ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01901328
Conditions: Opioid-Induced Constipation
Keywords: Opioid Constipation Chronic Pain
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2013-04-07; Completion date: 2014-02-13
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer pain.

Detailed description:
This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 600 participants (300 participants per treatment group) with OIC will be randomized at approximately 75 study centers to receive either oral 0.25 mg CB-5945 BID or oral matching placebo BID for the 12-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for clinical response for duration of their study participation. All participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. The clinical study report for this study includes pooled results for studies 5945-OIC-12-02 (NCT01901302) 5945-OIC-12-03 (NCT01901328), and 5945-OIC-12-04 (NCT01901341).

Arms: arm 1: 0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period arm 2: Placebo administered orally BID for a 12-week treatment period
Interventions: intervention 1: CB-5945 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01901341
Conditions: Opioid-Induced Constipation
Keywords: Opioid Constipation Chronic Pain
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2013-07-02; Completion date: 2014-02-13
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

Detailed description:
This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 600 participants (300 participants per treatment group) with OIC will be randomized at approximately 75 study centers to receive either oral 0.25 mg CB-5945 BID or oral matching placebo BID for the 12-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for clinical response for duration of their study participation. All participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. The clinical study report for this study includes pooled results for studies 5945-OIC-12-02 (NCT01901302) 5945-OIC-12-03 (NCT01901328), and 5945-OIC-12-04 (NCT01901341).

Arms: arm 1: 0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period arm 2: Placebo administered orally BID for a 12-week treatment period
Interventions: intervention 1: CB-5945 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01833754
Conditions: Osteoporosis
Keywords: Osteoporosis, Bone, Renal, Insufficiency, Kidney, Hemodialysis, Impairment
Sponsor: Amgen
Start date: 2013-04-22; Completion date: 2014-02-19
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients with stage 4 renal impairment (RI) or stage 5 RI requiring hemodialysis.

Detailed description:

Arms: arm 1: Participants with stage 4 renal impairment (defined as an estimated glomerular filtration rate \[eGFR\] 15 to 29 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1. arm 2: Participants with end stage renal disease (ESRD) requiring hemodialysis received a single subcutaneous injection of 210 mg romosozumab on day 1. arm 3: Healthy participants (eGFR ≥ 80 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
Interventions: intervention 1: Romosozumab
Intervention descriptions: intervention 1: Administered as three 70 mg/mL prefilled syringe injections

Protocol documents:
Clinical trial NCT01007448
Conditions: Refractory Cutaneous T-cell Lymphoma
Keywords: CTCL bexarotene Targretin Refractory Cutaneous T-cell Lymphoma cutaneous T-cell Lymphoma MF Mycoses fungoides
Sponsor: Bausch Health Americas, Inc.
Start date: 2010-01-06; Completion date: 2014-02-20
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability, and safety of 2 initial dose levels of bexarotene capsules in participants with refractory CTCL.

Detailed description:

Arms: arm 1: Participants will receive bexarotene 150 mg/m\^2/day once daily for 24 weeks. arm 2: Participants will receive bexarotene 300 mg/m\^2/day once daily for 24 weeks.
Interventions: intervention 1: Bexarotene
Intervention descriptions: intervention 1: Soft gelatin capsules to be taken orally with at least 6 ounces of water or other fluid either with or immediately following the evening meal (a moderate or full meal) or a nutritionally defined liquid food.

Protocol documents:
Clinical trial NCT00853125
Conditions: Kidney Cancer
Keywords: clear cell renal cell carcinoma stage IV renal cell cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2009-02-01; Completion date: 2014-02-22
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving sunitinib together with irradiated donor lymphocytes may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine progression-free survival of patients with metastatic clear cell renal cell carcinoma treated with sunitinib and irradiated allogeneic lymphocytes.

Secondary

* Determine rates and kinetics of clinical/radiographic response in these patients.
* Determine toxicities associated with treatment in these patients.
* Assess stable disease at 6 months in these patients.
* Assess overall survival of these patients.

OUTLINE: Patients receive oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning with course 2 of sunitinib malate, patients also receive irradiated allogeneic lymphocytes IV over 1 hour every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 60 days.

Arms: arm 1: None
Interventions: intervention 1: therapeutic allogeneic lymphocytes intervention 2: sunitinib malate
Intervention descriptions: intervention 1: Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response intervention 2: Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.

Protocol documents:
Clinical trial NCT01353339
Conditions: Disease Due to BK Polyomavirus Kidney Transplant Infection
Keywords: Kidney Transplant BK Polyomavirus Infection
Sponsor: Ottawa Hospital Research Institute
Start date: 2011-12-01; Completion date: 2014-02-25
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Research Questions:

Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be assessed.

1. Under efficacy, this pilot will determine whether levofloxacin can decrease the incidence of BK viruria and peak urine BK viral load.
2. Under safety, this pilot will determine the incidence of adverse events with levofloxacin.
3. Under feasibility, this pilot will determine the number of kidney transplant patients randomized over an eight month enrolment period, adherence to the levofloxacin and frequency of patient drop-out and loss to follow-up

Detailed description:
BK virus infection has emerged as a major complication in renal transplantation leading to a significant reduction in graft survival. There are currently no proven strategies to prevent or treat BK virus infection. Quinolone antibiotics, such as levofloxacin, have demonstrated activity against BK virus. The investigators hypothesize that administration of a quinolone antibiotic, when given early post-transplantation, will prevent the establishment of BK viral replication in the urine and thus prevent systemic BK virus infection. A non-randomized study in kidney transplant recipients found that patients given levofloxacin or ciprofloxacin had a significantly lower incidence of BK viremia compared to those not receiving a quinolone (4% versus 24.5%, P=0.02).

Objective: The primary objective of the full trial will be to determine if the quinolone levofloxacin decreases the occurrence of doubling creatinine, transplant failure or death in kidney transplant recipients. The aim of this pilot trial is to assess the efficacy, safety and feasibility of a 3-month course of levofloxacin in the kidney transplant population.

Results from this pilot study will provide vital information to design and conduct a large, multi-centre trial to determine if quinolone therapy decreases meaningful clinical outcomes in kidney transplantation. If levofloxacin significantly reduces BK viruria and urine viral loads in kidney transplantation it will provide important justification of biologic effect to progress to the larger trial. If the full trial shows that levofloxacin significantly reduces BK infection and improves outcomes, its use in renal transplantation will be strongly endorsed given the lack of proven therapies for this condition.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Levofloxacin
Intervention descriptions: intervention 1: 500mg, PO, once daily for 3 months

Protocol documents:
Clinical trial NCT01842282
Conditions: Diabetes Mellitus Type 2 Non Alcoholic Fatty Liver Disease Obesity
Keywords: diabetes mellitus type 2 non alcoholic fatty liver disease obesity amlexanox
Sponsor: University of Michigan
Start date: 2013-07-19; Completion date: 2014-02-25
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study involves the use of a research drug, Amlexanox, for the treatment of type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). Amlexanox is taken orally in a pill three times a day. The investigators plan to continue therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body). Seven eligible subjects in this study will also be evaluated for a change in liver disease by a liver biopsy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Amlexanox
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT03055221
Conditions: Pulmonary Arterial Hypertension
Keywords: Remodulin 6-Minute Walk Test
Sponsor: United Therapeutics
Start date: 2005-06-10; Completion date: 2014-02-25
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.

Detailed description:

Arms: arm 1: Intravenous treprostinil was supplied as 1 mg/mL.
Interventions: intervention 1: Intravenous Treprostinil
Intervention descriptions: intervention 1: Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.

Protocol documents:
Clinical trial NCT02045264
Conditions: Hereditary Angioedema (HAE)
Keywords: Firazyr Angioedema Angioedemas, Hereditary Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Genetic Diseases, Inborn Icatibant Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Agents
Sponsor: Shire
Start date: 2014-02-21; Completion date: 2014-02-27
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.

Detailed description:
Icatibant has been studied for the treatment of acute attacks of hereditary angioedema (HAE), an autosomal dominant disorder characterized by recurrent and self-limiting episodes of edema of the skin, larynx, and gastrointestinal tract. The most serious manifestation of an HAE attack is laryngeal edema, causing obstruction of the upper airways that may lead to death by asphyxiation if undiagnosed and/or untreated.

Icatibant has been approved in over 40 countries around the world including the United States (US) and Europe for the treatment of acute attacks of hereditary angioedema (HAE) in adults. This study is being conducted to evaluate the safety and tolerability of icatibant in a Japanese population and to evaluate whether race/ethnicity impacts the pharmacokinetics of icatibant after single subcutaneous injection.

This is an open-label, single-arm study that will enroll at least 12 Japanese subjects (in order to have 12 subjects complete the study), age 18-55 years inclusive. All subjects will receive a single subcutaneous injection of 30mg icatibant. The study will be conducted at 1 site in the US. The study will consist of a Screening Period, a Treatment Period, and a Follow-Up Period.

Arms: arm 1: 30mg dose of icatibant is administered as a single subcutaneous injection in the abdominal area
Interventions: intervention 1: Icatibant (30 mg)
Intervention descriptions: intervention 1: On Day 1, subjects will receive a single 30mg subcutaneous injection of icatibant in their abdominal area. Subjects will be discharged from the study on Day 3 after collection of study related assessments

Protocol documents:
Clinical trial NCT03662334
Conditions: Type 1 Diabetes Mellitus
Keywords: Diabetes Type 1 Diabetes Mellitus Type 1 Diabetes T1DM Continuous Subcutaneous Insulin Infusion (CSII) CSII Insulin pump Insulin rHuPH20 Hylenex recombinant human hyaluronidase (rHuPH20) Recombinant hyaluronidase
Sponsor: Halozyme Therapeutics
Start date: 2013-10-03; Completion date: 2014-02-27
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).

Detailed description:
There is a recognized need for more rapid insulin action than is available from current rapid-acting analog products. In addition, current products have inconstant absorption and action profiles over the course of infusion set life. Previous human studies of prandial insulin preparations have used co-mixtures of rHuPH20 (study drug) with insulin delivered to study participants by subcutaneous injection and have demonstrated acceleration of insulin absorption and action. CSII has been used clinically for the treatment of diabetes over the last three decades, and a previous study using a co-mixture of rHuPH20 during CSII showed that the combination resulted in a more consistent and ultrafast profile of insulin absorption and action across infusion set use as compared to rapid analog insulin alone.

Arms: arm 1: Comparing the preadministration of Hylenex recombinant in the setting of continuous subcutaneous insulin infusion (CSII). arm 2: Comparing the preadministration of a sham injection in the setting of CSII.
Interventions: intervention 1: Rapid Acting insulin with pre-treatment of rHuPH20 intervention 2: Sham injection
Intervention descriptions: intervention 1: Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area. intervention 2: A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.

Protocol documents:
Clinical trial NCT04578496
Conditions: Erythropoietic Protoporphyria
Sponsor: Clinuvel Pharmaceuticals Limited
Start date: 2011-07-11; Completion date: 2014-02-27
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objectives of the study were to evaluate the safety and tolerability of afamelanotide by measuring treatment emergent adverse events (AEs) and to determine whether afamelanotide can improve the quality of life of EPP patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Afamelanotide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01267253
Conditions: Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Persistent Disease Recurrent Cervical Carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2011-04-04; Completion date: 2014-02-28
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well brivanib alaninate works in treating patients with cervical cancer that has come back. Brivanib alaninate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the proportion of patients with persistent or recurrent cervical cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with brivanib (brivanib alaninate).

II. To determine the nature and degree of toxicity of brivanib in this cohort of patients.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent cervical cancer treated with brivanib.

TERTIARY OBJECTIVES:

I. To obtain the serum expression levels of surrogate markers of brivanib effects including angiogenic factors (vascular endothelial growth factor \[VEGF\] and basic fibroblast growth factor \[bFGF\]) and markers of endothelial damage (E-selectin, vascular cell adhesion molecule 1 \[VCAM-1\], and (intercellular adhesion molecule 1 \[ICAM-1\]). (exploratory) II. To determine whether these marker expression levels alone or in combination are associated with response, PFS, or overall survival. (exploratory)

OUTLINE:

Patients receive brivanib alaninate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive brivanib alaninate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Brivanib Alaninate intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00510068
Conditions: Advanced Neuroendocrine Tumors of Pancreatic Origin
Keywords: Phase III Advanced Neuroendocrine Tumor in adults RAD001 NET everolimus mTOr islet cell neuroendocrine
Sponsor: Novartis Pharmaceuticals
Start date: 2007-07-01; Completion date: 2014-03-01
Enrollment: 410 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.

Detailed description:

Arms: arm 1: Participants received 10 mg per day of Everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1). arm 2: Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
Interventions: intervention 1: Everolimus intervention 2: Everolimus Placebo
Intervention descriptions: intervention 1: A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets. intervention 2: a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.

Protocol documents:
Clinical trial NCT00632749
Conditions: Leukemia, Myeloid, Acute
Sponsor: Boehringer Ingelheim
Start date: 2008-05-01; Completion date: 2014-03-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients

Detailed description:

Arms: arm 1: BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10 arm 2: BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10
Interventions: intervention 1: BI 811283 (d 1 and 15) intervention 2: Cytarabine intervention 3: BI 811283 (d1) intervention 4: Cytarabine
Intervention descriptions: intervention 1: BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle intervention 2: Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle intervention 3: BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle intervention 4: Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle

Protocol documents: