ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01827475
Conditions: Pain
Keywords: musculoskeletal pain acetaminophen ibuprofen
Sponsor: Stony Brook University
Start date: 2010-07-01; Completion date: 2011-07-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.

Detailed description:
The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department. We hypothesize that the combination will be more effective than either agent alone in patients presenting to the emergency department with acute pain from musculoskeletal injuries such as sprain, and bruises. While each agent alone is effective to some degree, many patients do not find complete relief with them and often narcotic agents (with all of their potential side effects) are added. In this study patients experiencing any pain will be randomly given either ibuprofen OR acetaminophen OR their combination and their degree of pain severity will be measured every 15 minutes up to one hour. At the end of this 1 hour patients still experiencing pain and requiring additional pain relief will receive additional analgesics at the discretion of their treating physician. We will not only measure how much the pain severity was reduced but also the percentage of patients that require some form of additional or "rescue" medication.

Arms: arm 1: Ibuprofen 800 mg arm 2: Acetaminophen 1 gm arm 3: Ibuprofen 800 mg plus acetaminophen 1 gm
Interventions: intervention 1: Ibuprofen intervention 2: Acetaminophen intervention 3: Ibuprofen-acetaminophen combination
Intervention descriptions: intervention 1: single dose intervention 2: single dose intervention 3: single dose

Protocol documents:
Clinical trial NCT02162680
Conditions: IV Insertion Pain
Keywords: local anesthesia intravenous catheter
Sponsor: Duke University
Start date: 2010-03-01; Completion date: 2011-07-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.

Detailed description:

Arms: arm 1: 1% lidocaine intradermal injection arm 2: bacteriostatic normal saline (BNS) injection arm 3: usual care practice of no local anesthetic administration
Interventions: intervention 1: 1% lidocaine intervention 2: bacteriostatic normal saline (BNS)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02169427
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) BIA 9-1067 Opicapone
Sponsor: Bial - Portela C S.A.
Start date: 2011-03-01; Completion date: 2011-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the rate and routes of excretion of OPC and the mass balance in urine, faeces and expired air.

Detailed description:
This was a single-centre, open-label ADME study in 6 healthy male subjects. Subjects received a single dose of 100 mg OPC, containing 3.39 MBq of \[14C\] OPC as oral capsules.

The study consisted of an eligibility screening period within 3 weeks prior to drug administration, admission on Day -1, a treatment period involving drug administration on Day 1 followed by matrix collections for PK purposes and safety evaluations up to Day 11, discharge on Day 11, six 24-hour hospitalizations on Days 14/15, 21/22 (+/ 1 day), 28/29 (+/- 1 day), 42/43 (+/- 2 days), 56/57 (+/- 2 days) and 77/78 (+/ 3 days) for PK sample collections, and a follow up visit performed at least 14 days after discharge from the last 24-hour hospitalization or at early discontinuation.

Arms: arm 1: 100 mg OPC
Interventions: intervention 1: OPC
Intervention descriptions: intervention 1: The drug substance of 100 mg OPC was administered as 1 capsule.

Protocol documents:
Clinical trial NCT02314637
Conditions: Type 2 Diabetes Mellitus
Keywords: DPP-IV inhibitor
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-08-01; Completion date: 2011-07-01
Enrollment: 240 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.

Detailed description:

Arms: arm 1: Teneligliptin for 52 weeks arm 2: Teneligliptin for 52 weeks in combination with sulfonylurea
Interventions: intervention 1: Teneligliptin intervention 2: Teneligliptin + Sulfonylurea
Intervention descriptions: intervention 1: Teneligliptin for 52 weeks intervention 2: Teneligliptin for 52 weeks in combination with sulfonylurea

Protocol documents:
Clinical trial NCT03633448
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser LLC
Start date: 2011-06-18; Completion date: 2011-07-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and in adults when compared to Children.

Detailed description:

Arms: arm 1: 1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation arm 2: 1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
Interventions: intervention 1: Children's Mucinex® Grape Flavor intervention 2: Children's Mucinex® Grape Flavor
Intervention descriptions: intervention 1: 1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation intervention 2: 1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation

Protocol documents:
Clinical trial NCT00830518
Conditions: Acute Myelogenous Leukemia High-Grade Myelodysplastic Syndrome
Keywords: Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2009-02-10; Completion date: 2011-07-04
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Detailed description:
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS). This study looked at the antitumor activity in people who received alisertib.

The study enrolled 57 patients. Participants were categorized by disease sub-types AML and MDS. Participants received:

• Alisertib 50 mg

All participants took alisertib capsules every 12 hours each day for 7 days followed by a 14-day rest period in 21-day cycles for approximately 26 cycles.

This multi-center trial was conducted in North America and France. The overall time to participate in this study was until there is evidence of disease progression or unacceptable treatment-related toxicity. The participant could continue treatment beyond 12 months if it was considered by the Sponsor and the Investigator that they would derive benefit from continued alisertib treatment. Participants had weekly blood work and clinic visits, with disease assessments every 2 cycles (ie. every 6 weeks) up to and including Cycle 16. Reduced visits (every 12 weeks) were conducted for participants tolerating treatment beyond Cycle 16 and for participants off treatment without disease progression.

Arms: arm 1: Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
Interventions: intervention 1: Alisertib
Intervention descriptions: intervention 1: Alisertib capsules

Protocol documents:
Clinical trial NCT00003453
Conditions: Stage IV Adrenocortical Carcinoma
Keywords: recurrent adrenocortical carcinoma
Sponsor: Burzynski Research Institute
Start date: 1996-08-21; Completion date: 2011-07-05
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Current therapies for Stage IV adrenal gland cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV adrenal gland cancer

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.

Detailed description:
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV adrenal gland cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV adrenal gland cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV adrenal gland cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Protocol documents:
Clinical trial NCT00803712
Conditions: Chronic Kidney Disease Secondary Hyperparathyroidism
Sponsor: Amgen
Start date: 2009-02-01; Completion date: 2011-07-05
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

Detailed description:

Arms: arm 1: Cinacalcet plus low dose active Vitamin D (if prescribed) arm 2: Flexible active vitamin D dosing
Interventions: intervention 1: Cinacalcet intervention 2: Vitamin D
Intervention descriptions: intervention 1: Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt. intervention 2: Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.

Protocol documents:
Clinical trial NCT00404768
Conditions: Obstetric Labour, Premature
Keywords: Premature Labor Pre Term Labor intravenous fetal fibronectin
Sponsor: GlaxoSmithKline
Start date: 2007-10-12; Completion date: 2011-07-07
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.

Detailed description:
A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and to investigate the pharmacokinetics of GSK221149A administered orally to healthy, pregnant females with uncomplicated pre-term labor between 300/7 and 356/7 weeks' gestation

Arms: arm 1: GSK221149A arm 2: Placebo
Interventions: intervention 1: GSK221149A intervention 2: Placebo
Intervention descriptions: intervention 1: 6mg/h and 12 mg/h intervention 2: Matched Placebo to Drug

Protocol documents:
Clinical trial NCT01424397
Conditions: Rhinitis
Sponsor: GlaxoSmithKline
Start date: 2011-04-14; Completion date: 2011-07-07
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.

Detailed description:

Arms: arm 1: Experimental arm 2: Active Comparator arm 3: Placebo Comparator arm 4: Experimental
Interventions: intervention 1: SB-705498 intervention 2: FP intervention 3: placebo
Intervention descriptions: intervention 1: 12mg intranasal intervention 2: 200ug intranasal intervention 3: placebo intranasal

Protocol documents:
Clinical trial NCT00670488
Conditions: Locally Advanced Tumors Metastatic Solid Tumors Cancer Neoplasms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-04-15; Completion date: 2011-07-11
Enrollment: 104 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs), pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be investigated.

Detailed description:

Arms: arm 1: Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles. arm 2: Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles. arm 3: Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles. arm 4: Participants receive 90 mg oral MK-2206 QOD in repeating 4-week treatment cycles. arm 5: Participants receive 90 mg oral MK-2206 every week (QW) in repeating 4-week treatment cycles. arm 6: Participants receive 135 mg oral MK-2206 QW in repeating 4-week treatment cycles. arm 7: Participants receive 200 mg oral MK-2206 QW in repeating 4-week treatment cycles. arm 8: Participants receive 300 mg oral MK-2206 QW in repeating 4-week treatment cycles. arm 9: Participants receive 250 mg oral MK-2206 QW in repeating 4-week treatment cycles. arm 10: Participants receive 150 mg oral MK-2206 QW in repeating 4-week treatment cycles.
Interventions: intervention 1: MK-2206
Intervention descriptions: intervention 1: MK-2206 administered as an oral formulation in rising dose levels on a QOD schedule (30 mg, 60 mg, 75 mg, and 90 mg) or QW schedule (90 mg, 135 mg, 200 mg, 250 mg, and 300 mg) in repeating 4 week cycles, depending upon allocation.

Protocol documents:
Clinical trial NCT00547898
Conditions: HIV Associated Diarrhea
Keywords: HIV AIDS Diarrhea HIV Associated Diarrhea
Sponsor: Bausch Health Americas, Inc.
Start date: 2007-10-01; Completion date: 2011-07-11
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Crofelemer 125 mg intervention 2: Crofelemer 250 mg intervention 3: Crofelemer 500 mg intervention 4: Placebo
Intervention descriptions: intervention 1: Crofelemer 125 mg intervention 2: Crofelemer 250 mg intervention 3: Crofelemer 500 mg intervention 4: Placebo

Protocol documents:
Clinical trial NCT00539838
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Sponsor: Genentech, Inc.
Start date: 2007-12-19; Completion date: 2011-07-12
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.

Detailed description:

Arms: arm 1: Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks arm 2: Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks arm 3: Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
Interventions: intervention 1: Prednisone intervention 2: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) intervention 3: Methylprednisolone intervention 4: Ocrelizumab intervention 5: Placebo
Intervention descriptions: intervention 1: Oral repeating dose intervention 2: Oral repeating dose intervention 3: Intravenous repeating dose intervention 4: Intravenous repeating dose intervention 5: Intravenous repeating dose

Protocol documents:
Clinical trial NCT01130272
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome with diarrhea Irritable bowel syndrome Diarrhea predominant irritable bowel syndrome Colonic diseases Colonic diseases, functional Digestive system disease Gastrointestinal disease Intestinal disease Colonic pseudo-obstruction Diarrhea Signs and Symptoms, Digestive
Sponsor: Furiex Pharmaceuticals, Inc
Start date: 2010-04-28; Completion date: 2011-07-14
Enrollment: 807 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).

Detailed description:

Arms: arm 1: Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks. arm 2: Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. . arm 3: Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks. arm 4: Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks. arm 5: Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
Interventions: intervention 1: Eluxadoline intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, orally, twice daily. intervention 2: Matching placebo oral tablets twice daily.

Protocol documents:
Clinical trial NCT00939653
Conditions: Relapsed Acute Myelogenous Leukemia
Keywords: relapsed relapse refractory AML Acute myelogenous leukemia Relapsed AML
Sponsor: Therapeutic Advances in Childhood Leukemia Consortium
Start date: 2009-07-10; Completion date: 2011-07-15
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).

Detailed description:
Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to find out the highest doses of these drugs that can be safely given to children with relapsed or refractory leukemia. This study is a phase II study which will use the drugs to study how well these drugs work against AML. This study will also examine the safety of this drug combination.

Arms: arm 1: All patients receive the same treatment regimen consisting of clofarabine, etoposide, cyclophosphamide, cytarabine, and filgrastim. Up to 4 courses of therapy may be given.
Interventions: intervention 1: Clofarabine intervention 2: Etoposide intervention 3: Cyclophosphamide intervention 4: Filgrastim intervention 5: Cytarabine
Intervention descriptions: intervention 1: 40 mg/m2/day IV over 2 hours (given at hours 0 to 2) on days 1 through 5. intervention 2: 100 mg/m2/day IV over 2 hours (given at hours 2 to 4) on days 1 through 5. intervention 3: 440 mg/m2/day IV as a 30-60 minute infusion (given at hours 4 to 5) on days 1 through 5. intervention 4: Administered in Courses 1 and 2 only. 5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000 x 2 days. intervention 5: Given intrathecally on day 1 at the dose defined by age below:

30 mg for patients age 1-1.99 50 mg for patients age 2-2.99 70 mg for patients \>3 years of age

Protocol documents:
Clinical trial NCT01275755
Conditions: Constipation
Keywords: opioid therapy constipation chronic noncancer pain mu opioid receptor antagonist ADL5945 Opioid Induced Constipation
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2011-01-19; Completion date: 2011-07-15
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract. The most common symptoms associated with the effects of opioids are constipation and nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of long-term opioid therapy.

The primary objective of this study was to compare ADL5945 once daily, a MOR antagonist, with placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy for chronic noncancer pain.

Detailed description:

Arms: arm 1: Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week). arm 2: During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
Interventions: intervention 1: Placebo intervention 2: ADL5945 0.25 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: