: Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
Interventions: intervention 1: Octreotide capsules
Intervention descriptions: intervention 1: Octreotide was provided in hard gelatin capsules.

Protocol documents:
Clinical trial NCT01425879
Conditions: Advanced Adult Hepatocellular Carcinoma Localized Non-Resectable Adult Liver Carcinoma Recurrent Adult Liver Carcinoma Recurrent Gallbladder Carcinoma Stage IV Distal Bile Duct Cancer Stage IV Gallbladder Cancer Unresectable Extrahepatic Bile Duct Carcinoma Unresectable Gallbladder Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2011-04-01; Completion date: 2014-05-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (complete and partial response), as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, in patients with advanced refractory biliary cancers (BC) receiving Akt inhibitor MK2206 (MK2206).

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events and tolerability of the regimen in patients with advanced refractory BC receiving MK2206.

II. To determine the overall and progression-free survival of patients with advanced refractory BC receiving MK2206.

III. To determine the presence of genetic mutations of PI3-kinase/ Akt pathway signaling-pathway genes relevant to BC and how these correlate with objective response to treatment with MK2206.

IV. To determine the pharmacokinetic and pharmacogenetic profile as a way of assessing inter-individual variability as well as how these relate to clinical outcomes.

V. To determine genetic variants and mutations in genes encoding drug-metabolizing enzymes and transporters, and genes involved in tumor biology, and how these may be related to response to treatment.

OUTLINE: This is a multicenter study.

Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study for pharmacokinetic, pharmacogenetic, and other correlative studies. Previously collected tumor tissue is also analyzed.

After completion of study therapy, patients are followed up for 4 weeks.

Arms: arm 1: Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206 intervention 2: Diagnostic Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01439282
Conditions: Estrogen Receptor Positive Tumor Breast Cancer
Keywords: Estrogen Receptor-Positive Early Stage Breast Cancer
Sponsor: Eisai Inc.
Start date: 2011-08-01; Completion date: 2014-05-01
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: eribulin mesylate intervention 2: capecitabine
Intervention descriptions: intervention 1: Cohort I \& II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles intervention 2: Cohort 1: capecitabine 900 mg/m2 orally twice daily on Days 1 - 14 of a 21-day cycle for 4 cycles Cohort II: fixed dose of 1500 mg oral capecitabine twice daily, 7 days on then 7 days off for 4 cycles

Protocol documents:
Clinical trial NCT01453374
Conditions: Opioid Dependence
Keywords: opioid dependence VIVITROL criminal justice
Sponsor: Alkermes, Inc.
Start date: 2011-01-01; Completion date: 2014-05-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.

Detailed description:
This is an open-label study with a pre-post design. Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (three for men and one for women) will receive 1 injection of VIVITROL prior to release from prison and will be offered 6 monthly injections of VIVITROL for 6 months post release. Subjects will complete follow-up visits 1 and 2 months after the last VIVITROL injection. Subjects will be assessed at 10 time points, and adherence to VIVITROL, both in prison and in the community, will be assessed.

Arms: arm 1: 380 mg IM injection
Interventions: intervention 1: VIVITROL 380mg
Intervention descriptions: intervention 1: 380 mg IM injection given once monthly

Protocol documents:
Clinical trial NCT01465191
Conditions: Postoperative Pain
Keywords: cesarean postoperative morphine genetics opioid
Sponsor: Columbia University
Start date: 2011-11-01; Completion date: 2014-05-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
HYPOTHESIS: The response to a given dose of morphine given via a spinal anesthetic for cesarean section will be affected by the genetics of the woman's mu-opioid receptor

Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most receive a dose of preservative free morphine with the spinal anesthetic. Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.

The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at the 40th amino acid of the protein, with asparagine and asparate being present in different people. The less common variant (aspartate), present in 25-30% of the overall American population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in many studies to affect opioid analgesia.

This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150 micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other genes that may affect pain and analgesic responses. The primary outcome will be the amount of intravenous morphine patients self-administer in the 24 hours postsurgery.

The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.

It is anticipated that there will be an interim data analysis at 150 evaluable subjects for assessment of the dose response to morphine in the overall population; then a final analysis at 300 subjects for the genetic effect assessment.

Detailed description:

Arms: arm 1: Subjects will receive 50 mcg morphine in their spinal anesthetic for cesarean section arm 2: Subjects will receive 100 mcg morphine in their spinal anesthetic for cesarean section arm 3: Subjects will receive 150 mcg morphine in their spinal anesthetic for cesarean section
Interventions: intervention 1: Morphine
Intervention descriptions: intervention 1: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section

Protocol documents:
Clinical trial NCT01466127
Conditions: Posttraumatic Stress Disorder
Keywords: Effect of oxytocin on learning
Sponsor: Massachusetts General Hospital
Start date: 2011-10-01; Completion date: 2014-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.

Detailed description:

Arms: arm 1: Matched nasal spray placebo. arm 2: Liquid intranasal oxytocin administered in a nasal spray.
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: Liquid metered-dose nasal spray, 30 IUs, administered once. intervention 2: Matched nasal spray placebo

Protocol documents:
Clinical trial NCT01467492
Conditions: Hepatitis C
Keywords: VX-950, Incivek
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2012-01-01; Completion date: 2014-05-01
Enrollment: 121 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-experienced Black/African American and non-Black/African American participants with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a prior course of interferon-based therapy.

Detailed description:
This is a single-arm, open-label, multicenter study of treatment-experienced participants with Genotype 1 CHC, who self-identified as Black/African American (Group A) or who did not self-identify as Black/African American (Group B). Participants did not achieve a sustained virologic response 24 weeks after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration, and have 1 of the following viral responses:

* Prior relapse: Participant had a documented undetectable hepatitis C virus ribonucleic acid (HCV RNA) level at the planned end of treatment of at least 42 weeks duration (HCV RNA evaluated anytime between 3 weeks before and 6 weeks after the last dose of Peg IFN-alfa-2a or RBV).
* Prior null response: Participant had a \<2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.
* Prior partial response: Participant had a \>=2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.

Arms: arm 1: Telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 microgram per week (mcg/week) subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing \<75 kilograms \[kg\]) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks. arm 2: Telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
Interventions: intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated Interferon Alfa-2a
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Subcutaneous Injection

Protocol documents:
Clinical trial NCT01477463
Conditions: Melanoma, Skin
Keywords: quality of life
Sponsor: Stanford University
Start date: 2012-09-01; Completion date: 2014-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the signaling pathways and changes in gene expression in melanocytes of subjects with a history of non-melanoma skin cancer who are exposed to oral vitamin D. If vitamin D is found to inhibit a signaling pathway involved in the development of melanoma such as BRAF, a protein involved in cell proliferation, then oral vitamin D could be explored further as a chemoprevention for melanoma skin cancer.

Detailed description:
Background:

Vitamin D is an important hormone that has multiple genetic effects in different tissue types that are mediated by signaling through the vitamin D receptor.

Recent studies have shown that vitamin D signaling results in decreased innate immunity and increased adaptive immunity.

Multiple epidemiologic studies have suggested that vitamin D may play a role in decreasing the risk of developing multiple types of cancer, including skin cancer.

In the context of the relative success of novel immune-related therapies including PD1 inhibitors, which improves immuno-surveillance, and ipilimumab, which suppresses T cell response, there is increased promise for treatment strategies that activate innate immunity. This led us to ask the question of whether vitamin D could increase immune surveillance for melanoma via increased activity of the adaptive immune system.

Prior studies performed by our group and others have suggested that vitamin D may play a role in decreasing melanoma risk. An epidemiologic study from the Women's Health Initiative showed that women with a prior history of NMSC who received calcium and vitamin D supplementation had a lower risk of subsequently developing melanoma. At the same time, women with a lower serum vitamin D level had a higher risk of developing melanoma. Furthermore, a recent clinical study showed that vitamin D supplementation increases serum vitamin D levels and ultimately results in increased vitamin D receptor signaling in benign nevi.

Taken together, this findings led us to ask whether oral vitamin D supplementation could impact immune signaling in benign nevi and potentially underpin a theoretical chemo-preventive role for vitamin D in melanoma.

Arms: arm 1: 4,000 IU oral vitamin D3 arm 2: Placebo + 4000 IU oral Vitamin D3
Interventions: intervention 1: Vitamin D3 intervention 2: placebo and vitamin D
Intervention descriptions: intervention 1: 4,000 IU oral vitamin D3 intervention 2: None

Protocol documents:
Clinical trial NCT01486758
Conditions: RSV Bronchiolitis
Sponsor: Washington University School of Medicine
Start date: 2011-12-01; Completion date: 2014-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial Virus (RSV) bronchiolitis.

HYPOTHESES

In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in:

1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.
2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.

Detailed description:

Arms: arm 1: Oral azithromycin arm 2: Oral Placebo
Interventions: intervention 1: Azithromycin intervention 2: Placebo
Intervention descriptions: intervention 1: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. intervention 2: None

Protocol documents:
Clinical trial NCT01495793
Conditions: Restless Legs Syndrome
Keywords: Rotigotine Restless Legs Syndrome RLS Children Adolescents
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2011-12-01; Completion date: 2014-05-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system. The study was conducted in adolescent subjects (13 to \<18 years of age) with idiopathic Restless Legs Syndrome (RLS).

Detailed description:

Arms: arm 1: In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine transdermal patch:

Dose (size): 0.5 mg/24 h (2.5 cm\^2)- 1 mg/24 h (5 cm\^2)- 2 mg/24 h (10 cm\^2)- 3 mg/24 h (15 cm\^2) The patch has to be applied continuously for 24h. After 24h, the patch has to be removed and a new one applied.

Protocol documents:
Clinical trial NCT01497275
Conditions: Mantle-Cell Lymphoma
Sponsor: Duke University
Start date: 2012-02-01; Completion date: 2014-05-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effects (good and bad) of the combination of ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory mantle cell lymphoma.

Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer cells and releasing radiation to damage those cells. Both Zevalin and Rituxan are given in this study, along with Velcade.

Detailed description:
This is a non-randomized, unblinded single arm Phase II trial to evaluate the combination of yttrium90 ibritumomab tiuxetan and bortezomib in patients with relapsed/refractory mantle cell lymphoma (MCL). Standard hematology and chemistries, imaging and bone marrow biopsies will be done.

Research tests: 17cc of blood will be collected at screen, Day 8 OR 11 and month 3. Samples will be collected and stored for future analysis. These analyses may include but are not limited to measurements of proteasome inhibition. No genetic studies will be performed on these samples. Samples will be destroyed at the end of the study.

Primary Objective Estimate the overall response rate (CR + PR) of the combination of bortezomib and ibritumomab tiuxetan in patients with relapsed/refractory mantle cell lymphoma.

Secondary Objectives

* Estimate the progression free and overall survival in patients with relapsed/refractory mantle cell lymphoma who receive bortezomib and ibritumomab tiuxetan.
* Assess the toxicity of the combination of bortezomib and ibritumomab tiuxetan in patients with relapsed/refractory MCL.

Arms: arm 1: Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan

Other Names:

Rituxan Velcade Zevalin

Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
Interventions: intervention 1: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan
Intervention descriptions: intervention 1: Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4mCi/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.

Protocol documents:
Clinical trial NCT01514461
Conditions: Familial Chylomicronemia Syndrome (FCS)
Keywords: Hyperlipoproteinemia (HLP Type I) Fasting Triglycerides
Sponsor: Novartis Pharmaceuticals
Start date: 2012-07-01; Completion date: 2014-05-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia \[HLP\] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).

Detailed description:

Arms: arm 1: In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed.

In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily.

A low fat diet will be followed and recorded in patient diary. arm 2: In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed.

In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily.

A low fat diet will be followed and recorded in patient diary. arm 3: In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily.

In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily.

A low fat diet will be followed and recorded in patient diary.
Interventions: intervention 1: LCQ908 intervention 2: Placebo
Intervention descriptions: intervention 1: LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg intervention 2: LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg

Protocol documents: