ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01054300
Conditions: Diabetes Mellitus, Type 2 Adult
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-02-17; Completion date: 2010-04-07
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning \[AM\] and evening \[PM\]) in adults with type 2 diabetes.

Detailed description:

Arms: arm 1: Period 1: Ertu 2 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2. arm 2: Period 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Pbo in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2. arm 3: Period 1: Ertu 4 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2. arm 4: Period 1: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. Period 2: Ertu 4 mg in the AM and Pbo in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2.
Interventions: intervention 1: Ertugliflozin 2 mg single dose intervention 2: Ertugliflozin 2 mg split into twice daily intervention 3: Ertugliflozin 4 mg single dose intervention 4: Ertugliflozin 4 mg split into twice daily intervention 5: Placebo
Intervention descriptions: intervention 1: Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose intervention 2: Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day intervention 3: Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose intervention 4: Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day intervention 5: Placebo to ertugliflozin administered as a single dose

Protocol documents:
Clinical trial NCT00579995
Conditions: Nephropathy
Keywords: contrast induced nephropathy
Sponsor: University of Nebraska
Start date: 2005-05-01; Completion date: 2010-04-08
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.

Detailed description:
It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the expression of nitric oxide synthesis and may improve blood flow. Oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. These pathways seem to be sensitive to the redox state of the cell and are inhibited by N-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.

Arms: arm 1: Oral N-Acetylcysteine 600 mg arm 2: Sodium bicarbonate 3 milliliter per kilogram per hour (3 mL/kg/hr) infused at 1 mL/kg/hr for 6 hours post-procedure
Interventions: intervention 1: Oral N-Acetylcysteine intervention 2: Sodium Bicarbonate
Intervention descriptions: intervention 1: 600 milligrams (mg) intervention 2: 3 milliliters per kilogram per hour (mL/kg/hr) for one hour pre-procedure and infused at 1mL/kg/hr for 6 hours post-procedure

Protocol documents:
Clinical trial NCT01037413
Conditions: Scar Prevention
Keywords: Scarring Cicatrix Fibrosis Pathologic Process
Sponsor: Pfizer
Start date: 2009-12-22; Completion date: 2010-04-09
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: EXC 001 intervention 2: Placebo
Intervention descriptions: intervention 1: Multiple intradermal injections of EXC 001 and placebo intervention 2: Multiple intradermal injections of EXC 001 and placebo

Protocol documents:
Clinical trial NCT01128621
Conditions: Diabetes Mellitus, Type 2
Keywords: Pharmacokinetics Glucose Safety Male Female Metformin Pharmacodynamics Tolerability Type II Diabetes
Sponsor: GlaxoSmithKline
Start date: 2009-11-23; Completion date: 2010-04-12
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study in type 2 diabetic subjects on stable metformin therapy to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of co-administering single and multiple oral doses of GSK1292263

Detailed description:
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1292263 when co-administered with metformin. The study will be in 2 parts. Part A will determine the PK of GSK1292263 following single day dosing of type 2 diabetes (T2DM) subjects on metformin. Part B will investigate the effects of 14d of co-dosing of GSK1292263 BID, 50mg BID of sitagliptin or placebo to 48 T2DM subjects taking metformin.

Arms: arm 1: Part A is open label, in T2DM subjects on established metformin monotherapy. Subjects will receive a single dose of GSK1292263 with food. This will permit a comparison of GSK1292263 exposures in this cohort with those observed in study GPR111598 in which T2DM subjects were drug naïve or washed off prior anti-diabetic medications. arm 2: Part B is a single-blind, randomized, placebo-controlled, 4-arm cohort of 48 subjects dosed for 14 days with one of two doses of GSK1292263 BID, placebo BID or open-label sitagliptin 50mg BID. It is being conducted to assess safety, tolerability, PK and PD of GSK1292263 and open-label sitagliptin after 14-days of dosing in T2DM subjects already taking metformin monotherapy. arm 3: Part B is a single-blind, randomized, placebo-controlled, 4-arm cohort of 48 subjects dosed for 14 days with one of two doses of GSK1292263 BID, placebo BID or open-label sitagliptin 50mg BID. It is being conducted to assess safety, tolerability, PK and PD of GSK1292263 and open-label sitagliptin after 14-days of dosing in T2DM subjects already taking metformin monotherapy. arm 4: Part B is a single-blind, randomized, placebo-controlled, 4-arm cohort of 48 subjects dosed for 14 days with one of two doses of GSK1292263 BID, placebo BID or open-label sitagliptin 50mg BID. It is being conducted to assess safety, tolerability, PK and PD of GSK1292263 and open-label sitagliptin after 14-days of dosing in T2DM subjects already taking metformin monotherapy.
Interventions: intervention 1: GSK1292263 intervention 2: GSK1292263 matching placebo intervention 3: Sitagliptin
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Tablet

Protocol documents:
Clinical trial NCT00988065
Conditions: Hypersensitivity
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-09-06; Completion date: 2010-04-13
Enrollment: 448 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period.

In total 450 participants (all healthy subjects) were to be randomized to receive one of three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36, and Day 78 of the study in order to determine the safety of each treatment dose.

Detailed description:
All subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was stable, and the investigator considered it safe for the subject to leave the study center. Four sites participated in this trial.

Arms: arm 1: Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study. arm 2: Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study. arm 3: Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
Interventions: intervention 1: Placebo run-in dose intervention 2: Sugammadex 4 mg/kg intervention 3: Sugammadex 16 mg/kg intervention 4: Placebo
Intervention descriptions: intervention 1: Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization intervention 2: Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study intervention 3: Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study intervention 4: Placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study

Protocol documents:
Clinical trial NCT00436436
Conditions: Brain and Central Nervous System Tumors
Keywords: adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor adult glioblastoma
Sponsor: National Cancer Institute (NCI)
Start date: 2006-11-13; Completion date: 2010-04-14
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as O(6)-benzylguanine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving O(6)-benzylguanine together with temozolomide works in treating patients with glioblastoma multiforme that did not respond to previous temozolomide and radiation therapy.

Detailed description:
OBJECTIVES:

* Determine the antitumor activity of O6-benzylguanine and temozolomide in patients with temozolomide-resistant methylguanine methyltransferase-positive or -negative glioblastoma multiforme previously treated with radiotherapy.
* Determine, preliminarily, the toxicity of this regimen in these patients.

OUTLINE: Patients receive O6-benzylguanine intravenous (IV) over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 6 months.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Arms: arm 1: Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: O6-benzylguanine intervention 2: temozolomide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00704184
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-07-25; Completion date: 2010-04-14
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.

Detailed description:

Arms: arm 1: Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. arm 2: Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. arm 3: Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. arm 4: Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. arm 5: Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Interventions: intervention 1: Comparator: Vaniprevir intervention 2: Comparator: Pegylated-Interferon (Peg-IFN) intervention 3: Comparator: Ribavirin intervention 4: Comparator: placebo
Intervention descriptions: intervention 1: Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days intervention 2: Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks intervention 3: Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks intervention 4: Matching placebo to vaniprevir; duration of treatment: 28 days

Protocol documents:
Clinical trial NCT01043926
Conditions: Insomnia Hepatic Insufficiency
Keywords: Hepatic Insufficiency
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-02-22; Completion date: 2010-04-14
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.

Detailed description:
Study Design:

This study plans to enroll 16 participants in Part I (8 participants with moderate hepatic insufficiency and 8 healthy participants) and 16 participants in Part II (8 participants with mild hepatic insufficiency and 8 healthy participants).

Part II will be conducted only if the primary hypothesis is not met and there is a significant difference in the PK of suvorexant between healthy participants and moderate hepatic insufficiency participants in Part I.

Arms: arm 1: Participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study. arm 2: Healthy participants matched to participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study. arm 3: Participants with mild hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part II of the study (if conducted). arm 4: Healthy participants matched to participants with mild hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part II of the study (if conducted).
Interventions: intervention 1: Suvorexant
Intervention descriptions: intervention 1: single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.

Protocol documents:
Clinical trial NCT00865280
Conditions: Skin Diseases, Infectious
Keywords: CSSI Abscess Wound Cellulitis Complicated Skin and Skin Structure Infections (cSSSI)
Sponsor: Paratek Pharmaceuticals Inc
Start date: 2009-04-04; Completion date: 2010-04-15
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

Detailed description:
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.

In PTK 0796-CSSI-0804 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Arms: arm 1: PTK 0796 100 mg for injection; PTK 0796 tablet, 300 mg (2 x 150 mg tablets) arm 2: Gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; Gram negative treatment: moxifloxacin 400 mg tablet and moxifloxacin 400 mg IV infusion solution
Interventions: intervention 1: PTK 0796 intervention 2: linezolid intervention 3: moxifloxacin
Intervention descriptions: intervention 1: PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg intervention 2: For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution intervention 3: moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution

Protocol documents:
Clinical trial NCT00659828
Conditions: Obesity Metabolic Syndrome Diabetes
Keywords: Congenital leptin deficiency Obesity Metabolic Syndrome Diabetes
Sponsor: University of Miami
Start date: 2005-06-01; Completion date: 2010-04-16
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the endocrine and immune effects of leptin replacement in leptin-deficient children, from a consanguineous family. The hypothesis is that leptin replacement will have significant effects on endocrine function.

Detailed description:
The proposed study of the treatment of a child with congenital leptin deficiency will permit to elucidate key aspects of human endocrine function, and will give new insights on the role of leptin in human endocrine regulation.

Arms: arm 1: Recombinant methionyl human leptin: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss).
Interventions: intervention 1: Recombinant methionyl human leptin
Intervention descriptions: intervention 1: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.

Protocol documents:
Clinical trial NCT00447980
Conditions: Retinitis Pigmentosa
Keywords: Retinitis Pigmentosa eye disease retinal disorder CNTF
Sponsor: Neurotech Pharmaceuticals
Start date: 2007-01-22; Completion date: 2010-04-19
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at the safety and effectiveness of CNTF implants on vision in persons with retinitis pigmentosa, Usher type II \& III, and Choroideremia. This research is being done because there are no effective therapies for people with these retinal degenerations. They are genetic disorders that affect one's ability to see at night, and later cause tunnel vision and loss of central vision. Retinal degenerations affect the retina, a light sensitive layer of cells in the back of the eye. Slowly over time, these cells die and cause permanent loss of vision.

The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF and release it through the capsule membrane into the surrounding fluid. In this study, two different CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (or placebo) surgery in the other eye.

Detailed description:
This study will involve about 18 visits over 2½ years for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary effectiveness outcome for this study will be a visual field score one year after the implant surgery. There will be about 12 centers participating in this study, and up to 60 people enrolled, across the US. Each participant joining the study who has completed initial screening will then be scheduled to have a brief surgical procedure performed on each eye, one of which will include a very small cell-filled implant. Follow-up visits for repeat assessments will be required regularly to determine if the implant being tested is safe and effective for use to treat retinitis pigmentosa (RP).

Arms: arm 1: NT-501 Low Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina

Sham Implant in Fellow Eye arm 2: NT-501 High Dose Implant: encapsulated cell therapy that delivers ciliary neurotrophic factor to the retina

Sham Implant in Fellow Eye
Interventions: intervention 1: NT-501 intervention 2: NT-501
Intervention descriptions: intervention 1: Low Dose intervention 2: High Dose

Protocol documents:
Clinical trial NCT01039675
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: long-acting beta2-receptor agonist Safety and tolerability pharmacodynamics pharmacokinetics long-acting muscarinic receptor antagonist COPD
Sponsor: GlaxoSmithKline
Start date: 2010-01-01; Completion date: 2010-04-20
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of the combination of GSK573719 (500mcg) Inhalation Powder and GW642444 (25mcg) Inhalation Powder administered once-daily via a novel dry powder inhaler (Novel DPI) over 28 days in subjects with COPD

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 500mcg/25mcg once daily intervention 2: Placebo once daily
Intervention descriptions: intervention 1: GSK573719/GW642444 intervention 2: Inactive, excipients only

Protocol documents:
Clinical trial NCT00764868
Conditions: ADHD
Sponsor: Shire
Start date: 2008-11-13; Completion date: 2010-04-22
Enrollment: 269 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).

Detailed description:
Not Required

Arms: arm 1: Lisdexamfetamine Dimesylate (LDX)
Interventions: intervention 1: Lisdexamfetamine Dimesylate (LDX)
Intervention descriptions: intervention 1: optimal dose of 30, 50 or 70 mg once daily

Protocol documents: